Trial Outcomes & Findings for An Extension Study in Participants With Moderate to Severe Rheumatoid Arthritis (NCT NCT01885078)

Last Updated: 2022-04-25

Results Overview

An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. An AE can be any unfavorable and unintended sign (i.e., abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. Non-serious AEs are reported at a threshold of 5%. An SAE is an AE from this study that results in any of the following: death, initial or prolonged inpatient hospitalization, a life-threatening experience, persistent or significant disability/incapacity, congenital anomaly/birth defect, considered significant by the investigator for any other reason A summary of serious adverse events (SAEs) and other non-serious adverse events (AEs), regardless of causality, were reported in the Reported Adverse Events module.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

2877 participants

Primary outcome timeframe

Baseline through 84 Months

Results posted on

2022-04-25

Participant Flow

Participants were eligible to participate in the Step-down period if they achieved a sustained (at least 3 months in JADY) low disease activity (CDAI score ≤10; for participants originating in Studies JADV, JADX, JADW, and JAGS) or sustained remission (CDAI score ≤2.8; for participants originating in Study JADZ). Eligible participants were randomized to 4 mg or 2 mg baricitinib once daily to evaluate if treatment with 2 mg maintains the low disease activity achieved with 4 mg baricitinib.

Participants who completed an originating study: I4V-MC-JADZ (NCT01711359), I4V-MC-JADV (NCT017103580, I4V-MC-JADX (NCT01721057), I4V-MC-JADW (NCT01721044), I4V-MC-JADA (NCT01185353), or I4V-MC-JAGS (NCT02265705) were eligible for enrollment into study JADY.

Participant milestones

Participant milestones
Measure	JADZ 4 Milligram (mg) Baricitinib 4 mg Baricitinib administered orally once daily.	JADV 4 mg Baricitinib 4 mg Baricitinib administered orally once daily.	JADX 2 mg Baricitinib 2 mg Baricitinib administered orally once daily.	JADX 4 mg Baricitinib 4 mg Baricitinib administered orally once daily.	JADW 2 mg Baricitinib 2 mg Baricitinib administered orally once daily.	JADW 4 mg Baricitinib 4 mg Baricitinib administered orally once daily.	JAGS 4 mg Baricitinib 4 mg Baricitinib administered orally once daily.	JADA 4 mg Baricitinib 4 mg Baricitinib administered orally once daily.	2 mg Baricitinib Step-down 2 mg Baricitinib administered orally once daily in the 96-week Step-down period.	4 mg Baricitinib Step-down 4 mg Baricitinib administered orally once daily in the 96-week Step-down period.
Treatment Period STARTED	451	1091	180	403	117	331	221	83	0	0
Treatment Period Received at Least Once Dose of Study Drug	451	1090	180	403	117	331	221	83	0	0
Treatment Period COMPLETED	19	64	49	120	27	81	0	55	0	0
Treatment Period NOT COMPLETED	432	1027	131	283	90	250	221	28	0	0
Step-down Period STARTED	0	0	0	0	0	0	0	0	592	594
Step-down Period Complete Through Week 96	0	0	0	0	0	0	0	0	407	455
Step-down Period COMPLETED	0	0	0	0	0	0	0	0	523	533
Step-down Period NOT COMPLETED	0	0	0	0	0	0	0	0	69	61

Reasons for withdrawal

Reasons for withdrawal
Measure	JADZ 4 Milligram (mg) Baricitinib 4 mg Baricitinib administered orally once daily.	JADV 4 mg Baricitinib 4 mg Baricitinib administered orally once daily.	JADX 2 mg Baricitinib 2 mg Baricitinib administered orally once daily.	JADX 4 mg Baricitinib 4 mg Baricitinib administered orally once daily.	JADW 2 mg Baricitinib 2 mg Baricitinib administered orally once daily.	JADW 4 mg Baricitinib 4 mg Baricitinib administered orally once daily.	JAGS 4 mg Baricitinib 4 mg Baricitinib administered orally once daily.	JADA 4 mg Baricitinib 4 mg Baricitinib administered orally once daily.	2 mg Baricitinib Step-down 2 mg Baricitinib administered orally once daily in the 96-week Step-down period.	4 mg Baricitinib Step-down 4 mg Baricitinib administered orally once daily in the 96-week Step-down period.
Treatment Period Adverse Event	52	136	30	73	17	72	24	5	0	0
Treatment Period Death	13	33	5	9	2	10	3	2	0	0
Treatment Period Lack of Efficacy	12	33	10	23	24	58	9	5	0	0
Treatment Period Lost to Follow-up	16	19	7	9	2	8	2	0	0	0
Treatment Period Physician Decision	19	21	5	12	9	24	4	3	0	0
Treatment Period Protocol Violation	3	5	0	3	1	6	0	0	0	0
Treatment Period Sponsor Decision	245	648	49	90	20	38	162	3	0	0
Treatment Period Withdrawal by Subject	72	132	25	63	15	34	17	10	0	0
Treatment Period Other	0	0	0	1	0	0	0	0	0	0
Step-down Period Sponsor Decision	0	0	0	0	0	0	0	0	1	1
Step-down Period Adverse Event	0	0	0	0	0	0	0	0	29	38
Step-down Period Withdrawal by Subject	0	0	0	0	0	0	0	0	25	15
Step-down Period Physician Decision	0	0	0	0	0	0	0	0	7	2
Step-down Period Death	0	0	0	0	0	0	0	0	4	3
Step-down Period Lost to Follow-up	0	0	0	0	0	0	0	0	1	1
Step-down Period Lack of Efficacy	0	0	0	0	0	0	0	0	1	0
Step-down Period Protocol Violation	0	0	0	0	0	0	0	0	1	1

Baseline Characteristics

An Extension Study in Participants With Moderate to Severe Rheumatoid Arthritis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	JADZ 4 mg Baricitinib n=451 Participants 4 mg Baricitinib administered orally once daily.	JADV 4 mg Baricitinib n=1090 Participants 4 mg Baricitinib administered orally once daily.	JADX 2 mg Baricitinib n=180 Participants 2 mg Baricitinib administered orally once daily.	JADX 4 mg Baricitinib n=403 Participants 4 mg Baricitinib administered orally once daily.	JADW 2 mg Baricitinib n=117 Participants 2 mg Baricitinib administered orally once daily.	JADW 4 mg Baricitinib n=331 Participants 4 mg Baricitinib administered orally once daily.	JAGS 4 mg Baricitinib n=221 Participants 4 mg Baricitinib administered orally once daily.	JADA 4 mg Baricitinib n=83 Participants 4 mg Baricitinib administered orally once daily.	Total n=2876 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants	0 Participants n=6 Participants	0 Participants n=6 Participants
Age, Categorical Between 18 and 65 years	386 Participants n=5 Participants	881 Participants n=7 Participants	150 Participants n=5 Participants	335 Participants n=4 Participants	86 Participants n=21 Participants	253 Participants n=10 Participants	199 Participants n=115 Participants	68 Participants n=6 Participants	2358 Participants n=6 Participants
Age, Categorical >=65 years	65 Participants n=5 Participants	209 Participants n=7 Participants	30 Participants n=5 Participants	68 Participants n=4 Participants	31 Participants n=21 Participants	78 Participants n=10 Participants	22 Participants n=115 Participants	15 Participants n=6 Participants	518 Participants n=6 Participants
Sex: Female, Male Female	326 Participants n=5 Participants	847 Participants n=7 Participants	144 Participants n=5 Participants	335 Participants n=4 Participants	87 Participants n=21 Participants	275 Participants n=10 Participants	177 Participants n=115 Participants	71 Participants n=6 Participants	2262 Participants n=6 Participants
Sex: Female, Male Male	125 Participants n=5 Participants	243 Participants n=7 Participants	36 Participants n=5 Participants	68 Participants n=4 Participants	30 Participants n=21 Participants	56 Participants n=10 Participants	44 Participants n=115 Participants	12 Participants n=6 Participants	614 Participants n=6 Participants
Race (NIH/OMB) American Indian or Alaska Native	35 Participants n=5 Participants	56 Participants n=7 Participants	1 Participants n=5 Participants	12 Participants n=4 Participants	6 Participants n=21 Participants	21 Participants n=10 Participants	6 Participants n=115 Participants	6 Participants n=6 Participants	143 Participants n=6 Participants
Race (NIH/OMB) Asian	122 Participants n=5 Participants	321 Participants n=7 Participants	50 Participants n=5 Participants	94 Participants n=4 Participants	6 Participants n=21 Participants	19 Participants n=10 Participants	167 Participants n=115 Participants	2 Participants n=6 Participants	781 Participants n=6 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants	0 Participants n=6 Participants	1 Participants n=6 Participants
Race (NIH/OMB) Black or African American	17 Participants n=5 Participants	4 Participants n=7 Participants	9 Participants n=5 Participants	10 Participants n=4 Participants	7 Participants n=21 Participants	12 Participants n=10 Participants	3 Participants n=115 Participants	2 Participants n=6 Participants	64 Participants n=6 Participants
Race (NIH/OMB) White	275 Participants n=5 Participants	691 Participants n=7 Participants	119 Participants n=5 Participants	283 Participants n=4 Participants	98 Participants n=21 Participants	275 Participants n=10 Participants	45 Participants n=115 Participants	73 Participants n=6 Participants	1859 Participants n=6 Participants
Race (NIH/OMB) More than one race	2 Participants n=5 Participants	17 Participants n=7 Participants	1 Participants n=5 Participants	2 Participants n=4 Participants	0 Participants n=21 Participants	1 Participants n=10 Participants	0 Participants n=115 Participants	0 Participants n=6 Participants	23 Participants n=6 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	0 Participants n=21 Participants	3 Participants n=10 Participants	0 Participants n=115 Participants	0 Participants n=6 Participants	5 Participants n=6 Participants
Region of Enrollment United States	68 Participants n=5 Participants	64 Participants n=7 Participants	39 Participants n=5 Participants	103 Participants n=4 Participants	52 Participants n=21 Participants	136 Participants n=10 Participants	0 Participants n=115 Participants	26 Participants n=6 Participants	488 Participants n=6 Participants
Region of Enrollment Czechia	0 Participants n=5 Participants	29 Participants n=7 Participants	3 Participants n=5 Participants	10 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants	14 Participants n=6 Participants	56 Participants n=6 Participants
Region of Enrollment Portugal	3 Participants n=5 Participants	3 Participants n=7 Participants	2 Participants n=5 Participants	3 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants	0 Participants n=6 Participants	11 Participants n=6 Participants
Region of Enrollment Russia	35 Participants n=5 Participants	70 Participants n=7 Participants	10 Participants n=5 Participants	7 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants	0 Participants n=6 Participants	122 Participants n=6 Participants
Region of Enrollment Greece	0 Participants n=5 Participants	2 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	2 Participants n=21 Participants	4 Participants n=10 Participants	0 Participants n=115 Participants	0 Participants n=6 Participants	8 Participants n=6 Participants
Region of Enrollment South Korea	6 Participants n=5 Participants	43 Participants n=7 Participants	6 Participants n=5 Participants	8 Participants n=4 Participants	3 Participants n=21 Participants	6 Participants n=10 Participants	0 Participants n=115 Participants	0 Participants n=6 Participants	72 Participants n=6 Participants
Region of Enrollment Latvia	0 Participants n=5 Participants	8 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants	0 Participants n=6 Participants	8 Participants n=6 Participants
Region of Enrollment Sweden	3 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants	0 Participants n=6 Participants	3 Participants n=6 Participants
Region of Enrollment Austria	2 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	3 Participants n=21 Participants	12 Participants n=10 Participants	0 Participants n=115 Participants	0 Participants n=6 Participants	17 Participants n=6 Participants
Region of Enrollment Netherlands	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants	0 Participants n=6 Participants	1 Participants n=6 Participants
Region of Enrollment China	0 Participants n=5 Participants	41 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	167 Participants n=115 Participants	0 Participants n=6 Participants	208 Participants n=6 Participants
Region of Enrollment Poland	0 Participants n=5 Participants	66 Participants n=7 Participants	11 Participants n=5 Participants	37 Participants n=4 Participants	9 Participants n=21 Participants	22 Participants n=10 Participants	0 Participants n=115 Participants	11 Participants n=6 Participants	156 Participants n=6 Participants
Region of Enrollment Brazil	16 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	14 Participants n=115 Participants	0 Participants n=6 Participants	30 Participants n=6 Participants
Region of Enrollment Slovenia	0 Participants n=5 Participants	5 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants	0 Participants n=6 Participants	5 Participants n=6 Participants
Region of Enrollment Slovakia	0 Participants n=5 Participants	17 Participants n=7 Participants	3 Participants n=5 Participants	7 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants	0 Participants n=6 Participants	27 Participants n=6 Participants
Region of Enrollment France	0 Participants n=5 Participants	16 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	6 Participants n=21 Participants	14 Participants n=10 Participants	0 Participants n=115 Participants	0 Participants n=6 Participants	36 Participants n=6 Participants
Region of Enrollment Lithuania	0 Participants n=5 Participants	21 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants	0 Participants n=6 Participants	21 Participants n=6 Participants
Region of Enrollment Croatia	0 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants	1 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants	6 Participants n=6 Participants	9 Participants n=6 Participants
Region of Enrollment Argentina	87 Participants n=5 Participants	226 Participants n=7 Participants	15 Participants n=5 Participants	44 Participants n=4 Participants	3 Participants n=21 Participants	15 Participants n=10 Participants	40 Participants n=115 Participants	0 Participants n=6 Participants	430 Participants n=6 Participants
Region of Enrollment Romania	0 Participants n=5 Participants	14 Participants n=7 Participants	2 Participants n=5 Participants	2 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants	3 Participants n=6 Participants	21 Participants n=6 Participants
Region of Enrollment Hungary	0 Participants n=5 Participants	30 Participants n=7 Participants	8 Participants n=5 Participants	11 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants	11 Participants n=6 Participants	60 Participants n=6 Participants
Region of Enrollment Japan	82 Participants n=5 Participants	215 Participants n=7 Participants	4 Participants n=5 Participants	13 Participants n=4 Participants	3 Participants n=21 Participants	11 Participants n=10 Participants	0 Participants n=115 Participants	0 Participants n=6 Participants	328 Participants n=6 Participants
Region of Enrollment United Kingdom	10 Participants n=5 Participants	8 Participants n=7 Participants	3 Participants n=5 Participants	1 Participants n=4 Participants	1 Participants n=21 Participants	3 Participants n=10 Participants	0 Participants n=115 Participants	0 Participants n=6 Participants	26 Participants n=6 Participants
Region of Enrollment Switzerland	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	7 Participants n=10 Participants	0 Participants n=115 Participants	0 Participants n=6 Participants	7 Participants n=6 Participants
Region of Enrollment India	28 Participants n=5 Participants	0 Participants n=7 Participants	16 Participants n=5 Participants	27 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants	0 Participants n=6 Participants	71 Participants n=6 Participants
Region of Enrollment Spain	0 Participants n=5 Participants	28 Participants n=7 Participants	9 Participants n=5 Participants	24 Participants n=4 Participants	6 Participants n=21 Participants	19 Participants n=10 Participants	0 Participants n=115 Participants	0 Participants n=6 Participants	86 Participants n=6 Participants
Region of Enrollment Canada	13 Participants n=5 Participants	8 Participants n=7 Participants	8 Participants n=5 Participants	13 Participants n=4 Participants	3 Participants n=21 Participants	2 Participants n=10 Participants	0 Participants n=115 Participants	0 Participants n=6 Participants	47 Participants n=6 Participants
Region of Enrollment Turkey	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants	2 Participants n=10 Participants	0 Participants n=115 Participants	0 Participants n=6 Participants	3 Participants n=6 Participants
Region of Enrollment Belgium	20 Participants n=5 Participants	7 Participants n=7 Participants	3 Participants n=5 Participants	8 Participants n=4 Participants	0 Participants n=21 Participants	3 Participants n=10 Participants	0 Participants n=115 Participants	0 Participants n=6 Participants	41 Participants n=6 Participants
Region of Enrollment Taiwan	0 Participants n=5 Participants	12 Participants n=7 Participants	23 Participants n=5 Participants	46 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants	0 Participants n=6 Participants	81 Participants n=6 Participants
Region of Enrollment Denmark	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	2 Participants n=21 Participants	3 Participants n=10 Participants	0 Participants n=115 Participants	0 Participants n=6 Participants	5 Participants n=6 Participants
Region of Enrollment South Africa	16 Participants n=5 Participants	40 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants	0 Participants n=6 Participants	56 Participants n=6 Participants
Region of Enrollment Italy	12 Participants n=5 Participants	0 Participants n=7 Participants	3 Participants n=5 Participants	6 Participants n=4 Participants	3 Participants n=21 Participants	3 Participants n=10 Participants	0 Participants n=115 Participants	0 Participants n=6 Participants	27 Participants n=6 Participants
Region of Enrollment Mexico	39 Participants n=5 Participants	115 Participants n=7 Participants	8 Participants n=5 Participants	14 Participants n=4 Participants	5 Participants n=21 Participants	21 Participants n=10 Participants	0 Participants n=115 Participants	12 Participants n=6 Participants	214 Participants n=6 Participants
Region of Enrollment Israel	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	6 Participants n=21 Participants	21 Participants n=10 Participants	0 Participants n=115 Participants	0 Participants n=6 Participants	27 Participants n=6 Participants
Region of Enrollment Australia	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	12 Participants n=4 Participants	5 Participants n=21 Participants	14 Participants n=10 Participants	0 Participants n=115 Participants	0 Participants n=6 Participants	32 Participants n=6 Participants
Region of Enrollment Germany	11 Participants n=5 Participants	2 Participants n=7 Participants	1 Participants n=5 Participants	6 Participants n=4 Participants	3 Participants n=21 Participants	13 Participants n=10 Participants	0 Participants n=115 Participants	0 Participants n=6 Participants	36 Participants n=6 Participants

PRIMARY outcome

Timeframe: Baseline through 84 Months

Population: All enrolled participants who received at least one dose of study drug and did not discontinue the study for the reason 'Lost to Follow-up' at the first postbaseline visit in study JADY.

