Trial Outcomes & Findings for An Open-label Extension Study Evaluating the Safety and Efficacy of Upadacitinib (ABT-494) in Adults With Rheumatoid Arthritis (NCT NCT02049138)
NCT ID: NCT02049138
Last Updated: 2022-07-12
Results Overview
Participants who met the following 3 conditions for improvement from Baseline were classified as meeting the ACR20 response criteria: 1. ≥ 20% improvement in 68-tender joint count; 2. ≥ 20% improvement in 66-swollen joint count; and 3. ≥ 20% improvement in at least 3 of the 5 following parameters: * Physician global assessment of disease activity * Patient global assessment of disease activity * Patient assessment of pain * Health Assessment Questionnaire - Disability Index (HAQ-DI) * High-sensitivity C-reactive protein (hsCRP).
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
493 participants
Primary outcome timeframe
Baseline (of the preceding RCT study) and Weeks 6, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, and 312
Results posted on
2022-07-12
Participant Flow
Participants must have completed a preceding rheumatoid arthritis (RA) upadacitinib randomized controlled trial (RCT), Study M13-550 (NCT01960855) or Study M13-537 (NCT02066389) to be enrolled in this long-term extension study. Participants were enrolled at 113 study sites located in 17 countries (Belgium, Bulgaria, Chile, Czechia, Hungary, Israel, Latvia, Mexico, New Zealand, Poland, Russian Federation, Slovakia, South Africa, Spain, United Kingdom, Ukraine, and United States/Puerto Rico).
Participants were assigned to upadacitinib 6 mg twice-daily up to 30 days following the Last Visit (Week 12) of the preceding RCT. Participants may have been up-titrated to 12 mg BID and subsequently down-titrated per protocol-specified criteria. Efficacy results are reported by treatment sequence for each participant. Adverse event data are reported according to treatment received at the time of the event. Participants may have enrolled in a vaccine substudy during the main study.
Participant milestones
| Measure |
Upadacitinib Never Titrated
Participants received treatment with upadacitinib for up to 312 weeks. The starting dose was 6 mg twice a day (BID). From January 2017 participants were transitioned to a once-daily (QD) dose of 15 mg upadacitinib and remained on this dose throughout the study.
A subset of participants who opted-in to the vaccine substudy received a single-dose of 0.5 mL intramuscular injection of pneumococcal 13-valent conjugate vaccine (PCV-13).
|
Upadacitinib Titrated Up and Not Down
Participants received treatment with upadacitinib for up to 312 weeks. The starting dose was 6 mg BID. Participants who did not achieve protocol-specified improvement criteria at Week 6 or at any visits thereafter were up-titrated to upadacitinib 12 mg BID. From January 2017 participants were transitioned to a once-daily dose of 30 mg upadacitinib and remained on this dose throughout the study.
A subset of participants who opted-in to the vaccine substudy received a single-dose of 0.5 mL intramuscular injection of pneumococcal 13-valent conjugate vaccine (PCV-13).
|
Upadacitinib Titrated Up and Down
Participants received treatment with upadacitinib for up to 312 weeks. The starting dose was 6 mg BID. Participants who did not achieve protocol-specified improvement criteria at Week 6 or at any visits thereafter were up-titrated to upadacitinib 12 mg BID. From January 2017 participants were transitioned to once-daily dose of 30 mg upadacitinib. The upadacitinib dose was decreased back to 6 mg BID (or 15 mg QD from January 2017) per Investigator's judgment or safety and/or tolerability concerns.
A subset of participants who opted-in to the vaccine substudy received a single-dose of 0.5 mL intramuscular injection of pneumococcal 13-valent conjugate vaccine (PCV-13).
|
|---|---|---|---|
|
Overall Study
STARTED
|
306
|
149
|
38
|
|
Overall Study
Enrolled in Vaccine Sub-study
|
76
|
24
|
11
|
|
Overall Study
COMPLETED
|
142
|
51
|
30
|
|
Overall Study
NOT COMPLETED
|
164
|
98
|
8
|
Reasons for withdrawal
| Measure |
Upadacitinib Never Titrated
Participants received treatment with upadacitinib for up to 312 weeks. The starting dose was 6 mg twice a day (BID). From January 2017 participants were transitioned to a once-daily (QD) dose of 15 mg upadacitinib and remained on this dose throughout the study.
A subset of participants who opted-in to the vaccine substudy received a single-dose of 0.5 mL intramuscular injection of pneumococcal 13-valent conjugate vaccine (PCV-13).
|
Upadacitinib Titrated Up and Not Down
Participants received treatment with upadacitinib for up to 312 weeks. The starting dose was 6 mg BID. Participants who did not achieve protocol-specified improvement criteria at Week 6 or at any visits thereafter were up-titrated to upadacitinib 12 mg BID. From January 2017 participants were transitioned to a once-daily dose of 30 mg upadacitinib and remained on this dose throughout the study.
A subset of participants who opted-in to the vaccine substudy received a single-dose of 0.5 mL intramuscular injection of pneumococcal 13-valent conjugate vaccine (PCV-13).
|
Upadacitinib Titrated Up and Down
Participants received treatment with upadacitinib for up to 312 weeks. The starting dose was 6 mg BID. Participants who did not achieve protocol-specified improvement criteria at Week 6 or at any visits thereafter were up-titrated to upadacitinib 12 mg BID. From January 2017 participants were transitioned to once-daily dose of 30 mg upadacitinib. The upadacitinib dose was decreased back to 6 mg BID (or 15 mg QD from January 2017) per Investigator's judgment or safety and/or tolerability concerns.
A subset of participants who opted-in to the vaccine substudy received a single-dose of 0.5 mL intramuscular injection of pneumococcal 13-valent conjugate vaccine (PCV-13).
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
46
|
25
|
1
|
|
Overall Study
Withdrawal by Subject
|
57
|
21
|
5
|
|
Overall Study
Lost to Follow-up
|
18
|
5
|
1
|
|
Overall Study
Lack of Efficacy
|
10
|
26
|
1
|
|
Overall Study
Non-Compliance
|
15
|
6
|
0
|
|
Overall Study
Required Alternative / Prohibited Therapy
|
1
|
1
|
0
|
|
Overall Study
Coronavirus Disease-2019 (COVID-19) Infection
|
1
|
0
|
0
|
|
Overall Study
COVID-19 Logistical Restrictions
|
1
|
0
|
0
|
|
Overall Study
Other
|
15
|
13
|
0
|
|
Overall Study
Missing
|
0
|
1
|
0
|
Baseline Characteristics
Participants with available data
Baseline characteristics by cohort
| Measure |
Upadacitinib Never Titrated
n=306 Participants
Participants received treatment with upadacitinib for up to 312 weeks. The starting dose was 6 mg twice a day (BID). From January 2017 participants were transitioned to once-daily (QD) dose of 15 mg upadacitinib.
|
Upadacitinib Titrated Up and Not Down
n=149 Participants
Participants received treatment with upadacitinib for up to 312 weeks. The starting dose was 6 mg BID. Participants who did not achieve protocol-specified improvement criteria at Week 6 or at any visits thereafter were up-titrated to upadacitinib 12 mg BID. From January 2017 participants were transitioned to once-daily dose of 30 mg upadacitinib.
|
Upadacitinib Titrated Up and Down
n=38 Participants
Participants received treatment with upadacitinib for up to 312 weeks. The starting dose was 6 mg BID. Participants who did not achieve protocol-specified improvement criteria at Week 6 or at any visits thereafter were up-titrated to upadacitinib 12 mg BID. From January 2017 participants were transitioned to once-daily dose of 30 mg upadacitinib. The upadacitinib dose was decreased back to 6 mg BID (or 15 mg QD from January 2017) per Investigator's judgment or safety and/or tolerability concerns.
|
Total
n=493 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
55.8 years
STANDARD_DEVIATION 12.62 • n=306 Participants
|
56.0 years
STANDARD_DEVIATION 12.56 • n=149 Participants
|
53.7 years
STANDARD_DEVIATION 8.54 • n=38 Participants
|
55.7 years
STANDARD_DEVIATION 12.33 • n=493 Participants
|
|
Age, Customized
< 45 years
|
56 Participants
n=306 Participants
|
30 Participants
n=149 Participants
|
5 Participants
n=38 Participants
|
91 Participants
n=493 Participants
|
|
Age, Customized
45 - < 65 years
|
174 Participants
n=306 Participants
|
76 Participants
n=149 Participants
|
28 Participants
n=38 Participants
|
278 Participants
n=493 Participants
|
|
Age, Customized
≥ 65 years
|
76 Participants
n=306 Participants
|
43 Participants
n=149 Participants
|
5 Participants
n=38 Participants
|
124 Participants
n=493 Participants
|
|
Sex: Female, Male
Female
|
246 Participants
n=306 Participants
|
117 Participants
n=149 Participants
|
29 Participants
n=38 Participants
|
392 Participants
n=493 Participants
|
|
Sex: Female, Male
Male
|
60 Participants
n=306 Participants
|
32 Participants
n=149 Participants
|
9 Participants
n=38 Participants
|
101 Participants
n=493 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
76 Participants
n=306 Participants
|
40 Participants
n=149 Participants
|
7 Participants
n=38 Participants
|
123 Participants
n=493 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
230 Participants
n=306 Participants
|
109 Participants
n=149 Participants
|
31 Participants
n=38 Participants
|
370 Participants
n=493 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=306 Participants
|
0 Participants
n=149 Participants
|
0 Participants
n=38 Participants
|
0 Participants
n=493 Participants
|
|
Race/Ethnicity, Customized
White
|
293 Participants
n=306 Participants
|
132 Participants
n=149 Participants
|
37 Participants
n=38 Participants
|
462 Participants
n=493 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
9 Participants
n=306 Participants
|
12 Participants
n=149 Participants
|
1 Participants
n=38 Participants
|
22 Participants
n=493 Participants
|
|
Race/Ethnicity, Customized
Asian
|
1 Participants
n=306 Participants
|
2 Participants
n=149 Participants
|
0 Participants
n=38 Participants
|
3 Participants
n=493 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
0 Participants
n=306 Participants
|
0 Participants
n=149 Participants
|
0 Participants
n=38 Participants
|
0 Participants
n=493 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=306 Participants
|
0 Participants
n=149 Participants
|
0 Participants
n=38 Participants
|
1 Participants
n=493 Participants
|
|
Race/Ethnicity, Customized
Multiple
|
2 Participants
n=306 Participants
|
3 Participants
n=149 Participants
|
0 Participants
n=38 Participants
|
5 Participants
n=493 Participants
|
|
Region
Western Europe
|
27 Participants
n=306 Participants
|
13 Participants
n=149 Participants
|
5 Participants
n=38 Participants
|
45 Participants
n=493 Participants
|
|
Region
Eastern Europe
|
144 Participants
n=306 Participants
|
46 Participants
n=149 Participants
|
19 Participants
n=38 Participants
|
209 Participants
n=493 Participants
|
|
Region
North America
|
90 Participants
n=306 Participants
|
78 Participants
n=149 Participants
|
10 Participants
n=38 Participants
|
178 Participants
n=493 Participants
|
|
Region
South/Central America
|
42 Participants
n=306 Participants
|
5 Participants
n=149 Participants
|
3 Participants
n=38 Participants
|
50 Participants
n=493 Participants
|
|
Region
Other
|
3 Participants
n=306 Participants
|
7 Participants
n=149 Participants
|
1 Participants
n=38 Participants
|
11 Participants
n=493 Participants
|
|
Duration of RA
|
9.34 years
STANDARD_DEVIATION 8.73 • n=306 Participants
|
9.61 years
STANDARD_DEVIATION 8.36 • n=149 Participants
|
7.66 years
STANDARD_DEVIATION 6.54 • n=38 Participants
|
9.29 years
STANDARD_DEVIATION 8.47 • n=493 Participants
|
|
Tender Joint Count
|
25.8 joints
STANDARD_DEVIATION 14.49 • n=306 Participants
|
30.4 joints
STANDARD_DEVIATION 15.90 • n=149 Participants
|
31.3 joints
STANDARD_DEVIATION 15.67 • n=38 Participants
|
27.6 joints
STANDARD_DEVIATION 15.17 • n=493 Participants
|
|
Swollen Joint Count
|
16.7 joints
STANDARD_DEVIATION 10.45 • n=306 Participants
|
18.8 joints
STANDARD_DEVIATION 12.03 • n=149 Participants
|
19.3 joints
STANDARD_DEVIATION 9.53 • n=38 Participants
|
17.5 joints
STANDARD_DEVIATION 10.92 • n=493 Participants
|
|
Physician's Global Assessment of Disease Activity
|
64.4 score on a scale
STANDARD_DEVIATION 15.82 • n=298 Participants • Participants with available data
|
65.6 score on a scale
STANDARD_DEVIATION 15.41 • n=147 Participants • Participants with available data
|
65.0 score on a scale
STANDARD_DEVIATION 15.41 • n=38 Participants • Participants with available data
|
64.8 score on a scale
STANDARD_DEVIATION 15.64 • n=483 Participants • Participants with available data
|
|
Patient's Global Assessment of Disease Activity
|
62.4 score on a scale
STANDARD_DEVIATION 20.78 • n=305 Participants • Participants with available data
|
67.4 score on a scale
STANDARD_DEVIATION 20.52 • n=146 Participants • Participants with available data
|
66.5 score on a scale
STANDARD_DEVIATION 16.48 • n=37 Participants • Participants with available data
|
64.2 score on a scale
STANDARD_DEVIATION 20.51 • n=488 Participants • Participants with available data
|
|
Patient's Global Assessment of Pain
|
63.8 score on a scale
STANDARD_DEVIATION 19.73 • n=305 Participants • Participants with available data
|
67.2 score on a scale
STANDARD_DEVIATION 19.64 • n=146 Participants • Participants with available data
|
66.5 score on a scale
STANDARD_DEVIATION 13.13 • n=37 Participants • Participants with available data
|
65.0 score on a scale
STANDARD_DEVIATION 19.32 • n=488 Participants • Participants with available data
|
|
Health Assessment Questionnaire - Disability Index (HAQ-DI)
|
1.4811 score on a scale
STANDARD_DEVIATION 0.6848 • n=304 Participants • Participants with available data
|
1.6036 score on a scale
STANDARD_DEVIATION 0.6215 • n=146 Participants • Participants with available data
|
1.5304 score on a scale
STANDARD_DEVIATION 0.4969 • n=37 Participants • Participants with available data
|
1.5216 score on a scale
STANDARD_DEVIATION 0.6550 • n=487 Participants • Participants with available data
|
|
High-sensitivity reactive Protein (hsCRP)
|
12.8968 mg/L
STANDARD_DEVIATION 17.8329 • n=306 Participants
|
14.9212 mg/L
STANDARD_DEVIATION 20.1890 • n=149 Participants
|
17.1232 mg/L
STANDARD_DEVIATION 28.1184 • n=38 Participants
|
13.8344 mg/L
STANDARD_DEVIATION 19.5179 • n=493 Participants
|
PRIMARY outcome
Timeframe: Baseline (of the preceding RCT study) and Weeks 6, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, and 312Population: Open-label treated population with available data at each time point
Participants who met the following 3 conditions for improvement from Baseline were classified as meeting the ACR20 response criteria: 1. ≥ 20% improvement in 68-tender joint count; 2. ≥ 20% improvement in 66-swollen joint count; and 3. ≥ 20% improvement in at least 3 of the 5 following parameters: * Physician global assessment of disease activity * Patient global assessment of disease activity * Patient assessment of pain * Health Assessment Questionnaire - Disability Index (HAQ-DI) * High-sensitivity C-reactive protein (hsCRP).
Outcome measures
| Measure |
Upadacitinib Never Titrated
n=306 Participants
Participants received treatment with upadacitinib for up to 312 weeks. The starting dose was 6 mg twice a day (BID). From January 2017 participants were transitioned to once-daily dose of 15 mg upadacitinib.
|
Upadacitinib Titrated Up and Not Down
n=149 Participants
Participants received treatment with upadacitinib for up to 312 weeks. The starting dose was 6 mg BID. Participants who did not achieve protocol-specified improvement criteria at Week 6 or at any visits thereafter were up-titrated to upadacitinib 12 mg BID. From January 2017 participants were transitioned to once-daily dose of 30 mg upadacitinib.
|
Upadacitinib Titrated Up and Down
n=38 Participants
Participants received treatment with upadacitinib for up to 312 weeks. The starting dose was 6 mg BID. Participants who did not achieve protocol-specified improvement criteria at Week 6 or at any visits thereafter were up-titrated to upadacitinib 12 mg BID. From January 2017 participants were transitioned to once-daily dose of 30 mg upadacitinib. The upadacitinib dose was decreased back to 6 mg BID (or 15 mg QD from January 2017) per Investigator's judgment or safety and/or tolerability concerns.
|
|---|---|---|---|
|
Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response Over Time
Week 12
|
89.0 percentage of participants
|
73.8 percentage of participants
|
75.7 percentage of participants
|
|
Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response Over Time
Week 24
|
91.8 percentage of participants
|
73.3 percentage of participants
|
88.6 percentage of participants
|
|
Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response Over Time
Week 144
|
94.9 percentage of participants
|
88.0 percentage of participants
|
88.9 percentage of participants
|
|
Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response Over Time
Week 156
|
92.0 percentage of participants
|
87.7 percentage of participants
|
92.6 percentage of participants
|
|
Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response Over Time
Week 36
|
90.2 percentage of participants
|
83.2 percentage of participants
|
82.9 percentage of participants
|
|
Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response Over Time
Week 6
|
87.7 percentage of participants
|
73.4 percentage of participants
|
77.8 percentage of participants
|
|
Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response Over Time
Week 48
|
90.0 percentage of participants
|
82.1 percentage of participants
|
88.2 percentage of participants
|
|
Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response Over Time
Week 60
|
95.4 percentage of participants
|
83.8 percentage of participants
|
85.7 percentage of participants
|
|
Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response Over Time
Week 72
|
93.0 percentage of participants
|
84.2 percentage of participants
|
90.6 percentage of participants
|
|
Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response Over Time
Week 84
|
94.6 percentage of participants
|
76.3 percentage of participants
|
96.9 percentage of participants
|
|
Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response Over Time
Week 96
|
92.2 percentage of participants
|
86.0 percentage of participants
|
90.9 percentage of participants
|
|
Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response Over Time
Week 108
|
94.8 percentage of participants
|
85.7 percentage of participants
|
87.9 percentage of participants
|
|
Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response Over Time
Week 120
|
96.2 percentage of participants
|
89.5 percentage of participants
|
96.6 percentage of participants
|
|
Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response Over Time
Week 132
|
93.9 percentage of participants
|
87.5 percentage of participants
|
96.7 percentage of participants
|
|
Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response Over Time
Week 168
|
91.9 percentage of participants
|
88.7 percentage of participants
|
82.8 percentage of participants
|
|
Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response Over Time
Week 180
|
93.9 percentage of participants
|
79.1 percentage of participants
|
86.2 percentage of participants
|
|
Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response Over Time
Week 192
|
93.5 percentage of participants
|
87.1 percentage of participants
|
92.9 percentage of participants
|
|
Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response Over Time
Week 252
|
94.0 percentage of participants
|
87.9 percentage of participants
|
86.7 percentage of participants
|
|
Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response Over Time
Week 204
|
94.0 percentage of participants
|
81.2 percentage of participants
|
86.2 percentage of participants
|
|
Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response Over Time
Week 216
|
92.5 percentage of participants
|
85.9 percentage of participants
|
85.2 percentage of participants
|
|
Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response Over Time
Week 228
|
96.0 percentage of participants
|
83.6 percentage of participants
|
92.9 percentage of participants
|
|
Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response Over Time
Week 264
|
93.3 percentage of participants
|
81.5 percentage of participants
|
89.3 percentage of participants
|
|
Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response Over Time
Week 240
|
92.8 percentage of participants
|
85.2 percentage of participants
|
89.3 percentage of participants
|
|
Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response Over Time
Week 288
|
94.7 percentage of participants
|
88.0 percentage of participants
|
88.9 percentage of participants
|
|
Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response Over Time
Week 300
|
94.4 percentage of participants
|
82.0 percentage of participants
|
87.0 percentage of participants
|
|
Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response Over Time
Week 276
|
93.8 percentage of participants
|
84.6 percentage of participants
|
81.5 percentage of participants
|
|
Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response Over Time
Week 312
|
92.2 percentage of participants
|
87.8 percentage of participants
|
88.5 percentage of participants
|
PRIMARY outcome
Timeframe: Baseline (of the preceding RCT study) and Weeks 6, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, and 312Population: Open-label treated population with available data at each time point
Participants who met the following 3 conditions for improvement from Baseline were classified as meeting the ACR50 response criteria: 1. ≥ 50% improvement in 68-tender joint count; 2. ≥ 50% improvement in 66-swollen joint count; and 3. ≥ 50% improvement in at least 3 of the 5 following parameters: * Physician global assessment of disease activity * Patient global assessment of disease activity * Patient assessment of pain * Health Assessment Questionnaire - Disability Index (HAQ-DI) * High-sensitivity C-reactive protein (hsCRP).
Outcome measures
| Measure |
Upadacitinib Never Titrated
n=306 Participants
Participants received treatment with upadacitinib for up to 312 weeks. The starting dose was 6 mg twice a day (BID). From January 2017 participants were transitioned to once-daily dose of 15 mg upadacitinib.
|
Upadacitinib Titrated Up and Not Down
n=149 Participants
Participants received treatment with upadacitinib for up to 312 weeks. The starting dose was 6 mg BID. Participants who did not achieve protocol-specified improvement criteria at Week 6 or at any visits thereafter were up-titrated to upadacitinib 12 mg BID. From January 2017 participants were transitioned to once-daily dose of 30 mg upadacitinib.
|
Upadacitinib Titrated Up and Down
n=38 Participants
Participants received treatment with upadacitinib for up to 312 weeks. The starting dose was 6 mg BID. Participants who did not achieve protocol-specified improvement criteria at Week 6 or at any visits thereafter were up-titrated to upadacitinib 12 mg BID. From January 2017 participants were transitioned to once-daily dose of 30 mg upadacitinib. The upadacitinib dose was decreased back to 6 mg BID (or 15 mg QD from January 2017) per Investigator's judgment or safety and/or tolerability concerns.
|
|---|---|---|---|
|
Percentage of Participants With an American College of Rheumatology 50% (ACR50) Response Over Time
Week 192
|
80.7 percentage of participants
|
59.4 percentage of participants
|
76.9 percentage of participants
|
|
Percentage of Participants With an American College of Rheumatology 50% (ACR50) Response Over Time
Week 204
|
82.2 percentage of participants
|
59.4 percentage of participants
|
79.3 percentage of participants
|
|
Percentage of Participants With an American College of Rheumatology 50% (ACR50) Response Over Time
Week 216
|
76.6 percentage of participants
|
55.6 percentage of participants
|
66.7 percentage of participants
|
|
Percentage of Participants With an American College of Rheumatology 50% (ACR50) Response Over Time
Week 228
|
79.2 percentage of participants
|
58.2 percentage of participants
|
67.9 percentage of participants
|
|
Percentage of Participants With an American College of Rheumatology 50% (ACR50) Response Over Time
Week 240
|
79.6 percentage of participants
|
63.9 percentage of participants
|
71.4 percentage of participants
|
|
Percentage of Participants With an American College of Rheumatology 50% (ACR50) Response Over Time
Week 252
|
83.8 percentage of participants
|
55.2 percentage of participants
|
76.7 percentage of participants
|
|
Percentage of Participants With an American College of Rheumatology 50% (ACR50) Response Over Time
Week 264
|
79.7 percentage of participants
|
60.0 percentage of participants
|
75.0 percentage of participants
|
|
Percentage of Participants With an American College of Rheumatology 50% (ACR50) Response Over Time
Week 276
|
84.5 percentage of participants
|
52.9 percentage of participants
|
66.7 percentage of participants
|
|
Percentage of Participants With an American College of Rheumatology 50% (ACR50) Response Over Time
Week 288
|
82.2 percentage of participants
|
58.8 percentage of participants
|
61.5 percentage of participants
|
|
Percentage of Participants With an American College of Rheumatology 50% (ACR50) Response Over Time
Week 300
|
75.6 percentage of participants
|
61.2 percentage of participants
|
56.5 percentage of participants
|
|
Percentage of Participants With an American College of Rheumatology 50% (ACR50) Response Over Time
Week 312
|
84.3 percentage of participants
|
69.4 percentage of participants
|
69.2 percentage of participants
|
|
Percentage of Participants With an American College of Rheumatology 50% (ACR50) Response Over Time
Week 72
|
77.1 percentage of participants
|
49.0 percentage of participants
|
63.6 percentage of participants
|
|
Percentage of Participants With an American College of Rheumatology 50% (ACR50) Response Over Time
Week 6
|
63.6 percentage of participants
|
37.5 percentage of participants
|
48.6 percentage of participants
|
|
Percentage of Participants With an American College of Rheumatology 50% (ACR50) Response Over Time
Week 12
|
73.5 percentage of participants
|
41.8 percentage of participants
|
45.7 percentage of participants
|
|
Percentage of Participants With an American College of Rheumatology 50% (ACR50) Response Over Time
Week 24
|
75.7 percentage of participants
|
49.6 percentage of participants
|
60.0 percentage of participants
|
|
Percentage of Participants With an American College of Rheumatology 50% (ACR50) Response Over Time
Week 36
|
73.5 percentage of participants
|
51.6 percentage of participants
|
55.9 percentage of participants
|
|
Percentage of Participants With an American College of Rheumatology 50% (ACR50) Response Over Time
Week 48
|
74.2 percentage of participants
|
50.0 percentage of participants
|
55.6 percentage of participants
|
|
Percentage of Participants With an American College of Rheumatology 50% (ACR50) Response Over Time
Week 120
|
80.7 percentage of participants
|
58.0 percentage of participants
|
72.4 percentage of participants
|
|
Percentage of Participants With an American College of Rheumatology 50% (ACR50) Response Over Time
Week 132
|
79.2 percentage of participants
|
56.3 percentage of participants
|
69.0 percentage of participants
|
|
Percentage of Participants With an American College of Rheumatology 50% (ACR50) Response Over Time
Week 60
|
79.8 percentage of participants
|
52.8 percentage of participants
|
65.7 percentage of participants
|
|
Percentage of Participants With an American College of Rheumatology 50% (ACR50) Response Over Time
Week 84
|
78.8 percentage of participants
|
55.8 percentage of participants
|
75.8 percentage of participants
|
|
Percentage of Participants With an American College of Rheumatology 50% (ACR50) Response Over Time
Week 96
|
74.8 percentage of participants
|
53.8 percentage of participants
|
63.6 percentage of participants
|
|
Percentage of Participants With an American College of Rheumatology 50% (ACR50) Response Over Time
Week 108
|
79.4 percentage of participants
|
54.8 percentage of participants
|
58.8 percentage of participants
|
|
Percentage of Participants With an American College of Rheumatology 50% (ACR50) Response Over Time
Week 144
|
76.4 percentage of participants
|
65.8 percentage of participants
|
60.7 percentage of participants
|
|
Percentage of Participants With an American College of Rheumatology 50% (ACR50) Response Over Time
Week 156
|
79.5 percentage of participants
|
63.4 percentage of participants
|
76.9 percentage of participants
|
|
Percentage of Participants With an American College of Rheumatology 50% (ACR50) Response Over Time
Week 180
|
80.9 percentage of participants
|
64.3 percentage of participants
|
65.5 percentage of participants
|
|
Percentage of Participants With an American College of Rheumatology 50% (ACR50) Response Over Time
Week 168
|
79.2 percentage of participants
|
61.1 percentage of participants
|
75.9 percentage of participants
|
PRIMARY outcome
Timeframe: Baseline (of the preceding RCT study) and Weeks 6, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, and 312Population: Open-label treated population with available data at each time point
Participants who met the following 3 conditions for improvement from Baseline were classified as meeting the ACR70 response criteria: 1. ≥ 70% improvement in 68-tender joint count; 2. ≥ 70% improvement in 66-swollen joint count; and 3. ≥ 70% improvement in at least 3 of the 5 following parameters: * Physician global assessment of disease activity * Patient global assessment of disease activity * Patient assessment of pain * Health Assessment Questionnaire - Disability Index (HAQ-DI) * High-sensitivity C-reactive protein (hsCRP).
Outcome measures
| Measure |
Upadacitinib Never Titrated
n=306 Participants
Participants received treatment with upadacitinib for up to 312 weeks. The starting dose was 6 mg twice a day (BID). From January 2017 participants were transitioned to once-daily dose of 15 mg upadacitinib.
|
Upadacitinib Titrated Up and Not Down
n=149 Participants
Participants received treatment with upadacitinib for up to 312 weeks. The starting dose was 6 mg BID. Participants who did not achieve protocol-specified improvement criteria at Week 6 or at any visits thereafter were up-titrated to upadacitinib 12 mg BID. From January 2017 participants were transitioned to once-daily dose of 30 mg upadacitinib.
|
Upadacitinib Titrated Up and Down
n=38 Participants
Participants received treatment with upadacitinib for up to 312 weeks. The starting dose was 6 mg BID. Participants who did not achieve protocol-specified improvement criteria at Week 6 or at any visits thereafter were up-titrated to upadacitinib 12 mg BID. From January 2017 participants were transitioned to once-daily dose of 30 mg upadacitinib. The upadacitinib dose was decreased back to 6 mg BID (or 15 mg QD from January 2017) per Investigator's judgment or safety and/or tolerability concerns.
|
|---|---|---|---|
|
Percentage of Participants With an American College of Rheumatology 70% (ACR70) Response Over Time
Week 6
|
38.8 percentage of participants
|
15.1 percentage of participants
|
21.6 percentage of participants
|
|
Percentage of Participants With an American College of Rheumatology 70% (ACR70) Response Over Time
Week 12
|
47.1 percentage of participants
|
18.1 percentage of participants
|
24.3 percentage of participants
|
|
Percentage of Participants With an American College of Rheumatology 70% (ACR70) Response Over Time
Week 24
|
45.5 percentage of participants
|
27.6 percentage of participants
|
37.1 percentage of participants
|
|
Percentage of Participants With an American College of Rheumatology 70% (ACR70) Response Over Time
Week 36
|
49.0 percentage of participants
|
28.3 percentage of participants
|
34.3 percentage of participants
|
|
Percentage of Participants With an American College of Rheumatology 70% (ACR70) Response Over Time
Week 48
|
57.1 percentage of participants
|
26.7 percentage of participants
|
25.0 percentage of participants
|
|
Percentage of Participants With an American College of Rheumatology 70% (ACR70) Response Over Time
Week 60
|
60.2 percentage of participants
|
30.0 percentage of participants
|
42.9 percentage of participants
|
|
Percentage of Participants With an American College of Rheumatology 70% (ACR70) Response Over Time
Week 72
|
56.4 percentage of participants
|
29.1 percentage of participants
|
36.4 percentage of participants
|
|
Percentage of Participants With an American College of Rheumatology 70% (ACR70) Response Over Time
Week 84
|
60.3 percentage of participants
|
29.5 percentage of participants
|
54.5 percentage of participants
|
|
Percentage of Participants With an American College of Rheumatology 70% (ACR70) Response Over Time
Week 96
|
57.3 percentage of participants
|
34.0 percentage of participants
|
42.4 percentage of participants
|
|
Percentage of Participants With an American College of Rheumatology 70% (ACR70) Response Over Time
Week 108
|
59.9 percentage of participants
|
31.9 percentage of participants
|
47.1 percentage of participants
|
|
Percentage of Participants With an American College of Rheumatology 70% (ACR70) Response Over Time
Week 120
|
59.4 percentage of participants
|
30.7 percentage of participants
|
62.1 percentage of participants
|
|
Percentage of Participants With an American College of Rheumatology 70% (ACR70) Response Over Time
Week 132
|
61.8 percentage of participants
|
33.8 percentage of participants
|
48.3 percentage of participants
|
|
Percentage of Participants With an American College of Rheumatology 70% (ACR70) Response Over Time
Week 144
|
57.6 percentage of participants
|
34.2 percentage of participants
|
39.3 percentage of participants
|
|
Percentage of Participants With an American College of Rheumatology 70% (ACR70) Response Over Time
Week 156
|
64.7 percentage of participants
|
38.9 percentage of participants
|
55.6 percentage of participants
|
|
Percentage of Participants With an American College of Rheumatology 70% (ACR70) Response Over Time
Week 168
|
62.9 percentage of participants
|
42.3 percentage of participants
|
58.6 percentage of participants
|
|
Percentage of Participants With an American College of Rheumatology 70% (ACR70) Response Over Time
Week 180
|
59.1 percentage of participants
|
29.6 percentage of participants
|
48.3 percentage of participants
|
|
Percentage of Participants With an American College of Rheumatology 70% (ACR70) Response Over Time
Week 192
|
62.0 percentage of participants
|
31.9 percentage of participants
|
48.1 percentage of participants
|
|
Percentage of Participants With an American College of Rheumatology 70% (ACR70) Response Over Time
Week 204
|
65.0 percentage of participants
|
42.6 percentage of participants
|
58.6 percentage of participants
|
|
Percentage of Participants With an American College of Rheumatology 70% (ACR70) Response Over Time
Week 216
|
59.1 percentage of participants
|
41.9 percentage of participants
|
46.4 percentage of participants
|
|
Percentage of Participants With an American College of Rheumatology 70% (ACR70) Response Over Time
Week 228
|
60.0 percentage of participants
|
39.3 percentage of participants
|
60.7 percentage of participants
|
|
Percentage of Participants With an American College of Rheumatology 70% (ACR70) Response Over Time
Week 240
|
66.2 percentage of participants
|
38.7 percentage of participants
|
46.4 percentage of participants
|
|
Percentage of Participants With an American College of Rheumatology 70% (ACR70) Response Over Time
Week 252
|
62.9 percentage of participants
|
29.3 percentage of participants
|
50.0 percentage of participants
|
|
Percentage of Participants With an American College of Rheumatology 70% (ACR70) Response Over Time
Week 264
|
58.5 percentage of participants
|
37.0 percentage of participants
|
57.1 percentage of participants
|
|
Percentage of Participants With an American College of Rheumatology 70% (ACR70) Response Over Time
Week 276
|
66.1 percentage of participants
|
34.6 percentage of participants
|
48.0 percentage of participants
|
|
Percentage of Participants With an American College of Rheumatology 70% (ACR70) Response Over Time
Week 288
|
65.9 percentage of participants
|
44.2 percentage of participants
|
44.4 percentage of participants
|
|
Percentage of Participants With an American College of Rheumatology 70% (ACR70) Response Over Time
Week 300
|
60.8 percentage of participants
|
41.2 percentage of participants
|
43.5 percentage of participants
|
|
Percentage of Participants With an American College of Rheumatology 70% (ACR70) Response Over Time
Week 312
|
63.1 percentage of participants
|
39.6 percentage of participants
|
55.6 percentage of participants
|
PRIMARY outcome
Timeframe: Vaccination Baseline (defined as the last non-missing observation on or before the date of receiving PCV-13 vaccination) and 4 weeks after vaccinationPopulation: The sub-study full analysis set (FAS) included all participants enrolled in the sub-study who received PCV-13 vaccination and at least 1 dose of upadacitinib 15 mg or 30 mg after vaccination during the sub-study. Analysis includes participants with available data at the Week 4 visit of the sub-study.
Satisfactory humoral response is defined as greater than or equal to 2-fold increase in antibody concentration from the vaccination Baseline in at least 6 out of the 12 pneumococcal antigens 1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F).
Outcome measures
| Measure |
Upadacitinib Never Titrated
n=83 Participants
Participants received treatment with upadacitinib for up to 312 weeks. The starting dose was 6 mg twice a day (BID). From January 2017 participants were transitioned to once-daily dose of 15 mg upadacitinib.
|
Upadacitinib Titrated Up and Not Down
n=23 Participants
Participants received treatment with upadacitinib for up to 312 weeks. The starting dose was 6 mg BID. Participants who did not achieve protocol-specified improvement criteria at Week 6 or at any visits thereafter were up-titrated to upadacitinib 12 mg BID. From January 2017 participants were transitioned to once-daily dose of 30 mg upadacitinib.
|
Upadacitinib Titrated Up and Down
Participants received treatment with upadacitinib for up to 312 weeks. The starting dose was 6 mg BID. Participants who did not achieve protocol-specified improvement criteria at Week 6 or at any visits thereafter were up-titrated to upadacitinib 12 mg BID. From January 2017 participants were transitioned to once-daily dose of 30 mg upadacitinib. The upadacitinib dose was decreased back to 6 mg BID (or 15 mg QD from January 2017) per Investigator's judgment or safety and/or tolerability concerns.
|
|---|---|---|---|
|
Percentage of Participants With Satisfactory Humoral Response to PCV-13 Four Weeks After Vaccination
|
67.5 percentage of participants
Interval 57.4 to 77.5
|
56.5 percentage of participants
Interval 36.3 to 76.8
|
—
|
SECONDARY outcome
Timeframe: Weeks 6, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, and 312Population: Open-label treated population with available data at each time point
The DAS28(CRP) is a composite index used to assess rheumatoid arthritis disease activity, calculated based on the tender joint count (out of 28 evaluated joints), swollen joint count (out of 28 evaluated joints), Patient's Global Assessment of Disease Activity (measured on a VAS from 0-100 mm), and hsCRP (in mg/L). Scores on the DAS28 (CRP) range from 0 to approximately 10, where higher scores indicate more disease activity. LDA is defined as a DAS28(CRP) score ≤ 3.2.
