Trial Outcomes & Findings for Long-term Safety and Efficacy Study of Adalimumab in Pediatric Subjects With Ulcerative Colitis (NCT NCT02632175)

Last Updated: 2025-10-16

Results Overview

An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. The investigator assesses the relationship of each event to the use of study drug. A serious adverse event (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the participant and may require medical or surgical intervention to prevent any of the outcomes listed above. Treatment-emergent adverse events/treatment-emergent serious adverse events (TEAEs/TESAEs) are defined as any event that began or worsened in severity on or after the first dose of study drug.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

59 participants

Primary outcome timeframe

From first dose of study drug until 70 days following last dose of study drug (up to 298 weeks).

Results posted on

2025-10-16

Participant Flow

Participant milestones

Participant milestones
Measure	Adalimumab Participants received adalimumab every other week (EOW) or every week (EW) subcutaneous injection for up to 288 weeks. (Prior to Amendment 4): Participants who enrolled into the study from blinded treatment in Study M11-290 received open-label adalimumab 0.6 mg/kg (maximum dose of 40 mg) EOW. Participants who received open-label adalimumab 0.6 mg/kg (maximum of 40 mg) EW in Study M11-290 maintained the same dose in Study M10-870. (After Amendment 4): Participants with a body weight \< 25 kg received open-label adalimumab 20 mg EOW. Participants with a body weight ≥ 25 kg - \< 40 kg received open-label adalimumab 40 mg EOW. Participants with a body weight ≥ 40 kg received open-label adalimumab 80 mg EOW.
Overall Study STARTED	59
Overall Study COMPLETED	28
Overall Study NOT COMPLETED	31

Reasons for withdrawal

Reasons for withdrawal
Measure	Adalimumab Participants received adalimumab every other week (EOW) or every week (EW) subcutaneous injection for up to 288 weeks. (Prior to Amendment 4): Participants who enrolled into the study from blinded treatment in Study M11-290 received open-label adalimumab 0.6 mg/kg (maximum dose of 40 mg) EOW. Participants who received open-label adalimumab 0.6 mg/kg (maximum of 40 mg) EW in Study M11-290 maintained the same dose in Study M10-870. (After Amendment 4): Participants with a body weight \< 25 kg received open-label adalimumab 20 mg EOW. Participants with a body weight ≥ 25 kg - \< 40 kg received open-label adalimumab 40 mg EOW. Participants with a body weight ≥ 40 kg received open-label adalimumab 80 mg EOW.
Overall Study Withdrawal by Subject	6
Overall Study Lost to Follow-up	1
Overall Study Lack of Efficacy	18
Overall Study Required alternative (or prohibited) therapy	1
Overall Study Subject noncompliance	3
Overall Study other	2

Baseline Characteristics

Long-term Safety and Efficacy Study of Adalimumab in Pediatric Subjects With Ulcerative Colitis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Adalimumab n=59 Participants Participants received adalimumab every other week (EOW) or every week (EW) subcutaneous injection for up to 288 weeks. (Prior to Amendment 4): Participants who enrolled into the study from blinded treatment in Study M11-290 received open-label adalimumab 0.6 mg/kg (maximum dose of 40 mg) EOW. Participants who received open-label adalimumab 0.6 mg/kg (maximum of 40 mg) EW in Study M11-290 maintained the same dose in Study M10-870. (After Amendment 4): Participants with a body weight \< 25 kg received open-label adalimumab 20 mg EOW. Participants with a body weight ≥ 25 kg - \< 40 kg received open-label adalimumab 40 mg EOW. Participants with a body weight ≥ 40 kg received open-label adalimumab 80 mg EOW.
Age, Continuous	14.7 years STANDARD_DEVIATION 3.26 • n=5 Participants
Sex: Female, Male Female	30 Participants n=5 Participants
Sex: Female, Male Male	29 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	4 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	54 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	5 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	2 Participants n=5 Participants
Race (NIH/OMB) White	52 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Proportion of Participants with Partial Mayo Score (PMS) Remission at Baseline	46 Participants n=5 Participants
Proportion of Participants with PMS Response at Study M11-290 Baseline	54 Participants n=5 Participants
Proportion of Participants Who Achieve PUCAI Remission at Baseline	42 Participants n=5 Participants
Proportion of Participants Who Achieve PUCAI Response at Study M11-290 Baseline	46 Participants n=5 Participants

PRIMARY outcome

Timeframe: From first dose of study drug until 70 days following last dose of study drug (up to 298 weeks).

Population: Integrated Full Analysis Set (IFAS) included all enrolled participants who received at least 1 dose of study drug.

