Trial Outcomes & Findings for A Study of Baricitinib (LY3009104) in Participants With Systemic Lupus Erythematosus (SLE) (NCT NCT02708095)
NCT ID: NCT02708095
Last Updated: 2018-11-21
Results Overview
Participants were defined as responder as follows using SLEDAI-2K definitions of arthritis and rash. If only arthritis is present at baseline, then arthritis must be absent at Week 24 to meet the primary endpoint. If only rash is present at baseline, then rash must be absent at Week 24 to meet the primary endpoint. If both arthritis and rash are present at baseline, then the primary endpoint is met if either arthritis, or rash, or both arthritis and rash are absent at Week 24.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
314 participants
Primary outcome timeframe
Week 24
Results posted on
2018-11-21
Participant Flow
Participant milestones
| Measure |
Placebo
Participants received Placebo orally once daily (QD) for 24 weeks.
|
2 mg Baricitinib
Participants received 2 (milligrams) mg of Baricitinib tablet orally once a day for 24 weeks.
|
4 mg Baricitinib
Participants received 4 mg of Baricitinib tablet orally once a day for 24 weeks.
|
|---|---|---|---|
|
Overall Study
STARTED
|
105
|
105
|
104
|
|
Overall Study
Received at Least 1 Dose of Study Drug
|
105
|
105
|
104
|
|
Overall Study
COMPLETED
|
83
|
86
|
86
|
|
Overall Study
NOT COMPLETED
|
22
|
19
|
18
|
Reasons for withdrawal
| Measure |
Placebo
Participants received Placebo orally once daily (QD) for 24 weeks.
|
2 mg Baricitinib
Participants received 2 (milligrams) mg of Baricitinib tablet orally once a day for 24 weeks.
|
4 mg Baricitinib
Participants received 4 mg of Baricitinib tablet orally once a day for 24 weeks.
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
4
|
10
|
11
|
|
Overall Study
Lack of Efficacy
|
9
|
3
|
0
|
|
Overall Study
Lost to Follow-up
|
2
|
0
|
0
|
|
Overall Study
Physician Decision
|
2
|
3
|
2
|
|
Overall Study
Protocol Violation
|
0
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
5
|
3
|
4
|
Baseline Characteristics
A Study of Baricitinib (LY3009104) in Participants With Systemic Lupus Erythematosus (SLE)
Baseline characteristics by cohort
| Measure |
4 mg Baricitinib
n=104 Participants
Participants received 4 mg of Baricitinib tablet orally once a day for 24 weeks.
|
Total
n=314 Participants
Total of all reporting groups
|
Placebo
n=105 Participants
Participants received Placebo orally once daily (QD) for 24 weeks.
|
2 mg Baricitinib
n=105 Participants
Participants received 2 mg of Baricitinib tablet orally once a day for 24 weeks.
|
|---|---|---|---|---|
|
Age, Continuous
|
45.0 Years
STANDARD_DEVIATION 12.4 • n=27 Participants
|
44.3 Years
STANDARD_DEVIATION 12.1 • n=483 Participants
|
44.9 Years
STANDARD_DEVIATION 12.8 • n=93 Participants
|
43.2 Years
STANDARD_DEVIATION 11.0 • n=4 Participants
|
|
Sex: Female, Male
Female
|
99 Participants
n=27 Participants
|
294 Participants
n=483 Participants
|
99 Participants
n=93 Participants
|
96 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=27 Participants
|
20 Participants
n=483 Participants
|
6 Participants
n=93 Participants
|
9 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
32 Participants
n=27 Participants
|
102 Participants
n=483 Participants
|
38 Participants
n=93 Participants
|
32 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
60 Participants
n=27 Participants
|
174 Participants
n=483 Participants
|
52 Participants
n=93 Participants
|
62 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
12 Participants
n=27 Participants
|
38 Participants
n=483 Participants
|
15 Participants
n=93 Participants
|
11 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
10 Participants
n=27 Participants
|
25 Participants
n=483 Participants
|
9 Participants
n=93 Participants
|
6 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
20 Participants
n=27 Participants
|
60 Participants
n=483 Participants
|
20 Participants
n=93 Participants
|
20 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
7 Participants
n=27 Participants
|
21 Participants