Outcome measures
| Measure |
Upadacitinib Never Titrated
n=306 Participants
Participants received treatment with upadacitinib for up to 312 weeks. The starting dose was 6 mg twice a day (BID). From January 2017 participants were transitioned to once-daily dose of 15 mg upadacitinib.
|
Upadacitinib Titrated Up and Not Down
n=149 Participants
Participants received treatment with upadacitinib for up to 312 weeks. The starting dose was 6 mg BID. Participants who did not achieve protocol-specified improvement criteria at Week 6 or at any visits thereafter were up-titrated to upadacitinib 12 mg BID. From January 2017 participants were transitioned to once-daily dose of 30 mg upadacitinib.
|
Upadacitinib Titrated Up and Down
n=38 Participants
Participants received treatment with upadacitinib for up to 312 weeks. The starting dose was 6 mg BID. Participants who did not achieve protocol-specified improvement criteria at Week 6 or at any visits thereafter were up-titrated to upadacitinib 12 mg BID. From January 2017 participants were transitioned to once-daily dose of 30 mg upadacitinib. The upadacitinib dose was decreased back to 6 mg BID (or 15 mg QD from January 2017) per Investigator's judgment or safety and/or tolerability concerns.
|
|---|---|---|---|
|
Percentage of Participants Achieving Low Disease Activity (LDA) Based on Disease Activity Score-28 (DAS28[CRP]) Over Time
Week 132
|
88.6 percentage of participants
|
70.1 percentage of participants
|
87.1 percentage of participants
|
|
Percentage of Participants Achieving Low Disease Activity (LDA) Based on Disease Activity Score-28 (DAS28[CRP]) Over Time
Week 144
|
85.2 percentage of participants
|
68.6 percentage of participants
|
82.1 percentage of participants
|
|
Percentage of Participants Achieving Low Disease Activity (LDA) Based on Disease Activity Score-28 (DAS28[CRP]) Over Time
Week 156
|
86.1 percentage of participants
|
74.6 percentage of participants
|
86.2 percentage of participants
|
|
Percentage of Participants Achieving Low Disease Activity (LDA) Based on Disease Activity Score-28 (DAS28[CRP]) Over Time
Week 168
|
90.0 percentage of participants
|
78.3 percentage of participants
|
80.0 percentage of participants
|
|
Percentage of Participants Achieving Low Disease Activity (LDA) Based on Disease Activity Score-28 (DAS28[CRP]) Over Time
Week 180
|
90.4 percentage of participants
|
69.6 percentage of participants
|
80.0 percentage of participants
|
|
Percentage of Participants Achieving Low Disease Activity (LDA) Based on Disease Activity Score-28 (DAS28[CRP]) Over Time
Week 6
|
70.3 percentage of participants
|
43.2 percentage of participants
|
43.2 percentage of participants
|
|
Percentage of Participants Achieving Low Disease Activity (LDA) Based on Disease Activity Score-28 (DAS28[CRP]) Over Time
Week 12
|
77.9 percentage of participants
|
43.4 percentage of participants
|
43.2 percentage of participants
|
|
Percentage of Participants Achieving Low Disease Activity (LDA) Based on Disease Activity Score-28 (DAS28[CRP]) Over Time
Week 24
|
82.4 percentage of participants
|
48.5 percentage of participants
|
52.8 percentage of participants
|
|
Percentage of Participants Achieving Low Disease Activity (LDA) Based on Disease Activity Score-28 (DAS28[CRP]) Over Time
Week 36
|
80.5 percentage of participants
|
50.8 percentage of participants
|
55.6 percentage of participants
|
|
Percentage of Participants Achieving Low Disease Activity (LDA) Based on Disease Activity Score-28 (DAS28[CRP]) Over Time
Week 48
|
86.8 percentage of participants
|
54.2 percentage of participants
|
56.8 percentage of participants
|
|
Percentage of Participants Achieving Low Disease Activity (LDA) Based on Disease Activity Score-28 (DAS28[CRP]) Over Time
Week 60
|
86.2 percentage of participants
|
56.4 percentage of participants
|
66.7 percentage of participants
|
|
Percentage of Participants Achieving Low Disease Activity (LDA) Based on Disease Activity Score-28 (DAS28[CRP]) Over Time
Week 72
|
84.7 percentage of participants
|
51.0 percentage of participants
|
69.7 percentage of participants
|
|
Percentage of Participants Achieving Low Disease Activity (LDA) Based on Disease Activity Score-28 (DAS28[CRP]) Over Time
Week 84
|
88.9 percentage of participants
|
60.2 percentage of participants
|
85.3 percentage of participants
|
|
Percentage of Participants Achieving Low Disease Activity (LDA) Based on Disease Activity Score-28 (DAS28[CRP]) Over Time
Week 96
|
82.4 percentage of participants
|
64.9 percentage of participants
|
79.4 percentage of participants
|
|
Percentage of Participants Achieving Low Disease Activity (LDA) Based on Disease Activity Score-28 (DAS28[CRP]) Over Time
Week 108
|
88.2 percentage of participants
|
66.3 percentage of participants
|
70.6 percentage of participants
|
|
Percentage of Participants Achieving Low Disease Activity (LDA) Based on Disease Activity Score-28 (DAS28[CRP]) Over Time
Week 120
|
85.9 percentage of participants
|
69.0 percentage of participants
|
77.4 percentage of participants
|
|
Percentage of Participants Achieving Low Disease Activity (LDA) Based on Disease Activity Score-28 (DAS28[CRP]) Over Time
Week 192
|
89.3 percentage of participants
|
75.0 percentage of participants
|
96.3 percentage of participants
|
|
Percentage of Participants Achieving Low Disease Activity (LDA) Based on Disease Activity Score-28 (DAS28[CRP]) Over Time
Week 204
|
88.6 percentage of participants
|
61.4 percentage of participants
|
83.3 percentage of participants
|
|
Percentage of Participants Achieving Low Disease Activity (LDA) Based on Disease Activity Score-28 (DAS28[CRP]) Over Time
Week 216
|
89.9 percentage of participants
|
70.3 percentage of participants
|
82.1 percentage of participants
|
|
Percentage of Participants Achieving Low Disease Activity (LDA) Based on Disease Activity Score-28 (DAS28[CRP]) Over Time
Week 228
|
89.4 percentage of participants
|
70.9 percentage of participants
|
86.2 percentage of participants
|
|
Percentage of Participants Achieving Low Disease Activity (LDA) Based on Disease Activity Score-28 (DAS28[CRP]) Over Time
Week 240
|
89.5 percentage of participants
|
75.8 percentage of participants
|
86.2 percentage of participants
|
|
Percentage of Participants Achieving Low Disease Activity (LDA) Based on Disease Activity Score-28 (DAS28[CRP]) Over Time
Week 252
|
91.7 percentage of participants
|
67.2 percentage of participants
|
83.9 percentage of participants
|
|
Percentage of Participants Achieving Low Disease Activity (LDA) Based on Disease Activity Score-28 (DAS28[CRP]) Over Time
Week 264
|
86.2 percentage of participants
|
67.9 percentage of participants
|
82.1 percentage of participants
|
|
Percentage of Participants Achieving Low Disease Activity (LDA) Based on Disease Activity Score-28 (DAS28[CRP]) Over Time
Week 276
|
91.7 percentage of participants
|
74.1 percentage of participants
|
72.0 percentage of participants
|
|
Percentage of Participants Achieving Low Disease Activity (LDA) Based on Disease Activity Score-28 (DAS28[CRP]) Over Time
Week 288
|
90.6 percentage of participants
|
71.7 percentage of participants
|
76.0 percentage of participants
|
|
Percentage of Participants Achieving Low Disease Activity (LDA) Based on Disease Activity Score-28 (DAS28[CRP]) Over Time
Week 300
|
94.1 percentage of participants
|
67.6 percentage of participants
|
80.0 percentage of participants
|
|
Percentage of Participants Achieving Low Disease Activity (LDA) Based on Disease Activity Score-28 (DAS28[CRP]) Over Time
Week 312
|
84.5 percentage of participants
|
68.8 percentage of participants
|
70.4 percentage of participants
|
SECONDARY outcome
Timeframe: Weeks 6, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, and 312Population: Open-label treated population with available data at each time point
The DAS28 (CRP) is a composite index used to assess rheumatoid arthritis disease activity, calculated based on the tender joint count (out of 28 evaluated joints), swollen joint count (out of 28 evaluated joints), Patient's Global Assessment of Disease Activity (measured on a VAS from 0-100 mm), and hsCRP (in mg/L). Scores on the DAS28 (CRP) range from 0 to approximately 10, where higher scores indicate more disease activity. Clinical remission is defined as a DAS28(CRP) score \< 2.6.
Outcome measures
| Measure |
Upadacitinib Never Titrated
n=306 Participants
Participants received treatment with upadacitinib for up to 312 weeks. The starting dose was 6 mg twice a day (BID). From January 2017 participants were transitioned to once-daily dose of 15 mg upadacitinib.
|
Upadacitinib Titrated Up and Not Down
n=149 Participants
Participants received treatment with upadacitinib for up to 312 weeks. The starting dose was 6 mg BID. Participants who did not achieve protocol-specified improvement criteria at Week 6 or at any visits thereafter were up-titrated to upadacitinib 12 mg BID. From January 2017 participants were transitioned to once-daily dose of 30 mg upadacitinib.
|
Upadacitinib Titrated Up and Down
n=38 Participants
Participants received treatment with upadacitinib for up to 312 weeks. The starting dose was 6 mg BID. Participants who did not achieve protocol-specified improvement criteria at Week 6 or at any visits thereafter were up-titrated to upadacitinib 12 mg BID. From January 2017 participants were transitioned to once-daily dose of 30 mg upadacitinib. The upadacitinib dose was decreased back to 6 mg BID (or 15 mg QD from January 2017) per Investigator's judgment or safety and/or tolerability concerns.
|
|---|---|---|---|
|
Percentage of Participants Achieving Clinical Remission (CR) Based on Disease Activity Score-28 (DAS28[CRP]) Over Time
Week 6
|
53.0 percentage of participants
|
21.2 percentage of participants
|
29.7 percentage of participants
|
|
Percentage of Participants Achieving Clinical Remission (CR) Based on Disease Activity Score-28 (DAS28[CRP]) Over Time
Week 12
|
56.6 percentage of participants
|
25.5 percentage of participants
|
27.0 percentage of participants
|
|
Percentage of Participants Achieving Clinical Remission (CR) Based on Disease Activity Score-28 (DAS28[CRP]) Over Time
Week 24
|
60.8 percentage of participants
|
31.3 percentage of participants
|
38.9 percentage of participants
|
|
Percentage of Participants Achieving Clinical Remission (CR) Based on Disease Activity Score-28 (DAS28[CRP]) Over Time
Week 36
|
65.0 percentage of participants
|
35.2 percentage of participants
|
50.0 percentage of participants
|
|
Percentage of Participants Achieving Clinical Remission (CR) Based on Disease Activity Score-28 (DAS28[CRP]) Over Time
Week 48
|
66.2 percentage of participants
|
36.4 percentage of participants
|
35.1 percentage of participants
|
|
Percentage of Participants Achieving Clinical Remission (CR) Based on Disease Activity Score-28 (DAS28[CRP]) Over Time
Week 60
|
72.9 percentage of participants
|
38.2 percentage of participants
|
50.0 percentage of participants
|
|
Percentage of Participants Achieving Clinical Remission (CR) Based on Disease Activity Score-28 (DAS28[CRP]) Over Time
Week 72
|
69.0 percentage of participants
|
35.6 percentage of participants
|
51.5 percentage of participants
|
|
Percentage of Participants Achieving Clinical Remission (CR) Based on Disease Activity Score-28 (DAS28[CRP]) Over Time
Week 84
|
72.0 percentage of participants
|
36.7 percentage of participants
|
52.9 percentage of participants
|
|
Percentage of Participants Achieving Clinical Remission (CR) Based on Disease Activity Score-28 (DAS28[CRP]) Over Time
Week 96
|
71.7 percentage of participants
|
45.4 percentage of participants
|
52.9 percentage of participants
|
|
Percentage of Participants Achieving Clinical Remission (CR) Based on Disease Activity Score-28 (DAS28[CRP]) Over Time
Week 108
|
74.4 percentage of participants
|
42.4 percentage of participants
|
47.1 percentage of participants
|
|
Percentage of Participants Achieving Clinical Remission (CR) Based on Disease Activity Score-28 (DAS28[CRP]) Over Time
Week 120
|
74.1 percentage of participants
|
49.4 percentage of participants
|
45.2 percentage of participants
|
|
Percentage of Participants Achieving Clinical Remission (CR) Based on Disease Activity Score-28 (DAS28[CRP]) Over Time
Week 132
|
73.7 percentage of participants
|
40.3 percentage of participants
|
61.3 percentage of participants
|
|
Percentage of Participants Achieving Clinical Remission (CR) Based on Disease Activity Score-28 (DAS28[CRP]) Over Time
Week 144
|
71.0 percentage of participants
|
44.3 percentage of participants
|
60.7 percentage of participants
|
|
Percentage of Participants Achieving Clinical Remission (CR) Based on Disease Activity Score-28 (DAS28[CRP]) Over Time
Week 156
|
74.7 percentage of participants
|
50.7 percentage of participants
|
65.5 percentage of participants
|
|
Percentage of Participants Achieving Clinical Remission (CR) Based on Disease Activity Score-28 (DAS28[CRP]) Over Time
Week 168
|
77.5 percentage of participants
|
49.3 percentage of participants
|
66.7 percentage of participants
|
|
Percentage of Participants Achieving Clinical Remission (CR) Based on Disease Activity Score-28 (DAS28[CRP]) Over Time
Week 180
|
75.3 percentage of participants
|
44.9 percentage of participants
|
56.7 percentage of participants
|
|
Percentage of Participants Achieving Clinical Remission (CR) Based on Disease Activity Score-28 (DAS28[CRP]) Over Time
Week 192
|
76.9 percentage of participants
|
47.2 percentage of participants
|
55.6 percentage of participants
|
|
Percentage of Participants Achieving Clinical Remission (CR) Based on Disease Activity Score-28 (DAS28[CRP]) Over Time
Week 204
|
77.1 percentage of participants
|
47.1 percentage of participants
|
76.7 percentage of participants
|
|
Percentage of Participants Achieving Clinical Remission (CR) Based on Disease Activity Score-28 (DAS28[CRP]) Over Time
Week 216
|
79.2 percentage of participants
|
56.3 percentage of participants
|
53.6 percentage of participants
|
|
Percentage of Participants Achieving Clinical Remission (CR) Based on Disease Activity Score-28 (DAS28[CRP]) Over Time
Week 228
|
80.8 percentage of participants
|
49.1 percentage of participants
|
69.0 percentage of participants
|
|
Percentage of Participants Achieving Clinical Remission (CR) Based on Disease Activity Score-28 (DAS28[CRP]) Over Time
Week 240
|
75.2 percentage of participants
|
50.0 percentage of participants
|
69.0 percentage of participants
|
|
Percentage of Participants Achieving Clinical Remission (CR) Based on Disease Activity Score-28 (DAS28[CRP]) Over Time
Week 252
|
80.7 percentage of participants
|
44.8 percentage of participants
|
58.1 percentage of participants
|
|
Percentage of Participants Achieving Clinical Remission (CR) Based on Disease Activity Score-28 (DAS28[CRP]) Over Time
Week 264
|
73.8 percentage of participants
|
39.6 percentage of participants
|
67.9 percentage of participants
|
|
Percentage of Participants Achieving Clinical Remission (CR) Based on Disease Activity Score-28 (DAS28[CRP]) Over Time
Week 276
|
76.9 percentage of participants
|
50.0 percentage of participants
|
52.0 percentage of participants
|
|
Percentage of Participants Achieving Clinical Remission (CR) Based on Disease Activity Score-28 (DAS28[CRP]) Over Time
Week 288
|
74.5 percentage of participants
|
47.8 percentage of participants
|
48.0 percentage of participants
|
|
Percentage of Participants Achieving Clinical Remission (CR) Based on Disease Activity Score-28 (DAS28[CRP]) Over Time
Week 300
|
75.2 percentage of participants
|
43.2 percentage of participants
|
55.0 percentage of participants
|
|
Percentage of Participants Achieving Clinical Remission (CR) Based on Disease Activity Score-28 (DAS28[CRP]) Over Time
Week 312
|
72.4 percentage of participants
|
45.8 percentage of participants
|
63.0 percentage of participants
|
SECONDARY outcome
Timeframe: Weeks 6, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, and 312Population: Open-label treated population with available data at each time point
The clinical disease activity index (CDAI) is a composite index for assessing disease activity based on the summation of the counts of tender joint count (out of 28 evaluated joints) and swollen joint count (out of 28 evaluated joints), Patient's Global Assessment of Disease Activity measured on a VAS from 0 to 10 cm, and Physician's Global Assessment of Disease Activity measured on a VAS from 0 to 10 cm. The total CDAI score ranges from 0 to 78 with higher scores indicating higher disease activity. LDA is defined as a CDAI score ≤ 10.
Outcome measures
| Measure |
Upadacitinib Never Titrated
n=306 Participants
Participants received treatment with upadacitinib for up to 312 weeks. The starting dose was 6 mg twice a day (BID). From January 2017 participants were transitioned to once-daily dose of 15 mg upadacitinib.
|
Upadacitinib Titrated Up and Not Down
n=149 Participants
Participants received treatment with upadacitinib for up to 312 weeks. The starting dose was 6 mg BID. Participants who did not achieve protocol-specified improvement criteria at Week 6 or at any visits thereafter were up-titrated to upadacitinib 12 mg BID. From January 2017 participants were transitioned to once-daily dose of 30 mg upadacitinib.
|
Upadacitinib Titrated Up and Down
n=38 Participants
Participants received treatment with upadacitinib for up to 312 weeks. The starting dose was 6 mg BID. Participants who did not achieve protocol-specified improvement criteria at Week 6 or at any visits thereafter were up-titrated to upadacitinib 12 mg BID. From January 2017 participants were transitioned to once-daily dose of 30 mg upadacitinib. The upadacitinib dose was decreased back to 6 mg BID (or 15 mg QD from January 2017) per Investigator's judgment or safety and/or tolerability concerns.
|
|---|---|---|---|
|
Percentage of Participants Achieving Low Disease Activity (LDA) Based on Clinical Disease Activity Index (CDAI) Over Time
Week 6
|
65.3 percentage of participants
|
35.2 percentage of participants
|
35.1 percentage of participants
|
|
Percentage of Participants Achieving Low Disease Activity (LDA) Based on Clinical Disease Activity Index (CDAI) Over Time
Week 12
|
71.1 percentage of participants
|
39.7 percentage of participants
|
32.4 percentage of participants
|
|
Percentage of Participants Achieving Low Disease Activity (LDA) Based on Clinical Disease Activity Index (CDAI) Over Time
Week 24
|
80.3 percentage of participants
|
46.6 percentage of participants
|
51.4 percentage of participants
|
|
Percentage of Participants Achieving Low Disease Activity (LDA) Based on Clinical Disease Activity Index (CDAI) Over Time
Week 36
|
77.8 percentage of participants
|
44.4 percentage of participants
|
57.1 percentage of participants
|
|
Percentage of Participants Achieving Low Disease Activity (LDA) Based on Clinical Disease Activity Index (CDAI) Over Time
Week 48
|
83.0 percentage of participants
|
50.8 percentage of participants
|
38.9 percentage of participants
|
|
Percentage of Participants Achieving Low Disease Activity (LDA) Based on Clinical Disease Activity Index (CDAI) Over Time
Week 60
|
85.8 percentage of participants
|
58.9 percentage of participants
|
63.9 percentage of participants
|
|
Percentage of Participants Achieving Low Disease Activity (LDA) Based on Clinical Disease Activity Index (CDAI) Over Time
Week 72
|
85.5 percentage of participants
|
46.2 percentage of participants
|
60.6 percentage of participants
|
|
Percentage of Participants Achieving Low Disease Activity (LDA) Based on Clinical Disease Activity Index (CDAI) Over Time
Week 84
|
84.4 percentage of participants
|
52.6 percentage of participants
|
75.0 percentage of participants
|
|
Percentage of Participants Achieving Low Disease Activity (LDA) Based on Clinical Disease Activity Index (CDAI) Over Time
Week 96
|
81.3 percentage of participants
|
63.5 percentage of participants
|
57.6 percentage of participants
|
|
Percentage of Participants Achieving Low Disease Activity (LDA) Based on Clinical Disease Activity Index (CDAI) Over Time
Week 108
|
85.1 percentage of participants
|
67.4 percentage of participants
|
54.5 percentage of participants
|
|
Percentage of Participants Achieving Low Disease Activity (LDA) Based on Clinical Disease Activity Index (CDAI) Over Time
Week 120
|
87.2 percentage of participants
|
67.0 percentage of participants
|
77.4 percentage of participants
|
|
Percentage of Participants Achieving Low Disease Activity (LDA) Based on Clinical Disease Activity Index (CDAI) Over Time
Week 132
|
87.4 percentage of participants
|
72.5 percentage of participants
|
76.7 percentage of participants
|
|
Percentage of Participants Achieving Low Disease Activity (LDA) Based on Clinical Disease Activity Index (CDAI) Over Time
Week 144
|
88.4 percentage of participants
|
68.0 percentage of participants
|
78.6 percentage of participants
|
|
Percentage of Participants Achieving Low Disease Activity (LDA) Based on Clinical Disease Activity Index (CDAI) Over Time
Week 156
|
88.8 percentage of participants
|
73.2 percentage of participants
|
71.4 percentage of participants
|
|
Percentage of Participants Achieving Low Disease Activity (LDA) Based on Clinical Disease Activity Index (CDAI) Over Time
Week 168
|
90.8 percentage of participants
|
82.2 percentage of participants
|
83.3 percentage of participants
|
|
Percentage of Participants Achieving Low Disease Activity (LDA) Based on Clinical Disease Activity Index (CDAI) Over Time
Week 180
|
88.3 percentage of participants
|
73.9 percentage of participants
|
76.7 percentage of participants
|
|
Percentage of Participants Achieving Low Disease Activity (LDA) Based on Clinical Disease Activity Index (CDAI) Over Time
Week 192
|
88.1 percentage of participants
|
70.0 percentage of participants
|
79.3 percentage of participants
|
|
Percentage of Participants Achieving Low Disease Activity (LDA) Based on Clinical Disease Activity Index (CDAI) Over Time
Week 204
|
89.0 percentage of participants
|
71.4 percentage of participants
|
82.8 percentage of participants
|
|
Percentage of Participants Achieving Low Disease Activity (LDA) Based on Clinical Disease Activity Index (CDAI) Over Time
Week 216
|
88.6 percentage of participants
|
70.3 percentage of participants
|
78.6 percentage of participants
|
|
Percentage of Participants Achieving Low Disease Activity (LDA) Based on Clinical Disease Activity Index (CDAI) Over Time
Week 228
|
89.3 percentage of participants
|
67.9 percentage of participants
|
79.3 percentage of participants
|
|
Percentage of Participants Achieving Low Disease Activity (LDA) Based on Clinical Disease Activity Index (CDAI) Over Time
Week 240
|
87.6 percentage of participants
|
72.6 percentage of participants
|
75.9 percentage of participants
|
|
Percentage of Participants Achieving Low Disease Activity (LDA) Based on Clinical Disease Activity Index (CDAI) Over Time
Week 252
|
89.0 percentage of participants
|
73.7 percentage of participants
|
74.2 percentage of participants
|
|
Percentage of Participants Achieving Low Disease Activity (LDA) Based on Clinical Disease Activity Index (CDAI) Over Time
Week 264
|
83.5 percentage of participants
|
63.0 percentage of participants
|
75.9 percentage of participants
|
|
Percentage of Participants Achieving Low Disease Activity (LDA) Based on Clinical Disease Activity Index (CDAI) Over Time
Week 276
|
87.6 percentage of participants
|
67.9 percentage of participants
|
67.9 percentage of participants
|
|
Percentage of Participants Achieving Low Disease Activity (LDA) Based on Clinical Disease Activity Index (CDAI) Over Time
Week 288
|
90.3 percentage of participants
|
74.5 percentage of participants
|
75.0 percentage of participants
|
|
Percentage of Participants Achieving Low Disease Activity (LDA) Based on Clinical Disease Activity Index (CDAI) Over Time
Week 300
|
89.8 percentage of participants
|
72.0 percentage of participants
|
70.8 percentage of participants
|
|
Percentage of Participants Achieving Low Disease Activity (LDA) Based on Clinical Disease Activity Index (CDAI) Over Time
Week 312
|
86.6 percentage of participants
|
70.2 percentage of participants
|
73.1 percentage of participants
|
SECONDARY outcome
Timeframe: Weeks 6, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, and 312Population: Open-label treated population with available data at each time point
The clinical disease activity index (CDAI) is a composite index for assessing disease activity based on the summation of the counts of tender joint count (out of 28 evaluated joints) and swollen joint count (out of 28 evaluated joints), Patient's Global Assessment of Disease Activity measured on a VAS from 0 to 10 cm, and Physician's Global Assessment of Disease Activity measured on a VAS from 0 to 10 cm. The total CDAI score ranges from 0 to 78 with higher scores indicating higher disease activity. Clinical remission is defined as a CDAI score ≤ 2.8.
Outcome measures
| Measure |
Upadacitinib Never Titrated
n=306 Participants
Participants received treatment with upadacitinib for up to 312 weeks. The starting dose was 6 mg twice a day (BID). From January 2017 participants were transitioned to once-daily dose of 15 mg upadacitinib.
|
Upadacitinib Titrated Up and Not Down
n=149 Participants
Participants received treatment with upadacitinib for up to 312 weeks. The starting dose was 6 mg BID. Participants who did not achieve protocol-specified improvement criteria at Week 6 or at any visits thereafter were up-titrated to upadacitinib 12 mg BID. From January 2017 participants were transitioned to once-daily dose of 30 mg upadacitinib.
|
Upadacitinib Titrated Up and Down
n=38 Participants
Participants received treatment with upadacitinib for up to 312 weeks. The starting dose was 6 mg BID. Participants who did not achieve protocol-specified improvement criteria at Week 6 or at any visits thereafter were up-titrated to upadacitinib 12 mg BID. From January 2017 participants were transitioned to once-daily dose of 30 mg upadacitinib. The upadacitinib dose was decreased back to 6 mg BID (or 15 mg QD from January 2017) per Investigator's judgment or safety and/or tolerability concerns.
|
|---|---|---|---|
|
Percentage of Participants Achieving Clinical Remission (CR) Based on Clinical Disease Activity Index (CDAI) Over Time
Week 6
|
23.4 percentage of participants
|
4.9 percentage of participants
|
10.8 percentage of participants
|
|
Percentage of Participants Achieving Clinical Remission (CR) Based on Clinical Disease Activity Index (CDAI) Over Time
Week 12
|
26.4 percentage of participants
|
6.4 percentage of participants
|
8.8 percentage of participants
|
|
Percentage of Participants Achieving Clinical Remission (CR) Based on Clinical Disease Activity Index (CDAI) Over Time
Week 24
|
28.3 percentage of participants
|
12.8 percentage of participants
|
14.3 percentage of participants
|
|
Percentage of Participants Achieving Clinical Remission (CR) Based on Clinical Disease Activity Index (CDAI) Over Time
Week 36
|
32.5 percentage of participants
|
9.5 percentage of participants
|
17.1 percentage of participants
|
|
Percentage of Participants Achieving Clinical Remission (CR) Based on Clinical Disease Activity Index (CDAI) Over Time
Week 48
|
34.8 percentage of participants
|
11.0 percentage of participants
|
11.1 percentage of participants
|
|
Percentage of Participants Achieving Clinical Remission (CR) Based on Clinical Disease Activity Index (CDAI) Over Time
Week 60
|
43.1 percentage of participants
|
13.1 percentage of participants
|
22.2 percentage of participants
|
|
Percentage of Participants Achieving Clinical Remission (CR) Based on Clinical Disease Activity Index (CDAI) Over Time
Week 72
|
43.5 percentage of participants
|
12.5 percentage of participants
|
9.1 percentage of participants
|
|
Percentage of Participants Achieving Clinical Remission (CR) Based on Clinical Disease Activity Index (CDAI) Over Time
Week 84
|
43.4 percentage of participants
|
12.4 percentage of participants
|
18.8 percentage of participants
|
|
Percentage of Participants Achieving Clinical Remission (CR) Based on Clinical Disease Activity Index (CDAI) Over Time
Week 96
|
40.4 percentage of participants
|
15.6 percentage of participants
|
21.2 percentage of participants
|
|
Percentage of Participants Achieving Clinical Remission (CR) Based on Clinical Disease Activity Index (CDAI) Over Time
Week 108
|
44.8 percentage of participants
|
16.3 percentage of participants
|
18.2 percentage of participants
|
|
Percentage of Participants Achieving Clinical Remission (CR) Based on Clinical Disease Activity Index (CDAI) Over Time
Week 120
|
43.6 percentage of participants
|
12.5 percentage of participants
|
22.6 percentage of participants
|
|
Percentage of Participants Achieving Clinical Remission (CR) Based on Clinical Disease Activity Index (CDAI) Over Time
Week 132
|
46.7 percentage of participants
|
18.8 percentage of participants
|
33.3 percentage of participants
|
|
Percentage of Participants Achieving Clinical Remission (CR) Based on Clinical Disease Activity Index (CDAI) Over Time
Week 144
|
38.1 percentage of participants
|
14.7 percentage of participants
|
28.6 percentage of participants
|
|
Percentage of Participants Achieving Clinical Remission (CR) Based on Clinical Disease Activity Index (CDAI) Over Time
Week 156
|
47.2 percentage of participants
|
14.1 percentage of participants
|
32.1 percentage of participants
|
|
Percentage of Participants Achieving Clinical Remission (CR) Based on Clinical Disease Activity Index (CDAI) Over Time
Week 168
|
48.6 percentage of participants
|
20.5 percentage of participants
|
33.3 percentage of participants
|
|
Percentage of Participants Achieving Clinical Remission (CR) Based on Clinical Disease Activity Index (CDAI) Over Time
Week 180
|
48.0 percentage of participants
|
15.9 percentage of participants
|
20.0 percentage of participants
|
|
Percentage of Participants Achieving Clinical Remission (CR) Based on Clinical Disease Activity Index (CDAI) Over Time
Week 192
|
46.4 percentage of participants
|
18.6 percentage of participants
|
24.1 percentage of participants
|
|
Percentage of Participants Achieving Clinical Remission (CR) Based on Clinical Disease Activity Index (CDAI) Over Time
Week 204
|
51.2 percentage of participants
|
20.0 percentage of participants
|
34.5 percentage of participants
|
|
Percentage of Participants Achieving Clinical Remission (CR) Based on Clinical Disease Activity Index (CDAI) Over Time
Week 216
|
46.2 percentage of participants
|
21.9 percentage of participants
|
28.6 percentage of participants
|
|
Percentage of Participants Achieving Clinical Remission (CR) Based on Clinical Disease Activity Index (CDAI) Over Time
Week 228
|
44.3 percentage of participants
|
25.0 percentage of participants
|
31.0 percentage of participants
|
|
Percentage of Participants Achieving Clinical Remission (CR) Based on Clinical Disease Activity Index (CDAI) Over Time
Week 240
|
51.6 percentage of participants
|
24.2 percentage of participants
|
31.0 percentage of participants
|
|
Percentage of Participants Achieving Clinical Remission (CR) Based on Clinical Disease Activity Index (CDAI) Over Time
Week 252
|
52.7 percentage of participants
|
19.3 percentage of participants
|
22.6 percentage of participants
|
|
Percentage of Participants Achieving Clinical Remission (CR) Based on Clinical Disease Activity Index (CDAI) Over Time
Week 264
|
48.1 percentage of participants
|
20.4 percentage of participants
|
17.2 percentage of participants
|
|
Percentage of Participants Achieving Clinical Remission (CR) Based on Clinical Disease Activity Index (CDAI) Over Time
Week 276
|
53.5 percentage of participants
|
24.5 percentage of participants
|
28.6 percentage of participants
|
|
Percentage of Participants Achieving Clinical Remission (CR) Based on Clinical Disease Activity Index (CDAI) Over Time
Week 288
|
51.5 percentage of participants
|
25.5 percentage of participants
|
28.6 percentage of participants
|
|
Percentage of Participants Achieving Clinical Remission (CR) Based on Clinical Disease Activity Index (CDAI) Over Time
Week 300
|
51.2 percentage of participants
|
22.0 percentage of participants
|
29.2 percentage of participants
|
|
Percentage of Participants Achieving Clinical Remission (CR) Based on Clinical Disease Activity Index (CDAI) Over Time
Week 312
|
50.4 percentage of participants
|
27.7 percentage of participants
|
34.6 percentage of participants
|
SECONDARY outcome
Timeframe: Weeks 6, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, and 312Population: Open-label treated population with available data at each time point
The simplified disease activity index (SDAI) is a composite index for assessing disease activity based on the summation of the counts of tender joint count (out of 28 evaluated joints) and swollen joint count (out of 28 evaluated joints), Patient's Global Assessment of Disease Activity measured on a VAS from 0 to 10 cm, Physician's Global Assessment of Disease Activity measured on a VAS from 0 to 10 cm and hsCRP (mg/dL). The total SDAI score ranges from 0 to 86 with higher scores indicating higher disease activity. LDA is defined as a SDAI score ≤ 11.0.