Outcome measures

Outcome measures
Measure	Adalimumab n=59 Participants Participants received adalimumab every other week (EOW) or every week (EW) subcutaneous injection for up to 288 weeks. (Prior to Amendment 4): Participants who enrolled into the study from blinded treatment in Study M11-290 received open-label adalimumab 0.6 mg/kg (maximum dose of 40 mg) EOW. Participants who received open-label adalimumab 0.6 mg/kg (maximum of 40 mg) EW in Study M11-290 maintained the same dose in Study M10-870. (After Amendment 4): Participants with a body weight \< 25 kg received open-label adalimumab 20 mg EOW. Participants with a body weight ≥ 25 kg - \< 40 kg received open-label adalimumab 40 mg EOW. Participants with a body weight ≥ 40 kg received open-label adalimumab 80 mg EOW.
Number of Participants With Adverse Events (AEs) Any TEAE	55 Participants
Number of Participants With Adverse Events (AEs) TESAE	15 Participants

PRIMARY outcome

Timeframe: Weeks 4, 8, 12, 24, 36, 48, 60, 72, 84, 96,108,120, 144, 168, 192, 216, 240, 264, and 288

Population: Integrated Full Analysis Set (IFAS) included all enrolled participants who received at least 1 dose of study drug.

The Partial Mayo Score (PMS) is a composite score of UC disease activity based on the following 3 subscores: 1. Stool frequency subscore (SFS), scored from 0 (normal number of stools) to 3 (5 or more stools more than normal). 2. Rectal bleeding subscore (RBS), scored from 0 (no blood seen) to 3 (blood alone passed). 3. Physician's Global Assessment (PGA), scored from 0 (normal) to 3 (severe disease). The overall Partial Mayo score ranges from 0 to 9 with higher scores representing more severe disease. Clinical remission was defined as a PMS ≤ 2 and no individual subscore \> 1.

Outcome measures

Outcome measures
Measure	Adalimumab n=59 Participants Participants received adalimumab every other week (EOW) or every week (EW) subcutaneous injection for up to 288 weeks. (Prior to Amendment 4): Participants who enrolled into the study from blinded treatment in Study M11-290 received open-label adalimumab 0.6 mg/kg (maximum dose of 40 mg) EOW. Participants who received open-label adalimumab 0.6 mg/kg (maximum of 40 mg) EW in Study M11-290 maintained the same dose in Study M10-870. (After Amendment 4): Participants with a body weight \< 25 kg received open-label adalimumab 20 mg EOW. Participants with a body weight ≥ 25 kg - \< 40 kg received open-label adalimumab 40 mg EOW. Participants with a body weight ≥ 40 kg received open-label adalimumab 80 mg EOW.
Proportion of Participants Who Achieve Clinical Remission as Measured by Partial Mayo Score (PMS) Week 4	50 Participants
Proportion of Participants Who Achieve Clinical Remission as Measured by Partial Mayo Score (PMS) Week 8	47 Participants
Proportion of Participants Who Achieve Clinical Remission as Measured by Partial Mayo Score (PMS) Week 12	51 Participants
Proportion of Participants Who Achieve Clinical Remission as Measured by Partial Mayo Score (PMS) Week 24	43 Participants
Proportion of Participants Who Achieve Clinical Remission as Measured by Partial Mayo Score (PMS) Week 36	45 Participants
Proportion of Participants Who Achieve Clinical Remission as Measured by Partial Mayo Score (PMS) Week 48	40 Participants
Proportion of Participants Who Achieve Clinical Remission as Measured by Partial Mayo Score (PMS) Week 60	42 Participants
Proportion of Participants Who Achieve Clinical Remission as Measured by Partial Mayo Score (PMS) Week 72	42 Participants
Proportion of Participants Who Achieve Clinical Remission as Measured by Partial Mayo Score (PMS) Week 84	40 Participants
Proportion of Participants Who Achieve Clinical Remission as Measured by Partial Mayo Score (PMS) Week 96	36 Participants
Proportion of Participants Who Achieve Clinical Remission as Measured by Partial Mayo Score (PMS) Week 108	37 Participants
Proportion of Participants Who Achieve Clinical Remission as Measured by Partial Mayo Score (PMS) Week 120	33 Participants
Proportion of Participants Who Achieve Clinical Remission as Measured by Partial Mayo Score (PMS) Week 144	32 Participants
Proportion of Participants Who Achieve Clinical Remission as Measured by Partial Mayo Score (PMS) Week 168	31 Participants
Proportion of Participants Who Achieve Clinical Remission as Measured by Partial Mayo Score (PMS) Week 192	30 Participants
Proportion of Participants Who Achieve Clinical Remission as Measured by Partial Mayo Score (PMS) Week 216	29 Participants
Proportion of Participants Who Achieve Clinical Remission as Measured by Partial Mayo Score (PMS) Week 240	28 Participants
Proportion of Participants Who Achieve Clinical Remission as Measured by Partial Mayo Score (PMS) Week 264	27 Participants
Proportion of Participants Who Achieve Clinical Remission as Measured by Partial Mayo Score (PMS) Week 288	25 Participants

PRIMARY outcome

Timeframe: Weeks 4, 8, 12, 24, 36, 48, 60, 72, 84, 96,108,120, 144, 168, 192, 216, 240, 264, and 288

Population: Integrated Full Analysis Set (IFAS) included all enrolled participants who received at least 1 dose of study drug.

The Partial Mayo Score (PMS) is a composite score of UC disease activity based on the following 3 subscores: 1. Stool frequency subscore (SFS), scored from 0 (normal number of stools) to 3 (5 or more stools more than normal). 2. Rectal bleeding subscore (RBS), scored from 0 (no blood seen) to 3 (blood alone passed). 3. Physician's Global Assessment (PGA), scored from 0 (normal) to 3 (severe disease). The overall Partial Mayo score ranges from 0 to 9 with higher scores representing more severe disease. Clinical response was defined as a decrease in PMS ≥ 2 points and ≥ 30% from Study M11-290 Baseline.