n=483 Participants
|
5 Participants
n=93 Participants
|
9 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
65 Participants
n=27 Participants
|
204 Participants
n=483 Participants
|
71 Participants
n=93 Participants
|
68 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=27 Participants
|
2 Participants
n=483 Participants
|
0 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=27 Participants
|
2 Participants
n=483 Participants
|
0 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
|
Region of Enrollment
Puerto Rico
|
6 Participants
n=27 Participants
|
17 Participants
n=483 Participants
|
6 Participants
n=93 Participants
|
5 Participants
n=4 Participants
|
|
Region of Enrollment
Argentina
|
7 Participants
n=27 Participants
|
28 Participants
n=483 Participants
|
9 Participants
n=93 Participants
|
12 Participants
n=4 Participants
|
|
Region of Enrollment
Austria
|
3 Participants
n=27 Participants
|
8 Participants
n=483 Participants
|
3 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
|
Region of Enrollment
South Korea
|
3 Participants
n=27 Participants
|
6 Participants
n=483 Participants
|
1 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
|
Region of Enrollment
Romania
|
7 Participants
n=27 Participants
|
13 Participants
n=483 Participants
|
4 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
30 Participants
n=27 Participants
|
95 Participants
n=483 Participants
|
31 Participants
n=93 Participants
|
34 Participants
n=4 Participants
|
|
Region of Enrollment
Japan
|
10 Participants
n=27 Participants
|
33 Participants
n=483 Participants
|
13 Participants
n=93 Participants
|
10 Participants
n=4 Participants
|
|
Region of Enrollment
Taiwan
|
5 Participants
n=27 Participants
|
18 Participants
n=483 Participants
|
6 Participants
n=93 Participants
|
7 Participants
n=4 Participants
|
|
Region of Enrollment
Poland
|
9 Participants
n=27 Participants
|
32 Participants
n=483 Participants
|
13 Participants
n=93 Participants
|
10 Participants
n=4 Participants
|
|
Region of Enrollment
Mexico
|
14 Participants
n=27 Participants
|
33 Participants
n=483 Participants
|
11 Participants
n=93 Participants
|
8 Participants
n=4 Participants
|
|
Region of Enrollment
France
|
7 Participants
n=27 Participants
|
16 Participants
n=483 Participants
|
2 Participants
n=93 Participants
|
7 Participants
n=4 Participants
|
|
Region of Enrollment
Spain
|
3 Participants
n=27 Participants
|
15 Participants
n=483 Participants
|
6 Participants
n=93 Participants
|
6 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Week 24Population: All randomized participants who received at least 1 dose of study drug with baseline and post-baseline values at the specified time point for remission of arthritis and/or rash.
Participants were defined as responder as follows using SLEDAI-2K definitions of arthritis and rash. If only arthritis is present at baseline, then arthritis must be absent at Week 24 to meet the primary endpoint. If only rash is present at baseline, then rash must be absent at Week 24 to meet the primary endpoint. If both arthritis and rash are present at baseline, then the primary endpoint is met if either arthritis, or rash, or both arthritis and rash are absent at Week 24.
Outcome measures
| Measure |
Placebo
n=105 Participants
Participants received Placebo orally once daily (QD) for 24 weeks.
|
2 mg Baricitinib
n=105 Participants
Participants received 2 mg of Baricitinib tablet orally once a day for 24 weeks.
|
4 mg Baricitinib
n=104 Participants
Participants received 4 mg of Baricitinib tablet orally once a day for 24 weeks.
|
|---|---|---|---|
|
Percentage of Participants Who Achieve Remission of Arthritis and/or Rash Defined by the Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K)
|
53.3 Percentage of Participants
|
58.1 Percentage of Participants
|
67.3 Percentage of Participants
|
SECONDARY outcome
Timeframe: Week 24Population: All randomized participants who received at least 1 dose of study drug with baseline and post-baseline values at the specified time point for SRI-4 response.
