Trial Outcomes & Findings for Open-Label Extension Study of Upadacitinib in Adult Participants With Moderate to Severe Atopic Dermatitis (NCT NCT04195698)
NCT ID: NCT04195698
Last Updated: 2025-01-09
Results Overview
Treatment-emergent adverse events (TEAEs) are defined as any adverse events that begin or worsen in severity after initiation of upadacitinib during Lead-In Study M16-046 for the UPA/UPA arm or this Study M19-850 DUPI/UPA arm through 30 days following the last dose of upadacitinib.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
475 participants
Primary outcome timeframe
UPA/UPA arm: BL visit in Lead-In M16-046 to last dose in Long-Term Extension M19-850 (median time on follow-up is 536 days); DUPI/UPA arm: BL visit in Long-Term Extension M19-850 to last dose plus a 30-day follow-up (median time on follow-up is 399 days).
Results posted on
2025-01-09
Participant Flow
A total of 475 participants were enrolled at 114 sites located in 22 countries (Australia, Canada, Croatia, Czechia, Finland, France, Germany, Hungary, Ireland, Israel, Italy, Malaysia, Netherlands, New Zealand, Norway, Poland, Singapore, Spain, Taiwan, Ukraine, United Kingdom, and the US).
Participants originally randomized to upadacitinib or dupilumab in Lead-In Study M16-046 and continued on into this Long-Term Extension Study M19-850. The ITT Population consists of all enrolled participants who received at least 1 dose of study drug in this study and is used for all efficacy analyses. The Safety Population is the same as the ITT Population and is used for all safety analyses.
Participant milestones
| Measure |
DUPI 300mg to UPA 30mg
All participants in this study received upadacitinib 30 mg once a day (QD). Participants were grouped by previous treatment in Lead-In Study M16-046. Participants who received dupilumab (DUPI) in Lead-In Study M16-046 are included in the DUPI 300 mg Q2W/UPA 30 mg QD (DUPI/UPA) group.
|
UPA 30mg to UPA 30mg
All participants in this study received upadacitinib 30 mg once a day (QD). Participants were grouped by previous treatment in Lead-In Study M16-046. Participants who received upadacitinib (UPA) in Lead-In Study M16-046 are included in the UPA 30 mg QD/UPA 30 mg QD (UPA/UPA) group.
|
|---|---|---|
|
Overall Study
STARTED
|
239
|
236
|
|
Overall Study
COMPLETED
|
214
|
197
|
|
Overall Study
NOT COMPLETED
|
25
|
39
|
Reasons for withdrawal
| Measure |
DUPI 300mg to UPA 30mg
All participants in this study received upadacitinib 30 mg once a day (QD). Participants were grouped by previous treatment in Lead-In Study M16-046. Participants who received dupilumab (DUPI) in Lead-In Study M16-046 are included in the DUPI 300 mg Q2W/UPA 30 mg QD (DUPI/UPA) group.
|
UPA 30mg to UPA 30mg
All participants in this study received upadacitinib 30 mg once a day (QD). Participants were grouped by previous treatment in Lead-In Study M16-046. Participants who received upadacitinib (UPA) in Lead-In Study M16-046 are included in the UPA 30 mg QD/UPA 30 mg QD (UPA/UPA) group.
|
|---|---|---|
|
Overall Study
Adverse Event
|
4
|
11
|
|
Overall Study
Withdrawal by Subject
|
9
|
10
|
|
Overall Study
Lost to Follow-up
|
5
|
4
|
|
Overall Study
Lack of Efficacy
|
2
|
10
|
|
Overall Study
Other
|
5
|
4
|
Baseline Characteristics
Open-Label Extension Study of Upadacitinib in Adult Participants With Moderate to Severe Atopic Dermatitis
Baseline characteristics by cohort
| Measure |
DUPI 300mg to UPA 30mg
n=239 Participants
All participants in this study received upadacitinib 30 mg once a day (QD). Participants were grouped by previous treatment in Lead-In Study M16-046. Participants who received dupilumab (DUPI) in Lead-In Study M16-046 are included in the DUPI 300 mg Q2W/UPA 30 mg QD (DUPI/UPA) group.
|
UPA 30mg to UPA 30mg
n=236 Participants
All participants in this study received upadacitinib 30 mg once a day (QD). Participants were grouped by previous treatment in Lead-In Study M16-046. Participants who received upadacitinib (UPA) in Lead-In Study M16-046 are included in the UPA 30 mg QD/UPA 30 mg QD (UPA/UPA) group.
|
Total
n=475 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
35.3 years
STANDARD_DEVIATION 12.90 • n=5 Participants
|
36.1 years
STANDARD_DEVIATION 14.41 • n=7 Participants
|
35.7 years
STANDARD_DEVIATION 13.66 • n=5 Participants
|
|
Age, Customized
Not Specified · < 40 years
|
167 Participants
n=5 Participants
|
156 Participants
n=7 Participants
|
323 Participants
n=5 Participants
|
|
Age, Customized
Not Specified · ≥ 40 to < 65 years
|
66 Participants
n=5 Participants
|
70 Participants
n=7 Participants
|
136 Participants
n=5 Participants
|
|
Age, Customized
Not Specified · ≥ 65 years
|
6 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
100 Participants
n=5 Participants
|
104 Participants
n=7 Participants
|
204 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
139 Participants
n=5 Participants
|
132 Participants
n=7 Participants
|
271 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
17 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
33 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
222 Participants
n=5 Participants
|
220 Participants
n=7 Participants
|
442 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
49 Participants
n=5 Participants
|
46 Participants
n=7 Participants
|
95 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
11 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
172 Participants
n=5 Participants
|
170 Participants
n=7 Participants
|
342 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
5 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Eczema Area and Severity Index (EASI) Score
|
3.26 score on a scale
STANDARD_DEVIATION 4.172 • n=5 Participants
|
2.51 score on a scale
STANDARD_DEVIATION 4.274 • n=7 Participants
|
2.89 score on a scale
STANDARD_DEVIATION 4.236 • n=5 Participants
|
|
Duration Since AD Diagnosis
|
25.141 years
STANDARD_DEVIATION 13.6369 • n=5 Participants
|
23.938 years
STANDARD_DEVIATION 14.9433 • n=7 Participants
|
24.543 years
STANDARD_DEVIATION 14.2985 • n=5 Participants
|
PRIMARY outcome
Timeframe: UPA/UPA arm: BL visit in Lead-In M16-046 to last dose in Long-Term Extension M19-850 (median time on follow-up is 536 days); DUPI/UPA arm: BL visit in Long-Term Extension M19-850 to last dose plus a 30-day follow-up (median time on follow-up is 399 days).Population: The Safety Population is the same as the ITT Population for this study. Safety summaries will include data collected from the first dose of updacitinib in Lead-In Study M16-046 or Study M19-850, whichever is earlier.
Treatment-emergent adverse events (TEAEs) are defined as any adverse events that begin or worsen in severity after initiation of upadacitinib during Lead-In Study M16-046 for the UPA/UPA arm or this Study M19-850 DUPI/UPA arm through 30 days following the last dose of upadacitinib.
Outcome measures
| Measure |
DUPI 300mg to UPA 30mg
n=239 Participants
All participants in this study received upadacitinib 30 mg once a day (QD). Participants were grouped by previous treatment in Lead-In Study M16-046. Participants who received dupilumab (DUPI) in Lead-In Study M16-046 are included in the DUPI 300 mg Q2W/UPA 30 mg QD (DUPI/UPA) group.
|
UPA 30mg to UPA 30mg
n=236 Participants
All participants in this study received upadacitinib 30 mg once a day (QD). Participants were grouped by previous treatment in Lead-In Study M16-046. Participants who received upadacitinib (UPA) in Lead-In Study M16-046 are included in the UPA 30 mg QD/UPA 30 mg QD (UPA/UPA) group.
|
|---|---|---|
|
Number of Participants With Treatment-Emergent Adverse Events
Any TEAE
|
205 Participants
|
223 Participants
|
|
Number of Participants With Treatment-Emergent Adverse Events
TESAE
|
14 Participants
|
17 Participants
|
|
Number of Participants With Treatment-Emergent Adverse Events
TEAE leading to discontinuation of study drug
|
12 Participants
|
18 Participants
|
PRIMARY outcome
Timeframe: UPA/UPA arm: BL visit in Lead-In M16-046 to last dose in Long-Term Extension M19-850 (median time on follow-up is 536 days); DUPI/UPA arm: BL visit in Long-Term Extension M19-850 to last dose plus a 30-day follow-up (median time on follow-up is 399 days).Population: The Safety Population is the same as the ITT Population for this study. Safety summaries will include data collected from the first dose of updacitinib in Lead-In Study M16-046 or Study M19-850, whichever is earlier.