Outcome measures

Outcome measures
Measure	Adalimumab n=59 Participants Participants received adalimumab every other week (EOW) or every week (EW) subcutaneous injection for up to 288 weeks. (Prior to Amendment 4): Participants who enrolled into the study from blinded treatment in Study M11-290 received open-label adalimumab 0.6 mg/kg (maximum dose of 40 mg) EOW. Participants who received open-label adalimumab 0.6 mg/kg (maximum of 40 mg) EW in Study M11-290 maintained the same dose in Study M10-870. (After Amendment 4): Participants with a body weight \< 25 kg received open-label adalimumab 20 mg EOW. Participants with a body weight ≥ 25 kg - \< 40 kg received open-label adalimumab 40 mg EOW. Participants with a body weight ≥ 40 kg received open-label adalimumab 80 mg EOW.
Proportion of Participants Who Achieve Clinical Response as Measured by PMS (From Study M11-290 Baseline) Week 4	56 Participants
Proportion of Participants Who Achieve Clinical Response as Measured by PMS (From Study M11-290 Baseline) Week 8	55 Participants
Proportion of Participants Who Achieve Clinical Response as Measured by PMS (From Study M11-290 Baseline) Week 12	56 Participants
Proportion of Participants Who Achieve Clinical Response as Measured by PMS (From Study M11-290 Baseline) Week 24	51 Participants
Proportion of Participants Who Achieve Clinical Response as Measured by PMS (From Study M11-290 Baseline) Week 36	50 Participants
Proportion of Participants Who Achieve Clinical Response as Measured by PMS (From Study M11-290 Baseline) Week 48	47 Participants
Proportion of Participants Who Achieve Clinical Response as Measured by PMS (From Study M11-290 Baseline) Week 60	46 Participants
Proportion of Participants Who Achieve Clinical Response as Measured by PMS (From Study M11-290 Baseline) Week 72	44 Participants
Proportion of Participants Who Achieve Clinical Response as Measured by PMS (From Study M11-290 Baseline) Week 84	43 Participants
Proportion of Participants Who Achieve Clinical Response as Measured by PMS (From Study M11-290 Baseline) Week 96	42 Participants
Proportion of Participants Who Achieve Clinical Response as Measured by PMS (From Study M11-290 Baseline) Week 108	40 Participants
Proportion of Participants Who Achieve Clinical Response as Measured by PMS (From Study M11-290 Baseline) Week 120	39 Participants
Proportion of Participants Who Achieve Clinical Response as Measured by PMS (From Study M11-290 Baseline) Week 144	35 Participants
Proportion of Participants Who Achieve Clinical Response as Measured by PMS (From Study M11-290 Baseline) Week 168	35 Participants
Proportion of Participants Who Achieve Clinical Response as Measured by PMS (From Study M11-290 Baseline) Week 192	32 Participants
Proportion of Participants Who Achieve Clinical Response as Measured by PMS (From Study M11-290 Baseline) Week 216	30 Participants
Proportion of Participants Who Achieve Clinical Response as Measured by PMS (From Study M11-290 Baseline) Week 240	29 Participants
Proportion of Participants Who Achieve Clinical Response as Measured by PMS (From Study M11-290 Baseline) Week 264	28 Participants
Proportion of Participants Who Achieve Clinical Response as Measured by PMS (From Study M11-290 Baseline) Week 288	26 Participants

PRIMARY outcome

Timeframe: Weeks 4, 8, 12, 24, 36, 48, 60, 72, 84, 96,108,120, 144, 168, 192, 216, 240, 264, and 288

Population: Integrated Full Analysis Set (IFAS) included all enrolled participants who received at least 1 dose of study drug.

The Pediatric Ulcerative Colitis Activity Index (PUCAI) measures UC disease activity in children and adolescents by evaluating the following 6 areas: abdominal pain, number of stools per day, stool consistency, amount of blood in stools, nocturnal stooling, and activity level. The PUCAI score ranges from 0 to 85 with higher scores representing more severe disease. Recommended cut-off scores to differentiate disease activity are 0-9 (inactive), 10-34 (mild), 35-64 (moderate), and \> 65 (severe). Clinical remission was defined as a PUCAI score \< 10.