SRI-4 response is defined as: 1) Reduction of ≥4 points from baseline in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) score; 2) no new British Isles Lupus Assessment Group (BILAG) A or no more than 1 new BILAG B disease activity scores; and 3) no worsening (defined as an increase of ≥0.3 points \[10 mm\] from baseline) in Physician's Global Assessment of Disease Activity. The SRI-4 is a composite index used to assess disease activity in SLE. SLEDAI-2K assessment consists of 24 items with total score of 0 to 105, with higher scores representing increased disease activity. BILAG Index: assessing clinical signs, symptoms, or laboratory parameters related to SLE, divided into 9 organ systems. For each organ system: A=severe disease, B=moderate disease, C=mild stable disease, D=inactive, but previously active, E=inactive and never affected. PGA is a visual analog scale scored from 0 to 3 (0=none, 1=mild, 2=moderate, 3=severe).
Outcome measures
| Measure |
Placebo
n=105 Participants
Participants received Placebo orally once daily (QD) for 24 weeks.
|
2 mg Baricitinib
n=105 Participants
Participants received 2 mg of Baricitinib tablet orally once a day for 24 weeks.
|
4 mg Baricitinib
n=104 Participants
Participants received 4 mg of Baricitinib tablet orally once a day for 24 weeks.
|
|---|---|---|---|
|
Percentage of Participants Who Achieve SLE Responder Index 4 (SRI-4) Response
|
47.6 Percentage of Participants
|
51.4 Percentage of Participants
|
64.4 Percentage of Participants
|
SECONDARY outcome
Timeframe: Baseline, Week 24Population: All randomized participants who received at least 1 dose of study drug with baseline and post-baseline values at the specified time point for SLEDAI-2K.
SLE Disease Activity Index 2000 (SLEDAI-2K) score is a weighted, cumulative index of lupus disease activity. SLEDAI-2K is calculated from 24 individual descriptors across 9 organ systems; 0 indicates inactive disease and the maximum theoretical score is 105. Least Squares (LS) mean was determined by mixed-model repeated measures (MMRM) model with baseline of response, region, baseline disease activity (SLEDAI-2K \<10, \>=10), baseline anti-dsDNA status (positive, negative), treatment, time, treatment\*time (type III sum of squares).
Outcome measures
| Measure |
Placebo
n=86 Participants
Participants received Placebo orally once daily (QD) for 24 weeks.
|
2 mg Baricitinib
n=88 Participants
Participants received 2 mg of Baricitinib tablet orally once a day for 24 weeks.
|
4 mg Baricitinib
n=86 Participants
Participants received 4 mg of Baricitinib tablet orally once a day for 24 weeks.
|
|---|---|---|---|
|
Change From Baseline in SLEDAI-2K Score
|
-3.82 Units on a scale
Standard Error 0.352
|
-4.07 Units on a scale
Standard Error 0.356
|
-4.39 Units on a scale
Standard Error 0.353
|
SECONDARY outcome
Timeframe: Baseline, Week 24Population: All randomized participants who received at least 1 dose of study drug with baseline and post-baseline values at the specified time point for Patient's Global Assessment of Disease Activity.
The Patient's Global Assessment of Disease Activity is a single-item, patient reported scale developed for the assessment of the patient's overall rating of their disease activity due to SLE. The scale measures disease activity through a 5 point Likert scale ranging from 0 ("No disease activity") to 4 ("Severe disease activity") at its worst over the past 7 days. LS mean was determined by MMRM model with baseline of response, region, baseline disease activity (SLEDAI-2K \<10, \>=10), baseline anti-dsDNA status (positive, negative), treatment, time, treatment\*time (type III sum of squares).
Outcome measures
| Measure |
Placebo
n=84 Participants
Participants received Placebo orally once daily (QD) for 24 weeks.
|
2 mg Baricitinib
n=86 Participants
Participants received 2 mg of Baricitinib tablet orally once a day for 24 weeks.
|
4 mg Baricitinib
n=86 Participants
Participants received 4 mg of Baricitinib tablet orally once a day for 24 weeks.
|
|---|---|---|---|
|
Change From Baseline in Patient's Global Assessment of Disease Activity
|
-0.67 Units on a scale
Standard Error 0.105
|
-0.83 Units on a scale
Standard Error 0.107
|
-1.00 Units on a scale
Standard Error 0.105
|
SECONDARY outcome
Timeframe: Week (Wk) 0: 15-30 minutes (min) postdose; Wk 4: Predose, 1.5 - 4 hour (hr) postdose; Wk 8: 1 - 3 hr postdose; Wk 16: PredosePopulation: All randomized participants who received at least one dose of study drug and had evaluable PK (pharmacokinetics) data.