Treatment-emergent adverse events were monitored throughout the study to identify any adverse events of special interest that may indicate a trend or risk to participants. AESIs are defined as any adverse events that begin or worsen in severity after initiation of upadacitinib during Study M16-046 for the UPA/UPA arm or Study M19-850 for the DUPI/UPA arm through 30 days following the last dose of upadacitinib.
Outcome measures
| Measure |
DUPI 300mg to UPA 30mg
n=239 Participants
All participants in this study received upadacitinib 30 mg once a day (QD). Participants were grouped by previous treatment in Lead-In Study M16-046. Participants who received dupilumab (DUPI) in Lead-In Study M16-046 are included in the DUPI 300 mg Q2W/UPA 30 mg QD (DUPI/UPA) group.
|
UPA 30mg to UPA 30mg
n=236 Participants
All participants in this study received upadacitinib 30 mg once a day (QD). Participants were grouped by previous treatment in Lead-In Study M16-046. Participants who received upadacitinib (UPA) in Lead-In Study M16-046 are included in the UPA 30 mg QD/UPA 30 mg QD (UPA/UPA) group.
|
|---|---|---|
|
Number of Participants With Treatment-Emergent Adverse Events of Special Interest (AESI)
Neutropenia
|
10 Participants
|
8 Participants
|
|
Number of Participants With Treatment-Emergent Adverse Events of Special Interest (AESI)
Serious infections
|
7 Participants
|
8 Participants
|
|
Number of Participants With Treatment-Emergent Adverse Events of Special Interest (AESI)
Opportunistic infection excluding Tuberculosis and Herpes Zoster
|
6 Participants
|
4 Participants
|
|
Number of Participants With Treatment-Emergent Adverse Events of Special Interest (AESI)
Malignancy
|
1 Participants
|
0 Participants
|
|
Number of Participants With Treatment-Emergent Adverse Events of Special Interest (AESI)
Non-melanoma skin cancer (NMSC)
|
0 Participants
|
0 Participants
|
|
Number of Participants With Treatment-Emergent Adverse Events of Special Interest (AESI)
Malignancy excluding NMSC
|
1 Participants
|
0 Participants
|
|
Number of Participants With Treatment-Emergent Adverse Events of Special Interest (AESI)
Lymphoma
|
0 Participants
|
0 Participants
|
|
Number of Participants With Treatment-Emergent Adverse Events of Special Interest (AESI)
Hepatic disorder
|
19 Participants
|
15 Participants
|
|
Number of Participants With Treatment-Emergent Adverse Events of Special Interest (AESI)
Adjudicated gastrointestinal perforations
|
0 Participants
|
0 Participants
|
|
Number of Participants With Treatment-Emergent Adverse Events of Special Interest (AESI)
Anemia
|
7 Participants
|
8 Participants
|
|
Number of Participants With Treatment-Emergent Adverse Events of Special Interest (AESI)
Lymphopenia
|
4 Participants
|
5 Participants
|
|
Number of Participants With Treatment-Emergent Adverse Events of Special Interest (AESI)
Herpes zoster
|
26 Participants
|
25 Participants
|
|
Number of Participants With Treatment-Emergent Adverse Events of Special Interest (AESI)
Creatine phosphokinase (CPK) elevation
|
31 Participants
|
44 Participants
|
|
Number of Participants With Treatment-Emergent Adverse Events of Special Interest (AESI)
Renal dysfunction
|
0 Participants
|
0 Participants
|
|
Number of Participants With Treatment-Emergent Adverse Events of Special Interest (AESI)
Active tuberculosis
|
0 Participants
|
1 Participants
|
|
Number of Participants With Treatment-Emergent Adverse Events of Special Interest (AESI)
Adjudicated MACE
|
0 Participants
|
0 Participants
|
|
Number of Participants With Treatment-Emergent Adverse Events of Special Interest (AESI)
Adjudicated VTE
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: From Baseline to 30 days following last dose of study drug (Week 52)Population: The Safety Population is the same as the ITT Population for this study. Safety summaries will include data collected from the first dose of updacitinib in Lead-In Study M16-046 or Study M19-850, whichever is earlier.
Clinical laboratory test values are considered PCI if they meet either the lower-limit or higher-limit PCI criteria defined in the categories below. Percentage of participants with PCI laboratory values are summarized for hematology and chemistry. The Number Analyzed is defined as the number of participants with at least one post-baseline value for the specific criteria. Post-baseline grade must also be more extreme (worse) than the baseline grade in order to be included in the count. If a participant does not have a baseline value then the participant would be counted in the numerator if the participant had at least one post-baseline. xULN = Times upper limit of the normal range.
Outcome measures
| Measure |
DUPI 300mg to UPA 30mg
n=239 Participants
All participants in this study received upadacitinib 30 mg once a day (QD). Participants were grouped by previous treatment in Lead-In Study M16-046. Participants who received dupilumab (DUPI) in Lead-In Study M16-046 are included in the DUPI 300 mg Q2W/UPA 30 mg QD (DUPI/UPA) group.
|
UPA 30mg to UPA 30mg
n=236 Participants
All participants in this study received upadacitinib 30 mg once a day (QD). Participants were grouped by previous treatment in Lead-In Study M16-046. Participants who received upadacitinib (UPA) in Lead-In Study M16-046 are included in the UPA 30 mg QD/UPA 30 mg QD (UPA/UPA) group.
|
|---|---|---|
|
Percentage of Participants With Potentially Clinically Important (PCI) Laboratory Values as Assessed by the Investigator
Lymphocytes(10^9/L): Grade 4 (<0.2)
|
0 percentage of participants
|
0.4 percentage of participants
|
|
Percentage of Participants With Potentially Clinically Important (PCI) Laboratory Values as Assessed by the Investigator
Alanine Aminotransferase (U/L): Grade 3 or above
|
0.4 percentage of participants
|
0.4 percentage of participants
|
|
Percentage of Participants With Potentially Clinically Important (PCI) Laboratory Values as Assessed by the Investigator
Aspartate Aminotransferase (U/L): Grade 4 (>20.0 xULN)
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Potentially Clinically Important (PCI) Laboratory Values as Assessed by the Investigator
Creatine Kinase (U/L): Grade 4 (>10.0 xULN)
|
3.8 percentage of participants
|
5.1 percentage of participants
|
|
Percentage of Participants With Potentially Clinically Important (PCI) Laboratory Values as Assessed by the Investigator
Calcium Hyper (MMOL/L): Grade 3 (>3.1-3.4)
|
0 percentage of participants
|
0.4 percentage of participants
|
|
Percentage of Participants With Potentially Clinically Important (PCI) Laboratory Values as Assessed by the Investigator
Calcium Hypo (MMOL/L): Grade 4 (<1.5)
|
0 percentage of participants
|
0.4 percentage of participants
|
|
Percentage of Participants With Potentially Clinically Important (PCI) Laboratory Values as Assessed by the Investigator
Sodium Hyper (MMOL/L): Grade 4 (>160)
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Potentially Clinically Important (PCI) Laboratory Values as Assessed by the Investigator
Sodium Hypo (MMOL/L): Grade 4 (<120)
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Potentially Clinically Important (PCI) Laboratory Values as Assessed by the Investigator
Creatinine (UMOL/L): Grade 3 (>3.0-6.0 xULN OR >3.0 xBaseline)
|
0 percentage of participants
|
0.8 percentage of participants
|
|
Percentage of Participants With Potentially Clinically Important (PCI) Laboratory Values as Assessed by the Investigator
Aspartate Aminotransferase (U/L): Grade 3 or above
|
0 percentage of participants
|
1.3 percentage of participants
|
|
Percentage of Participants With Potentially Clinically Important (PCI) Laboratory Values as Assessed by the Investigator
Alkaline Phosphatase (U/L): Grade 3 (>5.0-20.0 xULN)
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Potentially Clinically Important (PCI) Laboratory Values as Assessed by the Investigator
Alkaline Phosphatase (U/L): Grade 4 (>20.0 xULN)
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Potentially Clinically Important (PCI) Laboratory Values as Assessed by the Investigator
Alkaline Phosphatase (U/L): Grade 3 or above
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Potentially Clinically Important (PCI) Laboratory Values as Assessed by the Investigator
Creatine Kinase (U/L): Grade 3 (>5.0-10.0 xULN)
|
4.2 percentage of participants
|
8.1 percentage of participants
|
|
Percentage of Participants With Potentially Clinically Important (PCI) Laboratory Values as Assessed by the Investigator
Creatine Kinase (U/L): Grade 3 or above
|
8.0 percentage of participants
|
13.1 percentage of participants
|
|
Percentage of Participants With Potentially Clinically Important (PCI) Laboratory Values as Assessed by the Investigator
Creatinine (UMOL/L): Grade 4 (>6.0 xULN)
|
0 percentage of participants
|
0.4 percentage of participants
|
|
Percentage of Participants With Potentially Clinically Important (PCI) Laboratory Values as Assessed by the Investigator
Creatinine (UMOL/L): Grade 3 or above
|
0 percentage of participants
|
1.3 percentage of participants
|
|
Percentage of Participants With Potentially Clinically Important (PCI) Laboratory Values as Assessed by the Investigator
Phosphate (MMOL/L): Grade 3 (0.3-<0.6)
|
1.7 percentage of participants
|
1.3 percentage of participants
|
|
Percentage of Participants With Potentially Clinically Important (PCI) Laboratory Values as Assessed by the Investigator
Phosphate (MMOL/L): Grade 4 (<0.3)
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Potentially Clinically Important (PCI) Laboratory Values as Assessed by the Investigator