Outcome measures
| Measure |
Upadacitinib Never Titrated
n=306 Participants
Participants received treatment with upadacitinib for up to 312 weeks. The starting dose was 6 mg twice a day (BID). From January 2017 participants were transitioned to once-daily dose of 15 mg upadacitinib.
|
Upadacitinib Titrated Up and Not Down
n=149 Participants
Participants received treatment with upadacitinib for up to 312 weeks. The starting dose was 6 mg BID. Participants who did not achieve protocol-specified improvement criteria at Week 6 or at any visits thereafter were up-titrated to upadacitinib 12 mg BID. From January 2017 participants were transitioned to once-daily dose of 30 mg upadacitinib.
|
Upadacitinib Titrated Up and Down
n=38 Participants
Participants received treatment with upadacitinib for up to 312 weeks. The starting dose was 6 mg BID. Participants who did not achieve protocol-specified improvement criteria at Week 6 or at any visits thereafter were up-titrated to upadacitinib 12 mg BID. From January 2017 participants were transitioned to once-daily dose of 30 mg upadacitinib. The upadacitinib dose was decreased back to 6 mg BID (or 15 mg QD from January 2017) per Investigator's judgment or safety and/or tolerability concerns.
|
|---|---|---|---|
|
Percentage of Participants Achieving Low Disease Activity (LDA) Based on Simplified Disease Activity Index (SDAI) Over Time
Week 6
|
54.2 percentage of participants
|
25.4 percentage of participants
|
32.4 percentage of participants
|
|
Percentage of Participants Achieving Low Disease Activity (LDA) Based on Simplified Disease Activity Index (SDAI) Over Time
Week 12
|
61.1 percentage of participants
|
33.3 percentage of participants
|
23.5 percentage of participants
|
|
Percentage of Participants Achieving Low Disease Activity (LDA) Based on Simplified Disease Activity Index (SDAI) Over Time
Week 24
|
66.8 percentage of participants
|
33.1 percentage of participants
|
48.6 percentage of participants
|
|
Percentage of Participants Achieving Low Disease Activity (LDA) Based on Simplified Disease Activity Index (SDAI) Over Time
Week 36
|
67.8 percentage of participants
|
34.9 percentage of participants
|
48.6 percentage of participants
|
|
Percentage of Participants Achieving Low Disease Activity (LDA) Based on Simplified Disease Activity Index (SDAI) Over Time
Week 48
|
73.7 percentage of participants
|
38.1 percentage of participants
|
41.7 percentage of participants
|
|
Percentage of Participants Achieving Low Disease Activity (LDA) Based on Simplified Disease Activity Index (SDAI) Over Time
Week 60
|
72.9 percentage of participants
|
41.1 percentage of participants
|
61.1 percentage of participants
|
|
Percentage of Participants Achieving Low Disease Activity (LDA) Based on Simplified Disease Activity Index (SDAI) Over Time
Week 72
|
71.5 percentage of participants
|
36.5 percentage of participants
|
51.5 percentage of participants
|
|
Percentage of Participants Achieving Low Disease Activity (LDA) Based on Simplified Disease Activity Index (SDAI) Over Time
Week 84
|
74.6 percentage of participants
|
40.2 percentage of participants
|
62.5 percentage of participants
|
|
Percentage of Participants Achieving Low Disease Activity (LDA) Based on Simplified Disease Activity Index (SDAI) Over Time
Week 96
|
71.2 percentage of participants
|
45.8 percentage of participants
|
51.5 percentage of participants
|
|
Percentage of Participants Achieving Low Disease Activity (LDA) Based on Simplified Disease Activity Index (SDAI) Over Time
Week 108
|
75.8 percentage of participants
|
51.2 percentage of participants
|
54.5 percentage of participants
|
|
Percentage of Participants Achieving Low Disease Activity (LDA) Based on Simplified Disease Activity Index (SDAI) Over Time
Week 120
|
74.6 percentage of participants
|
55.2 percentage of participants
|
64.5 percentage of participants
|
|
Percentage of Participants Achieving Low Disease Activity (LDA) Based on Simplified Disease Activity Index (SDAI) Over Time
Week 132
|
77.7 percentage of participants
|
43.4 percentage of participants
|
66.7 percentage of participants
|
|
Percentage of Participants Achieving Low Disease Activity (LDA) Based on Simplified Disease Activity Index (SDAI) Over Time
Week 144
|
70.7 percentage of participants
|
44.3 percentage of participants
|
67.9 percentage of participants
|
|
Percentage of Participants Achieving Low Disease Activity (LDA) Based on Simplified Disease Activity Index (SDAI) Over Time
Week 156
|
75.0 percentage of participants
|
58.5 percentage of participants
|
64.3 percentage of participants
|
|
Percentage of Participants Achieving Low Disease Activity (LDA) Based on Simplified Disease Activity Index (SDAI) Over Time
Week 168
|
75.8 percentage of participants
|
59.4 percentage of participants
|
66.7 percentage of participants
|
|
Percentage of Participants Achieving Low Disease Activity (LDA) Based on Simplified Disease Activity Index (SDAI) Over Time
Week 180
|
78.7 percentage of participants
|
55.9 percentage of participants
|
53.3 percentage of participants
|
|
Percentage of Participants Achieving Low Disease Activity (LDA) Based on Simplified Disease Activity Index (SDAI) Over Time
Week 192
|
76.2 percentage of participants
|
52.9 percentage of participants
|
66.7 percentage of participants
|
|
Percentage of Participants Achieving Low Disease Activity (LDA) Based on Simplified Disease Activity Index (SDAI) Over Time
Week 204
|
71.3 percentage of participants
|
52.9 percentage of participants
|
79.3 percentage of participants
|
|
Percentage of Participants Achieving Low Disease Activity (LDA) Based on Simplified Disease Activity Index (SDAI) Over Time
Week 216
|
79.0 percentage of participants
|
56.3 percentage of participants
|
57.1 percentage of participants
|
|
Percentage of Participants Achieving Low Disease Activity (LDA) Based on Simplified Disease Activity Index (SDAI) Over Time
Week 228
|
77.2 percentage of participants
|
56.4 percentage of participants
|
69.0 percentage of participants
|
|
Percentage of Participants Achieving Low Disease Activity (LDA) Based on Simplified Disease Activity Index (SDAI) Over Time
Week 240
|
74.5 percentage of participants
|
50.0 percentage of participants
|
69.0 percentage of participants
|
|
Percentage of Participants Achieving Low Disease Activity (LDA) Based on Simplified Disease Activity Index (SDAI) Over Time
Week 252
|
79.0 percentage of participants
|
52.6 percentage of participants
|
61.3 percentage of participants
|
|
Percentage of Participants Achieving Low Disease Activity (LDA) Based on Simplified Disease Activity Index (SDAI) Over Time
Week 264
|
71.1 percentage of participants
|
51.9 percentage of participants
|
67.9 percentage of participants
|
|
Percentage of Participants Achieving Low Disease Activity (LDA) Based on Simplified Disease Activity Index (SDAI) Over Time
Week 276
|
78.5 percentage of participants
|
56.6 percentage of participants
|
56.0 percentage of participants
|
|
Percentage of Participants Achieving Low Disease Activity (LDA) Based on Simplified Disease Activity Index (SDAI) Over Time
Week 288
|
74.5 percentage of participants
|
56.5 percentage of participants
|
68.0 percentage of participants
|
|
Percentage of Participants Achieving Low Disease Activity (LDA) Based on Simplified Disease Activity Index (SDAI) Over Time
Week 300
|
78.2 percentage of participants
|
50.0 percentage of participants
|
63.2 percentage of participants
|
|
Percentage of Participants Achieving Low Disease Activity (LDA) Based on Simplified Disease Activity Index (SDAI) Over Time
Week 312
|
72.1 percentage of participants
|
48.9 percentage of participants
|
65.4 percentage of participants
|
SECONDARY outcome
Timeframe: Weeks 6, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, and 312Population: Open-label treated population with available data at each time point
The simplified disease activity index (SDAI) is a composite index for assessing disease activity based on the summation of the counts of tender joint count (out of 28 evaluated joints) and swollen joint count (out of 28 evaluated joints), Patient's Global Assessment of Disease Activity measured on a VAS from 0 to 10 cm, Physician's Global Assessment of Disease Activity measured on a VAS from 0 to 10 cm and hsCRP (mg/dL). The total SDAI score ranges from 0 to 86 with higher scores indicating higher disease activity. Clinical remission is defined as a SDAI score ≤ 3.3.
Outcome measures
| Measure |
Upadacitinib Never Titrated
n=306 Participants
Participants received treatment with upadacitinib for up to 312 weeks. The starting dose was 6 mg twice a day (BID). From January 2017 participants were transitioned to once-daily dose of 15 mg upadacitinib.
|
Upadacitinib Titrated Up and Not Down
n=149 Participants
Participants received treatment with upadacitinib for up to 312 weeks. The starting dose was 6 mg BID. Participants who did not achieve protocol-specified improvement criteria at Week 6 or at any visits thereafter were up-titrated to upadacitinib 12 mg BID. From January 2017 participants were transitioned to once-daily dose of 30 mg upadacitinib.
|
Upadacitinib Titrated Up and Down
n=38 Participants
Participants received treatment with upadacitinib for up to 312 weeks. The starting dose was 6 mg BID. Participants who did not achieve protocol-specified improvement criteria at Week 6 or at any visits thereafter were up-titrated to upadacitinib 12 mg BID. From January 2017 participants were transitioned to once-daily dose of 30 mg upadacitinib. The upadacitinib dose was decreased back to 6 mg BID (or 15 mg QD from January 2017) per Investigator's judgment or safety and/or tolerability concerns.
|
|---|---|---|---|
|
Percentage of Participants Achieving Clinical Remission (CR) Based on Simplified Disease Activity Index (SDAI) Over Time
Week 168
|
31.8 percentage of participants
|
11.6 percentage of participants
|
26.7 percentage of participants
|
|
Percentage of Participants Achieving Clinical Remission (CR) Based on Simplified Disease Activity Index (SDAI) Over Time
Week 180
|
33.1 percentage of participants
|
10.3 percentage of participants
|
13.3 percentage of participants
|
|
Percentage of Participants Achieving Clinical Remission (CR) Based on Simplified Disease Activity Index (SDAI) Over Time
Week 192
|
32.7 percentage of participants
|
12.9 percentage of participants
|
14.8 percentage of participants
|
|
Percentage of Participants Achieving Clinical Remission (CR) Based on Simplified Disease Activity Index (SDAI) Over Time
Week 204
|
37.2 percentage of participants
|
11.4 percentage of participants
|
24.1 percentage of participants
|
|
Percentage of Participants Achieving Clinical Remission (CR) Based on Simplified Disease Activity Index (SDAI) Over Time
Week 216
|
32.5 percentage of participants
|
10.9 percentage of participants
|
10.7 percentage of participants
|
|
Percentage of Participants Achieving Clinical Remission (CR) Based on Simplified Disease Activity Index (SDAI) Over Time
Week 228
|
30.9 percentage of participants
|
16.4 percentage of participants
|
24.1 percentage of participants
|
|
Percentage of Participants Achieving Clinical Remission (CR) Based on Simplified Disease Activity Index (SDAI) Over Time
Week 240
|
34.0 percentage of participants
|
14.5 percentage of participants
|
10.3 percentage of participants
|
|
Percentage of Participants Achieving Clinical Remission (CR) Based on Simplified Disease Activity Index (SDAI) Over Time
Week 252
|
39.9 percentage of participants
|
12.3 percentage of participants
|
16.1 percentage of participants
|
|
Percentage of Participants Achieving Clinical Remission (CR) Based on Simplified Disease Activity Index (SDAI) Over Time
Week 264
|
32.8 percentage of participants
|
11.5 percentage of participants
|
7.1 percentage of participants
|
|
Percentage of Participants Achieving Clinical Remission (CR) Based on Simplified Disease Activity Index (SDAI) Over Time
Week 276
|
35.5 percentage of participants
|
17.0 percentage of participants
|
20.0 percentage of participants
|
|
Percentage of Participants Achieving Clinical Remission (CR) Based on Simplified Disease Activity Index (SDAI) Over Time
Week 288
|
35.8 percentage of participants
|
19.6 percentage of participants
|
8.0 percentage of participants
|
|
Percentage of Participants Achieving Clinical Remission (CR) Based on Simplified Disease Activity Index (SDAI) Over Time
Week 300
|
34.7 percentage of participants
|
16.7 percentage of participants
|
26.3 percentage of participants
|
|
Percentage of Participants Achieving Clinical Remission (CR) Based on Simplified Disease Activity Index (SDAI) Over Time
Week 312
|
30.6 percentage of participants
|
15.6 percentage of participants
|
26.9 percentage of participants
|
|
Percentage of Participants Achieving Clinical Remission (CR) Based on Simplified Disease Activity Index (SDAI) Over Time
Week 6
|
15.0 percentage of participants
|
4.2 percentage of participants
|
2.7 percentage of participants
|
|
Percentage of Participants Achieving Clinical Remission (CR) Based on Simplified Disease Activity Index (SDAI) Over Time
Week 12
|
17.8 percentage of participants
|
2.8 percentage of participants
|
5.9 percentage of participants
|
|
Percentage of Participants Achieving Clinical Remission (CR) Based on Simplified Disease Activity Index (SDAI) Over Time
Week 24
|
18.2 percentage of participants
|
6.0 percentage of participants
|
11.4 percentage of participants
|
|
Percentage of Participants Achieving Clinical Remission (CR) Based on Simplified Disease Activity Index (SDAI) Over Time
Week 36
|
23.6 percentage of participants
|
4.0 percentage of participants
|
8.6 percentage of participants
|
|
Percentage of Participants Achieving Clinical Remission (CR) Based on Simplified Disease Activity Index (SDAI) Over Time
Week 48
|
25.9 percentage of participants
|
7.6 percentage of participants
|
8.3 percentage of participants
|
|
Percentage of Participants Achieving Clinical Remission (CR) Based on Simplified Disease Activity Index (SDAI) Over Time
Week 60
|
32.6 percentage of participants
|
12.1 percentage of participants
|
13.9 percentage of participants
|
|
Percentage of Participants Achieving Clinical Remission (CR) Based on Simplified Disease Activity Index (SDAI) Over Time
Week 72
|
31.0 percentage of participants
|
9.6 percentage of participants
|
9.1 percentage of participants
|
|
Percentage of Participants Achieving Clinical Remission (CR) Based on Simplified Disease Activity Index (SDAI) Over Time
Week 84
|
32.2 percentage of participants
|
8.2 percentage of participants
|
12.5 percentage of participants
|
|
Percentage of Participants Achieving Clinical Remission (CR) Based on Simplified Disease Activity Index (SDAI) Over Time
Week 96
|
28.8 percentage of participants
|
13.5 percentage of participants
|
18.2 percentage of participants
|
|
Percentage of Participants Achieving Clinical Remission (CR) Based on Simplified Disease Activity Index (SDAI) Over Time
Week 108
|
31.4 percentage of participants
|
10.5 percentage of participants
|
12.1 percentage of participants
|
|
Percentage of Participants Achieving Clinical Remission (CR) Based on Simplified Disease Activity Index (SDAI) Over Time
Week 120
|
33.5 percentage of participants
|
8.0 percentage of participants
|
12.9 percentage of participants
|
|
Percentage of Participants Achieving Clinical Remission (CR) Based on Simplified Disease Activity Index (SDAI) Over Time
Week 132
|
33.1 percentage of participants
|
10.5 percentage of participants
|
20.0 percentage of participants
|
|
Percentage of Participants Achieving Clinical Remission (CR) Based on Simplified Disease Activity Index (SDAI) Over Time
Week 144
|
26.3 percentage of participants
|
5.7 percentage of participants
|
14.3 percentage of participants
|
|
Percentage of Participants Achieving Clinical Remission (CR) Based on Simplified Disease Activity Index (SDAI) Over Time
Week 156
|
33.5 percentage of participants
|
7.7 percentage of participants
|
28.6 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline (of the preceding RCT study) and Weeks 6, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, and 312Population: Open-label treated population with available data at Baseline and each time point
The disease activity score-28-CRP (DAS28 \[CRP\]) assesses RA disease activity based on a continuous scale of combined measures of 28 tender joint counts (TJC28), 28 swollen joint counts (SJC28), C-reactive protein (CRP), and the patient global assessment of disease activity (measured on a visual analog scale from 0 to 100 mm). DAS28(CRP) scores range from 0 to approximately 10 where higher scores indicate more disease activity. A negative change from Baseline in DAS28 (CRP) indicates improvement in disease activity.
Outcome measures
| Measure |
Upadacitinib Never Titrated
n=305 Participants
Participants received treatment with upadacitinib for up to 312 weeks. The starting dose was 6 mg twice a day (BID). From January 2017 participants were transitioned to once-daily dose of 15 mg upadacitinib.
|
Upadacitinib Titrated Up and Not Down
n=146 Participants
Participants received treatment with upadacitinib for up to 312 weeks. The starting dose was 6 mg BID. Participants who did not achieve protocol-specified improvement criteria at Week 6 or at any visits thereafter were up-titrated to upadacitinib 12 mg BID. From January 2017 participants were transitioned to once-daily dose of 30 mg upadacitinib.
|
Upadacitinib Titrated Up and Down
n=37 Participants
Participants received treatment with upadacitinib for up to 312 weeks. The starting dose was 6 mg BID. Participants who did not achieve protocol-specified improvement criteria at Week 6 or at any visits thereafter were up-titrated to upadacitinib 12 mg BID. From January 2017 participants were transitioned to once-daily dose of 30 mg upadacitinib. The upadacitinib dose was decreased back to 6 mg BID (or 15 mg QD from January 2017) per Investigator's judgment or safety and/or tolerability concerns.
|
|---|---|---|---|
|
Change From Baseline in Disease Activity Score Based on CRP (DAS28 [CRP]) Over Time
Week 12
|
-3.1 score on a scale
Standard Deviation 1.14
|
-2.5 score on a scale
Standard Deviation 1.27
|
-2.5 score on a scale
Standard Deviation 1.03
|
|
Change From Baseline in Disease Activity Score Based on CRP (DAS28 [CRP]) Over Time
Week 6
|
-2.9 score on a scale
Standard Deviation 1.21
|
-2.4 score on a scale
Standard Deviation 1.28
|
-2.5 score on a scale
Standard Deviation 1.01
|
|
Change From Baseline in Disease Activity Score Based on CRP (DAS28 [CRP]) Over Time
Week 24
|
-3.2 score on a scale
Standard Deviation 1.07
|
-2.7 score on a scale
Standard Deviation 1.36
|
-2.7 score on a scale
Standard Deviation 1.22
|
|
Change From Baseline in Disease Activity Score Based on CRP (DAS28 [CRP]) Over Time
Week 36
|
-3.2 score on a scale
Standard Deviation 1.20
|
-2.9 score on a scale
Standard Deviation 1.11
|
-3.0 score on a scale
Standard Deviation 1.17
|
|
Change From Baseline in Disease Activity Score Based on CRP (DAS28 [CRP]) Over Time
Week 48
|
-3.4 score on a scale
Standard Deviation 1.20
|
-2.9 score on a scale
Standard Deviation 1.20
|
-2.8 score on a scale
Standard Deviation 0.97
|
|
Change From Baseline in Disease Activity Score Based on CRP (DAS28 [CRP]) Over Time
Week 60
|
-3.5 score on a scale
Standard Deviation 1.15
|
-2.9 score on a scale
Standard Deviation 1.07
|
-3.1 score on a scale
Standard Deviation 0.98
|
|
Change From Baseline in Disease Activity Score Based on CRP (DAS28 [CRP]) Over Time
Week 72
|
-3.5 score on a scale
Standard Deviation 1.03
|
-2.9 score on a scale
Standard Deviation 1.24
|
-3.1 score on a scale
Standard Deviation 0.88
|
|
Change From Baseline in Disease Activity Score Based on CRP (DAS28 [CRP]) Over Time
Week 84
|
-3.5 score on a scale
Standard Deviation 1.06
|
-2.9 score on a scale
Standard Deviation 1.28
|
-3.3 score on a scale
Standard Deviation 0.62
|
|
Change From Baseline in Disease Activity Score Based on CRP (DAS28 [CRP]) Over Time
Week 96
|
-3.4 score on a scale
Standard Deviation 1.11
|
-3.1 score on a scale
Standard Deviation 1.21
|
-3.2 score on a scale
Standard Deviation 0.98
|
|
Change From Baseline in Disease Activity Score Based on CRP (DAS28 [CRP]) Over Time
Week 108
|
-3.5 score on a scale
Standard Deviation 1.09
|
-3.1 score on a scale
Standard Deviation 1.24
|
-3.1 score on a scale
Standard Deviation 0.94
|
|
Change From Baseline in Disease Activity Score Based on CRP (DAS28 [CRP]) Over Time
Week 120
|
-3.5 score on a scale
Standard Deviation 1.08
|
-3.1 score on a scale
Standard Deviation 1.29
|
-3.2 score on a scale
Standard Deviation 0.86
|
|
Change From Baseline in Disease Activity Score Based on CRP (DAS28 [CRP]) Over Time
Week 132
|
-3.5 score on a scale
Standard Deviation 1.02
|
-3.1 score on a scale
Standard Deviation 1.23
|
-3.3 score on a scale
Standard Deviation 1.02
|
|
Change From Baseline in Disease Activity Score Based on CRP (DAS28 [CRP]) Over Time
Week 144
|
-3.4 score on a scale
Standard Deviation 1.13
|
-3.0 score on a scale
Standard Deviation 1.18
|
-3.4 score on a scale
Standard Deviation 1.04
|
|
Change From Baseline in Disease Activity Score Based on CRP (DAS28 [CRP]) Over Time
Week 156
|
-3.5 score on a scale
Standard Deviation 1.13
|
-3.1 score on a scale
Standard Deviation 1.11
|
-3.6 score on a scale
Standard Deviation 1.00
|
|
Change From Baseline in Disease Activity Score Based on CRP (DAS28 [CRP]) Over Time
Week 168
|
-3.6 score on a scale
Standard Deviation 1.17
|
-3.2 score on a scale
Standard Deviation 1.23
|
-3.6 score on a scale
Standard Deviation 1.08
|
|
Change From Baseline in Disease Activity Score Based on CRP (DAS28 [CRP]) Over Time
Week 180
|
-3.6 score on a scale
Standard Deviation 1.10
|
-3.2 score on a scale
Standard Deviation 1.24
|
-3.5 score on a scale
Standard Deviation 1.13
|
|
Change From Baseline in Disease Activity Score Based on CRP (DAS28 [CRP]) Over Time
Week 192
|
-3.6 score on a scale
Standard Deviation 1.15
|
-3.2 score on a scale
Standard Deviation 1.31
|
-3.6 score on a scale
Standard Deviation 1.06
|
|
Change From Baseline in Disease Activity Score Based on CRP (DAS28 [CRP]) Over Time
Week 204
|
-3.6 score on a scale
Standard Deviation 1.13
|
-3.1 score on a scale
Standard Deviation 1.32
|
-3.7 score on a scale
Standard Deviation 1.13
|
|
Change From Baseline in Disease Activity Score Based on CRP (DAS28 [CRP]) Over Time
Week 216
|
-3.6 score on a scale
Standard Deviation 1.13
|
-3.2 score on a scale
Standard Deviation 1.15
|
-3.5 score on a scale
Standard Deviation 1.02
|
|
Change From Baseline in Disease Activity Score Based on CRP (DAS28 [CRP]) Over Time
Week 228
|
-3.6 score on a scale
Standard Deviation 1.12
|
-3.3 score on a scale
Standard Deviation 1.37
|
-3.7 score on a scale
Standard Deviation 0.91
|
|
Change From Baseline in Disease Activity Score Based on CRP (DAS28 [CRP]) Over Time
Week 240
|
-3.7 score on a scale
Standard Deviation 1.12
|
-3.2 score on a scale
Standard Deviation 1.30
|
-3.5 score on a scale
Standard Deviation 0.91
|
|
Change From Baseline in Disease Activity Score Based on CRP (DAS28 [CRP]) Over Time
Week 252
|
-3.7 score on a scale
Standard Deviation 1.20
|
-3.3 score on a scale
Standard Deviation 1.18
|
-3.3 score on a scale
Standard Deviation 1.04
|
|
Change From Baseline in Disease Activity Score Based on CRP (DAS28 [CRP]) Over Time
Week 264
|
-3.5 score on a scale
Standard Deviation 1.25
|
-3.1 score on a scale
Standard Deviation 1.24
|
-3.4 score on a scale
Standard Deviation 1.01
|
|
Change From Baseline in Disease Activity Score Based on CRP (DAS28 [CRP]) Over Time
Week 276
|
-3.7 score on a scale
Standard Deviation 1.01
|
-3.1 score on a scale
Standard Deviation 1.22
|
-3.5 score on a scale
Standard Deviation 0.90
|
|
Change From Baseline in Disease Activity Score Based on CRP (DAS28 [CRP]) Over Time
Week 288
|
-3.7 score on a scale
Standard Deviation 1.08
|
-3.3 score on a scale
Standard Deviation 1.44
|
-3.2 score on a scale
Standard Deviation 0.75
|
|
Change From Baseline in Disease Activity Score Based on CRP (DAS28 [CRP]) Over Time
Week 300
|
-3.7 score on a scale
Standard Deviation 1.00
|
-3.0 score on a scale
Standard Deviation 1.38
|
-3.4 score on a scale
Standard Deviation 0.81
|
|
Change From Baseline in Disease Activity Score Based on CRP (DAS28 [CRP]) Over Time
Week 312
|
-3.5 score on a scale
Standard Deviation 1.10
|
-3.2 score on a scale
Standard Deviation 1.25
|
-3.2 score on a scale
Standard Deviation 1.04
|
SECONDARY outcome
Timeframe: Baseline (of the preceding RCT study) and Weeks 6, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, and 312Population: Open-label treated population with available data at Baseline and each time point
The clinical disease activity index (CDAI) is a composite index for assessing disease activity based on the summation of the counts of tender joint count (out of 28 evaluated joints) and swollen joint count (out of 28 evaluated joints), Patient's Global Assessment of Disease Activity measured on a VAS from 0 to 10 cm, and Physician's Global Assessment of Disease Activity measured on a VAS from 0 to 10 cm. The total CDAI score ranges from 0 to 78 with higher scores indicating higher disease activity. A negative change from Baseline indicates improvement in disease activity.
Outcome measures
| Measure |
Upadacitinib Never Titrated
n=297 Participants
Participants received treatment with upadacitinib for up to 312 weeks. The starting dose was 6 mg twice a day (BID). From January 2017 participants were transitioned to once-daily dose of 15 mg upadacitinib.
|
Upadacitinib Titrated Up and Not Down
n=144 Participants
Participants received treatment with upadacitinib for up to 312 weeks. The starting dose was 6 mg BID. Participants who did not achieve protocol-specified improvement criteria at Week 6 or at any visits thereafter were up-titrated to upadacitinib 12 mg BID. From January 2017 participants were transitioned to once-daily dose of 30 mg upadacitinib.
|
Upadacitinib Titrated Up and Down
n=37 Participants
Participants received treatment with upadacitinib for up to 312 weeks. The starting dose was 6 mg BID. Participants who did not achieve protocol-specified improvement criteria at Week 6 or at any visits thereafter were up-titrated to upadacitinib 12 mg BID. From January 2017 participants were transitioned to once-daily dose of 30 mg upadacitinib. The upadacitinib dose was decreased back to 6 mg BID (or 15 mg QD from January 2017) per Investigator's judgment or safety and/or tolerability concerns.
|
|---|---|---|---|
|
Change From Baseline in Clinical Disease Activity Index (CDAI) Over Time
Week 6
|
-30.0 score on a scale
Standard Deviation 12.49
|
-27.5 score on a scale
Standard Deviation 13.54
|
-27.2 score on a scale
Standard Deviation 11.42
|
|
Change From Baseline in Clinical Disease Activity Index (CDAI) Over Time
Week 12
|
-31.6 score on a scale
Standard Deviation 11.82
|
-28.4 score on a scale
Standard Deviation 13.87
|
-27.9 score on a scale
Standard Deviation 11.12
|
|
Change From Baseline in Clinical Disease Activity Index (CDAI) Over Time
Week 24
|
-32.6 score on a scale
Standard Deviation 11.81
|
-30.6 score on a scale
Standard Deviation 13.59
|
-29.6 score on a scale
Standard Deviation 11.45
|
|
Change From Baseline in Clinical Disease Activity Index (CDAI) Over Time
Week 36
|
-32.2 score on a scale
Standard Deviation 12.43
|
-31.4 score on a scale
Standard Deviation 12.67
|
-29.6 score on a scale
Standard Deviation 11.63
|
|
Change From Baseline in Clinical Disease Activity Index (CDAI) Over Time
Week 48
|
-34.0 score on a scale
Standard Deviation 12.84
|
-31.8 score on a scale
Standard Deviation 13.35
|
-29.1 score on a scale
Standard Deviation 10.82
|
|
Change From Baseline in Clinical Disease Activity Index (CDAI) Over Time
Week 60
|
-34.7 score on a scale
Standard Deviation 12.52
|
-32.4 score on a scale
Standard Deviation 12.18
|
-32.2 score on a scale
Standard Deviation 12.09
|
|
Change From Baseline in Clinical Disease Activity Index (CDAI) Over Time
Week 72
|
-34.3 score on a scale
Standard Deviation 11.71
|
-32.3 score on a scale
Standard Deviation 13.33
|
-31.8 score on a scale
Standard Deviation 10.88
|
|
Change From Baseline in Clinical Disease Activity Index (CDAI) Over Time
Week 84
|
-34.9 score on a scale
Standard Deviation 12.08
|
-31.0 score on a scale
Standard Deviation 13.36
|
-33.5 score on a scale
Standard Deviation 9.66
|
|
Change From Baseline in Clinical Disease Activity Index (CDAI) Over Time
Week 96
|
-33.4 score on a scale
Standard Deviation 11.71
|
-32.1 score on a scale
Standard Deviation 12.37
|
-31.3 score on a scale
Standard Deviation 10.86
|
|
Change From Baseline in Clinical Disease Activity Index (CDAI) Over Time
Week 108
|
-34.5 score on a scale
Standard Deviation 11.83
|
-32.4 score on a scale
Standard Deviation 12.79
|
-32.3 score on a scale
Standard Deviation 10.81
|
|
Change From Baseline in Clinical Disease Activity Index (CDAI) Over Time
Week 120
|
-34.8 score on a scale
Standard Deviation 11.87
|
-32.3 score on a scale
Standard Deviation 12.94
|
-34.0 score on a scale
Standard Deviation 10.75
|
|
Change From Baseline in Clinical Disease Activity Index (CDAI) Over Time
Week 132
|
-35.0 score on a scale
Standard Deviation 12.24
|
-32.7 score on a scale
Standard Deviation 12.39
|
-34.5 score on a scale
Standard Deviation 12.14
|
|
Change From Baseline in Clinical Disease Activity Index (CDAI) Over Time
Week 144
|
-35.0 score on a scale
Standard Deviation 12.21
|
-33.1 score on a scale
Standard Deviation 12.67
|
-36.2 score on a scale
Standard Deviation 12.03
|
|
Change From Baseline in Clinical Disease Activity Index (CDAI) Over Time
Week 156
|
-35.6 score on a scale
Standard Deviation 12.24
|
-33.6 score on a scale
Standard Deviation 12.25
|
-36.1 score on a scale
Standard Deviation 11.80
|
|
Change From Baseline in Clinical Disease Activity Index (CDAI) Over Time
Week 168
|
-36.2 score on a scale
Standard Deviation 13.01
|
-33.8 score on a scale
Standard Deviation 12.97
|
-37.6 score on a scale
Standard Deviation 13.08
|
|
Change From Baseline in Clinical Disease Activity Index (CDAI) Over Time
Week 180
|
-35.5 score on a scale
Standard Deviation 12.60
|
-34.0 score on a scale
Standard Deviation 12.13
|
-36.9 score on a scale
Standard Deviation 12.07
|
|
Change From Baseline in Clinical Disease Activity Index (CDAI) Over Time
Week 192
|
-35.6 score on a scale
Standard Deviation 12.25
|
-34.0 score on a scale
Standard Deviation 12.89
|
-38.6 score on a scale
Standard Deviation 11.76
|
|
Change From Baseline in Clinical Disease Activity Index (CDAI) Over Time
Week 204
|
-36.0 score on a scale
Standard Deviation 12.36
|
-33.8 score on a scale
Standard Deviation 13.69
|
-37.9 score on a scale
Standard Deviation 12.59
|
|
Change From Baseline in Clinical Disease Activity Index (CDAI) Over Time
Week 216
|
-35.8 score on a scale
Standard Deviation 13.19
|
-33.9 score on a scale
Standard Deviation 11.87
|
-37.3 score on a scale
Standard Deviation 11.62
|
|
Change From Baseline in Clinical Disease Activity Index (CDAI) Over Time
Week 228
|
-35.6 score on a scale
Standard Deviation 12.68
|
-35.5 score on a scale
Standard Deviation 13.31
|
-37.9 score on a scale
Standard Deviation 11.55
|
|
Change From Baseline in Clinical Disease Activity Index (CDAI) Over Time
Week 240
|
-36.4 score on a scale
Standard Deviation 12.95
|
-34.7 score on a scale
Standard Deviation 13.02
|
-35.8 score on a scale
Standard Deviation 11.07
|
|
Change From Baseline in Clinical Disease Activity Index (CDAI) Over Time
Week 252
|
-35.9 score on a scale
Standard Deviation 13.41
|
-35.3 score on a scale
Standard Deviation 12.58
|
-34.3 score on a scale
Standard Deviation 11.71
|
|
Change From Baseline in Clinical Disease Activity Index (CDAI) Over Time
Week 264
|
-35.5 score on a scale
Standard Deviation 13.66
|
-33.2 score on a scale
Standard Deviation 12.38
|
-33.5 score on a scale
Standard Deviation 12.49
|
|
Change From Baseline in Clinical Disease Activity Index (CDAI) Over Time
Week 276
|
-36.5 score on a scale
Standard Deviation 12.59
|
-33.6 score on a scale
Standard Deviation 12.16
|
-34.7 score on a scale
Standard Deviation 11.92
|
|
Change From Baseline in Clinical Disease Activity Index (CDAI) Over Time
Week 288
|
-36.9 score on a scale
Standard Deviation 13.22
|
-35.3 score on a scale
Standard Deviation 14.34
|
-33.5 score on a scale
Standard Deviation 10.25
|
|
Change From Baseline in Clinical Disease Activity Index (CDAI) Over Time
Week 300
|
-36.0 score on a scale
Standard Deviation 12.17
|
-32.9 score on a scale
Standard Deviation 11.86
|
-34.6 score on a scale
Standard Deviation 11.27
|
|
Change From Baseline in Clinical Disease Activity Index (CDAI) Over Time
Week 312
|
-35.9 score on a scale
Standard Deviation 12.43
|
-34.4 score on a scale
Standard Deviation 12.63
|
-34.0 score on a scale
Standard Deviation 11.62
|
SECONDARY outcome
Timeframe: Baseline (of the preceding RCT study) and Weeks 6, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, and 312Population: Open-label treated population with available data at Baseline and each time point
The simplified disease activity index (SDAI) is a composite index for assessing disease activity based on the summation of the counts of tender joint count (out of 28 evaluated joints) and swollen joint count (out of 28 evaluated joints), Patient's Global Assessment of Disease Activity measured on a VAS from 0 to 10 cm, Physician's Global Assessment of Disease Activity measured on a VAS from 0 to 10 cm and hsCRP (mg/dL). The total SDAI score ranges from 0 to 86 with higher scores indicating higher disease activity. A negative change from Baseline indicates improvement in disease activity.