Outcome measures

Outcome measures
Measure	2 mg Baricitinib n=297 Participants 2 mg Baricitinib administered orally once daily.	4 mg Baricitinib n=2579 Participants 4 mg Baricitinib administered orally once daily.	2 mg Baricitinib Step-down n=592 Participants 2 mg Baricitinib administered orally once daily in the 96-week Step-down period.	4 mg Baricitinib Step-down n=594 Participants 4 mg Baricitinib administered orally once daily in the 96-week Step-down period.	JADW 2 mg Baricitinib 2 mg Baricitinib administered orally once daily.	JADW 4 mg Baricitinib 4 mg Baricitinib administered orally once daily.	JAGS 4 mg Baricitinib 4 mg Baricitinib administered orally once daily.	JADA 4 mg Baricitinib 4 mg Baricitinib administered orally once daily.
Number of Participants Who Experienced Adverse Events (AEs) or Serious AE Adverse Events	234 participants	1532 participants	270 participants	315 participants	—	—	—	—
Number of Participants Who Experienced Adverse Events (AEs) or Serious AE Serious Adverse Events	112 participants	517 participants	164 participants	178 participants	—	—	—	—

SECONDARY outcome

Timeframe: Year 1 after entry into JADY

Population: All enrolled participants who received at least one dose of study drug and completed at least 48 weeks in study JADY.

ACR20 Responder Index is a composite of clinical, laboratory, and functional measures in rheumatoid arthritis (RA). An ACR20 Responder is a participant who had ≥20% improvement from baseline in both 68 tender and 66 swollen joint counts and ≥20% improvement in at least 3 of 5 criteria: Patient's and Physician's Global Assessment of Disease Activity, Health Assessment Questionnaire-Disability Index (HAQ-DI) (assessment of participant's physical function), pain due to RA, and hsCRP. Percentage of participants achieving ACR20 response = (number of ACR20 responders) / (number of participants analyzed) \* 100

Outcome measures

Outcome measures
Measure	2 mg Baricitinib n=419 Participants 2 mg Baricitinib administered orally once daily.	4 mg Baricitinib n=1034 Participants 4 mg Baricitinib administered orally once daily.	2 mg Baricitinib Step-down n=169 Participants 2 mg Baricitinib administered orally once daily in the 96-week Step-down period.	4 mg Baricitinib Step-down n=366 Participants 4 mg Baricitinib administered orally once daily in the 96-week Step-down period.	JADW 2 mg Baricitinib n=101 Participants 2 mg Baricitinib administered orally once daily.	JADW 4 mg Baricitinib n=274 Participants 4 mg Baricitinib administered orally once daily.	JAGS 4 mg Baricitinib n=210 Participants 4 mg Baricitinib administered orally once daily.	JADA 4 mg Baricitinib n=78 Participants 4 mg Baricitinib administered orally once daily.
Percentage of Participants Maintaining an American College of Rheumatology (ACR) Response of ACR20	92.6 Percentage of Participants Interval 89.7 to 94.7	88.4 Percentage of Participants Interval 86.3 to 90.2	79.3 Percentage of Participants Interval 72.6 to 84.7	79.5 Percentage of Participants Interval 75.1 to 83.3	72.3 Percentage of Participants Interval 62.9 to 80.1	70.8 Percentage of Participants Interval 65.2 to 75.9	86.7 Percentage of Participants Interval 81.4 to 90.6	75.6 Percentage of Participants Interval 65.1 to 83.8

SECONDARY outcome

Timeframe: Year 3 after entry into JADY

Population: All enrolled participants who received at least one dose of study drug and completed at least 48 weeks in study JADY.

Outcome measures

Outcome measures
Measure	2 mg Baricitinib n=419 Participants 2 mg Baricitinib administered orally once daily.	4 mg Baricitinib n=1034 Participants 4 mg Baricitinib administered orally once daily.	2 mg Baricitinib Step-down n=169 Participants 2 mg Baricitinib administered orally once daily in the 96-week Step-down period.	4 mg Baricitinib Step-down n=366 Participants 4 mg Baricitinib administered orally once daily in the 96-week Step-down period.	JADW 2 mg Baricitinib n=101 Participants 2 mg Baricitinib administered orally once daily.	JADW 4 mg Baricitinib n=274 Participants 4 mg Baricitinib administered orally once daily.	JAGS 4 mg Baricitinib n=210 Participants 4 mg Baricitinib administered orally once daily.	JADA 4 mg Baricitinib n=78 Participants 4 mg Baricitinib administered orally once daily.
Percentage of Participants Maintaining an American College of Rheumatology (ACR) Response of ACR20	78.3 percentage of participants Interval 74.1 to 82.0	76.6 percentage of participants Interval 73.9 to 79.1	71.6 percentage of participants Interval 64.4 to 77.9	70.5 percentage of participants Interval 65.6 to 74.9	57.4 percentage of participants Interval 47.7 to 66.6	55.8 percentage of participants Interval 49.9 to 61.6	73.8 percentage of participants Interval 67.5 to 79.3	71.8 percentage of participants Interval 61.0 to 80.6

SECONDARY outcome

Timeframe: Year 5 after entry into JADY

Population: All enrolled participants who received at least one dose of study drug and completed at least 48 weeks in study JADY.

Outcome measures

Outcome measures
Measure	2 mg Baricitinib n=419 Participants 2 mg Baricitinib administered orally once daily.	4 mg Baricitinib n=1034 Participants 4 mg Baricitinib administered orally once daily.	2 mg Baricitinib Step-down n=169 Participants 2 mg Baricitinib administered orally once daily in the 96-week Step-down period.	4 mg Baricitinib Step-down n=366 Participants 4 mg Baricitinib administered orally once daily in the 96-week Step-down period.	JADW 2 mg Baricitinib n=101 Participants 2 mg Baricitinib administered orally once daily.	JADW 4 mg Baricitinib n=274 Participants 4 mg Baricitinib administered orally once daily.	JAGS 4 mg Baricitinib n=210 Participants 4 mg Baricitinib administered orally once daily.	JADA 4 mg Baricitinib n=78 Participants 4 mg Baricitinib administered orally once daily.
Percentage of Participants Maintaining an American College of Rheumatology (ACR) Response of ACR20	67.3 percentage of participants Interval 62.7 to 71.6	65.6 percentage of participants Interval 62.6 to 68.4	60.4 percentage of participants Interval 52.8 to 67.4	56.0 percentage of participants Interval 50.9 to 61.0	50.5 percentage of participants Interval 40.9 to 60.0	43.1 percentage of participants Interval 37.3 to 49.0	24.8 percentage of participants Interval 19.4 to 31.0	60.3 percentage of participants Interval 49.2 to 70.4

SECONDARY outcome

Timeframe: Year 1 after entry into JADY

Population: All enrolled participants who received at least one dose of study drug and completed at least 48 weeks in study JADY.

ACR50 Responder Index is a composite of clinical, laboratory, and functional measures in rheumatoid arthritis (RA). An ACR50 Responder is a participant who had ≥50% improvement from baseline in both 68 tender and 66 swollen joint counts and ≥50% improvement in at least 3 of 5 criteria: Patient's and Physician's Global Assessment of Disease Activity, Health Assessment Questionnaire-Disability Index (HAQ-DI) (assessment of participant's physical function), pain due to RA, and hsCRP. Percentage of participants achieving ACR50 response = (number of ACR50 responders) / (number of participants analyzed) \* 100

Outcome measures

Outcome measures
Measure	2 mg Baricitinib n=419 Participants 2 mg Baricitinib administered orally once daily.	4 mg Baricitinib n=1034 Participants 4 mg Baricitinib administered orally once daily.	2 mg Baricitinib Step-down n=169 Participants 2 mg Baricitinib administered orally once daily in the 96-week Step-down period.	4 mg Baricitinib Step-down n=366 Participants 4 mg Baricitinib administered orally once daily in the 96-week Step-down period.	JADW 2 mg Baricitinib n=101 Participants 2 mg Baricitinib administered orally once daily.	JADW 4 mg Baricitinib n=274 Participants 4 mg Baricitinib administered orally once daily.	JAGS 4 mg Baricitinib n=210 Participants 4 mg Baricitinib administered orally once daily.	JADA 4 mg Baricitinib n=78 Participants 4 mg Baricitinib administered orally once daily.
Percentage of Participants Maintaining an American College of Rheumatology (ACR) Response of ACR50	80.0 percentage of participants Interval 75.9 to 83.5	67.7 percentage of participants Interval 64.8 to 70.5	58.0 percentage of participants Interval 50.5 to 65.2	58.2 percentage of participants Interval 53.1 to 63.1	45.5 percentage of participants Interval 36.2 to 55.2	43.8 percentage of participants Interval 38.0 to 49.7	69.0 percentage of participants Interval 62.5 to 74.9	43.6 percentage of participants Interval 33.1 to 54.6

SECONDARY outcome

Timeframe: Year 3 after entry into JADY

Population: All enrolled participants who received at least one dose of study drug and completed at least 48 weeks in study JADY.

Outcome measures

Outcome measures
Measure	2 mg Baricitinib n=419 Participants 2 mg Baricitinib administered orally once daily.	4 mg Baricitinib n=1034 Participants 4 mg Baricitinib administered orally once daily.	2 mg Baricitinib Step-down n=169 Participants 2 mg Baricitinib administered orally once daily in the 96-week Step-down period.	4 mg Baricitinib Step-down n=366 Participants 4 mg Baricitinib administered orally once daily in the 96-week Step-down period.	JADW 2 mg Baricitinib n=101 Participants 2 mg Baricitinib administered orally once daily.	JADW 4 mg Baricitinib n=274 Participants 4 mg Baricitinib administered orally once daily.	JAGS 4 mg Baricitinib n=210 Participants 4 mg Baricitinib administered orally once daily.	JADA 4 mg Baricitinib n=78 Participants 4 mg Baricitinib administered orally once daily.
Percentage of Participants Maintaining an American College of Rheumatology (ACR) Response of ACR50	67.8 percentage of participants Interval 63.2 to 72.1	61.6 percentage of participants Interval 58.6 to 64.5	49.7 percentage of participants Interval 42.3 to 57.2	53.3 percentage of participants Interval 48.2 to 58.3	43.6 percentage of participants Interval 34.3 to 53.3	36.5 percentage of participants Interval 31.0 to 42.3	59.0 percentage of participants Interval 52.3 to 65.5	43.6 percentage of participants Interval 33.1 to 54.6

SECONDARY outcome

Timeframe: Year 5 after entry into JADY

Population: All enrolled participants who received at least one dose of study drug and completed at least 48 weeks in study JADY.

Outcome measures

Outcome measures
Measure	2 mg Baricitinib n=419 Participants 2 mg Baricitinib administered orally once daily.	4 mg Baricitinib n=1034 Participants 4 mg Baricitinib administered orally once daily.	2 mg Baricitinib Step-down n=169 Participants 2 mg Baricitinib administered orally once daily in the 96-week Step-down period.	4 mg Baricitinib Step-down n=366 Participants 4 mg Baricitinib administered orally once daily in the 96-week Step-down period.	JADW 2 mg Baricitinib n=101 Participants 2 mg Baricitinib administered orally once daily.	JADW 4 mg Baricitinib n=274 Participants 4 mg Baricitinib administered orally once daily.	JAGS 4 mg Baricitinib n=210 Participants 4 mg Baricitinib administered orally once daily.	JADA 4 mg Baricitinib n=78 Participants 4 mg Baricitinib administered orally once daily.
Percentage of Participants Maintaining an American College of Rheumatology (ACR) Response of ACR50	59.9 percentage of participants Interval 55.1 to 64.5	52.7 percentage of participants Interval 49.7 to 55.7	44.4 percentage of participants Interval 37.1 to 51.9	43.2 percentage of participants Interval 38.2 to 48.3	37.6 percentage of participants Interval 28.8 to 47.4	32.1 percentage of participants Interval 26.9 to 37.9	18.6 percentage of participants Interval 13.9 to 24.4	37.2 percentage of participants Interval 27.3 to 48.3

SECONDARY outcome

Timeframe: Year 1 after entry into JADY

Population: All enrolled participants who received at least one dose of study drug and completed at least 48 weeks in study JADY.

ACR70 Responder Index is a composite of clinical, laboratory, and functional measures in rheumatoid arthritis (RA). An ACR70 Responder is a participant who had ≥70% improvement from baseline in both 68 tender and 66 swollen joint counts and ≥70% improvement in at least 3 of 5 criteria: Patient's and Physician's Global Assessment of Disease Activity, Health Assessment Questionnaire-Disability Index (HAQ-DI) (assessment of participant's physical function), pain due to RA, and hsCRP. Percentage of participants achieving ACR70 response = (number of ACR70 responders) / (number of participants analyzed) \* 100

Outcome measures

Outcome measures
Measure	2 mg Baricitinib n=419 Participants 2 mg Baricitinib administered orally once daily.	4 mg Baricitinib n=1034 Participants 4 mg Baricitinib administered orally once daily.	2 mg Baricitinib Step-down n=169 Participants 2 mg Baricitinib administered orally once daily in the 96-week Step-down period.	4 mg Baricitinib Step-down n=366 Participants 4 mg Baricitinib administered orally once daily in the 96-week Step-down period.	JADW 2 mg Baricitinib n=101 Participants 2 mg Baricitinib administered orally once daily.	JADW 4 mg Baricitinib n=274 Participants 4 mg Baricitinib administered orally once daily.	JAGS 4 mg Baricitinib n=210 Participants 4 mg Baricitinib administered orally once daily.	JADA 4 mg Baricitinib n=78 Participants 4 mg Baricitinib administered orally once daily.
Percentage of Participants Maintaining an American College of Rheumatology (ACR) Response of ACR70	61.3 percentage of participants Interval 56.6 to 65.9	45.7 percentage of participants Interval 42.7 to 48.8	34.9 percentage of participants Interval 28.1 to 42.4	35.8 percentage of participants Interval 31.1 to 40.8	28.7 percentage of participants Interval 20.8 to 38.2	25.9 percentage of participants Interval 21.1 to 31.4	42.9 percentage of participants Interval 36.4 to 49.6	26.9 percentage of participants Interval 18.3 to 37.7

SECONDARY outcome

Timeframe: Year 3 after entry into JADY

Population: All enrolled participants who received at least one dose of study drug and completed at least 48 weeks in study JADY.