Phosphate (MMOL/L): Grade 3 or above
|
1.7 percentage of participants
|
1.3 percentage of participants
|
|
Percentage of Participants With Potentially Clinically Important (PCI) Laboratory Values as Assessed by the Investigator
Calcium Hyper (MMOL/L): Grade 4 (>3.4)
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Potentially Clinically Important (PCI) Laboratory Values as Assessed by the Investigator
Calcium Hyper (MMOL/L): Grade 3 or above
|
0 percentage of participants
|
0.4 percentage of participants
|
|
Percentage of Participants With Potentially Clinically Important (PCI) Laboratory Values as Assessed by the Investigator
Calcium Hypo (MMOL/L): Grade 3 (1.5-<1.75)
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Potentially Clinically Important (PCI) Laboratory Values as Assessed by the Investigator
Calcium Hypo (MMOL/L): Grade 3 or above
|
0 percentage of participants
|
0.4 percentage of participants
|
|
Percentage of Participants With Potentially Clinically Important (PCI) Laboratory Values as Assessed by the Investigator
Sodium Hyper (MMOL/L): Grade 3 (>155-160)
|
0.5 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Potentially Clinically Important (PCI) Laboratory Values as Assessed by the Investigator
Sodium Hyper (MMOL/L): Grade 3 or above
|
0.5 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Potentially Clinically Important (PCI) Laboratory Values as Assessed by the Investigator
Sodium Hypo (MMOL/L): Grade 3 (120-<130)
|
0 percentage of participants
|
0.4 percentage of participants
|
|
Percentage of Participants With Potentially Clinically Important (PCI) Laboratory Values as Assessed by the Investigator
Sodium Hypo (MMOL/L): Grade 3 or above
|
0 percentage of participants
|
0.4 percentage of participants
|
|
Percentage of Participants With Potentially Clinically Important (PCI) Laboratory Values as Assessed by the Investigator
Potassium Hyper (MMOL/L): Grade 3 (>6.0-7.0)
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Potentially Clinically Important (PCI) Laboratory Values as Assessed by the Investigator
Potassium Hyper (MMOL/L): Grade 4 (>7.0)
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Potentially Clinically Important (PCI) Laboratory Values as Assessed by the Investigator
Potassium Hyper (MMOL/L): Grade 3 or above
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Potentially Clinically Important (PCI) Laboratory Values as Assessed by the Investigator
Potassium Hypo (MMOL/L): Grade 3 (2.5-<3.0)
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Potentially Clinically Important (PCI) Laboratory Values as Assessed by the Investigator
Potassium Hypo (MMOL/L): Grade 4 (<2.5)
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Potentially Clinically Important (PCI) Laboratory Values as Assessed by the Investigator
Potassium Hypo (MMOL/L): Grade 3 or above
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Potentially Clinically Important (PCI) Laboratory Values as Assessed by the Investigator
Glucose Hyper (MMOL/L): Grade 3 (>13.9-27.8)
|
1.3 percentage of participants
|
0.4 percentage of participants
|
|
Percentage of Participants With Potentially Clinically Important (PCI) Laboratory Values as Assessed by the Investigator
Glucose Hyper (MMOL/L): Grade 4 (>27.8)
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Potentially Clinically Important (PCI) Laboratory Values as Assessed by the Investigator
Glucose Hyper (MMOL/L): Grade 3 or above
|
1.3 percentage of participants
|
0.4 percentage of participants
|
|
Percentage of Participants With Potentially Clinically Important (PCI) Laboratory Values as Assessed by the Investigator
Glucose Hypo (MMOL/L): Grade 3 (1.7-<2.2)
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Potentially Clinically Important (PCI) Laboratory Values as Assessed by the Investigator
Glucose Hypo (MMOL/L): Grade 4 (<1.7)
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Potentially Clinically Important (PCI) Laboratory Values as Assessed by the Investigator
Glucose Hypo (MMOL/L): Grade 3 or above
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Potentially Clinically Important (PCI) Laboratory Values as Assessed by the Investigator
Albumin (G/L): Grade 3 (<20)
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Potentially Clinically Important (PCI) Laboratory Values as Assessed by the Investigator
Albumin (G/L): Grade 3 or above
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Potentially Clinically Important (PCI) Laboratory Values as Assessed by the Investigator
Cholesterol (MMOL/L): Grade 3 (10.34<-12.92)
|
1.3 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Potentially Clinically Important (PCI) Laboratory Values as Assessed by the Investigator
Cholesterol (MMOL/L): Grade 4 (>12.92)
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Potentially Clinically Important (PCI) Laboratory Values as Assessed by the Investigator
Cholesterol (MMOL/L): Grade 3 or above
|
1.3 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Potentially Clinically Important (PCI) Laboratory Values as Assessed by the Investigator
Triglycerides (MMOL/L): Grade 3 (>5.7-11.4)
|
3.4 percentage of participants
|
5.1 percentage of participants
|
|
Percentage of Participants With Potentially Clinically Important (PCI) Laboratory Values as Assessed by the Investigator
Triglycerides (MMOL/L): Grade 4 (>11.4)
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Potentially Clinically Important (PCI) Laboratory Values as Assessed by the Investigator
Triglycerides (MMOL/L): Grade 3 or above
|
3.4 percentage of participants
|
5.1 percentage of participants
|
|
Percentage of Participants With Potentially Clinically Important (PCI) Laboratory Values as Assessed by the Investigator
Hemoglobin (G/L): Grade 3 (<80)
|
0 percentage of participants
|
0.8 percentage of participants
|
|
Percentage of Participants With Potentially Clinically Important (PCI) Laboratory Values as Assessed by the Investigator
Hemoglobin (G/L): Grade 3 or above
|
0 percentage of participants
|
0.8 percentage of participants
|
|
Percentage of Participants With Potentially Clinically Important (PCI) Laboratory Values as Assessed by the Investigator
Platelets (10^9/L): Grade 3 (25-<50)
|
0 percentage of participants
|
0.4 percentage of participants
|
|
Percentage of Participants With Potentially Clinically Important (PCI) Laboratory Values as Assessed by the Investigator
Platelets (10^9/L): Grade 4 (<25)
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Potentially Clinically Important (PCI) Laboratory Values as Assessed by the Investigator
Platelets (10^9/L): Grade 3 or above
|
0 percentage of participants
|
0.4 percentage of participants
|
|
Percentage of Participants With Potentially Clinically Important (PCI) Laboratory Values as Assessed by the Investigator
Leukocytes (10^9/L): Grade 3 (1.0-<2.0)
|
0 percentage of participants
|
1.3 percentage of participants
|
|
Percentage of Participants With Potentially Clinically Important (PCI) Laboratory Values as Assessed by the Investigator
Leukocytes (10^9/L): Grade 4 (<1.0)
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Potentially Clinically Important (PCI) Laboratory Values as Assessed by the Investigator
Leukocytes (10^9/L): Grade 3 or above
|
0 percentage of participants
|
1.3 percentage of participants
|
|
Percentage of Participants With Potentially Clinically Important (PCI) Laboratory Values as Assessed by the Investigator
Neutrophils(10^9/L): Grade 3 (0.5-<1.0)
|
2.5 percentage of participants
|
3.4 percentage of participants
|
|
Percentage of Participants With Potentially Clinically Important (PCI) Laboratory Values as Assessed by the Investigator
Neutrophils(10^9/L): Grade 4 (<0.5)
|
0.4 percentage of participants
|
0.4 percentage of participants
|
|
Percentage of Participants With Potentially Clinically Important (PCI) Laboratory Values as Assessed by the Investigator
Neutrophils(10^9/L): Grade 3 or above
|
2.9 percentage of participants
|
3.8 percentage of participants
|
|
Percentage of Participants With Potentially Clinically Important (PCI) Laboratory Values as Assessed by the Investigator
Lymphocytes(10^9/L): Grade 3 (0.2-<0.5)
|
0.8 percentage of participants
|
3.4 percentage of participants
|
|
Percentage of Participants With Potentially Clinically Important (PCI) Laboratory Values as Assessed by the Investigator
Lymphocytes(10^9/L): Grade 3 or above
|
0.8 percentage of participants
|
3.8 percentage of participants
|
|
Percentage of Participants With Potentially Clinically Important (PCI) Laboratory Values as Assessed by the Investigator
Alanine Aminotransferase (U/L): Grade 3 (>5.0-20.0 xULN)
|
0.4 percentage of participants
|
0.4 percentage of participants
|
|
Percentage of Participants With Potentially Clinically Important (PCI) Laboratory Values as Assessed by the Investigator
Alanine Aminotransferase (U/L): Grade 4 (>20.0 xULN)
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Potentially Clinically Important (PCI) Laboratory Values as Assessed by the Investigator
Aspartate Aminotransferase (U/L): Grade 3 (>5.0-20.0 xULN)
|
0 percentage of participants
|
1.3 percentage of participants
|
PRIMARY outcome
Timeframe: From Baseline to 30 days following last dose of study drug (Week 52)Population: The Safety Population is the same as the ITT Population for this study. Safety summaries will include data collected from the first dose of updacitinib in Lead-In Study M16-046 or Study M19-850, whichever is earlier.