Plasma samples for pharmacokinetic (PK) analysis were obtained in week 0, week 4, week 8, week 16 and 24. AUC takes all time points post dose into account and one value is reported.
Outcome measures
| Measure |
Placebo
n=104 Participants
Participants received Placebo orally once daily (QD) for 24 weeks.
|
2 mg Baricitinib
n=104 Participants
Participants received 2 mg of Baricitinib tablet orally once a day for 24 weeks.
|
4 mg Baricitinib
Participants received 4 mg of Baricitinib tablet orally once a day for 24 weeks.
|
|---|---|---|---|
|
Population Pharmacokinetics (PK): Area Under the Concentration-Time Curve of Baricitinib at Steady State (AUCτ, ss)
|
265 nanogram*hour per milliliter (ng*h/mL)
Geometric Coefficient of Variation 55
|
569 nanogram*hour per milliliter (ng*h/mL)
Geometric Coefficient of Variation 50
|
—
|
SECONDARY outcome
Timeframe: Week (Wk) 0: 15-30 minutes (min) postdose; Wk 4: Predose, 1.5 - 4 hour (hr) postdose; Wk 8: 1 - 3 hr postdose; Wk 16: PredosePopulation: All randomized participants who received at least one dose of study drug and had evaluable PK (pharmacokinetics) data.
Plasma samples for pharmacokinetic (PK) analysis were obtained in week 0, week 4, week 8, week 16 and 24. Cmax takes all time points post dose into account and one value is reported.
Outcome measures
| Measure |
Placebo
n=104 Participants
Participants received Placebo orally once daily (QD) for 24 weeks.
|
2 mg Baricitinib
n=104 Participants
Participants received 2 mg of Baricitinib tablet orally once a day for 24 weeks.
|
4 mg Baricitinib
Participants received 4 mg of Baricitinib tablet orally once a day for 24 weeks.
|
|---|---|---|---|
|
Population Pharmacokinetics (PK): Maximum Observed Drug Concentration at Steady State (Cmax,ss)
|
29.0 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 30
|
59.2 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 24
|
—
|
Adverse Events
Placebo
Serious events: 5 serious events
Other events: 27 other events
Deaths: 0 deaths
2 mg Baricitinib
Serious events: 11 serious events
Other events: 36 other events
Deaths: 0 deaths
4 mg Baricitinib
Serious events: 10 serious events
Other events: 32 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=105 participants at risk
Participants received Placebo orally once daily (QD) for 24 weeks.
|
2 mg Baricitinib
n=105 participants at risk
Participants received 2 mg of Baricitinib tablet orally once a day for 24 weeks.
|
4 mg Baricitinib
n=104 participants at risk
Participants received 4 mg of Baricitinib tablet orally once a day for 24 weeks.