Outcome measures
| Measure |
Upadacitinib Never Titrated
n=297 Participants
Participants received treatment with upadacitinib for up to 312 weeks. The starting dose was 6 mg twice a day (BID). From January 2017 participants were transitioned to once-daily dose of 15 mg upadacitinib.
|
Upadacitinib Titrated Up and Not Down
n=144 Participants
Participants received treatment with upadacitinib for up to 312 weeks. The starting dose was 6 mg BID. Participants who did not achieve protocol-specified improvement criteria at Week 6 or at any visits thereafter were up-titrated to upadacitinib 12 mg BID. From January 2017 participants were transitioned to once-daily dose of 30 mg upadacitinib.
|
Upadacitinib Titrated Up and Down
n=37 Participants
Participants received treatment with upadacitinib for up to 312 weeks. The starting dose was 6 mg BID. Participants who did not achieve protocol-specified improvement criteria at Week 6 or at any visits thereafter were up-titrated to upadacitinib 12 mg BID. From January 2017 participants were transitioned to once-daily dose of 30 mg upadacitinib. The upadacitinib dose was decreased back to 6 mg BID (or 15 mg QD from January 2017) per Investigator's judgment or safety and/or tolerability concerns.
|
|---|---|---|---|
|
Change From Baseline in SimplifiedDisease Activity Index (SDAI) Over Time
Week 36
|
-41.8 score on a scale
Standard Deviation 25.10
|
-41.6 score on a scale
Standard Deviation 25.59
|
-44.5 score on a scale
Standard Deviation 31.98
|
|
Change From Baseline in SimplifiedDisease Activity Index (SDAI) Over Time
Week 48
|
-42.9 score on a scale
Standard Deviation 23.24
|
-41.6 score on a scale
Standard Deviation 25.26
|
-44.6 score on a scale
Standard Deviation 29.09
|
|
Change From Baseline in SimplifiedDisease Activity Index (SDAI) Over Time
Week 60
|
-44.3 score on a scale
Standard Deviation 24.21
|
-42.5 score on a scale
Standard Deviation 24.51
|
-41.4 score on a scale
Standard Deviation 22.38
|
|
Change From Baseline in SimplifiedDisease Activity Index (SDAI) Over Time
Week 72
|
-43.4 score on a scale
Standard Deviation 24.62
|
-41.9 score on a scale
Standard Deviation 27.31
|
-41.8 score on a scale
Standard Deviation 21.19
|
|
Change From Baseline in SimplifiedDisease Activity Index (SDAI) Over Time
Week 84
|
-42.7 score on a scale
Standard Deviation 28.14
|
-39.0 score on a scale
Standard Deviation 31.94
|
-44.7 score on a scale
Standard Deviation 20.79
|
|
Change From Baseline in SimplifiedDisease Activity Index (SDAI) Over Time
Week 96
|
-42.0 score on a scale
Standard Deviation 18.50
|
-42.4 score on a scale
Standard Deviation 27.17
|
-43.2 score on a scale
Standard Deviation 22.39
|
|
Change From Baseline in SimplifiedDisease Activity Index (SDAI) Over Time
Week 108
|
-43.6 score on a scale
Standard Deviation 27.35
|
-42.9 score on a scale
Standard Deviation 24.31
|
-44.0 score on a scale
Standard Deviation 21.38
|
|
Change From Baseline in SimplifiedDisease Activity Index (SDAI) Over Time
Week 120
|
-42.7 score on a scale
Standard Deviation 22.25
|
-43.7 score on a scale
Standard Deviation 25.88
|
-43.4 score on a scale
Standard Deviation 23.39
|
|
Change From Baseline in SimplifiedDisease Activity Index (SDAI) Over Time
Week 132
|
-43.4 score on a scale
Standard Deviation 19.92
|
-41.4 score on a scale
Standard Deviation 27.64
|
-44.2 score on a scale
Standard Deviation 23.86
|
|
Change From Baseline in SimplifiedDisease Activity Index (SDAI) Over Time
Week 144
|
-41.7 score on a scale
Standard Deviation 22.60
|
-43.0 score on a scale
Standard Deviation 29.91
|
-46.0 score on a scale
Standard Deviation 25.20
|
|
Change From Baseline in SimplifiedDisease Activity Index (SDAI) Over Time
Week 156
|
-42.8 score on a scale
Standard Deviation 21.64
|
-43.6 score on a scale
Standard Deviation 29.88
|
-48.0 score on a scale
Standard Deviation 23.98
|
|
Change From Baseline in SimplifiedDisease Activity Index (SDAI) Over Time
Week 168
|
-43.7 score on a scale
Standard Deviation 23.75
|
-43.2 score on a scale
Standard Deviation 28.55
|
-46.4 score on a scale
Standard Deviation 23.28
|
|
Change From Baseline in SimplifiedDisease Activity Index (SDAI) Over Time
Week 180
|
-45.6 score on a scale
Standard Deviation 26.65
|
-45.0 score on a scale
Standard Deviation 27.57
|
-47.2 score on a scale
Standard Deviation 24.08
|
|
Change From Baseline in SimplifiedDisease Activity Index (SDAI) Over Time
Week 192
|
-44.7 score on a scale
Standard Deviation 30.13
|
-44.4 score on a scale
Standard Deviation 27.94
|
-48.5 score on a scale
Standard Deviation 25.36
|
|
Change From Baseline in SimplifiedDisease Activity Index (SDAI) Over Time
Week 204
|
-44.1 score on a scale
Standard Deviation 35.23
|
-43.5 score on a scale
Standard Deviation 28.81
|
-47.6 score on a scale
Standard Deviation 24.55
|
|
Change From Baseline in SimplifiedDisease Activity Index (SDAI) Over Time
Week 216
|
-47.3 score on a scale
Standard Deviation 27.43
|
-44.2 score on a scale
Standard Deviation 26.69
|
-47.4 score on a scale
Standard Deviation 23.26
|
|
Change From Baseline in SimplifiedDisease Activity Index (SDAI) Over Time
Week 228
|
-46.0 score on a scale
Standard Deviation 27.33
|
-47.9 score on a scale
Standard Deviation 28.86
|
-48.6 score on a scale
Standard Deviation 21.47
|
|
Change From Baseline in SimplifiedDisease Activity Index (SDAI) Over Time
Week 240
|
-46.8 score on a scale
Standard Deviation 31.40
|
-44.2 score on a scale
Standard Deviation 29.63
|
-45.0 score on a scale
Standard Deviation 21.97
|
|
Change From Baseline in SimplifiedDisease Activity Index (SDAI) Over Time
Week 252
|
-45.9 score on a scale
Standard Deviation 25.86
|
-45.7 score on a scale
Standard Deviation 29.98
|
-44.3 score on a scale
Standard Deviation 23.50
|
|
Change From Baseline in SimplifiedDisease Activity Index (SDAI) Over Time
Week 264
|
-44.9 score on a scale
Standard Deviation 24.26
|
-43.5 score on a scale
Standard Deviation 30.06
|
-44.4 score on a scale
Standard Deviation 21.96
|
|
Change From Baseline in SimplifiedDisease Activity Index (SDAI) Over Time
Week 276
|
-46.3 score on a scale
Standard Deviation 20.01
|
-44.2 score on a scale
Standard Deviation 26.93
|
-47.4 score on a scale
Standard Deviation 20.53
|
|
Change From Baseline in SimplifiedDisease Activity Index (SDAI) Over Time
Week 288
|
-47.1 score on a scale
Standard Deviation 22.36
|
-48.3 score on a scale
Standard Deviation 30.14
|
-41.6 score on a scale
Standard Deviation 17.15
|
|
Change From Baseline in SimplifiedDisease Activity Index (SDAI) Over Time
Week 300
|
-47.4 score on a scale
Standard Deviation 20.47
|
-41.6 score on a scale
Standard Deviation 26.38
|
-42.7 score on a scale
Standard Deviation 19.05
|
|
Change From Baseline in SimplifiedDisease Activity Index (SDAI) Over Time
Week 312
|
-45.8 score on a scale
Standard Deviation 28.64
|
-45.8 score on a scale
Standard Deviation 28.89
|
-41.2 score on a scale
Standard Deviation 17.55
|
|
Change From Baseline in SimplifiedDisease Activity Index (SDAI) Over Time
Week 6
|
-38.8 score on a scale
Standard Deviation 25.57
|
-37.2 score on a scale
Standard Deviation 27.36
|
-40.8 score on a scale
Standard Deviation 29.76
|
|
Change From Baseline in SimplifiedDisease Activity Index (SDAI) Over Time
Week 12
|
-40.6 score on a scale
Standard Deviation 24.84
|
-38.6 score on a scale
Standard Deviation 26.09
|
-41.7 score on a scale
Standard Deviation 30.24
|
|
Change From Baseline in SimplifiedDisease Activity Index (SDAI) Over Time
Week 24
|
-42.0 score on a scale
Standard Deviation 23.35
|
-36.7 score on a scale
Standard Deviation 43.09
|
-38.2 score on a scale
Standard Deviation 33.62
|
SECONDARY outcome
Timeframe: Baseline (of the preceding RCT study) and Weeks 6, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, and 312Population: Open-label treated population with available data at each time point
Sixty-eight joints were assessed by an evaluator for tenderness or pain. The presence of tenderness was scored as a "1" and absence of tenderness as a "0". The total tender joint count is the sum of the scores, and ranges from 0 to 68 (worst).
Outcome measures
| Measure |
Upadacitinib Never Titrated
n=306 Participants
Participants received treatment with upadacitinib for up to 312 weeks. The starting dose was 6 mg twice a day (BID). From January 2017 participants were transitioned to once-daily dose of 15 mg upadacitinib.
|
Upadacitinib Titrated Up and Not Down
n=149 Participants
Participants received treatment with upadacitinib for up to 312 weeks. The starting dose was 6 mg BID. Participants who did not achieve protocol-specified improvement criteria at Week 6 or at any visits thereafter were up-titrated to upadacitinib 12 mg BID. From January 2017 participants were transitioned to once-daily dose of 30 mg upadacitinib.
|
Upadacitinib Titrated Up and Down
n=38 Participants
Participants received treatment with upadacitinib for up to 312 weeks. The starting dose was 6 mg BID. Participants who did not achieve protocol-specified improvement criteria at Week 6 or at any visits thereafter were up-titrated to upadacitinib 12 mg BID. From January 2017 participants were transitioned to once-daily dose of 30 mg upadacitinib. The upadacitinib dose was decreased back to 6 mg BID (or 15 mg QD from January 2017) per Investigator's judgment or safety and/or tolerability concerns.
|
|---|---|---|---|
|
Change From Baseline in Tender Joint Count (TJC68) Over Time
Week 6
|
-20.6 joints
Standard Deviation 12.81
|
-21.3 joints
Standard Deviation 14.53
|
-22.1 joints
Standard Deviation 12.90
|
|
Change From Baseline in Tender Joint Count (TJC68) Over Time
Week 12
|
-21.3 joints
Standard Deviation 12.47
|
-22.5 joints
Standard Deviation 14.65
|
-20.5 joints
Standard Deviation 11.18
|
|
Change From Baseline in Tender Joint Count (TJC68) Over Time
Week 24
|
-22.0 joints
Standard Deviation 12.96
|
-23.9 joints
Standard Deviation 14.60
|
-22.9 joints
Standard Deviation 12.17
|
|
Change From Baseline in Tender Joint Count (TJC68) Over Time
Week 36
|
-21.7 joints
Standard Deviation 12.58
|
-24.2 joints
Standard Deviation 14.45
|
-23.4 joints
Standard Deviation 13.56
|
|
Change From Baseline in Tender Joint Count (TJC68) Over Time
Week 48
|
-23.1 joints
Standard Deviation 13.61
|
-24.1 joints
Standard Deviation 14.43
|
-24.0 joints
Standard Deviation 13.13
|
|
Change From Baseline in Tender Joint Count (TJC68) Over Time
Week 60
|
-23.6 joints
Standard Deviation 13.56
|
-25.0 joints
Standard Deviation 14.42
|
-25.6 joints
Standard Deviation 13.54
|
|
Change From Baseline in Tender Joint Count (TJC68) Over Time
Week 72
|
-23.3 joints
Standard Deviation 13.06
|
-24.3 joints
Standard Deviation 14.48
|
-26.1 joints
Standard Deviation 13.12
|
|
Change From Baseline in Tender Joint Count (TJC68) Over Time
Week 84
|
-23.2 joints
Standard Deviation 12.71
|
-23.4 joints
Standard Deviation 14.23
|
-27.4 joints
Standard Deviation 13.32
|
|
Change From Baseline in Tender Joint Count (TJC68) Over Time
Week 96
|
-23.1 joints
Standard Deviation 12.90
|
-23.9 joints
Standard Deviation 14.58
|
-24.6 joints
Standard Deviation 11.94
|
|
Change From Baseline in Tender Joint Count (TJC68) Over Time
Week 108
|
-23.3 joints
Standard Deviation 12.62
|
-23.7 joints
Standard Deviation 14.22
|
-25.2 joints
Standard Deviation 12.31
|
|
Change From Baseline in Tender Joint Count (TJC68) Over Time
Week 120
|
-23.1 joints
Standard Deviation 13.13
|
-23.9 joints
Standard Deviation 14.17
|
-26.9 joints
Standard Deviation 12.72
|
|
Change From Baseline in Tender Joint Count (TJC68) Over Time
Week 132
|
-23.1 joints
Standard Deviation 12.79
|
-23.7 joints
Standard Deviation 13.95
|
-26.8 joints
Standard Deviation 13.74
|
|
Change From Baseline in Tender Joint Count (TJC68) Over Time
Week 144
|
-23.5 joints
Standard Deviation 13.28
|
-23.8 joints
Standard Deviation 13.50
|
-29.3 joints
Standard Deviation 13.19
|
|
Change From Baseline in Tender Joint Count (TJC68) Over Time
Week 156
|
-23.7 joints
Standard Deviation 13.21
|
-23.9 joints
Standard Deviation 13.00
|
-28.1 joints
Standard Deviation 13.63
|
|
Change From Baseline in Tender Joint Count (TJC68) Over Time
Week 168
|
-24.1 joints
Standard Deviation 13.82
|
-24.4 joints
Standard Deviation 13.86
|
-31.0 joints
Standard Deviation 14.12
|
|
Change From Baseline in Tender Joint Count (TJC68) Over Time
Week 180
|
-23.7 joints
Standard Deviation 13.60
|
-24.9 joints
Standard Deviation 14.12
|
-29.5 joints
Standard Deviation 12.96
|
|
Change From Baseline in Tender Joint Count (TJC68) Over Time
Week 192
|
-24.0 joints
Standard Deviation 13.75
|
-24.4 joints
Standard Deviation 14.15
|
-31.3 joints
Standard Deviation 13.80
|
|
Change From Baseline in Tender Joint Count (TJC68) Over Time
Week 204
|
-24.2 joints
Standard Deviation 13.77
|
-23.6 joints
Standard Deviation 14.35
|
-30.4 joints
Standard Deviation 14.53
|
|
Change From Baseline in Tender Joint Count (TJC68) Over Time
Week 216
|
-24.2 joints
Standard Deviation 13.82
|
-24.1 joints
Standard Deviation 13.87
|
-31.6 joints
Standard Deviation 13.80
|
|
Change From Baseline in Tender Joint Count (TJC68) Over Time
Week 228
|
-23.9 joints
Standard Deviation 13.57
|
-26.6 joints
Standard Deviation 14.65
|
-30.5 joints
Standard Deviation 13.69
|
|
Change From Baseline in Tender Joint Count (TJC68) Over Time
Week 240
|
-24.7 joints
Standard Deviation 14.09
|
-25.6 joints
Standard Deviation 14.47
|
-29.4 joints
Standard Deviation 14.28
|
|
Change From Baseline in Tender Joint Count (TJC68) Over Time
Week 252
|
-24.2 joints
Standard Deviation 13.78
|
-25.6 joints
Standard Deviation 14.14
|
-27.5 joints
Standard Deviation 13.26
|
|
Change From Baseline in Tender Joint Count (TJC68) Over Time
Week 264
|
-23.7 joints
Standard Deviation 13.56
|
-23.7 joints
Standard Deviation 13.28
|
-27.0 joints
Standard Deviation 13.76
|
|
Change From Baseline in Tender Joint Count (TJC68) Over Time
Week 276
|
-23.6 joints
Standard Deviation 13.55
|
-23.9 joints
Standard Deviation 13.76
|
-28.0 joints
Standard Deviation 14.41
|
|
Change From Baseline in Tender Joint Count (TJC68) Over Time
Week 288
|
-24.9 joints
Standard Deviation 14.42
|
-25.7 joints
Standard Deviation 14.87
|
-26.6 joints
Standard Deviation 14.42
|
|
Change From Baseline in Tender Joint Count (TJC68) Over Time
Week 300
|
-24.3 joints
Standard Deviation 14.04
|
-24.5 joints
Standard Deviation 15.18
|
-28.2 joints
Standard Deviation 14.10
|
|
Change From Baseline in Tender Joint Count (TJC68) Over Time
Week 312
|
-24.1 joints
Standard Deviation 13.82
|
-23.2 joints
Standard Deviation 14.08
|
-26.8 joints
Standard Deviation 14.48
|
SECONDARY outcome
Timeframe: Baseline (of the preceding RCT study) and Weeks 6, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, and 312Population: Open-label treated population with available data at each time point
Sixty-six joints were assessed by an evaluator for swelling. The presence of swelling was scored as a "1" and absence of swelling as a "0". The total swollen joint count is the sum of the scores, and ranges from 0 to 66 (worst).
Outcome measures
| Measure |
Upadacitinib Never Titrated
n=306 Participants
Participants received treatment with upadacitinib for up to 312 weeks. The starting dose was 6 mg twice a day (BID). From January 2017 participants were transitioned to once-daily dose of 15 mg upadacitinib.
|
Upadacitinib Titrated Up and Not Down
n=149 Participants
Participants received treatment with upadacitinib for up to 312 weeks. The starting dose was 6 mg BID. Participants who did not achieve protocol-specified improvement criteria at Week 6 or at any visits thereafter were up-titrated to upadacitinib 12 mg BID. From January 2017 participants were transitioned to once-daily dose of 30 mg upadacitinib.
|
Upadacitinib Titrated Up and Down
n=38 Participants
Participants received treatment with upadacitinib for up to 312 weeks. The starting dose was 6 mg BID. Participants who did not achieve protocol-specified improvement criteria at Week 6 or at any visits thereafter were up-titrated to upadacitinib 12 mg BID. From January 2017 participants were transitioned to once-daily dose of 30 mg upadacitinib. The upadacitinib dose was decreased back to 6 mg BID (or 15 mg QD from January 2017) per Investigator's judgment or safety and/or tolerability concerns.
|
|---|---|---|---|
|
Change From Baseline in Swollen Joint Count (SJC66) Over Time
Week 6
|
-12.8 joints
Standard Deviation 7.76
|
-13.5 joints
Standard Deviation 10.89
|
-14.5 joints
Standard Deviation 8.70
|
|
Change From Baseline in Swollen Joint Count (SJC66) Over Time
Week 12
|
-13.7 joints
Standard Deviation 7.95
|
-13.9 joints
Standard Deviation 11.26
|
-13.5 joints
Standard Deviation 6.72
|
|
Change From Baseline in Swollen Joint Count (SJC66) Over Time
Week 24
|
-14.2 joints
Standard Deviation 8.31
|
-14.7 joints
Standard Deviation 10.87
|
-15.7 joints
Standard Deviation 5.67
|
|
Change From Baseline in Swollen Joint Count (SJC66) Over Time
Week 36
|
-14.1 joints
Standard Deviation 8.26
|
-15.1 joints
Standard Deviation 10.39
|
-15.6 joints
Standard Deviation 5.94
|
|
Change From Baseline in Swollen Joint Count (SJC66) Over Time
Week 48
|
-15.3 joints
Standard Deviation 9.47
|
-15.4 joints
Standard Deviation 11.19
|
-16.0 joints
Standard Deviation 6.10
|
|
Change From Baseline in Swollen Joint Count (SJC66) Over Time
Week 60
|
-15.6 joints
Standard Deviation 9.52
|
-15.9 joints
Standard Deviation 11.83
|
-17.4 joints
Standard Deviation 9.36
|
|
Change From Baseline in Swollen Joint Count (SJC66) Over Time
Week 72
|
-15.1 joints
Standard Deviation 8.50
|
-15.5 joints
Standard Deviation 10.47
|
-17.0 joints
Standard Deviation 6.31
|
|
Change From Baseline in Swollen Joint Count (SJC66) Over Time
Week 84
|
-15.6 joints
Standard Deviation 9.18
|
-14.7 joints
Standard Deviation 9.96
|
-17.0 joints
Standard Deviation 6.68
|
|
Change From Baseline in Swollen Joint Count (SJC66) Over Time
Week 96
|
-15.3 joints
Standard Deviation 9.27
|
-14.7 joints
Standard Deviation 9.48
|
-16.6 joints
Standard Deviation 6.79
|
|
Change From Baseline in Swollen Joint Count (SJC66) Over Time
Week 108
|
-15.2 joints
Standard Deviation 8.72
|
-15.2 joints
Standard Deviation 10.17
|
-16.6 joints
Standard Deviation 6.96
|
|
Change From Baseline in Swollen Joint Count (SJC66) Over Time
Week 120
|
-15.6 joints
Standard Deviation 8.77
|
-14.8 joints
Standard Deviation 9.06
|
-17.5 joints
Standard Deviation 7.15
|
|
Change From Baseline in Swollen Joint Count (SJC66) Over Time
Week 132
|
-15.7 joints
Standard Deviation 9.23
|
-14.6 joints
Standard Deviation 9.79
|
-17.3 joints
Standard Deviation 7.11
|
|
Change From Baseline in Swollen Joint Count (SJC66) Over Time
Week 144
|
-15.9 joints
Standard Deviation 9.03
|
-15.3 joints
Standard Deviation 9.81
|
-18.6 joints
Standard Deviation 7.17
|
|
Change From Baseline in Swollen Joint Count (SJC66) Over Time
Week 156
|
-16.1 joints
Standard Deviation 9.74
|
-15.5 joints
Standard Deviation 9.53
|
-17.5 joints
Standard Deviation 7.89
|
|
Change From Baseline in Swollen Joint Count (SJC66) Over Time
Week 168
|
-16.9 joints
Standard Deviation 11.11
|
-15.8 joints
Standard Deviation 10.51
|
-20.0 joints
Standard Deviation 9.94
|
|
Change From Baseline in Swollen Joint Count (SJC66) Over Time
Week 180
|
-16.6 joints
Standard Deviation 10.67
|
-16.2 joints
Standard Deviation 10.61
|
-20.0 joints
Standard Deviation 9.91
|
|
Change From Baseline in Swollen Joint Count (SJC66) Over Time
Week 192
|
-16.4 joints
Standard Deviation 9.87
|
-15.8 joints
Standard Deviation 9.23
|
-20.7 joints
Standard Deviation 10.08
|
|
Change From Baseline in Swollen Joint Count (SJC66) Over Time
Week 204
|
-16.7 joints
Standard Deviation 10.60
|
-15.9 joints
Standard Deviation 9.53
|
-19.6 joints
Standard Deviation 10.22
|
|
Change From Baseline in Swollen Joint Count (SJC66) Over Time
Week 216
|
-16.6 joints
Standard Deviation 10.29
|
-16.1 joints
Standard Deviation 8.86
|
-20.4 joints
Standard Deviation 10.12
|
|
Change From Baseline in Swollen Joint Count (SJC66) Over Time
Week 228
|
-16.2 joints
Standard Deviation 9.51
|
-17.3 joints
Standard Deviation 10.79
|
-19.8 joints
Standard Deviation 10.16
|
|
Change From Baseline in Swollen Joint Count (SJC66) Over Time
Week 240
|
-16.8 joints
Standard Deviation 10.41
|
-17.0 joints
Standard Deviation 10.43
|
-18.8 joints
Standard Deviation 7.86
|
|
Change From Baseline in Swollen Joint Count (SJC66) Over Time
Week 252
|
-16.8 joints
Standard Deviation 10.63
|
-16.9 joints
Standard Deviation 9.37
|
-18.1 joints
Standard Deviation 7.78
|
|
Change From Baseline in Swollen Joint Count (SJC66) Over Time
Week 264
|
-17.7 joints
Standard Deviation 11.38
|
-16.1 joints
Standard Deviation 8.72
|
-18.3 joints
Standard Deviation 7.55
|
|
Change From Baseline in Swollen Joint Count (SJC66) Over Time
Week 276
|
-17.8 joints
Standard Deviation 11.35
|
-17.0 joints
Standard Deviation 10.60
|
-18.9 joints
Standard Deviation 7.74
|
|
Change From Baseline in Swollen Joint Count (SJC66) Over Time
Week 288
|
-17.4 joints
Standard Deviation 11.28
|
-17.8 joints
Standard Deviation 11.76
|
-18.7 joints
Standard Deviation 7.67
|
|
Change From Baseline in Swollen Joint Count (SJC66) Over Time
Week 300
|
-16.7 joints
Standard Deviation 10.21
|
-17.1 joints
Standard Deviation 10.31
|
-19.3 joints
Standard Deviation 7.72
|
|
Change From Baseline in Swollen Joint Count (SJC66) Over Time
Week 312
|
-16.7 joints
Standard Deviation 9.71
|
-17.4 joints
Standard Deviation 10.41
|
-18.6 joints
Standard Deviation 7.51
|
SECONDARY outcome
Timeframe: Baseline (of the preceding RCT study) and Weeks 6, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, and 312Population: Open-label treated population with available data at Baseline and each time point
The physician rated the participant's current global RA disease activity (independently from the participant's assessment) on a visual analog scale (VAS) from 0 to 100 mm, where 0 mm indicates no disease activity and 100 mm indicates severe disease activity
Outcome measures
| Measure |
Upadacitinib Never Titrated
n=298 Participants
Participants received treatment with upadacitinib for up to 312 weeks. The starting dose was 6 mg twice a day (BID). From January 2017 participants were transitioned to once-daily dose of 15 mg upadacitinib.
|
Upadacitinib Titrated Up and Not Down
n=147 Participants
Participants received treatment with upadacitinib for up to 312 weeks. The starting dose was 6 mg BID. Participants who did not achieve protocol-specified improvement criteria at Week 6 or at any visits thereafter were up-titrated to upadacitinib 12 mg BID. From January 2017 participants were transitioned to once-daily dose of 30 mg upadacitinib.
|
Upadacitinib Titrated Up and Down
n=38 Participants
Participants received treatment with upadacitinib for up to 312 weeks. The starting dose was 6 mg BID. Participants who did not achieve protocol-specified improvement criteria at Week 6 or at any visits thereafter were up-titrated to upadacitinib 12 mg BID. From January 2017 participants were transitioned to once-daily dose of 30 mg upadacitinib. The upadacitinib dose was decreased back to 6 mg BID (or 15 mg QD from January 2017) per Investigator's judgment or safety and/or tolerability concerns.
|
|---|---|---|---|
|
Change From Baseline in Physician's Global Assessment of Disease Activity Over Time
Week 6
|
-46.8 score on a scale
Standard Deviation 20.58
|
-35.5 score on a scale
Standard Deviation 21.53
|
-38.4 score on a scale
Standard Deviation 24.08
|
|
Change From Baseline in Physician's Global Assessment of Disease Activity Over Time
Week 12
|
-48.9 score on a scale
Standard Deviation 20.45
|
-39.1 score on a scale
Standard Deviation 22.99
|
-37.5 score on a scale
Standard Deviation 21.78
|
|
Change From Baseline in Physician's Global Assessment of Disease Activity Over Time
Week 24
|
-51.2 score on a scale
Standard Deviation 18.71
|
-42.5 score on a scale
Standard Deviation 21.24
|
-40.9 score on a scale
Standard Deviation 22.79
|
|
Change From Baseline in Physician's Global Assessment of Disease Activity Over Time
Week 36
|
-51.6 score on a scale
Standard Deviation 19.08
|
-42.7 score on a scale
Standard Deviation 20.96
|
-39.5 score on a scale
Standard Deviation 24.20
|
|
Change From Baseline in Physician's Global Assessment of Disease Activity Over Time
Week 48
|
-52.8 score on a scale
Standard Deviation 19.12
|
-45.6 score on a scale
Standard Deviation 19.29
|
-40.6 score on a scale
Standard Deviation 20.97
|
|
Change From Baseline in Physician's Global Assessment of Disease Activity Over Time
Week 60
|
-54.2 score on a scale
Standard Deviation 16.44
|
-47.1 score on a scale
Standard Deviation 19.64
|
-44.7 score on a scale
Standard Deviation 24.33
|
|
Change From Baseline in Physician's Global Assessment of Disease Activity Over Time
Week 72
|
-53.4 score on a scale
Standard Deviation 17.46
|
-45.9 score on a scale
Standard Deviation 18.58
|
-47.2 score on a scale
Standard Deviation 18.47
|
|
Change From Baseline in Physician's Global Assessment of Disease Activity Over Time
Week 84
|
-54.3 score on a scale
Standard Deviation 16.44
|
-43.4 score on a scale
Standard Deviation 21.41
|
-48.5 score on a scale
Standard Deviation 17.25
|
|
Change From Baseline in Physician's Global Assessment of Disease Activity Over Time
Week 96
|
-52.3 score on a scale
Standard Deviation 17.69
|
-45.7 score on a scale
Standard Deviation 20.42
|
-46.8 score on a scale
Standard Deviation 20.97
|
|
Change From Baseline in Physician's Global Assessment of Disease Activity Over Time
Week 108
|
-55.5 score on a scale
Standard Deviation 16.72
|
-45.9 score on a scale
Standard Deviation 18.75
|
-47.4 score on a scale
Standard Deviation 21.09
|
|
Change From Baseline in Physician's Global Assessment of Disease Activity Over Time
Week 120
|
-55.9 score on a scale
Standard Deviation 16.38
|
-48.6 score on a scale
Standard Deviation 18.23
|
-50.1 score on a scale
Standard Deviation 21.51
|
|
Change From Baseline in Physician's Global Assessment of Disease Activity Over Time
Week 132
|
-56.1 score on a scale
Standard Deviation 16.60
|
-50.1 score on a scale
Standard Deviation 17.19
|
-52.5 score on a scale
Standard Deviation 20.62
|
|
Change From Baseline in Physician's Global Assessment of Disease Activity Over Time
Week 144
|
-56.7 score on a scale
Standard Deviation 15.79
|
-48.2 score on a scale
Standard Deviation 18.28
|
-51.4 score on a scale
Standard Deviation 19.66
|
|
Change From Baseline in Physician's Global Assessment of Disease Activity Over Time
Week 156
|
-57.0 score on a scale
Standard Deviation 16.90
|
-48.9 score on a scale
Standard Deviation 18.89
|
-52.4 score on a scale
Standard Deviation 19.49
|
|
Change From Baseline in Physician's Global Assessment of Disease Activity Over Time
Week 168
|
-57.0 score on a scale
Standard Deviation 15.94
|
-51.9 score on a scale
Standard Deviation 20.24
|
-55.6 score on a scale
Standard Deviation 21.25
|
|
Change From Baseline in Physician's Global Assessment of Disease Activity Over Time
Week 180
|
-57.2 score on a scale
Standard Deviation 17.11
|
-53.0 score on a scale
Standard Deviation 18.04
|
-53.1 score on a scale
Standard Deviation 19.34
|
|
Change From Baseline in Physician's Global Assessment of Disease Activity Over Time
Week 192
|
-56.3 score on a scale
Standard Deviation 17.25
|
-52.1 score on a scale
Standard Deviation 16.56
|
-55.1 score on a scale
Standard Deviation 20.69
|
|
Change From Baseline in Physician's Global Assessment of Disease Activity Over Time
Week 204
|
-58.0 score on a scale
Standard Deviation 16.73
|
-52.9 score on a scale
Standard Deviation 18.09
|
-54.7 score on a scale
Standard Deviation 19.50
|
|
Change From Baseline in Physician's Global Assessment of Disease Activity Over Time
Week 216
|
-58.3 score on a scale
Standard Deviation 16.50
|
-50.8 score on a scale
Standard Deviation 18.27
|
-51.3 score on a scale
Standard Deviation 20.42
|
|
Change From Baseline in Physician's Global Assessment of Disease Activity Over Time
Week 228
|
-56.3 score on a scale
Standard Deviation 19.63
|
-53.2 score on a scale
Standard Deviation 17.28
|
-55.0 score on a scale
Standard Deviation 19.69
|
|
Change From Baseline in Physician's Global Assessment of Disease Activity Over Time
Week 240
|
-58.1 score on a scale
Standard Deviation 17.63
|
-52.8 score on a scale
Standard Deviation 16.04
|
-49.6 score on a scale
Standard Deviation 18.67
|
|
Change From Baseline in Physician's Global Assessment of Disease Activity Over Time
Week 252
|
-57.2 score on a scale
Standard Deviation 17.56
|
-53.9 score on a scale
Standard Deviation 17.10
|
-52.2 score on a scale
Standard Deviation 18.12
|
|
Change From Baseline in Physician's Global Assessment of Disease Activity Over Time
Week 264
|
-56.5 score on a scale
Standard Deviation 16.68
|
-50.4 score on a scale
Standard Deviation 18.09
|
-46.4 score on a scale
Standard Deviation 18.60
|
|
Change From Baseline in Physician's Global Assessment of Disease Activity Over Time
Week 276
|
-56.9 score on a scale
Standard Deviation 16.79
|
-53.5 score on a scale
Standard Deviation 17.07
|
-50.1 score on a scale
Standard Deviation 17.96
|
|
Change From Baseline in Physician's Global Assessment of Disease Activity Over Time
Week 288
|
-57.3 score on a scale
Standard Deviation 18.97
|
-56.3 score on a scale
Standard Deviation 17.25
|
-49.4 score on a scale
Standard Deviation 16.31
|
|
Change From Baseline in Physician's Global Assessment of Disease Activity Over Time
Week 300
|
-56.8 score on a scale
Standard Deviation 17.93
|
-52.9 score on a scale
Standard Deviation 17.33
|
-53.6 score on a scale
Standard Deviation 17.36
|
|
Change From Baseline in Physician's Global Assessment of Disease Activity Over Time
Week 312
|
-58.7 score on a scale
Standard Deviation 16.12
|
-55.2 score on a scale
Standard Deviation 17.19
|
-49.4 score on a scale
Standard Deviation 17.96
|
SECONDARY outcome
Timeframe: Baseline (of the preceding RCT study) and Weeks 6, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, and 312Population: Open-label treated population with available data at Baseline and each time point
The participant was asked to rate their current RA disease activity over the past 24 hours on a 100 mm VAS, where 0 mm indicates very low disease activity and 100 mm indicates very high disease activity.
Outcome measures
| Measure |
Upadacitinib Never Titrated
n=305 Participants
Participants received treatment with upadacitinib for up to 312 weeks. The starting dose was 6 mg twice a day (BID). From January 2017 participants were transitioned to once-daily dose of 15 mg upadacitinib.
|
Upadacitinib Titrated Up and Not Down
n=146 Participants
Participants received treatment with upadacitinib for up to 312 weeks. The starting dose was 6 mg BID. Participants who did not achieve protocol-specified improvement criteria at Week 6 or at any visits thereafter were up-titrated to upadacitinib 12 mg BID. From January 2017 participants were transitioned to once-daily dose of 30 mg upadacitinib.
|
Upadacitinib Titrated Up and Down
n=37 Participants
Participants received treatment with upadacitinib for up to 312 weeks. The starting dose was 6 mg BID. Participants who did not achieve protocol-specified improvement criteria at Week 6 or at any visits thereafter were up-titrated to upadacitinib 12 mg BID. From January 2017 participants were transitioned to once-daily dose of 30 mg upadacitinib. The upadacitinib dose was decreased back to 6 mg BID (or 15 mg QD from January 2017) per Investigator's judgment or safety and/or tolerability concerns.
|
|---|---|---|---|
|
Change From Baseline in Patient's Global Assessment of Disease Activity Over Time
Week 6
|
-35.4 score on a scale
Standard Deviation 29.83
|
-27.2 score on a scale
Standard Deviation 27.74
|
-26.1 score on a scale
Standard Deviation 27.46
|
|
Change From Baseline in Patient's Global Assessment of Disease Activity Over Time
Week 12
|
-37.5 score on a scale
Standard Deviation 29.00
|
-29.2 score on a scale
Standard Deviation 28.05
|
-31.3 score on a scale
Standard Deviation 23.13
|
|
Change From Baseline in Patient's Global Assessment of Disease Activity Over Time
Week 24
|
-36.9 score on a scale
Standard Deviation 28.97
|
-30.4 score on a scale
Standard Deviation 31.16
|
-32.9 score on a scale
Standard Deviation 25.63
|
|
Change From Baseline in Patient's Global Assessment of Disease Activity Over Time
Week 36
|
-37.1 score on a scale
Standard Deviation 30.36
|
-32.6 score on a scale
Standard Deviation 28.62
|
-34.9 score on a scale
Standard Deviation 26.00
|
|
Change From Baseline in Patient's Global Assessment of Disease Activity Over Time
Week 48
|
-39.2 score on a scale
Standard Deviation 30.36
|
-30.7 score on a scale
Standard Deviation 30.46
|
-23.6 score on a scale
Standard Deviation 26.58
|
|
Change From Baseline in Patient's Global Assessment of Disease Activity Over Time
Week 60
|
-40.8 score on a scale
Standard Deviation 28.95
|
-34.4 score on a scale
Standard Deviation 28.36
|
-38.3 score on a scale
Standard Deviation 24.46
|
|
Change From Baseline in Patient's Global Assessment of Disease Activity Over Time
Week 72
|
-40.3 score on a scale
Standard Deviation 27.36
|
-32.1 score on a scale
Standard Deviation 30.19
|
-26.3 score on a scale
Standard Deviation 30.70
|
|
Change From Baseline in Patient's Global Assessment of Disease Activity Over Time
Week 84
|
-40.1 score on a scale
Standard Deviation 30.37
|
-32.0 score on a scale
Standard Deviation 31.27
|
-39.4 score on a scale
Standard Deviation 21.35
|
|
Change From Baseline in Patient's Global Assessment of Disease Activity Over Time
Week 96
|
-38.1 score on a scale
Standard Deviation 30.34
|
-33.5 score on a scale
Standard Deviation 33.51
|
-33.5 score on a scale
Standard Deviation 22.08
|
|
Change From Baseline in Patient's Global Assessment of Disease Activity Over Time
Week 108
|
-40.8 score on a scale
Standard Deviation 29.75
|
-35.0 score on a scale
Standard Deviation 29.93
|
-32.1 score on a scale
Standard Deviation 20.65
|
|
Change From Baseline in Patient's Global Assessment of Disease Activity Over Time
Week 120
|
-40.6 score on a scale
Standard Deviation 29.76
|
-32.4 score on a scale
Standard Deviation 32.91
|
-36.6 score on a scale
Standard Deviation 28.02
|
|
Change From Baseline in Patient's Global Assessment of Disease Activity Over Time
Week 132
|
-40.1 score on a scale
Standard Deviation 29.99
|
-37.0 score on a scale
Standard Deviation 28.43
|
-38.4 score on a scale
Standard Deviation 27.02
|
|
Change From Baseline in Patient's Global Assessment of Disease Activity Over Time
Week 144
|
-37.7 score on a scale
Standard Deviation 30.73
|
-36.8 score on a scale
Standard Deviation 28.24
|
-33.9 score on a scale
Standard Deviation 29.68
|
|
Change From Baseline in Patient's Global Assessment of Disease Activity Over Time
Week 156
|
-39.7 score on a scale
Standard Deviation 32.65
|
-36.9 score on a scale
Standard Deviation 25.93
|
-38.6 score on a scale
Standard Deviation 21.61
|
|
Change From Baseline in Patient's Global Assessment of Disease Activity Over Time
Week 168
|
-42.7 score on a scale
Standard Deviation 29.04
|
-37.9 score on a scale
Standard Deviation 29.10
|
-39.0 score on a scale
Standard Deviation 32.84
|
|
Change From Baseline in Patient's Global Assessment of Disease Activity Over Time
Week 180
|
-40.3 score on a scale
Standard Deviation 29.52
|
-30.7 score on a scale
Standard Deviation 33.34
|
-33.3 score on a scale
Standard Deviation 34.03
|
|
Change From Baseline in Patient's Global Assessment of Disease Activity Over Time
Week 192
|
-41.0 score on a scale
Standard Deviation 28.73
|
-33.4 score on a scale
Standard Deviation 33.30
|
-42.1 score on a scale
Standard Deviation 23.97
|
|
Change From Baseline in Patient's Global Assessment of Disease Activity Over Time
Week 204
|
-42.0 score on a scale
Standard Deviation 29.28
|
-33.2 score on a scale
Standard Deviation 34.00
|
-43.7 score on a scale
Standard Deviation 25.60
|
|
Change From Baseline in Patient's Global Assessment of Disease Activity Over Time
Week 216
|
-39.0 score on a scale
Standard Deviation 32.18
|
-32.5 score on a scale
Standard Deviation 30.72
|
-35.6 score on a scale
Standard Deviation 27.03
|
|
Change From Baseline in Patient's Global Assessment of Disease Activity Over Time
Week 228
|
-38.4 score on a scale
Standard Deviation 32.29
|
-28.5 score on a scale
Standard Deviation 37.86
|
-40.1 score on a scale
Standard Deviation 24.11
|
|
Change From Baseline in Patient's Global Assessment of Disease Activity Over Time
Week 240
|
-41.9 score on a scale
Standard Deviation 30.43
|
-37.6 score on a scale
Standard Deviation 28.56
|
-33.3 score on a scale
Standard Deviation 29.03
|
|
Change From Baseline in Patient's Global Assessment of Disease Activity Over Time
Week 252
|
-40.6 score on a scale
Standard Deviation 32.12
|
-33.8 score on a scale
Standard Deviation 31.76
|
-33.5 score on a scale
Standard Deviation 35.96
|
|
Change From Baseline in Patient's Global Assessment of Disease Activity Over Time
Week 264
|
-38.5 score on a scale
Standard Deviation 31.53
|
-31.6 score on a scale
Standard Deviation 34.26
|
-32.7 score on a scale
Standard Deviation 34.87
|
|
Change From Baseline in Patient's Global Assessment of Disease Activity Over Time
Week 276
|
-42.4 score on a scale
Standard Deviation 27.53
|
-36.8 score on a scale
Standard Deviation 29.40
|
-26.0 score on a scale
Standard Deviation 33.79
|
|
Change From Baseline in Patient's Global Assessment of Disease Activity Over Time
Week 288
|
-43.3 score on a scale
Standard Deviation 27.99
|
-38.5 score on a scale
Standard Deviation 32.21
|
-32.2 score on a scale
Standard Deviation 28.16
|
|
Change From Baseline in Patient's Global Assessment of Disease Activity Over Time
Week 300
|
-38.8 score on a scale
Standard Deviation 29.04
|
-33.4 score on a scale
Standard Deviation 34.89
|
-31.6 score on a scale
Standard Deviation 25.93
|
|
Change From Baseline in Patient's Global Assessment of Disease Activity Over Time
Week 312
|
-36.5 score on a scale
Standard Deviation 32.10
|
-39.4 score on a scale
Standard Deviation 30.60
|
-37.7 score on a scale
Standard Deviation 29.67
|
SECONDARY outcome
Timeframe: Baseline (of the preceding RCT study) and Weeks 6, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, and 312Population: Open-label treated population with available data at Baseline and each time point
Participants were asked to indicate the severity of their arthritis pain within the previous week on a visual analog scale from 0 to 100 mm. A score of 0 mm indicates "no pain" and a score of 100 mm indicates "worst possible pain."