PCI post-baseline vital sign values are summarized for categories: systolic and diastolic blood pressures \[sitting\], pulse rate \[sitting\], and weight. Only those categories where at least 1 person had a non-PCI value at Baseline and met the PCI criterion at least once during post-baseline are reported. The Number Analyzed is defined as the number of participants with at least one post-baseline value for the specific criteria. Post-baseline grade must also be more extreme (worse) than the baseline grade in order to be included in the count. If a participant does not have a baseline value then the participant would be counted in the numerator if the participant had at least one post-baseline.
Outcome measures
| Measure |
DUPI 300mg to UPA 30mg
n=239 Participants
All participants in this study received upadacitinib 30 mg once a day (QD). Participants were grouped by previous treatment in Lead-In Study M16-046. Participants who received dupilumab (DUPI) in Lead-In Study M16-046 are included in the DUPI 300 mg Q2W/UPA 30 mg QD (DUPI/UPA) group.
|
UPA 30mg to UPA 30mg
n=236 Participants
All participants in this study received upadacitinib 30 mg once a day (QD). Participants were grouped by previous treatment in Lead-In Study M16-046. Participants who received upadacitinib (UPA) in Lead-In Study M16-046 are included in the UPA 30 mg QD/UPA 30 mg QD (UPA/UPA) group.
|
|---|---|---|
|
Percentage of Participants With Potentially Clinically Important (PCI) Vital Sign Measurements and Physical Examination Findings as Assessed by the Investigator
Sitting Systolic Blood Pressure (MMHG): ≤90 and ≥20 Decrease
|
0.4 percentage of participants
|
0.8 percentage of participants
|
|
Percentage of Participants With Potentially Clinically Important (PCI) Vital Sign Measurements and Physical Examination Findings as Assessed by the Investigator
Sitting Systolic Blood Pressure (MMHG): ≥160 and ≥20 Increase
|
2.5 percentage of participants
|
5.5 percentage of participants
|
|
Percentage of Participants With Potentially Clinically Important (PCI) Vital Sign Measurements and Physical Examination Findings as Assessed by the Investigator
Sitting Diastolic Blood Pressure (MMHG): ≤50 and ≥10 Decrease
|
0.4 percentage of participants
|
1.3 percentage of participants
|
|
Percentage of Participants With Potentially Clinically Important (PCI) Vital Sign Measurements and Physical Examination Findings as Assessed by the Investigator
Sitting Diastolic Blood Pressure (MMHG): ≥100 and ≥10 Increase
|
2.1 percentage of participants
|
9.3 percentage of participants
|
|
Percentage of Participants With Potentially Clinically Important (PCI) Vital Sign Measurements and Physical Examination Findings as Assessed by the Investigator
Sitting Pulse Rate (BEATS/MIN): ≤50 and ≥15 Decrease
|
1.7 percentage of participants
|
4.7 percentage of participants
|
|
Percentage of Participants With Potentially Clinically Important (PCI) Vital Sign Measurements and Physical Examination Findings as Assessed by the Investigator
Sitting Pulse Rate (BEATS/MIN): ≥120 and ≥15 Increase
|
0 percentage of participants
|
2.1 percentage of participants
|
|
Percentage of Participants With Potentially Clinically Important (PCI) Vital Sign Measurements and Physical Examination Findings as Assessed by the Investigator
Weight (KG): >7% Decrease
|
5.5 percentage of participants
|
7.6 percentage of participants
|
|
Percentage of Participants With Potentially Clinically Important (PCI) Vital Sign Measurements and Physical Examination Findings as Assessed by the Investigator
Weight (KG): >7% Increase
|
22.5 percentage of participants
|
39.0 percentage of participants
|
Adverse Events
UPA 30mg to UPA 30mg
Serious events: 13 serious events
Other events: 154 other events
Deaths: 1 deaths
DUPI 300mg to UPA 30mg
Serious events: 14 serious events
Other events: 149 other events
Deaths: 0 deaths
Total
Serious events: 27 serious events
Other events: 303 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
UPA 30mg to UPA 30mg
n=236 participants at risk
All participants in this study received upadacitinib 30 mg once a day (QD). Participants were grouped by previous treatment in Lead-In Study M16-046. Participants who received upadacitinib (UPA) in Lead-In Study M16-046 are included in the UPA 30 mg QD/UPA 30 mg QD (UPA/UPA) group.
|
DUPI 300mg to UPA 30mg
n=239 participants at risk
All participants in this study received upadacitinib 30 mg once a day (QD). Participants were grouped by previous treatment in Lead-In Study M16-046. Participants who received dupilumab (DUPI) in Lead-In Study M16-046 are included in the DUPI 300 mg Q2W/UPA 30 mg QD (DUPI/UPA) group.
|
Total
n=475 participants at risk
All participants in this study received upadacitinib 30 mg once a day (QD). Participants were grouped by previous treatment in Lead-In Study M16-046. Participants who received upadacitinib (UPA) in Lead-In Study M16-046 are included in the UPA 30 mg QD/UPA 30 mg QD (UPA/UPA) group and participants who received dupilumab (DUPI) in Lead-In Study M16-046 are included in the DUPI 300 mg Q2W/UPA 30 mg QD (DUPI/UPA) group.
|
|---|---|---|---|
|
Gastrointestinal disorders
PANCREATITIS
|
0.42%
1/236 • Number of events 1 • All-cause mortality and adverse event tables include treatment-emergent events reported from the time of informed consent to end of study in M19-850 (52 weeks of treatment plus a 30 day follow-up after last dose). The median time on follow-up was 398 & 399 days for UPA/UPA & DUPI/UPA, respectively.
|
0.00%
0/239 • All-cause mortality and adverse event tables include treatment-emergent events reported from the time of informed consent to end of study in M19-850 (52 weeks of treatment plus a 30 day follow-up after last dose). The median time on follow-up was 398 & 399 days for UPA/UPA & DUPI/UPA, respectively.
|
0.21%
1/475 • Number of events 1 • All-cause mortality and adverse event tables include treatment-emergent events reported from the time of informed consent to end of study in M19-850 (52 weeks of treatment plus a 30 day follow-up after last dose). The median time on follow-up was 398 & 399 days for UPA/UPA & DUPI/UPA, respectively.
|
|
Immune system disorders
FOOD ALLERGY
|
0.42%
1/236 • Number of events 2 • All-cause mortality and adverse event tables include treatment-emergent events reported from the time of informed consent to end of study in M19-850 (52 weeks of treatment plus a 30 day follow-up after last dose). The median time on follow-up was 398 & 399 days for UPA/UPA & DUPI/UPA, respectively.
|
0.00%
0/239 • All-cause mortality and adverse event tables include treatment-emergent events reported from the time of informed consent to end of study in M19-850 (52 weeks of treatment plus a 30 day follow-up after last dose). The median time on follow-up was 398 & 399 days for UPA/UPA & DUPI/UPA, respectively.
|
0.21%
1/475 • Number of events 2 • All-cause mortality and adverse event tables include treatment-emergent events reported from the time of informed consent to end of study in M19-850 (52 weeks of treatment plus a 30 day follow-up after last dose). The median time on follow-up was 398 & 399 days for UPA/UPA & DUPI/UPA, respectively.
|
|
Infections and infestations
ABSCESS JAW
|
0.00%
0/236 • All-cause mortality and adverse event tables include treatment-emergent events reported from the time of informed consent to end of study in M19-850 (52 weeks of treatment plus a 30 day follow-up after last dose). The median time on follow-up was 398 & 399 days for UPA/UPA & DUPI/UPA, respectively.
|
0.42%
1/239 • Number of events 1 • All-cause mortality and adverse event tables include treatment-emergent events reported from the time of informed consent to end of study in M19-850 (52 weeks of treatment plus a 30 day follow-up after last dose). The median time on follow-up was 398 & 399 days for UPA/UPA & DUPI/UPA, respectively.
|
0.21%
1/475 • Number of events 1 • All-cause mortality and adverse event tables include treatment-emergent events reported from the time of informed consent to end of study in M19-850 (52 weeks of treatment plus a 30 day follow-up after last dose). The median time on follow-up was 398 & 399 days for UPA/UPA & DUPI/UPA, respectively.
