Trial Outcomes & Findings for A Study of the Long-term Safety and Efficacy of Adalimumab in Subjects With Intermediate-, Posterior-, or Pan-uveitis (NCT NCT01148225)

Last Updated: 2021-07-12

Results Overview

An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. The investigator assessed the relationship of each event to the use of study drug as either probably related, possibly related, probably not related or not related. 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 subject and may require medical or surgical intervention to prevent any of the outcomes listed above. Treatment-emergent events (TEAEs/TESAEs) are defined as any event with an onset date on or after the first dose of study drug and up to 70 days after the last dose. See the Adverse Event section for details.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

424 participants

Primary outcome timeframe

Baseline to Final Visit (up to 366 weeks)

Results posted on

2021-07-12

Participant Flow

A total of 424 participants were enrolled and received ≥1 dose of study drug (Safety population); 364 participants were included in the intent-to-treat (ITT) population (reasons for exclusion: incomplete efficacy data or GCP compliance issues at 2 sites (n=7); diabetic retinopathy \[n=1\]; cataract surgery \[n=26\]; and previous vitrectomy \[n=26\]).

Participant milestones

Participant milestones
Measure	Adalimumab Participants received open label (OL) adalimumab 40 mg by subcutaneous (SC) injection every other week (eow) until the final visit.
Overall Study STARTED	424
Overall Study COMPLETED	239
Overall Study NOT COMPLETED	185

Reasons for withdrawal

Reasons for withdrawal
Measure	Adalimumab Participants received open label (OL) adalimumab 40 mg by subcutaneous (SC) injection every other week (eow) until the final visit.
Overall Study Other	185

Baseline Characteristics

A Study of the Long-term Safety and Efficacy of Adalimumab in Subjects With Intermediate-, Posterior-, or Pan-uveitis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Adalimumab n=424 Participants Participants received open label (OL) adalimumab 40 mg by subcutaneous (SC) injection every other week (eow) until the final visit.
Age, Continuous	43.44 years STANDARD_DEVIATION 14.066 • n=5 Participants
Sex: Female, Male Female	249 Participants n=5 Participants
Sex: Female, Male Male	175 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	77 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	347 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline to Final Visit (up to 366 weeks)

Population: Safety analysis set: includes all participants who received at least one dose of study medication.

Outcome measures

Outcome measures
Measure	Adalimumab n=424 Participants Participants received open label (OL) adalimumab 40 mg by subcutaneous (SC) injection every other week (eow) until the final visit.
Number of Participants With Adverse Events Any TEAE	398 participants
Number of Participants With Adverse Events Any TESAE	101 participants

PRIMARY outcome

Timeframe: Baseline to Final Visit (Up to 366 weeks)

Population: Safety analysis set.

Outcome measures

Outcome measures
Measure	Adalimumab n=424 Participants Participants received open label (OL) adalimumab 40 mg by subcutaneous (SC) injection every other week (eow) until the final visit.
Hematology: Number of Participants With Potentially Clinically Significant (PCS) Values Hemoglobin (Low: <80-65 g/L)	3 participants
Hematology: Number of Participants With Potentially Clinically Significant (PCS) Values Neutrophils (Low: <1.0-0.5*10^9/L)	6 participants
Hematology: Number of Participants With Potentially Clinically Significant (PCS) Values Lymphocytes (Low: <0.5-0.2*10^9/L)	7 participants

PRIMARY outcome

Timeframe: Baseline to Final Visit (Up to 366 weeks)

Population: Safety analysis set.

PCS laboratory values were defined as Common Toxicity Criteria (CTC) according to the National Cancer Institute Common Terminology for Adverse Events (NCI CTCAE) v3.0 ≥ Grade 3. Abbreviations include ALT/SGPT=alanine aminotransferase/serum glutamate pyruvate transaminase; AST/SGOT=aspartate aminotransferase/serum glutamate oxaloacetate transaminase; g/L=grams/liter; mmol/L=millimoles/liter; ULN=upper limit of normal.

Outcome measures

Outcome measures
Measure	Adalimumab n=424 Participants Participants received open label (OL) adalimumab 40 mg by subcutaneous (SC) injection every other week (eow) until the final visit.
Chemistry: Number of Participants With PCS Values ALT/SGPT (High: >5.0-20.0*ULN)	2 participants
Chemistry: Number of Participants With PCS Values AST/SGOT (High: >5.0-20.0*ULN)	3 participants
Chemistry: Number of Participants With PCS Values Bilirubin, Total (High: >3.0-10.0*ULN)	1 participants
Chemistry: Number of Participants With PCS Values Creatinine (High: >3.0-6.0*ULN)	2 participants
Chemistry: Number of Participants With PCS Values Phosphate Inorganic (Low:<0.6-0.3 mmol/L)	5 participants
Chemistry: Number of Participants With PCS Values Sodium (Low: <130-120 mmol/L)	4 participants
Chemistry: Number of Participants With PCS Values Potassium (Low:<3.0-2.5 mmol/L)	7 participants
Chemistry: Number of Participants With PCS Values Glucose (High: >13.9-27.8 mmol/L)	18 participants
Chemistry: Number of Participants With PCS Values Albumin (Low: <20.0 g/L)	2 participants
Chemistry: Number of Participants With PCS Values Cholesterol (High: >10.34-12.92 mmol/L)	3 participants
Chemistry: Number of Participants With PCS Values Triglycerides (High: >5.0-10*ULN)	8 participants

PRIMARY outcome

Timeframe: Baseline to Final Visit (Up to 366 weeks)

Population: Safety analysis set.

Heart rate (beats per minute) was measured while the participant was sitting.

Outcome measures

Outcome measures
Measure	Adalimumab n=424 Participants Participants received open label (OL) adalimumab 40 mg by subcutaneous (SC) injection every other week (eow) until the final visit.
Pulse (Sitting): Mean Change (Beats Per Minute) From Baseline To Final Visit	-1.0 beats per minute Standard Deviation 11.92

PRIMARY outcome

Timeframe: Baseline to Final Visit (Up to 366 weeks)

Population: Safety analysis set.

Respiratory rate (respirations per minute) was measured while the participant was sitting.

Outcome measures

Outcome measures
Measure	Adalimumab n=424 Participants Participants received open label (OL) adalimumab 40 mg by subcutaneous (SC) injection every other week (eow) until the final visit.
Respiratory Rate (Sitting): Mean Change (Respirations Per Minute) From Baseline To Final Visit	-0.1 respirations per minute Standard Deviation 2.94

PRIMARY outcome

Timeframe: Baseline to Final Visit (Up to 366 weeks)

Population: Safety analysis set.

Temperature was measured while the participant was sitting.

Outcome measures

Outcome measures
Measure	Adalimumab n=424 Participants Participants received open label (OL) adalimumab 40 mg by subcutaneous (SC) injection every other week (eow) until the final visit.
Temperature (Sitting): Mean Change (Centigrade) From Baseline To Final Visit	-0.03 Centigrade Standard Deviation 0.516

PRIMARY outcome

Timeframe: Baseline to Final Visit (Up to 366 weeks)

Population: Safety analysis set.

Blood pressure was measured while the participant was sitting. Abbreviations used include mmHg=millimeters of mercury.

Outcome measures

Outcome measures
Measure	Adalimumab n=424 Participants Participants received open label (OL) adalimumab 40 mg by subcutaneous (SC) injection every other week (eow) until the final visit.
Diastolic and Systolic Blood Pressure (Sitting): Mean Change (mmHg) From Baseline To Final Visit Diastolic Blood Pressure (Sitting)	1.443 mmHg Standard Deviation 10.4373
Diastolic and Systolic Blood Pressure (Sitting): Mean Change (mmHg) From Baseline To Final Visit Systolic Blood Pressure (Sitting)	1.955 mmHg Standard Deviation 14.6281

SECONDARY outcome

Timeframe: Weeks 0, 2, 4, 8, 12, 18, 30, 42, 54, 66, 78, 90, 102, 114, 126, 138, 150, 162, 174, 186, 198, 210, 222, 234, and 246

Population: ITT analysis set: includes all participants who received at least one dose of study medication with evaluable data at a given timepoint.

Quiescence is defined as no active inflammatory lesions and anterior chamber (AC) cell grade ≤ 0.5+ and vitreous haze (VH) grade ≤0.5+. Participants with active uveitis at study entry could have been in quiescence at Week 0 because all participants were evaluated for uveitis status at the Final/Early Termination visit of the lead-in study and the Week 0 visit could have occurred up to 28 days later during which time the participant's disease status may have changed.

Outcome measures

Outcome measures
Measure	Adalimumab n=364 Participants Participants received open label (OL) adalimumab 40 mg by subcutaneous (SC) injection every other week (eow) until the final visit.
Percentage of Participants in Quiescence Over Time Week 210	88.6 percentage of participants Interval 80.1 to 94.4
Percentage of Participants in Quiescence Over Time Week 222	92.9 percentage of participants Interval 84.1 to 97.6
Percentage of Participants in Quiescence Over Time Week 0	33.5 percentage of participants Interval 28.7 to 38.6
Percentage of Participants in Quiescence Over Time Week 2	56.3 percentage of participants Interval 50.9 to 61.6
Percentage of Participants in Quiescence Over Time Week 4	63.8 percentage of participants Interval 58.3 to 69.0
Percentage of Participants in Quiescence Over Time Week 8	72.0 percentage of participants Interval 66.9 to 76.7
Percentage of Participants in Quiescence Over Time Week 12	72.4 percentage of participants Interval 67.2 to 77.1
Percentage of Participants in Quiescence Over Time Week 18	75.2 percentage of participants Interval 70.1 to 79.7
Percentage of Participants in Quiescence Over Time Week 30	79.9 percentage of participants Interval 75.1 to 84.2
Percentage of Participants in Quiescence Over Time Week 42	81.3 percentage of participants Interval 76.5 to 85.5
Percentage of Participants in Quiescence Over Time Week 54	81.1 percentage of participants Interval 76.1 to 85.4
Percentage of Participants in Quiescence Over Time Week 66	85.9 percentage of participants Interval 81.3 to 89.7
Percentage of Participants in Quiescence Over Time Week 78	86.3 percentage of participants Interval 81.7 to 90.2
Percentage of Participants in Quiescence Over Time Week 90	87.4 percentage of participants Interval 82.7 to 91.1
Percentage of Participants in Quiescence Over Time Week 102	87.3 percentage of participants Interval 82.5 to 91.2
Percentage of Participants in Quiescence Over Time Week 114	87.9 percentage of participants Interval 83.0 to 91.8
Percentage of Participants in Quiescence Over Time Week 126	88.4 percentage of participants Interval 83.3 to 92.3
Percentage of Participants in Quiescence Over Time Week 138	89.3 percentage of participants Interval 84.1 to 93.2
Percentage of Participants in Quiescence Over Time Week 150	85.0 percentage of participants Interval 78.9 to 89.9
Percentage of Participants in Quiescence Over Time Week 162	87.0 percentage of participants Interval 80.7 to 91.9
Percentage of Participants in Quiescence Over Time Week 174	87.3 percentage of participants Interval 80.7 to 92.3
Percentage of Participants in Quiescence Over Time Week 186	90.6 percentage of participants Interval 84.2 to 95.1
Percentage of Participants in Quiescence Over Time Week 198	89.4 percentage of participants Interval 82.2 to 94.4
Percentage of Participants in Quiescence Over Time Week 234	96.1 percentage of participants Interval 86.5 to 99.5
Percentage of Participants in Quiescence Over Time Week 246	95.2 percentage of participants Interval 83.8 to 99.4

SECONDARY outcome

Timeframe: 366 Weeks

Population: All participants in the ITT analysis set with inactive uveitis with evaluable data at a given timepoint.

Uveitis flare is defined as no quiescence (active inflammatory lesions and AC cell grade \> 0.5+ and/or VH grade \>0.5+).

Outcome measures

Outcome measures
Measure	Adalimumab n=124 Participants Participants received open label (OL) adalimumab 40 mg by subcutaneous (SC) injection every other week (eow) until the final visit.
Percentage of Participants With Uveitis Flare Among Participants With Inactive Uveitis at Study Start	38.7 percentage of participants Interval 30.1 to 47.9

SECONDARY outcome

Timeframe: Weeks 8 to 246 (238 Weeks)

Population: All participants in the ITT analysis set with active uveitis at study start with evaluable data at a given timepoint.

Uveitis flare is defined as no quiescence (active inflammatory lesions and AC cell grade \> 0.5+ and/or VH grade \>0.5+).

Outcome measures

Outcome measures
Measure	Adalimumab n=232 Participants Participants received open label (OL) adalimumab 40 mg by subcutaneous (SC) injection every other week (eow) until the final visit.
Percentage of Participants With Uveitis Flare From Week 8 Through Last Visit Among Participants With Active Uveitis at Study Start	67.7 percentage of participants Interval 61.2 to 73.6

SECONDARY outcome

Timeframe: Weeks 2, 4, 8, 12, 18, 30, 42, 54, 66, 78, 90, 102, 114, 126, 138, 150, 162, 174, 186, 198, 210, 222, 234, and 246

Population: All participants in the ITT analysis set with evaluable data at a given time point.

Dilated indirect ophthalmoscopy is performed to determine both vitreous haze grading and the absence/presence of inflammatory chorioretinal and/or inflammatory retinal vascular lesions. The number of AC cells observed within a 1 mm \* 1 mm slit beam was recorded for each eye and this number was used to determine the grade according to Standardization of Uveitis Nomenclature (SUN) criteria. Grading of VH was based on the National Eye Institute (NEI) publication which was adapted by the SUN working group. The percentage of participants with new active inflammatory lesions or grade ≥2 in AC cells or grade ≥2 in VH are presented.

Outcome measures

Outcome measures
Measure	Adalimumab n=364 Participants Participants received open label (OL) adalimumab 40 mg by subcutaneous (SC) injection every other week (eow) until the final visit.
Percentage of Participants With New Active Inflammatory Lesions or Grade ≥2 in Anterior Chamber (AC) Cells or Grade ≥2 in Vitreous Haze (VH) Over Time Week 12	6.9 percentage of participants Interval 4.4 to 10.2
Percentage of Participants With New Active Inflammatory Lesions or Grade ≥2 in Anterior Chamber (AC) Cells or Grade ≥2 in Vitreous Haze (VH) Over Time Week 66	1.4 percentage of participants Interval 0.4 to 3.6
Percentage of Participants With New Active Inflammatory Lesions or Grade ≥2 in Anterior Chamber (AC) Cells or Grade ≥2 in Vitreous Haze (VH) Over Time Week 2	11.8 percentage of participants Interval 8.6 to 15.6
Percentage of Participants With New Active Inflammatory Lesions or Grade ≥2 in Anterior Chamber (AC) Cells or Grade ≥2 in Vitreous Haze (VH) Over Time Week 4	8.4 percentage of participants Interval 5.6 to 11.9
Percentage of Participants With New Active Inflammatory Lesions or Grade ≥2 in Anterior Chamber (AC) Cells or Grade ≥2 in Vitreous Haze (VH) Over Time Week 8	7.6 percentage of participants Interval 5.0 to 10.9
Percentage of Participants With New Active Inflammatory Lesions or Grade ≥2 in Anterior Chamber (AC) Cells or Grade ≥2 in Vitreous Haze (VH) Over Time Week 18	3.6 percentage of participants Interval 1.9 to 6.3
Percentage of Participants With New Active Inflammatory Lesions or Grade ≥2 in Anterior Chamber (AC) Cells or Grade ≥2 in Vitreous Haze (VH) Over Time Week 30	5.3 percentage of participants Interval 3.1 to 8.4
Percentage of Participants With New Active Inflammatory Lesions or Grade ≥2 in Anterior Chamber (AC) Cells or Grade ≥2 in Vitreous Haze (VH) Over Time Week 42	4.2 percentage of participants Interval 2.3 to 7.1
Percentage of Participants With New Active Inflammatory Lesions or Grade ≥2 in Anterior Chamber (AC) Cells or Grade ≥2 in Vitreous Haze (VH) Over Time Week 54	4.1 percentage of participants Interval 2.1 to 7.0
Percentage of Participants With New Active Inflammatory Lesions or Grade ≥2 in Anterior Chamber (AC) Cells or Grade ≥2 in Vitreous Haze (VH) Over Time Week 78	4.1 percentage of participants Interval 2.0 to 7.1
Percentage of Participants With New Active Inflammatory Lesions or Grade ≥2 in Anterior Chamber (AC) Cells or Grade ≥2 in Vitreous Haze (VH) Over Time Week 90	4.6 percentage of participants Interval 2.4 to 7.9
Percentage of Participants With New Active Inflammatory Lesions or Grade ≥2 in Anterior Chamber (AC) Cells or Grade ≥2 in Vitreous Haze (VH) Over Time Week 102	4.1 percentage of participants Interval 2.0 to 7.4
Percentage of Participants With New Active Inflammatory Lesions or Grade ≥2 in Anterior Chamber (AC) Cells or Grade ≥2 in Vitreous Haze (VH) Over Time Week 114	4.8 percentage of participants Interval 2.4 to 8.4
Percentage of Participants With New Active Inflammatory Lesions or Grade ≥2 in Anterior Chamber (AC) Cells or Grade ≥2 in Vitreous Haze (VH) Over Time Week 126	3.3 percentage of participants Interval 1.3 to 6.6
Percentage of Participants With New Active Inflammatory Lesions or Grade ≥2 in Anterior Chamber (AC) Cells or Grade ≥2 in Vitreous Haze (VH) Over Time Week 138	2.0 percentage of participants Interval 0.6 to 5.1
Percentage of Participants With New Active Inflammatory Lesions or Grade ≥2 in Anterior Chamber (AC) Cells or Grade ≥2 in Vitreous Haze (VH) Over Time Week 150	4.4 percentage of participants Interval 1.9 to 8.6
Percentage of Participants With New Active Inflammatory Lesions or Grade ≥2 in Anterior Chamber (AC) Cells or Grade ≥2 in Vitreous Haze (VH) Over Time Week 162	3.2 percentage of participants Interval 1.1 to 7.4
Percentage of Participants With New Active Inflammatory Lesions or Grade ≥2 in Anterior Chamber (AC) Cells or Grade ≥2 in Vitreous Haze (VH) Over Time Week 174	1.4 percentage of participants Interval 0.2 to 5.0
Percentage of Participants With New Active Inflammatory Lesions or Grade ≥2 in Anterior Chamber (AC) Cells or Grade ≥2 in Vitreous Haze (VH) Over Time Week 186	1.6 percentage of participants Interval 0.2 to 5.5
Percentage of Participants With New Active Inflammatory Lesions or Grade ≥2 in Anterior Chamber (AC) Cells or Grade ≥2 in Vitreous Haze (VH) Over Time Week 198	0 percentage of participants Interval 0.0 to 0.0
Percentage of Participants With New Active Inflammatory Lesions or Grade ≥2 in Anterior Chamber (AC) Cells or Grade ≥2 in Vitreous Haze (VH) Over Time Week 210	3.4 percentage of participants Interval 0.7 to 9.6
Percentage of Participants With New Active Inflammatory Lesions or Grade ≥2 in Anterior Chamber (AC) Cells or Grade ≥2 in Vitreous Haze (VH) Over Time Week 222	1.4 percentage of participants Interval 0.0 to 7.7
Percentage of Participants With New Active Inflammatory Lesions or Grade ≥2 in Anterior Chamber (AC) Cells or Grade ≥2 in Vitreous Haze (VH) Over Time Week 234	0 percentage of participants Interval 0.0 to 0.0
Percentage of Participants With New Active Inflammatory Lesions or Grade ≥2 in Anterior Chamber (AC) Cells or Grade ≥2 in Vitreous Haze (VH) Over Time Week 246	0 percentage of participants Interval 0.0 to 0.0

SECONDARY outcome

Timeframe: Weeks 0, 2, 4, 8, 12, 18, 30, 42, 54, 66, 78, 90, 102, 114, 126, 138, 150, 162, 174, 186, 198, 210, 222, 234, and 246

Population: All participants in the ITT analysis set in steroid-free quiescence with evaluable data at a given timepoint.

Steroid-free quiescence is defined as no active inflammatory lesions and AC cell grade ≤ 0.5+ and VH grade ≤0.5+ and no uveitis-related corticosteroids on the day of assessment.

Outcome measures

Outcome measures
Measure	Adalimumab n=364 Participants Participants received open label (OL) adalimumab 40 mg by subcutaneous (SC) injection every other week (eow) until the final visit.
Percentage of Participants With Steroid-free Quiescence Over Time Week 102	65.7 percentage of participants Interval 59.4 to 71.6
Percentage of Participants With Steroid-free Quiescence Over Time Week 0	30.5 percentage of participants Interval 25.8 to 35.5
Percentage of Participants With Steroid-free Quiescence Over Time Week 2	34.8 percentage of participants Interval 29.8 to 40.0
Percentage of Participants With Steroid-free Quiescence Over Time Week 4	35.6 percentage of participants Interval 30.4 to 41.1
Percentage of Participants With Steroid-free Quiescence Over Time Week 8	41.4 percentage of participants Interval 36.1 to 46.8
Percentage of Participants With Steroid-free Quiescence Over Time Week 12	44.4 percentage of participants Interval 39.0 to 50.0
Percentage of Participants With Steroid-free Quiescence Over Time Week 18	47.6 percentage of participants Interval 42.1 to 53.1
Percentage of Participants With Steroid-free Quiescence Over Time Week 30	52.4 percentage of participants Interval 46.7 to 57.9
Percentage of Participants With Steroid-free Quiescence Over Time Week 42	55.8 percentage of participants Interval 50.1 to 61.4
Percentage of Participants With Steroid-free Quiescence Over Time Week 114	66.2 percentage of participants Interval 59.7 to 72.3
Percentage of Participants With Steroid-free Quiescence Over Time Week 54	55.7 percentage of participants Interval 49.9 to 61.5
Percentage of Participants With Steroid-free Quiescence Over Time Week 66	56.7 percentage of participants Interval 50.7 to 62.5
Percentage of Participants With Steroid-free Quiescence Over Time Week 78	57.7 percentage of participants Interval 51.6 to 63.7
Percentage of Participants With Steroid-free Quiescence Over Time Week 90	60.2 percentage of participants Interval 53.9 to 66.1
Percentage of Participants With Steroid-free Quiescence Over Time Week 126	66.0 percentage of participants Interval 59.3 to 72.3
Percentage of Participants With Steroid-free Quiescence Over Time Week 138	67.9 percentage of participants Interval 60.8 to 74.3
Percentage of Participants With Steroid-free Quiescence Over Time Week 150	65.0 percentage of participants Interval 57.6 to 71.9
Percentage of Participants With Steroid-free Quiescence Over Time Week 162	63.0 percentage of participants Interval 54.8 to 70.6
Percentage of Participants With Steroid-free Quiescence Over Time Week 174	65.5 percentage of participants Interval 57.1 to 73.3
Percentage of Participants With Steroid-free Quiescence Over Time Week 186	68.0 percentage of participants Interval 59.1 to 75.9
Percentage of Participants With Steroid-free Quiescence Over Time Week 198	64.6 percentage of participants Interval 55.0 to 73.4
Percentage of Participants With Steroid-free Quiescence Over Time Week 210	64.0 percentage of participants Interval 53.2 to 73.9
Percentage of Participants With Steroid-free Quiescence Over Time Week 222	69.0 percentage of participants Interval 56.9 to 79.5
Percentage of Participants With Steroid-free Quiescence Over Time Week 234	78.4 percentage of participants Interval 64.7 to 88.7
Percentage of Participants With Steroid-free Quiescence Over Time Week 246	83.3 percentage of participants Interval 68.6 to 93.0

SECONDARY outcome

Timeframe: 366 Weeks

Population: All participants in the ITT analysis set with inactive uveitis at Week 0 in nonquiescence with evaluable data at a given timepoint.