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.00%
0/105 • Up to 32 weeks
All randomized participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.95%
1/105 • Number of events 1 • Up to 32 weeks
All randomized participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/104 • Up to 32 weeks
All randomized participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/105 • Up to 32 weeks
All randomized participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.95%
1/105 • Number of events 1 • Up to 32 weeks
All randomized participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/104 • Up to 32 weeks
All randomized participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/105 • Up to 32 weeks
All randomized participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/105 • Up to 32 weeks
All randomized participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.96%
1/104 • Number of events 1 • Up to 32 weeks
All randomized participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Gastrointestinal disorders
Gastric ulcer
|
0.00%
0/105 • Up to 32 weeks
All randomized participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/105 • Up to 32 weeks
All randomized participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.96%
1/104 • Number of events 1 • Up to 32 weeks
All randomized participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Gastrointestinal disorders
Intestinal perforation
|
0.00%
0/105 • Up to 32 weeks
All randomized participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/105 • Up to 32 weeks
All randomized participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.96%
1/104 • Number of events 1 • Up to 32 weeks
All randomized participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/105 • Up to 32 weeks
All randomized participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/105 • Up to 32 weeks
All randomized participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.96%
1/104 • Number of events 1 • Up to 32 weeks
All randomized participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Gastrointestinal disorders
Umbilical hernia
|
0.95%
1/105 • Number of events 1 • Up to 32 weeks
All randomized participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/105 • Up to 32 weeks
All randomized participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/104 • Up to 32 weeks
All randomized participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Gastrointestinal disorders
Volvulus
|
0.00%
0/105 • Up to 32 weeks
All randomized participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.95%
1/105 • Number of events 1 • Up to 32 weeks
All randomized participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/104 • Up to 32 weeks
All randomized participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Infections and infestations
Appendicitis
|
0.00%
0/105 • Up to 32 weeks
All randomized participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/105 • Up to 32 weeks
All randomized participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.96%
1/104 • Number of events 1 • Up to 32 weeks
All randomized participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Infections and infestations
Cellulitis
|
0.95%
1/105 • Number of events 1 • Up to 32 weeks
All randomized participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/105 • Up to 32 weeks
All randomized participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/104 • Up to 32 weeks
All randomized participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Infections and infestations
Diverticulitis
|
0.00%
0/105 • Up to 32 weeks
All randomized participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/105 • Up to 32 weeks
All randomized participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.96%
1/104 • Number of events 1 • Up to 32 weeks
All randomized participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Infections and infestations
Influenza
|
0.00%
0/105 • Up to 32 weeks
All randomized participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/105 • Up to 32 weeks
All randomized participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.96%
1/104 • Number of events 1 • Up to 32 weeks
All randomized participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/105 • Up to 32 weeks
All randomized participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.95%
1/105 • Number of events 1 • Up to 32 weeks
All randomized participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
1.9%
2/104 • Number of events 2 • Up to 32 weeks
All randomized participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Infections and infestations
Tooth abscess
|
0.95%
1/105 • Number of events 1 • Up to 32 weeks
All randomized participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/105 • Up to 32 weeks
All randomized participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/104 • Up to 32 weeks
All randomized participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/105 • Up to 32 weeks
All randomized participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.95%
1/105 • Number of events 1 • Up to 32 weeks
All randomized participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.96%
1/104 • Number of events 1 • Up to 32 weeks
All randomized participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.95%
1/105 • Number of events 1 • Up to 32 weeks
All randomized participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/105 • Up to 32 weeks
All randomized participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/104 • Up to 32 weeks
All randomized participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Joint dislocation
|
0.00%
0/105 • Up to 32 weeks
All randomized participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.95%
1/105 • Number of events 1 • Up to 32 weeks
All randomized participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/104 • Up to 32 weeks
All randomized participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Tibia fracture
|
0.95%
1/105 • Number of events 1 • Up to 32 weeks
All randomized participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/105 • Up to 32 weeks
All randomized participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.96%
1/104 • Number of events 1 • Up to 32 weeks
All randomized participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Investigations
Lipase increased
|
0.00%
0/105 • Up to 32 weeks
All randomized participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/105 • Up to 32 weeks
All randomized participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.96%
1/104 • Number of events 1 • Up to 32 weeks
All randomized participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Osteonecrosis
|
0.00%
0/105 • Up to 32 weeks
All randomized participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/105 • Up to 32 weeks
All randomized participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.96%