|
|
Infections and infestations
APPENDICITIS
|
0.00%
0/236 • All-cause mortality and adverse event tables include treatment-emergent events reported from the time of informed consent to end of study in M19-850 (52 weeks of treatment plus a 30 day follow-up after last dose). The median time on follow-up was 398 & 399 days for UPA/UPA & DUPI/UPA, respectively.
|
0.42%
1/239 • Number of events 1 • All-cause mortality and adverse event tables include treatment-emergent events reported from the time of informed consent to end of study in M19-850 (52 weeks of treatment plus a 30 day follow-up after last dose). The median time on follow-up was 398 & 399 days for UPA/UPA & DUPI/UPA, respectively.
|
0.21%
1/475 • Number of events 1 • All-cause mortality and adverse event tables include treatment-emergent events reported from the time of informed consent to end of study in M19-850 (52 weeks of treatment plus a 30 day follow-up after last dose). The median time on follow-up was 398 & 399 days for UPA/UPA & DUPI/UPA, respectively.
|
|
Infections and infestations
BONE TUBERCULOSIS
|
0.42%
1/236 • Number of events 1 • All-cause mortality and adverse event tables include treatment-emergent events reported from the time of informed consent to end of study in M19-850 (52 weeks of treatment plus a 30 day follow-up after last dose). The median time on follow-up was 398 & 399 days for UPA/UPA & DUPI/UPA, respectively.
|
0.00%
0/239 • All-cause mortality and adverse event tables include treatment-emergent events reported from the time of informed consent to end of study in M19-850 (52 weeks of treatment plus a 30 day follow-up after last dose). The median time on follow-up was 398 & 399 days for UPA/UPA & DUPI/UPA, respectively.
|
0.21%
1/475 • Number of events 1 • All-cause mortality and adverse event tables include treatment-emergent events reported from the time of informed consent to end of study in M19-850 (52 weeks of treatment plus a 30 day follow-up after last dose). The median time on follow-up was 398 & 399 days for UPA/UPA & DUPI/UPA, respectively.
|
|
Infections and infestations
BULLOUS IMPETIGO
|
0.42%
1/236 • Number of events 1 • All-cause mortality and adverse event tables include treatment-emergent events reported from the time of informed consent to end of study in M19-850 (52 weeks of treatment plus a 30 day follow-up after last dose). The median time on follow-up was 398 & 399 days for UPA/UPA & DUPI/UPA, respectively.
|
0.00%
0/239 • All-cause mortality and adverse event tables include treatment-emergent events reported from the time of informed consent to end of study in M19-850 (52 weeks of treatment plus a 30 day follow-up after last dose). The median time on follow-up was 398 & 399 days for UPA/UPA & DUPI/UPA, respectively.
|
0.21%
1/475 • Number of events 1 • All-cause mortality and adverse event tables include treatment-emergent events reported from the time of informed consent to end of study in M19-850 (52 weeks of treatment plus a 30 day follow-up after last dose). The median time on follow-up was 398 & 399 days for UPA/UPA & DUPI/UPA, respectively.
|
|
Infections and infestations
COVID-19
|
0.00%
0/236 • All-cause mortality and adverse event tables include treatment-emergent events reported from the time of informed consent to end of study in M19-850 (52 weeks of treatment plus a 30 day follow-up after last dose). The median time on follow-up was 398 & 399 days for UPA/UPA & DUPI/UPA, respectively.
|
0.42%
1/239 • Number of events 1 • All-cause mortality and adverse event tables include treatment-emergent events reported from the time of informed consent to end of study in M19-850 (52 weeks of treatment plus a 30 day follow-up after last dose). The median time on follow-up was 398 & 399 days for UPA/UPA & DUPI/UPA, respectively.
|
0.21%
1/475 • Number of events 1 • All-cause mortality and adverse event tables include treatment-emergent events reported from the time of informed consent to end of study in M19-850 (52 weeks of treatment plus a 30 day follow-up after last dose). The median time on follow-up was 398 & 399 days for UPA/UPA & DUPI/UPA, respectively.
|
|
Infections and infestations
COVID-19 PNEUMONIA
|
1.3%
3/236 • Number of events 3 • All-cause mortality and adverse event tables include treatment-emergent events reported from the time of informed consent to end of study in M19-850 (52 weeks of treatment plus a 30 day follow-up after last dose). The median time on follow-up was 398 & 399 days for UPA/UPA & DUPI/UPA, respectively.
|
0.00%
0/239 • All-cause mortality and adverse event tables include treatment-emergent events reported from the time of informed consent to end of study in M19-850 (52 weeks of treatment plus a 30 day follow-up after last dose). The median time on follow-up was 398 & 399 days for UPA/UPA & DUPI/UPA, respectively.
|
0.63%
3/475 • Number of events 3 • All-cause mortality and adverse event tables include treatment-emergent events reported from the time of informed consent to end of study in M19-850 (52 weeks of treatment plus a 30 day follow-up after last dose). The median time on follow-up was 398 & 399 days for UPA/UPA & DUPI/UPA, respectively.
|
|
Infections and infestations
ECZEMA HERPETICUM
|
0.42%
1/236 • Number of events 1 • All-cause mortality and adverse event tables include treatment-emergent events reported from the time of informed consent to end of study in M19-850 (52 weeks of treatment plus a 30 day follow-up after last dose). The median time on follow-up was 398 & 399 days for UPA/UPA & DUPI/UPA, respectively.
|
0.84%
2/239 • Number of events 2 • All-cause mortality and adverse event tables include treatment-emergent events reported from the time of informed consent to end of study in M19-850 (52 weeks of treatment plus a 30 day follow-up after last dose). The median time on follow-up was 398 & 399 days for UPA/UPA & DUPI/UPA, respectively.
|
0.63%
3/475 • Number of events 3 • All-cause mortality and adverse event tables include treatment-emergent events reported from the time of informed consent to end of study in M19-850 (52 weeks of treatment plus a 30 day follow-up after last dose). The median time on follow-up was 398 & 399 days for UPA/UPA & DUPI/UPA, respectively.
|
|
Infections and infestations
ERYSIPELAS
|
0.00%
0/236 • All-cause mortality and adverse event tables include treatment-emergent events reported from the time of informed consent to end of study in M19-850 (52 weeks of treatment plus a 30 day follow-up after last dose). The median time on follow-up was 398 & 399 days for UPA/UPA & DUPI/UPA, respectively.
|
0.42%
1/239 • Number of events 1 • All-cause mortality and adverse event tables include treatment-emergent events reported from the time of informed consent to end of study in M19-850 (52 weeks of treatment plus a 30 day follow-up after last dose). The median time on follow-up was 398 & 399 days for UPA/UPA & DUPI/UPA, respectively.
|
0.21%
1/475 • Number of events 1 • All-cause mortality and adverse event tables include treatment-emergent events reported from the time of informed consent to end of study in M19-850 (52 weeks of treatment plus a 30 day follow-up after last dose). The median time on follow-up was 398 & 399 days for UPA/UPA & DUPI/UPA, respectively.
|
|
Infections and infestations
GASTROENTERITIS VIRAL
|
0.00%
0/236 • All-cause mortality and adverse event tables include treatment-emergent events reported from the time of informed consent to end of study in M19-850 (52 weeks of treatment plus a 30 day follow-up after last dose). The median time on follow-up was 398 & 399 days for UPA/UPA & DUPI/UPA, respectively.
|
0.42%
1/239 • Number of events 1 • All-cause mortality and adverse event tables include treatment-emergent events reported from the time of informed consent to end of study in M19-850 (52 weeks of treatment plus a 30 day follow-up after last dose). The median time on follow-up was 398 & 399 days for UPA/UPA & DUPI/UPA, respectively.
|
0.21%
1/475 • Number of events 1 • All-cause mortality and adverse event tables include treatment-emergent events reported from the time of informed consent to end of study in M19-850 (52 weeks of treatment plus a 30 day follow-up after last dose). The median time on follow-up was 398 & 399 days for UPA/UPA & DUPI/UPA, respectively.
|
|
Infections and infestations
PERICHONDRITIS
|
0.00%
0/236 • All-cause mortality and adverse event tables include treatment-emergent events reported from the time of informed consent to end of study in M19-850 (52 weeks of treatment plus a 30 day follow-up after last dose). The median time on follow-up was 398 & 399 days for UPA/UPA & DUPI/UPA, respectively.
|
0.42%
1/239 • Number of events 1 • All-cause mortality and adverse event tables include treatment-emergent events reported from the time of informed consent to end of study in M19-850 (52 weeks of treatment plus a 30 day follow-up after last dose). The median time on follow-up was 398 & 399 days for UPA/UPA & DUPI/UPA, respectively.
|
0.21%
1/475 • Number of events 1 • All-cause mortality and adverse event tables include treatment-emergent events reported from the time of informed consent to end of study in M19-850 (52 weeks of treatment plus a 30 day follow-up after last dose). The median time on follow-up was 398 & 399 days for UPA/UPA & DUPI/UPA, respectively.