Percentage of participants, without quiescence, with/without change in concomitant medications within 5 days after non-quiescence and with/without quiescence at next visit at least 8 weeks after non-quiescence among participants with inactive uveitis at study start. Quiescence is defined as no active inflammatory lesions and AC cell grade ≤ 0.5+ and VH grade ≤0.5+. Abbreviations used are as follows: CM=concomitant medications; NQ=non-quiescence.

Outcome measures

Outcome measures
Measure	Adalimumab n=124 Participants Participants received open label (OL) adalimumab 40 mg by subcutaneous (SC) injection every other week (eow) until the final visit.
Percentage of Participants in Non-quiescence (With/Without Change in Concomitant Medications Within 5 Days and With/Without Quiescence at Next Visit at Least 8 Weeks After Non-quiescence) Among Participants With Inactive Uveitis at Study Start NQ With CM Change and quiescence at next visit	10.5 percentage of participants
Percentage of Participants in Non-quiescence (With/Without Change in Concomitant Medications Within 5 Days and With/Without Quiescence at Next Visit at Least 8 Weeks After Non-quiescence) Among Participants With Inactive Uveitis at Study Start NQ With CM Change and nonquiescence at next visit	2.4 percentage of participants
Percentage of Participants in Non-quiescence (With/Without Change in Concomitant Medications Within 5 Days and With/Without Quiescence at Next Visit at Least 8 Weeks After Non-quiescence) Among Participants With Inactive Uveitis at Study Start NQ Without CM Change and quiescence at next visit	13.7 percentage of participants
Percentage of Participants in Non-quiescence (With/Without Change in Concomitant Medications Within 5 Days and With/Without Quiescence at Next Visit at Least 8 Weeks After Non-quiescence) Among Participants With Inactive Uveitis at Study Start NQ Without CM Change and NQ at next visit	8.9 percentage of participants
Percentage of Participants in Non-quiescence (With/Without Change in Concomitant Medications Within 5 Days and With/Without Quiescence at Next Visit at Least 8 Weeks After Non-quiescence) Among Participants With Inactive Uveitis at Study Start NQ With Premature Discontinuation	3.2 percentage of participants
Percentage of Participants in Non-quiescence (With/Without Change in Concomitant Medications Within 5 Days and With/Without Quiescence at Next Visit at Least 8 Weeks After Non-quiescence) Among Participants With Inactive Uveitis at Study Start NQ And Completion	0.8 percentage of participants

SECONDARY outcome

Timeframe: 366 Weeks

Population: All participants in the ITT analysis set with active uveitis at Week 0 in nonquiescence with evaluable data at a given timepoint.

Percentage of participants, without quiescence, with/without change in concomitant medications within 5 days after non-quiescence and with/without quiescence at next visit at least 8 weeks after non-quiescence, among participants with active uveitis at study start. Quiescence is defined as no active inflammatory lesions and AC cell grade ≤ 0.5+ and VH grade ≤0.5+. Abbreviations used include: CM=concomitant medications, NQ=non-quiescence.

Outcome measures

Outcome measures
Measure	Adalimumab n=240 Participants Participants received open label (OL) adalimumab 40 mg by subcutaneous (SC) injection every other week (eow) until the final visit.
Percentage of Participants in Non-quiescence (With/Without Change in Concomitant Medications Within 5 Days and With/Without Quiescence at Next Visit at Least 8 Weeks After Non-quiescence) Among Participants With Active Uveitis at Study Start NQ With CM Change and quiescence at next visit	19.2 percentage of participants
Percentage of Participants in Non-quiescence (With/Without Change in Concomitant Medications Within 5 Days and With/Without Quiescence at Next Visit at Least 8 Weeks After Non-quiescence) Among Participants With Active Uveitis at Study Start NQ With CM Change and nonquiescence at next visit	10.8 percentage of participants
Percentage of Participants in Non-quiescence (With/Without Change in Concomitant Medications Within 5 Days and With/Without Quiescence at Next Visit at Least 8 Weeks After Non-quiescence) Among Participants With Active Uveitis at Study Start NQ Without CM Change and quiescence at next visit	15.0 percentage of participants
Percentage of Participants in Non-quiescence (With/Without Change in Concomitant Medications Within 5 Days and With/Without Quiescence at Next Visit at Least 8 Weeks After Non-quiescence) Among Participants With Active Uveitis at Study Start NQ Without CM Change and NQ at next visit	15.4 percentage of participants
Percentage of Participants in Non-quiescence (With/Without Change in Concomitant Medications Within 5 Days and With/Without Quiescence at Next Visit at Least 8 Weeks After Non-quiescence) Among Participants With Active Uveitis at Study Start NQ With Premature Discontinuation	6.7 percentage of participants
Percentage of Participants in Non-quiescence (With/Without Change in Concomitant Medications Within 5 Days and With/Without Quiescence at Next Visit at Least 8 Weeks After Non-quiescence) Among Participants With Active Uveitis at Study Start NQ And Completion	0.4 percentage of participants

SECONDARY outcome

Timeframe: 366 Weeks

Population: All participants in the ITT analysis set without systemic corticosteroids at baseline with evaluable data at a given timepoint.

Percentage of participants who started uveitis-related systemic corticosteroids during the study.

Outcome measures

Outcome measures
Measure	Adalimumab n=364 Participants Participants received open label (OL) adalimumab 40 mg by subcutaneous (SC) injection every other week (eow) until the final visit.
Percentage of Participants Who Started Uveitis-related Systemic Corticosteroids During the Study	20.3 percentage of participants Interval 16.3 to 24.8

SECONDARY outcome

Timeframe: Weeks 0, 2, 4, 8, 12, 18, 30, 42, 54, 66, 78, 90, 102, 114, 126, 138, 150, 162, 174, 186, 198, 210, 222, 234, and 246

Population: All participants in the ITT analysis set with active uveitis with a daily dose of uveitis-related systemic corticosteroids with evaluable data at a given timepoint.

Corticosteroid doses were converted into prednisone equivalents. Participants with uveitis-related systemic corticosteroid that could not be converted to prednisone equivalents were excluded. Individual mean daily doses were calculated within the respective visit windows. For Week 0, only uveitis-related systemic corticosteroids at Baseline (Day 1 for all participants) were considered. Baseline was defined as Week 0 for all participants.

Outcome measures

Outcome measures
Measure	Adalimumab n=235 Participants Participants received open label (OL) adalimumab 40 mg by subcutaneous (SC) injection every other week (eow) until the final visit.
Mean Daily Dose in Milligrams (mg) of Uveitis-related Systemic Corticosteroids in Participants With Active Uveitis Over Time Week 138	2.2 milligrams Standard Deviation 5.65
Mean Daily Dose in Milligrams (mg) of Uveitis-related Systemic Corticosteroids in Participants With Active Uveitis Over Time Week 210	1.4 milligrams Standard Deviation 3.57
Mean Daily Dose in Milligrams (mg) of Uveitis-related Systemic Corticosteroids in Participants With Active Uveitis Over Time Week 246	0.6 milligrams Standard Deviation 1.69
Mean Daily Dose in Milligrams (mg) of Uveitis-related Systemic Corticosteroids in Participants With Active Uveitis Over Time Week 0	13.6 milligrams Standard Deviation 19.21
Mean Daily Dose in Milligrams (mg) of Uveitis-related Systemic Corticosteroids in Participants With Active Uveitis Over Time Week 2	14.8 milligrams Standard Deviation 17.12
Mean Daily Dose in Milligrams (mg) of Uveitis-related Systemic Corticosteroids in Participants With Active Uveitis Over Time Week 4	10.1 milligrams Standard Deviation 12.27
Mean Daily Dose in Milligrams (mg) of Uveitis-related Systemic Corticosteroids in Participants With Active Uveitis Over Time Week 8	7.3 milligrams Standard Deviation 9.75
Mean Daily Dose in Milligrams (mg) of Uveitis-related Systemic Corticosteroids in Participants With Active Uveitis Over Time Week 12	6.0 milligrams Standard Deviation 9.34
Mean Daily Dose in Milligrams (mg) of Uveitis-related Systemic Corticosteroids in Participants With Active Uveitis Over Time Week 18	5.1 milligrams Standard Deviation 8.47
Mean Daily Dose in Milligrams (mg) of Uveitis-related Systemic Corticosteroids in Participants With Active Uveitis Over Time Week 30	4.4 milligrams Standard Deviation 7.12
Mean Daily Dose in Milligrams (mg) of Uveitis-related Systemic Corticosteroids in Participants With Active Uveitis Over Time Week 42	3.5 milligrams Standard Deviation 5.54
Mean Daily Dose in Milligrams (mg) of Uveitis-related Systemic Corticosteroids in Participants With Active Uveitis Over Time Week 54	3.5 milligrams Standard Deviation 6.71
Mean Daily Dose in Milligrams (mg) of Uveitis-related Systemic Corticosteroids in Participants With Active Uveitis Over Time Week 66	3.1 milligrams Standard Deviation 6.32
Mean Daily Dose in Milligrams (mg) of Uveitis-related Systemic Corticosteroids in Participants With Active Uveitis Over Time Week 78	2.6 milligrams Standard Deviation 5.10
Mean Daily Dose in Milligrams (mg) of Uveitis-related Systemic Corticosteroids in Participants With Active Uveitis Over Time Week 90	2.2 milligrams Standard Deviation 4.47
Mean Daily Dose in Milligrams (mg) of Uveitis-related Systemic Corticosteroids in Participants With Active Uveitis Over Time Week 102	2.1 milligrams Standard Deviation 4.80
Mean Daily Dose in Milligrams (mg) of Uveitis-related Systemic Corticosteroids in Participants With Active Uveitis Over Time Week 114	1.8 milligrams Standard Deviation 4.50
Mean Daily Dose in Milligrams (mg) of Uveitis-related Systemic Corticosteroids in Participants With Active Uveitis Over Time Week 126	1.6 milligrams Standard Deviation 4.16
Mean Daily Dose in Milligrams (mg) of Uveitis-related Systemic Corticosteroids in Participants With Active Uveitis Over Time Week 150	2.0 milligrams Standard Deviation 4.49
Mean Daily Dose in Milligrams (mg) of Uveitis-related Systemic Corticosteroids in Participants With Active Uveitis Over Time Week 162	1.9 milligrams Standard Deviation 4.31
Mean Daily Dose in Milligrams (mg) of Uveitis-related Systemic Corticosteroids in Participants With Active Uveitis Over Time Week 174	1.9 milligrams Standard Deviation 4.46
Mean Daily Dose in Milligrams (mg) of Uveitis-related Systemic Corticosteroids in Participants With Active Uveitis Over Time Week 186	1.6 milligrams Standard Deviation 4.27
Mean Daily Dose in Milligrams (mg) of Uveitis-related Systemic Corticosteroids in Participants With Active Uveitis Over Time Week 198	1.6 milligrams Standard Deviation 4.05
Mean Daily Dose in Milligrams (mg) of Uveitis-related Systemic Corticosteroids in Participants With Active Uveitis Over Time Week 222	2.3 milligrams Standard Deviation 8.48
Mean Daily Dose in Milligrams (mg) of Uveitis-related Systemic Corticosteroids in Participants With Active Uveitis Over Time Week 234	1.1 milligrams Standard Deviation 3.17

SECONDARY outcome

Timeframe: Weeks 0, 2, 4, 8, 12, 18, 30, 42, 54, 66, 78, 90, 102, 114, 126, 138, 150, 162, 174, 186, 198, 210, 222, 234, and 246

Population: All participants in the ITT analysis set with inactive uveitis with a daily dose of uveitis-related systemic corticosteroids with evaluable data at a given timepoint.

Outcome measures

Outcome measures
Measure	Adalimumab n=124 Participants Participants received open label (OL) adalimumab 40 mg by subcutaneous (SC) injection every other week (eow) until the final visit.
Mean Daily Dose (mg) of Uveitis-related Systemic Corticosteroids in Participants With Inactive Uveitis Over Time Week 0	1.5 milligrams Standard Deviation 7.32
Mean Daily Dose (mg) of Uveitis-related Systemic Corticosteroids in Participants With Inactive Uveitis Over Time Week 2	1.6 milligrams Standard Deviation 6.65
Mean Daily Dose (mg) of Uveitis-related Systemic Corticosteroids in Participants With Inactive Uveitis Over Time Week 4	1.4 milligrams Standard Deviation 4.89
Mean Daily Dose (mg) of Uveitis-related Systemic Corticosteroids in Participants With Inactive Uveitis Over Time Week 8	0.9 milligrams Standard Deviation 3.41
Mean Daily Dose (mg) of Uveitis-related Systemic Corticosteroids in Participants With Inactive Uveitis Over Time Week 12	0.9 milligrams Standard Deviation 4.12
Mean Daily Dose (mg) of Uveitis-related Systemic Corticosteroids in Participants With Inactive Uveitis Over Time Week 18	0.8 milligrams Standard Deviation 3.29
Mean Daily Dose (mg) of Uveitis-related Systemic Corticosteroids in Participants With Inactive Uveitis Over Time Week 30	0.7 milligrams Standard Deviation 2.74
Mean Daily Dose (mg) of Uveitis-related Systemic Corticosteroids in Participants With Inactive Uveitis Over Time Week 42	0.7 milligrams Standard Deviation 2.64
Mean Daily Dose (mg) of Uveitis-related Systemic Corticosteroids in Participants With Inactive Uveitis Over Time Week 54	1.8 milligrams Standard Deviation 7.09
Mean Daily Dose (mg) of Uveitis-related Systemic Corticosteroids in Participants With Inactive Uveitis Over Time Week 66	1.3 milligrams Standard Deviation 5.32
Mean Daily Dose (mg) of Uveitis-related Systemic Corticosteroids in Participants With Inactive Uveitis Over Time Week 78	1.1 milligrams Standard Deviation 4.36
Mean Daily Dose (mg) of Uveitis-related Systemic Corticosteroids in Participants With Inactive Uveitis Over Time Week 90	1.2 milligrams Standard Deviation 4.54
Mean Daily Dose (mg) of Uveitis-related Systemic Corticosteroids in Participants With Inactive Uveitis Over Time Week 102	0.6 milligrams Standard Deviation 2.63
Mean Daily Dose (mg) of Uveitis-related Systemic Corticosteroids in Participants With Inactive Uveitis Over Time Week 114	0.6 milligrams Standard Deviation 2.67
Mean Daily Dose (mg) of Uveitis-related Systemic Corticosteroids in Participants With Inactive Uveitis Over Time Week 126	0.7 milligrams Standard Deviation 2.95
Mean Daily Dose (mg) of Uveitis-related Systemic Corticosteroids in Participants With Inactive Uveitis Over Time Week 138	0.5 milligrams Standard Deviation 2.09
Mean Daily Dose (mg) of Uveitis-related Systemic Corticosteroids in Participants With Inactive Uveitis Over Time Week 150	0.5 milligrams Standard Deviation 1.91
Mean Daily Dose (mg) of Uveitis-related Systemic Corticosteroids in Participants With Inactive Uveitis Over Time Week 162	0.2 milligrams Standard Deviation 1.00
Mean Daily Dose (mg) of Uveitis-related Systemic Corticosteroids in Participants With Inactive Uveitis Over Time Week 174	0.2 milligrams Standard Deviation 1.07
Mean Daily Dose (mg) of Uveitis-related Systemic Corticosteroids in Participants With Inactive Uveitis Over Time Week 186	0.3 milligrams Standard Deviation 1.12
Mean Daily Dose (mg) of Uveitis-related Systemic Corticosteroids in Participants With Inactive Uveitis Over Time Week 198	0.3 milligrams Standard Deviation 1.23
Mean Daily Dose (mg) of Uveitis-related Systemic Corticosteroids in Participants With Inactive Uveitis Over Time Week 210	0.4 milligrams Standard Deviation 1.50
Mean Daily Dose (mg) of Uveitis-related Systemic Corticosteroids in Participants With Inactive Uveitis Over Time Week 222	0.5 milligrams Standard Deviation 1.73
Mean Daily Dose (mg) of Uveitis-related Systemic Corticosteroids in Participants With Inactive Uveitis Over Time Week 234	0.5 milligrams Standard Deviation 1.57
Mean Daily Dose (mg) of Uveitis-related Systemic Corticosteroids in Participants With Inactive Uveitis Over Time Week 246	0.0 milligrams Standard Deviation 0.00

SECONDARY outcome

Timeframe: Weeks 0, 2, 4, 8, 12, 18, 30, 42, 54, 66, 78, 90, 102, 114, 126, 138, 150, 162, 174, 186, and 198

Population: All participants in the ITT analysis set who received systemic corticosteroids at Week 0 with evaluable data at a given timepoint.

Outcome measures

Outcome measures
Measure	Adalimumab n=7 Participants Participants received open label (OL) adalimumab 40 mg by subcutaneous (SC) injection every other week (eow) until the final visit.
Percent Change in Mean Daily Dose of Uveitis-related Systemic Corticosteroids Relative to Week 0 in Participants With Inactive Uveitis Using Systemic Corticosteroids at Week 0 Over Time Week 4	-46.6 percent change from baseline Interval -64.2 to -29.0
Percent Change in Mean Daily Dose of Uveitis-related Systemic Corticosteroids Relative to Week 0 in Participants With Inactive Uveitis Using Systemic Corticosteroids at Week 0 Over Time Week 18	-30.8 percent change from baseline Interval -128.4 to 66.7
Percent Change in Mean Daily Dose of Uveitis-related Systemic Corticosteroids Relative to Week 0 in Participants With Inactive Uveitis Using Systemic Corticosteroids at Week 0 Over Time Week 54	-11.9 percent change from baseline Interval -186.2 to 162.5
Percent Change in Mean Daily Dose of Uveitis-related Systemic Corticosteroids Relative to Week 0 in Participants With Inactive Uveitis Using Systemic Corticosteroids at Week 0 Over Time Week 90	-27.5 percent change from baseline Interval -162.6 to 107.6
Percent Change in Mean Daily Dose of Uveitis-related Systemic Corticosteroids Relative to Week 0 in Participants With Inactive Uveitis Using Systemic Corticosteroids at Week 0 Over Time Week 150	-99.5 percent change from baseline Interval -106.3 to -92.7
Percent Change in Mean Daily Dose of Uveitis-related Systemic Corticosteroids Relative to Week 0 in Participants With Inactive Uveitis Using Systemic Corticosteroids at Week 0 Over Time Week 174	-100.0 percent change from baseline Interval -100.0 to -100.0
Percent Change in Mean Daily Dose of Uveitis-related Systemic Corticosteroids Relative to Week 0 in Participants With Inactive Uveitis Using Systemic Corticosteroids at Week 0 Over Time Week 186	-100.0 percent change from baseline Interval -100.0 to -100.0
Percent Change in Mean Daily Dose of Uveitis-related Systemic Corticosteroids Relative to Week 0 in Participants With Inactive Uveitis Using Systemic Corticosteroids at Week 0 Over Time Week 2	-11.8 percent change from baseline Interval -21.6 to -2.1
Percent Change in Mean Daily Dose of Uveitis-related Systemic Corticosteroids Relative to Week 0 in Participants With Inactive Uveitis Using Systemic Corticosteroids at Week 0 Over Time Week 8	-64.5 percent change from baseline Interval -88.1 to -40.8
Percent Change in Mean Daily Dose of Uveitis-related Systemic Corticosteroids Relative to Week 0 in Participants With Inactive Uveitis Using Systemic Corticosteroids at Week 0 Over Time Week 12	-29.7 percent change from baseline Interval -91.5 to 32.1
Percent Change in Mean Daily Dose of Uveitis-related Systemic Corticosteroids Relative to Week 0 in Participants With Inactive Uveitis Using Systemic Corticosteroids at Week 0 Over Time Week 30	-25.0 percent change from baseline Interval -159.6 to 109.5
Percent Change in Mean Daily Dose of Uveitis-related Systemic Corticosteroids Relative to Week 0 in Participants With Inactive Uveitis Using Systemic Corticosteroids at Week 0 Over Time Week 42	-36.7 percent change from baseline Interval -150.4 to 76.9
Percent Change in Mean Daily Dose of Uveitis-related Systemic Corticosteroids Relative to Week 0 in Participants With Inactive Uveitis Using Systemic Corticosteroids at Week 0 Over Time Week 66	-25.1 percent change from baseline Interval -156.9 to 106.6
Percent Change in Mean Daily Dose of Uveitis-related Systemic Corticosteroids Relative to Week 0 in Participants With Inactive Uveitis Using Systemic Corticosteroids at Week 0 Over Time Week 78	-28.3 percent change from baseline Interval -157.9 to 101.2
Percent Change in Mean Daily Dose of Uveitis-related Systemic Corticosteroids Relative to Week 0 in Participants With Inactive Uveitis Using Systemic Corticosteroids at Week 0 Over Time Week 102	-78.1 percent change from baseline Interval -120.7 to -35.4
Percent Change in Mean Daily Dose of Uveitis-related Systemic Corticosteroids Relative to Week 0 in Participants With Inactive Uveitis Using Systemic Corticosteroids at Week 0 Over Time Week 114	-84.2 percent change from baseline Interval -96.8 to -67.2
Percent Change in Mean Daily Dose of Uveitis-related Systemic Corticosteroids Relative to Week 0 in Participants With Inactive Uveitis Using Systemic Corticosteroids at Week 0 Over Time Week 126	-88.9 percent change from baseline Interval -113.9 to -63.9
Percent Change in Mean Daily Dose of Uveitis-related Systemic Corticosteroids Relative to Week 0 in Participants With Inactive Uveitis Using Systemic Corticosteroids at Week 0 Over Time Week 138	-95.9 percent change from baseline Interval -148.4 to -43.3
Percent Change in Mean Daily Dose of Uveitis-related Systemic Corticosteroids Relative to Week 0 in Participants With Inactive Uveitis Using Systemic Corticosteroids at Week 0 Over Time Week 162	-100.0 percent change from baseline Interval -100.0 to -100.0
Percent Change in Mean Daily Dose of Uveitis-related Systemic Corticosteroids Relative to Week 0 in Participants With Inactive Uveitis Using Systemic Corticosteroids at Week 0 Over Time Week 198	-100.0 percent change from baseline Interval -100.0 to -100.0

SECONDARY outcome

Timeframe: Weeks 0, 2, 4, 8, 12, 18, 30, 42, 54, 66, 78, 90, 102, 114, 126, 138, 150, 162, 174, 186, 198, 210, 222, 234, and 246

Population: All participants in the ITT analysis set receiving systemic corticosteroids at Week 0 with evaluable data at a given timepoint.