1/104 • Number of events 1 • Up to 32 weeks
All randomized participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/105 • Up to 32 weeks
All randomized participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/105 • Up to 32 weeks
All randomized participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.96%
1/104 • Number of events 1 • Up to 32 weeks
All randomized participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Nervous system disorders
Migraine
|
0.00%
0/105 • Up to 32 weeks
All randomized participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.95%
1/105 • Number of events 1 • Up to 32 weeks
All randomized participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/104 • Up to 32 weeks
All randomized participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Nervous system disorders
Syncope
|
0.00%
0/105 • Up to 32 weeks
All randomized participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.95%
1/105 • Number of events 1 • Up to 32 weeks
All randomized participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/104 • Up to 32 weeks
All randomized participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Pregnancy, puerperium and perinatal conditions
Abortion
|
0.00%
0/99 • Up to 32 weeks
All randomized participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
1.0%
1/96 • Number of events 1 • Up to 32 weeks
All randomized participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/99 • Up to 32 weeks
All randomized participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/105 • Up to 32 weeks
All randomized participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.95%
1/105 • Number of events 1 • Up to 32 weeks
All randomized participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/104 • Up to 32 weeks
All randomized participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Psychiatric disorders
Depression
|
0.00%
0/105 • Up to 32 weeks
All randomized participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/105 • Up to 32 weeks
All randomized participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
1.9%
2/104 • Number of events 2 • Up to 32 weeks
All randomized participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Psychiatric disorders
Mental status changes
|
0.00%
0/105 • Up to 32 weeks
All randomized participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.95%
1/105 • Number of events 1 • Up to 32 weeks
All randomized participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/104 • Up to 32 weeks
All randomized participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/105 • Up to 32 weeks
All randomized participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/105 • Up to 32 weeks
All randomized participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.96%
1/104 • Number of events 1 • Up to 32 weeks
All randomized participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Renal and urinary disorders
Lupus nephritis
|
0.95%
1/105 • Number of events 1 • Up to 32 weeks
All randomized participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/105 • Up to 32 weeks
All randomized participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/104 • Up to 32 weeks
All randomized participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Reproductive system and breast disorders
Cervical dysplasia
|
0.00%
0/99 • Up to 32 weeks
All randomized participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
1.0%
1/96 • Number of events 1 • Up to 32 weeks
All randomized participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/99 • Up to 32 weeks
All randomized participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/105 • Up to 32 weeks
All randomized participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/105 • Up to 32 weeks
All randomized participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.96%
1/104 • Number of events 1 • Up to 32 weeks
All randomized participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Vascular disorders
Hypertension
|
0.00%
0/105 • Up to 32 weeks
All randomized participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.95%
1/105 • Number of events 1 • Up to 32 weeks
All randomized participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/104 • Up to 32 weeks
All randomized participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
Other adverse events
| Measure |
Placebo
n=105 participants at risk
Participants received Placebo orally once daily (QD) for 24 weeks.
|
2 mg Baricitinib
n=105 participants at risk
Participants received 2 mg of Baricitinib tablet orally once a day for 24 weeks.
|
4 mg Baricitinib
n=104 participants at risk
Participants received 4 mg of Baricitinib tablet orally once a day for 24 weeks.
|
|---|---|---|---|
|
Infections and infestations
Pharyngitis
|
2.9%
3/105 • Number of events 3 • Up to 32 weeks
All randomized participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
5.7%
6/105 • Number of events 6 • Up to 32 weeks
All randomized participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
4.8%
5/104 • Number of events 5 • Up to 32 weeks
All randomized participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Infections and infestations
Upper respiratory tract infection
|
5.7%
6/105 • Number of events 6 • Up to 32 weeks
All randomized participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
6.7%
7/105 • Number of events 7 • Up to 32 weeks
All randomized participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
7.7%
8/104 • Number of events 8 • Up to 32 weeks
All randomized participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Infections and infestations
Urinary tract infection
|
10.5%
11/105 • Number of events 15 • Up to 32 weeks
All randomized participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
9.5%
10/105 • Number of events 12 • Up to 32 weeks
All randomized participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
8.7%
9/104 • Number of events 15 • Up to 32 weeks
All randomized participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Infections and infestations
Viral upper respiratory tract infection
|
3.8%
4/105 • Number of events 5 • Up to 32 weeks
All randomized participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
9.5%
10/105 • Number of events 13 • Up to 32 weeks
All randomized participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
9.6%
10/104 • Number of events 12 • Up to 32 weeks
All randomized participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Nervous system disorders
Headache
|
2.9%
3/105 • Number of events 3 • Up to 32 weeks
All randomized participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
5.7%
6/105 • Number of events 8 • Up to 32 weeks
All randomized participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
2.9%
3/104 • Number of events 4 • Up to 32 weeks
All randomized participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60