|
|
Infections and infestations
PILONIDAL DISEASE
|
0.42%
1/236 • Number of events 1 • All-cause mortality and adverse event tables include treatment-emergent events reported from the time of informed consent to end of study in M19-850 (52 weeks of treatment plus a 30 day follow-up after last dose). The median time on follow-up was 398 & 399 days for UPA/UPA & DUPI/UPA, respectively.
|
0.00%
0/239 • All-cause mortality and adverse event tables include treatment-emergent events reported from the time of informed consent to end of study in M19-850 (52 weeks of treatment plus a 30 day follow-up after last dose). The median time on follow-up was 398 & 399 days for UPA/UPA & DUPI/UPA, respectively.
|
0.21%
1/475 • Number of events 1 • All-cause mortality and adverse event tables include treatment-emergent events reported from the time of informed consent to end of study in M19-850 (52 weeks of treatment plus a 30 day follow-up after last dose). The median time on follow-up was 398 & 399 days for UPA/UPA & DUPI/UPA, respectively.
|
|
Infections and infestations
PNEUMONIA
|
0.42%
1/236 • Number of events 1 • All-cause mortality and adverse event tables include treatment-emergent events reported from the time of informed consent to end of study in M19-850 (52 weeks of treatment plus a 30 day follow-up after last dose). The median time on follow-up was 398 & 399 days for UPA/UPA & DUPI/UPA, respectively.
|
0.00%
0/239 • All-cause mortality and adverse event tables include treatment-emergent events reported from the time of informed consent to end of study in M19-850 (52 weeks of treatment plus a 30 day follow-up after last dose). The median time on follow-up was 398 & 399 days for UPA/UPA & DUPI/UPA, respectively.
|
0.21%
1/475 • Number of events 1 • All-cause mortality and adverse event tables include treatment-emergent events reported from the time of informed consent to end of study in M19-850 (52 weeks of treatment plus a 30 day follow-up after last dose). The median time on follow-up was 398 & 399 days for UPA/UPA & DUPI/UPA, respectively.
|
|
Infections and infestations
RESPIRATORY SYNCYTIAL VIRUS INFECTION
|
0.00%
0/236 • All-cause mortality and adverse event tables include treatment-emergent events reported from the time of informed consent to end of study in M19-850 (52 weeks of treatment plus a 30 day follow-up after last dose). The median time on follow-up was 398 & 399 days for UPA/UPA & DUPI/UPA, respectively.
|
0.42%
1/239 • Number of events 1 • All-cause mortality and adverse event tables include treatment-emergent events reported from the time of informed consent to end of study in M19-850 (52 weeks of treatment plus a 30 day follow-up after last dose). The median time on follow-up was 398 & 399 days for UPA/UPA & DUPI/UPA, respectively.
|
0.21%
1/475 • Number of events 1 • All-cause mortality and adverse event tables include treatment-emergent events reported from the time of informed consent to end of study in M19-850 (52 weeks of treatment plus a 30 day follow-up after last dose). The median time on follow-up was 398 & 399 days for UPA/UPA & DUPI/UPA, respectively.
|
|
Injury, poisoning and procedural complications
FOOT FRACTURE
|
0.00%
0/236 • All-cause mortality and adverse event tables include treatment-emergent events reported from the time of informed consent to end of study in M19-850 (52 weeks of treatment plus a 30 day follow-up after last dose). The median time on follow-up was 398 & 399 days for UPA/UPA & DUPI/UPA, respectively.
|
0.42%
1/239 • Number of events 1 • All-cause mortality and adverse event tables include treatment-emergent events reported from the time of informed consent to end of study in M19-850 (52 weeks of treatment plus a 30 day follow-up after last dose). The median time on follow-up was 398 & 399 days for UPA/UPA & DUPI/UPA, respectively.
|
0.21%
1/475 • Number of events 1 • All-cause mortality and adverse event tables include treatment-emergent events reported from the time of informed consent to end of study in M19-850 (52 weeks of treatment plus a 30 day follow-up after last dose). The median time on follow-up was 398 & 399 days for UPA/UPA & DUPI/UPA, respectively.
|
|
Investigations
HAEMOGLOBIN DECREASED
|
0.42%
1/236 • Number of events 1 • All-cause mortality and adverse event tables include treatment-emergent events reported from the time of informed consent to end of study in M19-850 (52 weeks of treatment plus a 30 day follow-up after last dose). The median time on follow-up was 398 & 399 days for UPA/UPA & DUPI/UPA, respectively.
|
0.00%
0/239 • All-cause mortality and adverse event tables include treatment-emergent events reported from the time of informed consent to end of study in M19-850 (52 weeks of treatment plus a 30 day follow-up after last dose). The median time on follow-up was 398 & 399 days for UPA/UPA & DUPI/UPA, respectively.
|
0.21%
1/475 • Number of events 1 • All-cause mortality and adverse event tables include treatment-emergent events reported from the time of informed consent to end of study in M19-850 (52 weeks of treatment plus a 30 day follow-up after last dose). The median time on follow-up was 398 & 399 days for UPA/UPA & DUPI/UPA, respectively.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
PROSTATE CANCER
|
0.00%
0/236 • All-cause mortality and adverse event tables include treatment-emergent events reported from the time of informed consent to end of study in M19-850 (52 weeks of treatment plus a 30 day follow-up after last dose). The median time on follow-up was 398 & 399 days for UPA/UPA & DUPI/UPA, respectively.
|
0.42%
1/239 • Number of events 1 • All-cause mortality and adverse event tables include treatment-emergent events reported from the time of informed consent to end of study in M19-850 (52 weeks of treatment plus a 30 day follow-up after last dose). The median time on follow-up was 398 & 399 days for UPA/UPA & DUPI/UPA, respectively.
|
0.21%
1/475 • Number of events 1 • All-cause mortality and adverse event tables include treatment-emergent events reported from the time of informed consent to end of study in M19-850 (52 weeks of treatment plus a 30 day follow-up after last dose). The median time on follow-up was 398 & 399 days for UPA/UPA & DUPI/UPA, respectively.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
UTERINE LEIOMYOMA
|
0.00%
0/236 • All-cause mortality and adverse event tables include treatment-emergent events reported from the time of informed consent to end of study in M19-850 (52 weeks of treatment plus a 30 day follow-up after last dose). The median time on follow-up was 398 & 399 days for UPA/UPA & DUPI/UPA, respectively.
|
0.84%
2/239 • Number of events 2 • All-cause mortality and adverse event tables include treatment-emergent events reported from the time of informed consent to end of study in M19-850 (52 weeks of treatment plus a 30 day follow-up after last dose). The median time on follow-up was 398 & 399 days for UPA/UPA & DUPI/UPA, respectively.
|
0.42%
2/475 • Number of events 2 • All-cause mortality and adverse event tables include treatment-emergent events reported from the time of informed consent to end of study in M19-850 (52 weeks of treatment plus a 30 day follow-up after last dose). The median time on follow-up was 398 & 399 days for UPA/UPA & DUPI/UPA, respectively.
|
|
Nervous system disorders
HEADACHE
|
0.00%
0/236 • All-cause mortality and adverse event tables include treatment-emergent events reported from the time of informed consent to end of study in M19-850 (52 weeks of treatment plus a 30 day follow-up after last dose). The median time on follow-up was 398 & 399 days for UPA/UPA & DUPI/UPA, respectively.
|
0.42%
1/239 • Number of events 1 • All-cause mortality and adverse event tables include treatment-emergent events reported from the time of informed consent to end of study in M19-850 (52 weeks of treatment plus a 30 day follow-up after last dose). The median time on follow-up was 398 & 399 days for UPA/UPA & DUPI/UPA, respectively.
|
0.21%
1/475 • Number of events 1 • All-cause mortality and adverse event tables include treatment-emergent events reported from the time of informed consent to end of study in M19-850 (52 weeks of treatment plus a 30 day follow-up after last dose). The median time on follow-up was 398 & 399 days for UPA/UPA & DUPI/UPA, respectively.
|
|
Reproductive system and breast disorders
ADNEXAL TORSION
|
0.00%
0/236 • All-cause mortality and adverse event tables include treatment-emergent events reported from the time of informed consent to end of study in M19-850 (52 weeks of treatment plus a 30 day follow-up after last dose). The median time on follow-up was 398 & 399 days for UPA/UPA & DUPI/UPA, respectively.
|
0.42%
1/239 • Number of events 1 • All-cause mortality and adverse event tables include treatment-emergent events reported from the time of informed consent to end of study in M19-850 (52 weeks of treatment plus a 30 day follow-up after last dose). The median time on follow-up was 398 & 399 days for UPA/UPA & DUPI/UPA, respectively.