Outcome measures
| Measure |
Upadacitinib Never Titrated
n=305 Participants
Participants received treatment with upadacitinib for up to 312 weeks. The starting dose was 6 mg twice a day (BID). From January 2017 participants were transitioned to once-daily dose of 15 mg upadacitinib.
|
Upadacitinib Titrated Up and Not Down
n=146 Participants
Participants received treatment with upadacitinib for up to 312 weeks. The starting dose was 6 mg BID. Participants who did not achieve protocol-specified improvement criteria at Week 6 or at any visits thereafter were up-titrated to upadacitinib 12 mg BID. From January 2017 participants were transitioned to once-daily dose of 30 mg upadacitinib.
|
Upadacitinib Titrated Up and Down
n=37 Participants
Participants received treatment with upadacitinib for up to 312 weeks. The starting dose was 6 mg BID. Participants who did not achieve protocol-specified improvement criteria at Week 6 or at any visits thereafter were up-titrated to upadacitinib 12 mg BID. From January 2017 participants were transitioned to once-daily dose of 30 mg upadacitinib. The upadacitinib dose was decreased back to 6 mg BID (or 15 mg QD from January 2017) per Investigator's judgment or safety and/or tolerability concerns.
|
|---|---|---|---|
|
Change From Baseline in Patient's Assessment of Pain Over Time
Week 300
|
-43.0 score on a scale
Standard Deviation 25.18
|
-34.7 score on a scale
Standard Deviation 32.36
|
-29.9 score on a scale
Standard Deviation 30.21
|
|
Change From Baseline in Patient's Assessment of Pain Over Time
Week 6
|
-38.5 score on a scale
Standard Deviation 27.16
|
-29.9 score on a scale
Standard Deviation 24.46
|
-30.0 score on a scale
Standard Deviation 26.37
|
|
Change From Baseline in Patient's Assessment of Pain Over Time
Week 12
|
-41.3 score on a scale
Standard Deviation 26.07
|
-29.9 score on a scale
Standard Deviation 26.20
|
-31.9 score on a scale
Standard Deviation 20.23
|
|
Change From Baseline in Patient's Assessment of Pain Over Time
Week 24
|
-42.2 score on a scale
Standard Deviation 25.41
|
-30.9 score on a scale
Standard Deviation 28.77
|
-36.0 score on a scale
Standard Deviation 21.73
|
|
Change From Baseline in Patient's Assessment of Pain Over Time
Week 36
|
-40.6 score on a scale
Standard Deviation 26.41
|
-34.6 score on a scale
Standard Deviation 26.56
|
-34.8 score on a scale
Standard Deviation 21.83
|
|
Change From Baseline in Patient's Assessment of Pain Over Time
Week 48
|
-42.4 score on a scale
Standard Deviation 26.50
|
-31.9 score on a scale
Standard Deviation 28.73
|
-32.6 score on a scale
Standard Deviation 23.67
|
|
Change From Baseline in Patient's Assessment of Pain Over Time
Week 60
|
-41.9 score on a scale
Standard Deviation 27.89
|
-32.2 score on a scale
Standard Deviation 26.50
|
-38.6 score on a scale
Standard Deviation 23.34
|
|
Change From Baseline in Patient's Assessment of Pain Over Time
Week 72
|
-42.5 score on a scale
Standard Deviation 24.76
|
-32.0 score on a scale
Standard Deviation 25.38
|
-31.4 score on a scale
Standard Deviation 22.95
|
|
Change From Baseline in Patient's Assessment of Pain Over Time
Week 84
|
-42.1 score on a scale
Standard Deviation 25.87
|
-33.3 score on a scale
Standard Deviation 26.52
|
-43.0 score on a scale
Standard Deviation 20.51
|
|
Change From Baseline in Patient's Assessment of Pain Over Time
Week 96
|
-40.5 score on a scale
Standard Deviation 28.02
|
-34.2 score on a scale
Standard Deviation 26.14
|
-37.6 score on a scale
Standard Deviation 20.15
|
|
Change From Baseline in Patient's Assessment of Pain Over Time
Week 108
|
-43.6 score on a scale
Standard Deviation 26.28
|
-33.9 score on a scale
Standard Deviation 27.60
|
-36.3 score on a scale
Standard Deviation 23.12
|
|
Change From Baseline in Patient's Assessment of Pain Over Time
Week 120
|
-43.0 score on a scale
Standard Deviation 26.67
|
-36.2 score on a scale
Standard Deviation 27.69
|
-41.9 score on a scale
Standard Deviation 21.40
|
|
Change From Baseline in Patient's Assessment of Pain Over Time
Week 132
|
-42.2 score on a scale
Standard Deviation 26.89
|
-36.7 score on a scale
Standard Deviation 26.71
|
-34.4 score on a scale
Standard Deviation 27.27
|
|
Change From Baseline in Patient's Assessment of Pain Over Time
Week 144
|
-41.7 score on a scale
Standard Deviation 27.02
|
-36.7 score on a scale
Standard Deviation 27.14
|
-33.8 score on a scale
Standard Deviation 24.60
|
|
Change From Baseline in Patient's Assessment of Pain Over Time
Week 156
|
-43.5 score on a scale
Standard Deviation 25.72
|
-37.4 score on a scale
Standard Deviation 25.27
|
-34.6 score on a scale
Standard Deviation 24.91
|
|
Change From Baseline in Patient's Assessment of Pain Over Time
Week 168
|
-43.6 score on a scale
Standard Deviation 27.19
|
-38.8 score on a scale
Standard Deviation 27.67
|
-41.6 score on a scale
Standard Deviation 25.76
|
|
Change From Baseline in Patient's Assessment of Pain Over Time
Week 180
|
-42.7 score on a scale
Standard Deviation 26.54
|
-33.6 score on a scale
Standard Deviation 30.24
|
-36.5 score on a scale
Standard Deviation 29.20
|
|
Change From Baseline in Patient's Assessment of Pain Over Time
Week 192
|
-41.6 score on a scale
Standard Deviation 27.90
|
-33.8 score on a scale
Standard Deviation 29.13
|
-39.9 score on a scale
Standard Deviation 25.44
|
|
Change From Baseline in Patient's Assessment of Pain Over Time
Week 204
|
-44.4 score on a scale
Standard Deviation 25.26
|
-33.4 score on a scale
Standard Deviation 33.05
|
-41.9 score on a scale
Standard Deviation 22.39
|
|
Change From Baseline in Patient's Assessment of Pain Over Time
Week 216
|
-42.2 score on a scale
Standard Deviation 28.01
|
-32.5 score on a scale
Standard Deviation 32.06
|
-33.6 score on a scale
Standard Deviation 25.98
|
|
Change From Baseline in Patient's Assessment of Pain Over Time
Week 228
|
-45.1 score on a scale
Standard Deviation 24.96
|
-29.6 score on a scale
Standard Deviation 35.17
|
-39.8 score on a scale
Standard Deviation 24.70
|
|
Change From Baseline in Patient's Assessment of Pain Over Time
Week 240
|
-43.4 score on a scale
Standard Deviation 27.78
|
-34.1 score on a scale
Standard Deviation 31.98
|
-36.1 score on a scale
Standard Deviation 25.38
|
|
Change From Baseline in Patient's Assessment of Pain Over Time
Week 252
|
-44.4 score on a scale
Standard Deviation 27.49
|
-34.3 score on a scale
Standard Deviation 28.12
|
-38.3 score on a scale
Standard Deviation 24.92
|
|
Change From Baseline in Patient's Assessment of Pain Over Time
Week 264
|
-44.0 score on a scale
Standard Deviation 25.43
|
-35.6 score on a scale
Standard Deviation 31.33
|
-38.2 score on a scale
Standard Deviation 24.11
|
|
Change From Baseline in Patient's Assessment of Pain Over Time
Week 276
|
-46.3 score on a scale
Standard Deviation 24.53
|
-35.6 score on a scale
Standard Deviation 27.39
|
-34.1 score on a scale
Standard Deviation 26.80
|
|
Change From Baseline in Patient's Assessment of Pain Over Time
Week 288
|
-46.2 score on a scale
Standard Deviation 25.61
|
-37.6 score on a scale
Standard Deviation 28.74
|
-33.3 score on a scale
Standard Deviation 23.30
|
|
Change From Baseline in Patient's Assessment of Pain Over Time
Week 312
|
-44.1 score on a scale
Standard Deviation 25.87
|
-40.3 score on a scale
Standard Deviation 27.37
|
-33.4 score on a scale
Standard Deviation 30.11
|
SECONDARY outcome
Timeframe: Baseline (of the preceding RCT study) and Weeks 6, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, and 312Population: Open-label treated population with available data at Baseline and each time point
The Health Assessment Questionnaire - Disability Index is a patient-reported questionnaire that measures the degree of difficulty a person has in accomplishing tasks in 8 functional areas (dressing, arising, eating, walking, hygiene, reaching, gripping, and errands and chores) over the past week. Participants assessed their ability to do each task on a scale from 0 (without any difficulty) to 3 (unable to do). Scores were averaged to provide an overall score ranging from 0 to 3, where 0 represents no disability and 3 represents very severe, high-dependency disability.
Outcome measures
| Measure |
Upadacitinib Never Titrated
n=304 Participants
Participants received treatment with upadacitinib for up to 312 weeks. The starting dose was 6 mg twice a day (BID). From January 2017 participants were transitioned to once-daily dose of 15 mg upadacitinib.
|
Upadacitinib Titrated Up and Not Down
n=146 Participants
Participants received treatment with upadacitinib for up to 312 weeks. The starting dose was 6 mg BID. Participants who did not achieve protocol-specified improvement criteria at Week 6 or at any visits thereafter were up-titrated to upadacitinib 12 mg BID. From January 2017 participants were transitioned to once-daily dose of 30 mg upadacitinib.
|
Upadacitinib Titrated Up and Down
n=37 Participants
Participants received treatment with upadacitinib for up to 312 weeks. The starting dose was 6 mg BID. Participants who did not achieve protocol-specified improvement criteria at Week 6 or at any visits thereafter were up-titrated to upadacitinib 12 mg BID. From January 2017 participants were transitioned to once-daily dose of 30 mg upadacitinib. The upadacitinib dose was decreased back to 6 mg BID (or 15 mg QD from January 2017) per Investigator's judgment or safety and/or tolerability concerns.
|
|---|---|---|---|
|
Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) Over Time
Week 6
|
-0.7 score on a scale
Standard Deviation 0.62
|
-0.6 score on a scale
Standard Deviation 0.56
|
-0.6 score on a scale
Standard Deviation 0.47
|
|
Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) Over Time
Week 12
|
-0.7 score on a scale
Standard Deviation 0.64
|
-0.6 score on a scale
Standard Deviation 0.63
|
-0.7 score on a scale
Standard Deviation 0.55
|
|
Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) Over Time
Week 24
|
-0.8 score on a scale
Standard Deviation 0.60
|
-0.6 score on a scale
Standard Deviation 0.61
|
-0.7 score on a scale
Standard Deviation 0.58
|
|
Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) Over Time
Week 36
|
-0.7 score on a scale
Standard Deviation 0.66
|
-0.6 score on a scale
Standard Deviation 0.62
|
-0.7 score on a scale
Standard Deviation 0.66
|
|
Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) Over Time
Week 48
|
-0.8 score on a scale
Standard Deviation 0.63
|
-0.7 score on a scale
Standard Deviation 0.61
|
-0.7 score on a scale
Standard Deviation 0.58
|
|
Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) Over Time
Week 60
|
-0.8 score on a scale
Standard Deviation 0.67
|
-0.7 score on a scale
Standard Deviation 0.66
|
-0.7 score on a scale
Standard Deviation 0.52
|
|
Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) Over Time
Week 72
|
-0.8 score on a scale
Standard Deviation 0.65
|
-0.7 score on a scale
Standard Deviation 0.63
|
-0.7 score on a scale
Standard Deviation 0.54
|
|
Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) Over Time
Week 84
|
-0.9 score on a scale
Standard Deviation 0.62
|
-0.7 score on a scale
Standard Deviation 0.64
|
-0.7 score on a scale
Standard Deviation 0.57
|
|
Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) Over Time
Week 96
|
-0.8 score on a scale
Standard Deviation 0.64
|
-0.8 score on a scale
Standard Deviation 0.69
|
-0.8 score on a scale
Standard Deviation 0.52
|
|
Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) Over Time
Week 108
|
-0.9 score on a scale
Standard Deviation 0.67
|
-0.7 score on a scale
Standard Deviation 0.67
|
-0.7 score on a scale
Standard Deviation 0.58
|
|
Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) Over Time
Week 120
|
-0.8 score on a scale
Standard Deviation 0.64
|
-0.7 score on a scale
Standard Deviation 0.64
|
-0.8 score on a scale
Standard Deviation 0.62
|
|
Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) Over Time
Week 132
|
-0.9 score on a scale
Standard Deviation 0.66
|
-0.7 score on a scale
Standard Deviation 0.64
|
-0.8 score on a scale
Standard Deviation 0.51
|
|
Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) Over Time
Week 144
|
-0.8 score on a scale
Standard Deviation 0.72
|
-0.8 score on a scale
Standard Deviation 0.68
|
-0.7 score on a scale
Standard Deviation 0.61
|
|
Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) Over Time
Week 156
|
-0.8 score on a scale
Standard Deviation 0.69
|
-0.7 score on a scale
Standard Deviation 0.57
|
-0.8 score on a scale
Standard Deviation 0.61
|
|
Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) Over Time
Week 168
|
-0.8 score on a scale
Standard Deviation 0.68
|
-0.7 score on a scale
Standard Deviation 0.67
|
-0.8 score on a scale
Standard Deviation 0.60
|
|
Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) Over Time
Week 180
|
-0.8 score on a scale
Standard Deviation 0.70
|
-0.7 score on a scale
Standard Deviation 0.70
|
-0.7 score on a scale
Standard Deviation 0.64
|
|
Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) Over Time
Week 192
|
-0.8 score on a scale
Standard Deviation 0.68
|
-0.7 score on a scale
Standard Deviation 0.69
|
-0.8 score on a scale
Standard Deviation 0.57
|
|
Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) Over Time
Week 204
|
-0.9 score on a scale
Standard Deviation 0.68
|
-0.7 score on a scale
Standard Deviation 0.79
|
-0.8 score on a scale
Standard Deviation 0.51
|
|
Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) Over Time
Week 216
|
-0.8 score on a scale
Standard Deviation 0.69
|
-0.7 score on a scale
Standard Deviation 0.73
|
-0.8 score on a scale
Standard Deviation 0.61
|
|
Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) Over Time
Week 228
|
-0.9 score on a scale
Standard Deviation 0.72
|
-0.7 score on a scale
Standard Deviation 0.77
|
-0.7 score on a scale
Standard Deviation 0.61
|
|
Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) Over Time
Week 240
|
-0.8 score on a scale
Standard Deviation 0.69
|
-0.7 score on a scale
Standard Deviation 0.77
|
-0.6 score on a scale
Standard Deviation 0.61
|
|
Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) Over Time
Week 252
|
-0.9 score on a scale
Standard Deviation 0.69
|
-0.7 score on a scale
Standard Deviation 0.77
|
-0.7 score on a scale
Standard Deviation 0.59
|
|
Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) Over Time
Week 264
|
-0.8 score on a scale
Standard Deviation 0.68
|
-0.7 score on a scale
Standard Deviation 0.65
|
-0.7 score on a scale
Standard Deviation 0.59
|
|
Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) Over Time
Week 276
|
-0.8 score on a scale
Standard Deviation 0.69
|
-0.6 score on a scale
Standard Deviation 0.66
|
-0.7 score on a scale
Standard Deviation 0.61
|
|
Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) Over Time
Week 288
|
-0.9 score on a scale
Standard Deviation 0.70
|
-0.7 score on a scale
Standard Deviation 0.74
|
-0.8 score on a scale
Standard Deviation 0.61
|
|
Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) Over Time
Week 300
|
-0.8 score on a scale
Standard Deviation 0.76
|
-0.7 score on a scale
Standard Deviation 0.70
|
-0.7 score on a scale
Standard Deviation 0.68
|
|
Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) Over Time
Week 312
|
-0.8 score on a scale
Standard Deviation 0.71
|
-0.8 score on a scale
Standard Deviation 0.74
|
-0.7 score on a scale
Standard Deviation 0.69
|
SECONDARY outcome
Timeframe: Baseline (of the preceding RCT study) and Weeks 6, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, and 312Population: Open-label treated population with available data at each time point
Outcome measures
| Measure |
Upadacitinib Never Titrated
n=306 Participants
Participants received treatment with upadacitinib for up to 312 weeks. The starting dose was 6 mg twice a day (BID). From January 2017 participants were transitioned to once-daily dose of 15 mg upadacitinib.
|
Upadacitinib Titrated Up and Not Down
n=149 Participants
Participants received treatment with upadacitinib for up to 312 weeks. The starting dose was 6 mg BID. Participants who did not achieve protocol-specified improvement criteria at Week 6 or at any visits thereafter were up-titrated to upadacitinib 12 mg BID. From January 2017 participants were transitioned to once-daily dose of 30 mg upadacitinib.
|
Upadacitinib Titrated Up and Down
n=38 Participants
Participants received treatment with upadacitinib for up to 312 weeks. The starting dose was 6 mg BID. Participants who did not achieve protocol-specified improvement criteria at Week 6 or at any visits thereafter were up-titrated to upadacitinib 12 mg BID. From January 2017 participants were transitioned to once-daily dose of 30 mg upadacitinib. The upadacitinib dose was decreased back to 6 mg BID (or 15 mg QD from January 2017) per Investigator's judgment or safety and/or tolerability concerns.
|
|---|---|---|---|
|
Change From Baseline in High-sensitivity C-reactive Protein (hsCRP) Over Time
Week 228
|
-11.0 mg/L
Standard Deviation 20.71
|
-12.2 mg/L
Standard Deviation 20.89
|
-10.0 mg/L
Standard Deviation 17.46
|
|
Change From Baseline in High-sensitivity C-reactive Protein (hsCRP) Over Time
Week 6
|
-7.9 mg/L
Standard Deviation 21.74
|
-10.0 mg/L
Standard Deviation 21.95
|
-13.0 mg/L
Standard Deviation 29.00
|
|
Change From Baseline in High-sensitivity C-reactive Protein (hsCRP) Over Time
Week 12
|
-9.0 mg/L
Standard Deviation 18.96
|
-10.7 mg/L
Standard Deviation 20.94
|
-12.8 mg/L
Standard Deviation 26.93
|
|
Change From Baseline in High-sensitivity C-reactive Protein (hsCRP) Over Time
Week 24
|
-9.4 mg/L
Standard Deviation 17.38
|
-7.2 mg/L
Standard Deviation 36.97
|
-9.1 mg/L
Standard Deviation 29.38
|
|
Change From Baseline in High-sensitivity C-reactive Protein (hsCRP) Over Time
Week 36
|
-9.5 mg/L
Standard Deviation 18.62
|
-11.1 mg/L
Standard Deviation 22.03
|
-13.5 mg/L
Standard Deviation 28.34
|
|
Change From Baseline in High-sensitivity C-reactive Protein (hsCRP) Over Time
Week 48
|
-8.8 mg/L
Standard Deviation 17.50
|
-10.2 mg/L
Standard Deviation 22.28
|
-13.3 mg/L
Standard Deviation 22.69
|
|
Change From Baseline in High-sensitivity C-reactive Protein (hsCRP) Over Time
Week 60
|
-9.6 mg/L
Standard Deviation 17.78
|
-10.3 mg/L
Standard Deviation 22.10
|
-11.0 mg/L
Standard Deviation 21.62
|
|
Change From Baseline in High-sensitivity C-reactive Protein (hsCRP) Over Time
Week 72
|
-9.2 mg/L
Standard Deviation 19.42
|
-9.9 mg/L
Standard Deviation 22.95
|
-11.2 mg/L
Standard Deviation 20.16
|
|
Change From Baseline in High-sensitivity C-reactive Protein (hsCRP) Over Time
Week 84
|
-8.3 mg/L
Standard Deviation 24.66
|
-10.0 mg/L
Standard Deviation 28.56
|
-10.2 mg/L
Standard Deviation 16.57
|
|
Change From Baseline in High-sensitivity C-reactive Protein (hsCRP) Over Time
Week 96
|
-10.1 mg/L
Standard Deviation 17.74
|
-10.3 mg/L
Standard Deviation 22.36
|
-11.1 mg/L
Standard Deviation 17.61
|
|
Change From Baseline in High-sensitivity C-reactive Protein (hsCRP) Over Time
Week 108
|
-9.8 mg/L
Standard Deviation 21.56
|
-10.7 mg/L
Standard Deviation 19.36
|
-10.8 mg/L
Standard Deviation 17.39
|
|
Change From Baseline in High-sensitivity C-reactive Protein (hsCRP) Over Time
Week 120
|
-8.4 mg/L
Standard Deviation 18.27
|
-10.9 mg/L
Standard Deviation 19.63
|
-9.2 mg/L
Standard Deviation 18.62
|
|
Change From Baseline in High-sensitivity C-reactive Protein (hsCRP) Over Time
Week 132
|
-8.9 mg/L
Standard Deviation 15.19
|
-9.0 mg/L
Standard Deviation 21.32
|
-9.3 mg/L
Standard Deviation 17.53
|
|
Change From Baseline in High-sensitivity C-reactive Protein (hsCRP) Over Time
Week 144
|
-7.3 mg/L
Standard Deviation 17.15
|
-9.9 mg/L
Standard Deviation 23.45
|
-5.9 mg/L
Standard Deviation 26.82
|
|
Change From Baseline in High-sensitivity C-reactive Protein (hsCRP) Over Time
Week 156
|
-8.6 mg/L
Standard Deviation 16.60
|
-6.0 mg/L
Standard Deviation 52.17
|
-10.9 mg/L
Standard Deviation 18.20
|
|
Change From Baseline in High-sensitivity C-reactive Protein (hsCRP) Over Time
Week 168
|
-7.7 mg/L
Standard Deviation 18.37
|
-7.5 mg/L
Standard Deviation 28.96
|
-8.8 mg/L
Standard Deviation 17.88
|
|
Change From Baseline in High-sensitivity C-reactive Protein (hsCRP) Over Time
Week 180
|
-10.0 mg/L
Standard Deviation 19.41
|
-10.3 mg/L
Standard Deviation 21.44
|
-9.2 mg/L
Standard Deviation 19.16
|
|
Change From Baseline in High-sensitivity C-reactive Protein (hsCRP) Over Time
Week 192
|
-9.4 mg/L
Standard Deviation 23.81
|
-9.9 mg/L
Standard Deviation 21.04
|
-9.3 mg/L
Standard Deviation 20.07
|
|
Change From Baseline in High-sensitivity C-reactive Protein (hsCRP) Over Time
Week 204
|
-8.4 mg/L
Standard Deviation 28.90
|
-9.6 mg/L
Standard Deviation 21.29
|
-9.0 mg/L
Standard Deviation 19.07
|
|
Change From Baseline in High-sensitivity C-reactive Protein (hsCRP) Over Time
Week 216
|
-11.5 mg/L
Standard Deviation 20.22
|
-10.0 mg/L
Standard Deviation 22.42
|
-8.4 mg/L
Standard Deviation 19.70
|
|
Change From Baseline in High-sensitivity C-reactive Protein (hsCRP) Over Time
Week 240
|
-10.6 mg/L
Standard Deviation 24.45
|
-9.1 mg/L
Standard Deviation 22.38
|
-9.2 mg/L
Standard Deviation 17.55
|
|
Change From Baseline in High-sensitivity C-reactive Protein (hsCRP) Over Time
Week 252
|
-10.4 mg/L
Standard Deviation 19.33
|
-9.4 mg/L
Standard Deviation 24.28
|
-9.9 mg/L
Standard Deviation 18.83
|
|
Change From Baseline in High-sensitivity C-reactive Protein (hsCRP) Over Time
Week 264
|
-11.2 mg/L
Standard Deviation 21.02
|
-9.9 mg/L
Standard Deviation 23.99
|
-11.1 mg/L
Standard Deviation 18.19
|
|
Change From Baseline in High-sensitivity C-reactive Protein (hsCRP) Over Time
Week 276
|
-10.5 mg/L
Standard Deviation 18.04
|
-11.2 mg/L
Standard Deviation 20.20
|
-10.9 mg/L
Standard Deviation 17.95
|
|
Change From Baseline in High-sensitivity C-reactive Protein (hsCRP) Over Time
Week 288
|
-10.6 mg/L
Standard Deviation 16.09
|
-12.9 mg/L
Standard Deviation 21.85
|
-7.5 mg/L
Standard Deviation 14.48
|
|
Change From Baseline in High-sensitivity C-reactive Protein (hsCRP) Over Time
Week 300
|
-11.1 mg/L
Standard Deviation 14.63
|
-11.4 mg/L
Standard Deviation 21.67
|
-11.0 mg/L
Standard Deviation 19.69
|
|
Change From Baseline in High-sensitivity C-reactive Protein (hsCRP) Over Time
Week 312
|
-10.3 mg/L
Standard Deviation 22.22
|
-12.0 mg/L
Standard Deviation 21.14
|
-8.7 mg/L
Standard Deviation 15.19
|
SECONDARY outcome
Timeframe: Baseline (of the preceding RCT study) and Weeks 6, 12, 24, 36, 48, 72, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, and 312Population: Open-label treated population with available data at Baseline and each time point
The FACIT Fatigue scale is a 13-item tool that measures an individual's level of fatigue during their usual daily activities over the past 7 days. Each of the fatigue and impact of fatigue items are measured on a four point Likert scale (4 = not at all fatigued to 0 = very much fatigued). The FACIT Fatigue Scale is the sum of the individual 13 scores and ranges from 0 to 52 where higher scores indicate better quality of life. A positive change from Baseline indicates improvement.
Outcome measures
| Measure |
Upadacitinib Never Titrated
n=304 Participants
Participants received treatment with upadacitinib for up to 312 weeks. The starting dose was 6 mg twice a day (BID). From January 2017 participants were transitioned to once-daily dose of 15 mg upadacitinib.
|
Upadacitinib Titrated Up and Not Down
n=146 Participants
Participants received treatment with upadacitinib for up to 312 weeks. The starting dose was 6 mg BID. Participants who did not achieve protocol-specified improvement criteria at Week 6 or at any visits thereafter were up-titrated to upadacitinib 12 mg BID. From January 2017 participants were transitioned to once-daily dose of 30 mg upadacitinib.
|
Upadacitinib Titrated Up and Down
n=37 Participants
Participants received treatment with upadacitinib for up to 312 weeks. The starting dose was 6 mg BID. Participants who did not achieve protocol-specified improvement criteria at Week 6 or at any visits thereafter were up-titrated to upadacitinib 12 mg BID. From January 2017 participants were transitioned to once-daily dose of 30 mg upadacitinib. The upadacitinib dose was decreased back to 6 mg BID (or 15 mg QD from January 2017) per Investigator's judgment or safety and/or tolerability concerns.
|
|---|---|---|---|
|
Change From Baseline in in Functional Assessment of Chronic Illness Therapy (FACIT) - Fatigue Scale Over Time
Week 6
|
9.5 score on a scale
Standard Deviation 10.50
|
9.0 score on a scale
Standard Deviation 9.69
|
8.8 score on a scale
Standard Deviation 9.26
|
|
Change From Baseline in in Functional Assessment of Chronic Illness Therapy (FACIT) - Fatigue Scale Over Time
Week 12
|
9.9 score on a scale
Standard Deviation 10.49
|
8.7 score on a scale
Standard Deviation 10.87
|
8.6 score on a scale
Standard Deviation 10.43
|
|
Change From Baseline in in Functional Assessment of Chronic Illness Therapy (FACIT) - Fatigue Scale Over Time
Week 24
|
10.7 score on a scale
Standard Deviation 10.04
|
10.6 score on a scale
Standard Deviation 11.60
|
8.3 score on a scale
Standard Deviation 9.65
|
|
Change From Baseline in in Functional Assessment of Chronic Illness Therapy (FACIT) - Fatigue Scale Over Time
Week 36
|
10.1 score on a scale
Standard Deviation 10.59
|
10.0 score on a scale
Standard Deviation 11.58
|
8.0 score on a scale
Standard Deviation 11.50
|
|
Change From Baseline in in Functional Assessment of Chronic Illness Therapy (FACIT) - Fatigue Scale Over Time
Week 48
|
10.4 score on a scale
Standard Deviation 10.58
|
10.8 score on a scale
Standard Deviation 10.44
|
8.4 score on a scale
Standard Deviation 10.83
|
|
Change From Baseline in in Functional Assessment of Chronic Illness Therapy (FACIT) - Fatigue Scale Over Time
Week 72
|
10.8 score on a scale
Standard Deviation 9.55
|
10.9 score on a scale
Standard Deviation 10.64
|
9.2 score on a scale
Standard Deviation 11.44
|
|
Change From Baseline in in Functional Assessment of Chronic Illness Therapy (FACIT) - Fatigue Scale Over Time
Week 96
|
10.3 score on a scale
Standard Deviation 10.45
|
11.7 score on a scale
Standard Deviation 12.72
|
9.5 score on a scale
Standard Deviation 11.27
|
|
Change From Baseline in in Functional Assessment of Chronic Illness Therapy (FACIT) - Fatigue Scale Over Time
Week 108
|
10.5 score on a scale
Standard Deviation 10.49
|
11.9 score on a scale
Standard Deviation 12.08
|
7.9 score on a scale
Standard Deviation 10.62
|
|
Change From Baseline in in Functional Assessment of Chronic Illness Therapy (FACIT) - Fatigue Scale Over Time
Week 120
|
11.0 score on a scale
Standard Deviation 10.76
|
11.6 score on a scale
Standard Deviation 11.95
|
10.7 score on a scale
Standard Deviation 11.30
|
|
Change From Baseline in in Functional Assessment of Chronic Illness Therapy (FACIT) - Fatigue Scale Over Time
Week 132
|
11.4 score on a scale
Standard Deviation 10.13
|
10.7 score on a scale
Standard Deviation 11.47
|
10.7 score on a scale
Standard Deviation 10.36
|
|
Change From Baseline in in Functional Assessment of Chronic Illness Therapy (FACIT) - Fatigue Scale Over Time
Week 144
|
9.9 score on a scale
Standard Deviation 11.36
|
11.2 score on a scale
Standard Deviation 12.09
|
9.8 score on a scale
Standard Deviation 11.67
|
|
Change From Baseline in in Functional Assessment of Chronic Illness Therapy (FACIT) - Fatigue Scale Over Time
Week 156
|
10.6 score on a scale
Standard Deviation 10.94
|
11.2 score on a scale
Standard Deviation 11.48
|
8.6 score on a scale
Standard Deviation 12.32
|
|
Change From Baseline in in Functional Assessment of Chronic Illness Therapy (FACIT) - Fatigue Scale Over Time
Week 168
|
10.8 score on a scale
Standard Deviation 12.27
|
10.6 score on a scale
Standard Deviation 12.46
|
11.4 score on a scale
Standard Deviation 13.18
|
|
Change From Baseline in in Functional Assessment of Chronic Illness Therapy (FACIT) - Fatigue Scale Over Time
Week 180
|
11.0 score on a scale
Standard Deviation 11.59
|
9.6 score on a scale
Standard Deviation 13.56
|
11.4 score on a scale
Standard Deviation 12.45
|
|
Change From Baseline in in Functional Assessment of Chronic Illness Therapy (FACIT) - Fatigue Scale Over Time
Week 192
|
10.8 score on a scale
Standard Deviation 10.50
|
10.9 score on a scale
Standard Deviation 11.82
|
11.5 score on a scale
Standard Deviation 13.27
|
|
Change From Baseline in in Functional Assessment of Chronic Illness Therapy (FACIT) - Fatigue Scale Over Time
Week 204
|
11.3 score on a scale
Standard Deviation 10.56
|
10.2 score on a scale
Standard Deviation 13.01
|
11.2 score on a scale
Standard Deviation 12.70
|
|
Change From Baseline in in Functional Assessment of Chronic Illness Therapy (FACIT) - Fatigue Scale Over Time
Week 216
|
11.4 score on a scale
Standard Deviation 11.93
|
10.4 score on a scale
Standard Deviation 13.92
|
10.1 score on a scale
Standard Deviation 12.87
|
|
Change From Baseline in in Functional Assessment of Chronic Illness Therapy (FACIT) - Fatigue Scale Over Time
Week 228
|
11.0 score on a scale
Standard Deviation 11.25
|
10.8 score on a scale
Standard Deviation 14.00
|
11.1 score on a scale
Standard Deviation 13.18
|
|
Change From Baseline in in Functional Assessment of Chronic Illness Therapy (FACIT) - Fatigue Scale Over Time
Week 240
|
11.9 score on a scale
Standard Deviation 10.93
|
11.4 score on a scale
Standard Deviation 13.08
|
9.2 score on a scale
Standard Deviation 13.81
|
|
Change From Baseline in in Functional Assessment of Chronic Illness Therapy (FACIT) - Fatigue Scale Over Time
Week 252
|
11.5 score on a scale
Standard Deviation 10.83
|
10.2 score on a scale
Standard Deviation 13.68
|
8.4 score on a scale
Standard Deviation 13.48
|
|
Change From Baseline in in Functional Assessment of Chronic Illness Therapy (FACIT) - Fatigue Scale Over Time
Week 264
|
11.6 score on a scale
Standard Deviation 10.95
|
10.7 score on a scale
Standard Deviation 12.52
|
7.8 score on a scale
Standard Deviation 13.94
|
|
Change From Baseline in in Functional Assessment of Chronic Illness Therapy (FACIT) - Fatigue Scale Over Time
Week 276
|
12.1 score on a scale
Standard Deviation 10.98
|
9.2 score on a scale
Standard Deviation 13.02
|
7.3 score on a scale
Standard Deviation 13.02
|
|
Change From Baseline in in Functional Assessment of Chronic Illness Therapy (FACIT) - Fatigue Scale Over Time
Week 288
|
11.6 score on a scale
Standard Deviation 10.88
|
12.3 score on a scale
Standard Deviation 11.83
|
9.0 score on a scale
Standard Deviation 13.94
|
|
Change From Baseline in in Functional Assessment of Chronic Illness Therapy (FACIT) - Fatigue Scale Over Time
Week 300
|
11.1 score on a scale
Standard Deviation 11.14
|
9.7 score on a scale
Standard Deviation 13.12
|
7.0 score on a scale
Standard Deviation 13.46
|
|
Change From Baseline in in Functional Assessment of Chronic Illness Therapy (FACIT) - Fatigue Scale Over Time
Week 312
|
10.7 score on a scale
Standard Deviation 11.24
|
11.6 score on a scale
Standard Deviation 12.67
|
8.6 score on a scale
Standard Deviation 14.35
|
SECONDARY outcome
Timeframe: Baseline (of the preceding RCT study) and Weeks 6, 12, 24, 36, 48, 72, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, and 312Population: Open-label treated population who were currently working at Baseline and at each visit visit and with available data at each time point
RA-WIS is a tool to evaluate work instability (the consequence of a mismatch between an individual's functional ability and their work tasks). RA-WIS consists of 23 questions relating to the participant's functioning in their work environment, each answered as Yes or No. The total score is the number of questions answered Yes, and ranges from 0 to 23. A score \< 10 means low risk, scores between 10 and 17 indicate medium risk, and scores \> 17 indicate high risk of work instability. A negative change from Baseline indicates improvement in work instability.