Outcome measures

Outcome measures
Measure	2 mg Baricitinib n=419 Participants 2 mg Baricitinib administered orally once daily.	4 mg Baricitinib n=1034 Participants 4 mg Baricitinib administered orally once daily.	2 mg Baricitinib Step-down n=169 Participants 2 mg Baricitinib administered orally once daily in the 96-week Step-down period.	4 mg Baricitinib Step-down n=366 Participants 4 mg Baricitinib administered orally once daily in the 96-week Step-down period.	JADW 2 mg Baricitinib n=101 Participants 2 mg Baricitinib administered orally once daily.	JADW 4 mg Baricitinib n=274 Participants 4 mg Baricitinib administered orally once daily.	JAGS 4 mg Baricitinib n=210 Participants 4 mg Baricitinib administered orally once daily.	JADA 4 mg Baricitinib n=78 Participants 4 mg Baricitinib administered orally once daily.
Percentage of Participants Maintaining an American College of Rheumatology (ACR) Response of ACR70	54.4 percentage of participants Interval 49.6 to 59.1	44.1 percentage of participants Interval 41.1 to 47.1	35.5 percentage of participants Interval 28.7 to 43.0	32.5 percentage of participants Interval 27.9 to 37.5	24.8 percentage of participants Interval 17.4 to 34.0	21.5 percentage of participants Interval 17.1 to 26.8	35.2 percentage of participants Interval 29.1 to 41.9	21.8 percentage of participants Interval 14.1 to 32.2

SECONDARY outcome

Timeframe: Year 5 after entry into JADY

Population: All enrolled participants who received at least one dose of study drug and completed at least 48 weeks in study JADY.

Outcome measures

Outcome measures
Measure	2 mg Baricitinib n=419 Participants 2 mg Baricitinib administered orally once daily.	4 mg Baricitinib n=1034 Participants 4 mg Baricitinib administered orally once daily.	2 mg Baricitinib Step-down n=169 Participants 2 mg Baricitinib administered orally once daily in the 96-week Step-down period.	4 mg Baricitinib Step-down n=366 Participants 4 mg Baricitinib administered orally once daily in the 96-week Step-down period.	JADW 2 mg Baricitinib n=101 Participants 2 mg Baricitinib administered orally once daily.	JADW 4 mg Baricitinib n=274 Participants 4 mg Baricitinib administered orally once daily.	JAGS 4 mg Baricitinib n=210 Participants 4 mg Baricitinib administered orally once daily.	JADA 4 mg Baricitinib n=78 Participants 4 mg Baricitinib administered orally once daily.
Percentage of Participants Maintaining an American College of Rheumatology (ACR) Response of ACR70	48.2 percentage of participants Interval 43.5 to 53.0	39.1 percentage of participants Interval 36.1 to 42.1	28.4 percentage of participants Interval 22.1 to 35.6	28.4 percentage of participants Interval 24.0 to 33.2	23.8 percentage of participants Interval 16.5 to 32.9	18.2 percentage of participants Interval 14.1 to 23.2	12.9 percentage of participants Interval 9.0 to 18.1	19.2 percentage of participants Interval 12.0 to 29.3

SECONDARY outcome

Timeframe: Year 1 after entry into JADY

Population: All enrolled participants who received at least one dose of study drug and completed at least 48 weeks in study JADY.

Disease Activity Score (DAS) modified to include 28 joint count (DAS28) consisted of composite score of following variables: tender joint count-28 (TJC28), swollen joint count-28 (SJC28), CRP (mg/L), and Patient's Global Assessment of Disease Activity using VAS (patient's global VAS). DAS28-CRP=0.56\*square root (sqrt)(TJC28)+0.28\*sqrt(SJC28)+0.36\*natural log(CRP+1)+0.014\*patient's global VAS+0.96. Scores ranged from 1.0-9.4, where lower scores indicated less disease activity, low disease activity was DAS28-CRP ≤3.2 and remission was DAS28-CRP \<2.6. A decrease in DAS28-CRP indicated an improvement in participant's condition.

Outcome measures

Outcome measures
Measure	2 mg Baricitinib n=419 Participants 2 mg Baricitinib administered orally once daily.	4 mg Baricitinib n=1034 Participants 4 mg Baricitinib administered orally once daily.	2 mg Baricitinib Step-down n=169 Participants 2 mg Baricitinib administered orally once daily in the 96-week Step-down period.	4 mg Baricitinib Step-down n=366 Participants 4 mg Baricitinib administered orally once daily in the 96-week Step-down period.	JADW 2 mg Baricitinib n=101 Participants 2 mg Baricitinib administered orally once daily.	JADW 4 mg Baricitinib n=274 Participants 4 mg Baricitinib administered orally once daily.	JAGS 4 mg Baricitinib n=210 Participants 4 mg Baricitinib administered orally once daily.	JADA 4 mg Baricitinib n=78 Participants 4 mg Baricitinib administered orally once daily.
Percentage of Participants Maintaining a Disease Activity Score (DAS28) High-Sensitivity C-Reactive Protein (hsCRP) ≤3.2	81.9 percentage of participants Interval 77.9 to 85.3	71.9 percentage of participants Interval 69.0 to 74.5	66.3 percentage of participants Interval 58.9 to 73.0	68.6 percentage of participants Interval 63.7 to 73.1	50.5 percentage of participants Interval 40.9 to 60.0	51.1 percentage of participants Interval 45.2 to 57.0	72.4 percentage of participants Interval 66.0 to 78.0	59.0 percentage of participants Interval 47.9 to 69.2

SECONDARY outcome

Timeframe: Year 3 after entry into JADY

Population: All enrolled participants who received at least one dose of study drug and completed at least 48 weeks in study JADY.

Outcome measures

Outcome measures
Measure	2 mg Baricitinib n=419 Participants 2 mg Baricitinib administered orally once daily.	4 mg Baricitinib n=1034 Participants 4 mg Baricitinib administered orally once daily.	2 mg Baricitinib Step-down n=169 Participants 2 mg Baricitinib administered orally once daily in the 96-week Step-down period.	4 mg Baricitinib Step-down n=366 Participants 4 mg Baricitinib administered orally once daily in the 96-week Step-down period.	JADW 2 mg Baricitinib n=101 Participants 2 mg Baricitinib administered orally once daily.	JADW 4 mg Baricitinib n=274 Participants 4 mg Baricitinib administered orally once daily.	JAGS 4 mg Baricitinib n=210 Participants 4 mg Baricitinib administered orally once daily.	JADA 4 mg Baricitinib n=78 Participants 4 mg Baricitinib administered orally once daily.
Percentage of Participants Maintaining a Disease Activity Score (DAS28) High-Sensitivity C-Reactive Protein (hsCRP) ≤3.2	71.8 percentage of participants Interval 67.3 to 75.9	65.5 percentage of participants Interval 62.5 to 68.3	59.2 percentage of participants Interval 51.6 to 66.3	59.3 percentage of participants Interval 54.2 to 64.2	47.5 percentage of participants Interval 38.1 to 57.2	41.6 percentage of participants Interval 35.9 to 47.5	61.0 percentage of participants Interval 54.2 to 67.3	60.3 percentage of participants Interval 49.2 to 70.4

SECONDARY outcome

Timeframe: Year 5 after entry into JADY

Population: All enrolled participants who received at least one dose of study drug and completed at least 48 weeks in study JADY.

Outcome measures

Outcome measures
Measure	2 mg Baricitinib n=419 Participants 2 mg Baricitinib administered orally once daily.	4 mg Baricitinib n=1034 Participants 4 mg Baricitinib administered orally once daily.	2 mg Baricitinib Step-down n=169 Participants 2 mg Baricitinib administered orally once daily in the 96-week Step-down period.	4 mg Baricitinib Step-down n=366 Participants 4 mg Baricitinib administered orally once daily in the 96-week Step-down period.	JADW 2 mg Baricitinib n=101 Participants 2 mg Baricitinib administered orally once daily.	JADW 4 mg Baricitinib n=274 Participants 4 mg Baricitinib administered orally once daily.	JAGS 4 mg Baricitinib n=210 Participants 4 mg Baricitinib administered orally once daily.	JADA 4 mg Baricitinib n=78 Participants 4 mg Baricitinib administered orally once daily.
Percentage of Participants Maintaining a Disease Activity Score (DAS28) High-Sensitivity C-Reactive Protein (hsCRP) ≤3.2	61.1 percentage of participants Interval 56.3 to 65.6	58.9 percentage of participants Interval 55.9 to 61.9	46.7 percentage of participants Interval 39.4 to 54.3	50.0 percentage of participants Interval 44.9 to 55.1	44.6 percentage of participants Interval 35.2 to 54.3	34.3 percentage of participants Interval 28.9 to 40.1	21.0 percentage of participants Interval 16.0 to 27.0	53.8 percentage of participants Interval 42.9 to 64.5

SECONDARY outcome

Timeframe: Year 1 after entry into JADY

Population: All enrolled participants who received at least one dose of study drug and completed at least 48 weeks in study JADY.

Outcome measures

Outcome measures
Measure	2 mg Baricitinib n=419 Participants 2 mg Baricitinib administered orally once daily.	4 mg Baricitinib n=1034 Participants 4 mg Baricitinib administered orally once daily.	2 mg Baricitinib Step-down n=169 Participants 2 mg Baricitinib administered orally once daily in the 96-week Step-down period.	4 mg Baricitinib Step-down n=366 Participants 4 mg Baricitinib administered orally once daily in the 96-week Step-down period.	JADW 2 mg Baricitinib n=101 Participants 2 mg Baricitinib administered orally once daily.	JADW 4 mg Baricitinib n=274 Participants 4 mg Baricitinib administered orally once daily.	JAGS 4 mg Baricitinib n=210 Participants 4 mg Baricitinib administered orally once daily.	JADA 4 mg Baricitinib n=78 Participants 4 mg Baricitinib administered orally once daily.
Percentage of Participants Maintaining a Disease Activity Score (DAS28) High-Sensitivity C-Reactive Protein (hsCRP)<2.6	65.6 percentage of participants Interval 61.0 to 70.0	52.3 percentage of participants Interval 49.3 to 55.4	50.9 percentage of participants Interval 43.4 to 58.3	46.2 percentage of participants Interval 41.1 to 51.3	34.7 percentage of participants Interval 26.1 to 44.3	32.8 percentage of participants Interval 27.6 to 38.6	52.4 percentage of participants Interval 45.6 to 59.0	44.9 percentage of participants Interval 34.3 to 55.9

SECONDARY outcome

Timeframe: Year 3 after entry into JADY

Population: All enrolled participants who received at least one dose of study drug and completed at least 48 weeks in study JADY.

Outcome measures

Outcome measures
Measure	2 mg Baricitinib n=419 Participants 2 mg Baricitinib administered orally once daily.	4 mg Baricitinib n=1034 Participants 4 mg Baricitinib administered orally once daily.	2 mg Baricitinib Step-down n=169 Participants 2 mg Baricitinib administered orally once daily in the 96-week Step-down period.	4 mg Baricitinib Step-down n=366 Participants 4 mg Baricitinib administered orally once daily in the 96-week Step-down period.	JADW 2 mg Baricitinib n=101 Participants 2 mg Baricitinib administered orally once daily.	JADW 4 mg Baricitinib n=274 Participants 4 mg Baricitinib administered orally once daily.	JAGS 4 mg Baricitinib n=210 Participants 4 mg Baricitinib administered orally once daily.	JADA 4 mg Baricitinib n=78 Participants 4 mg Baricitinib administered orally once daily.
Percentage of Participants Maintaining a Disease Activity Score (DAS28) High-Sensitivity C-Reactive Protein (hsCRP)<2.6	59.9 percentage of participants Interval 55.1 to 64.5	51.0 percentage of participants Interval 47.9 to 54.0	43.8 percentage of participants Interval 36.5 to 51.3	43.2 percentage of participants Interval 38.2 to 48.3	31.7 percentage of participants Interval 23.4 to 41.3	26.3 percentage of participants Interval 21.4 to 31.8	38.6 percentage of participants Interval 32.2 to 45.3	35.9 percentage of participants Interval 26.1 to 47.0

SECONDARY outcome

Timeframe: Year 5 after entry into JADY

Population: All enrolled participants who received at least one dose of study drug and completed at least 48 weeks in study JADY.

Outcome measures

Outcome measures
Measure	2 mg Baricitinib n=419 Participants 2 mg Baricitinib administered orally once daily.	4 mg Baricitinib n=1034 Participants 4 mg Baricitinib administered orally once daily.	2 mg Baricitinib Step-down n=169 Participants 2 mg Baricitinib administered orally once daily in the 96-week Step-down period.	4 mg Baricitinib Step-down n=366 Participants 4 mg Baricitinib administered orally once daily in the 96-week Step-down period.	JADW 2 mg Baricitinib n=101 Participants 2 mg Baricitinib administered orally once daily.	JADW 4 mg Baricitinib n=274 Participants 4 mg Baricitinib administered orally once daily.	JAGS 4 mg Baricitinib n=210 Participants 4 mg Baricitinib administered orally once daily.	JADA 4 mg Baricitinib n=78 Participants 4 mg Baricitinib administered orally once daily.
Percentage of Participants Maintaining a Disease Activity Score (DAS28) High-Sensitivity C-Reactive Protein (hsCRP)<2.6	51.1 percentage of participants Interval 46.3 to 55.8	44.0 percentage of participants Interval 41.0 to 47.0	36.1 percentage of participants Interval 29.2 to 43.6	37.7 percentage of participants Interval 32.9 to 42.8	29.7 percentage of participants Interval 21.7 to 39.2	26.6 percentage of participants Interval 21.8 to 32.2	13.3 percentage of participants Interval 9.4 to 18.6	43.6 percentage of participants Interval 33.1 to 54.6

SECONDARY outcome

Timeframe: Year 1 after entry into JADY

Population: All enrolled participants who received at least one dose of study drug and completed at least 48 weeks in study JADY.

DAS28 consisted of composite score of following variables: tender joint count (TJC28), swollen joint count (SJC28), ESR (millimeters per hour), and Patient's Global Assessment of Disease Activity. DAS28 was calculated using following formula: DAS28-ESR=0.56\*square root (sqrt)(TJC28)+0.28\*sqrt(SJC28)+0.70\*natural log(ESR)+0.014\*Patient's Global VAS. Total scores ranged from 1.0-9.4, where lower scores indicated less disease activity.

Outcome measures

Outcome measures
Measure	2 mg Baricitinib n=419 Participants 2 mg Baricitinib administered orally once daily.	4 mg Baricitinib n=1034 Participants 4 mg Baricitinib administered orally once daily.	2 mg Baricitinib Step-down n=169 Participants 2 mg Baricitinib administered orally once daily in the 96-week Step-down period.	4 mg Baricitinib Step-down n=366 Participants 4 mg Baricitinib administered orally once daily in the 96-week Step-down period.	JADW 2 mg Baricitinib n=101 Participants 2 mg Baricitinib administered orally once daily.	JADW 4 mg Baricitinib n=274 Participants 4 mg Baricitinib administered orally once daily.	JAGS 4 mg Baricitinib n=210 Participants 4 mg Baricitinib administered orally once daily.	JADA 4 mg Baricitinib n=78 Participants 4 mg Baricitinib administered orally once daily.
Percentage of Participants Maintaining a DAS28-Erythrocyte Sedimentation Rate (ESR) Score of ≤3.2	61.8 percentage of participants Interval 57.1 to 66.3	48.4 percentage of participants Interval 45.3 to 51.4	46.2 percentage of participants Interval 38.8 to 53.7	48.4 percentage of participants Interval 43.3 to 53.5	31.7 percentage of participants Interval 23.4 to 41.3	31.8 percentage of participants Interval 26.5 to 37.5	41.0 percentage of participants Interval 34.5 to 47.7	35.9 percentage of participants Interval 26.1 to 47.0

SECONDARY outcome

Timeframe: Year 3 after entry into JADY

Population: All enrolled participants who received at least one dose of study drug and completed at least 48 weeks in study JADY.