Outcome measures

Outcome measures
Measure	Adalimumab n=59 Participants Participants received adalimumab every other week (EOW) or every week (EW) subcutaneous injection for up to 288 weeks. (Prior to Amendment 4): Participants who enrolled into the study from blinded treatment in Study M11-290 received open-label adalimumab 0.6 mg/kg (maximum dose of 40 mg) EOW. Participants who received open-label adalimumab 0.6 mg/kg (maximum of 40 mg) EW in Study M11-290 maintained the same dose in Study M10-870. (After Amendment 4): Participants with a body weight \< 25 kg received open-label adalimumab 20 mg EOW. Participants with a body weight ≥ 25 kg - \< 40 kg received open-label adalimumab 40 mg EOW. Participants with a body weight ≥ 40 kg received open-label adalimumab 80 mg EOW.
Proportion of Participants Who Achieve Pediatric Ulcerative Colitis Activity Index (PUCAI) Remission Week 4	50 Participants
Proportion of Participants Who Achieve Pediatric Ulcerative Colitis Activity Index (PUCAI) Remission Week 8	46 Participants
Proportion of Participants Who Achieve Pediatric Ulcerative Colitis Activity Index (PUCAI) Remission Week 12	50 Participants
Proportion of Participants Who Achieve Pediatric Ulcerative Colitis Activity Index (PUCAI) Remission Week 24	42 Participants
Proportion of Participants Who Achieve Pediatric Ulcerative Colitis Activity Index (PUCAI) Remission Week 36	44 Participants
Proportion of Participants Who Achieve Pediatric Ulcerative Colitis Activity Index (PUCAI) Remission Week 48	39 Participants
Proportion of Participants Who Achieve Pediatric Ulcerative Colitis Activity Index (PUCAI) Remission Week 60	38 Participants
Proportion of Participants Who Achieve Pediatric Ulcerative Colitis Activity Index (PUCAI) Remission Week 72	42 Participants
Proportion of Participants Who Achieve Pediatric Ulcerative Colitis Activity Index (PUCAI) Remission Week 84	40 Participants
Proportion of Participants Who Achieve Pediatric Ulcerative Colitis Activity Index (PUCAI) Remission Week 96	37 Participants
Proportion of Participants Who Achieve Pediatric Ulcerative Colitis Activity Index (PUCAI) Remission Week 108	37 Participants
Proportion of Participants Who Achieve Pediatric Ulcerative Colitis Activity Index (PUCAI) Remission Week 120	34 Participants
Proportion of Participants Who Achieve Pediatric Ulcerative Colitis Activity Index (PUCAI) Remission Week 144	33 Participants
Proportion of Participants Who Achieve Pediatric Ulcerative Colitis Activity Index (PUCAI) Remission Week 168	30 Participants
Proportion of Participants Who Achieve Pediatric Ulcerative Colitis Activity Index (PUCAI) Remission Week 192	28 Participants
Proportion of Participants Who Achieve Pediatric Ulcerative Colitis Activity Index (PUCAI) Remission Week 216	28 Participants
Proportion of Participants Who Achieve Pediatric Ulcerative Colitis Activity Index (PUCAI) Remission Week 240	27 Participants
Proportion of Participants Who Achieve Pediatric Ulcerative Colitis Activity Index (PUCAI) Remission Week 264	26 Participants
Proportion of Participants Who Achieve Pediatric Ulcerative Colitis Activity Index (PUCAI) Remission Week 288	24 Participants

PRIMARY outcome

Timeframe: Weeks 4, 8, 12, 24, 36, 48, 60, 72, 84, 96,108,120, 144, 168, 192, 216, 240, 264, and 288

Population: Integrated Full Analysis Set (IFAS) included all enrolled participants who received at least 1 dose of study drug.

The Pediatric Ulcerative Colitis Activity Index (PUCAI) measures UC disease activity in children and adolescents by evaluating the following 6 areas: abdominal pain, number of stools per day, stool consistency, amount of blood in stools, nocturnal stooling, and activity level. The PUCAI score ranges from 0 to 85 with higher scores representing more severe disease. Recommended cut-off scores to differentiate disease activity are 0-9 (inactive), 10-34 (mild), 35-64 (moderate), and \> 65 (severe). PUCAI response was defined as a decrease in PUCAI score ≥ 20 points from Study M11-290 Baseline.

Outcome measures

Outcome measures
Measure	Adalimumab n=59 Participants Participants received adalimumab every other week (EOW) or every week (EW) subcutaneous injection for up to 288 weeks. (Prior to Amendment 4): Participants who enrolled into the study from blinded treatment in Study M11-290 received open-label adalimumab 0.6 mg/kg (maximum dose of 40 mg) EOW. Participants who received open-label adalimumab 0.6 mg/kg (maximum of 40 mg) EW in Study M11-290 maintained the same dose in Study M10-870. (After Amendment 4): Participants with a body weight \< 25 kg received open-label adalimumab 20 mg EOW. Participants with a body weight ≥ 25 kg - \< 40 kg received open-label adalimumab 40 mg EOW. Participants with a body weight ≥ 40 kg received open-label adalimumab 80 mg EOW.
Proportion of Participants Who Achieve PUCAI Response (From Study M11-290 Baseline) Week 4	47 Participants
Proportion of Participants Who Achieve PUCAI Response (From Study M11-290 Baseline) Week 8	47 Participants
Proportion of Participants Who Achieve PUCAI Response (From Study M11-290 Baseline) Week 12	49 Participants
Proportion of Participants Who Achieve PUCAI Response (From Study M11-290 Baseline) Week 24	42 Participants
Proportion of Participants Who Achieve PUCAI Response (From Study M11-290 Baseline) Week 36	43 Participants
Proportion of Participants Who Achieve PUCAI Response (From Study M11-290 Baseline) Week 48	38 Participants
Proportion of Participants Who Achieve PUCAI Response (From Study M11-290 Baseline) Week 60	39 Participants
Proportion of Participants Who Achieve PUCAI Response (From Study M11-290 Baseline) Week 72	40 Participants
Proportion of Participants Who Achieve PUCAI Response (From Study M11-290 Baseline) Week 84	37 Participants
Proportion of Participants Who Achieve PUCAI Response (From Study M11-290 Baseline) Week 96	37 Participants
Proportion of Participants Who Achieve PUCAI Response (From Study M11-290 Baseline) Week 108	36 Participants
Proportion of Participants Who Achieve PUCAI Response (From Study M11-290 Baseline) Week 120	34 Participants
Proportion of Participants Who Achieve PUCAI Response (From Study M11-290 Baseline) Week 144	32 Participants
Proportion of Participants Who Achieve PUCAI Response (From Study M11-290 Baseline) Week 168	30 Participants
Proportion of Participants Who Achieve PUCAI Response (From Study M11-290 Baseline) Week 192	27 Participants
Proportion of Participants Who Achieve PUCAI Response (From Study M11-290 Baseline) Week 216	25 Participants
Proportion of Participants Who Achieve PUCAI Response (From Study M11-290 Baseline) Week 240	26 Participants
Proportion of Participants Who Achieve PUCAI Response (From Study M11-290 Baseline) Week 264	23 Participants
Proportion of Participants Who Achieve PUCAI Response (From Study M11-290 Baseline) Week 288	21 Participants