Outcome measures
| Measure |
Upadacitinib Never Titrated
n=87 Participants
Participants received treatment with upadacitinib for up to 312 weeks. The starting dose was 6 mg twice a day (BID). From January 2017 participants were transitioned to once-daily dose of 15 mg upadacitinib.
|
Upadacitinib Titrated Up and Not Down
n=53 Participants
Participants received treatment with upadacitinib for up to 312 weeks. The starting dose was 6 mg BID. Participants who did not achieve protocol-specified improvement criteria at Week 6 or at any visits thereafter were up-titrated to upadacitinib 12 mg BID. From January 2017 participants were transitioned to once-daily dose of 30 mg upadacitinib.
|
Upadacitinib Titrated Up and Down
n=13 Participants
Participants received treatment with upadacitinib for up to 312 weeks. The starting dose was 6 mg BID. Participants who did not achieve protocol-specified improvement criteria at Week 6 or at any visits thereafter were up-titrated to upadacitinib 12 mg BID. From January 2017 participants were transitioned to once-daily dose of 30 mg upadacitinib. The upadacitinib dose was decreased back to 6 mg BID (or 15 mg QD from January 2017) per Investigator's judgment or safety and/or tolerability concerns.
|
|---|---|---|---|
|
Change From Baseline in Work Instability Scale for RA (RA-WIS) Over Time
Week 6
|
-6.2 score on a scale
Standard Deviation 5.55
|
-3.3 score on a scale
Standard Deviation 5.51
|
-4.1 score on a scale
Standard Deviation 3.00
|
|
Change From Baseline in Work Instability Scale for RA (RA-WIS) Over Time
Week 12
|
-6.6 score on a scale
Standard Deviation 6.16
|
-4.0 score on a scale
Standard Deviation 6.32
|
-4.2 score on a scale
Standard Deviation 3.35
|
|
Change From Baseline in Work Instability Scale for RA (RA-WIS) Over Time
Week 24
|
-7.0 score on a scale
Standard Deviation 6.51
|
-4.6 score on a scale
Standard Deviation 6.63
|
-3.6 score on a scale
Standard Deviation 3.53
|
|
Change From Baseline in Work Instability Scale for RA (RA-WIS) Over Time
Week 36
|
-6.8 score on a scale
Standard Deviation 6.29
|
-4.6 score on a scale
Standard Deviation 6.21
|
-3.3 score on a scale
Standard Deviation 6.18
|
|
Change From Baseline in Work Instability Scale for RA (RA-WIS) Over Time
Week 48
|
-6.8 score on a scale
Standard Deviation 5.94
|
-5.0 score on a scale
Standard Deviation 6.47
|
-3.5 score on a scale
Standard Deviation 4.98
|
|
Change From Baseline in Work Instability Scale for RA (RA-WIS) Over Time
Week 72
|
-7.5 score on a scale
Standard Deviation 6.83
|
-4.8 score on a scale
Standard Deviation 6.27
|
-4.3 score on a scale
Standard Deviation 4.10
|
|
Change From Baseline in Work Instability Scale for RA (RA-WIS) Over Time
Week 96
|
-6.5 score on a scale
Standard Deviation 6.72
|
-6.3 score on a scale
Standard Deviation 7.55
|
-4.0 score on a scale
Standard Deviation 4.18
|
|
Change From Baseline in Work Instability Scale for RA (RA-WIS) Over Time
Week 108
|
-6.8 score on a scale
Standard Deviation 6.80
|
-6.5 score on a scale
Standard Deviation 6.71
|
-3.5 score on a scale
Standard Deviation 4.80
|
|
Change From Baseline in Work Instability Scale for RA (RA-WIS) Over Time
Week 120
|
-7.6 score on a scale
Standard Deviation 6.66
|
-5.1 score on a scale
Standard Deviation 7.38
|
-5.7 score on a scale
Standard Deviation 4.44
|
|
Change From Baseline in Work Instability Scale for RA (RA-WIS) Over Time
Week 132
|
-7.2 score on a scale
Standard Deviation 6.04
|
-5.6 score on a scale
Standard Deviation 6.99
|
-4.7 score on a scale
Standard Deviation 3.47
|
|
Change From Baseline in Work Instability Scale for RA (RA-WIS) Over Time
Week 144
|
-5.9 score on a scale
Standard Deviation 6.51
|
-5.6 score on a scale
Standard Deviation 7.65
|
-4.3 score on a scale
Standard Deviation 3.41
|
|
Change From Baseline in Work Instability Scale for RA (RA-WIS) Over Time
Week 156
|
-6.2 score on a scale
Standard Deviation 7.13
|
-4.3 score on a scale
Standard Deviation 7.62
|
-4.9 score on a scale
Standard Deviation 3.72
|
|
Change From Baseline in Work Instability Scale for RA (RA-WIS) Over Time
Week 168
|
-5.8 score on a scale
Standard Deviation 6.01
|
-4.3 score on a scale
Standard Deviation 6.96
|
-5.1 score on a scale
Standard Deviation 6.69
|
|
Change From Baseline in Work Instability Scale for RA (RA-WIS) Over Time
Week 180
|
-5.3 score on a scale
Standard Deviation 6.61
|
-3.5 score on a scale
Standard Deviation 7.03
|
-4.2 score on a scale
Standard Deviation 3.19
|
|
Change From Baseline in Work Instability Scale for RA (RA-WIS) Over Time
Week 192
|
-5.5 score on a scale
Standard Deviation 6.42
|
-3.5 score on a scale
Standard Deviation 7.36
|
-4.3 score on a scale
Standard Deviation 2.93
|
|
Change From Baseline in Work Instability Scale for RA (RA-WIS) Over Time
Week 204
|
-6.4 score on a scale
Standard Deviation 7.06
|
-3.7 score on a scale
Standard Deviation 7.52
|
-5.0 score on a scale
Standard Deviation 3.78
|
|
Change From Baseline in Work Instability Scale for RA (RA-WIS) Over Time
Week 216
|
-6.0 score on a scale
Standard Deviation 7.55
|
-3.4 score on a scale
Standard Deviation 7.11
|
-5.0 score on a scale
Standard Deviation 2.92
|
|
Change From Baseline in Work Instability Scale for RA (RA-WIS) Over Time
Week 228
|
-6.5 score on a scale
Standard Deviation 7.16
|
-1.9 score on a scale
Standard Deviation 7.55
|
-4.6 score on a scale
Standard Deviation 4.24
|
|
Change From Baseline in Work Instability Scale for RA (RA-WIS) Over Time
Week 240
|
-5.9 score on a scale
Standard Deviation 7.05
|
-3.1 score on a scale
Standard Deviation 7.61
|
-4.5 score on a scale
Standard Deviation 4.09
|
|
Change From Baseline in Work Instability Scale for RA (RA-WIS) Over Time
Week 252
|
-5.8 score on a scale
Standard Deviation 6.43
|
-2.0 score on a scale
Standard Deviation 8.05
|
-5.0 score on a scale
Standard Deviation 3.70
|
|
Change From Baseline in Work Instability Scale for RA (RA-WIS) Over Time
Week 264
|
-5.0 score on a scale
Standard Deviation 6.53
|
-3.4 score on a scale
Standard Deviation 8.00
|
-4.5 score on a scale
Standard Deviation 3.89
|
|
Change From Baseline in Work Instability Scale for RA (RA-WIS) Over Time
Week 276
|
-5.0 score on a scale
Standard Deviation 6.74
|
-2.7 score on a scale
Standard Deviation 8.27
|
-5.0 score on a scale
Standard Deviation 2.52
|
|
Change From Baseline in Work Instability Scale for RA (RA-WIS) Over Time
Week 288
|
-5.0 score on a scale
Standard Deviation 7.05
|
-4.8 score on a scale
Standard Deviation 7.38
|
-4.8 score on a scale
Standard Deviation 3.45
|
|
Change From Baseline in Work Instability Scale for RA (RA-WIS) Over Time
Week 300
|
-4.6 score on a scale
Standard Deviation 7.23
|
-4.3 score on a scale
Standard Deviation 8.51
|
-4.6 score on a scale
Standard Deviation 4.07
|
|
Change From Baseline in Work Instability Scale for RA (RA-WIS) Over Time
Week 312
|
-4.2 score on a scale
Standard Deviation 7.00
|
-3.9 score on a scale
Standard Deviation 8.37
|
-2.9 score on a scale
Standard Deviation 4.45
|
SECONDARY outcome
Timeframe: Baseline (of the preceding RCT study) and Weeks 6, 12, 24, 36, 48, 72, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, and 312Population: Open-label treated population with available data at Baseline and each time point
The EQ-5D-5L is a generic measure of health status consisting of two parts. The first part (the descriptive system) assesses health in five dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) each of which is rated on 5 levels of severity (1: no problem, 2: slight problems, 3: moderate problems, 4: severe problems, 5: extreme problems). A health state index score was calculated from individual health profiles using a UK scoring algorithm. Health state index scores generally range from less than 0 (where 0 is the value of a health state equivalent to dead; negative values representing values as worse than dead) to 1 (the value of full health), with higher scores indicating higher health utility. The higher the score the better the health status. A positive change from baseline indicates improvement in health status.
Outcome measures
| Measure |
Upadacitinib Never Titrated
n=304 Participants
Participants received treatment with upadacitinib for up to 312 weeks. The starting dose was 6 mg twice a day (BID). From January 2017 participants were transitioned to once-daily dose of 15 mg upadacitinib.
|
Upadacitinib Titrated Up and Not Down
n=146 Participants
Participants received treatment with upadacitinib for up to 312 weeks. The starting dose was 6 mg BID. Participants who did not achieve protocol-specified improvement criteria at Week 6 or at any visits thereafter were up-titrated to upadacitinib 12 mg BID. From January 2017 participants were transitioned to once-daily dose of 30 mg upadacitinib.
|
Upadacitinib Titrated Up and Down
n=37 Participants
Participants received treatment with upadacitinib for up to 312 weeks. The starting dose was 6 mg BID. Participants who did not achieve protocol-specified improvement criteria at Week 6 or at any visits thereafter were up-titrated to upadacitinib 12 mg BID. From January 2017 participants were transitioned to once-daily dose of 30 mg upadacitinib. The upadacitinib dose was decreased back to 6 mg BID (or 15 mg QD from January 2017) per Investigator's judgment or safety and/or tolerability concerns.
|
|---|---|---|---|
|
Change From Baseline in EuroQoL-5D (EQ-5D) Index Over Time
Week 6
|
0.2 score on a scale
Standard Deviation 0.24
|
0.2 score on a scale
Standard Deviation 0.27
|
0.2 score on a scale
Standard Deviation 0.18
|
|
Change From Baseline in EuroQoL-5D (EQ-5D) Index Over Time
Week 12
|
0.2 score on a scale
Standard Deviation 0.23
|
0.2 score on a scale
Standard Deviation 0.29
|
0.2 score on a scale
Standard Deviation 0.14
|
|
Change From Baseline in EuroQoL-5D (EQ-5D) Index Over Time
Week 24
|
0.2 score on a scale
Standard Deviation 0.23
|
0.2 score on a scale
Standard Deviation 0.28
|
0.2 score on a scale
Standard Deviation 0.16
|
|
Change From Baseline in EuroQoL-5D (EQ-5D) Index Over Time
Week 36
|
0.2 score on a scale
Standard Deviation 0.24
|
0.2 score on a scale
Standard Deviation 0.27
|
0.2 score on a scale
Standard Deviation 0.16
|
|
Change From Baseline in EuroQoL-5D (EQ-5D) Index Over Time
Week 48
|
0.2 score on a scale
Standard Deviation 0.25
|
0.2 score on a scale
Standard Deviation 0.31
|
0.1 score on a scale
Standard Deviation 0.20
|
|
Change From Baseline in EuroQoL-5D (EQ-5D) Index Over Time
Week 72
|
0.2 score on a scale
Standard Deviation 0.24
|
0.2 score on a scale
Standard Deviation 0.28
|
0.2 score on a scale
Standard Deviation 0.16
|
|
Change From Baseline in EuroQoL-5D (EQ-5D) Index Over Time
Week 96
|
0.2 score on a scale
Standard Deviation 0.25
|
0.2 score on a scale
Standard Deviation 0.28
|
0.2 score on a scale
Standard Deviation 0.15
|
|
Change From Baseline in EuroQoL-5D (EQ-5D) Index Over Time
Week 108
|
0.2 score on a scale
Standard Deviation 0.26
|
0.2 score on a scale
Standard Deviation 0.28
|
0.1 score on a scale
Standard Deviation 0.16
|
|
Change From Baseline in EuroQoL-5D (EQ-5D) Index Over Time
Week 120
|
0.2 score on a scale
Standard Deviation 0.26
|
0.2 score on a scale
Standard Deviation 0.27
|
0.2 score on a scale
Standard Deviation 0.16
|
|
Change From Baseline in EuroQoL-5D (EQ-5D) Index Over Time
Week 132
|
0.2 score on a scale
Standard Deviation 0.25
|
0.2 score on a scale
Standard Deviation 0.26
|
0.2 score on a scale
Standard Deviation 0.15
|
|
Change From Baseline in EuroQoL-5D (EQ-5D) Index Over Time
Week 144
|
0.2 score on a scale
Standard Deviation 0.28
|
0.2 score on a scale
Standard Deviation 0.27
|
0.2 score on a scale
Standard Deviation 0.17
|
|
Change From Baseline in EuroQoL-5D (EQ-5D) Index Over Time
Week 156
|
0.2 score on a scale
Standard Deviation 0.27
|
0.2 score on a scale
Standard Deviation 0.26
|
0.1 score on a scale
Standard Deviation 0.18
|
|
Change From Baseline in EuroQoL-5D (EQ-5D) Index Over Time
Week 168
|
0.2 score on a scale
Standard Deviation 0.29
|
0.2 score on a scale
Standard Deviation 0.28
|
0.2 score on a scale
Standard Deviation 0.20
|
|
Change From Baseline in EuroQoL-5D (EQ-5D) Index Over Time
Week 180
|
0.2 score on a scale
Standard Deviation 0.27
|
0.2 score on a scale
Standard Deviation 0.33
|
0.2 score on a scale
Standard Deviation 0.20
|
|
Change From Baseline in EuroQoL-5D (EQ-5D) Index Over Time
Week 192
|
0.2 score on a scale
Standard Deviation 0.27
|
0.2 score on a scale
Standard Deviation 0.27
|
0.2 score on a scale
Standard Deviation 0.20
|
|
Change From Baseline in EuroQoL-5D (EQ-5D) Index Over Time
Week 204
|
0.2 score on a scale
Standard Deviation 0.27
|
0.2 score on a scale
Standard Deviation 0.31
|
0.2 score on a scale
Standard Deviation 0.21
|
|
Change From Baseline in EuroQoL-5D (EQ-5D) Index Over Time
Week 216
|
0.2 score on a scale
Standard Deviation 0.29
|
0.2 score on a scale
Standard Deviation 0.30
|
0.2 score on a scale
Standard Deviation 0.18
|
|
Change From Baseline in EuroQoL-5D (EQ-5D) Index Over Time
Week 228
|
0.2 score on a scale
Standard Deviation 0.26
|
0.2 score on a scale
Standard Deviation 0.31
|
0.1 score on a scale
Standard Deviation 0.22
|
|
Change From Baseline in EuroQoL-5D (EQ-5D) Index Over Time
Week 240
|
0.3 score on a scale
Standard Deviation 0.29
|
0.2 score on a scale
Standard Deviation 0.26
|
0.1 score on a scale
Standard Deviation 0.22
|
|
Change From Baseline in EuroQoL-5D (EQ-5D) Index Over Time
Week 252
|
0.2 score on a scale
Standard Deviation 0.26
|
0.2 score on a scale
Standard Deviation 0.28
|
0.2 score on a scale
Standard Deviation 0.22
|
|
Change From Baseline in EuroQoL-5D (EQ-5D) Index Over Time
Week 264
|
0.3 score on a scale
Standard Deviation 0.29
|
0.2 score on a scale
Standard Deviation 0.25
|
0.1 score on a scale
Standard Deviation 0.23
|
|
Change From Baseline in EuroQoL-5D (EQ-5D) Index Over Time
Week 276
|
0.2 score on a scale
Standard Deviation 0.30
|
0.2 score on a scale
Standard Deviation 0.26
|
0.1 score on a scale
Standard Deviation 0.22
|
|
Change From Baseline in EuroQoL-5D (EQ-5D) Index Over Time
Week 288
|
0.3 score on a scale
Standard Deviation 0.27
|
0.2 score on a scale
Standard Deviation 0.27
|
0.1 score on a scale
Standard Deviation 0.23
|
|
Change From Baseline in EuroQoL-5D (EQ-5D) Index Over Time
Week 300
|
0.2 score on a scale
Standard Deviation 0.28
|
0.2 score on a scale
Standard Deviation 0.27
|
0.1 score on a scale
Standard Deviation 0.19
|
|
Change From Baseline in EuroQoL-5D (EQ-5D) Index Over Time
Week 312
|
0.2 score on a scale
Standard Deviation 0.29
|
0.2 score on a scale
Standard Deviation 0.26
|
0.1 score on a scale
Standard Deviation 0.25
|
SECONDARY outcome
Timeframe: Baseline (of the preceding RCT study) and Weeks 6, 12, 24, 36, 48, 72, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, and 312Population: Open-label treated population with available data at Baseline and each time point
The EQ-5D-5L is a generic measure of health status consisting of two parts. The second part of the questionnaire consists of a visual analog scale (VAS) on which the participant rates his/her perceived health from 0 (the worst imaginable health) to 100 (the best imaginable health). A positive change from baseline indicates improvement.
Outcome measures
| Measure |
Upadacitinib Never Titrated
n=304 Participants
Participants received treatment with upadacitinib for up to 312 weeks. The starting dose was 6 mg twice a day (BID). From January 2017 participants were transitioned to once-daily dose of 15 mg upadacitinib.
|
Upadacitinib Titrated Up and Not Down
n=146 Participants
Participants received treatment with upadacitinib for up to 312 weeks. The starting dose was 6 mg BID. Participants who did not achieve protocol-specified improvement criteria at Week 6 or at any visits thereafter were up-titrated to upadacitinib 12 mg BID. From January 2017 participants were transitioned to once-daily dose of 30 mg upadacitinib.
|
Upadacitinib Titrated Up and Down
n=37 Participants
Participants received treatment with upadacitinib for up to 312 weeks. The starting dose was 6 mg BID. Participants who did not achieve protocol-specified improvement criteria at Week 6 or at any visits thereafter were up-titrated to upadacitinib 12 mg BID. From January 2017 participants were transitioned to once-daily dose of 30 mg upadacitinib. The upadacitinib dose was decreased back to 6 mg BID (or 15 mg QD from January 2017) per Investigator's judgment or safety and/or tolerability concerns.
|
|---|---|---|---|
|
Change From Baseline in EuroQoL-5D VAS Score Over Time
Week 144
|
28.6 score on a scale
Standard Deviation 26.71
|
23.5 score on a scale
Standard Deviation 24.29
|
24.7 score on a scale
Standard Deviation 25.32
|
|
Change From Baseline in EuroQoL-5D VAS Score Over Time
Week 156
|
29.9 score on a scale
Standard Deviation 25.48
|
22.5 score on a scale
Standard Deviation 24.62
|
22.1 score on a scale
Standard Deviation 23.52
|
|
Change From Baseline in EuroQoL-5D VAS Score Over Time
Week 6
|
23.7 score on a scale
Standard Deviation 25.21
|
14.4 score on a scale
Standard Deviation 24.94
|
21.6 score on a scale
Standard Deviation 20.49
|
|
Change From Baseline in EuroQoL-5D VAS Score Over Time
Week 12
|
26.0 score on a scale
Standard Deviation 25.62
|
15.9 score on a scale
Standard Deviation 25.83
|
19.4 score on a scale
Standard Deviation 25.07
|
|
Change From Baseline in EuroQoL-5D VAS Score Over Time
Week 24
|
27.5 score on a scale
Standard Deviation 25.24
|
16.8 score on a scale
Standard Deviation 27.31
|
20.7 score on a scale
Standard Deviation 20.67
|
|
Change From Baseline in EuroQoL-5D VAS Score Over Time
Week 36
|
27.0 score on a scale
Standard Deviation 26.29
|
18.6 score on a scale
Standard Deviation 27.10
|
18.6 score on a scale
Standard Deviation 21.05
|
|
Change From Baseline in EuroQoL-5D VAS Score Over Time
Week 48
|
25.9 score on a scale
Standard Deviation 26.87
|
19.1 score on a scale
Standard Deviation 28.61
|
19.7 score on a scale
Standard Deviation 21.07
|
|
Change From Baseline in EuroQoL-5D VAS Score Over Time
Week 72
|
28.0 score on a scale
Standard Deviation 24.36
|
21.9 score on a scale
Standard Deviation 26.33
|
26.7 score on a scale
Standard Deviation 21.43
|
|
Change From Baseline in EuroQoL-5D VAS Score Over Time
Week 96
|
27.5 score on a scale
Standard Deviation 26.86
|
22.4 score on a scale
Standard Deviation 27.73
|
25.4 score on a scale
Standard Deviation 19.25
|
|
Change From Baseline in EuroQoL-5D VAS Score Over Time
Week 108
|
28.8 score on a scale
Standard Deviation 25.72
|
23.2 score on a scale
Standard Deviation 25.81
|
20.5 score on a scale
Standard Deviation 19.06
|
|
Change From Baseline in EuroQoL-5D VAS Score Over Time
Week 120
|
28.4 score on a scale
Standard Deviation 27.22
|
23.7 score on a scale
Standard Deviation 25.36
|
27.2 score on a scale
Standard Deviation 23.54
|
|
Change From Baseline in EuroQoL-5D VAS Score Over Time
Week 132
|
26.3 score on a scale
Standard Deviation 28.75
|
23.5 score on a scale
Standard Deviation 26.23
|
28.1 score on a scale
Standard Deviation 19.62
|
|
Change From Baseline in EuroQoL-5D VAS Score Over Time
Week 168
|
30.3 score on a scale
Standard Deviation 25.29
|
22.6 score on a scale
Standard Deviation 23.74
|
28.1 score on a scale
Standard Deviation 24.06
|
|
Change From Baseline in EuroQoL-5D VAS Score Over Time
Week 180
|
30.0 score on a scale
Standard Deviation 24.30
|
22.0 score on a scale
Standard Deviation 27.24
|
27.0 score on a scale
Standard Deviation 21.68
|
|
Change From Baseline in EuroQoL-5D VAS Score Over Time
Week 192
|
29.7 score on a scale
Standard Deviation 24.65
|
23.6 score on a scale
Standard Deviation 26.41
|
30.8 score on a scale
Standard Deviation 21.96
|
|
Change From Baseline in EuroQoL-5D VAS Score Over Time
Week 204
|
32.0 score on a scale
Standard Deviation 24.41
|
23.1 score on a scale
Standard Deviation 27.13
|
30.7 score on a scale
Standard Deviation 22.99
|
|
Change From Baseline in EuroQoL-5D VAS Score Over Time
Week 216
|
30.0 score on a scale
Standard Deviation 26.93
|
24.0 score on a scale
Standard Deviation 26.40
|
28.0 score on a scale
Standard Deviation 21.73
|
|
Change From Baseline in EuroQoL-5D VAS Score Over Time
Week 228
|
31.6 score on a scale
Standard Deviation 24.92
|
19.7 score on a scale
Standard Deviation 26.70
|
29.5 score on a scale
Standard Deviation 23.85
|
|
Change From Baseline in EuroQoL-5D VAS Score Over Time
Week 240
|
31.3 score on a scale
Standard Deviation 26.18
|
21.9 score on a scale
Standard Deviation 25.62
|
28.4 score on a scale
Standard Deviation 26.55
|
|
Change From Baseline in EuroQoL-5D VAS Score Over Time
Week 252
|
31.2 score on a scale
Standard Deviation 24.46
|
22.8 score on a scale
Standard Deviation 26.74
|
25.6 score on a scale
Standard Deviation 23.74
|
|
Change From Baseline in EuroQoL-5D VAS Score Over Time
Week 264
|
30.8 score on a scale
Standard Deviation 25.30
|
22.2 score on a scale
Standard Deviation 23.60
|
21.9 score on a scale
Standard Deviation 24.81
|
|
Change From Baseline in EuroQoL-5D VAS Score Over Time
Week 276
|
32.4 score on a scale
Standard Deviation 23.37
|
20.5 score on a scale
Standard Deviation 25.68
|
25.4 score on a scale
Standard Deviation 20.62
|
|
Change From Baseline in EuroQoL-5D VAS Score Over Time
Week 288
|
32.3 score on a scale
Standard Deviation 24.66
|
24.6 score on a scale
Standard Deviation 25.54
|
25.3 score on a scale
Standard Deviation 22.57
|
|
Change From Baseline in EuroQoL-5D VAS Score Over Time
Week 300
|
30.5 score on a scale
Standard Deviation 24.39
|
20.4 score on a scale
Standard Deviation 27.31
|
23.6 score on a scale
Standard Deviation 17.27
|
|
Change From Baseline in EuroQoL-5D VAS Score Over Time
Week 312
|
31.2 score on a scale
Standard Deviation 25.15
|
25.8 score on a scale
Standard Deviation 24.81
|
24.1 score on a scale
Standard Deviation 25.18
|
SECONDARY outcome
Timeframe: Vaccination Baseline and 12 weeks after vaccinationPopulation: The sub-study full analysis set (FAS) included all participants enrolled in the sub-study who received PCV-13 vaccination and at least 1 dose of upadacitinib 15 mg or 30 mg after vaccination during the sub-study. Analysis includes participants with available data at the Week 12 visit of the sub-study.
Satisfactory humoral response is defined as greater than or equal to 2-fold increase in antibody concentration from the vaccination Baseline in at least 6 out of the 12 pneumococcal antigens 1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F).
Outcome measures
| Measure |
Upadacitinib Never Titrated
n=79 Participants
Participants received treatment with upadacitinib for up to 312 weeks. The starting dose was 6 mg twice a day (BID). From January 2017 participants were transitioned to once-daily dose of 15 mg upadacitinib.
|
Upadacitinib Titrated Up and Not Down
n=22 Participants
Participants received treatment with upadacitinib for up to 312 weeks. The starting dose was 6 mg BID. Participants who did not achieve protocol-specified improvement criteria at Week 6 or at any visits thereafter were up-titrated to upadacitinib 12 mg BID. From January 2017 participants were transitioned to once-daily dose of 30 mg upadacitinib.
|
Upadacitinib Titrated Up and Down
Participants received treatment with upadacitinib for up to 312 weeks. The starting dose was 6 mg BID. Participants who did not achieve protocol-specified improvement criteria at Week 6 or at any visits thereafter were up-titrated to upadacitinib 12 mg BID. From January 2017 participants were transitioned to once-daily dose of 30 mg upadacitinib. The upadacitinib dose was decreased back to 6 mg BID (or 15 mg QD from January 2017) per Investigator's judgment or safety and/or tolerability concerns.
|
|---|---|---|---|
|
Percentage of Participants With Satisfactory Humoral Response to PCV-13 12 Weeks After Vaccination
|
64.6 percentage of participants
Interval 54.0 to 75.1
|
54.5 percentage of participants
Interval 33.7 to 75.4
|
—
|
SECONDARY outcome
Timeframe: Vaccination Baseline and 4 and 12 weeks after vaccinationPopulation: Sub-study full analysis set with available data at each time point.
Outcome measures
| Measure |
Upadacitinib Never Titrated
n=83 Participants
Participants received treatment with upadacitinib for up to 312 weeks. The starting dose was 6 mg twice a day (BID). From January 2017 participants were transitioned to once-daily dose of 15 mg upadacitinib.
|
Upadacitinib Titrated Up and Not Down
n=23 Participants
Participants received treatment with upadacitinib for up to 312 weeks. The starting dose was 6 mg BID. Participants who did not achieve protocol-specified improvement criteria at Week 6 or at any visits thereafter were up-titrated to upadacitinib 12 mg BID. From January 2017 participants were transitioned to once-daily dose of 30 mg upadacitinib.
|
Upadacitinib Titrated Up and Down
Participants received treatment with upadacitinib for up to 312 weeks. The starting dose was 6 mg BID. Participants who did not achieve protocol-specified improvement criteria at Week 6 or at any visits thereafter were up-titrated to upadacitinib 12 mg BID. From January 2017 participants were transitioned to once-daily dose of 30 mg upadacitinib. The upadacitinib dose was decreased back to 6 mg BID (or 15 mg QD from January 2017) per Investigator's judgment or safety and/or tolerability concerns.
|
|---|---|---|---|
|
Geometric Mean Fold Rise (GMFR) of Anti-pneumococcal Antibody Levels to Each of the 12 Pneumococcal Antigens 4 and 12 Weeks After Vaccination
Antigen 1: Week 4
|
7.90 fold-rise
Interval 6.096 to 10.244
|
6.53 fold-rise
Interval 3.985 to 10.684
|
—
|
|
Geometric Mean Fold Rise (GMFR) of Anti-pneumococcal Antibody Levels to Each of the 12 Pneumococcal Antigens 4 and 12 Weeks After Vaccination
Antigen 1: Week 12
|
8.07 fold-rise
Interval 6.158 to 10.567
|
6.54 fold-rise
Interval 3.922 to 10.911
|
—
|
|
Geometric Mean Fold Rise (GMFR) of Anti-pneumococcal Antibody Levels to Each of the 12 Pneumococcal Antigens 4 and 12 Weeks After Vaccination
Antigen 3: Week 4
|
2.59 fold-rise
Interval 2.088 to 3.205
|
2.30 fold-rise
Interval 1.53 to 3.467
|
—
|
|
Geometric Mean Fold Rise (GMFR) of Anti-pneumococcal Antibody Levels to Each of the 12 Pneumococcal Antigens 4 and 12 Weeks After Vaccination
Antigen 3: Week 12
|
2.26 fold-rise
Interval 1.805 to 2.824
|
2.24 fold-rise
Interval 1.464 to 3.431
|
—
|
|
Geometric Mean Fold Rise (GMFR) of Anti-pneumococcal Antibody Levels to Each of the 12 Pneumococcal Antigens 4 and 12 Weeks After Vaccination
Antigen 4: Week 4
|
5.61 fold-rise
Interval 4.279 to 7.362
|
3.82 fold-rise
Interval 2.283 to 6.402
|
—
|
|
Geometric Mean Fold Rise (GMFR) of Anti-pneumococcal Antibody Levels to Each of the 12 Pneumococcal Antigens 4 and 12 Weeks After Vaccination
Antigen 4: Week 12
|
5.17 fold-rise
Interval 3.888 to 6.885
|
3.39 fold-rise
Interval 1.97 to 5.826
|
—
|
|
Geometric Mean Fold Rise (GMFR) of Anti-pneumococcal Antibody Levels to Each of the 12 Pneumococcal Antigens 4 and 12 Weeks After Vaccination
Antigen 5: Week 4
|
1.90 fold-rise
Interval 1.521 to 2.366
|
1.60 fold-rise
Interval 1.05 to 2.431
|
—
|
|
Geometric Mean Fold Rise (GMFR) of Anti-pneumococcal Antibody Levels to Each of the 12 Pneumococcal Antigens 4 and 12 Weeks After Vaccination
Antigen 5: Week 12
|
1.84 fold-rise
Interval 1.485 to 2.288
|
1.57 fold-rise
Interval 1.043 to 2.367
|
—
|
|
Geometric Mean Fold Rise (GMFR) of Anti-pneumococcal Antibody Levels to Each of the 12 Pneumococcal Antigens 4 and 12 Weeks After Vaccination
Antigen 6B: Week 4
|
4.50 fold-rise
Interval 3.325 to 6.077
|
3.10 fold-rise
Interval 1.748 to 5.511
|
—
|
|
Geometric Mean Fold Rise (GMFR) of Anti-pneumococcal Antibody Levels to Each of the 12 Pneumococcal Antigens 4 and 12 Weeks After Vaccination
Antigen 6B: Week 12
|
3.90 fold-rise
Interval 2.801 to 5.436
|
3.25 fold-rise
Interval 1.732 to 6.092
|
—
|
|
Geometric Mean Fold Rise (GMFR) of Anti-pneumococcal Antibody Levels to Each of the 12 Pneumococcal Antigens 4 and 12 Weeks After Vaccination
Antigen 7F: Week 4
|
3.58 fold-rise
Interval 2.824 to 4.548
|
2.83 fold-rise
Interval 1.797 to 4.446
|
—
|
|
Geometric Mean Fold Rise (GMFR) of Anti-pneumococcal Antibody Levels to Each of the 12 Pneumococcal Antigens 4 and 12 Weeks After Vaccination
Antigen 7F: Week 12
|
3.30 fold-rise
Interval 2.552 to 4.255
|
3.02 fold-rise
Interval 1.856 to 4.897
|
—
|
|
Geometric Mean Fold Rise (GMFR) of Anti-pneumococcal Antibody Levels to Each of the 12 Pneumococcal Antigens 4 and 12 Weeks After Vaccination
Antigen 9V: Week 4
|
5.69 fold-rise
Interval 4.26 to 7.611
|
2.76 fold-rise
Interval 1.588 to 4.794
|
—
|
|
Geometric Mean Fold Rise (GMFR) of Anti-pneumococcal Antibody Levels to Each of the 12 Pneumococcal Antigens 4 and 12 Weeks After Vaccination
Antigen 9V: Week 12
|
6.18 fold-rise
Interval 4.583 to 8.325
|
2.91 fold-rise
Interval 1.649 to 5.138
|
—
|
|
Geometric Mean Fold Rise (GMFR) of Anti-pneumococcal Antibody Levels to Each of the 12 Pneumococcal Antigens 4 and 12 Weeks After Vaccination
Antigen 14: Week 4
|
2.97 fold-rise
Interval 2.373 to 3.723
|
2.42 fold-rise
Interval 1.573 to 3.707
|
—
|
|
Geometric Mean Fold Rise (GMFR) of Anti-pneumococcal Antibody Levels to Each of the 12 Pneumococcal Antigens 4 and 12 Weeks After Vaccination
Antigen 14: Week 12
|
2.84 fold-rise
Interval 2.231 to 3.613
|
2.41 fold-rise
Interval 1.524 to 3.804
|
—
|
|
Geometric Mean Fold Rise (GMFR) of Anti-pneumococcal Antibody Levels to Each of the 12 Pneumococcal Antigens 4 and 12 Weeks After Vaccination
Antigen 18C: Week 4
|
4.52 fold-rise
Interval 3.526 to 5.801
|
3.23 fold-rise
Interval 2.009 to 5.179
|
—
|
|
Geometric Mean Fold Rise (GMFR) of Anti-pneumococcal Antibody Levels to Each of the 12 Pneumococcal Antigens 4 and 12 Weeks After Vaccination
Antigen 18C: Week 12
|
4.42 fold-rise
Interval 3.443 to 5.67
|
3.53 fold-rise
Interval 2.201 to 5.666
|
—
|
|
Geometric Mean Fold Rise (GMFR) of Anti-pneumococcal Antibody Levels to Each of the 12 Pneumococcal Antigens 4 and 12 Weeks After Vaccination
Antigen 19A: Week 4
|
1.47 fold-rise
Interval 1.264 to 1.702
|
1.12 fold-rise
Interval 0.844 to 1.485
|
—
|
|
Geometric Mean Fold Rise (GMFR) of Anti-pneumococcal Antibody Levels to Each of the 12 Pneumococcal Antigens 4 and 12 Weeks After Vaccination
Antigen 19A: Week 12
|
1.44 fold-rise
Interval 1.245 to 1.666
|
1.15 fold-rise
Interval 0.876 to 1.521
|
—
|
|
Geometric Mean Fold Rise (GMFR) of Anti-pneumococcal Antibody Levels to Each of the 12 Pneumococcal Antigens 4 and 12 Weeks After Vaccination
Antigen 19F: Week 4
|
2.27 fold-rise
Interval 1.834 to 2.808
|
2.32 fold-rise
Interval 1.549 to 3.476
|
—
|
|
Geometric Mean Fold Rise (GMFR) of Anti-pneumococcal Antibody Levels to Each of the 12 Pneumococcal Antigens 4 and 12 Weeks After Vaccination
Antigen 19F: Week 12
|
2.17 fold-rise
Interval 1.761 to 2.671
|
1.99 fold-rise
Interval 1.344 to 2.958
|
—
|
|
Geometric Mean Fold Rise (GMFR) of Anti-pneumococcal Antibody Levels to Each of the 12 Pneumococcal Antigens 4 and 12 Weeks After Vaccination
Antigen 23F: Week 4
|
4.32 fold-rise
Interval 3.291 to 5.672
|
3.11 fold-rise
Interval 1.855 to 5.218
|
—
|
|
Geometric Mean Fold Rise (GMFR) of Anti-pneumococcal Antibody Levels to Each of the 12 Pneumococcal Antigens 4 and 12 Weeks After Vaccination
Antigen 23F: Week 12
|
4.06 fold-rise
Interval 3.048 to 5.413
|
3.29 fold-rise
Interval 1.908 to 5.666
|
—
|
Adverse Events
Upadacitinib 6 mg BID/15 mg QD
Serious events: 68 serious events
Other events: 233 other events
Deaths: 5 deaths
Upadacitinib 12 mg BID/30 mg QD
Serious events: 42 serious events
Other events: 113 other events
Deaths: 3 deaths
Upadacitinib 6 mg BID/15 mg QD Post Down-titration
Serious events: 5 serious events
Other events: 23 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Upadacitinib 6 mg BID/15 mg QD
n=493 participants at risk
Participants received upadacitinib 6 mg BID. From January 2017 participants were transitioned to 15 mg upadacitinib QD. Includes events that occurred until the time of up-titration for participants who were up-titrated.