Outcome measures

Outcome measures
Measure	2 mg Baricitinib n=419 Participants 2 mg Baricitinib administered orally once daily.	4 mg Baricitinib n=1034 Participants 4 mg Baricitinib administered orally once daily.	2 mg Baricitinib Step-down n=169 Participants 2 mg Baricitinib administered orally once daily in the 96-week Step-down period.	4 mg Baricitinib Step-down n=366 Participants 4 mg Baricitinib administered orally once daily in the 96-week Step-down period.	JADW 2 mg Baricitinib n=101 Participants 2 mg Baricitinib administered orally once daily.	JADW 4 mg Baricitinib n=274 Participants 4 mg Baricitinib administered orally once daily.	JAGS 4 mg Baricitinib n=210 Participants 4 mg Baricitinib administered orally once daily.	JADA 4 mg Baricitinib n=78 Participants 4 mg Baricitinib administered orally once daily.
Percentage of Participants Maintaining a DAS28-Erythrocyte Sedimentation Rate (ESR) Score of ≤3.2	54.4 percentage of participants Interval 49.6 to 59.1	46.1 percentage of participants Interval 43.1 to 49.2	40.2 percentage of participants Interval 33.1 to 47.8	41.0 percentage of participants Interval 36.1 to 46.1	22.8 percentage of participants Interval 15.7 to 31.9	23.7 percentage of participants Interval 19.1 to 29.1	33.8 percentage of participants Interval 27.8 to 40.4	37.2 percentage of participants Interval 27.3 to 48.3

SECONDARY outcome

Timeframe: Year 5 after entry into JADY

Population: All enrolled participants who received at least one dose of study drug and completed at least 48 weeks in study JADY.

Outcome measures

Outcome measures
Measure	2 mg Baricitinib n=419 Participants 2 mg Baricitinib administered orally once daily.	4 mg Baricitinib n=1034 Participants 4 mg Baricitinib administered orally once daily.	2 mg Baricitinib Step-down n=169 Participants 2 mg Baricitinib administered orally once daily in the 96-week Step-down period.	4 mg Baricitinib Step-down n=366 Participants 4 mg Baricitinib administered orally once daily in the 96-week Step-down period.	JADW 2 mg Baricitinib n=101 Participants 2 mg Baricitinib administered orally once daily.	JADW 4 mg Baricitinib n=274 Participants 4 mg Baricitinib administered orally once daily.	JAGS 4 mg Baricitinib n=210 Participants 4 mg Baricitinib administered orally once daily.	JADA 4 mg Baricitinib n=78 Participants 4 mg Baricitinib administered orally once daily.
Percentage of Participants Maintaining a DAS28-Erythrocyte Sedimentation Rate (ESR) Score of ≤3.2	48.7 percentage of participants Interval 43.9 to 53.5	41.3 percentage of participants Interval 38.3 to 44.3	36.1 percentage of participants Interval 29.2 to 43.6	32.5 percentage of participants Interval 27.9 to 37.5	23.8 percentage of participants Interval 16.5 to 32.9	21.9 percentage of participants Interval 17.4 to 27.2	11.4 percentage of participants Interval 7.8 to 16.4	37.2 percentage of participants Interval 27.3 to 48.3

SECONDARY outcome

Timeframe: Year 1 after entry into JADY

Population: All enrolled participants who received at least one dose of study drug and completed at least 48 weeks in study JADY.

Outcome measures

Outcome measures
Measure	2 mg Baricitinib n=419 Participants 2 mg Baricitinib administered orally once daily.	4 mg Baricitinib n=1034 Participants 4 mg Baricitinib administered orally once daily.	2 mg Baricitinib Step-down n=169 Participants 2 mg Baricitinib administered orally once daily in the 96-week Step-down period.	4 mg Baricitinib Step-down n=366 Participants 4 mg Baricitinib administered orally once daily in the 96-week Step-down period.	JADW 2 mg Baricitinib n=101 Participants 2 mg Baricitinib administered orally once daily.	JADW 4 mg Baricitinib n=274 Participants 4 mg Baricitinib administered orally once daily.	JAGS 4 mg Baricitinib n=210 Participants 4 mg Baricitinib administered orally once daily.	JADA 4 mg Baricitinib n=78 Participants 4 mg Baricitinib administered orally once daily.
Percentage of Participants Maintaining a DAS28-Erythrocyte Sedimentation Rate (ESR) Sore of <2.6	36.8 percentage of participants Interval 32.3 to 41.5	29.3 percentage of participants Interval 26.6 to 32.2	24.3 percentage of participants Interval 18.4 to 31.2	26.8 percentage of participants Interval 22.5 to 31.5	20.8 percentage of participants Interval 14.0 to 29.7	13.1 percentage of participants Interval 9.6 to 17.7	25.2 percentage of participants Interval 19.8 to 31.5	15.4 percentage of participants Interval 9.0 to 25.0

SECONDARY outcome

Timeframe: Year 3 after entry into JADY

Population: All enrolled participants who received at least one dose of study drug and completed at least 48 weeks in study JADY.

Outcome measures

Outcome measures
Measure	2 mg Baricitinib n=419 Participants 2 mg Baricitinib administered orally once daily.	4 mg Baricitinib n=1034 Participants 4 mg Baricitinib administered orally once daily.	2 mg Baricitinib Step-down n=169 Participants 2 mg Baricitinib administered orally once daily in the 96-week Step-down period.	4 mg Baricitinib Step-down n=366 Participants 4 mg Baricitinib administered orally once daily in the 96-week Step-down period.	JADW 2 mg Baricitinib n=101 Participants 2 mg Baricitinib administered orally once daily.	JADW 4 mg Baricitinib n=274 Participants 4 mg Baricitinib administered orally once daily.	JAGS 4 mg Baricitinib n=210 Participants 4 mg Baricitinib administered orally once daily.	JADA 4 mg Baricitinib n=78 Participants 4 mg Baricitinib administered orally once daily.
Percentage of Participants Maintaining a DAS28-Erythrocyte Sedimentation Rate (ESR) Sore of <2.6	38.9 percentage of participants Interval 34.4 to 43.7	24.7 percentage of participants Interval 22.1 to 27.4	24.3 percentage of participants Interval 18.4 to 31.2	23.2 percentage of participants Interval 19.2 to 27.8	15.8 percentage of participants Interval 10.0 to 24.2	10.2 percentage of participants Interval 7.2 to 14.4	19.5 percentage of participants Interval 14.7 to 25.4	23.1 percentage of participants Interval 15.1 to 33.6

SECONDARY outcome

Timeframe: Year 5 after entry into JADY

Population: All enrolled participants who received at least one dose of study drug and completed at least 48 weeks in study JADY.

Outcome measures

Outcome measures
Measure	2 mg Baricitinib n=419 Participants 2 mg Baricitinib administered orally once daily.	4 mg Baricitinib n=1034 Participants 4 mg Baricitinib administered orally once daily.	2 mg Baricitinib Step-down n=169 Participants 2 mg Baricitinib administered orally once daily in the 96-week Step-down period.	4 mg Baricitinib Step-down n=366 Participants 4 mg Baricitinib administered orally once daily in the 96-week Step-down period.	JADW 2 mg Baricitinib n=101 Participants 2 mg Baricitinib administered orally once daily.	JADW 4 mg Baricitinib n=274 Participants 4 mg Baricitinib administered orally once daily.	JAGS 4 mg Baricitinib n=210 Participants 4 mg Baricitinib administered orally once daily.	JADA 4 mg Baricitinib n=78 Participants 4 mg Baricitinib administered orally once daily.
Percentage of Participants Maintaining a DAS28-Erythrocyte Sedimentation Rate (ESR) Sore of <2.6	31.3 percentage of participants Interval 27.0 to 35.9	23.9 percentage of participants Interval 21.4 to 26.6	22.5 percentage of participants Interval 16.8 to 29.4	19.4 percentage of participants Interval 15.7 to 23.8	11.9 percentage of participants Interval 6.9 to 19.6	8.8 percentage of participants Interval 6.0 to 12.7	7.1 percentage of participants Interval 4.4 to 11.4	19.2 percentage of participants Interval 12.0 to 29.3

SECONDARY outcome

Timeframe: Year 1 after entry into JADY

Population: All enrolled participants who received at least one dose of study drug and completed at least 48 weeks in study JADY.

Boolean-based definition of remission, all 4 criteria below must be met: tender joint count (TJC28 ) \<=1, swollen joint count (SJC28) \<=1, hsCRP \<=1 milligram per deciliter (mg/dL), Patient Global Assessment of Disease Activity using visual analog scale (VAS) \<=1 cm.

Outcome measures

Outcome measures
Measure	2 mg Baricitinib n=419 Participants 2 mg Baricitinib administered orally once daily.	4 mg Baricitinib n=1034 Participants 4 mg Baricitinib administered orally once daily.	2 mg Baricitinib Step-down n=169 Participants 2 mg Baricitinib administered orally once daily in the 96-week Step-down period.	4 mg Baricitinib Step-down n=366 Participants 4 mg Baricitinib administered orally once daily in the 96-week Step-down period.	JADW 2 mg Baricitinib n=101 Participants 2 mg Baricitinib administered orally once daily.	JADW 4 mg Baricitinib n=274 Participants 4 mg Baricitinib administered orally once daily.	JAGS 4 mg Baricitinib n=210 Participants 4 mg Baricitinib administered orally once daily.	JADA 4 mg Baricitinib n=78 Participants 4 mg Baricitinib administered orally once daily.
Percentage of Participants Maintaining American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) Boolean Remission Response	30.5 percentage of participants Interval 26.3 to 35.1	20.8 percentage of participants Interval 18.4 to 23.4	17.8 percentage of participants Interval 12.7 to 24.2	17.8 percentage of participants Interval 14.2 to 22.0	8.9 percentage of participants Interval 4.8 to 16.1	9.5 percentage of participants Interval 6.6 to 13.5	17.1 percentage of participants Interval 12.6 to 22.8	12.8 percentage of participants Interval 7.1 to 22.0

SECONDARY outcome

Timeframe: Year 3 after entry into JADY

Population: All enrolled participants who received at least one dose of study drug and completed at least 48 weeks in study JADY.

Outcome measures

Outcome measures
Measure	2 mg Baricitinib n=419 Participants 2 mg Baricitinib administered orally once daily.	4 mg Baricitinib n=1034 Participants 4 mg Baricitinib administered orally once daily.	2 mg Baricitinib Step-down n=169 Participants 2 mg Baricitinib administered orally once daily in the 96-week Step-down period.	4 mg Baricitinib Step-down n=366 Participants 4 mg Baricitinib administered orally once daily in the 96-week Step-down period.	JADW 2 mg Baricitinib n=101 Participants 2 mg Baricitinib administered orally once daily.	JADW 4 mg Baricitinib n=274 Participants 4 mg Baricitinib administered orally once daily.	JAGS 4 mg Baricitinib n=210 Participants 4 mg Baricitinib administered orally once daily.	JADA 4 mg Baricitinib n=78 Participants 4 mg Baricitinib administered orally once daily.
Percentage of Participants Maintaining American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) Boolean Remission Response	30.8 percentage of participants Interval 26.6 to 35.4	20.3 percentage of participants Interval 18.0 to 22.9	16.6 percentage of participants Interval 11.7 to 22.9	15.0 percentage of participants Interval 11.7 to 19.1	9.9 percentage of participants Interval 5.5 to 17.3	8.0 percentage of participants Interval 5.4 to 11.9	11.9 percentage of participants Interval 8.2 to 17.0	15.4 percentage of participants Interval 9.0 to 25.0

SECONDARY outcome

Timeframe: Year 5 after entry into JADY

Population: All enrolled participants who received at least one dose of study drug and completed at least 48 weeks in study JADY.

Outcome measures

Outcome measures
Measure	2 mg Baricitinib n=419 Participants 2 mg Baricitinib administered orally once daily.	4 mg Baricitinib n=1034 Participants 4 mg Baricitinib administered orally once daily.	2 mg Baricitinib Step-down n=169 Participants 2 mg Baricitinib administered orally once daily in the 96-week Step-down period.	4 mg Baricitinib Step-down n=366 Participants 4 mg Baricitinib administered orally once daily in the 96-week Step-down period.	JADW 2 mg Baricitinib n=101 Participants 2 mg Baricitinib administered orally once daily.	JADW 4 mg Baricitinib n=274 Participants 4 mg Baricitinib administered orally once daily.	JAGS 4 mg Baricitinib n=210 Participants 4 mg Baricitinib administered orally once daily.	JADA 4 mg Baricitinib n=78 Participants 4 mg Baricitinib administered orally once daily.
Percentage of Participants Maintaining American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) Boolean Remission Response	26.5 percentage of participants Interval 22.5 to 30.9	17.7 percentage of participants Interval 15.5 to 20.1	13.6 percentage of participants Interval 9.2 to 19.6	14.2 percentage of participants Interval 11.0 to 18.2	6.9 percentage of participants Interval 3.4 to 13.6	7.3 percentage of participants Interval 4.8 to 11.0	5.2 percentage of participants Interval 2.9 to 9.1	15.4 percentage of participants Interval 9.0 to 25.0

SECONDARY outcome

Timeframe: Baseline, Year 1

Population: All enrolled participants who received at least one dose of study drug in JADY with available baseline x-ray (from originating study) and at least 1 postbaseline x-ray assessment (collected in JADY) and Year 1 data. Zero participants analyzed, no data collected in this study or originating study.

X-rays of the hands/wrists and feet were scored for structural progression as measured using the mTSS. This methodology quantified the extent of bone erosions and joint space narrowing (JSN) for 44 and 42 joints, with higher scores representing greater damage. The mTSS at a time point is the sum of the erosion (range from 0 to 280) and JSN (range from 0 to 168) scores, for a maximum score of 448. Least Squares Mean (LSM) was calculated using a mixed model for repeated measures (MMRM) with treatment, visit, treatment-by-visit-interactions as fixed categorical effects and baseline and baseline-by-visit-interactions as fixed continuous effects.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline, Year 3

Population: All enrolled participants treated with at least one dose of study drug in JADY with available baseline x-ray (from originating study) and at least 1 postbaseline x-ray assessment (collected in JADY) and Year 3 data. JADW and JADA, zero participants analyzed due to no data collected in this study or originating study.

Outcome measures

Outcome measures
Measure	2 mg Baricitinib n=387 Participants 2 mg Baricitinib administered orally once daily.	4 mg Baricitinib n=343 Participants 4 mg Baricitinib administered orally once daily.	2 mg Baricitinib Step-down n=137 Participants 2 mg Baricitinib administered orally once daily in the 96-week Step-down period.	4 mg Baricitinib Step-down n=301 Participants 4 mg Baricitinib administered orally once daily in the 96-week Step-down period.	JADW 2 mg Baricitinib 2 mg Baricitinib administered orally once daily.	JADW 4 mg Baricitinib 4 mg Baricitinib administered orally once daily.	JAGS 4 mg Baricitinib n=203 Participants 4 mg Baricitinib administered orally once daily.	JADA 4 mg Baricitinib 4 mg Baricitinib administered orally once daily.
Change From Baseline of Originating Study in Modified Total Sharp Score (mTSS)	1.30 score on a scale Interval 0.94 to 1.67	1.64 score on a scale Interval 1.38 to 1.9	1.13 score on a scale Interval 0.61 to 1.66	1.13 score on a scale Interval 0.78 to 1.48	—	—	1.20 score on a scale Interval 0.61 to 1.8	—

SECONDARY outcome

Timeframe: Baseline, Year 5

Population: All enrolled participants treated with at least one dose of study drug in JADY with available baseline x-ray (from originating study) and at least 1 postbaseline x-ray assessment (collected in JADY) and Year 5 data. JAGS, JADW and JADA, zero participants analyzed due to no data collected in this study or originating study.