Adverse Events

Adalimumab

Serious events: 16 serious events

Other events: 54 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Adalimumab n=59 participants at risk Participants received adalimumab every other week (EOW) or every week (EW) subcutaneous injection for up to 288 weeks. (Prior to Amendment 4): Participants who enrolled into the study from blinded treatment in Study M11-290 received open-label adalimumab 0.6 mg/kg (maximum dose of 40 mg) EOW. Participants who received open-label adalimumab 0.6 mg/kg (maximum of 40 mg) EW in Study M11-290 maintained the same dose in Study M10-870. (After Amendment 4): Participants with a body weight \< 25 kg received open-label adalimumab 20 mg EOW. Participants with a body weight ≥ 25 kg - \< 40 kg received open-label adalimumab 40 mg EOW. Participants with a body weight ≥ 40 kg received open-label adalimumab 80 mg EOW.
Blood and lymphatic system disorders ANAEMIA	3.4% 2/59 • Number of events 2 • All-cause mortality were reported from enrollment up to 298 weeks, median time on follow up (median time subjects were followed) was 1723.0 days for adalimumab. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 70 days after the last dose of study drug; mean duration on study drug was 1354.2 days for adalimumab.
Blood and lymphatic system disorders BLOOD LOSS ANAEMIA	1.7% 1/59 • Number of events 1 • All-cause mortality were reported from enrollment up to 298 weeks, median time on follow up (median time subjects were followed) was 1723.0 days for adalimumab. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 70 days after the last dose of study drug; mean duration on study drug was 1354.2 days for adalimumab.
Gastrointestinal disorders COLITIS ULCERATIVE	8.5% 5/59 • Number of events 6 • All-cause mortality were reported from enrollment up to 298 weeks, median time on follow up (median time subjects were followed) was 1723.0 days for adalimumab. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 70 days after the last dose of study drug; mean duration on study drug was 1354.2 days for adalimumab.
Gastrointestinal disorders DYSPEPSIA	1.7% 1/59 • Number of events 1 • All-cause mortality were reported from enrollment up to 298 weeks, median time on follow up (median time subjects were followed) was 1723.0 days for adalimumab. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 70 days after the last dose of study drug; mean duration on study drug was 1354.2 days for adalimumab.
Gastrointestinal disorders LARGE INTESTINE POLYP	3.4% 2/59 • Number of events 2 • All-cause mortality were reported from enrollment up to 298 weeks, median time on follow up (median time subjects were followed) was 1723.0 days for adalimumab. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 70 days after the last dose of study drug; mean duration on study drug was 1354.2 days for adalimumab.
Gastrointestinal disorders RECTAL HAEMORRHAGE	1.7% 1/59 • Number of events 1 • All-cause mortality were reported from enrollment up to 298 weeks, median time on follow up (median time subjects were followed) was 1723.0 days for adalimumab. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 70 days after the last dose of study drug; mean duration on study drug was 1354.2 days for adalimumab.
Hepatobiliary disorders CHOLECYSTITIS	1.7% 1/59 • Number of events 1 • All-cause mortality were reported from enrollment up to 298 weeks, median time on follow up (median time subjects were followed) was 1723.0 days for adalimumab. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 70 days after the last dose of study drug; mean duration on study drug was 1354.2 days for adalimumab.
Infections and infestations BRONCHITIS	1.7% 1/59 • Number of events 1 • All-cause mortality were reported from enrollment up to 298 weeks, median time on follow up (median time subjects were followed) was 1723.0 days for adalimumab. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 70 days after the last dose of study drug; mean duration on study drug was 1354.2 days for adalimumab.
Infections and infestations LATENT TUBERCULOSIS	1.7% 1/59 • Number of events 1 • All-cause mortality were reported from enrollment up to 298 weeks, median time on follow up (median time subjects were followed) was 1723.0 days for adalimumab. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 70 days after the last dose of study drug; mean duration on study drug was 1354.2 days for adalimumab.