Outcome measures

Outcome measures
Measure	Adalimumab n=114 Participants Participants received open label (OL) adalimumab 40 mg by subcutaneous (SC) injection every other week (eow) until the final visit.
Percent Change in Mean Daily Dose of Uveitis-related Systemic Corticosteroids Relative to Week 0 in Participants With Active Uveitis Using Systemic Corticosteroids at Week 0 Over Time Week 12	-46.3 percent change from baseline Interval -65.0 to -27.7
Percent Change in Mean Daily Dose of Uveitis-related Systemic Corticosteroids Relative to Week 0 in Participants With Active Uveitis Using Systemic Corticosteroids at Week 0 Over Time Week 18	-55.1 percent change from baseline Interval -73.1 to -37.1
Percent Change in Mean Daily Dose of Uveitis-related Systemic Corticosteroids Relative to Week 0 in Participants With Active Uveitis Using Systemic Corticosteroids at Week 0 Over Time Week 30	-62.8 percent change from baseline Interval -78.1 to -47.5
Percent Change in Mean Daily Dose of Uveitis-related Systemic Corticosteroids Relative to Week 0 in Participants With Active Uveitis Using Systemic Corticosteroids at Week 0 Over Time Week 114	-82.0 percent change from baseline Interval -96.8 to -66.9
Percent Change in Mean Daily Dose of Uveitis-related Systemic Corticosteroids Relative to Week 0 in Participants With Active Uveitis Using Systemic Corticosteroids at Week 0 Over Time Week 150	-86.9 percent change from baseline Interval -94.5 to -79.2
Percent Change in Mean Daily Dose of Uveitis-related Systemic Corticosteroids Relative to Week 0 in Participants With Active Uveitis Using Systemic Corticosteroids at Week 0 Over Time Week 162	-90.7 percent change from baseline Interval -94.9 to -86.4
Percent Change in Mean Daily Dose of Uveitis-related Systemic Corticosteroids Relative to Week 0 in Participants With Active Uveitis Using Systemic Corticosteroids at Week 0 Over Time Week 222	-87.1 percent change from baseline Interval -102.0 to -72.2
Percent Change in Mean Daily Dose of Uveitis-related Systemic Corticosteroids Relative to Week 0 in Participants With Active Uveitis Using Systemic Corticosteroids at Week 0 Over Time Week 2	-4.6 percent change from baseline Interval -14.2 to 5.0
Percent Change in Mean Daily Dose of Uveitis-related Systemic Corticosteroids Relative to Week 0 in Participants With Active Uveitis Using Systemic Corticosteroids at Week 0 Over Time Week 4	-25.0 percent change from baseline Interval -38.6 to -11.4
Percent Change in Mean Daily Dose of Uveitis-related Systemic Corticosteroids Relative to Week 0 in Participants With Active Uveitis Using Systemic Corticosteroids at Week 0 Over Time Week 8	-41.7 percent change from baseline Interval -55.0 to -28.4
Percent Change in Mean Daily Dose of Uveitis-related Systemic Corticosteroids Relative to Week 0 in Participants With Active Uveitis Using Systemic Corticosteroids at Week 0 Over Time Week 42	-73.4 percent change from baseline Interval -85.0 to -61.9
Percent Change in Mean Daily Dose of Uveitis-related Systemic Corticosteroids Relative to Week 0 in Participants With Active Uveitis Using Systemic Corticosteroids at Week 0 Over Time Week 54	-73.2 percent change from baseline Interval -85.3 to -61.0
Percent Change in Mean Daily Dose of Uveitis-related Systemic Corticosteroids Relative to Week 0 in Participants With Active Uveitis Using Systemic Corticosteroids at Week 0 Over Time Week 66	-77.1 percent change from baseline Interval -89.3 to -64.9
Percent Change in Mean Daily Dose of Uveitis-related Systemic Corticosteroids Relative to Week 0 in Participants With Active Uveitis Using Systemic Corticosteroids at Week 0 Over Time Week 78	-77.3 percent change from baseline Interval -90.2 to -64.4
Percent Change in Mean Daily Dose of Uveitis-related Systemic Corticosteroids Relative to Week 0 in Participants With Active Uveitis Using Systemic Corticosteroids at Week 0 Over Time Week 90	-82.1 percent change from baseline Interval -93.3 to -70.9
Percent Change in Mean Daily Dose of Uveitis-related Systemic Corticosteroids Relative to Week 0 in Participants With Active Uveitis Using Systemic Corticosteroids at Week 0 Over Time Week 102	-78.8 percent change from baseline Interval -95.7 to -62.0
Percent Change in Mean Daily Dose of Uveitis-related Systemic Corticosteroids Relative to Week 0 in Participants With Active Uveitis Using Systemic Corticosteroids at Week 0 Over Time Week 126	-82.8 percent change from baseline Interval -98.6 to -66.9
Percent Change in Mean Daily Dose of Uveitis-related Systemic Corticosteroids Relative to Week 0 in Participants With Active Uveitis Using Systemic Corticosteroids at Week 0 Over Time Week 138	-87.8 percent change from baseline Interval -94.2 to -81.4
Percent Change in Mean Daily Dose of Uveitis-related Systemic Corticosteroids Relative to Week 0 in Participants With Active Uveitis Using Systemic Corticosteroids at Week 0 Over Time Week 174	-91.4 percent change from baseline Interval -95.8 to -86.9
Percent Change in Mean Daily Dose of Uveitis-related Systemic Corticosteroids Relative to Week 0 in Participants With Active Uveitis Using Systemic Corticosteroids at Week 0 Over Time Week 186	-90.3 percent change from baseline Interval -95.9 to -84.7
Percent Change in Mean Daily Dose of Uveitis-related Systemic Corticosteroids Relative to Week 0 in Participants With Active Uveitis Using Systemic Corticosteroids at Week 0 Over Time Week 198	-91.0 percent change from baseline Interval -96.6 to -85.5
Percent Change in Mean Daily Dose of Uveitis-related Systemic Corticosteroids Relative to Week 0 in Participants With Active Uveitis Using Systemic Corticosteroids at Week 0 Over Time Week 210	-89.9 percent change from baseline Interval -96.8 to -82.9
Percent Change in Mean Daily Dose of Uveitis-related Systemic Corticosteroids Relative to Week 0 in Participants With Active Uveitis Using Systemic Corticosteroids at Week 0 Over Time Week 234	-93.8 percent change from baseline Interval -103.8 to -83.9
Percent Change in Mean Daily Dose of Uveitis-related Systemic Corticosteroids Relative to Week 0 in Participants With Active Uveitis Using Systemic Corticosteroids at Week 0 Over Time Week 246	-98.3 percent change from baseline Interval -101.3 to -95.4

SECONDARY outcome

Timeframe: Weeks 0, 2, 4, 8, 12, 18, 30, 42, 54, 66, 78, 90, 102, 114, 126, 138, 150, 162, 174, 186, 198, 210, 222, 234, and 246

Population: All participants in the ITT analysis set with evaluable data at each timepoint.

Outcome measures

Outcome measures
Measure	Adalimumab n=359 Participants Participants received open label (OL) adalimumab 40 mg by subcutaneous (SC) injection every other week (eow) until the final visit.
Percentage of Participants Not Using Systemic Corticosteroids Over Time Week 12	64.7 percentage of participants Interval 59.3 to 69.8
Percentage of Participants Not Using Systemic Corticosteroids Over Time Week 18	68.3 percentage of participants Interval 63.0 to 73.3
Percentage of Participants Not Using Systemic Corticosteroids Over Time Week 54	71.9 percentage of participants Interval 66.4 to 77.0
Percentage of Participants Not Using Systemic Corticosteroids Over Time Week 174	79.4 percentage of participants Interval 71.6 to 85.9
Percentage of Participants Not Using Systemic Corticosteroids Over Time Week 246	94.1 percentage of participants Interval 80.3 to 99.3
Percentage of Participants Not Using Systemic Corticosteroids Over Time Week 0	66.3 percentage of participants Interval 61.1 to 71.2
Percentage of Participants Not Using Systemic Corticosteroids Over Time Week 2	58.7 percentage of participants Interval 53.4 to 63.8
Percentage of Participants Not Using Systemic Corticosteroids Over Time Week 4	60.2 percentage of participants Interval 54.8 to 65.3
Percentage of Participants Not Using Systemic Corticosteroids Over Time Week 8	61.9 percentage of participants Interval 56.5 to 67.1
Percentage of Participants Not Using Systemic Corticosteroids Over Time Week 30	70.2 percentage of participants Interval 64.8 to 75.2
Percentage of Participants Not Using Systemic Corticosteroids Over Time Week 42	70.9 percentage of participants Interval 65.5 to 75.9
Percentage of Participants Not Using Systemic Corticosteroids Over Time Week 66	73.1 percentage of participants Interval 67.4 to 78.2
Percentage of Participants Not Using Systemic Corticosteroids Over Time Week 78	75.2 percentage of participants Interval 69.5 to 80.3
Percentage of Participants Not Using Systemic Corticosteroids Over Time Week 90	77.0 percentage of participants Interval 71.4 to 82.0
Percentage of Participants Not Using Systemic Corticosteroids Over Time Week 102	80.8 percentage of participants Interval 75.2 to 85.6
Percentage of Participants Not Using Systemic Corticosteroids Over Time Week 114	83.6 percentage of participants Interval 78.1 to 88.1
Percentage of Participants Not Using Systemic Corticosteroids Over Time Week 126	84.2 percentage of participants Interval 78.5 to 88.9
Percentage of Participants Not Using Systemic Corticosteroids Over Time Week 138	82.1 percentage of participants Interval 75.9 to 87.3
Percentage of Participants Not Using Systemic Corticosteroids Over Time Week 150	81.5 percentage of participants Interval 74.9 to 87.0
Percentage of Participants Not Using Systemic Corticosteroids Over Time Week 162	80.5 percentage of participants Interval 73.3 to 86.6
Percentage of Participants Not Using Systemic Corticosteroids Over Time Week 186	80.5 percentage of participants Interval 72.4 to 87.1
Percentage of Participants Not Using Systemic Corticosteroids Over Time Week 198	80.4 percentage of participants Interval 71.1 to 87.8
Percentage of Participants Not Using Systemic Corticosteroids Over Time Week 210	81.7 percentage of participants Interval 71.6 to 89.4
Percentage of Participants Not Using Systemic Corticosteroids Over Time Week 222	86.4 percentage of participants Interval 75.0 to 94.0
Percentage of Participants Not Using Systemic Corticosteroids Over Time Week 234	89.6 percentage of participants Interval 77.3 to 96.5

SECONDARY outcome

Timeframe: Weeks 2, 4, 8, 12, 18, 30, 42, 54, 66, 78, 90, 102, 114, 126, 138, 150, 162, 174, 186, 198, 210, 222, 234, and 246

Population: All participants in the ITT analysis set with evaluable data at each timepoint.

Percentage of participants at each study time point without a worsening of Best Corrected Visual Acuity (BCVA) by ≥15 letters on the Early Treatment Diabetic Retinopathy Study (ETDRS) in both eyes relative to Baseline for participants who had inactive uveitis when they entered the study.

Outcome measures

Outcome measures
Measure	Adalimumab n=124 Participants Participants received open label (OL) adalimumab 40 mg by subcutaneous (SC) injection every other week (eow) until the final visit.
Percentage of Participants Without Worsening of Best Corrected Visual Acuity (BCVA) by ≥15 Letters on Early Treatment Diabetic Retinopathy Study (ETDRS) in Both Eyes Relative to Baseline Over Time Among Participants Who Had Inactive Uveitis at Study Entry Week 2	100 percentage of participants Interval 96.9 to 100.0
Percentage of Participants Without Worsening of Best Corrected Visual Acuity (BCVA) by ≥15 Letters on Early Treatment Diabetic Retinopathy Study (ETDRS) in Both Eyes Relative to Baseline Over Time Among Participants Who Had Inactive Uveitis at Study Entry Week 12	100 percentage of participants Interval 96.8 to 100.0
Percentage of Participants Without Worsening of Best Corrected Visual Acuity (BCVA) by ≥15 Letters on Early Treatment Diabetic Retinopathy Study (ETDRS) in Both Eyes Relative to Baseline Over Time Among Participants Who Had Inactive Uveitis at Study Entry Week 138	96.9 percentage of participants Interval 89.2 to 99.6
Percentage of Participants Without Worsening of Best Corrected Visual Acuity (BCVA) by ≥15 Letters on Early Treatment Diabetic Retinopathy Study (ETDRS) in Both Eyes Relative to Baseline Over Time Among Participants Who Had Inactive Uveitis at Study Entry Week 150	100 percentage of participants Interval 93.7 to 100.0
Percentage of Participants Without Worsening of Best Corrected Visual Acuity (BCVA) by ≥15 Letters on Early Treatment Diabetic Retinopathy Study (ETDRS) in Both Eyes Relative to Baseline Over Time Among Participants Who Had Inactive Uveitis at Study Entry Week 162	100 percentage of participants Interval 91.0 to 100.0
Percentage of Participants Without Worsening of Best Corrected Visual Acuity (BCVA) by ≥15 Letters on Early Treatment Diabetic Retinopathy Study (ETDRS) in Both Eyes Relative to Baseline Over Time Among Participants Who Had Inactive Uveitis at Study Entry Week 174	100 percentage of participants Interval 89.7 to 100.0
Percentage of Participants Without Worsening of Best Corrected Visual Acuity (BCVA) by ≥15 Letters on Early Treatment Diabetic Retinopathy Study (ETDRS) in Both Eyes Relative to Baseline Over Time Among Participants Who Had Inactive Uveitis at Study Entry Week 4	99.1 percentage of participants Interval 94.9 to 100.0
Percentage of Participants Without Worsening of Best Corrected Visual Acuity (BCVA) by ≥15 Letters on Early Treatment Diabetic Retinopathy Study (ETDRS) in Both Eyes Relative to Baseline Over Time Among Participants Who Had Inactive Uveitis at Study Entry Week 8	100 percentage of participants Interval 96.8 to 100.0
Percentage of Participants Without Worsening of Best Corrected Visual Acuity (BCVA) by ≥15 Letters on Early Treatment Diabetic Retinopathy Study (ETDRS) in Both Eyes Relative to Baseline Over Time Among Participants Who Had Inactive Uveitis at Study Entry Week 18	100 percentage of participants Interval 96.8 to 100.0
Percentage of Participants Without Worsening of Best Corrected Visual Acuity (BCVA) by ≥15 Letters on Early Treatment Diabetic Retinopathy Study (ETDRS) in Both Eyes Relative to Baseline Over Time Among Participants Who Had Inactive Uveitis at Study Entry Week 30	99.1 percentage of participants Interval 95.1 to 100.0
Percentage of Participants Without Worsening of Best Corrected Visual Acuity (BCVA) by ≥15 Letters on Early Treatment Diabetic Retinopathy Study (ETDRS) in Both Eyes Relative to Baseline Over Time Among Participants Who Had Inactive Uveitis at Study Entry Week 42	98.2 percentage of participants Interval 93.7 to 99.8
Percentage of Participants Without Worsening of Best Corrected Visual Acuity (BCVA) by ≥15 Letters on Early Treatment Diabetic Retinopathy Study (ETDRS) in Both Eyes Relative to Baseline Over Time Among Participants Who Had Inactive Uveitis at Study Entry Week 54	97.2 percentage of participants Interval 92.0 to 99.4
Percentage of Participants Without Worsening of Best Corrected Visual Acuity (BCVA) by ≥15 Letters on Early Treatment Diabetic Retinopathy Study (ETDRS) in Both Eyes Relative to Baseline Over Time Among Participants Who Had Inactive Uveitis at Study Entry Week 66	98.1 percentage of participants Interval 93.2 to 99.8
Percentage of Participants Without Worsening of Best Corrected Visual Acuity (BCVA) by ≥15 Letters on Early Treatment Diabetic Retinopathy Study (ETDRS) in Both Eyes Relative to Baseline Over Time Among Participants Who Had Inactive Uveitis at Study Entry Week 78	97.0 percentage of participants Interval 91.4 to 99.4
Percentage of Participants Without Worsening of Best Corrected Visual Acuity (BCVA) by ≥15 Letters on Early Treatment Diabetic Retinopathy Study (ETDRS) in Both Eyes Relative to Baseline Over Time Among Participants Who Had Inactive Uveitis at Study Entry Week 90	98.9 percentage of participants Interval 94.3 to 100.0
Percentage of Participants Without Worsening of Best Corrected Visual Acuity (BCVA) by ≥15 Letters on Early Treatment Diabetic Retinopathy Study (ETDRS) in Both Eyes Relative to Baseline Over Time Among Participants Who Had Inactive Uveitis at Study Entry Week 102	97.8 percentage of participants Interval 92.1 to 99.7
Percentage of Participants Without Worsening of Best Corrected Visual Acuity (BCVA) by ≥15 Letters on Early Treatment Diabetic Retinopathy Study (ETDRS) in Both Eyes Relative to Baseline Over Time Among Participants Who Had Inactive Uveitis at Study Entry Week 114	97.6 percentage of participants Interval 91.7 to 99.7
Percentage of Participants Without Worsening of Best Corrected Visual Acuity (BCVA) by ≥15 Letters on Early Treatment Diabetic Retinopathy Study (ETDRS) in Both Eyes Relative to Baseline Over Time Among Participants Who Had Inactive Uveitis at Study Entry Week 126	96.1 percentage of participants Interval 88.9 to 99.2
Percentage of Participants Without Worsening of Best Corrected Visual Acuity (BCVA) by ≥15 Letters on Early Treatment Diabetic Retinopathy Study (ETDRS) in Both Eyes Relative to Baseline Over Time Among Participants Who Had Inactive Uveitis at Study Entry Week 186	100 percentage of participants Interval 88.8 to 100.0
Percentage of Participants Without Worsening of Best Corrected Visual Acuity (BCVA) by ≥15 Letters on Early Treatment Diabetic Retinopathy Study (ETDRS) in Both Eyes Relative to Baseline Over Time Among Participants Who Had Inactive Uveitis at Study Entry Week 198	100 percentage of participants Interval 86.8 to 100.0
Percentage of Participants Without Worsening of Best Corrected Visual Acuity (BCVA) by ≥15 Letters on Early Treatment Diabetic Retinopathy Study (ETDRS) in Both Eyes Relative to Baseline Over Time Among Participants Who Had Inactive Uveitis at Study Entry Week 210	100 percentage of participants Interval 79.4 to 100.0
Percentage of Participants Without Worsening of Best Corrected Visual Acuity (BCVA) by ≥15 Letters on Early Treatment Diabetic Retinopathy Study (ETDRS) in Both Eyes Relative to Baseline Over Time Among Participants Who Had Inactive Uveitis at Study Entry Week 222	91.7 percentage of participants Interval 61.5 to 99.8
Percentage of Participants Without Worsening of Best Corrected Visual Acuity (BCVA) by ≥15 Letters on Early Treatment Diabetic Retinopathy Study (ETDRS) in Both Eyes Relative to Baseline Over Time Among Participants Who Had Inactive Uveitis at Study Entry Week 234	88.9 percentage of participants Interval 51.8 to 99.7
Percentage of Participants Without Worsening of Best Corrected Visual Acuity (BCVA) by ≥15 Letters on Early Treatment Diabetic Retinopathy Study (ETDRS) in Both Eyes Relative to Baseline Over Time Among Participants Who Had Inactive Uveitis at Study Entry Week 246	85.7 percentage of participants Interval 42.1 to 99.6

SECONDARY outcome

Timeframe: Weeks 12, 18, 30, 42, 54, 66, 78, 90, 102, 114, 126, 138, 150, 162, 174, 186, 198, 210, 222, 234, and 246

Population: All participants in the ITT analysis set with evaluable data at each timepoint.

Percentage of participants at each study time point without a worsening of BCVA by ≥15 letters on the ETDRS in both eyes relative to Week 8 for participant who had active uveitis when they entered the study.