Outcome measures

Outcome measures
Measure	2 mg Baricitinib n=349 Participants 2 mg Baricitinib administered orally once daily.	4 mg Baricitinib n=870 Participants 4 mg Baricitinib administered orally once daily.	2 mg Baricitinib Step-down n=127 Participants 2 mg Baricitinib administered orally once daily in the 96-week Step-down period.	4 mg Baricitinib Step-down n=276 Participants 4 mg Baricitinib administered orally once daily in the 96-week Step-down period.	JADW 2 mg Baricitinib 2 mg Baricitinib administered orally once daily.	JADW 4 mg Baricitinib 4 mg Baricitinib administered orally once daily.	JAGS 4 mg Baricitinib 4 mg Baricitinib administered orally once daily.	JADA 4 mg Baricitinib 4 mg Baricitinib administered orally once daily.
Change From Baseline of Originating Study in Modified Total Sharp Score (mTSS)	1.64 score on a scale Interval 1.18 to 2.09	2.18 score on a scale Interval 1.85 to 2.51	1.32 score on a scale Interval 0.69 to 1.96	1.58 score on a scale Interval 1.15 to 2.02	—	—	—	—

SECONDARY outcome

Timeframe: Year 1 after entry into JADY

Population: All enrolled participants who received at least one dose of study drug and completed at least 48 weeks in study JADY. Year 1 data not available, zero participants analyzed due to no data collected in this study or originating study.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Year 3 after entry into JADY

Population: All enrolled participants who received at least one dose of study drug and completed at least 48 weeks in study JADY. JADW and JADA, zero participants analyzed due to no data collected in this study or originating study.

Outcome measures

Outcome measures
Measure	2 mg Baricitinib n=419 Participants 2 mg Baricitinib administered orally once daily.	4 mg Baricitinib n=1034 Participants 4 mg Baricitinib administered orally once daily.	2 mg Baricitinib Step-down n=169 Participants 2 mg Baricitinib administered orally once daily in the 96-week Step-down period.	4 mg Baricitinib Step-down n=366 Participants 4 mg Baricitinib administered orally once daily in the 96-week Step-down period.	JADW 2 mg Baricitinib 2 mg Baricitinib administered orally once daily.	JADW 4 mg Baricitinib 4 mg Baricitinib administered orally once daily.	JAGS 4 mg Baricitinib n=210 Participants 4 mg Baricitinib administered orally once daily.	JADA 4 mg Baricitinib 4 mg Baricitinib administered orally once daily.
Percentage of Participants With mTSS Change ≤0	53.5 percentage of participants Interval 48.7 to 58.2	53.0 percentage of participants Interval 50.0 to 56.0	0.6 percentage of participants Interval 0.1 to 3.3	0.8 percentage of participants Interval 0.3 to 2.4	—	—	0 percentage of participants Interval 0.0 to 1.8	—

SECONDARY outcome

Timeframe: Year 5 after entry into JADY

Outcome measures

Outcome measures
Measure	2 mg Baricitinib n=419 Participants 2 mg Baricitinib administered orally once daily.	4 mg Baricitinib n=1034 Participants 4 mg Baricitinib administered orally once daily.	2 mg Baricitinib Step-down n=169 Participants 2 mg Baricitinib administered orally once daily in the 96-week Step-down period.	4 mg Baricitinib Step-down n=366 Participants 4 mg Baricitinib administered orally once daily in the 96-week Step-down period.	JADW 2 mg Baricitinib 2 mg Baricitinib administered orally once daily.	JADW 4 mg Baricitinib 4 mg Baricitinib administered orally once daily.	JAGS 4 mg Baricitinib n=210 Participants 4 mg Baricitinib administered orally once daily.	JADA 4 mg Baricitinib 4 mg Baricitinib administered orally once daily.
Percentage of Participants With mTSS Change ≤0	1.7 percentage of participants Interval 0.8 to 3.4	0.6 percentage of participants Interval 0.3 to 1.3	0 percentage of participants Interval 0.0 to 2.2	0.5 percentage of participants Interval 0.1 to 2.0	—	—	0 percentage of participants Interval 0.0 to 1.8	—

SECONDARY outcome

Timeframe: Baseline, Year 1

Population: All enrolled participants treated with at least one dose of study drug in JADY with available baseline (from originating study) and at least 1 postbaseline x-ray assessment (collected in JADY). Year 1 data not available, zero participants analyzed due to no data collected in this study or originating study.

X-rays of the hands/wrists and feet were assessed for joint space narrowing (JSN) and bone erosions. Assessment of JSN for each hand (15 joints per hand) and foot (6 joints per foot), including subluxation, is scored from 0 to 4, with 0 indicating no (normal) JSN and 4 indicating complete loss of joint space, bony ankylosis or luxation. JSN scores ranged from 0-168. A score of 0 would indicate no change and higher scores represent a worsening of joint space narrowing.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline, Year 3

Population: All enrolled participants treated with at least one dose of study drug in JADY with available baseline (from originating study) and at least 1 postbaseline x-ray assessment (collected in JADY). JADW and JADA, zero participants analyzed due to no data collected in this study or originating study.

Outcome measures

Outcome measures
Measure	2 mg Baricitinib n=387 Participants 2 mg Baricitinib administered orally once daily.	4 mg Baricitinib n=943 Participants 4 mg Baricitinib administered orally once daily.	2 mg Baricitinib Step-down n=137 Participants 2 mg Baricitinib administered orally once daily in the 96-week Step-down period.	4 mg Baricitinib Step-down n=301 Participants 4 mg Baricitinib administered orally once daily in the 96-week Step-down period.	JADW 2 mg Baricitinib 2 mg Baricitinib administered orally once daily.	JADW 4 mg Baricitinib 4 mg Baricitinib administered orally once daily.	JAGS 4 mg Baricitinib n=203 Participants 4 mg Baricitinib administered orally once daily.	JADA 4 mg Baricitinib 4 mg Baricitinib administered orally once daily.
Change From Baseline of Originating Study in Joint Space Narrowing at Year 3	0.45 score on a scale Interval 0.26 to 0.63	0.72 score on a scale Interval 0.59 to 0.86	0.54 score on a scale Interval 0.25 to 0.83	0.44 score on a scale Interval 0.24 to 0.63	—	—	0.52 score on a scale Interval 0.23 to 0.82	—

SECONDARY outcome

Timeframe: Baseline, Year 5

Population: All enrolled participants treated with at least one dose of study drug in JADY with available baseline (from originating study) and at least 1 postbaseline x-ray assessment (collected in JADY). JAGS, JADW, and JADA, zero participants analyzed due to no data collected in this study or originating study.

Outcome measures

Outcome measures
Measure	2 mg Baricitinib n=349 Participants 2 mg Baricitinib administered orally once daily.	4 mg Baricitinib n=870 Participants 4 mg Baricitinib administered orally once daily.	2 mg Baricitinib Step-down n=127 Participants 2 mg Baricitinib administered orally once daily in the 96-week Step-down period.	4 mg Baricitinib Step-down n=276 Participants 4 mg Baricitinib administered orally once daily in the 96-week Step-down period.	JADW 2 mg Baricitinib 2 mg Baricitinib administered orally once daily.	JADW 4 mg Baricitinib 4 mg Baricitinib administered orally once daily.	JAGS 4 mg Baricitinib 4 mg Baricitinib administered orally once daily.	JADA 4 mg Baricitinib 4 mg Baricitinib administered orally once daily.
Change From Baseline of Originating Study in Joint Space Narrowing at Year 5	0.59 score on a scale Interval 0.36 to 0.83	1.00 score on a scale Interval 0.84 to 1.17	0.68 score on a scale Interval 0.34 to 1.02	0.60 score on a scale Interval 0.37 to 0.83	—	—	—	—

SECONDARY outcome

Timeframe: Baseline, Year 1

Population: All enrolled participants who received at least one dose of study drug in JADY and had evaluable morning stiffness data. Data not collected for JADX; zero participants analyzed.

Participants reported the duration of their morning joint stiffness (MJS) in hours and minutes. The participants were asked about their duration of morning joint stiffness on the day prior to the study visit to capture actual symptoms, since the participant may have had an atypical morning routine on the day of the study visit. If morning joint stiffness duration was longer than 12 hours (720 minutes), it was truncated to 720 minutes for statistical presentations and analyses. A decrease in duration of morning joint stiffness indicated an improvement in the participant's condition.

Outcome measures

Outcome measures
Measure	2 mg Baricitinib n=450 Participants 2 mg Baricitinib administered orally once daily.	4 mg Baricitinib n=633 Participants 4 mg Baricitinib administered orally once daily.	2 mg Baricitinib Step-down 2 mg Baricitinib administered orally once daily in the 96-week Step-down period.	4 mg Baricitinib Step-down 4 mg Baricitinib administered orally once daily in the 96-week Step-down period.	JADW 2 mg Baricitinib n=110 Participants 2 mg Baricitinib administered orally once daily.	JADW 4 mg Baricitinib n=308 Participants 4 mg Baricitinib administered orally once daily.	JAGS 4 mg Baricitinib n=221 Participants 4 mg Baricitinib administered orally once daily.	JADA 4 mg Baricitinib n=78 Participants 4 mg Baricitinib administered orally once daily.
Change From Baseline of Originating Study in Duration of Morning Stiffness	-102.72 minutes Standard Deviation 155.27	-73.53 minutes Standard Deviation 144.22	—	—	-75.07 minutes Standard Deviation 139.00	-73.88 minutes Standard Deviation 149.55	-68.74 minutes Standard Deviation 148.34	-37.12 minutes Standard Deviation 61.34

SECONDARY outcome

Timeframe: Baseline, Year 3

Population: All enrolled participants who received at least one dose of study drug in JADY and had evaluable morning stiffness data. Data not collected for JADX; zero participants analyzed.

Outcome measures

Outcome measures
Measure	2 mg Baricitinib n=387 Participants 2 mg Baricitinib administered orally once daily.	4 mg Baricitinib n=556 Participants 4 mg Baricitinib administered orally once daily.	2 mg Baricitinib Step-down 2 mg Baricitinib administered orally once daily in the 96-week Step-down period.	4 mg Baricitinib Step-down 4 mg Baricitinib administered orally once daily in the 96-week Step-down period.	JADW 2 mg Baricitinib n=81 Participants 2 mg Baricitinib administered orally once daily.	JADW 4 mg Baricitinib n=222 Participants 4 mg Baricitinib administered orally once daily.	JAGS 4 mg Baricitinib n=192 Participants 4 mg Baricitinib administered orally once daily.	JADA 4 mg Baricitinib n=69 Participants 4 mg Baricitinib administered orally once daily.
Change From Baseline of Originating Study in Duration of Morning Stiffness	-112.41 minutes Standard Deviation 159.78	-77.78 minutes Standard Deviation 141.01	—	—	-84.60 minutes Standard Deviation 127.85	-67.79 minutes Standard Deviation 154.05	-90.61 minutes Standard Deviation 147.70	-47.13 minutes Standard Deviation 52.97

SECONDARY outcome

Timeframe: Baseline, Year 5

Population: All enrolled participants who received at least one dose of study drug in JADY and had evaluable morning stiffness data. Data not collected for JADX; zero participants analyzed.

Outcome measures

Outcome measures
Measure	2 mg Baricitinib n=330 Participants 2 mg Baricitinib administered orally once daily.	4 mg Baricitinib n=470 Participants 4 mg Baricitinib administered orally once daily.	2 mg Baricitinib Step-down 2 mg Baricitinib administered orally once daily in the 96-week Step-down period.	4 mg Baricitinib Step-down 4 mg Baricitinib administered orally once daily in the 96-week Step-down period.	JADW 2 mg Baricitinib n=70 Participants 2 mg Baricitinib administered orally once daily.	JADW 4 mg Baricitinib n=169 Participants 4 mg Baricitinib administered orally once daily.	JAGS 4 mg Baricitinib n=128 Participants 4 mg Baricitinib administered orally once daily.	JADA 4 mg Baricitinib n=57 Participants 4 mg Baricitinib administered orally once daily.
Change From Baseline of Originating Study in Duration of Morning Stiffness	-111.45 minutes Standard Deviation 164.74	-82.48 minutes Standard Deviation 137.23	—	—	-88.37 minutes Standard Deviation 146.73	-91.57 minutes Standard Deviation 163.88	-92.75 minutes Standard Deviation 125.39	-45.89 minutes Standard Deviation 60.43

SECONDARY outcome

Timeframe: Baseline, Year 1

Population: All enrolled participants who received at least one dose of study drug and had evaluable EQ-5D-5L data. EQ-5D-5L data was not collected during the JADA originating study, zero participants analyzed.

The European Quality of Life-5 Dimensions-5 Level (EQ-5D-5L) is a standardized measure of health status of the participant. The first component is a descriptive system of the respondent's health comprised of the following 5 participant-reported dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems, and extreme problems. The responses are used to derive the health state index scores using the United Kingdom (UK) algorithm, with scores ranging from -0.594 to 1, and the United States (US) algorithm, with scores ranging from -0.109 to 1. A higher score indicates better health state.

Outcome measures

Outcome measures
Measure	2 mg Baricitinib n=450 Participants 2 mg Baricitinib administered orally once daily.	4 mg Baricitinib n=1088 Participants 4 mg Baricitinib administered orally once daily.	2 mg Baricitinib Step-down n=171 Participants 2 mg Baricitinib administered orally once daily in the 96-week Step-down period.	4 mg Baricitinib Step-down n=383 Participants 4 mg Baricitinib administered orally once daily in the 96-week Step-down period.	JADW 2 mg Baricitinib n=108 Participants 2 mg Baricitinib administered orally once daily.	JADW 4 mg Baricitinib n=305 Participants 4 mg Baricitinib administered orally once daily.	JAGS 4 mg Baricitinib n=221 Participants 4 mg Baricitinib administered orally once daily.	JADA 4 mg Baricitinib 4 mg Baricitinib administered orally once daily.
Change From Baseline of Originating Study in European Quality of Life-5 Dimensions-5 Level (EQ-5D-5L) Health State Scores UK	0.28 score on a scale Standard Deviation 0.26	0.23 score on a scale Standard Deviation 0.24	0.19 score on a scale Standard Deviation 0.26	0.20 score on a scale Standard Deviation 0.23	0.21 score on a scale Standard Deviation 0.22	0.19 score on a scale Standard Deviation 0.24	0.20 score on a scale Standard Deviation 0.26	—
Change From Baseline of Originating Study in European Quality of Life-5 Dimensions-5 Level (EQ-5D-5L) Health State Scores US	0.19 score on a scale Standard Deviation 0.18	0.16 score on a scale Standard Deviation 0.17	0.13 score on a scale Standard Deviation 0.18	0.14 score on a scale Standard Deviation 0.16	0.14 score on a scale Standard Deviation 0.15	0.13 score on a scale Standard Deviation 0.16	0.14 score on a scale Standard Deviation 0.18	—

SECONDARY outcome

Timeframe: Baseline, Year 3

Outcome measures

Outcome measures
Measure	2 mg Baricitinib n=386 Participants 2 mg Baricitinib administered orally once daily.	4 mg Baricitinib n=952 Participants 4 mg Baricitinib administered orally once daily.	2 mg Baricitinib Step-down n=146 Participants 2 mg Baricitinib administered orally once daily in the 96-week Step-down period.	4 mg Baricitinib Step-down n=309 Participants 4 mg Baricitinib administered orally once daily in the 96-week Step-down period.	JADW 2 mg Baricitinib n=80 Participants 2 mg Baricitinib administered orally once daily.	JADW 4 mg Baricitinib n=219 Participants 4 mg Baricitinib administered orally once daily.	JAGS 4 mg Baricitinib n=190 Participants 4 mg Baricitinib administered orally once daily.	JADA 4 mg Baricitinib 4 mg Baricitinib administered orally once daily.
Change From Baseline of Originating Study in European Quality of Life-5 Dimensions-5 Level (EQ-5D-5L) Health State Scores UK	0.33 score on a scale Standard Deviation 0.24	0.24 score on a scale Standard Deviation 0.25	0.20 score on a scale Standard Deviation 0.26	0.21 score on a scale Standard Deviation 0.26	0.21 score on a scale Standard Deviation 0.22	0.22 score on a scale Standard Deviation 0.25	0.24 score on a scale Standard Deviation 0.24	—
Change From Baseline of Originating Study in European Quality of Life-5 Dimensions-5 Level (EQ-5D-5L) Health State Scores US	0.23 score on a scale Standard Deviation 0.17	0.17 score on a scale Standard Deviation 0.17	0.15 score on a scale Standard Deviation 0.18	0.15 score on a scale Standard Deviation 0.18	0.14 score on a scale Standard Deviation 0.15	0.15 score on a scale Standard Deviation 0.17	0.17 score on a scale Standard Deviation 0.17	—