|
0.21%
1/475 • Number of events 1 • All-cause mortality and adverse event tables include treatment-emergent events reported from the time of informed consent to end of study in M19-850 (52 weeks of treatment plus a 30 day follow-up after last dose). The median time on follow-up was 398 & 399 days for UPA/UPA & DUPI/UPA, respectively.
|
|
Reproductive system and breast disorders
ENDOMETRIOSIS
|
0.42%
1/236 • Number of events 1 • All-cause mortality and adverse event tables include treatment-emergent events reported from the time of informed consent to end of study in M19-850 (52 weeks of treatment plus a 30 day follow-up after last dose). The median time on follow-up was 398 & 399 days for UPA/UPA & DUPI/UPA, respectively.
|
0.00%
0/239 • All-cause mortality and adverse event tables include treatment-emergent events reported from the time of informed consent to end of study in M19-850 (52 weeks of treatment plus a 30 day follow-up after last dose). The median time on follow-up was 398 & 399 days for UPA/UPA & DUPI/UPA, respectively.
|
0.21%
1/475 • Number of events 1 • All-cause mortality and adverse event tables include treatment-emergent events reported from the time of informed consent to end of study in M19-850 (52 weeks of treatment plus a 30 day follow-up after last dose). The median time on follow-up was 398 & 399 days for UPA/UPA & DUPI/UPA, respectively.
|
|
Skin and subcutaneous tissue disorders
DERMATITIS ATOPIC
|
0.42%
1/236 • Number of events 1 • All-cause mortality and adverse event tables include treatment-emergent events reported from the time of informed consent to end of study in M19-850 (52 weeks of treatment plus a 30 day follow-up after last dose). The median time on follow-up was 398 & 399 days for UPA/UPA & DUPI/UPA, respectively.
|
0.42%
1/239 • Number of events 1 • All-cause mortality and adverse event tables include treatment-emergent events reported from the time of informed consent to end of study in M19-850 (52 weeks of treatment plus a 30 day follow-up after last dose). The median time on follow-up was 398 & 399 days for UPA/UPA & DUPI/UPA, respectively.
|
0.42%
2/475 • Number of events 2 • All-cause mortality and adverse event tables include treatment-emergent events reported from the time of informed consent to end of study in M19-850 (52 weeks of treatment plus a 30 day follow-up after last dose). The median time on follow-up was 398 & 399 days for UPA/UPA & DUPI/UPA, respectively.
|
|
Surgical and medical procedures
ABORTION INDUCED
|
0.42%
1/236 • Number of events 1 • All-cause mortality and adverse event tables include treatment-emergent events reported from the time of informed consent to end of study in M19-850 (52 weeks of treatment plus a 30 day follow-up after last dose). The median time on follow-up was 398 & 399 days for UPA/UPA & DUPI/UPA, respectively.
|
0.00%
0/239 • All-cause mortality and adverse event tables include treatment-emergent events reported from the time of informed consent to end of study in M19-850 (52 weeks of treatment plus a 30 day follow-up after last dose). The median time on follow-up was 398 & 399 days for UPA/UPA & DUPI/UPA, respectively.
|
0.21%
1/475 • Number of events 1 • All-cause mortality and adverse event tables include treatment-emergent events reported from the time of informed consent to end of study in M19-850 (52 weeks of treatment plus a 30 day follow-up after last dose). The median time on follow-up was 398 & 399 days for UPA/UPA & DUPI/UPA, respectively.
|
|
Vascular disorders
ESSENTIAL HYPERTENSION
|
0.42%
1/236 • Number of events 1 • All-cause mortality and adverse event tables include treatment-emergent events reported from the time of informed consent to end of study in M19-850 (52 weeks of treatment plus a 30 day follow-up after last dose). The median time on follow-up was 398 & 399 days for UPA/UPA & DUPI/UPA, respectively.
|
0.00%
0/239 • All-cause mortality and adverse event tables include treatment-emergent events reported from the time of informed consent to end of study in M19-850 (52 weeks of treatment plus a 30 day follow-up after last dose). The median time on follow-up was 398 & 399 days for UPA/UPA & DUPI/UPA, respectively.
|
0.21%
1/475 • Number of events 1 • All-cause mortality and adverse event tables include treatment-emergent events reported from the time of informed consent to end of study in M19-850 (52 weeks of treatment plus a 30 day follow-up after last dose). The median time on follow-up was 398 & 399 days for UPA/UPA & DUPI/UPA, respectively.
|
Other adverse events
| Measure |
UPA 30mg to UPA 30mg
n=236 participants at risk
All participants in this study received upadacitinib 30 mg once a day (QD). Participants were grouped by previous treatment in Lead-In Study M16-046. Participants who received upadacitinib (UPA) in Lead-In Study M16-046 are included in the UPA 30 mg QD/UPA 30 mg QD (UPA/UPA) group.
|
DUPI 300mg to UPA 30mg
n=239 participants at risk
All participants in this study received upadacitinib 30 mg once a day (QD). Participants were grouped by previous treatment in Lead-In Study M16-046. Participants who received dupilumab (DUPI) in Lead-In Study M16-046 are included in the DUPI 300 mg Q2W/UPA 30 mg QD (DUPI/UPA) group.
|
Total
n=475 participants at risk
All participants in this study received upadacitinib 30 mg once a day (QD). Participants were grouped by previous treatment in Lead-In Study M16-046. Participants who received upadacitinib (UPA) in Lead-In Study M16-046 are included in the UPA 30 mg QD/UPA 30 mg QD (UPA/UPA) group and participants who received dupilumab (DUPI) in Lead-In Study M16-046 are included in the DUPI 300 mg Q2W/UPA 30 mg QD (DUPI/UPA) group.
|
|---|---|---|---|
|
Infections and infestations
COVID-19
|
13.1%
31/236 • Number of events 34 • All-cause mortality and adverse event tables include treatment-emergent events reported from the time of informed consent to end of study in M19-850 (52 weeks of treatment plus a 30 day follow-up after last dose). The median time on follow-up was 398 & 399 days for UPA/UPA & DUPI/UPA, respectively.
|
13.4%
32/239 • Number of events 34 • All-cause mortality and adverse event tables include treatment-emergent events reported from the time of informed consent to end of study in M19-850 (52 weeks of treatment plus a 30 day follow-up after last dose). The median time on follow-up was 398 & 399 days for UPA/UPA & DUPI/UPA, respectively.
|
13.3%
63/475 • Number of events 68 • All-cause mortality and adverse event tables include treatment-emergent events reported from the time of informed consent to end of study in M19-850 (52 weeks of treatment plus a 30 day follow-up after last dose). The median time on follow-up was 398 & 399 days for UPA/UPA & DUPI/UPA, respectively.
|
|
Infections and infestations
HERPES SIMPLEX
|
5.1%
12/236 • Number of events 13 • All-cause mortality and adverse event tables include treatment-emergent events reported from the time of informed consent to end of study in M19-850 (52 weeks of treatment plus a 30 day follow-up after last dose). The median time on follow-up was 398 & 399 days for UPA/UPA & DUPI/UPA, respectively.
|
3.3%
8/239 • Number of events 10 • All-cause mortality and adverse event tables include treatment-emergent events reported from the time of informed consent to end of study in M19-850 (52 weeks of treatment plus a 30 day follow-up after last dose). The median time on follow-up was 398 & 399 days for UPA/UPA & DUPI/UPA, respectively.
|
4.2%
20/475 • Number of events 23 • All-cause mortality and adverse event tables include treatment-emergent events reported from the time of informed consent to end of study in M19-850 (52 weeks of treatment plus a 30 day follow-up after last dose). The median time on follow-up was 398 & 399 days for UPA/UPA & DUPI/UPA, respectively.
|
|
Infections and infestations
HERPES ZOSTER
|
8.1%
19/236 • Number of events 20 • All-cause mortality and adverse event tables include treatment-emergent events reported from the time of informed consent to end of study in M19-850 (52 weeks of treatment plus a 30 day follow-up after last dose). The median time on follow-up was 398 & 399 days for UPA/UPA & DUPI/UPA, respectively.
|
10.5%
25/239 • Number of events 25 • All-cause mortality and adverse event tables include treatment-emergent events reported from the time of informed consent to end of study in M19-850 (52 weeks of treatment plus a 30 day follow-up after last dose). The median time on follow-up was 398 & 399 days for UPA/UPA & DUPI/UPA, respectively.
|
9.3%
44/475 • Number of events 45 • All-cause mortality and adverse event tables include treatment-emergent events reported from the time of informed consent to end of study in M19-850 (52 weeks of treatment plus a 30 day follow-up after last dose). The median time on follow-up was 398 & 399 days for UPA/UPA & DUPI/UPA, respectively.
|
|
Infections and infestations
NASOPHARYNGITIS
|
6.4%
15/236 • Number of events 23 • All-cause mortality and adverse event tables include treatment-emergent events reported from the time of informed consent to end of study in M19-850 (52 weeks of treatment plus a 30 day follow-up after last dose). The median time on follow-up was 398 & 399 days for UPA/UPA & DUPI/UPA, respectively.