Outcome measures

Outcome measures
Measure	Adalimumab n=222 Participants Participants received open label (OL) adalimumab 40 mg by subcutaneous (SC) injection every other week (eow) until the final visit.
Percentage of Participants Without Worsening of BCVA by ≥15 Letters on the ETDRS in Both Eyes Relative to Week 8 Over Time Among Participants With Active Uveitis at Study Entry Week 30	96.6 percentage of participants Interval 93.1 to 98.6
Percentage of Participants Without Worsening of BCVA by ≥15 Letters on the ETDRS in Both Eyes Relative to Week 8 Over Time Among Participants With Active Uveitis at Study Entry Week 42	94.9 percentage of participants Interval 90.8 to 97.5
Percentage of Participants Without Worsening of BCVA by ≥15 Letters on the ETDRS in Both Eyes Relative to Week 8 Over Time Among Participants With Active Uveitis at Study Entry Week 12	96.8 percentage of participants Interval 93.5 to 98.7
Percentage of Participants Without Worsening of BCVA by ≥15 Letters on the ETDRS in Both Eyes Relative to Week 8 Over Time Among Participants With Active Uveitis at Study Entry Week 18	96.3 percentage of participants Interval 92.8 to 98.4
Percentage of Participants Without Worsening of BCVA by ≥15 Letters on the ETDRS in Both Eyes Relative to Week 8 Over Time Among Participants With Active Uveitis at Study Entry Week 54	94.7 percentage of participants Interval 90.4 to 97.4
Percentage of Participants Without Worsening of BCVA by ≥15 Letters on the ETDRS in Both Eyes Relative to Week 8 Over Time Among Participants With Active Uveitis at Study Entry Week 66	93.3 percentage of participants Interval 88.6 to 96.5
Percentage of Participants Without Worsening of BCVA by ≥15 Letters on the ETDRS in Both Eyes Relative to Week 8 Over Time Among Participants With Active Uveitis at Study Entry Week 78	93.6 percentage of participants Interval 88.8 to 96.8
Percentage of Participants Without Worsening of BCVA by ≥15 Letters on the ETDRS in Both Eyes Relative to Week 8 Over Time Among Participants With Active Uveitis at Study Entry Week 90	96.4 percentage of participants Interval 92.3 to 98.7
Percentage of Participants Without Worsening of BCVA by ≥15 Letters on the ETDRS in Both Eyes Relative to Week 8 Over Time Among Participants With Active Uveitis at Study Entry Week 102	94.8 percentage of participants Interval 90.0 to 97.7
Percentage of Participants Without Worsening of BCVA by ≥15 Letters on the ETDRS in Both Eyes Relative to Week 8 Over Time Among Participants With Active Uveitis at Study Entry Week 114	93.8 percentage of participants Interval 88.6 to 97.1
Percentage of Participants Without Worsening of BCVA by ≥15 Letters on the ETDRS in Both Eyes Relative to Week 8 Over Time Among Participants With Active Uveitis at Study Entry Week 126	95.0 percentage of participants Interval 90.0 to 98.0
Percentage of Participants Without Worsening of BCVA by ≥15 Letters on the ETDRS in Both Eyes Relative to Week 8 Over Time Among Participants With Active Uveitis at Study Entry Week 138	93.9 percentage of participants Interval 88.3 to 97.3
Percentage of Participants Without Worsening of BCVA by ≥15 Letters on the ETDRS in Both Eyes Relative to Week 8 Over Time Among Participants With Active Uveitis at Study Entry Week 150	92.7 percentage of participants Interval 86.6 to 96.6
Percentage of Participants Without Worsening of BCVA by ≥15 Letters on the ETDRS in Both Eyes Relative to Week 8 Over Time Among Participants With Active Uveitis at Study Entry Week 162	93.9 percentage of participants Interval 87.8 to 97.5
Percentage of Participants Without Worsening of BCVA by ≥15 Letters on the ETDRS in Both Eyes Relative to Week 8 Over Time Among Participants With Active Uveitis at Study Entry Week 174	91.6 percentage of participants Interval 84.6 to 96.1
Percentage of Participants Without Worsening of BCVA by ≥15 Letters on the ETDRS in Both Eyes Relative to Week 8 Over Time Among Participants With Active Uveitis at Study Entry Week 186	92.7 percentage of participants Interval 85.6 to 97.0
Percentage of Participants Without Worsening of BCVA by ≥15 Letters on the ETDRS in Both Eyes Relative to Week 8 Over Time Among Participants With Active Uveitis at Study Entry Week 198	95.3 percentage of participants Interval 88.5 to 98.7
Percentage of Participants Without Worsening of BCVA by ≥15 Letters on the ETDRS in Both Eyes Relative to Week 8 Over Time Among Participants With Active Uveitis at Study Entry Week 210	95.8 percentage of participants Interval 88.1 to 99.1
Percentage of Participants Without Worsening of BCVA by ≥15 Letters on the ETDRS in Both Eyes Relative to Week 8 Over Time Among Participants With Active Uveitis at Study Entry Week 222	96.6 percentage of participants Interval 88.1 to 99.6
Percentage of Participants Without Worsening of BCVA by ≥15 Letters on the ETDRS in Both Eyes Relative to Week 8 Over Time Among Participants With Active Uveitis at Study Entry Week 234	95.2 percentage of participants Interval 83.8 to 99.4
Percentage of Participants Without Worsening of BCVA by ≥15 Letters on the ETDRS in Both Eyes Relative to Week 8 Over Time Among Participants With Active Uveitis at Study Entry Week 246	91.2 percentage of participants Interval 76.3 to 98.1

SECONDARY outcome

Timeframe: Weeks 0, 2, 4, 8, 12, 18, 30, 42, 54, 66, 78, 90, 102, 114, 126, 138, 150, 162, 174, 186, 198, 210, 222, 234, and 246

Population: All participants in the ITT analysis set with evaluable data at each study timepoint.

Using corrective lenses based on that visit's refraction testing, participant's BCVA was measured using an ETDRS logMAR chart. On the logMAR scale, 0 is equivalent to 20/20 visual acuity, the range of normal vision is considered to be from -0.2 to 0.1; higher values indicate visual impairment. Data presented includes the mean of both eyes for all participants (active or inactive uveitis) for all study time points.

Outcome measures

Outcome measures
Measure	Adalimumab n=364 Participants Participants received open label (OL) adalimumab 40 mg by subcutaneous (SC) injection every other week (eow) until the final visit.
Mean of Both Eyes of the Logarithm of the Minimum Angle of Resolution (LogMAR) BCVA Over Time Week 234	0.07 Log (Mar) BCVA Both Eyes Standard Deviation 0.222
Mean of Both Eyes of the Logarithm of the Minimum Angle of Resolution (LogMAR) BCVA Over Time Week 114	0.09 Log (Mar) BCVA Both Eyes Standard Deviation 0.233
Mean of Both Eyes of the Logarithm of the Minimum Angle of Resolution (LogMAR) BCVA Over Time Week 126	0.09 Log (Mar) BCVA Both Eyes Standard Deviation 0.231
Mean of Both Eyes of the Logarithm of the Minimum Angle of Resolution (LogMAR) BCVA Over Time Week 198	0.07 Log (Mar) BCVA Both Eyes Standard Deviation 0.205
Mean of Both Eyes of the Logarithm of the Minimum Angle of Resolution (LogMAR) BCVA Over Time Week 210	0.07 Log (Mar) BCVA Both Eyes Standard Deviation 0.211
Mean of Both Eyes of the Logarithm of the Minimum Angle of Resolution (LogMAR) BCVA Over Time Week 0	0.20 Log (Mar) BCVA Both Eyes Standard Deviation 0.275
Mean of Both Eyes of the Logarithm of the Minimum Angle of Resolution (LogMAR) BCVA Over Time Week 2	0.17 Log (Mar) BCVA Both Eyes Standard Deviation 0.265
Mean of Both Eyes of the Logarithm of the Minimum Angle of Resolution (LogMAR) BCVA Over Time Week 4	0.15 Log (Mar) BCVA Both Eyes Standard Deviation 0.248
Mean of Both Eyes of the Logarithm of the Minimum Angle of Resolution (LogMAR) BCVA Over Time Week 8	0.14 Log (Mar) BCVA Both Eyes Standard Deviation 0.247
Mean of Both Eyes of the Logarithm of the Minimum Angle of Resolution (LogMAR) BCVA Over Time Week 12	0.13 Log (Mar) BCVA Both Eyes Standard Deviation 0.244
Mean of Both Eyes of the Logarithm of the Minimum Angle of Resolution (LogMAR) BCVA Over Time Week 18	0.12 Log (Mar) BCVA Both Eyes Standard Deviation 0.240
Mean of Both Eyes of the Logarithm of the Minimum Angle of Resolution (LogMAR) BCVA Over Time Week 222	0.07 Log (Mar) BCVA Both Eyes Standard Deviation 0.218
Mean of Both Eyes of the Logarithm of the Minimum Angle of Resolution (LogMAR) BCVA Over Time Week 30	0.12 Log (Mar) BCVA Both Eyes Standard Deviation 0.249
Mean of Both Eyes of the Logarithm of the Minimum Angle of Resolution (LogMAR) BCVA Over Time Week 42	0.12 Log (Mar) BCVA Both Eyes Standard Deviation 0.227
Mean of Both Eyes of the Logarithm of the Minimum Angle of Resolution (LogMAR) BCVA Over Time Week 54	0.11 Log (Mar) BCVA Both Eyes Standard Deviation 0.238
Mean of Both Eyes of the Logarithm of the Minimum Angle of Resolution (LogMAR) BCVA Over Time Week 66	0.11 Log (Mar) BCVA Both Eyes Standard Deviation 0.241
Mean of Both Eyes of the Logarithm of the Minimum Angle of Resolution (LogMAR) BCVA Over Time Week 78	0.11 Log (Mar) BCVA Both Eyes Standard Deviation 0.238
Mean of Both Eyes of the Logarithm of the Minimum Angle of Resolution (LogMAR) BCVA Over Time Week 90	0.09 Log (Mar) BCVA Both Eyes Standard Deviation 0.214
Mean of Both Eyes of the Logarithm of the Minimum Angle of Resolution (LogMAR) BCVA Over Time Week 102	0.09 Log (Mar) BCVA Both Eyes Standard Deviation 0.219
Mean of Both Eyes of the Logarithm of the Minimum Angle of Resolution (LogMAR) BCVA Over Time Week 138	0.09 Log (Mar) BCVA Both Eyes Standard Deviation 0.224
Mean of Both Eyes of the Logarithm of the Minimum Angle of Resolution (LogMAR) BCVA Over Time Week 150	0.10 Log (Mar) BCVA Both Eyes Standard Deviation 0.255
Mean of Both Eyes of the Logarithm of the Minimum Angle of Resolution (LogMAR) BCVA Over Time Week 162	0.09 Log (Mar) BCVA Both Eyes Standard Deviation 0.249
Mean of Both Eyes of the Logarithm of the Minimum Angle of Resolution (LogMAR) BCVA Over Time Week 174	0.09 Log (Mar) BCVA Both Eyes Standard Deviation 0.261
Mean of Both Eyes of the Logarithm of the Minimum Angle of Resolution (LogMAR) BCVA Over Time Week 186	0.09 Log (Mar) BCVA Both Eyes Standard Deviation 0.244
Mean of Both Eyes of the Logarithm of the Minimum Angle of Resolution (LogMAR) BCVA Over Time Week 246	0.08 Log (Mar) BCVA Both Eyes Standard Deviation 0.217

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline (Week 0) and Weeks 2, 4, 8, 12, 18, 30, 42, 54, 66, 78, 90, 102, 114, 126, 138, 150, 162, 174, 186, 198, 210, 222, 234, and 246

Population: All participants in the ITT analysis set with evaluable data at each timepoint.

Central retinal thickness was measured using optical coherence tomography (OCT) and assessed by a central reader. Percent change in left eye from baseline (Week 0) to each study time point relative to baseline for participants who had inactive uveitis at study entry is presented.

Outcome measures

Outcome measures
Measure	Adalimumab n=111 Participants Participants received open label (OL) adalimumab 40 mg by subcutaneous (SC) injection every other week (eow) until the final visit.
Percent Change in Left Eye in Central Retinal Thickness (1 mm Subfield) From Baseline to Each Study Time Point Relative to Baseline for Participants Who Had Inactive Uveitis at Study Entry Over Time Week 2	0.3 percent change from baseline Interval -1.41 to 1.97
Percent Change in Left Eye in Central Retinal Thickness (1 mm Subfield) From Baseline to Each Study Time Point Relative to Baseline for Participants Who Had Inactive Uveitis at Study Entry Over Time Week 4	-0.2 percent change from baseline Interval -2.03 to 1.56
Percent Change in Left Eye in Central Retinal Thickness (1 mm Subfield) From Baseline to Each Study Time Point Relative to Baseline for Participants Who Had Inactive Uveitis at Study Entry Over Time Week 8	-0.7 percent change from baseline Interval -2.07 to 0.72
Percent Change in Left Eye in Central Retinal Thickness (1 mm Subfield) From Baseline to Each Study Time Point Relative to Baseline for Participants Who Had Inactive Uveitis at Study Entry Over Time Week 12	-1.0 percent change from baseline Interval -2.27 to 0.23
Percent Change in Left Eye in Central Retinal Thickness (1 mm Subfield) From Baseline to Each Study Time Point Relative to Baseline for Participants Who Had Inactive Uveitis at Study Entry Over Time Week 18	-0.5 percent change from baseline Interval -2.02 to 1.07
Percent Change in Left Eye in Central Retinal Thickness (1 mm Subfield) From Baseline to Each Study Time Point Relative to Baseline for Participants Who Had Inactive Uveitis at Study Entry Over Time Week 30	-1.9 percent change from baseline Interval -3.25 to -0.6
Percent Change in Left Eye in Central Retinal Thickness (1 mm Subfield) From Baseline to Each Study Time Point Relative to Baseline for Participants Who Had Inactive Uveitis at Study Entry Over Time Week 42	-1.3 percent change from baseline Interval -2.83 to 0.17
Percent Change in Left Eye in Central Retinal Thickness (1 mm Subfield) From Baseline to Each Study Time Point Relative to Baseline for Participants Who Had Inactive Uveitis at Study Entry Over Time Week 54	-2.1 percent change from baseline Interval -3.9 to -0.22
Percent Change in Left Eye in Central Retinal Thickness (1 mm Subfield) From Baseline to Each Study Time Point Relative to Baseline for Participants Who Had Inactive Uveitis at Study Entry Over Time Week 66	-1.9 percent change from baseline Interval -3.95 to 0.11
Percent Change in Left Eye in Central Retinal Thickness (1 mm Subfield) From Baseline to Each Study Time Point Relative to Baseline for Participants Who Had Inactive Uveitis at Study Entry Over Time Week 78	-1.4 percent change from baseline Interval -4.54 to 1.7
Percent Change in Left Eye in Central Retinal Thickness (1 mm Subfield) From Baseline to Each Study Time Point Relative to Baseline for Participants Who Had Inactive Uveitis at Study Entry Over Time Week 90	-2.9 percent change from baseline Interval -4.51 to -1.22
Percent Change in Left Eye in Central Retinal Thickness (1 mm Subfield) From Baseline to Each Study Time Point Relative to Baseline for Participants Who Had Inactive Uveitis at Study Entry Over Time Week 102	-3.1 percent change from baseline Interval -4.95 to -1.34
Percent Change in Left Eye in Central Retinal Thickness (1 mm Subfield) From Baseline to Each Study Time Point Relative to Baseline for Participants Who Had Inactive Uveitis at Study Entry Over Time Week 114	-2.8 percent change from baseline Interval -4.44 to -1.14
Percent Change in Left Eye in Central Retinal Thickness (1 mm Subfield) From Baseline to Each Study Time Point Relative to Baseline for Participants Who Had Inactive Uveitis at Study Entry Over Time Week 126	-3.7 percent change from baseline Interval -5.66 to -1.68
Percent Change in Left Eye in Central Retinal Thickness (1 mm Subfield) From Baseline to Each Study Time Point Relative to Baseline for Participants Who Had Inactive Uveitis at Study Entry Over Time Week 138	-3.4 percent change from baseline Interval -5.38 to -1.46
Percent Change in Left Eye in Central Retinal Thickness (1 mm Subfield) From Baseline to Each Study Time Point Relative to Baseline for Participants Who Had Inactive Uveitis at Study Entry Over Time Week 150	-3.5 percent change from baseline Interval -5.48 to -1.58
Percent Change in Left Eye in Central Retinal Thickness (1 mm Subfield) From Baseline to Each Study Time Point Relative to Baseline for Participants Who Had Inactive Uveitis at Study Entry Over Time Week 162	-3.3 percent change from baseline Interval -6.25 to -0.29
Percent Change in Left Eye in Central Retinal Thickness (1 mm Subfield) From Baseline to Each Study Time Point Relative to Baseline for Participants Who Had Inactive Uveitis at Study Entry Over Time Week 174	-3.0 percent change from baseline Interval -5.45 to -0.52
Percent Change in Left Eye in Central Retinal Thickness (1 mm Subfield) From Baseline to Each Study Time Point Relative to Baseline for Participants Who Had Inactive Uveitis at Study Entry Over Time Week 186	-3.8 percent change from baseline Interval -6.69 to -1.0
Percent Change in Left Eye in Central Retinal Thickness (1 mm Subfield) From Baseline to Each Study Time Point Relative to Baseline for Participants Who Had Inactive Uveitis at Study Entry Over Time Week 198	-3.2 percent change from baseline Interval -5.99 to -0.35
Percent Change in Left Eye in Central Retinal Thickness (1 mm Subfield) From Baseline to Each Study Time Point Relative to Baseline for Participants Who Had Inactive Uveitis at Study Entry Over Time Week 210	-5.2 percent change from baseline Interval -10.23 to -0.17
Percent Change in Left Eye in Central Retinal Thickness (1 mm Subfield) From Baseline to Each Study Time Point Relative to Baseline for Participants Who Had Inactive Uveitis at Study Entry Over Time Week 222	-4.6 percent change from baseline Interval -11.17 to 1.93
Percent Change in Left Eye in Central Retinal Thickness (1 mm Subfield) From Baseline to Each Study Time Point Relative to Baseline for Participants Who Had Inactive Uveitis at Study Entry Over Time Week 234	-3.6 percent change from baseline Interval -13.06 to 5.77
Percent Change in Left Eye in Central Retinal Thickness (1 mm Subfield) From Baseline to Each Study Time Point Relative to Baseline for Participants Who Had Inactive Uveitis at Study Entry Over Time Week 246	-3.4 percent change from baseline Interval -14.83 to 7.93

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline (Week 0) and Weeks 2, 4, 8, 12, 18, 30, 42, 54, 66, 78, 90, 102, 114, 126, 138, 150, 162, 174, 186, 198, 210, 222, 234, and 246

Population: All participants in the ITT analysis set with evaluable data at each timepoint.

Central retinal thickness was measured using optical coherence tomography (OCT) and assessed by a central reader. Percent change in right eye from baseline (Week 0) to each study time point relative to baseline for participants who had inactive uveitis at study entry is presented.

Outcome measures

Outcome measures
Measure	Adalimumab n=109 Participants Participants received open label (OL) adalimumab 40 mg by subcutaneous (SC) injection every other week (eow) until the final visit.
Percent Change in Right Eye in Central Retinal Thickness (1 mm Subfield) From Baseline to Each Study Time Point Relative to Baseline for Participants Who Had Inactive Uveitis at Study Entry Over Time Week 2	-0.2 percent change from baseline Interval -1.92 to 1.45
Percent Change in Right Eye in Central Retinal Thickness (1 mm Subfield) From Baseline to Each Study Time Point Relative to Baseline for Participants Who Had Inactive Uveitis at Study Entry Over Time Week 4	-0.8 percent change from baseline Interval -2.99 to 1.39
Percent Change in Right Eye in Central Retinal Thickness (1 mm Subfield) From Baseline to Each Study Time Point Relative to Baseline for Participants Who Had Inactive Uveitis at Study Entry Over Time Week 8	-1.5 percent change from baseline Interval -3.19 to 0.25
Percent Change in Right Eye in Central Retinal Thickness (1 mm Subfield) From Baseline to Each Study Time Point Relative to Baseline for Participants Who Had Inactive Uveitis at Study Entry Over Time Week 12	-1.0 percent change from baseline Interval -2.76 to 0.66
Percent Change in Right Eye in Central Retinal Thickness (1 mm Subfield) From Baseline to Each Study Time Point Relative to Baseline for Participants Who Had Inactive Uveitis at Study Entry Over Time Week 18	-0.4 percent change from baseline Interval -2.73 to 1.84
Percent Change in Right Eye in Central Retinal Thickness (1 mm Subfield) From Baseline to Each Study Time Point Relative to Baseline for Participants Who Had Inactive Uveitis at Study Entry Over Time Week 30	-2.8 percent change from baseline Interval -4.78 to -0.86
Percent Change in Right Eye in Central Retinal Thickness (1 mm Subfield) From Baseline to Each Study Time Point Relative to Baseline for Participants Who Had Inactive Uveitis at Study Entry Over Time Week 42	-2.2 percent change from baseline Interval -4.31 to -0.15
Percent Change in Right Eye in Central Retinal Thickness (1 mm Subfield) From Baseline to Each Study Time Point Relative to Baseline for Participants Who Had Inactive Uveitis at Study Entry Over Time Week 54	-3.7 percent change from baseline Interval -6.0 to -1.44
Percent Change in Right Eye in Central Retinal Thickness (1 mm Subfield) From Baseline to Each Study Time Point Relative to Baseline for Participants Who Had Inactive Uveitis at Study Entry Over Time Week 66	-3.3 percent change from baseline Interval -5.66 to -0.97
Percent Change in Right Eye in Central Retinal Thickness (1 mm Subfield) From Baseline to Each Study Time Point Relative to Baseline for Participants Who Had Inactive Uveitis at Study Entry Over Time Week 78	-3.9 percent change from baseline Interval -6.36 to -1.38
Percent Change in Right Eye in Central Retinal Thickness (1 mm Subfield) From Baseline to Each Study Time Point Relative to Baseline for Participants Who Had Inactive Uveitis at Study Entry Over Time Week 90	-3.8 percent change from baseline Interval -6.47 to -1.08
Percent Change in Right Eye in Central Retinal Thickness (1 mm Subfield) From Baseline to Each Study Time Point Relative to Baseline for Participants Who Had Inactive Uveitis at Study Entry Over Time Week 102	-5.3 percent change from baseline Interval -7.99 to -2.67
Percent Change in Right Eye in Central Retinal Thickness (1 mm Subfield) From Baseline to Each Study Time Point Relative to Baseline for Participants Who Had Inactive Uveitis at Study Entry Over Time Week 114	-5.6 percent change from baseline Interval -8.65 to -2.53
Percent Change in Right Eye in Central Retinal Thickness (1 mm Subfield) From Baseline to Each Study Time Point Relative to Baseline for Participants Who Had Inactive Uveitis at Study Entry Over Time Week 126	-5.4 percent change from baseline Interval -8.57 to -2.21
Percent Change in Right Eye in Central Retinal Thickness (1 mm Subfield) From Baseline to Each Study Time Point Relative to Baseline for Participants Who Had Inactive Uveitis at Study Entry Over Time Week 138	-4.7 percent change from baseline Interval -7.75 to -1.72
Percent Change in Right Eye in Central Retinal Thickness (1 mm Subfield) From Baseline to Each Study Time Point Relative to Baseline for Participants Who Had Inactive Uveitis at Study Entry Over Time Week 150	-2.1 percent change from baseline Interval -9.07 to 4.9
Percent Change in Right Eye in Central Retinal Thickness (1 mm Subfield) From Baseline to Each Study Time Point Relative to Baseline for Participants Who Had Inactive Uveitis at Study Entry Over Time Week 162	-2.9 percent change from baseline Interval -6.06 to 0.36
Percent Change in Right Eye in Central Retinal Thickness (1 mm Subfield) From Baseline to Each Study Time Point Relative to Baseline for Participants Who Had Inactive Uveitis at Study Entry Over Time Week 174	-2.7 percent change from baseline Interval -5.88 to 0.56
Percent Change in Right Eye in Central Retinal Thickness (1 mm Subfield) From Baseline to Each Study Time Point Relative to Baseline for Participants Who Had Inactive Uveitis at Study Entry Over Time Week 186	-2.0 percent change from baseline Interval -5.49 to 1.46
Percent Change in Right Eye in Central Retinal Thickness (1 mm Subfield) From Baseline to Each Study Time Point Relative to Baseline for Participants Who Had Inactive Uveitis at Study Entry Over Time Week 198	-1.2 percent change from baseline Interval -5.91 to 3.48
Percent Change in Right Eye in Central Retinal Thickness (1 mm Subfield) From Baseline to Each Study Time Point Relative to Baseline for Participants Who Had Inactive Uveitis at Study Entry Over Time Week 210	-2.3 percent change from baseline Interval -6.35 to 1.66
Percent Change in Right Eye in Central Retinal Thickness (1 mm Subfield) From Baseline to Each Study Time Point Relative to Baseline for Participants Who Had Inactive Uveitis at Study Entry Over Time Week 222	-1.7 percent change from baseline Interval -4.76 to 1.44
Percent Change in Right Eye in Central Retinal Thickness (1 mm Subfield) From Baseline to Each Study Time Point Relative to Baseline for Participants Who Had Inactive Uveitis at Study Entry Over Time Week 234	-1.3 percent change from baseline Interval -6.32 to 3.78
Percent Change in Right Eye in Central Retinal Thickness (1 mm Subfield) From Baseline to Each Study Time Point Relative to Baseline for Participants Who Had Inactive Uveitis at Study Entry Over Time Week 246	1.6 percent change from baseline Interval -0.78 to 3.93

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline (Week 8) and Weeks 12, 18, 30, 42, 54, 66, 78, 90, 102, 114, 126, 138, 150, 162, 174, 186, 198, 210, 222, 234, and 246

Population: All participants in the ITT analysis set with evaluable data at each timepoint.