SECONDARY outcome

Timeframe: Baseline, Year 5

Outcome measures

Outcome measures
Measure	2 mg Baricitinib n=330 Participants 2 mg Baricitinib administered orally once daily.	4 mg Baricitinib n=820 Participants 4 mg Baricitinib administered orally once daily.	2 mg Baricitinib Step-down n=122 Participants 2 mg Baricitinib administered orally once daily in the 96-week Step-down period.	4 mg Baricitinib Step-down n=264 Participants 4 mg Baricitinib administered orally once daily in the 96-week Step-down period.	JADW 2 mg Baricitinib n=70 Participants 2 mg Baricitinib administered orally once daily.	JADW 4 mg Baricitinib n=169 Participants 4 mg Baricitinib administered orally once daily.	JAGS 4 mg Baricitinib n=127 Participants 4 mg Baricitinib administered orally once daily.	JADA 4 mg Baricitinib 4 mg Baricitinib administered orally once daily.
Change From Baseline of Originating Study in European Quality of Life-5 Dimensions-5 Level (EQ-5D-5L) Health State Scores UK	0.35 score on a scale Standard Deviation 0.24	0.26 score on a scale Standard Deviation 0.26	0.19 score on a scale Standard Deviation 0.25	0.20 score on a scale Standard Deviation 0.26	0.21 score on a scale Standard Deviation 0.22	0.22 score on a scale Standard Deviation 0.30	0.25 score on a scale Standard Deviation 0.26	—
Change From Baseline of Originating Study in European Quality of Life-5 Dimensions-5 Level (EQ-5D-5L) Health State Scores US	0.24 score on a scale Standard Deviation 0.16	0.18 score on a scale Standard Deviation 0.18	0.13 score on a scale Standard Deviation 0.17	0.14 score on a scale Standard Deviation 0.18	0.15 score on a scale Standard Deviation 0.15	0.15 score on a scale Standard Deviation 0.20	0.18 score on a scale Standard Deviation 0.18	—

SECONDARY outcome

Timeframe: Baseline, Year 1

The European Quality of Life-5 Dimensions-5 Level (EQ-5D-5L) is a standardized measure of health status of the participant. The second component is a self-perceived health score which is assessed using a VAS that ranged from 0 to 100 millimeter (mm), where 0 mm indicated the worst health you can imagine and 100 mm indicated the best health you can imagine.

Outcome measures

Outcome measures
Measure	2 mg Baricitinib n=450 Participants 2 mg Baricitinib administered orally once daily.	4 mg Baricitinib n=1088 Participants 4 mg Baricitinib administered orally once daily.	2 mg Baricitinib Step-down n=171 Participants 2 mg Baricitinib administered orally once daily in the 96-week Step-down period.	4 mg Baricitinib Step-down n=383 Participants 4 mg Baricitinib administered orally once daily in the 96-week Step-down period.	JADW 2 mg Baricitinib n=108 Participants 2 mg Baricitinib administered orally once daily.	JADW 4 mg Baricitinib n=305 Participants 4 mg Baricitinib administered orally once daily.	JAGS 4 mg Baricitinib n=221 Participants 4 mg Baricitinib administered orally once daily.	JADA 4 mg Baricitinib 4 mg Baricitinib administered orally once daily.
Change From Baseline of Originating Study in European Quality of Life-5 Dimensions-5 Level (EQ-5D-5L) Scores (Self-Perceived Health)	24.69 millimeter (mm) Standard Deviation 28.50	19.72 millimeter (mm) Standard Deviation 28.17	15.13 millimeter (mm) Standard Deviation 26.78	18.32 millimeter (mm) Standard Deviation 26.35	20.96 millimeter (mm) Standard Deviation 24.53	14.98 millimeter (mm) Standard Deviation 30.21	18.47 millimeter (mm) Standard Deviation 27.31	—

SECONDARY outcome

Timeframe: Baseline, Year 3

Outcome measures

Outcome measures
Measure	2 mg Baricitinib n=386 Participants 2 mg Baricitinib administered orally once daily.	4 mg Baricitinib n=952 Participants 4 mg Baricitinib administered orally once daily.	2 mg Baricitinib Step-down n=146 Participants 2 mg Baricitinib administered orally once daily in the 96-week Step-down period.	4 mg Baricitinib Step-down n=309 Participants 4 mg Baricitinib administered orally once daily in the 96-week Step-down period.	JADW 2 mg Baricitinib n=80 Participants 2 mg Baricitinib administered orally once daily.	JADW 4 mg Baricitinib n=219 Participants 4 mg Baricitinib administered orally once daily.	JAGS 4 mg Baricitinib n=190 Participants 4 mg Baricitinib administered orally once daily.	JADA 4 mg Baricitinib 4 mg Baricitinib administered orally once daily.
Change From Baseline of Originating Study in European Quality of Life-5 Dimensions-5 Level (EQ-5D-5L) Scores (Self-Perceived Health)	28.48 mm Standard Deviation 29.88	22.10 mm Standard Deviation 28.02	16.29 mm Standard Deviation 25.37	16.48 mm Standard Deviation 30.24	23.53 mm Standard Deviation 24.70	18.79 mm Standard Deviation 30.03	21.45 mm Standard Deviation 29.64	—

SECONDARY outcome

Timeframe: Baseline, Year 5

Outcome measures

Outcome measures
Measure	2 mg Baricitinib n=330 Participants 2 mg Baricitinib administered orally once daily.	4 mg Baricitinib n=820 Participants 4 mg Baricitinib administered orally once daily.	2 mg Baricitinib Step-down n=122 Participants 2 mg Baricitinib administered orally once daily in the 96-week Step-down period.	4 mg Baricitinib Step-down n=264 Participants 4 mg Baricitinib administered orally once daily in the 96-week Step-down period.	JADW 2 mg Baricitinib n=70 Participants 2 mg Baricitinib administered orally once daily.	JADW 4 mg Baricitinib n=169 Participants 4 mg Baricitinib administered orally once daily.	JAGS 4 mg Baricitinib n=127 Participants 4 mg Baricitinib administered orally once daily.	JADA 4 mg Baricitinib 4 mg Baricitinib administered orally once daily.
Change From Baseline of Originating Study in European Quality of Life-5 Dimensions-5 Level (EQ-5D-5L) Scores (Self-Perceived Health)	31.13 mm Standard Deviation 28.15	23.93 mm Standard Deviation 28.45	13.82 mm Standard Deviation 29.59	19.34 mm Standard Deviation 27.48	26.19 mm Standard Deviation 27.09	23.57 mm Standard Deviation 31.67	27.31 mm Standard Deviation 27.19	—

SECONDARY outcome

Timeframe: Year 1 after entry into JADY

Population: All enrolled participants who received at least one dose of study drug and completed at least 48 weeks in study JADY.

The CDAI is a tool for measurement of disease activity in RA that does not require a laboratory component and was scored by the investigative site. It integrates TJC28 (scored 0-28 with higher scores indicating higher disease activity), SJC28 (scored 0-28 with higher scores indicating higher disease activity), Patient's Global Assessment of Disease Activity (scored on a visual analogue scale from 0-10 cm with higher scores indicating higher disease activity), and Physician's Global Assessment of Disease Activity (scored on a visual analogue scale from 0-10 cm with higher scores indicating higher disease activity). The CDAI is calculated by summing the values of the 4 components. CDAI scores range from 0 to 76; lower scores indicated lower disease activity. A negative change from baseline indicates improvement in condition.

Outcome measures

Outcome measures
Measure	2 mg Baricitinib n=419 Participants 2 mg Baricitinib administered orally once daily.	4 mg Baricitinib n=1034 Participants 4 mg Baricitinib administered orally once daily.	2 mg Baricitinib Step-down n=169 Participants 2 mg Baricitinib administered orally once daily in the 96-week Step-down period.	4 mg Baricitinib Step-down n=366 Participants 4 mg Baricitinib administered orally once daily in the 96-week Step-down period.	JADW 2 mg Baricitinib n=101 Participants 2 mg Baricitinib administered orally once daily.	JADW 4 mg Baricitinib n=274 Participants 4 mg Baricitinib administered orally once daily.	JAGS 4 mg Baricitinib n=210 Participants 4 mg Baricitinib administered orally once daily.	JADA 4 mg Baricitinib n=78 Participants 4 mg Baricitinib administered orally once daily.
Percentage of Participants Maintaining a Clinical Disease Activity Index Score (CDAI) ≤10	81.6 percentage of participants Interval 77.6 to 85.0	75.3 percentage of participants Interval 72.6 to 77.9	68.6 percentage of participants Interval 61.3 to 75.2	69.9 percentage of participants Interval 65.1 to 74.4	52.5 percentage of participants Interval 42.8 to 61.9	50.7 percentage of participants Interval 44.8 to 56.6	73.3 percentage of participants Interval 67.0 to 78.9	60.3 percentage of participants Interval 49.2 to 70.4

SECONDARY outcome

Timeframe: Year 3 after entry into JADY

Population: All enrolled participants who received at least one dose of study drug and completed at least 48 weeks in study JADY.

Outcome measures

Outcome measures
Measure	2 mg Baricitinib n=419 Participants 2 mg Baricitinib administered orally once daily.	4 mg Baricitinib n=1034 Participants 4 mg Baricitinib administered orally once daily.	2 mg Baricitinib Step-down n=169 Participants 2 mg Baricitinib administered orally once daily in the 96-week Step-down period.	4 mg Baricitinib Step-down n=366 Participants 4 mg Baricitinib administered orally once daily in the 96-week Step-down period.	JADW 2 mg Baricitinib n=101 Participants 2 mg Baricitinib administered orally once daily.	JADW 4 mg Baricitinib n=274 Participants 4 mg Baricitinib administered orally once daily.	JAGS 4 mg Baricitinib n=210 Participants 4 mg Baricitinib administered orally once daily.	JADA 4 mg Baricitinib n=78 Participants 4 mg Baricitinib administered orally once daily.
Percentage of Participants Maintaining a Clinical Disease Activity Index Score (CDAI) ≤10	73.3 percentage of participants Interval 68.8 to 77.3	67.7 percentage of participants Interval 64.8 to 70.5	60.4 percentage of participants Interval 52.8 to 67.4	60.4 percentage of participants Interval 55.3 to 65.3	49.5 percentage of participants Interval 40.0 to 59.1	44.5 percentage of participants Interval 38.8 to 50.4	61.4 percentage of participants Interval 54.7 to 67.8	56.4 percentage of participants Interval 45.4 to 66.9

SECONDARY outcome

Timeframe: Years 5 after entry into JADY

Population: All enrolled participants who received at least one dose of study drug and completed at least 48 weeks in study JADY.

Outcome measures

Outcome measures
Measure	2 mg Baricitinib n=419 Participants 2 mg Baricitinib administered orally once daily.	4 mg Baricitinib n=1034 Participants 4 mg Baricitinib administered orally once daily.	2 mg Baricitinib Step-down n=169 Participants 2 mg Baricitinib administered orally once daily in the 96-week Step-down period.	4 mg Baricitinib Step-down n=366 Participants 4 mg Baricitinib administered orally once daily in the 96-week Step-down period.	JADW 2 mg Baricitinib n=101 Participants 2 mg Baricitinib administered orally once daily.	JADW 4 mg Baricitinib n=274 Participants 4 mg Baricitinib administered orally once daily.	JAGS 4 mg Baricitinib n=210 Participants 4 mg Baricitinib administered orally once daily.	JADA 4 mg Baricitinib n=78 Participants 4 mg Baricitinib administered orally once daily.
Percentage of Participants Maintaining a Clinical Disease Activity Index Score (CDAI) ≤10	61.6 percentage of participants Interval 56.8 to 66.1	61.1 percentage of participants Interval 58.1 to 64.0	51.5 percentage of participants Interval 44.0 to 58.9	54.6 percentage of participants Interval 49.5 to 59.7	44.6 percentage of participants Interval 35.2 to 54.3	35.4 percentage of participants Interval 30.0 to 41.2	21.9 percentage of participants Interval 16.8 to 28.0	56.4 percentage of participants Interval 45.4 to 66.9

SECONDARY outcome

Timeframe: Year 1 after entry into JADY

Population: All enrolled participants who received at least one dose of study drug and completed at least 48 weeks in study JADY.

Outcome measures

Outcome measures
Measure	2 mg Baricitinib n=419 Participants 2 mg Baricitinib administered orally once daily.	4 mg Baricitinib n=1034 Participants 4 mg Baricitinib administered orally once daily.	2 mg Baricitinib Step-down n=169 Participants 2 mg Baricitinib administered orally once daily in the 96-week Step-down period.	4 mg Baricitinib Step-down n=366 Participants 4 mg Baricitinib administered orally once daily in the 96-week Step-down period.	JADW 2 mg Baricitinib n=101 Participants 2 mg Baricitinib administered orally once daily.	JADW 4 mg Baricitinib n=274 Participants 4 mg Baricitinib administered orally once daily.	JAGS 4 mg Baricitinib n=210 Participants 4 mg Baricitinib administered orally once daily.	JADA 4 mg Baricitinib n=78 Participants 4 mg Baricitinib administered orally once daily.
Percentage of Participants Maintaining a Clinical Disease Activity Index Score (CDAI) ≤ 2.8	44.9 percentage of participants Interval 40.2 to 49.7	28.3 percentage of participants Interval 25.7 to 31.2	21.9 percentage of participants Interval 16.3 to 28.7	25.1 percentage of participants Interval 21.0 to 29.8	16.8 percentage of participants Interval 10.8 to 25.3	13.5 percentage of participants Interval 10.0 to 18.1	22.9 percentage of participants Interval 17.7 to 29.0	14.1 percentage of participants Interval 8.1 to 23.5

SECONDARY outcome

Timeframe: Year 3 after entry into JADY

Population: All enrolled participants who received at least one dose of study drug and completed at least 48 weeks in study JADY.

Outcome measures

Outcome measures
Measure	2 mg Baricitinib n=419 Participants 2 mg Baricitinib administered orally once daily.	4 mg Baricitinib n=1034 Participants 4 mg Baricitinib administered orally once daily.	2 mg Baricitinib Step-down n=169 Participants 2 mg Baricitinib administered orally once daily in the 96-week Step-down period.	4 mg Baricitinib Step-down n=366 Participants 4 mg Baricitinib administered orally once daily in the 96-week Step-down period.	JADW 2 mg Baricitinib n=101 Participants 2 mg Baricitinib administered orally once daily.	JADW 4 mg Baricitinib n=274 Participants 4 mg Baricitinib administered orally once daily.	JAGS 4 mg Baricitinib n=210 Participants 4 mg Baricitinib administered orally once daily.	JADA 4 mg Baricitinib n=78 Participants 4 mg Baricitinib administered orally once daily.
Percentage of Participants Maintaining a Clinical Disease Activity Index Score (CDAI) ≤2.8	40.1 percentage of participants Interval 35.5 to 44.9	30.0 percentage of participants Interval 27.3 to 32.8	21.9 percentage of participants Interval 16.3 to 28.7	23.5 percentage of participants Interval 19.4 to 28.1	22.8 percentage of participants Interval 15.7 to 31.9	15.0 percentage of participants Interval 11.2 to 19.7	18.6 percentage of participants Interval 13.9 to 24.4	20.5 percentage of participants Interval 13.0 to 30.8

SECONDARY outcome

Timeframe: Year 5 after entry into JADY

Population: All enrolled participants who received at least one dose of study drug and completed at least 48 weeks in study JADY.