Infections and infestations LYMPH NODE ABSCESS	1.7% 1/59 • Number of events 1 • All-cause mortality were reported from enrollment up to 298 weeks, median time on follow up (median time subjects were followed) was 1723.0 days for adalimumab. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 70 days after the last dose of study drug; mean duration on study drug was 1354.2 days for adalimumab.
Infections and infestations SEPSIS	1.7% 1/59 • Number of events 1 • All-cause mortality were reported from enrollment up to 298 weeks, median time on follow up (median time subjects were followed) was 1723.0 days for adalimumab. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 70 days after the last dose of study drug; mean duration on study drug was 1354.2 days for adalimumab.
Infections and infestations TONSILLITIS	1.7% 1/59 • Number of events 1 • All-cause mortality were reported from enrollment up to 298 weeks, median time on follow up (median time subjects were followed) was 1723.0 days for adalimumab. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 70 days after the last dose of study drug; mean duration on study drug was 1354.2 days for adalimumab.
Infections and infestations URINARY TRACT INFECTION	1.7% 1/59 • Number of events 1 • All-cause mortality were reported from enrollment up to 298 weeks, median time on follow up (median time subjects were followed) was 1723.0 days for adalimumab. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 70 days after the last dose of study drug; mean duration on study drug was 1354.2 days for adalimumab.
Injury, poisoning and procedural complications FOOT FRACTURE	1.7% 1/59 • Number of events 1 • All-cause mortality were reported from enrollment up to 298 weeks, median time on follow up (median time subjects were followed) was 1723.0 days for adalimumab. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 70 days after the last dose of study drug; mean duration on study drug was 1354.2 days for adalimumab.
Injury, poisoning and procedural complications UPPER LIMB FRACTURE	1.7% 1/59 • Number of events 1 • All-cause mortality were reported from enrollment up to 298 weeks, median time on follow up (median time subjects were followed) was 1723.0 days for adalimumab. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 70 days after the last dose of study drug; mean duration on study drug was 1354.2 days for adalimumab.
Musculoskeletal and connective tissue disorders GROWTH FAILURE	1.7% 1/59 • Number of events 1 • All-cause mortality were reported from enrollment up to 298 weeks, median time on follow up (median time subjects were followed) was 1723.0 days for adalimumab. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 70 days after the last dose of study drug; mean duration on study drug was 1354.2 days for adalimumab.
Nervous system disorders HEADACHE	1.7% 1/59 • Number of events 1 • All-cause mortality were reported from enrollment up to 298 weeks, median time on follow up (median time subjects were followed) was 1723.0 days for adalimumab. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 70 days after the last dose of study drug; mean duration on study drug was 1354.2 days for adalimumab.
Psychiatric disorders SUICIDE ATTEMPT	1.7% 1/59 • Number of events 1 • All-cause mortality were reported from enrollment up to 298 weeks, median time on follow up (median time subjects were followed) was 1723.0 days for adalimumab. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 70 days after the last dose of study drug; mean duration on study drug was 1354.2 days for adalimumab.
Reproductive system and breast disorders HAEMATOCOLPOS	1.7% 1/59 • Number of events 1 • All-cause mortality were reported from enrollment up to 298 weeks, median time on follow up (median time subjects were followed) was 1723.0 days for adalimumab. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 70 days after the last dose of study drug; mean duration on study drug was 1354.2 days for adalimumab.
Reproductive system and breast disorders OVARIAN CYST	1.7% 1/59 • Number of events 2 • All-cause mortality were reported from enrollment up to 298 weeks, median time on follow up (median time subjects were followed) was 1723.0 days for adalimumab. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 70 days after the last dose of study drug; mean duration on study drug was 1354.2 days for adalimumab.
Respiratory, thoracic and mediastinal disorders ASTHMA	1.7% 1/59 • Number of events 1 • All-cause mortality were reported from enrollment up to 298 weeks, median time on follow up (median time subjects were followed) was 1723.0 days for adalimumab. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 70 days after the last dose of study drug; mean duration on study drug was 1354.2 days for adalimumab.