Central retinal thickness was measured using OCT and assessed by a central reader. Percent change in left eye at each study time point relative to Week 8 (baseline) for participants who had active uveitis at study entry is presented.

Outcome measures

Outcome measures
Measure	Adalimumab n=206 Participants Participants received open label (OL) adalimumab 40 mg by subcutaneous (SC) injection every other week (eow) until the final visit.
Percent Change in Left Eye of Central Retinal Thickness (1 mm Subfield) at Each Study Time Point Relative to Week 8 for Participants Who Had Active Uveitis at Study Entry Over Time Week 12	1.0 percent change from baseline Interval -0.5 to 2.42
Percent Change in Left Eye of Central Retinal Thickness (1 mm Subfield) at Each Study Time Point Relative to Week 8 for Participants Who Had Active Uveitis at Study Entry Over Time Week 18	-0.3 percent change from baseline Interval -2.36 to 1.71
Percent Change in Left Eye of Central Retinal Thickness (1 mm Subfield) at Each Study Time Point Relative to Week 8 for Participants Who Had Active Uveitis at Study Entry Over Time Week 30	-2.4 percent change from baseline Interval -4.24 to -0.55
Percent Change in Left Eye of Central Retinal Thickness (1 mm Subfield) at Each Study Time Point Relative to Week 8 for Participants Who Had Active Uveitis at Study Entry Over Time Week 42	-2.8 percent change from baseline Interval -4.62 to -1.0
Percent Change in Left Eye of Central Retinal Thickness (1 mm Subfield) at Each Study Time Point Relative to Week 8 for Participants Who Had Active Uveitis at Study Entry Over Time Week 54	-3.2 percent change from baseline Interval -5.52 to -0.9
Percent Change in Left Eye of Central Retinal Thickness (1 mm Subfield) at Each Study Time Point Relative to Week 8 for Participants Who Had Active Uveitis at Study Entry Over Time Week 66	-2.3 percent change from baseline Interval -4.52 to 0.01
Percent Change in Left Eye of Central Retinal Thickness (1 mm Subfield) at Each Study Time Point Relative to Week 8 for Participants Who Had Active Uveitis at Study Entry Over Time Week 78	-3.5 percent change from baseline Interval -5.99 to -1.02
Percent Change in Left Eye of Central Retinal Thickness (1 mm Subfield) at Each Study Time Point Relative to Week 8 for Participants Who Had Active Uveitis at Study Entry Over Time Week 90	-4.8 percent change from baseline Interval -7.19 to -2.42
Percent Change in Left Eye of Central Retinal Thickness (1 mm Subfield) at Each Study Time Point Relative to Week 8 for Participants Who Had Active Uveitis at Study Entry Over Time Week 102	-5.3 percent change from baseline Interval -7.41 to -3.1
Percent Change in Left Eye of Central Retinal Thickness (1 mm Subfield) at Each Study Time Point Relative to Week 8 for Participants Who Had Active Uveitis at Study Entry Over Time Week 114	-6.6 percent change from baseline Interval -9.15 to -3.95
Percent Change in Left Eye of Central Retinal Thickness (1 mm Subfield) at Each Study Time Point Relative to Week 8 for Participants Who Had Active Uveitis at Study Entry Over Time Week 126	-5.3 percent change from baseline Interval -8.66 to -1.92
Percent Change in Left Eye of Central Retinal Thickness (1 mm Subfield) at Each Study Time Point Relative to Week 8 for Participants Who Had Active Uveitis at Study Entry Over Time Week 138	-7.0 percent change from baseline Interval -9.96 to -3.99
Percent Change in Left Eye of Central Retinal Thickness (1 mm Subfield) at Each Study Time Point Relative to Week 8 for Participants Who Had Active Uveitis at Study Entry Over Time Week 150	-7.3 percent change from baseline Interval -10.22 to -4.48
Percent Change in Left Eye of Central Retinal Thickness (1 mm Subfield) at Each Study Time Point Relative to Week 8 for Participants Who Had Active Uveitis at Study Entry Over Time Week 162	-7.5 percent change from baseline Interval -11.31 to -3.72
Percent Change in Left Eye of Central Retinal Thickness (1 mm Subfield) at Each Study Time Point Relative to Week 8 for Participants Who Had Active Uveitis at Study Entry Over Time Week 174	-9.5 percent change from baseline Interval -13.2 to -5.81
Percent Change in Left Eye of Central Retinal Thickness (1 mm Subfield) at Each Study Time Point Relative to Week 8 for Participants Who Had Active Uveitis at Study Entry Over Time Week 186	-7.6 percent change from baseline Interval -10.21 to -4.93
Percent Change in Left Eye of Central Retinal Thickness (1 mm Subfield) at Each Study Time Point Relative to Week 8 for Participants Who Had Active Uveitis at Study Entry Over Time Week 198	-8.4 percent change from baseline Interval -11.84 to -4.99
Percent Change in Left Eye of Central Retinal Thickness (1 mm Subfield) at Each Study Time Point Relative to Week 8 for Participants Who Had Active Uveitis at Study Entry Over Time Week 210	-6.6 percent change from baseline Interval -10.4 to -2.74
Percent Change in Left Eye of Central Retinal Thickness (1 mm Subfield) at Each Study Time Point Relative to Week 8 for Participants Who Had Active Uveitis at Study Entry Over Time Week 222	-9.3 percent change from baseline Interval -13.42 to -5.17
Percent Change in Left Eye of Central Retinal Thickness (1 mm Subfield) at Each Study Time Point Relative to Week 8 for Participants Who Had Active Uveitis at Study Entry Over Time Week 234	-8.2 percent change from baseline Interval -11.85 to -4.46
Percent Change in Left Eye of Central Retinal Thickness (1 mm Subfield) at Each Study Time Point Relative to Week 8 for Participants Who Had Active Uveitis at Study Entry Over Time Week 246	-9.1 percent change from baseline Interval -13.41 to -4.82

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline (Week 8) and Weeks 12, 18, 30, 42, 54, 66, 78, 90, 102, 114, 126, 138, 150, 162, 174, 186, 198, 210, 222, 234, and 246

Population: All participants in the ITT analysis set with evaluable data at each timepoint.

Central retinal thickness was measured using OCT and assessed by a central reader. Percent change in right eye at each study time point relative to Week 8 (baseline) for participants who had active uveitis at study entry is presented.

Outcome measures

Outcome measures
Measure	Adalimumab n=205 Participants Participants received open label (OL) adalimumab 40 mg by subcutaneous (SC) injection every other week (eow) until the final visit.
Percent Change in Right Eye of Central Retinal Thickness (1 mm Subfield) at Each Study Time Point Relative to Week 8 for Participants Who Had Active Uveitis at Study Entry Over Time Week 174	-5.4 percent change from baseline Interval -9.46 to -1.27
Percent Change in Right Eye of Central Retinal Thickness (1 mm Subfield) at Each Study Time Point Relative to Week 8 for Participants Who Had Active Uveitis at Study Entry Over Time Week 12	0.4 percent change from baseline Interval -1.58 to 2.47
Percent Change in Right Eye of Central Retinal Thickness (1 mm Subfield) at Each Study Time Point Relative to Week 8 for Participants Who Had Active Uveitis at Study Entry Over Time Week 18	-0.7 percent change from baseline Interval -2.71 to 1.3
Percent Change in Right Eye of Central Retinal Thickness (1 mm Subfield) at Each Study Time Point Relative to Week 8 for Participants Who Had Active Uveitis at Study Entry Over Time Week 30	-0.7 percent change from baseline Interval -3.36 to 1.9
Percent Change in Right Eye of Central Retinal Thickness (1 mm Subfield) at Each Study Time Point Relative to Week 8 for Participants Who Had Active Uveitis at Study Entry Over Time Week 42	-2.4 percent change from baseline Interval -4.85 to 0.05
Percent Change in Right Eye of Central Retinal Thickness (1 mm Subfield) at Each Study Time Point Relative to Week 8 for Participants Who Had Active Uveitis at Study Entry Over Time Week 54	-2.4 percent change from baseline Interval -5.25 to 0.36
Percent Change in Right Eye of Central Retinal Thickness (1 mm Subfield) at Each Study Time Point Relative to Week 8 for Participants Who Had Active Uveitis at Study Entry Over Time Week 66	-1.3 percent change from baseline Interval -4.81 to 2.27
Percent Change in Right Eye of Central Retinal Thickness (1 mm Subfield) at Each Study Time Point Relative to Week 8 for Participants Who Had Active Uveitis at Study Entry Over Time Week 78	-2.1 percent change from baseline Interval -5.61 to 1.5
Percent Change in Right Eye of Central Retinal Thickness (1 mm Subfield) at Each Study Time Point Relative to Week 8 for Participants Who Had Active Uveitis at Study Entry Over Time Week 90	-3.6 percent change from baseline Interval -6.44 to -0.76
Percent Change in Right Eye of Central Retinal Thickness (1 mm Subfield) at Each Study Time Point Relative to Week 8 for Participants Who Had Active Uveitis at Study Entry Over Time Week 102	-3.4 percent change from baseline Interval -6.98 to 0.13
Percent Change in Right Eye of Central Retinal Thickness (1 mm Subfield) at Each Study Time Point Relative to Week 8 for Participants Who Had Active Uveitis at Study Entry Over Time Week 114	-2.2 percent change from baseline Interval -6.18 to 1.81
Percent Change in Right Eye of Central Retinal Thickness (1 mm Subfield) at Each Study Time Point Relative to Week 8 for Participants Who Had Active Uveitis at Study Entry Over Time Week 126	-3.5 percent change from baseline Interval -7.43 to 0.47
Percent Change in Right Eye of Central Retinal Thickness (1 mm Subfield) at Each Study Time Point Relative to Week 8 for Participants Who Had Active Uveitis at Study Entry Over Time Week 138	-4.6 percent change from baseline Interval -8.22 to -0.92
Percent Change in Right Eye of Central Retinal Thickness (1 mm Subfield) at Each Study Time Point Relative to Week 8 for Participants Who Had Active Uveitis at Study Entry Over Time Week 150	-6.5 percent change from baseline Interval -9.81 to -3.15
Percent Change in Right Eye of Central Retinal Thickness (1 mm Subfield) at Each Study Time Point Relative to Week 8 for Participants Who Had Active Uveitis at Study Entry Over Time Week 162	-4.8 percent change from baseline Interval -8.91 to -0.75
Percent Change in Right Eye of Central Retinal Thickness (1 mm Subfield) at Each Study Time Point Relative to Week 8 for Participants Who Had Active Uveitis at Study Entry Over Time Week 186	-7.9 percent change from baseline Interval -12.74 to -3.03
Percent Change in Right Eye of Central Retinal Thickness (1 mm Subfield) at Each Study Time Point Relative to Week 8 for Participants Who Had Active Uveitis at Study Entry Over Time Week 198	-8.2 percent change from baseline Interval -12.3 to -4.13
Percent Change in Right Eye of Central Retinal Thickness (1 mm Subfield) at Each Study Time Point Relative to Week 8 for Participants Who Had Active Uveitis at Study Entry Over Time Week 210	-6.6 percent change from baseline Interval -10.76 to -2.43
Percent Change in Right Eye of Central Retinal Thickness (1 mm Subfield) at Each Study Time Point Relative to Week 8 for Participants Who Had Active Uveitis at Study Entry Over Time Week 222	-9.7 percent change from baseline Interval -13.24 to -6.19
Percent Change in Right Eye of Central Retinal Thickness (1 mm Subfield) at Each Study Time Point Relative to Week 8 for Participants Who Had Active Uveitis at Study Entry Over Time Week 234	-9.7 percent change from baseline Interval -14.24 to -5.07
Percent Change in Right Eye of Central Retinal Thickness (1 mm Subfield) at Each Study Time Point Relative to Week 8 for Participants Who Had Active Uveitis at Study Entry Over Time Week 246	-9.9 percent change from baseline Interval -15.43 to -4.35

OTHER_PRE_SPECIFIED outcome

Timeframe: Weeks 0, 2, 4, 8, 12, 18, 30, 42, 54, 66, 78, 90, 102, 114, 126, 138, 150, 162, 174, 186, 198, 210, 222, 234, and 246

Population: All participants in the ITT analysis set with evaluable data at each timepoint.

Slit lamp examinations were conducted at each visit to assess AC cell count. The number of AC cells observed within a 1 mm \* 1 mm slit beam was used to determine the grade according to the Standardization of Uveitis Nomenclature (SUN) criteria: Grade 0: ˂ 1 cell; Grade 0.5+: 1 - 5 cells; Grade 1+: 6 - 15 cells; Grade 2+: 16 - 25 cells; Grade 3+: 26 - 50 cells; and Grade 4+: ≥ 50 cells.

Outcome measures

Outcome measures
Measure	Adalimumab n=364 Participants Participants received open label (OL) adalimumab 40 mg by subcutaneous (SC) injection every other week (eow) until the final visit.
Percentage of Participants With Grade ≤0.5+ in Anterior Chamber (AC) Cells in Both Eyes on Slit Lamp Exam According to Standardization of Uveitis Nomenclature (SUN) Criteria Over Time Week 138	93.4 percentage of participants Interval 89.0 to 96.4
Percentage of Participants With Grade ≤0.5+ in Anterior Chamber (AC) Cells in Both Eyes on Slit Lamp Exam According to Standardization of Uveitis Nomenclature (SUN) Criteria Over Time Week 0	65.4 percentage of participants Interval 60.3 to 70.3
Percentage of Participants With Grade ≤0.5+ in Anterior Chamber (AC) Cells in Both Eyes on Slit Lamp Exam According to Standardization of Uveitis Nomenclature (SUN) Criteria Over Time Week 2	85.9 percentage of participants Interval 81.8 to 89.4
Percentage of Participants With Grade ≤0.5+ in Anterior Chamber (AC) Cells in Both Eyes on Slit Lamp Exam According to Standardization of Uveitis Nomenclature (SUN) Criteria Over Time Week 4	90.4 percentage of participants Interval 86.7 to 93.4
Percentage of Participants With Grade ≤0.5+ in Anterior Chamber (AC) Cells in Both Eyes on Slit Lamp Exam According to Standardization of Uveitis Nomenclature (SUN) Criteria Over Time Week 8	91.5 percentage of participants Interval 88.1 to 94.3
Percentage of Participants With Grade ≤0.5+ in Anterior Chamber (AC) Cells in Both Eyes on Slit Lamp Exam According to Standardization of Uveitis Nomenclature (SUN) Criteria Over Time Week 12	91.3 percentage of participants Interval 87.7 to 94.1
Percentage of Participants With Grade ≤0.5+ in Anterior Chamber (AC) Cells in Both Eyes on Slit Lamp Exam According to Standardization of Uveitis Nomenclature (SUN) Criteria Over Time Week 18	90.9 percentage of participants Interval 87.3 to 93.8
Percentage of Participants With Grade ≤0.5+ in Anterior Chamber (AC) Cells in Both Eyes on Slit Lamp Exam According to Standardization of Uveitis Nomenclature (SUN) Criteria Over Time Week 30	94.7 percentage of participants Interval 91.6 to 96.9
Percentage of Participants With Grade ≤0.5+ in Anterior Chamber (AC) Cells in Both Eyes on Slit Lamp Exam According to Standardization of Uveitis Nomenclature (SUN) Criteria Over Time Week 42	92.3 percentage of participants Interval 88.7 to 95.0
Percentage of Participants With Grade ≤0.5+ in Anterior Chamber (AC) Cells in Both Eyes on Slit Lamp Exam According to Standardization of Uveitis Nomenclature (SUN) Criteria Over Time Week 54	92.9 percentage of participants Interval 89.4 to 95.6
Percentage of Participants With Grade ≤0.5+ in Anterior Chamber (AC) Cells in Both Eyes on Slit Lamp Exam According to Standardization of Uveitis Nomenclature (SUN) Criteria Over Time Week 66	95.1 percentage of participants Interval 91.9 to 97.3
Percentage of Participants With Grade ≤0.5+ in Anterior Chamber (AC) Cells in Both Eyes on Slit Lamp Exam According to Standardization of Uveitis Nomenclature (SUN) Criteria Over Time Week 78	93.0 percentage of participants Interval 89.3 to 95.7
Percentage of Participants With Grade ≤0.5+ in Anterior Chamber (AC) Cells in Both Eyes on Slit Lamp Exam According to Standardization of Uveitis Nomenclature (SUN) Criteria Over Time Week 90	94.3 percentage of participants Interval 90.7 to 96.7
Percentage of Participants With Grade ≤0.5+ in Anterior Chamber (AC) Cells in Both Eyes on Slit Lamp Exam According to Standardization of Uveitis Nomenclature (SUN) Criteria Over Time Week 102	93.5 percentage of participants Interval 89.6 to 96.2
Percentage of Participants With Grade ≤0.5+ in Anterior Chamber (AC) Cells in Both Eyes on Slit Lamp Exam According to Standardization of Uveitis Nomenclature (SUN) Criteria Over Time Week 114	93.5 percentage of participants Interval 89.5 to 96.3
Percentage of Participants With Grade ≤0.5+ in Anterior Chamber (AC) Cells in Both Eyes on Slit Lamp Exam According to Standardization of Uveitis Nomenclature (SUN) Criteria Over Time Week 126	94.0 percentage of participants Interval 90.0 to 96.8
Percentage of Participants With Grade ≤0.5+ in Anterior Chamber (AC) Cells in Both Eyes on Slit Lamp Exam According to Standardization of Uveitis Nomenclature (SUN) Criteria Over Time Week 150	94.5 percentage of participants Interval 90.1 to 97.3
Percentage of Participants With Grade ≤0.5+ in Anterior Chamber (AC) Cells in Both Eyes on Slit Lamp Exam According to Standardization of Uveitis Nomenclature (SUN) Criteria Over Time Week 162	95.5 percentage of participants Interval 90.9 to 98.2
Percentage of Participants With Grade ≤0.5+ in Anterior Chamber (AC) Cells in Both Eyes on Slit Lamp Exam According to Standardization of Uveitis Nomenclature (SUN) Criteria Over Time Week 174	94.4 percentage of participants Interval 89.2 to 97.5
Percentage of Participants With Grade ≤0.5+ in Anterior Chamber (AC) Cells in Both Eyes on Slit Lamp Exam According to Standardization of Uveitis Nomenclature (SUN) Criteria Over Time Week 186	96.1 percentage of participants Interval 91.1 to 98.7
Percentage of Participants With Grade ≤0.5+ in Anterior Chamber (AC) Cells in Both Eyes on Slit Lamp Exam According to Standardization of Uveitis Nomenclature (SUN) Criteria Over Time Week 198	94.7 percentage of participants Interval 88.8 to 98.0
Percentage of Participants With Grade ≤0.5+ in Anterior Chamber (AC) Cells in Both Eyes on Slit Lamp Exam According to Standardization of Uveitis Nomenclature (SUN) Criteria Over Time Week 210	96.6 percentage of participants Interval 90.5 to 99.3
Percentage of Participants With Grade ≤0.5+ in Anterior Chamber (AC) Cells in Both Eyes on Slit Lamp Exam According to Standardization of Uveitis Nomenclature (SUN) Criteria Over Time Week 222	98.6 percentage of participants Interval 92.4 to 100.0
Percentage of Participants With Grade ≤0.5+ in Anterior Chamber (AC) Cells in Both Eyes on Slit Lamp Exam According to Standardization of Uveitis Nomenclature (SUN) Criteria Over Time Week 234	100 percentage of participants Interval 93.0 to 100.0
Percentage of Participants With Grade ≤0.5+ in Anterior Chamber (AC) Cells in Both Eyes on Slit Lamp Exam According to Standardization of Uveitis Nomenclature (SUN) Criteria Over Time Week 246	95.2 percentage of participants Interval 83.8 to 99.4

OTHER_PRE_SPECIFIED outcome

Timeframe: Weeks 2, 4, 8, 12, 18, 30, 42, 54, 66, 78, 90, 102, 114, 126, 138, 150, 162, 174, 186, 198, 210, 222, and 234

Population: All participants in the ITT analysis set with an immunosuppression load greater than 0 at baseline (Week 0) with evaluable data at each timepoint.

Immunosuppression load was assessed using a weighted semiquantitative scale, applying grades ranging from 0 to 9 for each immunosuppressive agent on a scale for the total daily dose in milligrams per kilogram per day or per week if dosed weekly. A higher score indicating a higher immunosuppression load and a lower or decreased score indicated improvement or less need for immunosuppressive therapy. The grading scheme was used to accommodate the simultaneous use of multiple agents and provided a combined, single numeric score for the total immunosuppression load per unit body weight per day at each visit. For participants receiving multiple medications, the sum of the grading scores for each drug was used to calculate a total immunosuppression score at each visit. Data not presented after Week 234 as no participants remained on study as of Week 234.