Outcome measures

Outcome measures
Measure	2 mg Baricitinib n=419 Participants 2 mg Baricitinib administered orally once daily.	4 mg Baricitinib n=1034 Participants 4 mg Baricitinib administered orally once daily.	2 mg Baricitinib Step-down n=169 Participants 2 mg Baricitinib administered orally once daily in the 96-week Step-down period.	4 mg Baricitinib Step-down n=366 Participants 4 mg Baricitinib administered orally once daily in the 96-week Step-down period.	JADW 2 mg Baricitinib n=101 Participants 2 mg Baricitinib administered orally once daily.	JADW 4 mg Baricitinib n=274 Participants 4 mg Baricitinib administered orally once daily.	JAGS 4 mg Baricitinib n=210 Participants 4 mg Baricitinib administered orally once daily.	JADA 4 mg Baricitinib n=78 Participants 4 mg Baricitinib administered orally once daily.
Percentage of Participants Maintaining a Clinical Disease Activity Index Score (CDAI) ≤2.8	33.9 percentage of participants Interval 29.5 to 38.6	25.0 percentage of participants Interval 22.5 to 27.8	19.5 percentage of participants Interval 14.3 to 26.2	22.4 percentage of participants Interval 18.4 to 27.0	15.8 percentage of participants Interval 10.0 to 24.2	12.8 percentage of participants Interval 9.3 to 17.2	8.1 percentage of participants Interval 5.1 to 12.6	19.2 percentage of participants Interval 12.0 to 29.3

SECONDARY outcome

Timeframe: Year 1 after entry into JADY

Population: All enrolled participants who received at least one dose of study drug and completed at least 48 weeks in study JADY.

The HAQ-DI questionnaire assesses the participant's self-perception on the degree of difficulty \[0 (without any difficulty), 1 (with some difficulty), 2 (with much difficulty), and 3 (unable to do)\] when dressing and grooming, arising, eating, walking, hygiene, reaching, gripping, and performing other daily activities. Scores for each functional area were averaged to calculate HAQ-DI scores, which ranged from 0 (no disability) to 3 (worst disability). A decrease in HAQ-DI score indicated an improvement in the participant's condition. An improvement of 0.22 or 0.3 points on the HAQ-DI has been identified as a minimal clinically important difference in Rheumatoid Arthritis participants.

Outcome measures

Outcome measures
Measure	2 mg Baricitinib n=419 Participants 2 mg Baricitinib administered orally once daily.	4 mg Baricitinib n=1034 Participants 4 mg Baricitinib administered orally once daily.	2 mg Baricitinib Step-down n=169 Participants 2 mg Baricitinib administered orally once daily in the 96-week Step-down period.	4 mg Baricitinib Step-down n=366 Participants 4 mg Baricitinib administered orally once daily in the 96-week Step-down period.	JADW 2 mg Baricitinib n=101 Participants 2 mg Baricitinib administered orally once daily.	JADW 4 mg Baricitinib n=274 Participants 4 mg Baricitinib administered orally once daily.	JAGS 4 mg Baricitinib n=210 Participants 4 mg Baricitinib administered orally once daily.	JADA 4 mg Baricitinib n=78 Participants 4 mg Baricitinib administered orally once daily.
Percentage of Participants Maintaining a Health Assessment Questionnaire Disability Index (HAQ-DI) Improvement ≥0.22	89.7 percentage of participants Interval 86.5 to 92.3	81.4 percentage of participants Interval 78.9 to 83.7	78.7 percentage of participants Interval 71.9 to 84.2	75.4 percentage of participants Interval 70.7 to 79.5	74.3 percentage of participants Interval 65.0 to 81.8	69.3 percentage of participants Interval 63.6 to 74.5	80.0 percentage of participants Interval 74.1 to 84.8	48.7 percentage of participants Interval 37.9 to 59.6

SECONDARY outcome

Timeframe: Year 3 after entry into JADY

Population: All enrolled participants who received at least one dose of study drug and completed at least 48 weeks in study JADY.

Outcome measures

Outcome measures
Measure	2 mg Baricitinib n=419 Participants 2 mg Baricitinib administered orally once daily.	4 mg Baricitinib n=1034 Participants 4 mg Baricitinib administered orally once daily.	2 mg Baricitinib Step-down n=169 Participants 2 mg Baricitinib administered orally once daily in the 96-week Step-down period.	4 mg Baricitinib Step-down n=366 Participants 4 mg Baricitinib administered orally once daily in the 96-week Step-down period.	JADW 2 mg Baricitinib n=101 Participants 2 mg Baricitinib administered orally once daily.	JADW 4 mg Baricitinib n=274 Participants 4 mg Baricitinib administered orally once daily.	JAGS 4 mg Baricitinib n=210 Participants 4 mg Baricitinib administered orally once daily.	JADA 4 mg Baricitinib n=78 Participants 4 mg Baricitinib administered orally once daily.
Percentage of Participants Maintaining a Health Assessment Questionnaire Disability Index (HAQ-DI) Improvement ≥0.22	75.4 percentage of participants Interval 71.1 to 79.3	70.4 percentage of participants Interval 67.6 to 73.1	64.5 percentage of participants Interval 57.0 to 71.3	63.4 percentage of participants Interval 58.3 to 68.2	56.4 percentage of participants Interval 46.7 to 65.7	54.4 percentage of participants Interval 48.5 to 60.2	68.1 percentage of participants Interval 61.5 to 74.0	47.4 percentage of participants Interval 36.7 to 58.4

SECONDARY outcome

Timeframe: Year 5 after entry into JADY

Population: All enrolled participants who received at least one dose of study drug and completed at least 48 weeks in study JADY.

Outcome measures

Outcome measures
Measure	2 mg Baricitinib n=419 Participants 2 mg Baricitinib administered orally once daily.	4 mg Baricitinib n=1034 Participants 4 mg Baricitinib administered orally once daily.	2 mg Baricitinib Step-down n=169 Participants 2 mg Baricitinib administered orally once daily in the 96-week Step-down period.	4 mg Baricitinib Step-down n=366 Participants 4 mg Baricitinib administered orally once daily in the 96-week Step-down period.	JADW 2 mg Baricitinib n=101 Participants 2 mg Baricitinib administered orally once daily.	JADW 4 mg Baricitinib n=274 Participants 4 mg Baricitinib administered orally once daily.	JAGS 4 mg Baricitinib n=210 Participants 4 mg Baricitinib administered orally once daily.	JADA 4 mg Baricitinib n=78 Participants 4 mg Baricitinib administered orally once daily.
Percentage of Participants Maintaining a Health Assessment Questionnaire Disability Index (HAQ-DI) Improvement ≥0.22	65.2 percentage of participants Interval 60.5 to 69.6	58.5 percentage of participants Interval 55.5 to 61.5	51.5 percentage of participants Interval 44.0 to 58.9	51.4 percentage of participants Interval 46.3 to 56.4	50.5 percentage of participants Interval 40.9 to 60.0	39.4 percentage of participants Interval 33.8 to 45.3	20.0 percentage of participants Interval 15.2 to 25.9	39.7 percentage of participants Interval 29.6 to 50.8

SECONDARY outcome

Timeframe: Year 1 after entry into JADY

Population: All enrolled participants who received at least one dose of study drug and completed at least 48 weeks in study JADY.

Outcome measures

Outcome measures
Measure	2 mg Baricitinib n=419 Participants 2 mg Baricitinib administered orally once daily.	4 mg Baricitinib n=1034 Participants 4 mg Baricitinib administered orally once daily.	2 mg Baricitinib Step-down n=169 Participants 2 mg Baricitinib administered orally once daily in the 96-week Step-down period.	4 mg Baricitinib Step-down n=366 Participants 4 mg Baricitinib administered orally once daily in the 96-week Step-down period.	JADW 2 mg Baricitinib n=101 Participants 2 mg Baricitinib administered orally once daily.	JADW 4 mg Baricitinib n=274 Participants 4 mg Baricitinib administered orally once daily.	JAGS 4 mg Baricitinib n=210 Participants 4 mg Baricitinib administered orally once daily.	JADA 4 mg Baricitinib n=78 Participants 4 mg Baricitinib administered orally once daily.
Percentage of Participants Maintaining a Health Assessment Questionnaire Disability Index (HAQ-DI) Improvement ≥0.3	85.4 percentage of participants Interval 81.7 to 88.5	75.6 percentage of participants Interval 72.9 to 78.1	72.8 percentage of participants Interval 65.6 to 78.9	69.4 percentage of participants Interval 64.5 to 73.9	65.3 percentage of participants Interval 55.7 to 73.9	61.7 percentage of participants Interval 55.8 to 67.2	75.2 percentage of participants Interval 69.0 to 80.6	43.6 percentage of participants Interval 33.1 to 54.6

SECONDARY outcome

Timeframe: Year 3 after entry into JADY

Population: All enrolled participants who received at least one dose of study drug and completed at least 48 weeks in study JADY.

Outcome measures

Outcome measures
Measure	2 mg Baricitinib n=419 Participants 2 mg Baricitinib administered orally once daily.	4 mg Baricitinib n=1034 Participants 4 mg Baricitinib administered orally once daily.	2 mg Baricitinib Step-down n=169 Participants 2 mg Baricitinib administered orally once daily in the 96-week Step-down period.	4 mg Baricitinib Step-down n=366 Participants 4 mg Baricitinib administered orally once daily in the 96-week Step-down period.	JADW 2 mg Baricitinib n=101 Participants 2 mg Baricitinib administered orally once daily.	JADW 4 mg Baricitinib n=274 Participants 4 mg Baricitinib administered orally once daily.	JAGS 4 mg Baricitinib n=210 Participants 4 mg Baricitinib administered orally once daily.	JADA 4 mg Baricitinib n=78 Participants 4 mg Baricitinib administered orally once daily.
Percentage of Participants Maintaining a Health Assessment Questionnaire Disability Index (HAQ-DI) Improvement ≥0.3	72.6 percentage of participants Interval 68.1 to 76.6	64.8 percentage of participants Interval 61.8 to 67.6	61.5 percentage of participants Interval 54.0 to 68.5	58.5 percentage of participants Interval 53.4 to 63.4	50.5 percentage of participants Interval 40.9 to 60.0	47.8 percentage of participants Interval 42.0 to 53.7	63.8 percentage of participants Interval 57.1 to 70.0	38.5 percentage of participants Interval 28.4 to 49.6

SECONDARY outcome

Timeframe: Year 5 after entry into JADY

Population: All enrolled participants who received at least one dose of study drug and completed at least 48 weeks in study JADY.

Outcome measures

Outcome measures
Measure	2 mg Baricitinib n=419 Participants 2 mg Baricitinib administered orally once daily.	4 mg Baricitinib n=1034 Participants 4 mg Baricitinib administered orally once daily.	2 mg Baricitinib Step-down n=169 Participants 2 mg Baricitinib administered orally once daily in the 96-week Step-down period.	4 mg Baricitinib Step-down n=366 Participants 4 mg Baricitinib administered orally once daily in the 96-week Step-down period.	JADW 2 mg Baricitinib n=101 Participants 2 mg Baricitinib administered orally once daily.	JADW 4 mg Baricitinib n=274 Participants 4 mg Baricitinib administered orally once daily.	JAGS 4 mg Baricitinib n=210 Participants 4 mg Baricitinib administered orally once daily.	JADA 4 mg Baricitinib n=78 Participants 4 mg Baricitinib administered orally once daily.
Percentage of Participants Maintaining a Health Assessment Questionnaire Disability Index (HAQ-DI) Improvement ≥0.3	62.8 percentage of participants Interval 58.0 to 67.3	53.4 percentage of participants Interval 50.3 to 56.4	46.7 percentage of participants Interval 39.4 to 54.3	46.2 percentage of participants Interval 41.1 to 51.3	46.5 percentage of participants Interval 37.1 to 56.2	35.0 percentage of participants Interval 29.6 to 40.9	19.5 percentage of participants Interval 14.7 to 25.4	34.6 percentage of participants Interval 25.0 to 45.7

SECONDARY outcome

Timeframe: Baseline, Year 1

The joint erosion score is a summary of erosion severity in 32 joints of the hands and 12 joints of the feet. The maximum erosion score for a hand joint is 5 and for a foot joint is 10. Thus, the maximal erosion score is 280 for a timepoint (160 for both hands/ wrists and 120 for both feet). Each joint is scored according to the surface area involved from 0 to 5 for hand joints and 0 to 10 for the foot joints. The highest score (5 for the hand and 10 for the foot) indicates extensive loss of bone from more than one half of the articulating bone. A score of 0 in either the hand or foot joints indicates no erosion. LSM was calculated using an MMRM model with treatment, baseline value, visit, and the interactions of baseline-by-visit and treatment-by-visit as fixed factors.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline, Year 3

Population: All enrolled participants treated with at least one dose of study drug in JADY with available baseline (from originating study) and at least 1 postbaseline x-ray assessment (collected in JADY). JADW and JADA, zero participants analyzed due to no data collected in this study or originating study.

Outcome measures

Outcome measures
Measure	2 mg Baricitinib n=387 Participants 2 mg Baricitinib administered orally once daily.	4 mg Baricitinib n=943 Participants 4 mg Baricitinib administered orally once daily.	2 mg Baricitinib Step-down n=137 Participants 2 mg Baricitinib administered orally once daily in the 96-week Step-down period.	4 mg Baricitinib Step-down n=301 Participants 4 mg Baricitinib administered orally once daily in the 96-week Step-down period.	JADW 2 mg Baricitinib 2 mg Baricitinib administered orally once daily.	JADW 4 mg Baricitinib 4 mg Baricitinib administered orally once daily.	JAGS 4 mg Baricitinib n=203 Participants 4 mg Baricitinib administered orally once daily.	JADA 4 mg Baricitinib 4 mg Baricitinib administered orally once daily.
Change From Baseline of Originating Study in Bone Erosion Score	0.85 score on a scale Interval 0.63 to 1.08	0.92 score on a scale Interval 0.76 to 1.07	0.59 score on a scale Interval 0.3 to 0.89	0.69 score on a scale Interval 0.49 to 0.89	—	—	0.68 score on a scale Interval 0.32 to 1.03	—

SECONDARY outcome

Timeframe: Baseline, Year 5

Population: All enrolled participants treated with at least one dose of study drug in JADY with available baseline (from originating study) and at least 1 postbaseline x-ray assessment (collected in JADY). JAGS, JADW, and JADA, zero participants analyzed due to no data collected in this study or originating study.

Outcome measures

Outcome measures
Measure	2 mg Baricitinib n=349 Participants 2 mg Baricitinib administered orally once daily.	4 mg Baricitinib n=870 Participants 4 mg Baricitinib administered orally once daily.	2 mg Baricitinib Step-down n=127 Participants 2 mg Baricitinib administered orally once daily in the 96-week Step-down period.	4 mg Baricitinib Step-down n=276 Participants 4 mg Baricitinib administered orally once daily in the 96-week Step-down period.	JADW 2 mg Baricitinib 2 mg Baricitinib administered orally once daily.	JADW 4 mg Baricitinib 4 mg Baricitinib administered orally once daily.	JAGS 4 mg Baricitinib 4 mg Baricitinib administered orally once daily.	JADA 4 mg Baricitinib 4 mg Baricitinib administered orally once daily.
Change From Baseline of Originating Study in Bone Erosion Score	1.04 score on a scale Interval 0.77 to 1.32	1.18 score on a scale Interval 0.98 to 1.38	0.65 score on a scale Interval 0.28 to 1.01	0.98 score on a scale Interval 0.74 to 1.23	—	—	—	—

SECONDARY outcome

Timeframe: Baseline up to 84 Months

Population: All enrolled participants who received at least one dose of study drug and had access to and utilized healthcare services outside of the clinical study.

Number of visits to medical care providers related to treatment of Rheumatoid Arthritis (RA) outside of the clinical study. Reported here are healthcare consultations and emergency room consultations from end of originating study to end of participation in study JADY.