|
10.9%
26/239 • Number of events 35 • All-cause mortality and adverse event tables include treatment-emergent events reported from the time of informed consent to end of study in M19-850 (52 weeks of treatment plus a 30 day follow-up after last dose). The median time on follow-up was 398 & 399 days for UPA/UPA & DUPI/UPA, respectively.
|
8.6%
41/475 • Number of events 58 • All-cause mortality and adverse event tables include treatment-emergent events reported from the time of informed consent to end of study in M19-850 (52 weeks of treatment plus a 30 day follow-up after last dose). The median time on follow-up was 398 & 399 days for UPA/UPA & DUPI/UPA, respectively.
|
|
Infections and infestations
UPPER RESPIRATORY TRACT INFECTION
|
5.1%
12/236 • Number of events 13 • All-cause mortality and adverse event tables include treatment-emergent events reported from the time of informed consent to end of study in M19-850 (52 weeks of treatment plus a 30 day follow-up after last dose). The median time on follow-up was 398 & 399 days for UPA/UPA & DUPI/UPA, respectively.
|
5.9%
14/239 • Number of events 24 • All-cause mortality and adverse event tables include treatment-emergent events reported from the time of informed consent to end of study in M19-850 (52 weeks of treatment plus a 30 day follow-up after last dose). The median time on follow-up was 398 & 399 days for UPA/UPA & DUPI/UPA, respectively.
|
5.5%
26/475 • Number of events 37 • All-cause mortality and adverse event tables include treatment-emergent events reported from the time of informed consent to end of study in M19-850 (52 weeks of treatment plus a 30 day follow-up after last dose). The median time on follow-up was 398 & 399 days for UPA/UPA & DUPI/UPA, respectively.
|
|
Investigations
BLOOD CREATINE PHOSPHOKINASE INCREASED
|
14.8%
35/236 • Number of events 47 • All-cause mortality and adverse event tables include treatment-emergent events reported from the time of informed consent to end of study in M19-850 (52 weeks of treatment plus a 30 day follow-up after last dose). The median time on follow-up was 398 & 399 days for UPA/UPA & DUPI/UPA, respectively.
|
13.0%
31/239 • Number of events 42 • All-cause mortality and adverse event tables include treatment-emergent events reported from the time of informed consent to end of study in M19-850 (52 weeks of treatment plus a 30 day follow-up after last dose). The median time on follow-up was 398 & 399 days for UPA/UPA & DUPI/UPA, respectively.
|
13.9%
66/475 • Number of events 89 • All-cause mortality and adverse event tables include treatment-emergent events reported from the time of informed consent to end of study in M19-850 (52 weeks of treatment plus a 30 day follow-up after last dose). The median time on follow-up was 398 & 399 days for UPA/UPA & DUPI/UPA, respectively.
|
|
Metabolism and nutrition disorders
HYPERCHOLESTEROLAEMIA
|
5.5%
13/236 • Number of events 14 • All-cause mortality and adverse event tables include treatment-emergent events reported from the time of informed consent to end of study in M19-850 (52 weeks of treatment plus a 30 day follow-up after last dose). The median time on follow-up was 398 & 399 days for UPA/UPA & DUPI/UPA, respectively.
|
0.42%
1/239 • Number of events 1 • All-cause mortality and adverse event tables include treatment-emergent events reported from the time of informed consent to end of study in M19-850 (52 weeks of treatment plus a 30 day follow-up after last dose). The median time on follow-up was 398 & 399 days for UPA/UPA & DUPI/UPA, respectively.
|
2.9%
14/475 • Number of events 15 • All-cause mortality and adverse event tables include treatment-emergent events reported from the time of informed consent to end of study in M19-850 (52 weeks of treatment plus a 30 day follow-up after last dose). The median time on follow-up was 398 & 399 days for UPA/UPA & DUPI/UPA, respectively.
|
|
Nervous system disorders
HEADACHE
|
6.4%
15/236 • Number of events 22 • All-cause mortality and adverse event tables include treatment-emergent events reported from the time of informed consent to end of study in M19-850 (52 weeks of treatment plus a 30 day follow-up after last dose). The median time on follow-up was 398 & 399 days for UPA/UPA & DUPI/UPA, respectively.
|
5.9%
14/239 • Number of events 16 • All-cause mortality and adverse event tables include treatment-emergent events reported from the time of informed consent to end of study in M19-850 (52 weeks of treatment plus a 30 day follow-up after last dose). The median time on follow-up was 398 & 399 days for UPA/UPA & DUPI/UPA, respectively.
|
6.1%
29/475 • Number of events 38 • All-cause mortality and adverse event tables include treatment-emergent events reported from the time of informed consent to end of study in M19-850 (52 weeks of treatment plus a 30 day follow-up after last dose). The median time on follow-up was 398 & 399 days for UPA/UPA & DUPI/UPA, respectively.
|
|
Skin and subcutaneous tissue disorders
ACNE
|
22.9%
54/236 • Number of events 65 • All-cause mortality and adverse event tables include treatment-emergent events reported from the time of informed consent to end of study in M19-850 (52 weeks of treatment plus a 30 day follow-up after last dose). The median time on follow-up was 398 & 399 days for UPA/UPA & DUPI/UPA, respectively.
|
20.5%
49/239 • Number of events 53 • All-cause mortality and adverse event tables include treatment-emergent events reported from the time of informed consent to end of study in M19-850 (52 weeks of treatment plus a 30 day follow-up after last dose). The median time on follow-up was 398 & 399 days for UPA/UPA & DUPI/UPA, respectively.
|
21.7%
103/475 • Number of events 118 • All-cause mortality and adverse event tables include treatment-emergent events reported from the time of informed consent to end of study in M19-850 (52 weeks of treatment plus a 30 day follow-up after last dose). The median time on follow-up was 398 & 399 days for UPA/UPA & DUPI/UPA, respectively.
|
|
Skin and subcutaneous tissue disorders
DERMATITIS ATOPIC
|
19.1%
45/236 • Number of events 61 • All-cause mortality and adverse event tables include treatment-emergent events reported from the time of informed consent to end of study in M19-850 (52 weeks of treatment plus a 30 day follow-up after last dose). The median time on follow-up was 398 & 399 days for UPA/UPA & DUPI/UPA, respectively.
|
12.6%
30/239 • Number of events 48 • All-cause mortality and adverse event tables include treatment-emergent events reported from the time of informed consent to end of study in M19-850 (52 weeks of treatment plus a 30 day follow-up after last dose). The median time on follow-up was 398 & 399 days for UPA/UPA & DUPI/UPA, respectively.
|
15.8%
75/475 • Number of events 109 • All-cause mortality and adverse event tables include treatment-emergent events reported from the time of informed consent to end of study in M19-850 (52 weeks of treatment plus a 30 day follow-up after last dose). The median time on follow-up was 398 & 399 days for UPA/UPA & DUPI/UPA, respectively.
|
|
Skin and subcutaneous tissue disorders
ECZEMA
|
5.9%
14/236 • Number of events 32 • All-cause mortality and adverse event tables include treatment-emergent events reported from the time of informed consent to end of study in M19-850 (52 weeks of treatment plus a 30 day follow-up after last dose). The median time on follow-up was 398 & 399 days for UPA/UPA & DUPI/UPA, respectively.
|
5.4%
13/239 • Number of events 17 • All-cause mortality and adverse event tables include treatment-emergent events reported from the time of informed consent to end of study in M19-850 (52 weeks of treatment plus a 30 day follow-up after last dose). The median time on follow-up was 398 & 399 days for UPA/UPA & DUPI/UPA, respectively.
|
5.7%
27/475 • Number of events 49 • All-cause mortality and adverse event tables include treatment-emergent events reported from the time of informed consent to end of study in M19-850 (52 weeks of treatment plus a 30 day follow-up after last dose). The median time on follow-up was 398 & 399 days for UPA/UPA & DUPI/UPA, respectively.
|
|
Vascular disorders
HYPERTENSION
|
5.9%
14/236 • Number of events 14 • All-cause mortality and adverse event tables include treatment-emergent events reported from the time of informed consent to end of study in M19-850 (52 weeks of treatment plus a 30 day follow-up after last dose). The median time on follow-up was 398 & 399 days for UPA/UPA & DUPI/UPA, respectively.
|
1.7%
4/239 • Number of events 4 • All-cause mortality and adverse event tables include treatment-emergent events reported from the time of informed consent to end of study in M19-850 (52 weeks of treatment plus a 30 day follow-up after last dose). The median time on follow-up was 398 & 399 days for UPA/UPA & DUPI/UPA, respectively.
|
3.8%
18/475 • Number of events 18 • All-cause mortality and adverse event tables include treatment-emergent events reported from the time of informed consent to end of study in M19-850 (52 weeks of treatment plus a 30 day follow-up after last dose). The median time on follow-up was 398 & 399 days for UPA/UPA & DUPI/UPA, respectively.
|
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