Outcome measures

Outcome measures
Measure	Adalimumab n=55 Participants Participants received open label (OL) adalimumab 40 mg by subcutaneous (SC) injection every other week (eow) until the final visit.
Percentage of Participants Achieving a ≥50% Reduction in Immunosuppression Load Relative to Baseline Over Time Among Participants With Inactive Uveitis at Study Entry Week 2	3.6 percentage of participants Interval 0.4 to 12.5
Percentage of Participants Achieving a ≥50% Reduction in Immunosuppression Load Relative to Baseline Over Time Among Participants With Inactive Uveitis at Study Entry Week 4	9.1 percentage of participants Interval 3.0 to 20.0
Percentage of Participants Achieving a ≥50% Reduction in Immunosuppression Load Relative to Baseline Over Time Among Participants With Inactive Uveitis at Study Entry Week 8	17.3 percentage of participants Interval 8.2 to 30.3
Percentage of Participants Achieving a ≥50% Reduction in Immunosuppression Load Relative to Baseline Over Time Among Participants With Inactive Uveitis at Study Entry Week 12	17.3 percentage of participants Interval 8.2 to 30.3
Percentage of Participants Achieving a ≥50% Reduction in Immunosuppression Load Relative to Baseline Over Time Among Participants With Inactive Uveitis at Study Entry Week 18	21.6 percentage of participants Interval 11.3 to 35.3
Percentage of Participants Achieving a ≥50% Reduction in Immunosuppression Load Relative to Baseline Over Time Among Participants With Inactive Uveitis at Study Entry Week 30	24.5 percentage of participants Interval 13.3 to 38.9
Percentage of Participants Achieving a ≥50% Reduction in Immunosuppression Load Relative to Baseline Over Time Among Participants With Inactive Uveitis at Study Entry Week 42	22.9 percentage of participants Interval 12.0 to 37.3
Percentage of Participants Achieving a ≥50% Reduction in Immunosuppression Load Relative to Baseline Over Time Among Participants With Inactive Uveitis at Study Entry Week 54	17.8 percentage of participants Interval 8.0 to 32.1
Percentage of Participants Achieving a ≥50% Reduction in Immunosuppression Load Relative to Baseline Over Time Among Participants With Inactive Uveitis at Study Entry Week 66	15.0 percentage of participants Interval 5.7 to 29.8
Percentage of Participants Achieving a ≥50% Reduction in Immunosuppression Load Relative to Baseline Over Time Among Participants With Inactive Uveitis at Study Entry Week 78	15.0 percentage of participants Interval 5.7 to 29.8
Percentage of Participants Achieving a ≥50% Reduction in Immunosuppression Load Relative to Baseline Over Time Among Participants With Inactive Uveitis at Study Entry Week 90	13.5 percentage of participants Interval 4.5 to 28.8
Percentage of Participants Achieving a ≥50% Reduction in Immunosuppression Load Relative to Baseline Over Time Among Participants With Inactive Uveitis at Study Entry Week 102	14.7 percentage of participants Interval 5.0 to 31.1
Percentage of Participants Achieving a ≥50% Reduction in Immunosuppression Load Relative to Baseline Over Time Among Participants With Inactive Uveitis at Study Entry Week 114	25.0 percentage of participants Interval 11.5 to 43.4
Percentage of Participants Achieving a ≥50% Reduction in Immunosuppression Load Relative to Baseline Over Time Among Participants With Inactive Uveitis at Study Entry Week 126	25.0 percentage of participants Interval 10.7 to 44.9
Percentage of Participants Achieving a ≥50% Reduction in Immunosuppression Load Relative to Baseline Over Time Among Participants With Inactive Uveitis at Study Entry Week 138	25.0 percentage of participants Interval 9.8 to 46.7
Percentage of Participants Achieving a ≥50% Reduction in Immunosuppression Load Relative to Baseline Over Time Among Participants With Inactive Uveitis at Study Entry Week 150	23.8 percentage of participants Interval 8.2 to 47.2
Percentage of Participants Achieving a ≥50% Reduction in Immunosuppression Load Relative to Baseline Over Time Among Participants With Inactive Uveitis at Study Entry Week 162	18.8 percentage of participants Interval 4.0 to 45.6
Percentage of Participants Achieving a ≥50% Reduction in Immunosuppression Load Relative to Baseline Over Time Among Participants With Inactive Uveitis at Study Entry Week 174	12.5 percentage of participants Interval 1.6 to 38.3
Percentage of Participants Achieving a ≥50% Reduction in Immunosuppression Load Relative to Baseline Over Time Among Participants With Inactive Uveitis at Study Entry Week 186	12.5 percentage of participants Interval 1.6 to 38.3
Percentage of Participants Achieving a ≥50% Reduction in Immunosuppression Load Relative to Baseline Over Time Among Participants With Inactive Uveitis at Study Entry Week 198	0 percentage of participants Interval 0.0 to 0.0
Percentage of Participants Achieving a ≥50% Reduction in Immunosuppression Load Relative to Baseline Over Time Among Participants With Inactive Uveitis at Study Entry Week 210	12.5 percentage of participants Interval 0.3 to 52.7
Percentage of Participants Achieving a ≥50% Reduction in Immunosuppression Load Relative to Baseline Over Time Among Participants With Inactive Uveitis at Study Entry Week 222	25.0 percentage of participants Interval 0.6 to 80.6
Percentage of Participants Achieving a ≥50% Reduction in Immunosuppression Load Relative to Baseline Over Time Among Participants With Inactive Uveitis at Study Entry Week 234	50.0 percentage of participants Interval 6.8 to 93.2

OTHER_PRE_SPECIFIED outcome

Timeframe: Weeks 12, 18, 30, 42, 54, 66, 78, 90, 102, 114, 126, 138, 150, 162, 174, 186, 198, 210, 222, 234, and 246

Population: All participants in the ITT analysis set with an immunosuppression load greater than 0 at baseline (Week 8) with evaluable data at each timepoint.

Outcome measures

Outcome measures
Measure	Adalimumab n=140 Participants Participants received open label (OL) adalimumab 40 mg by subcutaneous (SC) injection every other week (eow) until the final visit.
Percentage of Participants Achieving a ≥50% Reduction in Immunosuppression Load Relative to Week 8 Over Time Among Participants With Active Uveitis at Study Entry Week 12	17.1 percentage of participants Interval 11.3 to 24.4
Percentage of Participants Achieving a ≥50% Reduction in Immunosuppression Load Relative to Week 8 Over Time Among Participants With Active Uveitis at Study Entry Week 18	27.2 percentage of participants Interval 19.9 to 35.5
Percentage of Participants Achieving a ≥50% Reduction in Immunosuppression Load Relative to Week 8 Over Time Among Participants With Active Uveitis at Study Entry Week 30	33.6 percentage of participants Interval 25.5 to 42.5
Percentage of Participants Achieving a ≥50% Reduction in Immunosuppression Load Relative to Week 8 Over Time Among Participants With Active Uveitis at Study Entry Week 42	41.6 percentage of participants Interval 32.9 to 50.8
Percentage of Participants Achieving a ≥50% Reduction in Immunosuppression Load Relative to Week 8 Over Time Among Participants With Active Uveitis at Study Entry Week 54	44.5 percentage of participants Interval 35.4 to 53.9
Percentage of Participants Achieving a ≥50% Reduction in Immunosuppression Load Relative to Week 8 Over Time Among Participants With Active Uveitis at Study Entry Week 66	48.7 percentage of participants Interval 39.2 to 58.3
Percentage of Participants Achieving a ≥50% Reduction in Immunosuppression Load Relative to Week 8 Over Time Among Participants With Active Uveitis at Study Entry Week 78	48.6 percentage of participants Interval 38.9 to 58.4
Percentage of Participants Achieving a ≥50% Reduction in Immunosuppression Load Relative to Week 8 Over Time Among Participants With Active Uveitis at Study Entry Week 90	53.8 percentage of participants Interval 43.8 to 63.5
Percentage of Participants Achieving a ≥50% Reduction in Immunosuppression Load Relative to Week 8 Over Time Among Participants With Active Uveitis at Study Entry Week 102	54.1 percentage of participants Interval 43.7 to 64.2
Percentage of Participants Achieving a ≥50% Reduction in Immunosuppression Load Relative to Week 8 Over Time Among Participants With Active Uveitis at Study Entry Week 114	51.1 percentage of participants Interval 40.3 to 61.8
Percentage of Participants Achieving a ≥50% Reduction in Immunosuppression Load Relative to Week 8 Over Time Among Participants With Active Uveitis at Study Entry Week 126	52.9 percentage of participants Interval 41.9 to 63.7
Percentage of Participants Achieving a ≥50% Reduction in Immunosuppression Load Relative to Week 8 Over Time Among Participants With Active Uveitis at Study Entry Week 138	52.5 percentage of participants Interval 41.0 to 63.8
Percentage of Participants Achieving a ≥50% Reduction in Immunosuppression Load Relative to Week 8 Over Time Among Participants With Active Uveitis at Study Entry Week 150	53.9 percentage of participants Interval 42.1 to 65.5
Percentage of Participants Achieving a ≥50% Reduction in Immunosuppression Load Relative to Week 8 Over Time Among Participants With Active Uveitis at Study Entry Week 162	53.5 percentage of participants Interval 41.3 to 65.5
Percentage of Participants Achieving a ≥50% Reduction in Immunosuppression Load Relative to Week 8 Over Time Among Participants With Active Uveitis at Study Entry Week 174	55.6 percentage of participants Interval 42.5 to 68.1
Percentage of Participants Achieving a ≥50% Reduction in Immunosuppression Load Relative to Week 8 Over Time Among Participants With Active Uveitis at Study Entry Week 186	55.9 percentage of participants Interval 42.4 to 68.8
Percentage of Participants Achieving a ≥50% Reduction in Immunosuppression Load Relative to Week 8 Over Time Among Participants With Active Uveitis at Study Entry Week 198	52.0 percentage of participants Interval 37.4 to 66.3
Percentage of Participants Achieving a ≥50% Reduction in Immunosuppression Load Relative to Week 8 Over Time Among Participants With Active Uveitis at Study Entry Week 210	51.2 percentage of participants Interval 35.1 to 67.1
Percentage of Participants Achieving a ≥50% Reduction in Immunosuppression Load Relative to Week 8 Over Time Among Participants With Active Uveitis at Study Entry Week 222	54.8 percentage of participants Interval 36.0 to 72.7
Percentage of Participants Achieving a ≥50% Reduction in Immunosuppression Load Relative to Week 8 Over Time Among Participants With Active Uveitis at Study Entry Week 234	56.5 percentage of participants Interval 34.5 to 76.8
Percentage of Participants Achieving a ≥50% Reduction in Immunosuppression Load Relative to Week 8 Over Time Among Participants With Active Uveitis at Study Entry Week 246	63.2 percentage of participants Interval 38.4 to 83.7

OTHER_PRE_SPECIFIED outcome

Timeframe: Weeks 2, 4, 8, 12, 18, 30, 42, 54, 66, 78, 90, 102, 114, 126, 138, 150, 162, 174, 186, 198, 210, 222, 234, and 246

Population: All participants in the ITT analysis set that had evaluable data at each timepoint.

Percentage of participants at each study time point with no new active, inflammatory chorioretinal or inflammatory retinal vascular lesion in both eyes relative to Baseline for participants who had inactive uveitis when they entered the study.

Outcome measures

Outcome measures
Measure	Adalimumab n=124 Participants Participants received open label (OL) adalimumab 40 mg by subcutaneous (SC) injection every other week (eow) until the final visit.
Percentage of Participants With No New Active, Inflammatory Chorioretinal or Inflammatory Retinal Vascular Lesion in Both Eyes Relative to Baseline Over Time Among Participants With Inactive Uveitis at Study Entry Week 234	100 percentage of participants Interval 66.4 to 100.0
Percentage of Participants With No New Active, Inflammatory Chorioretinal or Inflammatory Retinal Vascular Lesion in Both Eyes Relative to Baseline Over Time Among Participants With Inactive Uveitis at Study Entry Week 2	100 percentage of participants Interval 96.9 to 100.0
Percentage of Participants With No New Active, Inflammatory Chorioretinal or Inflammatory Retinal Vascular Lesion in Both Eyes Relative to Baseline Over Time Among Participants With Inactive Uveitis at Study Entry Week 4	99.1 percentage of participants Interval 94.9 to 100.0
Percentage of Participants With No New Active, Inflammatory Chorioretinal or Inflammatory Retinal Vascular Lesion in Both Eyes Relative to Baseline Over Time Among Participants With Inactive Uveitis at Study Entry Week 8	100 percentage of participants Interval 96.8 to 100.0
Percentage of Participants With No New Active, Inflammatory Chorioretinal or Inflammatory Retinal Vascular Lesion in Both Eyes Relative to Baseline Over Time Among Participants With Inactive Uveitis at Study Entry Week 12	100 percentage of participants Interval 96.8 to 100.0
Percentage of Participants With No New Active, Inflammatory Chorioretinal or Inflammatory Retinal Vascular Lesion in Both Eyes Relative to Baseline Over Time Among Participants With Inactive Uveitis at Study Entry Week 18	98.2 percentage of participants Interval 93.7 to 99.8
Percentage of Participants With No New Active, Inflammatory Chorioretinal or Inflammatory Retinal Vascular Lesion in Both Eyes Relative to Baseline Over Time Among Participants With Inactive Uveitis at Study Entry Week 30	100 percentage of participants Interval 96.8 to 100.0
Percentage of Participants With No New Active, Inflammatory Chorioretinal or Inflammatory Retinal Vascular Lesion in Both Eyes Relative to Baseline Over Time Among Participants With Inactive Uveitis at Study Entry Week 42	98.2 percentage of participants Interval 93.7 to 99.8
Percentage of Participants With No New Active, Inflammatory Chorioretinal or Inflammatory Retinal Vascular Lesion in Both Eyes Relative to Baseline Over Time Among Participants With Inactive Uveitis at Study Entry Week 54	99.1 percentage of participants Interval 94.9 to 100.0
Percentage of Participants With No New Active, Inflammatory Chorioretinal or Inflammatory Retinal Vascular Lesion in Both Eyes Relative to Baseline Over Time Among Participants With Inactive Uveitis at Study Entry Week 66	100 percentage of participants Interval 96.5 to 100.0
Percentage of Participants With No New Active, Inflammatory Chorioretinal or Inflammatory Retinal Vascular Lesion in Both Eyes Relative to Baseline Over Time Among Participants With Inactive Uveitis at Study Entry Week 78	100 percentage of participants Interval 96.3 to 100.0
Percentage of Participants With No New Active, Inflammatory Chorioretinal or Inflammatory Retinal Vascular Lesion in Both Eyes Relative to Baseline Over Time Among Participants With Inactive Uveitis at Study Entry Week 90	98.9 percentage of participants Interval 94.3 to 100.0
Percentage of Participants With No New Active, Inflammatory Chorioretinal or Inflammatory Retinal Vascular Lesion in Both Eyes Relative to Baseline Over Time Among Participants With Inactive Uveitis at Study Entry Week 102	98.9 percentage of participants Interval 93.9 to 100.0
Percentage of Participants With No New Active, Inflammatory Chorioretinal or Inflammatory Retinal Vascular Lesion in Both Eyes Relative to Baseline Over Time Among Participants With Inactive Uveitis at Study Entry Week 114	100 percentage of participants Interval 95.7 to 100.0
Percentage of Participants With No New Active, Inflammatory Chorioretinal or Inflammatory Retinal Vascular Lesion in Both Eyes Relative to Baseline Over Time Among Participants With Inactive Uveitis at Study Entry Week 126	100 percentage of participants Interval 95.2 to 100.0
Percentage of Participants With No New Active, Inflammatory Chorioretinal or Inflammatory Retinal Vascular Lesion in Both Eyes Relative to Baseline Over Time Among Participants With Inactive Uveitis at Study Entry Week 138	98.4 percentage of participants Interval 91.6 to 100.0
Percentage of Participants With No New Active, Inflammatory Chorioretinal or Inflammatory Retinal Vascular Lesion in Both Eyes Relative to Baseline Over Time Among Participants With Inactive Uveitis at Study Entry Week 150	96.5 percentage of participants Interval 87.9 to 99.6
Percentage of Participants With No New Active, Inflammatory Chorioretinal or Inflammatory Retinal Vascular Lesion in Both Eyes Relative to Baseline Over Time Among Participants With Inactive Uveitis at Study Entry Week 162	97.4 percentage of participants Interval 86.5 to 99.9
Percentage of Participants With No New Active, Inflammatory Chorioretinal or Inflammatory Retinal Vascular Lesion in Both Eyes Relative to Baseline Over Time Among Participants With Inactive Uveitis at Study Entry Week 174	100 percentage of participants Interval 89.7 to 100.0
Percentage of Participants With No New Active, Inflammatory Chorioretinal or Inflammatory Retinal Vascular Lesion in Both Eyes Relative to Baseline Over Time Among Participants With Inactive Uveitis at Study Entry Week 186	100 percentage of participants Interval 88.8 to 100.0
Percentage of Participants With No New Active, Inflammatory Chorioretinal or Inflammatory Retinal Vascular Lesion in Both Eyes Relative to Baseline Over Time Among Participants With Inactive Uveitis at Study Entry Week 198	100 percentage of participants Interval 86.8 to 100.0
Percentage of Participants With No New Active, Inflammatory Chorioretinal or Inflammatory Retinal Vascular Lesion in Both Eyes Relative to Baseline Over Time Among Participants With Inactive Uveitis at Study Entry Week 210	100 percentage of participants Interval 79.4 to 100.0
Percentage of Participants With No New Active, Inflammatory Chorioretinal or Inflammatory Retinal Vascular Lesion in Both Eyes Relative to Baseline Over Time Among Participants With Inactive Uveitis at Study Entry Week 222	100 percentage of participants Interval 73.5 to 100.0
Percentage of Participants With No New Active, Inflammatory Chorioretinal or Inflammatory Retinal Vascular Lesion in Both Eyes Relative to Baseline Over Time Among Participants With Inactive Uveitis at Study Entry Week 246	100 percentage of participants Interval 59.0 to 100.0

OTHER_PRE_SPECIFIED outcome

Timeframe: Weeks 12, 18, 30, 42, 54, 66, 78, 90, 102, 114, 126, 138, 150, 162, 174, 186, 198, 210, 222, 234, and 246

Population: All participants in the ITT analysis set with evaluable data at each timepoint.

Percentage of participants at each study time point with no new active, inflammatory chorioretinal or inflammatory retinal vascular lesion in both eyes relative to Week 8 for participants who had active uveitis when they entered the study.

Outcome measures

Outcome measures
Measure	Adalimumab n=225 Participants Participants received open label (OL) adalimumab 40 mg by subcutaneous (SC) injection every other week (eow) until the final visit.
Percentage of Participants With No New Active, Inflammatory Chorioretinal or Inflammatory Retinal Vascular Lesion in Both Eyes Relative to Week 8 Over Time Among Participants With Active Uveitis at Study Entry Week 12	97.7 percentage of participants Interval 94.8 to 99.3
Percentage of Participants With No New Active, Inflammatory Chorioretinal or Inflammatory Retinal Vascular Lesion in Both Eyes Relative to Week 8 Over Time Among Participants With Active Uveitis at Study Entry Week 18	99.1 percentage of participants Interval 96.7 to 99.9
Percentage of Participants With No New Active, Inflammatory Chorioretinal or Inflammatory Retinal Vascular Lesion in Both Eyes Relative to Week 8 Over Time Among Participants With Active Uveitis at Study Entry Week 30	97.1 percentage of participants Interval 93.8 to 98.9
Percentage of Participants With No New Active, Inflammatory Chorioretinal or Inflammatory Retinal Vascular Lesion in Both Eyes Relative to Week 8 Over Time Among Participants With Active Uveitis at Study Entry Week 42	99.0 percentage of participants Interval 96.4 to 99.9
Percentage of Participants With No New Active, Inflammatory Chorioretinal or Inflammatory Retinal Vascular Lesion in Both Eyes Relative to Week 8 Over Time Among Participants With Active Uveitis at Study Entry Week 54	98.9 percentage of participants Interval 96.2 to 99.9
Percentage of Participants With No New Active, Inflammatory Chorioretinal or Inflammatory Retinal Vascular Lesion in Both Eyes Relative to Week 8 Over Time Among Participants With Active Uveitis at Study Entry Week 66	98.3 percentage of participants Interval 95.2 to 99.7
Percentage of Participants With No New Active, Inflammatory Chorioretinal or Inflammatory Retinal Vascular Lesion in Both Eyes Relative to Week 8 Over Time Among Participants With Active Uveitis at Study Entry Week 78	97.7 percentage of participants Interval 94.2 to 99.4
Percentage of Participants With No New Active, Inflammatory Chorioretinal or Inflammatory Retinal Vascular Lesion in Both Eyes Relative to Week 8 Over Time Among Participants With Active Uveitis at Study Entry Week 90	97.6 percentage of participants Interval 93.9 to 99.3
Percentage of Participants With No New Active, Inflammatory Chorioretinal or Inflammatory Retinal Vascular Lesion in Both Eyes Relative to Week 8 Over Time Among Participants With Active Uveitis at Study Entry Week 102	99.4 percentage of participants Interval 96.5 to 100.0
Percentage of Participants With No New Active, Inflammatory Chorioretinal or Inflammatory Retinal Vascular Lesion in Both Eyes Relative to Week 8 Over Time Among Participants With Active Uveitis at Study Entry Week 114	97.3 percentage of participants Interval 93.2 to 99.3
Percentage of Participants With No New Active, Inflammatory Chorioretinal or Inflammatory Retinal Vascular Lesion in Both Eyes Relative to Week 8 Over Time Among Participants With Active Uveitis at Study Entry Week 126	99.3 percentage of participants Interval 96.1 to 100.0
Percentage of Participants With No New Active, Inflammatory Chorioretinal or Inflammatory Retinal Vascular Lesion in Both Eyes Relative to Week 8 Over Time Among Participants With Active Uveitis at Study Entry Week 138	100 percentage of participants Interval 97.2 to 100.0
Percentage of Participants With No New Active, Inflammatory Chorioretinal or Inflammatory Retinal Vascular Lesion in Both Eyes Relative to Week 8 Over Time Among Participants With Active Uveitis at Study Entry Week 150	96.7 percentage of participants Interval 91.9 to 99.1
Percentage of Participants With No New Active, Inflammatory Chorioretinal or Inflammatory Retinal Vascular Lesion in Both Eyes Relative to Week 8 Over Time Among Participants With Active Uveitis at Study Entry Week 162	97.4 percentage of participants Interval 92.6 to 99.5
Percentage of Participants With No New Active, Inflammatory Chorioretinal or Inflammatory Retinal Vascular Lesion in Both Eyes Relative to Week 8 Over Time Among Participants With Active Uveitis at Study Entry Week 174	100 percentage of participants Interval 96.6 to 100.0
Percentage of Participants With No New Active, Inflammatory Chorioretinal or Inflammatory Retinal Vascular Lesion in Both Eyes Relative to Week 8 Over Time Among Participants With Active Uveitis at Study Entry Week 186	99.0 percentage of participants Interval 94.4 to 100.0
Percentage of Participants With No New Active, Inflammatory Chorioretinal or Inflammatory Retinal Vascular Lesion in Both Eyes Relative to Week 8 Over Time Among Participants With Active Uveitis at Study Entry Week 198	100 percentage of participants Interval 95.8 to 100.0
Percentage of Participants With No New Active, Inflammatory Chorioretinal or Inflammatory Retinal Vascular Lesion in Both Eyes Relative to Week 8 Over Time Among Participants With Active Uveitis at Study Entry Week 210	100 percentage of participants Interval 95.1 to 100.0
Percentage of Participants With No New Active, Inflammatory Chorioretinal or Inflammatory Retinal Vascular Lesion in Both Eyes Relative to Week 8 Over Time Among Participants With Active Uveitis at Study Entry Week 222	100 percentage of participants Interval 93.9 to 100.0
Percentage of Participants With No New Active, Inflammatory Chorioretinal or Inflammatory Retinal Vascular Lesion in Both Eyes Relative to Week 8 Over Time Among Participants With Active Uveitis at Study Entry Week 234	100 percentage of participants Interval 91.6 to 100.0
Percentage of Participants With No New Active, Inflammatory Chorioretinal or Inflammatory Retinal Vascular Lesion in Both Eyes Relative to Week 8 Over Time Among Participants With Active Uveitis at Study Entry Week 246	100 percentage of participants Interval 90.0 to 100.0

OTHER_PRE_SPECIFIED outcome

Timeframe: Weeks 0, 2, 4, 8, 12, 18, 30, 42, 54, 66, 78, 90, 102, 114, 126, 138, 150, 162, 174, 186, 198, 210, 222, 234, and 246

Population: All participants in the ITT analysis set with evaluable data at each timepoint.