Outcome measures

Outcome measures
Measure	2 mg Baricitinib n=451 Participants 2 mg Baricitinib administered orally once daily.	4 mg Baricitinib n=1090 Participants 4 mg Baricitinib administered orally once daily.	2 mg Baricitinib Step-down n=180 Participants 2 mg Baricitinib administered orally once daily in the 96-week Step-down period.	4 mg Baricitinib Step-down n=403 Participants 4 mg Baricitinib administered orally once daily in the 96-week Step-down period.	JADW 2 mg Baricitinib n=117 Participants 2 mg Baricitinib administered orally once daily.	JADW 4 mg Baricitinib n=331 Participants 4 mg Baricitinib administered orally once daily.	JAGS 4 mg Baricitinib n=221 Participants 4 mg Baricitinib administered orally once daily.	JADA 4 mg Baricitinib n=83 Participants 4 mg Baricitinib administered orally once daily.
Healthcare Resource Utilization Healthcare Consultations	3134 consultations	11108 consultations	2160 consultations	4573 consultations	2380 consultations	5410 consultations	717 consultations	749 consultations
Healthcare Resource Utilization Emergency Room Consultations	95 consultations	244 consultations	52 consultations	131 consultations	73 consultations	154 consultations	40 consultations	16 consultations

SECONDARY outcome

Timeframe: Year 1 after entry into JADY

Population: All enrolled participants who received at least one dose of study drug and completed at least 48 weeks in study JADY.

SDAI is a tool for measurement of disease activity in RA that integrates TJC28, SJC28, acute phase response using C-reactive protein (milligrams per liter), Patient's Global Assessment of Disease Activity using visual analog scale (cm), and Physician's Global Assessment of Disease Activity using visual analog scale (cm). The SDAI is calculated by summing the values of the 5 components. Lower scores indicated less disease activity. The SDAI is expressed as a score on a scale with the minimum score=0 (best) to maximum score=86 (worst). Low disease activity is defined as a SDAI score ≤11.

Outcome measures

Outcome measures
Measure	2 mg Baricitinib n=419 Participants 2 mg Baricitinib administered orally once daily.	4 mg Baricitinib n=1034 Participants 4 mg Baricitinib administered orally once daily.	2 mg Baricitinib Step-down n=169 Participants 2 mg Baricitinib administered orally once daily in the 96-week Step-down period.	4 mg Baricitinib Step-down n=366 Participants 4 mg Baricitinib administered orally once daily in the 96-week Step-down period.	JADW 2 mg Baricitinib n=101 Participants 2 mg Baricitinib administered orally once daily.	JADW 4 mg Baricitinib n=274 Participants 4 mg Baricitinib administered orally once daily.	JAGS 4 mg Baricitinib n=210 Participants 4 mg Baricitinib administered orally once daily.	JADA 4 mg Baricitinib n=78 Participants 4 mg Baricitinib administered orally once daily.
Percentage of Participants Maintaining a Simplified Disease Activity Index (SDAI) ≤11	81.6 percentage of participants Interval 77.6 to 85.0	75.2 percentage of participants Interval 72.5 to 77.8	70.4 percentage of participants Interval 63.1 to 76.8	69.1 percentage of participants Interval 64.2 to 73.6	53.5 percentage of participants Interval 43.8 to 62.9	53.6 percentage of participants Interval 47.7 to 59.5	72.4 percentage of participants Interval 66.0 to 78.0	59.0 percentage of participants Interval 47.9 to 69.2

SECONDARY outcome

Timeframe: Year 3 after entry into JADY

Population: All enrolled participants who received at least one dose of study drug and completed at least 48 weeks in study JADY.

Outcome measures

Outcome measures
Measure	2 mg Baricitinib n=419 Participants 2 mg Baricitinib administered orally once daily.	4 mg Baricitinib n=1034 Participants 4 mg Baricitinib administered orally once daily.	2 mg Baricitinib Step-down n=169 Participants 2 mg Baricitinib administered orally once daily in the 96-week Step-down period.	4 mg Baricitinib Step-down n=366 Participants 4 mg Baricitinib administered orally once daily in the 96-week Step-down period.	JADW 2 mg Baricitinib n=101 Participants 2 mg Baricitinib administered orally once daily.	JADW 4 mg Baricitinib n=274 Participants 4 mg Baricitinib administered orally once daily.	JAGS 4 mg Baricitinib n=210 Participants 4 mg Baricitinib administered orally once daily.	JADA 4 mg Baricitinib n=78 Participants 4 mg Baricitinib administered orally once daily.
Percentage of Participants Maintaining a Simplified Disease Activity Index (SDAI) ≤11	73.3 percentage of participants Interval 68.8 to 77.3	67.8 percentage of participants Interval 64.9 to 70.6	60.9 percentage of participants Interval 53.4 to 68.0	62.3 percentage of participants Interval 57.2 to 67.1	48.5 percentage of participants Interval 39.0 to 58.1	44.5 percentage of participants Interval 38.8 to 50.4	60.0 percentage of participants Interval 53.3 to 66.4	57.7 percentage of participants Interval 46.6 to 68.0

SECONDARY outcome

Timeframe: Year 5 after entry into JADY

Population: All enrolled participants who received at least one dose of study drug and completed at least 48 weeks in study JADY.

Outcome measures

Outcome measures
Measure	2 mg Baricitinib n=419 Participants 2 mg Baricitinib administered orally once daily.	4 mg Baricitinib n=1034 Participants 4 mg Baricitinib administered orally once daily.	2 mg Baricitinib Step-down n=169 Participants 2 mg Baricitinib administered orally once daily in the 96-week Step-down period.	4 mg Baricitinib Step-down n=366 Participants 4 mg Baricitinib administered orally once daily in the 96-week Step-down period.	JADW 2 mg Baricitinib n=101 Participants 2 mg Baricitinib administered orally once daily.	JADW 4 mg Baricitinib n=274 Participants 4 mg Baricitinib administered orally once daily.	JAGS 4 mg Baricitinib n=210 Participants 4 mg Baricitinib administered orally once daily.	JADA 4 mg Baricitinib n=78 Participants 4 mg Baricitinib administered orally once daily.
Percentage of Participants Maintaining a Simplified Disease Activity Index (SDAI) ≤11	61.3 percentage of participants Interval 56.6 to 65.9	61.2 percentage of participants Interval 58.2 to 64.1	51.5 percentage of participants Interval 44.0 to 58.9	53.3 percentage of participants Interval 48.2 to 58.3	46.5 percentage of participants Interval 37.1 to 56.2	35.4 percentage of participants Interval 30.0 to 41.2	23.3 percentage of participants Interval 18.1 to 29.5	57.7 percentage of participants Interval 46.6 to 68.0

SECONDARY outcome

Timeframe: Year 1 after entry into JADY

Population: All enrolled participants who received at least one dose of study drug and completed at least 48 weeks in study JADY.

SDAI is a tool for measurement of disease activity in RA that integrates TJC28, SJC28, acute phase response using C-reactive protein (milligrams per liter), Patient's Global Assessment of Disease Activity using visual analog scale (cm), and Physician's Global Assessment of Disease Activity using visual analog scale (cm). The SDAI is calculated by summing the values of the 5 components. Lower scores indicated less disease activity. The SDAI is expressed as a score on a scale with the minimum score=0 (best) to maximum score=86 (worst). Disease remission is defined as an SDAI score of ≤3.3.

Outcome measures

Outcome measures
Measure	2 mg Baricitinib n=419 Participants 2 mg Baricitinib administered orally once daily.	4 mg Baricitinib n=1034 Participants 4 mg Baricitinib administered orally once daily.	2 mg Baricitinib Step-down n=169 Participants 2 mg Baricitinib administered orally once daily in the 96-week Step-down period.	4 mg Baricitinib Step-down n=366 Participants 4 mg Baricitinib administered orally once daily in the 96-week Step-down period.	JADW 2 mg Baricitinib n=101 Participants 2 mg Baricitinib administered orally once daily.	JADW 4 mg Baricitinib n=274 Participants 4 mg Baricitinib administered orally once daily.	JAGS 4 mg Baricitinib n=210 Participants 4 mg Baricitinib administered orally once daily.	JADA 4 mg Baricitinib n=78 Participants 4 mg Baricitinib administered orally once daily.
Percentage of Participants Maintaining a Simplified Disease Activity Index (SDAI) ≤3.3	45.3 percentage of participants Interval 40.6 to 50.1	28.9 percentage of participants Interval 26.2 to 31.8	24.3 percentage of participants Interval 18.4 to 31.2	23.5 percentage of participants Interval 19.4 to 28.1	13.9 percentage of participants Interval 8.4 to 21.9	13.1 percentage of participants Interval 9.6 to 17.7	22.9 percentage of participants Interval 17.7 to 29.0	14.1 percentage of participants Interval 8.1 to 23.5

SECONDARY outcome

Timeframe: Year 3 after entry into JADY

Population: All enrolled participants who received at least one dose of study drug and completed at least 48 weeks in study JADY.

SDAI is a tool for measurement of disease activity in RA that integrates TJC28, SJC28, acute phase response using C-reactive protein (milligrams per liter), Patient's Global Assessment of Disease Activity using visual analog scale (cm), and Physician's Global Assessment of Disease Activity using visual analog scale (cm). The SDAI is calculated by summing the values of the 5 components. Lower scores indicated less disease activity. The SDAI is expressed as a score on a scale with the minimum score=0 (best) to maximum score=86 (worst). Disease remission is defined as an SDAI score of ≤3.3.

Outcome measures

Outcome measures
Measure	2 mg Baricitinib n=419 Participants 2 mg Baricitinib administered orally once daily.	4 mg Baricitinib n=1034 Participants 4 mg Baricitinib administered orally once daily.	2 mg Baricitinib Step-down n=169 Participants 2 mg Baricitinib administered orally once daily in the 96-week Step-down period.	4 mg Baricitinib Step-down n=366 Participants 4 mg Baricitinib administered orally once daily in the 96-week Step-down period.	JADW 2 mg Baricitinib n=101 Participants 2 mg Baricitinib administered orally once daily.	JADW 4 mg Baricitinib n=274 Participants 4 mg Baricitinib administered orally once daily.	JAGS 4 mg Baricitinib n=210 Participants 4 mg Baricitinib administered orally once daily.	JADA 4 mg Baricitinib n=78 Participants 4 mg Baricitinib administered orally once daily.
Percentage of Participants Maintaining a Simplified Disease Activity Index (SDAI) ≤3.3	39.9 percentage of participants Interval 35.3 to 44.6	29.8 percentage of participants Interval 27.1 to 32.6	22.5 percentage of participants Interval 16.8 to 29.4	21.6 percentage of participants Interval 17.7 to 26.1	19.8 percentage of participants Interval 13.2 to 28.6	13.5 percentage of participants Interval 10.0 to 18.1	15.7 percentage of participants Interval 11.4 to 21.2	21.8 percentage of participants Interval 14.1 to 32.2

SECONDARY outcome

Timeframe: Year 5 after entry into JADY

Population: All enrolled participants who received at least one dose of study drug and completed at least 48 weeks in study JADY.

SDAI is a tool for measurement of disease activity in RA that integrates TJC28, SJC28, acute phase response using C-reactive protein (milligrams per liter), Patient's Global Assessment of Disease Activity using visual analog scale (cm), and Physician's Global Assessment of Disease Activity using visual analog scale (cm). The SDAI is calculated by summing the values of the 5 components. Lower scores indicated less disease activity. The SDAI is expressed as a score on a scale with the minimum score=0 (best) to maximum score=86 (worst). Disease remission is defined as an SDAI score of ≤3.3.

Outcome measures

Outcome measures
Measure	2 mg Baricitinib n=419 Participants 2 mg Baricitinib administered orally once daily.	4 mg Baricitinib n=1034 Participants 4 mg Baricitinib administered orally once daily.	2 mg Baricitinib Step-down n=169 Participants 2 mg Baricitinib administered orally once daily in the 96-week Step-down period.	4 mg Baricitinib Step-down n=366 Participants 4 mg Baricitinib administered orally once daily in the 96-week Step-down period.	JADW 2 mg Baricitinib n=101 Participants 2 mg Baricitinib administered orally once daily.	JADW 4 mg Baricitinib n=274 Participants 4 mg Baricitinib administered orally once daily.	JAGS 4 mg Baricitinib n=210 Participants 4 mg Baricitinib administered orally once daily.	JADA 4 mg Baricitinib n=78 Participants 4 mg Baricitinib administered orally once daily.
Percentage of Participants Maintaining a Simplified Disease Activity Index (SDAI) ≤3.3	34.8 percentage of participants Interval 30.4 to 39.5	24.7 percentage of participants Interval 22.1 to 27.4	20.7 percentage of participants Interval 15.3 to 27.4	21.3 percentage of participants Interval 17.4 to 25.8	13.9 percentage of participants Interval 8.4 to 21.9	11.3 percentage of participants Interval 8.1 to 15.6	8.1 percentage of participants Interval 5.1 to 12.6	21.8 percentage of participants Interval 14.1 to 32.2

SECONDARY outcome

Timeframe: Week 0 through Week 96 of Step-down

Population: All enrolled participants who were randomized and received at least one dose of study drug during the step-down period for Studies JADX, JADV, JADW, and JAGS.

Relapse is defined as a Clinical Disease Activity Index score \> 10. The CDAI is a tool for measurement of disease activity in RA that does not require a laboratory component and was scored by the investigative site. It integrates TJC28 (scored 0-28 with higher scores indicating higher disease activity), SJC28 (scored 0-28 with higher scores indicating higher disease activity), Patient's Global Assessment of Disease Activity (scored on a visual analogue scale from 0-10 cm with higher scores indicating higher disease activity), and Physician's Global Assessment of Disease Activity (scored on a visual analogue scale from 0-10 cm with higher scores indicating higher disease activity). The CDAI is calculated by summing the values of the 4 components. CDAI scores range from 0 to 76; lower scores indicated lower disease activity. Total number of participants at risk multiplied by estimate of cumulative event probability would need to be rounded up or down to get a whole number.

Outcome measures

Outcome measures
Measure	2 mg Baricitinib n=498 Participants 2 mg Baricitinib administered orally once daily.	4 mg Baricitinib n=498 Participants 4 mg Baricitinib administered orally once daily.	2 mg Baricitinib Step-down 2 mg Baricitinib administered orally once daily in the 96-week Step-down period.	4 mg Baricitinib Step-down 4 mg Baricitinib administered orally once daily in the 96-week Step-down period.	JADW 2 mg Baricitinib 2 mg Baricitinib administered orally once daily.	JADW 4 mg Baricitinib 4 mg Baricitinib administered orally once daily.	JAGS 4 mg Baricitinib 4 mg Baricitinib administered orally once daily.	JADA 4 mg Baricitinib 4 mg Baricitinib administered orally once daily.
Percentage of Participants With Relapse Event During the 96-Week Step-Down Period Week 12	11.8 percentage of participants	5.4 percentage of participants	—	—	—	—	—	—
Percentage of Participants With Relapse Event During the 96-Week Step-Down Period Week 24	26.0 percentage of participants	12.5 percentage of participants	—	—	—	—	—	—
Percentage of Participants With Relapse Event During the 96-Week Step-Down Period Week 36	31.0 percentage of participants	18.2 percentage of participants	—	—	—	—	—	—
Percentage of Participants With Relapse Event During the 96-Week Step-Down Period Week 48	36.0 percentage of participants	21.1 percentage of participants	—	—	—	—	—	—
Percentage of Participants With Relapse Event During the 96-Week Step-Down Period Week 60	41.0 percentage of participants	26.6 percentage of participants	—	—	—	—	—	—
Percentage of Participants With Relapse Event During the 96-Week Step-Down Period Week 72	45.1 percentage of participants	29.1 percentage of participants	—	—	—	—	—	—
Percentage of Participants With Relapse Event During the 96-Week Step-Down Period Week 84	46.7 percentage of participants	31.0 percentage of participants	—	—	—	—	—	—
Percentage of Participants With Relapse Event During the 96-Week Step-Down Period Week 96	47.8 percentage of participants	34.5 percentage of participants	—	—	—	—	—	—

Adverse Events

2 mg Baricitinib

Serious events: 112 serious events

Other events: 234 other events

Deaths: 7 deaths

4 mg Baricitinib

Serious events: 517 serious events

Other events: 1532 other events

Deaths: 70 deaths

2 mg Baricitinib Step-Down

Serious events: 164 serious events

Other events: 270 other events

Deaths: 4 deaths

4 mg Baricitinib Step-Down

Serious events: 178 serious events

Other events: 315 other events

Deaths: 4 deaths

Serious adverse events

Other adverse events

Additional Information

Chief Medical Officer

Eli Lilly & Company

Phone: 800-595-5979

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: GT60