Other adverse events

Other adverse events
Measure	Adalimumab n=59 participants at risk Participants received adalimumab every other week (EOW) or every week (EW) subcutaneous injection for up to 288 weeks. (Prior to Amendment 4): Participants who enrolled into the study from blinded treatment in Study M11-290 received open-label adalimumab 0.6 mg/kg (maximum dose of 40 mg) EOW. Participants who received open-label adalimumab 0.6 mg/kg (maximum of 40 mg) EW in Study M11-290 maintained the same dose in Study M10-870. (After Amendment 4): Participants with a body weight \< 25 kg received open-label adalimumab 20 mg EOW. Participants with a body weight ≥ 25 kg - \< 40 kg received open-label adalimumab 40 mg EOW. Participants with a body weight ≥ 40 kg received open-label adalimumab 80 mg EOW.
Blood and lymphatic system disorders ANAEMIA	11.9% 7/59 • Number of events 7 • All-cause mortality were reported from enrollment up to 298 weeks, median time on follow up (median time subjects were followed) was 1723.0 days for adalimumab. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 70 days after the last dose of study drug; mean duration on study drug was 1354.2 days for adalimumab.
Gastrointestinal disorders ABDOMINAL PAIN UPPER	5.1% 3/59 • Number of events 4 • All-cause mortality were reported from enrollment up to 298 weeks, median time on follow up (median time subjects were followed) was 1723.0 days for adalimumab. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 70 days after the last dose of study drug; mean duration on study drug was 1354.2 days for adalimumab.
Gastrointestinal disorders COLITIS ULCERATIVE	33.9% 20/59 • Number of events 26 • All-cause mortality were reported from enrollment up to 298 weeks, median time on follow up (median time subjects were followed) was 1723.0 days for adalimumab. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 70 days after the last dose of study drug; mean duration on study drug was 1354.2 days for adalimumab.
Gastrointestinal disorders CONSTIPATION	5.1% 3/59 • Number of events 3 • All-cause mortality were reported from enrollment up to 298 weeks, median time on follow up (median time subjects were followed) was 1723.0 days for adalimumab. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 70 days after the last dose of study drug; mean duration on study drug was 1354.2 days for adalimumab.
Gastrointestinal disorders DIARRHOEA	5.1% 3/59 • Number of events 4 • All-cause mortality were reported from enrollment up to 298 weeks, median time on follow up (median time subjects were followed) was 1723.0 days for adalimumab. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 70 days after the last dose of study drug; mean duration on study drug was 1354.2 days for adalimumab.
Gastrointestinal disorders GASTRITIS	5.1% 3/59 • Number of events 3 • All-cause mortality were reported from enrollment up to 298 weeks, median time on follow up (median time subjects were followed) was 1723.0 days for adalimumab. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 70 days after the last dose of study drug; mean duration on study drug was 1354.2 days for adalimumab.
Gastrointestinal disorders HAEMATOCHEZIA	5.1% 3/59 • Number of events 3 • All-cause mortality were reported from enrollment up to 298 weeks, median time on follow up (median time subjects were followed) was 1723.0 days for adalimumab. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 70 days after the last dose of study drug; mean duration on study drug was 1354.2 days for adalimumab.
Gastrointestinal disorders NAUSEA	8.5% 5/59 • Number of events 6 • All-cause mortality were reported from enrollment up to 298 weeks, median time on follow up (median time subjects were followed) was 1723.0 days for adalimumab. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 70 days after the last dose of study drug; mean duration on study drug was 1354.2 days for adalimumab.
Gastrointestinal disorders VOMITING	5.1% 3/59 • Number of events 3 • All-cause mortality were reported from enrollment up to 298 weeks, median time on follow up (median time subjects were followed) was 1723.0 days for adalimumab. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 70 days after the last dose of study drug; mean duration on study drug was 1354.2 days for adalimumab.
General disorders FATIGUE	5.1% 3/59 • Number of events 4 • All-cause mortality were reported from enrollment up to 298 weeks, median time on follow up (median time subjects were followed) was 1723.0 days for adalimumab. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 70 days after the last dose of study drug; mean duration on study drug was 1354.2 days for adalimumab.
General disorders PYREXIA	8.5% 5/59 • Number of events 6 • All-cause mortality were reported from enrollment up to 298 weeks, median time on follow up (median time subjects were followed) was 1723.0 days for adalimumab. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 70 days after the last dose of study drug; mean duration on study drug was 1354.2 days for adalimumab.
Immune system disorders SEASONAL ALLERGY	8.5% 5/59 • Number of events 5 • All-cause mortality were reported from enrollment up to 298 weeks, median time on follow up (median time subjects were followed) was 1723.0 days for adalimumab. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 70 days after the last dose of study drug; mean duration on study drug was 1354.2 days for adalimumab.
Infections and infestations BRONCHITIS	8.5% 5/59 • Number of events 6 • All-cause mortality were reported from enrollment up to 298 weeks, median time on follow up (median time subjects were followed) was 1723.0 days for adalimumab. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 70 days after the last dose of study drug; mean duration on study drug was 1354.2 days for adalimumab.
Infections and infestations COVID-19	16.9% 10/59 • Number of events 13 • All-cause mortality were reported from enrollment up to 298 weeks, median time on follow up (median time subjects were followed) was 1723.0 days for adalimumab. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 70 days after the last dose of study drug; mean duration on study drug was 1354.2 days for adalimumab.
Infections and infestations HERPES ZOSTER	6.8% 4/59 • Number of events 4 • All-cause mortality were reported from enrollment up to 298 weeks, median time on follow up (median time subjects were followed) was 1723.0 days for adalimumab. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 70 days after the last dose of study drug; mean duration on study drug was 1354.2 days for adalimumab.