Vitreous haze was measured using dilated indirect ophthalmoscopy (DIO) and assessed by the Investigator according to NEI and SUN criteria: Grade 0: No evident vitreous haze; Grade 0.5+: Slight blurring of the optic disc margin because of the haze; normal striations and reflex of the nerve fiber layer cannot be visualized; Grade 1+: Permits a better definition of both the optic nerve head and the retinal vessels (compared to higher grades); Grade 2+: Permits better visualization of the retinal vessels (compared to higher grades); Grade 3+: Permits the observer to see the optic nerve head, but the borders are quite blurry; Grade 4+: Optic nerve head is obscured.

Outcome measures

Outcome measures
Measure	Adalimumab n=364 Participants Participants received open label (OL) adalimumab 40 mg by subcutaneous (SC) injection every other week (eow) until the final visit.
Percentage of Participants With Grade ≤0.5+ in VH in Both Eyes on Indirect Ophthalmoscopy According to NEI/SUN Criteria Over Time Week 162	91.6 percentage of participants Interval 86.0 to 95.4
Percentage of Participants With Grade ≤0.5+ in VH in Both Eyes on Indirect Ophthalmoscopy According to NEI/SUN Criteria Over Time Week 0	58.0 percentage of participants Interval 52.7 to 63.1
Percentage of Participants With Grade ≤0.5+ in VH in Both Eyes on Indirect Ophthalmoscopy According to NEI/SUN Criteria Over Time Week 2	75.6 percentage of participants Interval 70.7 to 80.0
Percentage of Participants With Grade ≤0.5+ in VH in Both Eyes on Indirect Ophthalmoscopy According to NEI/SUN Criteria Over Time Week 4	77.7 percentage of participants Interval 72.8 to 82.1
Percentage of Participants With Grade ≤0.5+ in VH in Both Eyes on Indirect Ophthalmoscopy According to NEI/SUN Criteria Over Time Week 8	84.2 percentage of participants Interval 79.9 to 87.9
Percentage of Participants With Grade ≤0.5+ in VH in Both Eyes on Indirect Ophthalmoscopy According to NEI/SUN Criteria Over Time Week 12	84.4 percentage of participants Interval 80.0 to 88.1
Percentage of Participants With Grade ≤0.5+ in VH in Both Eyes on Indirect Ophthalmoscopy According to NEI/SUN Criteria Over Time Week 18	87.3 percentage of participants Interval 83.2 to 90.7
Percentage of Participants With Grade ≤0.5+ in VH in Both Eyes on Indirect Ophthalmoscopy According to NEI/SUN Criteria Over Time Week 30	87.1 percentage of participants Interval 83.0 to 90.6
Percentage of Participants With Grade ≤0.5+ in VH in Both Eyes on Indirect Ophthalmoscopy According to NEI/SUN Criteria Over Time Week 42	90.3 percentage of participants Interval 86.5 to 93.4
Percentage of Participants With Grade ≤0.5+ in VH in Both Eyes on Indirect Ophthalmoscopy According to NEI/SUN Criteria Over Time Week 54	89.5 percentage of participants Interval 85.4 to 92.7
Percentage of Participants With Grade ≤0.5+ in VH in Both Eyes on Indirect Ophthalmoscopy According to NEI/SUN Criteria Over Time Week 66	92.2 percentage of participants Interval 88.5 to 95.1
Percentage of Participants With Grade ≤0.5+ in VH in Both Eyes on Indirect Ophthalmoscopy According to NEI/SUN Criteria Over Time Week 78	93.3 percentage of participants Interval 89.7 to 96.0
Percentage of Participants With Grade ≤0.5+ in VH in Both Eyes on Indirect Ophthalmoscopy According to NEI/SUN Criteria Over Time Week 90	93.5 percentage of participants Interval 89.8 to 96.2
Percentage of Participants With Grade ≤0.5+ in VH in Both Eyes on Indirect Ophthalmoscopy According to NEI/SUN Criteria Over Time Week 102	93.9 percentage of participants Interval 90.1 to 96.5
Percentage of Participants With Grade ≤0.5+ in VH in Both Eyes on Indirect Ophthalmoscopy According to NEI/SUN Criteria Over Time Week 114	93.1 percentage of participants Interval 89.0 to 96.0
Percentage of Participants With Grade ≤0.5+ in VH in Both Eyes on Indirect Ophthalmoscopy According to NEI/SUN Criteria Over Time Week 126	94.9 percentage of participants Interval 91.0 to 97.4
Percentage of Participants With Grade ≤0.5+ in VH in Both Eyes on Indirect Ophthalmoscopy According to NEI/SUN Criteria Over Time Week 138	95.4 percentage of participants Interval 91.5 to 97.9
Percentage of Participants With Grade ≤0.5+ in VH in Both Eyes on Indirect Ophthalmoscopy According to NEI/SUN Criteria Over Time Week 150	92.2 percentage of participants Interval 87.3 to 95.7
Percentage of Participants With Grade ≤0.5+ in VH in Both Eyes on Indirect Ophthalmoscopy According to NEI/SUN Criteria Over Time Week 174	92.3 percentage of participants Interval 86.6 to 96.1
Percentage of Participants With Grade ≤0.5+ in VH in Both Eyes on Indirect Ophthalmoscopy According to NEI/SUN Criteria Over Time Week 186	96.1 percentage of participants Interval 91.1 to 98.7
Percentage of Participants With Grade ≤0.5+ in VH in Both Eyes on Indirect Ophthalmoscopy According to NEI/SUN Criteria Over Time Week 198	93.8 percentage of participants Interval 87.7 to 97.5
Percentage of Participants With Grade ≤0.5+ in VH in Both Eyes on Indirect Ophthalmoscopy According to NEI/SUN Criteria Over Time Week 210	92.0 percentage of participants Interval 84.3 to 96.7
Percentage of Participants With Grade ≤0.5+ in VH in Both Eyes on Indirect Ophthalmoscopy According to NEI/SUN Criteria Over Time Week 222	95.7 percentage of participants Interval 88.0 to 99.1
Percentage of Participants With Grade ≤0.5+ in VH in Both Eyes on Indirect Ophthalmoscopy According to NEI/SUN Criteria Over Time Week 234	96.1 percentage of participants Interval 86.5 to 99.5
Percentage of Participants With Grade ≤0.5+ in VH in Both Eyes on Indirect Ophthalmoscopy According to NEI/SUN Criteria Over Time Week 246	97.6 percentage of participants Interval 87.4 to 99.9

OTHER_PRE_SPECIFIED outcome

Timeframe: Weeks 0, 8, 18, 30, 42, 54, 66, 78, 90, 102, 114, 126, 138, 150, 162, 174, 186, 198, 210, 222, 234, and 246

Population: All participants in the ITT analysis set with evaluable data at each timepoint.

The National Eye Institute (NEI) Visual Functioning Questionnaire (VFQ-25) is an ocular disease-specific survey that measures the influence of visual disability and visual symptoms on generic health domains such as emotional well-being and social functioning, in addition to task-oriented domains related to daily visual functioning.The VFQ-25 consists of a base set of 25 vision-targeted questions plus an additional single-item general health rating question. The overall composite score ranges from 0 to 100, where higher scores or increases in score indicate better vision-related functioning. Baseline was defined as Week 0 for participants with inactive uveitis.

Outcome measures

Outcome measures
Measure	Adalimumab n=122 Participants Participants received open label (OL) adalimumab 40 mg by subcutaneous (SC) injection every other week (eow) until the final visit.
Change in National Eye Institute (NEI) Visual Functioning Questionnaire (VFQ-25) Score at Each Study Time Point Relative to Baseline for Participants Who Had Inactive Uveitis at Study Entry Over Time Week 30	84.75 score on a scale Interval 81.91 to 87.59
Change in National Eye Institute (NEI) Visual Functioning Questionnaire (VFQ-25) Score at Each Study Time Point Relative to Baseline for Participants Who Had Inactive Uveitis at Study Entry Over Time Week 0	84.77 score on a scale Interval 81.93 to 87.62
Change in National Eye Institute (NEI) Visual Functioning Questionnaire (VFQ-25) Score at Each Study Time Point Relative to Baseline for Participants Who Had Inactive Uveitis at Study Entry Over Time Week 8	84.37 score on a scale Interval 81.37 to 87.37
Change in National Eye Institute (NEI) Visual Functioning Questionnaire (VFQ-25) Score at Each Study Time Point Relative to Baseline for Participants Who Had Inactive Uveitis at Study Entry Over Time Week 18	85.21 score on a scale Interval 82.3 to 88.13
Change in National Eye Institute (NEI) Visual Functioning Questionnaire (VFQ-25) Score at Each Study Time Point Relative to Baseline for Participants Who Had Inactive Uveitis at Study Entry Over Time Week 42	84.41 score on a scale Interval 81.29 to 87.53
Change in National Eye Institute (NEI) Visual Functioning Questionnaire (VFQ-25) Score at Each Study Time Point Relative to Baseline for Participants Who Had Inactive Uveitis at Study Entry Over Time Week 54	84.87 score on a scale Interval 81.82 to 87.91
Change in National Eye Institute (NEI) Visual Functioning Questionnaire (VFQ-25) Score at Each Study Time Point Relative to Baseline for Participants Who Had Inactive Uveitis at Study Entry Over Time Week 66	84.09 score on a scale Interval 80.97 to 87.21
Change in National Eye Institute (NEI) Visual Functioning Questionnaire (VFQ-25) Score at Each Study Time Point Relative to Baseline for Participants Who Had Inactive Uveitis at Study Entry Over Time Week 78	83.59 score on a scale Interval 80.33 to 86.85
Change in National Eye Institute (NEI) Visual Functioning Questionnaire (VFQ-25) Score at Each Study Time Point Relative to Baseline for Participants Who Had Inactive Uveitis at Study Entry Over Time Week 90	83.66 score on a scale Interval 80.18 to 87.15
Change in National Eye Institute (NEI) Visual Functioning Questionnaire (VFQ-25) Score at Each Study Time Point Relative to Baseline for Participants Who Had Inactive Uveitis at Study Entry Over Time Week 102	84.19 score on a scale Interval 80.62 to 87.76
Change in National Eye Institute (NEI) Visual Functioning Questionnaire (VFQ-25) Score at Each Study Time Point Relative to Baseline for Participants Who Had Inactive Uveitis at Study Entry Over Time Week 114	84.09 score on a scale Interval 80.4 to 87.78
Change in National Eye Institute (NEI) Visual Functioning Questionnaire (VFQ-25) Score at Each Study Time Point Relative to Baseline for Participants Who Had Inactive Uveitis at Study Entry Over Time Week 126	84.44 score on a scale Interval 80.59 to 88.28
Change in National Eye Institute (NEI) Visual Functioning Questionnaire (VFQ-25) Score at Each Study Time Point Relative to Baseline for Participants Who Had Inactive Uveitis at Study Entry Over Time Week 138	84.85 score on a scale Interval 80.56 to 89.14
Change in National Eye Institute (NEI) Visual Functioning Questionnaire (VFQ-25) Score at Each Study Time Point Relative to Baseline for Participants Who Had Inactive Uveitis at Study Entry Over Time Week 150	83.90 score on a scale Interval 78.95 to 88.85
Change in National Eye Institute (NEI) Visual Functioning Questionnaire (VFQ-25) Score at Each Study Time Point Relative to Baseline for Participants Who Had Inactive Uveitis at Study Entry Over Time Week 162	86.60 score on a scale Interval 81.31 to 91.9
Change in National Eye Institute (NEI) Visual Functioning Questionnaire (VFQ-25) Score at Each Study Time Point Relative to Baseline for Participants Who Had Inactive Uveitis at Study Entry Over Time Week 174	87.25 score on a scale Interval 81.51 to 92.99
Change in National Eye Institute (NEI) Visual Functioning Questionnaire (VFQ-25) Score at Each Study Time Point Relative to Baseline for Participants Who Had Inactive Uveitis at Study Entry Over Time Week 186	87.25 score on a scale Interval 81.43 to 93.06
Change in National Eye Institute (NEI) Visual Functioning Questionnaire (VFQ-25) Score at Each Study Time Point Relative to Baseline for Participants Who Had Inactive Uveitis at Study Entry Over Time Week 198	85.30 score on a scale Interval 78.35 to 92.26
Change in National Eye Institute (NEI) Visual Functioning Questionnaire (VFQ-25) Score at Each Study Time Point Relative to Baseline for Participants Who Had Inactive Uveitis at Study Entry Over Time Week 210	85.71 score on a scale Interval 76.61 to 94.82
Change in National Eye Institute (NEI) Visual Functioning Questionnaire (VFQ-25) Score at Each Study Time Point Relative to Baseline for Participants Who Had Inactive Uveitis at Study Entry Over Time Week 222	85.67 score on a scale Interval 74.6 to 96.74
Change in National Eye Institute (NEI) Visual Functioning Questionnaire (VFQ-25) Score at Each Study Time Point Relative to Baseline for Participants Who Had Inactive Uveitis at Study Entry Over Time Week 234	82.90 score on a scale Interval 68.16 to 97.63
Change in National Eye Institute (NEI) Visual Functioning Questionnaire (VFQ-25) Score at Each Study Time Point Relative to Baseline for Participants Who Had Inactive Uveitis at Study Entry Over Time Week 246	79.83 score on a scale Interval 61.0 to 98.66

OTHER_PRE_SPECIFIED outcome

Timeframe: Weeks 0, 8, 18, 30, 42, 54, 66, 78, 90, 102, 114, 126, 138, 150, 162, 174, 186, 198, 210, 222, 234, and 246

Population: All participants in the ITT analysis set with evaluable data at each timepoint.

Outcome measures

Outcome measures
Measure	Adalimumab n=240 Participants Participants received open label (OL) adalimumab 40 mg by subcutaneous (SC) injection every other week (eow) until the final visit.
Change in NEI VFQ-25 Score at Each Study Time Point Relative to Week 8 for Participants Who Had Active Uveitis at Study Entry Over Time Week 102	81.44 score on a scale Interval 78.74 to 84.14
Change in NEI VFQ-25 Score at Each Study Time Point Relative to Week 8 for Participants Who Had Active Uveitis at Study Entry Over Time Week 138	81.76 score on a scale Interval 78.94 to 84.59
Change in NEI VFQ-25 Score at Each Study Time Point Relative to Week 8 for Participants Who Had Active Uveitis at Study Entry Over Time Week 186	81.27 score on a scale Interval 78.07 to 84.46
Change in NEI VFQ-25 Score at Each Study Time Point Relative to Week 8 for Participants Who Had Active Uveitis at Study Entry Over Time Week 210	80.75 score on a scale Interval 76.99 to 84.51
Change in NEI VFQ-25 Score at Each Study Time Point Relative to Week 8 for Participants Who Had Active Uveitis at Study Entry Over Time Week 0	72.00 score on a scale Interval 69.52 to 74.48
Change in NEI VFQ-25 Score at Each Study Time Point Relative to Week 8 for Participants Who Had Active Uveitis at Study Entry Over Time Week 8	75.77 score on a scale Interval 73.27 to 78.26
Change in NEI VFQ-25 Score at Each Study Time Point Relative to Week 8 for Participants Who Had Active Uveitis at Study Entry Over Time Week 18	78.12 score on a scale Interval 75.65 to 80.58
Change in NEI VFQ-25 Score at Each Study Time Point Relative to Week 8 for Participants Who Had Active Uveitis at Study Entry Over Time Week 30	78.98 score on a scale Interval 76.46 to 81.5
Change in NEI VFQ-25 Score at Each Study Time Point Relative to Week 8 for Participants Who Had Active Uveitis at Study Entry Over Time Week 42	79.77 score on a scale Interval 77.37 to 82.18
Change in NEI VFQ-25 Score at Each Study Time Point Relative to Week 8 for Participants Who Had Active Uveitis at Study Entry Over Time Week 54	80.10 score on a scale Interval 77.69 to 82.5
Change in NEI VFQ-25 Score at Each Study Time Point Relative to Week 8 for Participants Who Had Active Uveitis at Study Entry Over Time Week 66	80.42 score on a scale Interval 77.87 to 82.97
Change in NEI VFQ-25 Score at Each Study Time Point Relative to Week 8 for Participants Who Had Active Uveitis at Study Entry Over Time Week 78	80.98 score on a scale Interval 78.39 to 83.58
Change in NEI VFQ-25 Score at Each Study Time Point Relative to Week 8 for Participants Who Had Active Uveitis at Study Entry Over Time Week 90	81.85 score on a scale Interval 79.32 to 84.37
Change in NEI VFQ-25 Score at Each Study Time Point Relative to Week 8 for Participants Who Had Active Uveitis at Study Entry Over Time Week 114	81.76 score on a scale Interval 78.99 to 84.54
Change in NEI VFQ-25 Score at Each Study Time Point Relative to Week 8 for Participants Who Had Active Uveitis at Study Entry Over Time Week 126	81.86 score on a scale Interval 79.11 to 84.61
Change in NEI VFQ-25 Score at Each Study Time Point Relative to Week 8 for Participants Who Had Active Uveitis at Study Entry Over Time Week 150	82.41 score on a scale Interval 79.51 to 85.31
Change in NEI VFQ-25 Score at Each Study Time Point Relative to Week 8 for Participants Who Had Active Uveitis at Study Entry Over Time Week 162	81.87 score on a scale Interval 78.9 to 84.85
Change in NEI VFQ-25 Score at Each Study Time Point Relative to Week 8 for Participants Who Had Active Uveitis at Study Entry Over Time Week 174	81.96 score on a scale Interval 78.78 to 85.14
Change in NEI VFQ-25 Score at Each Study Time Point Relative to Week 8 for Participants Who Had Active Uveitis at Study Entry Over Time Week 198	82.08 score on a scale Interval 78.82 to 85.34
Change in NEI VFQ-25 Score at Each Study Time Point Relative to Week 8 for Participants Who Had Active Uveitis at Study Entry Over Time Week 222	81.65 score on a scale Interval 77.24 to 86.05
Change in NEI VFQ-25 Score at Each Study Time Point Relative to Week 8 for Participants Who Had Active Uveitis at Study Entry Over Time Week 234	81.86 score on a scale Interval 76.32 to 87.4
Change in NEI VFQ-25 Score at Each Study Time Point Relative to Week 8 for Participants Who Had Active Uveitis at Study Entry Over Time Week 246	81.57 score on a scale Interval 75.44 to 87.7