|
Upadacitinib 12 mg BID/30 mg QD
n=187 participants at risk
Participants received upadacitinib 12 mg BID. From January 2017 participants were transitioned to 30 mg upadacitinib QD. Includes events that occurred from the time of up-titration until time of down titration to 6 mg BID/15 mg QD for participants who titrated up and back down.
|
Upadacitinib 6 mg BID/15 mg QD Post Down-titration
n=38 participants at risk
Participants who down-titrated to 6 mg BID/15 mg QD after up-titration to 15 mg BID/30 mg QD. Includes events that occurred after down titration.
|
|---|---|---|---|
|
Blood and lymphatic system disorders
BLOOD LOSS ANAEMIA
|
0.00%
0/493 • From the first dose of open-label upadacitinib up to 30 days after the last dose, up to 316 weeks.
|
0.53%
1/187 • Number of events 1 • From the first dose of open-label upadacitinib up to 30 days after the last dose, up to 316 weeks.
|
0.00%
0/38 • From the first dose of open-label upadacitinib up to 30 days after the last dose, up to 316 weeks.
|
|
Cardiac disorders
ACUTE MYOCARDIAL INFARCTION
|
0.81%
4/493 • Number of events 4 • From the first dose of open-label upadacitinib up to 30 days after the last dose, up to 316 weeks.
|
0.00%
0/187 • From the first dose of open-label upadacitinib up to 30 days after the last dose, up to 316 weeks.
|
0.00%
0/38 • From the first dose of open-label upadacitinib up to 30 days after the last dose, up to 316 weeks.
|
|
Cardiac disorders
ANGINA PECTORIS
|
0.20%
1/493 • Number of events 1 • From the first dose of open-label upadacitinib up to 30 days after the last dose, up to 316 weeks.
|
0.00%
0/187 • From the first dose of open-label upadacitinib up to 30 days after the last dose, up to 316 weeks.
|
0.00%
0/38 • From the first dose of open-label upadacitinib up to 30 days after the last dose, up to 316 weeks.
|
|
Cardiac disorders
ANGINA UNSTABLE
|
0.00%
0/493 • From the first dose of open-label upadacitinib up to 30 days after the last dose, up to 316 weeks.
|
0.00%
0/187 • From the first dose of open-label upadacitinib up to 30 days after the last dose, up to 316 weeks.
|
2.6%
1/38 • Number of events 1 • From the first dose of open-label upadacitinib up to 30 days after the last dose, up to 316 weeks.
|
|
Cardiac disorders
AORTIC VALVE INCOMPETENCE
|
0.20%
1/493 • Number of events 1 • From the first dose of open-label upadacitinib up to 30 days after the last dose, up to 316 weeks.
|
0.00%
0/187 • From the first dose of open-label upadacitinib up to 30 days after the last dose, up to 316 weeks.
|
0.00%
0/38 • From the first dose of open-label upadacitinib up to 30 days after the last dose, up to 316 weeks.
|
|
Cardiac disorders
ATRIAL FLUTTER
|
0.20%
1/493 • Number of events 2 • From the first dose of open-label upadacitinib up to 30 days after the last dose, up to 316 weeks.
|
0.00%
0/187 • From the first dose of open-label upadacitinib up to 30 days after the last dose, up to 316 weeks.
|
0.00%
0/38 • From the first dose of open-label upadacitinib up to 30 days after the last dose, up to 316 weeks.
|
|
Cardiac disorders
ATRIOVENTRICULAR BLOCK SECOND DEGREE
|
0.20%
1/493 • Number of events 1 • From the first dose of open-label upadacitinib up to 30 days after the last dose, up to 316 weeks.
|
0.00%
0/187 • From the first dose of open-label upadacitinib up to 30 days after the last dose, up to 316 weeks.
|
0.00%
0/38 • From the first dose of open-label upadacitinib up to 30 days after the last dose, up to 316 weeks.
|
|
Cardiac disorders
CARDIAC FAILURE
|
0.00%
0/493 • From the first dose of open-label upadacitinib up to 30 days after the last dose, up to 316 weeks.
|
0.53%
1/187 • Number of events 1 • From the first dose of open-label upadacitinib up to 30 days after the last dose, up to 316 weeks.
|
0.00%
0/38 • From the first dose of open-label upadacitinib up to 30 days after the last dose, up to 316 weeks.
|
|
Cardiac disorders
CARDIOMYOPATHY
|
0.20%
1/493 • Number of events 1 • From the first dose of open-label upadacitinib up to 30 days after the last dose, up to 316 weeks.
|
0.00%
0/187 • From the first dose of open-label upadacitinib up to 30 days after the last dose, up to 316 weeks.
|
0.00%
0/38 • From the first dose of open-label upadacitinib up to 30 days after the last dose, up to 316 weeks.
|
|
Cardiac disorders
CORONARY ARTERY DISEASE
|
0.20%
1/493 • Number of events 1 • From the first dose of open-label upadacitinib up to 30 days after the last dose, up to 316 weeks.
|
0.00%
0/187 • From the first dose of open-label upadacitinib up to 30 days after the last dose, up to 316 weeks.
|
0.00%
0/38 • From the first dose of open-label upadacitinib up to 30 days after the last dose, up to 316 weeks.
|
|
Cardiac disorders
CORONARY ARTERY DISSECTION
|
0.00%
0/493 • From the first dose of open-label upadacitinib up to 30 days after the last dose, up to 316 weeks.
|
0.53%
1/187 • Number of events 1 • From the first dose of open-label upadacitinib up to 30 days after the last dose, up to 316 weeks.
|
0.00%
0/38 • From the first dose of open-label upadacitinib up to 30 days after the last dose, up to 316 weeks.
|
|
Cardiac disorders
MYOCARDIAL INFARCTION
|
0.20%
1/493 • Number of events 1 • From the first dose of open-label upadacitinib up to 30 days after the last dose, up to 316 weeks.
|
0.00%
0/187 • From the first dose of open-label upadacitinib up to 30 days after the last dose, up to 316 weeks.
|
0.00%
0/38 • From the first dose of open-label upadacitinib up to 30 days after the last dose, up to 316 weeks.
|
|
Cardiac disorders
MYOCARDIAL ISCHAEMIA
|
0.20%
1/493 • Number of events 1 • From the first dose of open-label upadacitinib up to 30 days after the last dose, up to 316 weeks.
|
0.53%
1/187 • Number of events 1 • From the first dose of open-label upadacitinib up to 30 days after the last dose, up to 316 weeks.
|
0.00%
0/38 • From the first dose of open-label upadacitinib up to 30 days after the last dose, up to 316 weeks.
|
|
Cardiac disorders
STRESS CARDIOMYOPATHY
|
0.00%
0/493 • From the first dose of open-label upadacitinib up to 30 days after the last dose, up to 316 weeks.
|
0.53%
1/187 • Number of events 1 • From the first dose of open-label upadacitinib up to 30 days after the last dose, up to 316 weeks.
|
0.00%
0/38 • From the first dose of open-label upadacitinib up to 30 days after the last dose, up to 316 weeks.
|
|
Ear and labyrinth disorders
VESTIBULAR DISORDER
|
0.20%
1/493 • Number of events 1 • From the first dose of open-label upadacitinib up to 30 days after the last dose, up to 316 weeks.
|
0.00%
0/187 • From the first dose of open-label upadacitinib up to 30 days after the last dose, up to 316 weeks.
|
0.00%
0/38 • From the first dose of open-label upadacitinib up to 30 days after the last dose, up to 316 weeks.
|
|
Endocrine disorders
GOITRE
|
0.00%
0/493 • From the first dose of open-label upadacitinib up to 30 days after the last dose, up to 316 weeks.
|
0.53%
1/187 • Number of events 1 • From the first dose of open-label upadacitinib up to 30 days after the last dose, up to 316 weeks.
|
0.00%
0/38 • From the first dose of open-label upadacitinib up to 30 days after the last dose, up to 316 weeks.
|
|
Eye disorders
CORNEAL PERFORATION
|
0.00%
0/493 • From the first dose of open-label upadacitinib up to 30 days after the last dose, up to 316 weeks.
|
0.53%
1/187 • Number of events 1 • From the first dose of open-label upadacitinib up to 30 days after the last dose, up to 316 weeks.
|
0.00%
0/38 • From the first dose of open-label upadacitinib up to 30 days after the last dose, up to 316 weeks.
|
|
Eye disorders
GLAUCOMA
|
0.00%
0/493 • From the first dose of open-label upadacitinib up to 30 days after the last dose, up to 316 weeks.
|
0.53%
1/187 • Number of events 1 • From the first dose of open-label upadacitinib up to 30 days after the last dose, up to 316 weeks.
|
0.00%
0/38 • From the first dose of open-label upadacitinib up to 30 days after the last dose, up to 316 weeks.
|
|
Eye disorders
MACULAR HOLE
|
0.00%
0/493 • From the first dose of open-label upadacitinib up to 30 days after the last dose, up to 316 weeks.
|
0.53%
1/187 • Number of events 1 • From the first dose of open-label upadacitinib up to 30 days after the last dose, up to 316 weeks.
|
0.00%
0/38 • From the first dose of open-label upadacitinib up to 30 days after the last dose, up to 316 weeks.
|
|
Gastrointestinal disorders
ENTEROCOLITIS
|
0.00%
0/493 • From the first dose of open-label upadacitinib up to 30 days after the last dose, up to 316 weeks.
|
0.53%
1/187 • Number of events 1 • From the first dose of open-label upadacitinib up to 30 days after the last dose, up to 316 weeks.
|
0.00%
0/38 • From the first dose of open-label upadacitinib up to 30 days after the last dose, up to 316 weeks.
|
|
Gastrointestinal disorders
VOMITING
|
0.20%
1/493 • Number of events 1 • From the first dose of open-label upadacitinib up to 30 days after the last dose, up to 316 weeks.
|
0.00%
0/187 • From the first dose of open-label upadacitinib up to 30 days after the last dose, up to 316 weeks.
|
0.00%
0/38 • From the first dose of open-label upadacitinib up to 30 days after the last dose, up to 316 weeks.
|
|
General disorders
CHEST PAIN
|
0.20%
1/493 • Number of events 1 • From the first dose of open-label upadacitinib up to 30 days after the last dose, up to 316 weeks.
|
0.00%
0/187 • From the first dose of open-label upadacitinib up to 30 days after the last dose, up to 316 weeks.
|
0.00%
0/38 • From the first dose of open-label upadacitinib up to 30 days after the last dose, up to 316 weeks.
|
|
General disorders
DEATH
|
0.41%
2/493 • Number of events 2 • From the first dose of open-label upadacitinib up to 30 days after the last dose, up to 316 weeks.
|
0.00%
0/187 • From the first dose of open-label upadacitinib up to 30 days after the last dose, up to 316 weeks.
|
0.00%
0/38 • From the first dose of open-label upadacitinib up to 30 days after the last dose, up to 316 weeks.
|
|
Hepatobiliary disorders
HEPATITIS
|
0.00%
0/493 • From the first dose of open-label upadacitinib up to 30 days after the last dose, up to 316 weeks.
|
0.53%
1/187 • Number of events 1 • From the first dose of open-label upadacitinib up to 30 days after the last dose, up to 316 weeks.
|
0.00%
0/38 • From the first dose of open-label upadacitinib up to 30 days after the last dose, up to 316 weeks.
|
|
Hepatobiliary disorders
HEPATOTOXICITY
|
0.20%
1/493 • Number of events 1 • From the first dose of open-label upadacitinib up to 30 days after the last dose, up to 316 weeks.
|
0.00%
0/187 • From the first dose of open-label upadacitinib up to 30 days after the last dose, up to 316 weeks.
|
0.00%
0/38 • From the first dose of open-label upadacitinib up to 30 days after the last dose, up to 316 weeks.
|
|
Infections and infestations
APPENDICITIS
|
0.00%
0/493 • From the first dose of open-label upadacitinib up to 30 days after the last dose, up to 316 weeks.
|
0.53%
1/187 • Number of events 1 • From the first dose of open-label upadacitinib up to 30 days after the last dose, up to 316 weeks.
|
0.00%
0/38 • From the first dose of open-label upadacitinib up to 30 days after the last dose, up to 316 weeks.
|
|
Infections and infestations
BRONCHITIS
|
0.20%
1/493 • Number of events 1 • From the first dose of open-label upadacitinib up to 30 days after the last dose, up to 316 weeks.
|
0.53%
1/187 • Number of events 1 • From the first dose of open-label upadacitinib up to 30 days after the last dose, up to 316 weeks.
|
0.00%
0/38 • From the first dose of open-label upadacitinib up to 30 days after the last dose, up to 316 weeks.
|
|
Infections and infestations
CELLULITIS
|
0.20%
1/493 • Number of events 1 • From the first dose of open-label upadacitinib up to 30 days after the last dose, up to 316 weeks.
|
1.6%
3/187 • Number of events 3 • From the first dose of open-label upadacitinib up to 30 days after the last dose, up to 316 weeks.
|
0.00%
0/38 • From the first dose of open-label upadacitinib up to 30 days after the last dose, up to 316 weeks.
|
|
Infections and infestations
COVID-19
|
0.00%
0/493 • From the first dose of open-label upadacitinib up to 30 days after the last dose, up to 316 weeks.
|
1.1%
2/187 • Number of events 2 • From the first dose of open-label upadacitinib up to 30 days after the last dose, up to 316 weeks.
|
0.00%
0/38 • From the first dose of open-label upadacitinib up to 30 days after the last dose, up to 316 weeks.
|
|
Infections and infestations
COVID-19 PNEUMONIA
|
0.00%
0/493 • From the first dose of open-label upadacitinib up to 30 days after the last dose, up to 316 weeks.
|
0.00%
0/187 • From the first dose of open-label upadacitinib up to 30 days after the last dose, up to 316 weeks.
|
2.6%
1/38 • Number of events 1 • From the first dose of open-label upadacitinib up to 30 days after the last dose, up to 316 weeks.
|
|
Infections and infestations
DIVERTICULITIS
|
0.20%
1/493 • Number of events 1 • From the first dose of open-label upadacitinib up to 30 days after the last dose, up to 316 weeks.
|
0.00%
0/187 • From the first dose of open-label upadacitinib up to 30 days after the last dose, up to 316 weeks.
|
0.00%
0/38 • From the first dose of open-label upadacitinib up to 30 days after the last dose, up to 316 weeks.
|
|
Infections and infestations
ENDOMETRITIS
|
0.00%
0/493 • From the first dose of open-label upadacitinib up to 30 days after the last dose, up to 316 weeks.
|
0.53%
1/187 • Number of events 1 • From the first dose of open-label upadacitinib up to 30 days after the last dose, up to 316 weeks.
|
0.00%
0/38 • From the first dose of open-label upadacitinib up to 30 days after the last dose, up to 316 weeks.
|
|
Infections and infestations
GASTROENTERITIS
|
0.20%
1/493 • Number of events 1 • From the first dose of open-label upadacitinib up to 30 days after the last dose, up to 316 weeks.
|
0.00%
0/187 • From the first dose of open-label upadacitinib up to 30 days after the last dose, up to 316 weeks.
|
0.00%
0/38 • From the first dose of open-label upadacitinib up to 30 days after the last dose, up to 316 weeks.
|
|
Infections and infestations
GASTROENTERITIS VIRAL
|
0.00%
0/493 • From the first dose of open-label upadacitinib up to 30 days after the last dose, up to 316 weeks.
|
0.53%
1/187 • Number of events 1 • From the first dose of open-label upadacitinib up to 30 days after the last dose, up to 316 weeks.
|
0.00%
0/38 • From the first dose of open-label upadacitinib up to 30 days after the last dose, up to 316 weeks.
|
|
Infections and infestations
HEPATITIS A
|
0.20%
1/493 • Number of events 1 • From the first dose of open-label upadacitinib up to 30 days after the last dose, up to 316 weeks.
|
0.00%
0/187 • From the first dose of open-label upadacitinib up to 30 days after the last dose, up to 316 weeks.
|
0.00%
0/38 • From the first dose of open-label upadacitinib up to 30 days after the last dose, up to 316 weeks.
|
|
Infections and infestations
HERPES ZOSTER
|
0.20%
1/493 • Number of events 1 • From the first dose of open-label upadacitinib up to 30 days after the last dose, up to 316 weeks.
|
0.53%
1/187 • Number of events 1 • From the first dose of open-label upadacitinib up to 30 days after the last dose, up to 316 weeks.
|
0.00%
0/38 • From the first dose of open-label upadacitinib up to 30 days after the last dose, up to 316 weeks.
|
|
Infections and infestations
HISTOPLASMOSIS DISSEMINATED
|
0.00%
0/493 • From the first dose of open-label upadacitinib up to 30 days after the last dose, up to 316 weeks.
|
0.53%
1/187 • Number of events 1 • From the first dose of open-label upadacitinib up to 30 days after the last dose, up to 316 weeks.
|
0.00%
0/38 • From the first dose of open-label upadacitinib up to 30 days after the last dose, up to 316 weeks.
|
|
Infections and infestations
INFLUENZA
|
0.00%
0/493 • From the first dose of open-label upadacitinib up to 30 days after the last dose, up to 316 weeks.
|
0.53%
1/187 • Number of events 1 • From the first dose of open-label upadacitinib up to 30 days after the last dose, up to 316 weeks.
|
0.00%
0/38 • From the first dose of open-label upadacitinib up to 30 days after the last dose, up to 316 weeks.
|
|
Infections and infestations
LATENT TUBERCULOSIS
|
0.20%
1/493 • Number of events 1 • From the first dose of open-label upadacitinib up to 30 days after the last dose, up to 316 weeks.
|
0.00%
0/187 • From the first dose of open-label upadacitinib up to 30 days after the last dose, up to 316 weeks.
|
0.00%
0/38 • From the first dose of open-label upadacitinib up to 30 days after the last dose, up to 316 weeks.
|
|
Infections and infestations
PNEUMONIA
|
1.4%
7/493 • Number of events 7 • From the first dose of open-label upadacitinib up to 30 days after the last dose, up to 316 weeks.
|
1.6%
3/187 • Number of events 3 • From the first dose of open-label upadacitinib up to 30 days after the last dose, up to 316 weeks.
|
0.00%
0/38 • From the first dose of open-label upadacitinib up to 30 days after the last dose, up to 316 weeks.
|
|
Infections and infestations
POSTOPERATIVE WOUND INFECTION
|
0.00%
0/493 • From the first dose of open-label upadacitinib up to 30 days after the last dose, up to 316 weeks.
|
0.00%
0/187 • From the first dose of open-label upadacitinib up to 30 days after the last dose, up to 316 weeks.
|
2.6%
1/38 • Number of events 1 • From the first dose of open-label upadacitinib up to 30 days after the last dose, up to 316 weeks.
|
|
Infections and infestations
PYELONEPHRITIS ACUTE
|
0.20%
1/493 • Number of events 1 • From the first dose of open-label upadacitinib up to 30 days after the last dose, up to 316 weeks.
|
0.00%
0/187 • From the first dose of open-label upadacitinib up to 30 days after the last dose, up to 316 weeks.
|
0.00%
0/38 • From the first dose of open-label upadacitinib up to 30 days after the last dose, up to 316 weeks.
|
|
Infections and infestations
RESPIRATORY TRACT INFECTION
|
0.00%
0/493 • From the first dose of open-label upadacitinib up to 30 days after the last dose, up to 316 weeks.
|
0.53%
1/187 • Number of events 1 • From the first dose of open-label upadacitinib up to 30 days after the last dose, up to 316 weeks.
|
0.00%
0/38 • From the first dose of open-label upadacitinib up to 30 days after the last dose, up to 316 weeks.
|
|
Infections and infestations
SEPSIS
|
0.00%
0/493 • From the first dose of open-label upadacitinib up to 30 days after the last dose, up to 316 weeks.
|
1.1%
2/187 • Number of events 2 • From the first dose of open-label upadacitinib up to 30 days after the last dose, up to 316 weeks.
|
0.00%
0/38 • From the first dose of open-label upadacitinib up to 30 days after the last dose, up to 316 weeks.
|
|
Infections and infestations
SOFT TISSUE INFECTION
|
0.00%
0/493 • From the first dose of open-label upadacitinib up to 30 days after the last dose, up to 316 weeks.
|
0.53%
1/187 • Number of events 1 • From the first dose of open-label upadacitinib up to 30 days after the last dose, up to 316 weeks.
|
0.00%
0/38 • From the first dose of open-label upadacitinib up to 30 days after the last dose, up to 316 weeks.
|
|
Infections and infestations
TUBERCULOSIS
|
0.20%
1/493 • Number of events 1 • From the first dose of open-label upadacitinib up to 30 days after the last dose, up to 316 weeks.
|
0.00%
0/187 • From the first dose of open-label upadacitinib up to 30 days after the last dose, up to 316 weeks.
|
0.00%
0/38 • From the first dose of open-label upadacitinib up to 30 days after the last dose, up to 316 weeks.
|
|
Infections and infestations
VARICELLA
|
0.20%
1/493 • Number of events 1 • From the first dose of open-label upadacitinib up to 30 days after the last dose, up to 316 weeks.
|
0.00%
0/187 • From the first dose of open-label upadacitinib up to 30 days after the last dose, up to 316 weeks.
|
0.00%
0/38 • From the first dose of open-label upadacitinib up to 30 days after the last dose, up to 316 weeks.
|
|
Infections and infestations
VARICELLA ZOSTER VIRUS INFECTION
|
0.20%
1/493 • Number of events 1 • From the first dose of open-label upadacitinib up to 30 days after the last dose, up to 316 weeks.
|
0.00%
0/187 • From the first dose of open-label upadacitinib up to 30 days after the last dose, up to 316 weeks.
|
0.00%
0/38 • From the first dose of open-label upadacitinib up to 30 days after the last dose, up to 316 weeks.
|
|
Injury, poisoning and procedural complications
CONTUSION
|
0.00%
0/493 • From the first dose of open-label upadacitinib up to 30 days after the last dose, up to 316 weeks.
|
0.53%
1/187 • Number of events 1 • From the first dose of open-label upadacitinib up to 30 days after the last dose, up to 316 weeks.
|
0.00%
0/38 • From the first dose of open-label upadacitinib up to 30 days after the last dose, up to 316 weeks.
|
|
Injury, poisoning and procedural complications
FACIAL BONES FRACTURE
|
0.00%
0/493 • From the first dose of open-label upadacitinib up to 30 days after the last dose, up to 316 weeks.
|
0.53%
1/187 • Number of events 1 • From the first dose of open-label upadacitinib up to 30 days after the last dose, up to 316 weeks.
|
0.00%
0/38 • From the first dose of open-label upadacitinib up to 30 days after the last dose, up to 316 weeks.
|
|
Injury, poisoning and procedural complications
FALL
|
0.20%
1/493 • Number of events 1 • From the first dose of open-label upadacitinib up to 30 days after the last dose, up to 316 weeks.
|
1.1%
2/187 • Number of events 2 • From the first dose of open-label upadacitinib up to 30 days after the last dose, up to 316 weeks.
|
0.00%
0/38 • From the first dose of open-label upadacitinib up to 30 days after the last dose, up to 316 weeks.
|
|
Injury, poisoning and procedural complications
FEMORAL NECK FRACTURE
|
0.20%
1/493 • Number of events 1 • From the first dose of open-label upadacitinib up to 30 days after the last dose, up to 316 weeks.
|
0.00%
0/187 • From the first dose of open-label upadacitinib up to 30 days after the last dose, up to 316 weeks.
|
0.00%
0/38 • From the first dose of open-label upadacitinib up to 30 days after the last dose, up to 316 weeks.
|
|
Injury, poisoning and procedural complications
FEMUR FRACTURE
|
0.20%
1/493 • Number of events 2 • From the first dose of open-label upadacitinib up to 30 days after the last dose, up to 316 weeks.
|
0.00%
0/187 • From the first dose of open-label upadacitinib up to 30 days after the last dose, up to 316 weeks.
|
0.00%
0/38 • From the first dose of open-label upadacitinib up to 30 days after the last dose, up to 316 weeks.
|
|
Injury, poisoning and procedural complications
FOREARM FRACTURE
|
0.00%
0/493 • From the first dose of open-label upadacitinib up to 30 days after the last dose, up to 316 weeks.
|
0.53%
1/187 • Number of events 1 • From the first dose of open-label upadacitinib up to 30 days after the last dose, up to 316 weeks.
|
0.00%
0/38 • From the first dose of open-label upadacitinib up to 30 days after the last dose, up to 316 weeks.
|
|
Injury, poisoning and procedural complications
HAND FRACTURE
|
0.20%
1/493 • Number of events 1 • From the first dose of open-label upadacitinib up to 30 days after the last dose, up to 316 weeks.
|
0.00%
0/187 • From the first dose of open-label upadacitinib up to 30 days after the last dose, up to 316 weeks.
|
0.00%
0/38 • From the first dose of open-label upadacitinib up to 30 days after the last dose, up to 316 weeks.
|
|
Injury, poisoning and procedural complications
HIP FRACTURE
|
0.20%
1/493 • Number of events 1 • From the first dose of open-label upadacitinib up to 30 days after the last dose, up to 316 weeks.
|
0.53%
1/187 • Number of events 1 • From the first dose of open-label upadacitinib up to 30 days after the last dose, up to 316 weeks.
|
0.00%
0/38 • From the first dose of open-label upadacitinib up to 30 days after the last dose, up to 316 weeks.
|
|
Injury, poisoning and procedural complications
HUMERUS FRACTURE
|
0.41%
2/493 • Number of events 2 • From the first dose of open-label upadacitinib up to 30 days after the last dose, up to 316 weeks.
|
0.00%
0/187 • From the first dose of open-label upadacitinib up to 30 days after the last dose, up to 316 weeks.
|
0.00%
0/38 • From the first dose of open-label upadacitinib up to 30 days after the last dose, up to 316 weeks.
|
|
Injury, poisoning and procedural complications
INCARCERATED INCISIONAL HERNIA
|
0.20%
1/493 • Number of events 2 • From the first dose of open-label upadacitinib up to 30 days after the last dose, up to 316 weeks.
|
0.00%
0/187 • From the first dose of open-label upadacitinib up to 30 days after the last dose, up to 316 weeks.
|
0.00%
0/38 • From the first dose of open-label upadacitinib up to 30 days after the last dose, up to 316 weeks.
|
|
Injury, poisoning and procedural complications
INCISIONAL HERNIA
|
0.20%
1/493 • Number of events 1 • From the first dose of open-label upadacitinib up to 30 days after the last dose, up to 316 weeks.
|
0.00%
0/187 • From the first dose of open-label upadacitinib up to 30 days after the last dose, up to 316 weeks.
|
0.00%
0/38 • From the first dose of open-label upadacitinib up to 30 days after the last dose, up to 316 weeks.
|
|
Injury, poisoning and procedural complications
LOWER LIMB FRACTURE
|
0.20%
1/493 • Number of events 1 • From the first dose of open-label upadacitinib up to 30 days after the last dose, up to 316 weeks.
|
0.00%
0/187 • From the first dose of open-label upadacitinib up to 30 days after the last dose, up to 316 weeks.
|
0.00%
0/38 • From the first dose of open-label upadacitinib up to 30 days after the last dose, up to 316 weeks.
|
|
Injury, poisoning and procedural complications
MULTIPLE FRACTURES
|
0.00%
0/493 • From the first dose of open-label upadacitinib up to 30 days after the last dose, up to 316 weeks.
|
0.00%
0/187 • From the first dose of open-label upadacitinib up to 30 days after the last dose, up to 316 weeks.
|
2.6%
1/38 • Number of events 1 • From the first dose of open-label upadacitinib up to 30 days after the last dose, up to 316 weeks.
|
|
Injury, poisoning and procedural complications
MULTIPLE INJURIES
|
0.00%
0/493 • From the first dose of open-label upadacitinib up to 30 days after the last dose, up to 316 weeks.
|
0.00%
0/187 • From the first dose of open-label upadacitinib up to 30 days after the last dose, up to 316 weeks.
|
2.6%
1/38 • Number of events 1 • From the first dose of open-label upadacitinib up to 30 days after the last dose, up to 316 weeks.
|
|
Injury, poisoning and procedural complications
OVERDOSE
|
0.00%
0/493 • From the first dose of open-label upadacitinib up to 30 days after the last dose, up to 316 weeks.
|
0.53%
1/187 • Number of events 1 • From the first dose of open-label upadacitinib up to 30 days after the last dose, up to 316 weeks.
|
0.00%
0/38 • From the first dose of open-label upadacitinib up to 30 days after the last dose, up to 316 weeks.
|
|
Injury, poisoning and procedural complications
POST PROCEDURAL DISCHARGE
|
0.00%
0/493 • From the first dose of open-label upadacitinib up to 30 days after the last dose, up to 316 weeks.
|
0.53%
1/187 • Number of events 1 • From the first dose of open-label upadacitinib up to 30 days after the last dose, up to 316 weeks.
|
0.00%
0/38 • From the first dose of open-label upadacitinib up to 30 days after the last dose, up to 316 weeks.
|
|
Injury, poisoning and procedural complications
RADIUS FRACTURE
|
0.20%
1/493 • Number of events 1 • From the first dose of open-label upadacitinib up to 30 days after the last dose, up to 316 weeks.
|
0.00%
0/187 • From the first dose of open-label upadacitinib up to 30 days after the last dose, up to 316 weeks.
|
0.00%
0/38 • From the first dose of open-label upadacitinib up to 30 days after the last dose, up to 316 weeks.
|
|
Injury, poisoning and procedural complications
SKIN LACERATION
|
0.20%
1/493 • Number of events 1 • From the first dose of open-label upadacitinib up to 30 days after the last dose, up to 316 weeks.
|
0.00%
0/187 • From the first dose of open-label upadacitinib up to 30 days after the last dose, up to 316 weeks.
|
0.00%
0/38 • From the first dose of open-label upadacitinib up to 30 days after the last dose, up to 316 weeks.
|
|
Injury, poisoning and procedural complications
SKULL FRACTURED BASE
|
0.20%
1/493 • Number of events 1 • From the first dose of open-label upadacitinib up to 30 days after the last dose, up to 316 weeks.
|
0.00%
0/187 • From the first dose of open-label upadacitinib up to 30 days after the last dose, up to 316 weeks.
|
0.00%
0/38 • From the first dose of open-label upadacitinib up to 30 days after the last dose, up to 316 weeks.
|
|
Injury, poisoning and procedural complications
TENDON RUPTURE
|
0.00%
0/493 • From the first dose of open-label upadacitinib up to 30 days after the last dose, up to 316 weeks.
|
0.53%
1/187 • Number of events 1 • From the first dose of open-label upadacitinib up to 30 days after the last dose, up to 316 weeks.
|
0.00%
0/38 • From the first dose of open-label upadacitinib up to 30 days after the last dose, up to 316 weeks.
|
|
Injury, poisoning and procedural complications
VASCULAR PSEUDOANEURYSM
|
0.00%
0/493 • From the first dose of open-label upadacitinib up to 30 days after the last dose, up to 316 weeks.
|
0.53%
1/187 • Number of events 1 • From the first dose of open-label upadacitinib up to 30 days after the last dose, up to 316 weeks.
|
0.00%
0/38 • From the first dose of open-label upadacitinib up to 30 days after the last dose, up to 316 weeks.
|
|
Metabolism and nutrition disorders
HYPONATRAEMIA
|
0.00%
0/493 • From the first dose of open-label upadacitinib up to 30 days after the last dose, up to 316 weeks.
|
0.00%
0/187 • From the first dose of open-label upadacitinib up to 30 days after the last dose, up to 316 weeks.
|
2.6%
1/38 • Number of events 2 • From the first dose of open-label upadacitinib up to 30 days after the last dose, up to 316 weeks.
|
|
Musculoskeletal and connective tissue disorders
ARTHRALGIA
|
0.00%
0/493 • From the first dose of open-label upadacitinib up to 30 days after the last dose, up to 316 weeks.
|
0.53%
1/187 • Number of events 1 • From the first dose of open-label upadacitinib up to 30 days after the last dose, up to 316 weeks.
|
0.00%
0/38 • From the first dose of open-label upadacitinib up to 30 days after the last dose, up to 316 weeks.
|
|
Musculoskeletal and connective tissue disorders
INTERVERTEBRAL DISC COMPRESSION
|
0.00%
0/493 • From the first dose of open-label upadacitinib up to 30 days after the last dose, up to 316 weeks.
|
0.53%
1/187 • Number of events 1 • From the first dose of open-label upadacitinib up to 30 days after the last dose, up to 316 weeks.
|
0.00%
0/38 • From the first dose of open-label upadacitinib up to 30 days after the last dose, up to 316 weeks.
|
|
Musculoskeletal and connective tissue disorders
INTERVERTEBRAL DISC PROTRUSION
|
0.41%
2/493 • Number of events 2 • From the first dose of open-label upadacitinib up to 30 days after the last dose, up to 316 weeks.
|
0.00%
0/187 • From the first dose of open-label upadacitinib up to 30 days after the last dose, up to 316 weeks.
|
0.00%
0/38 • From the first dose of open-label upadacitinib up to 30 days after the last dose, up to 316 weeks.
|
|
Musculoskeletal and connective tissue disorders
LUMBAR SPINAL STENOSIS
|
0.20%
1/493 • Number of events 1 • From the first dose of open-label upadacitinib up to 30 days after the last dose, up to 316 weeks.
|
0.53%
1/187 • Number of events 1 • From the first dose of open-label upadacitinib up to 30 days after the last dose, up to 316 weeks.
|
0.00%
0/38 • From the first dose of open-label upadacitinib up to 30 days after the last dose, up to 316 weeks.
|
|
Musculoskeletal and connective tissue disorders
OSTEOARTHRITIS
|
0.81%
4/493 • Number of events 4 • From the first dose of open-label upadacitinib up to 30 days after the last dose, up to 316 weeks.
|
1.6%
3/187 • Number of events 3 • From the first dose of open-label upadacitinib up to 30 days after the last dose, up to 316 weeks.
|
0.00%
0/38 • From the first dose of open-label upadacitinib up to 30 days after the last dose, up to 316 weeks.
|
|
Musculoskeletal and connective tissue disorders
RHEUMATOID ARTHRITIS
|
0.20%
1/493 • Number of events 1 • From the first dose of open-label upadacitinib up to 30 days after the last dose, up to 316 weeks.
|
0.00%
0/187 • From the first dose of open-label upadacitinib up to 30 days after the last dose, up to 316 weeks.
|
2.6%
1/38 • Number of events 1 • From the first dose of open-label upadacitinib up to 30 days after the last dose, up to 316 weeks.
|
|
Musculoskeletal and connective tissue disorders
SPINAL OSTEOARTHRITIS
|
0.20%
1/493 • Number of events 1 • From the first dose of open-label upadacitinib up to 30 days after the last dose, up to 316 weeks.
|
0.53%
1/187 • Number of events 1 • From the first dose of open-label upadacitinib up to 30 days after the last dose, up to 316 weeks.
|
0.00%
0/38 • From the first dose of open-label upadacitinib up to 30 days after the last dose, up to 316 weeks.
|
|
Musculoskeletal and connective tissue disorders
SPONDYLOLISTHESIS
|
0.20%
1/493 • Number of events 1 • From the first dose of open-label upadacitinib up to 30 days after the last dose, up to 316 weeks.