Infections and infestations NASOPHARYNGITIS	22.0% 13/59 • Number of events 21 • All-cause mortality were reported from enrollment up to 298 weeks, median time on follow up (median time subjects were followed) was 1723.0 days for adalimumab. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 70 days after the last dose of study drug; mean duration on study drug was 1354.2 days for adalimumab.
Infections and infestations PHARYNGITIS	13.6% 8/59 • Number of events 9 • All-cause mortality were reported from enrollment up to 298 weeks, median time on follow up (median time subjects were followed) was 1723.0 days for adalimumab. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 70 days after the last dose of study drug; mean duration on study drug was 1354.2 days for adalimumab.
Infections and infestations TONSILLITIS	5.1% 3/59 • Number of events 4 • All-cause mortality were reported from enrollment up to 298 weeks, median time on follow up (median time subjects were followed) was 1723.0 days for adalimumab. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 70 days after the last dose of study drug; mean duration on study drug was 1354.2 days for adalimumab.
Infections and infestations UPPER RESPIRATORY TRACT INFECTION	27.1% 16/59 • Number of events 26 • All-cause mortality were reported from enrollment up to 298 weeks, median time on follow up (median time subjects were followed) was 1723.0 days for adalimumab. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 70 days after the last dose of study drug; mean duration on study drug was 1354.2 days for adalimumab.
Infections and infestations URINARY TRACT INFECTION	6.8% 4/59 • Number of events 7 • All-cause mortality were reported from enrollment up to 298 weeks, median time on follow up (median time subjects were followed) was 1723.0 days for adalimumab. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 70 days after the last dose of study drug; mean duration on study drug was 1354.2 days for adalimumab.
Infections and infestations VIRAL UPPER RESPIRATORY TRACT INFECTION	13.6% 8/59 • Number of events 9 • All-cause mortality were reported from enrollment up to 298 weeks, median time on follow up (median time subjects were followed) was 1723.0 days for adalimumab. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 70 days after the last dose of study drug; mean duration on study drug was 1354.2 days for adalimumab.
Investigations MYCOBACTERIUM TUBERCULOSIS COMPLEX TEST POSITIVE	16.9% 10/59 • Number of events 12 • All-cause mortality were reported from enrollment up to 298 weeks, median time on follow up (median time subjects were followed) was 1723.0 days for adalimumab. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 70 days after the last dose of study drug; mean duration on study drug was 1354.2 days for adalimumab.
Musculoskeletal and connective tissue disorders ARTHRALGIA	10.2% 6/59 • Number of events 9 • All-cause mortality were reported from enrollment up to 298 weeks, median time on follow up (median time subjects were followed) was 1723.0 days for adalimumab. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 70 days after the last dose of study drug; mean duration on study drug was 1354.2 days for adalimumab.
Nervous system disorders HEADACHE	15.3% 9/59 • Number of events 11 • All-cause mortality were reported from enrollment up to 298 weeks, median time on follow up (median time subjects were followed) was 1723.0 days for adalimumab. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 70 days after the last dose of study drug; mean duration on study drug was 1354.2 days for adalimumab.
Psychiatric disorders DEPRESSION	6.8% 4/59 • Number of events 4 • All-cause mortality were reported from enrollment up to 298 weeks, median time on follow up (median time subjects were followed) was 1723.0 days for adalimumab. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 70 days after the last dose of study drug; mean duration on study drug was 1354.2 days for adalimumab.
Respiratory, thoracic and mediastinal disorders OROPHARYNGEAL PAIN	6.8% 4/59 • Number of events 4 • All-cause mortality were reported from enrollment up to 298 weeks, median time on follow up (median time subjects were followed) was 1723.0 days for adalimumab. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 70 days after the last dose of study drug; mean duration on study drug was 1354.2 days for adalimumab.
Respiratory, thoracic and mediastinal disorders RHINITIS ALLERGIC	6.8% 4/59 • Number of events 5 • All-cause mortality were reported from enrollment up to 298 weeks, median time on follow up (median time subjects were followed) was 1723.0 days for adalimumab. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 70 days after the last dose of study drug; mean duration on study drug was 1354.2 days for adalimumab.
Skin and subcutaneous tissue disorders ACNE	8.5% 5/59 • Number of events 6 • All-cause mortality were reported from enrollment up to 298 weeks, median time on follow up (median time subjects were followed) was 1723.0 days for adalimumab. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 70 days after the last dose of study drug; mean duration on study drug was 1354.2 days for adalimumab.
Skin and subcutaneous tissue disorders DERMATITIS	5.1% 3/59 • Number of events 5 • All-cause mortality were reported from enrollment up to 298 weeks, median time on follow up (median time subjects were followed) was 1723.0 days for adalimumab. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 70 days after the last dose of study drug; mean duration on study drug was 1354.2 days for adalimumab.
Skin and subcutaneous tissue disorders RASH	6.8% 4/59 • Number of events 5 • All-cause mortality were reported from enrollment up to 298 weeks, median time on follow up (median time subjects were followed) was 1723.0 days for adalimumab. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 70 days after the last dose of study drug; mean duration on study drug was 1354.2 days for adalimumab.
Skin and subcutaneous tissue disorders URTICARIA	5.1% 3/59 • Number of events 4 • All-cause mortality were reported from enrollment up to 298 weeks, median time on follow up (median time subjects were followed) was 1723.0 days for adalimumab. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 70 days after the last dose of study drug; mean duration on study drug was 1354.2 days for adalimumab.

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