|
0.53%
1/187 • Number of events 1 • From the first dose of open-label upadacitinib up to 30 days after the last dose, up to 316 weeks.
|
0.00%
0/38 • From the first dose of open-label upadacitinib up to 30 days after the last dose, up to 316 weeks.
|
|
Musculoskeletal and connective tissue disorders
SYNOVITIS
|
0.00%
0/493 • From the first dose of open-label upadacitinib up to 30 days after the last dose, up to 316 weeks.
|
0.53%
1/187 • Number of events 1 • From the first dose of open-label upadacitinib up to 30 days after the last dose, up to 316 weeks.
|
0.00%
0/38 • From the first dose of open-label upadacitinib up to 30 days after the last dose, up to 316 weeks.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
BASAL CELL CARCINOMA
|
0.00%
0/493 • From the first dose of open-label upadacitinib up to 30 days after the last dose, up to 316 weeks.
|
0.53%
1/187 • Number of events 1 • From the first dose of open-label upadacitinib up to 30 days after the last dose, up to 316 weeks.
|
0.00%
0/38 • From the first dose of open-label upadacitinib up to 30 days after the last dose, up to 316 weeks.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
CLEAR CELL RENAL CELL CARCINOMA
|
0.20%
1/493 • Number of events 1 • From the first dose of open-label upadacitinib up to 30 days after the last dose, up to 316 weeks.
|
0.00%
0/187 • From the first dose of open-label upadacitinib up to 30 days after the last dose, up to 316 weeks.
|
0.00%
0/38 • From the first dose of open-label upadacitinib up to 30 days after the last dose, up to 316 weeks.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
ENDOMETRIAL CANCER
|
0.20%
1/493 • Number of events 1 • From the first dose of open-label upadacitinib up to 30 days after the last dose, up to 316 weeks.
|
0.00%
0/187 • From the first dose of open-label upadacitinib up to 30 days after the last dose, up to 316 weeks.
|
0.00%
0/38 • From the first dose of open-label upadacitinib up to 30 days after the last dose, up to 316 weeks.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
HODGKIN'S DISEASE
|
0.20%
1/493 • Number of events 1 • From the first dose of open-label upadacitinib up to 30 days after the last dose, up to 316 weeks.
|
0.00%
0/187 • From the first dose of open-label upadacitinib up to 30 days after the last dose, up to 316 weeks.
|
0.00%
0/38 • From the first dose of open-label upadacitinib up to 30 days after the last dose, up to 316 weeks.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
INVASIVE BREAST CARCINOMA
|
0.00%
0/493 • From the first dose of open-label upadacitinib up to 30 days after the last dose, up to 316 weeks.
|
0.53%
1/187 • Number of events 1 • From the first dose of open-label upadacitinib up to 30 days after the last dose, up to 316 weeks.
|
0.00%
0/38 • From the first dose of open-label upadacitinib up to 30 days after the last dose, up to 316 weeks.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
INVASIVE DUCTAL BREAST CARCINOMA
|
0.00%
0/493 • From the first dose of open-label upadacitinib up to 30 days after the last dose, up to 316 weeks.
|
0.00%
0/187 • From the first dose of open-label upadacitinib up to 30 days after the last dose, up to 316 weeks.
|
2.6%
1/38 • Number of events 1 • From the first dose of open-label upadacitinib up to 30 days after the last dose, up to 316 weeks.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
INVASIVE LOBULAR BREAST CARCINOMA
|
0.20%
1/493 • Number of events 1 • From the first dose of open-label upadacitinib up to 30 days after the last dose, up to 316 weeks.
|
0.00%
0/187 • From the first dose of open-label upadacitinib up to 30 days after the last dose, up to 316 weeks.
|
0.00%
0/38 • From the first dose of open-label upadacitinib up to 30 days after the last dose, up to 316 weeks.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
INVASIVE PAPILLARY BREAST CARCINOMA
|
0.20%
1/493 • Number of events 1 • From the first dose of open-label upadacitinib up to 30 days after the last dose, up to 316 weeks.
|
0.00%
0/187 • From the first dose of open-label upadacitinib up to 30 days after the last dose, up to 316 weeks.
|
0.00%
0/38 • From the first dose of open-label upadacitinib up to 30 days after the last dose, up to 316 weeks.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
LUNG ADENOCARCINOMA
|
0.00%
0/493 • From the first dose of open-label upadacitinib up to 30 days after the last dose, up to 316 weeks.
|
0.53%
1/187 • Number of events 1 • From the first dose of open-label upadacitinib up to 30 days after the last dose, up to 316 weeks.
|
0.00%
0/38 • From the first dose of open-label upadacitinib up to 30 days after the last dose, up to 316 weeks.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
LUNG ADENOCARCINOMA STAGE I
|
0.00%
0/493 • From the first dose of open-label upadacitinib up to 30 days after the last dose, up to 316 weeks.
|
0.53%
1/187 • Number of events 1 • From the first dose of open-label upadacitinib up to 30 days after the last dose, up to 316 weeks.
|
0.00%
0/38 • From the first dose of open-label upadacitinib up to 30 days after the last dose, up to 316 weeks.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
NON-SMALL CELL LUNG CANCER
|
0.00%
0/493 • From the first dose of open-label upadacitinib up to 30 days after the last dose, up to 316 weeks.
|
0.53%
1/187 • Number of events 1 • From the first dose of open-label upadacitinib up to 30 days after the last dose, up to 316 weeks.
|
0.00%
0/38 • From the first dose of open-label upadacitinib up to 30 days after the last dose, up to 316 weeks.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
PAPILLARY THYROID CANCER
|
0.20%
1/493 • Number of events 1 • From the first dose of open-label upadacitinib up to 30 days after the last dose, up to 316 weeks.
|
0.00%
0/187 • From the first dose of open-label upadacitinib up to 30 days after the last dose, up to 316 weeks.
|
0.00%
0/38 • From the first dose of open-label upadacitinib up to 30 days after the last dose, up to 316 weeks.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
PROSTATE CANCER
|
0.20%
1/493 • Number of events 1 • From the first dose of open-label upadacitinib up to 30 days after the last dose, up to 316 weeks.
|
0.00%
0/187 • From the first dose of open-label upadacitinib up to 30 days after the last dose, up to 316 weeks.
|
0.00%
0/38 • From the first dose of open-label upadacitinib up to 30 days after the last dose, up to 316 weeks.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
SEBACEOUS CARCINOMA
|
0.20%
1/493 • Number of events 1 • From the first dose of open-label upadacitinib up to 30 days after the last dose, up to 316 weeks.
|
0.00%
0/187 • From the first dose of open-label upadacitinib up to 30 days after the last dose, up to 316 weeks.
|
0.00%
0/38 • From the first dose of open-label upadacitinib up to 30 days after the last dose, up to 316 weeks.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
SQUAMOUS CELL CARCINOMA OF LUNG
|
0.00%
0/493 • From the first dose of open-label upadacitinib up to 30 days after the last dose, up to 316 weeks.
|
0.53%
1/187 • Number of events 1 • From the first dose of open-label upadacitinib up to 30 days after the last dose, up to 316 weeks.
|
0.00%
0/38 • From the first dose of open-label upadacitinib up to 30 days after the last dose, up to 316 weeks.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
SQUAMOUS CELL CARCINOMA OF THE CERVIX
|
0.00%
0/493 • From the first dose of open-label upadacitinib up to 30 days after the last dose, up to 316 weeks.
|
0.53%
1/187 • Number of events 1 • From the first dose of open-label upadacitinib up to 30 days after the last dose, up to 316 weeks.
|
0.00%
0/38 • From the first dose of open-label upadacitinib up to 30 days after the last dose, up to 316 weeks.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
THYROID B-CELL LYMPHOMA
|
0.20%
1/493 • Number of events 1 • From the first dose of open-label upadacitinib up to 30 days after the last dose, up to 316 weeks.
|
0.00%
0/187 • From the first dose of open-label upadacitinib up to 30 days after the last dose, up to 316 weeks.
|
0.00%
0/38 • From the first dose of open-label upadacitinib up to 30 days after the last dose, up to 316 weeks.
|
|
Nervous system disorders
BRAIN STEM INFARCTION
|
0.00%
0/493 • From the first dose of open-label upadacitinib up to 30 days after the last dose, up to 316 weeks.
|
0.53%
1/187 • Number of events 1 • From the first dose of open-label upadacitinib up to 30 days after the last dose, up to 316 weeks.
|
0.00%
0/38 • From the first dose of open-label upadacitinib up to 30 days after the last dose, up to 316 weeks.
|
|
Nervous system disorders
CEREBRAL INFARCTION
|
0.20%
1/493 • Number of events 1 • From the first dose of open-label upadacitinib up to 30 days after the last dose, up to 316 weeks.
|
0.53%
1/187 • Number of events 1 • From the first dose of open-label upadacitinib up to 30 days after the last dose, up to 316 weeks.
|
0.00%
0/38 • From the first dose of open-label upadacitinib up to 30 days after the last dose, up to 316 weeks.
|
|
Nervous system disorders
CEREBROVASCULAR ACCIDENT
|
0.00%
0/493 • From the first dose of open-label upadacitinib up to 30 days after the last dose, up to 316 weeks.
|
0.53%
1/187 • Number of events 2 • From the first dose of open-label upadacitinib up to 30 days after the last dose, up to 316 weeks.
|
0.00%
0/38 • From the first dose of open-label upadacitinib up to 30 days after the last dose, up to 316 weeks.
|
|
Nervous system disorders
DIZZINESS
|
0.41%
2/493 • Number of events 2 • From the first dose of open-label upadacitinib up to 30 days after the last dose, up to 316 weeks.
|
0.00%
0/187 • From the first dose of open-label upadacitinib up to 30 days after the last dose, up to 316 weeks.
|
0.00%
0/38 • From the first dose of open-label upadacitinib up to 30 days after the last dose, up to 316 weeks.
|
|
Nervous system disorders
HEADACHE
|
0.20%
1/493 • Number of events 1 • From the first dose of open-label upadacitinib up to 30 days after the last dose, up to 316 weeks.
|
0.00%
0/187 • From the first dose of open-label upadacitinib up to 30 days after the last dose, up to 316 weeks.
|
0.00%
0/38 • From the first dose of open-label upadacitinib up to 30 days after the last dose, up to 316 weeks.
|
|
Nervous system disorders
INTRACRANIAL ANEURYSM
|
0.20%
1/493 • Number of events 1 • From the first dose of open-label upadacitinib up to 30 days after the last dose, up to 316 weeks.
|
0.00%
0/187 • From the first dose of open-label upadacitinib up to 30 days after the last dose, up to 316 weeks.
|
0.00%
0/38 • From the first dose of open-label upadacitinib up to 30 days after the last dose, up to 316 weeks.
|
|
Nervous system disorders
LACUNAR INFARCTION
|
0.00%
0/493 • From the first dose of open-label upadacitinib up to 30 days after the last dose, up to 316 weeks.
|
0.53%
1/187 • Number of events 1 • From the first dose of open-label upadacitinib up to 30 days after the last dose, up to 316 weeks.
|
0.00%
0/38 • From the first dose of open-label upadacitinib up to 30 days after the last dose, up to 316 weeks.
|
|
Nervous system disorders
METABOLIC ENCEPHALOPATHY
|
0.00%
0/493 • From the first dose of open-label upadacitinib up to 30 days after the last dose, up to 316 weeks.
|
0.53%
1/187 • Number of events 1 • From the first dose of open-label upadacitinib up to 30 days after the last dose, up to 316 weeks.
|
0.00%
0/38 • From the first dose of open-label upadacitinib up to 30 days after the last dose, up to 316 weeks.
|
|
Nervous system disorders
OCCIPITAL NEURALGIA
|
0.20%
1/493 • Number of events 1 • From the first dose of open-label upadacitinib up to 30 days after the last dose, up to 316 weeks.
|
0.00%
0/187 • From the first dose of open-label upadacitinib up to 30 days after the last dose, up to 316 weeks.
|
0.00%
0/38 • From the first dose of open-label upadacitinib up to 30 days after the last dose, up to 316 weeks.
|
|
Nervous system disorders
SCIATICA
|
0.20%
1/493 • Number of events 1 • From the first dose of open-label upadacitinib up to 30 days after the last dose, up to 316 weeks.
|
0.00%
0/187 • From the first dose of open-label upadacitinib up to 30 days after the last dose, up to 316 weeks.
|
0.00%
0/38 • From the first dose of open-label upadacitinib up to 30 days after the last dose, up to 316 weeks.
|
|
Nervous system disorders
SYNCOPE
|
0.00%
0/493 • From the first dose of open-label upadacitinib up to 30 days after the last dose, up to 316 weeks.
|
0.53%
1/187 • Number of events 1 • From the first dose of open-label upadacitinib up to 30 days after the last dose, up to 316 weeks.
|
0.00%
0/38 • From the first dose of open-label upadacitinib up to 30 days after the last dose, up to 316 weeks.
|
|
Nervous system disorders
TRANSIENT ISCHAEMIC ATTACK
|
0.20%
1/493 • Number of events 1 • From the first dose of open-label upadacitinib up to 30 days after the last dose, up to 316 weeks.
|
0.00%
0/187 • From the first dose of open-label upadacitinib up to 30 days after the last dose, up to 316 weeks.
|
0.00%
0/38 • From the first dose of open-label upadacitinib up to 30 days after the last dose, up to 316 weeks.
|
|
Product Issues
DEVICE LOOSENING
|
0.20%
1/493 • Number of events 1 • From the first dose of open-label upadacitinib up to 30 days after the last dose, up to 316 weeks.
|
0.00%
0/187 • From the first dose of open-label upadacitinib up to 30 days after the last dose, up to 316 weeks.
|
0.00%
0/38 • From the first dose of open-label upadacitinib up to 30 days after the last dose, up to 316 weeks.
|
|
Psychiatric disorders
ANXIETY
|
0.00%
0/493 • From the first dose of open-label upadacitinib up to 30 days after the last dose, up to 316 weeks.
|
0.53%
1/187 • Number of events 1 • From the first dose of open-label upadacitinib up to 30 days after the last dose, up to 316 weeks.
|
0.00%
0/38 • From the first dose of open-label upadacitinib up to 30 days after the last dose, up to 316 weeks.
|
|
Psychiatric disorders
DEPRESSION
|
0.20%
1/493 • Number of events 1 • From the first dose of open-label upadacitinib up to 30 days after the last dose, up to 316 weeks.
|
0.53%
1/187 • Number of events 1 • From the first dose of open-label upadacitinib up to 30 days after the last dose, up to 316 weeks.
|
0.00%
0/38 • From the first dose of open-label upadacitinib up to 30 days after the last dose, up to 316 weeks.
|
|
Psychiatric disorders
DISSOCIATIVE DISORDER
|
0.00%
0/493 • From the first dose of open-label upadacitinib up to 30 days after the last dose, up to 316 weeks.
|
0.53%
1/187 • Number of events 1 • From the first dose of open-label upadacitinib up to 30 days after the last dose, up to 316 weeks.
|
0.00%
0/38 • From the first dose of open-label upadacitinib up to 30 days after the last dose, up to 316 weeks.
|
|
Renal and urinary disorders
BLADDER PROLAPSE
|
0.20%
1/493 • Number of events 1 • From the first dose of open-label upadacitinib up to 30 days after the last dose, up to 316 weeks.
|
0.53%
1/187 • Number of events 1 • From the first dose of open-label upadacitinib up to 30 days after the last dose, up to 316 weeks.
|
0.00%
0/38 • From the first dose of open-label upadacitinib up to 30 days after the last dose, up to 316 weeks.
|
|
Reproductive system and breast disorders
CERVICAL DYSPLASIA
|
0.41%
2/493 • Number of events 2 • From the first dose of open-label upadacitinib up to 30 days after the last dose, up to 316 weeks.
|
0.00%
0/187 • From the first dose of open-label upadacitinib up to 30 days after the last dose, up to 316 weeks.
|
0.00%
0/38 • From the first dose of open-label upadacitinib up to 30 days after the last dose, up to 316 weeks.
|
|
Reproductive system and breast disorders
HYDROSALPINX
|
0.20%
1/493 • Number of events 1 • From the first dose of open-label upadacitinib up to 30 days after the last dose, up to 316 weeks.
|
0.00%
0/187 • From the first dose of open-label upadacitinib up to 30 days after the last dose, up to 316 weeks.
|
0.00%
0/38 • From the first dose of open-label upadacitinib up to 30 days after the last dose, up to 316 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
EPISTAXIS
|
0.00%
0/493 • From the first dose of open-label upadacitinib up to 30 days after the last dose, up to 316 weeks.
|
0.53%
1/187 • Number of events 1 • From the first dose of open-label upadacitinib up to 30 days after the last dose, up to 316 weeks.
|
0.00%
0/38 • From the first dose of open-label upadacitinib up to 30 days after the last dose, up to 316 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
LUNG INFILTRATION
|
0.20%
1/493 • Number of events 1 • From the first dose of open-label upadacitinib up to 30 days after the last dose, up to 316 weeks.
|
0.00%
0/187 • From the first dose of open-label upadacitinib up to 30 days after the last dose, up to 316 weeks.
|
0.00%
0/38 • From the first dose of open-label upadacitinib up to 30 days after the last dose, up to 316 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
PARANASAL CYST
|
0.20%
1/493 • Number of events 1 • From the first dose of open-label upadacitinib up to 30 days after the last dose, up to 316 weeks.
|
0.00%
0/187 • From the first dose of open-label upadacitinib up to 30 days after the last dose, up to 316 weeks.
|
0.00%
0/38 • From the first dose of open-label upadacitinib up to 30 days after the last dose, up to 316 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
PLEURAL EFFUSION
|
0.20%
1/493 • Number of events 1 • From the first dose of open-label upadacitinib up to 30 days after the last dose, up to 316 weeks.
|
0.00%
0/187 • From the first dose of open-label upadacitinib up to 30 days after the last dose, up to 316 weeks.
|
0.00%
0/38 • From the first dose of open-label upadacitinib up to 30 days after the last dose, up to 316 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
PLEURISY
|
0.20%
1/493 • Number of events 1 • From the first dose of open-label upadacitinib up to 30 days after the last dose, up to 316 weeks.
|
0.00%
0/187 • From the first dose of open-label upadacitinib up to 30 days after the last dose, up to 316 weeks.
|
0.00%
0/38 • From the first dose of open-label upadacitinib up to 30 days after the last dose, up to 316 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
PNEUMONITIS
|
0.00%
0/493 • From the first dose of open-label upadacitinib up to 30 days after the last dose, up to 316 weeks.
|
0.53%
1/187 • Number of events 1 • From the first dose of open-label upadacitinib up to 30 days after the last dose, up to 316 weeks.
|
0.00%
0/38 • From the first dose of open-label upadacitinib up to 30 days after the last dose, up to 316 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
PULMONARY EMBOLISM
|
0.41%
2/493 • Number of events 2 • From the first dose of open-label upadacitinib up to 30 days after the last dose, up to 316 weeks.
|
1.1%
2/187 • Number of events 4 • From the first dose of open-label upadacitinib up to 30 days after the last dose, up to 316 weeks.
|
0.00%
0/38 • From the first dose of open-label upadacitinib up to 30 days after the last dose, up to 316 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
RESPIRATORY FAILURE
|
0.20%
1/493 • Number of events 1 • From the first dose of open-label upadacitinib up to 30 days after the last dose, up to 316 weeks.
|
0.00%
0/187 • From the first dose of open-label upadacitinib up to 30 days after the last dose, up to 316 weeks.
|
0.00%
0/38 • From the first dose of open-label upadacitinib up to 30 days after the last dose, up to 316 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
SLEEP APNOEA SYNDROME
|
0.20%
1/493 • Number of events 1 • From the first dose of open-label upadacitinib up to 30 days after the last dose, up to 316 weeks.
|
0.00%
0/187 • From the first dose of open-label upadacitinib up to 30 days after the last dose, up to 316 weeks.
|
0.00%
0/38 • From the first dose of open-label upadacitinib up to 30 days after the last dose, up to 316 weeks.
|
|
Skin and subcutaneous tissue disorders
SKIN ULCER
|
0.20%
1/493 • Number of events 2 • From the first dose of open-label upadacitinib up to 30 days after the last dose, up to 316 weeks.
|
0.00%
0/187 • From the first dose of open-label upadacitinib up to 30 days after the last dose, up to 316 weeks.
|
0.00%
0/38 • From the first dose of open-label upadacitinib up to 30 days after the last dose, up to 316 weeks.
|
|
Surgical and medical procedures
ABORTION INDUCED
|
0.00%
0/493 • From the first dose of open-label upadacitinib up to 30 days after the last dose, up to 316 weeks.
|
0.53%
1/187 • Number of events 1 • From the first dose of open-label upadacitinib up to 30 days after the last dose, up to 316 weeks.
|
0.00%
0/38 • From the first dose of open-label upadacitinib up to 30 days after the last dose, up to 316 weeks.
|
|
Vascular disorders
DEEP VEIN THROMBOSIS
|
0.61%
3/493 • Number of events 3 • From the first dose of open-label upadacitinib up to 30 days after the last dose, up to 316 weeks.
|
1.1%
2/187 • Number of events 2 • From the first dose of open-label upadacitinib up to 30 days after the last dose, up to 316 weeks.
|
0.00%
0/38 • From the first dose of open-label upadacitinib up to 30 days after the last dose, up to 316 weeks.
|
|
Vascular disorders
PERIPHERAL ARTERY STENOSIS
|
0.20%
1/493 • Number of events 1 • From the first dose of open-label upadacitinib up to 30 days after the last dose, up to 316 weeks.
|
0.00%
0/187 • From the first dose of open-label upadacitinib up to 30 days after the last dose, up to 316 weeks.
|
0.00%
0/38 • From the first dose of open-label upadacitinib up to 30 days after the last dose, up to 316 weeks.
|
|
Vascular disorders
PERIPHERAL ARTERY THROMBOSIS
|
0.20%
1/493 • Number of events 1 • From the first dose of open-label upadacitinib up to 30 days after the last dose, up to 316 weeks.
|
0.00%
0/187 • From the first dose of open-label upadacitinib up to 30 days after the last dose, up to 316 weeks.
|
0.00%
0/38 • From the first dose of open-label upadacitinib up to 30 days after the last dose, up to 316 weeks.
|
|
Vascular disorders
VENOUS THROMBOSIS
|
0.20%
1/493 • Number of events 1 • From the first dose of open-label upadacitinib up to 30 days after the last dose, up to 316 weeks.
|
0.00%
0/187 • From the first dose of open-label upadacitinib up to 30 days after the last dose, up to 316 weeks.
|
0.00%
0/38 • From the first dose of open-label upadacitinib up to 30 days after the last dose, up to 316 weeks.
|
Other adverse events
| Measure |
Upadacitinib 6 mg BID/15 mg QD
n=493 participants at risk
Participants received upadacitinib 6 mg BID. From January 2017 participants were transitioned to 15 mg upadacitinib QD. Includes events that occurred until the time of up-titration for participants who were up-titrated.
|
Upadacitinib 12 mg BID/30 mg QD
n=187 participants at risk
Participants received upadacitinib 12 mg BID. From January 2017 participants were transitioned to 30 mg upadacitinib QD. Includes events that occurred from the time of up-titration until time of down titration to 6 mg BID/15 mg QD for participants who titrated up and back down.
|
Upadacitinib 6 mg BID/15 mg QD Post Down-titration
n=38 participants at risk
Participants who down-titrated to 6 mg BID/15 mg QD after up-titration to 15 mg BID/30 mg QD. Includes events that occurred after down titration.
|
|---|---|---|---|
|
Blood and lymphatic system disorders
ANAEMIA
|
1.4%
7/493 • Number of events 7 • From the first dose of open-label upadacitinib up to 30 days after the last dose, up to 316 weeks.
|
5.9%
11/187 • Number of events 12 • From the first dose of open-label upadacitinib up to 30 days after the last dose, up to 316 weeks.
|
2.6%
1/38 • Number of events 1 • From the first dose of open-label upadacitinib up to 30 days after the last dose, up to 316 weeks.
|
|
Blood and lymphatic system disorders
LYMPHOPENIA
|
3.0%
15/493 • Number of events 17 • From the first dose of open-label upadacitinib up to 30 days after the last dose, up to 316 weeks.
|
2.7%
5/187 • Number of events 6 • From the first dose of open-label upadacitinib up to 30 days after the last dose, up to 316 weeks.
|
5.3%
2/38 • Number of events 2 • From the first dose of open-label upadacitinib up to 30 days after the last dose, up to 316 weeks.
|
|
Blood and lymphatic system disorders
NEUTROPENIA
|
2.0%
10/493 • Number of events 13 • From the first dose of open-label upadacitinib up to 30 days after the last dose, up to 316 weeks.
|
1.1%
2/187 • Number of events 3 • From the first dose of open-label upadacitinib up to 30 days after the last dose, up to 316 weeks.
|
5.3%
2/38 • Number of events 2 • From the first dose of open-label upadacitinib up to 30 days after the last dose, up to 316 weeks.
|
|
Gastrointestinal disorders
DIARRHOEA
|
1.4%
7/493 • Number of events 7 • From the first dose of open-label upadacitinib up to 30 days after the last dose, up to 316 weeks.
|
5.3%
10/187 • Number of events 11 • From the first dose of open-label upadacitinib up to 30 days after the last dose, up to 316 weeks.
|
0.00%
0/38 • From the first dose of open-label upadacitinib up to 30 days after the last dose, up to 316 weeks.
|
|
General disorders
INFLUENZA LIKE ILLNESS
|
1.2%
6/493 • Number of events 9 • From the first dose of open-label upadacitinib up to 30 days after the last dose, up to 316 weeks.
|
5.3%
10/187 • Number of events 11 • From the first dose of open-label upadacitinib up to 30 days after the last dose, up to 316 weeks.
|
5.3%
2/38 • Number of events 2 • From the first dose of open-label upadacitinib up to 30 days after the last dose, up to 316 weeks.
|
|
Infections and infestations
BRONCHITIS
|
8.5%
42/493 • Number of events 66 • From the first dose of open-label upadacitinib up to 30 days after the last dose, up to 316 weeks.
|
7.5%
14/187 • Number of events 23 • From the first dose of open-label upadacitinib up to 30 days after the last dose, up to 316 weeks.
|
15.8%
6/38 • Number of events 8 • From the first dose of open-label upadacitinib up to 30 days after the last dose, up to 316 weeks.
|
|
Infections and infestations
HERPES ZOSTER
|
4.5%
22/493 • Number of events 23 • From the first dose of open-label upadacitinib up to 30 days after the last dose, up to 316 weeks.
|
11.2%
21/187 • Number of events 24 • From the first dose of open-label upadacitinib up to 30 days after the last dose, up to 316 weeks.
|
7.9%
3/38 • Number of events 3 • From the first dose of open-label upadacitinib up to 30 days after the last dose, up to 316 weeks.
|
|
Infections and infestations
LATENT TUBERCULOSIS
|
2.0%
10/493 • Number of events 10 • From the first dose of open-label upadacitinib up to 30 days after the last dose, up to 316 weeks.
|
1.1%
2/187 • Number of events 2 • From the first dose of open-label upadacitinib up to 30 days after the last dose, up to 316 weeks.
|
5.3%
2/38 • Number of events 2 • From the first dose of open-label upadacitinib up to 30 days after the last dose, up to 316 weeks.
|
|
Infections and infestations
LOWER RESPIRATORY TRACT INFECTION
|
0.20%
1/493 • Number of events 1 • From the first dose of open-label upadacitinib up to 30 days after the last dose, up to 316 weeks.
|
0.53%
1/187 • Number of events 1 • From the first dose of open-label upadacitinib up to 30 days after the last dose, up to 316 weeks.
|
7.9%
3/38 • Number of events 4 • From the first dose of open-label upadacitinib up to 30 days after the last dose, up to 316 weeks.
|
|
Infections and infestations
NASOPHARYNGITIS
|
9.5%
47/493 • Number of events 75 • From the first dose of open-label upadacitinib up to 30 days after the last dose, up to 316 weeks.
|
8.6%
16/187 • Number of events 19 • From the first dose of open-label upadacitinib up to 30 days after the last dose, up to 316 weeks.
|
7.9%
3/38 • Number of events 3 • From the first dose of open-label upadacitinib up to 30 days after the last dose, up to 316 weeks.
|
|
Infections and infestations
PHARYNGITIS
|
2.0%
10/493 • Number of events 12 • From the first dose of open-label upadacitinib up to 30 days after the last dose, up to 316 weeks.
|
1.6%
3/187 • Number of events 3 • From the first dose of open-label upadacitinib up to 30 days after the last dose, up to 316 weeks.
|
5.3%
2/38 • Number of events 2 • From the first dose of open-label upadacitinib up to 30 days after the last dose, up to 316 weeks.
|
|
Infections and infestations
SINUSITIS
|
2.6%
13/493 • Number of events 15 • From the first dose of open-label upadacitinib up to 30 days after the last dose, up to 316 weeks.
|
7.5%
14/187 • Number of events 24 • From the first dose of open-label upadacitinib up to 30 days after the last dose, up to 316 weeks.
|
0.00%
0/38 • From the first dose of open-label upadacitinib up to 30 days after the last dose, up to 316 weeks.
|
|
Infections and infestations
UPPER RESPIRATORY TRACT INFECTION
|
9.9%
49/493 • Number of events 71 • From the first dose of open-label upadacitinib up to 30 days after the last dose, up to 316 weeks.
|
20.3%
38/187 • Number of events 63 • From the first dose of open-label upadacitinib up to 30 days after the last dose, up to 316 weeks.
|
7.9%
3/38 • Number of events 8 • From the first dose of open-label upadacitinib up to 30 days after the last dose, up to 316 weeks.
|
|
Infections and infestations
URINARY TRACT INFECTION
|
9.5%
47/493 • Number of events 84 • From the first dose of open-label upadacitinib up to 30 days after the last dose, up to 316 weeks.
|
15.0%
28/187 • Number of events 54 • From the first dose of open-label upadacitinib up to 30 days after the last dose, up to 316 weeks.
|
7.9%
3/38 • Number of events 6 • From the first dose of open-label upadacitinib up to 30 days after the last dose, up to 316 weeks.
|
|
Infections and infestations
VIRAL UPPER RESPIRATORY TRACT INFECTION
|
0.61%
3/493 • Number of events 3 • From the first dose of open-label upadacitinib up to 30 days after the last dose, up to 316 weeks.
|
1.6%
3/187 • Number of events 3 • From the first dose of open-label upadacitinib up to 30 days after the last dose, up to 316 weeks.
|
5.3%
2/38 • Number of events 2 • From the first dose of open-label upadacitinib up to 30 days after the last dose, up to 316 weeks.
|
|
Injury, poisoning and procedural complications
FALL
|
1.4%
7/493 • Number of events 8 • From the first dose of open-label upadacitinib up to 30 days after the last dose, up to 316 weeks.
|
7.5%
14/187 • Number of events 20 • From the first dose of open-label upadacitinib up to 30 days after the last dose, up to 316 weeks.
|
2.6%
1/38 • Number of events 1 • From the first dose of open-label upadacitinib up to 30 days after the last dose, up to 316 weeks.
|
|
Investigations
ALANINE AMINOTRANSFERASE INCREASED
|
2.4%
12/493 • Number of events 15 • From the first dose of open-label upadacitinib up to 30 days after the last dose, up to 316 weeks.
|
2.1%
4/187 • Number of events 4 • From the first dose of open-label upadacitinib up to 30 days after the last dose, up to 316 weeks.
|
7.9%
3/38 • Number of events 4 • From the first dose of open-label upadacitinib up to 30 days after the last dose, up to 316 weeks.
|
|
Investigations
ASPARTATE AMINOTRANSFERASE INCREASED
|
3.2%
16/493 • Number of events 17 • From the first dose of open-label upadacitinib up to 30 days after the last dose, up to 316 weeks.
|
2.7%
5/187 • Number of events 5 • From the first dose of open-label upadacitinib up to 30 days after the last dose, up to 316 weeks.
|
5.3%
2/38 • Number of events 3 • From the first dose of open-label upadacitinib up to 30 days after the last dose, up to 316 weeks.
|
|
Investigations
BLOOD CREATINE PHOSPHOKINASE INCREASED
|
6.9%
34/493 • Number of events 44 • From the first dose of open-label upadacitinib up to 30 days after the last dose, up to 316 weeks.
|
9.1%
17/187 • Number of events 27 • From the first dose of open-label upadacitinib up to 30 days after the last dose, up to 316 weeks.
|
7.9%
3/38 • Number of events 4 • From the first dose of open-label upadacitinib up to 30 days after the last dose, up to 316 weeks.
|
|
Metabolism and nutrition disorders
HYPERCHOLESTEROLAEMIA
|
5.9%
29/493 • Number of events 35 • From the first dose of open-label upadacitinib up to 30 days after the last dose, up to 316 weeks.
|
9.1%
17/187 • Number of events 18 • From the first dose of open-label upadacitinib up to 30 days after the last dose, up to 316 weeks.
|
7.9%
3/38 • Number of events 3 • From the first dose of open-label upadacitinib up to 30 days after the last dose, up to 316 weeks.
|
|
Musculoskeletal and connective tissue disorders
RHEUMATOID ARTHRITIS
|
4.3%
21/493 • Number of events 32 • From the first dose of open-label upadacitinib up to 30 days after the last dose, up to 316 weeks.
|
11.2%
21/187 • Number of events 35 • From the first dose of open-label upadacitinib up to 30 days after the last dose, up to 316 weeks.
|
0.00%
0/38 • From the first dose of open-label upadacitinib up to 30 days after the last dose, up to 316 weeks.
|
|
Nervous system disorders
HEADACHE
|
3.7%
18/493 • Number of events 23 • From the first dose of open-label upadacitinib up to 30 days after the last dose, up to 316 weeks.
|
2.7%
5/187 • Number of events 7 • From the first dose of open-label upadacitinib up to 30 days after the last dose, up to 316 weeks.
|
7.9%
3/38 • Number of events 3 • From the first dose of open-label upadacitinib up to 30 days after the last dose, up to 316 weeks.
|
|
Renal and urinary disorders
NEPHROLITHIASIS
|
1.4%
7/493 • Number of events 10 • From the first dose of open-label upadacitinib up to 30 days after the last dose, up to 316 weeks.
|
0.53%
1/187 • Number of events 1 • From the first dose of open-label upadacitinib up to 30 days after the last dose, up to 316 weeks.
|
5.3%
2/38 • Number of events 3 • From the first dose of open-label upadacitinib up to 30 days after the last dose, up to 316 weeks.
|
|
Renal and urinary disorders
RENAL COLIC
|
0.00%
0/493 • From the first dose of open-label upadacitinib up to 30 days after the last dose, up to 316 weeks.
|
1.1%
2/187 • Number of events 2 • From the first dose of open-label upadacitinib up to 30 days after the last dose, up to 316 weeks.
|
5.3%
2/38 • Number of events 3 • From the first dose of open-label upadacitinib up to 30 days after the last dose, up to 316 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
COUGH
|
2.8%
14/493 • Number of events 14 • From the first dose of open-label upadacitinib up to 30 days after the last dose, up to 316 weeks.
|
5.3%
10/187 • Number of events 11 • From the first dose of open-label upadacitinib up to 30 days after the last dose, up to 316 weeks.
|
2.6%
1/38 • Number of events 2 • From the first dose of open-label upadacitinib up to 30 days after the last dose, up to 316 weeks.
|
|
Skin and subcutaneous tissue disorders
RASH
|
0.81%
4/493 • Number of events 4 • From the first dose of open-label upadacitinib up to 30 days after the last dose, up to 316 weeks.
|
2.7%
5/187 • Number of events 5 • From the first dose of open-label upadacitinib up to 30 days after the last dose, up to 316 weeks.
|
5.3%
2/38 • Number of events 2 • From the first dose of open-label upadacitinib up to 30 days after the last dose, up to 316 weeks.
|
|
Skin and subcutaneous tissue disorders
ROSACEA
|
0.81%
4/493 • Number of events 4 • From the first dose of open-label upadacitinib up to 30 days after the last dose, up to 316 weeks.
|
1.1%
2/187 • Number of events 2 • From the first dose of open-label upadacitinib up to 30 days after the last dose, up to 316 weeks.
|
5.3%
2/38 • Number of events 2 • From the first dose of open-label upadacitinib up to 30 days after the last dose, up to 316 weeks.
|
|
Vascular disorders
HYPERTENSION
|
4.5%
22/493 • Number of events 23 • From the first dose of open-label upadacitinib up to 30 days after the last dose, up to 316 weeks.
|
10.2%
19/187 • Number of events 19 • From the first dose of open-label upadacitinib up to 30 days after the last dose, up to 316 weeks.
|
2.6%
1/38 • Number of events 1 • From the first dose of open-label upadacitinib up to 30 days after the last dose, up to 316 weeks.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee AbbVie requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. AbbVie requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if AbbVie needs to secure patent or proprietary protection.
- Publication restrictions are in place
Restriction type: OTHER