Adverse Events

Adalimumab

Serious events: 101 serious events

Other events: 332 other events

Deaths: 4 deaths

Serious adverse events

Serious adverse events
Measure	Adalimumab n=424 participants at risk Participants received open label (OL) adalimumab 40 mg by subcutaneous (SC) injection every other week (eow) until the final visit.
Blood and lymphatic system disorders PSEUDOLYMPHOMA	0.24% 1/424 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until either 70 days after the last dose of study drug or until the first dose of commercially available drug (up to 370 weeks). TEAEs and SAEs are defined as any AE or SAE with onset or worsening reported by a participant from the time first dose of adalimumab is administered in Study M11-327 until 5 half-lives (70 days) have elapsed following discontinuation of adalimumab or until first dose of commercially available adalimumab post regulatory and/or reimbursement approval for treatment of uveitis in adults in their respective countries. TEAEs were collected whether elicited or spontaneously reported by the participant.
Cardiac disorders ACUTE MYOCARDIAL INFARCTION	0.24% 1/424 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until either 70 days after the last dose of study drug or until the first dose of commercially available drug (up to 370 weeks). TEAEs and SAEs are defined as any AE or SAE with onset or worsening reported by a participant from the time first dose of adalimumab is administered in Study M11-327 until 5 half-lives (70 days) have elapsed following discontinuation of adalimumab or until first dose of commercially available adalimumab post regulatory and/or reimbursement approval for treatment of uveitis in adults in their respective countries. TEAEs were collected whether elicited or spontaneously reported by the participant.
Cardiac disorders AORTIC VALVE STENOSIS	0.24% 1/424 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until either 70 days after the last dose of study drug or until the first dose of commercially available drug (up to 370 weeks). TEAEs and SAEs are defined as any AE or SAE with onset or worsening reported by a participant from the time first dose of adalimumab is administered in Study M11-327 until 5 half-lives (70 days) have elapsed following discontinuation of adalimumab or until first dose of commercially available adalimumab post regulatory and/or reimbursement approval for treatment of uveitis in adults in their respective countries. TEAEs were collected whether elicited or spontaneously reported by the participant.
Cardiac disorders CARDIAC FAILURE ACUTE	0.24% 1/424 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until either 70 days after the last dose of study drug or until the first dose of commercially available drug (up to 370 weeks). TEAEs and SAEs are defined as any AE or SAE with onset or worsening reported by a participant from the time first dose of adalimumab is administered in Study M11-327 until 5 half-lives (70 days) have elapsed following discontinuation of adalimumab or until first dose of commercially available adalimumab post regulatory and/or reimbursement approval for treatment of uveitis in adults in their respective countries. TEAEs were collected whether elicited or spontaneously reported by the participant.
Cardiac disorders CORONARY ARTERY DISEASE	0.24% 1/424 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until either 70 days after the last dose of study drug or until the first dose of commercially available drug (up to 370 weeks). TEAEs and SAEs are defined as any AE or SAE with onset or worsening reported by a participant from the time first dose of adalimumab is administered in Study M11-327 until 5 half-lives (70 days) have elapsed following discontinuation of adalimumab or until first dose of commercially available adalimumab post regulatory and/or reimbursement approval for treatment of uveitis in adults in their respective countries. TEAEs were collected whether elicited or spontaneously reported by the participant.
Cardiac disorders MYOCARDIAL INFARCTION	0.24% 1/424 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until either 70 days after the last dose of study drug or until the first dose of commercially available drug (up to 370 weeks). TEAEs and SAEs are defined as any AE or SAE with onset or worsening reported by a participant from the time first dose of adalimumab is administered in Study M11-327 until 5 half-lives (70 days) have elapsed following discontinuation of adalimumab or until first dose of commercially available adalimumab post regulatory and/or reimbursement approval for treatment of uveitis in adults in their respective countries. TEAEs were collected whether elicited or spontaneously reported by the participant.
Congenital, familial and genetic disorders BICUSPID AORTIC VALVE	0.24% 1/424 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until either 70 days after the last dose of study drug or until the first dose of commercially available drug (up to 370 weeks). TEAEs and SAEs are defined as any AE or SAE with onset or worsening reported by a participant from the time first dose of adalimumab is administered in Study M11-327 until 5 half-lives (70 days) have elapsed following discontinuation of adalimumab or until first dose of commercially available adalimumab post regulatory and/or reimbursement approval for treatment of uveitis in adults in their respective countries. TEAEs were collected whether elicited or spontaneously reported by the participant.
Eye disorders BLINDNESS	0.24% 1/424 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until either 70 days after the last dose of study drug or until the first dose of commercially available drug (up to 370 weeks). TEAEs and SAEs are defined as any AE or SAE with onset or worsening reported by a participant from the time first dose of adalimumab is administered in Study M11-327 until 5 half-lives (70 days) have elapsed following discontinuation of adalimumab or until first dose of commercially available adalimumab post regulatory and/or reimbursement approval for treatment of uveitis in adults in their respective countries. TEAEs were collected whether elicited or spontaneously reported by the participant.
Eye disorders CATARACT	1.7% 7/424 • Number of events 11 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until either 70 days after the last dose of study drug or until the first dose of commercially available drug (up to 370 weeks). TEAEs and SAEs are defined as any AE or SAE with onset or worsening reported by a participant from the time first dose of adalimumab is administered in Study M11-327 until 5 half-lives (70 days) have elapsed following discontinuation of adalimumab or until first dose of commercially available adalimumab post regulatory and/or reimbursement approval for treatment of uveitis in adults in their respective countries. TEAEs were collected whether elicited or spontaneously reported by the participant.
Eye disorders CILIARY ZONULAR DEHISCENCE	0.24% 1/424 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until either 70 days after the last dose of study drug or until the first dose of commercially available drug (up to 370 weeks). TEAEs and SAEs are defined as any AE or SAE with onset or worsening reported by a participant from the time first dose of adalimumab is administered in Study M11-327 until 5 half-lives (70 days) have elapsed following discontinuation of adalimumab or until first dose of commercially available adalimumab post regulatory and/or reimbursement approval for treatment of uveitis in adults in their respective countries. TEAEs were collected whether elicited or spontaneously reported by the participant.
Eye disorders CORNEAL OEDEMA	0.24% 1/424 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until either 70 days after the last dose of study drug or until the first dose of commercially available drug (up to 370 weeks). TEAEs and SAEs are defined as any AE or SAE with onset or worsening reported by a participant from the time first dose of adalimumab is administered in Study M11-327 until 5 half-lives (70 days) have elapsed following discontinuation of adalimumab or until first dose of commercially available adalimumab post regulatory and/or reimbursement approval for treatment of uveitis in adults in their respective countries. TEAEs were collected whether elicited or spontaneously reported by the participant.
Eye disorders EYE INFLAMMATION	0.24% 1/424 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until either 70 days after the last dose of study drug or until the first dose of commercially available drug (up to 370 weeks). TEAEs and SAEs are defined as any AE or SAE with onset or worsening reported by a participant from the time first dose of adalimumab is administered in Study M11-327 until 5 half-lives (70 days) have elapsed following discontinuation of adalimumab or until first dose of commercially available adalimumab post regulatory and/or reimbursement approval for treatment of uveitis in adults in their respective countries. TEAEs were collected whether elicited or spontaneously reported by the participant.
Eye disorders GLAUCOMA	0.24% 1/424 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until either 70 days after the last dose of study drug or until the first dose of commercially available drug (up to 370 weeks). TEAEs and SAEs are defined as any AE or SAE with onset or worsening reported by a participant from the time first dose of adalimumab is administered in Study M11-327 until 5 half-lives (70 days) have elapsed following discontinuation of adalimumab or until first dose of commercially available adalimumab post regulatory and/or reimbursement approval for treatment of uveitis in adults in their respective countries. TEAEs were collected whether elicited or spontaneously reported by the participant.
Eye disorders MACULAR FIBROSIS	0.24% 1/424 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until either 70 days after the last dose of study drug or until the first dose of commercially available drug (up to 370 weeks). TEAEs and SAEs are defined as any AE or SAE with onset or worsening reported by a participant from the time first dose of adalimumab is administered in Study M11-327 until 5 half-lives (70 days) have elapsed following discontinuation of adalimumab or until first dose of commercially available adalimumab post regulatory and/or reimbursement approval for treatment of uveitis in adults in their respective countries. TEAEs were collected whether elicited or spontaneously reported by the participant.
Eye disorders OCULAR HYPERTENSION	0.24% 1/424 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until either 70 days after the last dose of study drug or until the first dose of commercially available drug (up to 370 weeks). TEAEs and SAEs are defined as any AE or SAE with onset or worsening reported by a participant from the time first dose of adalimumab is administered in Study M11-327 until 5 half-lives (70 days) have elapsed following discontinuation of adalimumab or until first dose of commercially available adalimumab post regulatory and/or reimbursement approval for treatment of uveitis in adults in their respective countries. TEAEs were collected whether elicited or spontaneously reported by the participant.
Eye disorders OPTIC NEUROPATHY	0.24% 1/424 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until either 70 days after the last dose of study drug or until the first dose of commercially available drug (up to 370 weeks). TEAEs and SAEs are defined as any AE or SAE with onset or worsening reported by a participant from the time first dose of adalimumab is administered in Study M11-327 until 5 half-lives (70 days) have elapsed following discontinuation of adalimumab or until first dose of commercially available adalimumab post regulatory and/or reimbursement approval for treatment of uveitis in adults in their respective countries. TEAEs were collected whether elicited or spontaneously reported by the participant.
Eye disorders PAPILLOEDEMA	0.24% 1/424 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until either 70 days after the last dose of study drug or until the first dose of commercially available drug (up to 370 weeks). TEAEs and SAEs are defined as any AE or SAE with onset or worsening reported by a participant from the time first dose of adalimumab is administered in Study M11-327 until 5 half-lives (70 days) have elapsed following discontinuation of adalimumab or until first dose of commercially available adalimumab post regulatory and/or reimbursement approval for treatment of uveitis in adults in their respective countries. TEAEs were collected whether elicited or spontaneously reported by the participant.
Eye disorders RETINAL DETACHMENT	0.71% 3/424 • Number of events 3 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until either 70 days after the last dose of study drug or until the first dose of commercially available drug (up to 370 weeks). TEAEs and SAEs are defined as any AE or SAE with onset or worsening reported by a participant from the time first dose of adalimumab is administered in Study M11-327 until 5 half-lives (70 days) have elapsed following discontinuation of adalimumab or until first dose of commercially available adalimumab post regulatory and/or reimbursement approval for treatment of uveitis in adults in their respective countries. TEAEs were collected whether elicited or spontaneously reported by the participant.
Eye disorders RETINAL VASCULITIS	0.24% 1/424 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until either 70 days after the last dose of study drug or until the first dose of commercially available drug (up to 370 weeks). TEAEs and SAEs are defined as any AE or SAE with onset or worsening reported by a participant from the time first dose of adalimumab is administered in Study M11-327 until 5 half-lives (70 days) have elapsed following discontinuation of adalimumab or until first dose of commercially available adalimumab post regulatory and/or reimbursement approval for treatment of uveitis in adults in their respective countries. TEAEs were collected whether elicited or spontaneously reported by the participant.
Eye disorders UVEITIS	1.2% 5/424 • Number of events 5 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until either 70 days after the last dose of study drug or until the first dose of commercially available drug (up to 370 weeks). TEAEs and SAEs are defined as any AE or SAE with onset or worsening reported by a participant from the time first dose of adalimumab is administered in Study M11-327 until 5 half-lives (70 days) have elapsed following discontinuation of adalimumab or until first dose of commercially available adalimumab post regulatory and/or reimbursement approval for treatment of uveitis in adults in their respective countries. TEAEs were collected whether elicited or spontaneously reported by the participant.
Eye disorders VISUAL ACUITY REDUCED	0.47% 2/424 • Number of events 2 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until either 70 days after the last dose of study drug or until the first dose of commercially available drug (up to 370 weeks). TEAEs and SAEs are defined as any AE or SAE with onset or worsening reported by a participant from the time first dose of adalimumab is administered in Study M11-327 until 5 half-lives (70 days) have elapsed following discontinuation of adalimumab or until first dose of commercially available adalimumab post regulatory and/or reimbursement approval for treatment of uveitis in adults in their respective countries. TEAEs were collected whether elicited or spontaneously reported by the participant.
Eye disorders VITREOUS FLOATERS	0.24% 1/424 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until either 70 days after the last dose of study drug or until the first dose of commercially available drug (up to 370 weeks). TEAEs and SAEs are defined as any AE or SAE with onset or worsening reported by a participant from the time first dose of adalimumab is administered in Study M11-327 until 5 half-lives (70 days) have elapsed following discontinuation of adalimumab or until first dose of commercially available adalimumab post regulatory and/or reimbursement approval for treatment of uveitis in adults in their respective countries. TEAEs were collected whether elicited or spontaneously reported by the participant.
Eye disorders VITREOUS HAEMORRHAGE	0.71% 3/424 • Number of events 3 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until either 70 days after the last dose of study drug or until the first dose of commercially available drug (up to 370 weeks). TEAEs and SAEs are defined as any AE or SAE with onset or worsening reported by a participant from the time first dose of adalimumab is administered in Study M11-327 until 5 half-lives (70 days) have elapsed following discontinuation of adalimumab or until first dose of commercially available adalimumab post regulatory and/or reimbursement approval for treatment of uveitis in adults in their respective countries. TEAEs were collected whether elicited or spontaneously reported by the participant.
Eye disorders VITREOUS OPACITIES	0.24% 1/424 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until either 70 days after the last dose of study drug or until the first dose of commercially available drug (up to 370 weeks). TEAEs and SAEs are defined as any AE or SAE with onset or worsening reported by a participant from the time first dose of adalimumab is administered in Study M11-327 until 5 half-lives (70 days) have elapsed following discontinuation of adalimumab or until first dose of commercially available adalimumab post regulatory and/or reimbursement approval for treatment of uveitis in adults in their respective countries. TEAEs were collected whether elicited or spontaneously reported by the participant.
Gastrointestinal disorders COLITIS	0.24% 1/424 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until either 70 days after the last dose of study drug or until the first dose of commercially available drug (up to 370 weeks). TEAEs and SAEs are defined as any AE or SAE with onset or worsening reported by a participant from the time first dose of adalimumab is administered in Study M11-327 until 5 half-lives (70 days) have elapsed following discontinuation of adalimumab or until first dose of commercially available adalimumab post regulatory and/or reimbursement approval for treatment of uveitis in adults in their respective countries. TEAEs were collected whether elicited or spontaneously reported by the participant.
Gastrointestinal disorders CROHN'S DISEASE	0.47% 2/424 • Number of events 2 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until either 70 days after the last dose of study drug or until the first dose of commercially available drug (up to 370 weeks). TEAEs and SAEs are defined as any AE or SAE with onset or worsening reported by a participant from the time first dose of adalimumab is administered in Study M11-327 until 5 half-lives (70 days) have elapsed following discontinuation of adalimumab or until first dose of commercially available adalimumab post regulatory and/or reimbursement approval for treatment of uveitis in adults in their respective countries. TEAEs were collected whether elicited or spontaneously reported by the participant.
Gastrointestinal disorders GASTRIC ULCER	0.24% 1/424 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until either 70 days after the last dose of study drug or until the first dose of commercially available drug (up to 370 weeks). TEAEs and SAEs are defined as any AE or SAE with onset or worsening reported by a participant from the time first dose of adalimumab is administered in Study M11-327 until 5 half-lives (70 days) have elapsed following discontinuation of adalimumab or until first dose of commercially available adalimumab post regulatory and/or reimbursement approval for treatment of uveitis in adults in their respective countries. TEAEs were collected whether elicited or spontaneously reported by the participant.
Gastrointestinal disorders GASTRITIS	0.24% 1/424 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until either 70 days after the last dose of study drug or until the first dose of commercially available drug (up to 370 weeks). TEAEs and SAEs are defined as any AE or SAE with onset or worsening reported by a participant from the time first dose of adalimumab is administered in Study M11-327 until 5 half-lives (70 days) have elapsed following discontinuation of adalimumab or until first dose of commercially available adalimumab post regulatory and/or reimbursement approval for treatment of uveitis in adults in their respective countries. TEAEs were collected whether elicited or spontaneously reported by the participant.
Gastrointestinal disorders INTESTINAL OBSTRUCTION	0.24% 1/424 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until either 70 days after the last dose of study drug or until the first dose of commercially available drug (up to 370 weeks). TEAEs and SAEs are defined as any AE or SAE with onset or worsening reported by a participant from the time first dose of adalimumab is administered in Study M11-327 until 5 half-lives (70 days) have elapsed following discontinuation of adalimumab or until first dose of commercially available adalimumab post regulatory and/or reimbursement approval for treatment of uveitis in adults in their respective countries. TEAEs were collected whether elicited or spontaneously reported by the participant.
Gastrointestinal disorders LARGE INTESTINE POLYP	0.47% 2/424 • Number of events 2 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until either 70 days after the last dose of study drug or until the first dose of commercially available drug (up to 370 weeks). TEAEs and SAEs are defined as any AE or SAE with onset or worsening reported by a participant from the time first dose of adalimumab is administered in Study M11-327 until 5 half-lives (70 days) have elapsed following discontinuation of adalimumab or until first dose of commercially available adalimumab post regulatory and/or reimbursement approval for treatment of uveitis in adults in their respective countries. TEAEs were collected whether elicited or spontaneously reported by the participant.
Gastrointestinal disorders PANCREATITIS	0.24% 1/424 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until either 70 days after the last dose of study drug or until the first dose of commercially available drug (up to 370 weeks). TEAEs and SAEs are defined as any AE or SAE with onset or worsening reported by a participant from the time first dose of adalimumab is administered in Study M11-327 until 5 half-lives (70 days) have elapsed following discontinuation of adalimumab or until first dose of commercially available adalimumab post regulatory and/or reimbursement approval for treatment of uveitis in adults in their respective countries. TEAEs were collected whether elicited or spontaneously reported by the participant.
General disorders CHEST PAIN	0.47% 2/424 • Number of events 2 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until either 70 days after the last dose of study drug or until the first dose of commercially available drug (up to 370 weeks). TEAEs and SAEs are defined as any AE or SAE with onset or worsening reported by a participant from the time first dose of adalimumab is administered in Study M11-327 until 5 half-lives (70 days) have elapsed following discontinuation of adalimumab or until first dose of commercially available adalimumab post regulatory and/or reimbursement approval for treatment of uveitis in adults in their respective countries. TEAEs were collected whether elicited or spontaneously reported by the participant.
General disorders DEATH	0.24% 1/424 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until either 70 days after the last dose of study drug or until the first dose of commercially available drug (up to 370 weeks). TEAEs and SAEs are defined as any AE or SAE with onset or worsening reported by a participant from the time first dose of adalimumab is administered in Study M11-327 until 5 half-lives (70 days) have elapsed following discontinuation of adalimumab or until first dose of commercially available adalimumab post regulatory and/or reimbursement approval for treatment of uveitis in adults in their respective countries. TEAEs were collected whether elicited or spontaneously reported by the participant.
General disorders GENERALISED OEDEMA	0.24% 1/424 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until either 70 days after the last dose of study drug or until the first dose of commercially available drug (up to 370 weeks). TEAEs and SAEs are defined as any AE or SAE with onset or worsening reported by a participant from the time first dose of adalimumab is administered in Study M11-327 until 5 half-lives (70 days) have elapsed following discontinuation of adalimumab or until first dose of commercially available adalimumab post regulatory and/or reimbursement approval for treatment of uveitis in adults in their respective countries. TEAEs were collected whether elicited or spontaneously reported by the participant.
Hepatobiliary disorders BILIARY COLIC	0.24% 1/424 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until either 70 days after the last dose of study drug or until the first dose of commercially available drug (up to 370 weeks). TEAEs and SAEs are defined as any AE or SAE with onset or worsening reported by a participant from the time first dose of adalimumab is administered in Study M11-327 until 5 half-lives (70 days) have elapsed following discontinuation of adalimumab or until first dose of commercially available adalimumab post regulatory and/or reimbursement approval for treatment of uveitis in adults in their respective countries. TEAEs were collected whether elicited or spontaneously reported by the participant.
Hepatobiliary disorders CHOLELITHIASIS	0.71% 3/424 • Number of events 3 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until either 70 days after the last dose of study drug or until the first dose of commercially available drug (up to 370 weeks). TEAEs and SAEs are defined as any AE or SAE with onset or worsening reported by a participant from the time first dose of adalimumab is administered in Study M11-327 until 5 half-lives (70 days) have elapsed following discontinuation of adalimumab or until first dose of commercially available adalimumab post regulatory and/or reimbursement approval for treatment of uveitis in adults in their respective countries. TEAEs were collected whether elicited or spontaneously reported by the participant.
Immune system disorders SARCOIDOSIS	0.24% 1/424 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until either 70 days after the last dose of study drug or until the first dose of commercially available drug (up to 370 weeks). TEAEs and SAEs are defined as any AE or SAE with onset or worsening reported by a participant from the time first dose of adalimumab is administered in Study M11-327 until 5 half-lives (70 days) have elapsed following discontinuation of adalimumab or until first dose of commercially available adalimumab post regulatory and/or reimbursement approval for treatment of uveitis in adults in their respective countries. TEAEs were collected whether elicited or spontaneously reported by the participant.
Infections and infestations APPENDICITIS	0.24% 1/424 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until either 70 days after the last dose of study drug or until the first dose of commercially available drug (up to 370 weeks). TEAEs and SAEs are defined as any AE or SAE with onset or worsening reported by a participant from the time first dose of adalimumab is administered in Study M11-327 until 5 half-lives (70 days) have elapsed following discontinuation of adalimumab or until first dose of commercially available adalimumab post regulatory and/or reimbursement approval for treatment of uveitis in adults in their respective countries. TEAEs were collected whether elicited or spontaneously reported by the participant.
Infections and infestations APPENDICITIS PERFORATED	0.24% 1/424 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until either 70 days after the last dose of study drug or until the first dose of commercially available drug (up to 370 weeks). TEAEs and SAEs are defined as any AE or SAE with onset or worsening reported by a participant from the time first dose of adalimumab is administered in Study M11-327 until 5 half-lives (70 days) have elapsed following discontinuation of adalimumab or until first dose of commercially available adalimumab post regulatory and/or reimbursement approval for treatment of uveitis in adults in their respective countries. TEAEs were collected whether elicited or spontaneously reported by the participant.
Infections and infestations ASPERGILLUS INFECTION	0.24% 1/424 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until either 70 days after the last dose of study drug or until the first dose of commercially available drug (up to 370 weeks). TEAEs and SAEs are defined as any AE or SAE with onset or worsening reported by a participant from the time first dose of adalimumab is administered in Study M11-327 until 5 half-lives (70 days) have elapsed following discontinuation of adalimumab or until first dose of commercially available adalimumab post regulatory and/or reimbursement approval for treatment of uveitis in adults in their respective countries. TEAEs were collected whether elicited or spontaneously reported by the participant.
Infections and infestations BRAIN ABSCESS	0.24% 1/424 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until either 70 days after the last dose of study drug or until the first dose of commercially available drug (up to 370 weeks). TEAEs and SAEs are defined as any AE or SAE with onset or worsening reported by a participant from the time first dose of adalimumab is administered in Study M11-327 until 5 half-lives (70 days) have elapsed following discontinuation of adalimumab or until first dose of commercially available adalimumab post regulatory and/or reimbursement approval for treatment of uveitis in adults in their respective countries. TEAEs were collected whether elicited or spontaneously reported by the participant.
Infections and infestations CELLULITIS	0.24% 1/424 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until either 70 days after the last dose of study drug or until the first dose of commercially available drug (up to 370 weeks). TEAEs and SAEs are defined as any AE or SAE with onset or worsening reported by a participant from the time first dose of adalimumab is administered in Study M11-327 until 5 half-lives (70 days) have elapsed following discontinuation of adalimumab or until first dose of commercially available adalimumab post regulatory and/or reimbursement approval for treatment of uveitis in adults in their respective countries. TEAEs were collected whether elicited or spontaneously reported by the participant.
Infections and infestations CYTOMEGALOVIRUS CHORIORETINITIS	0.24% 1/424 • Number of events 2 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until either 70 days after the last dose of study drug or until the first dose of commercially available drug (up to 370 weeks). TEAEs and SAEs are defined as any AE or SAE with onset or worsening reported by a participant from the time first dose of adalimumab is administered in Study M11-327 until 5 half-lives (70 days) have elapsed following discontinuation of adalimumab or until first dose of commercially available adalimumab post regulatory and/or reimbursement approval for treatment of uveitis in adults in their respective countries. TEAEs were collected whether elicited or spontaneously reported by the participant.
Infections and infestations CYTOMEGALOVIRUS INFECTION	0.24% 1/424 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until either 70 days after the last dose of study drug or until the first dose of commercially available drug (up to 370 weeks). TEAEs and SAEs are defined as any AE or SAE with onset or worsening reported by a participant from the time first dose of adalimumab is administered in Study M11-327 until 5 half-lives (70 days) have elapsed following discontinuation of adalimumab or until first dose of commercially available adalimumab post regulatory and/or reimbursement approval for treatment of uveitis in adults in their respective countries. TEAEs were collected whether elicited or spontaneously reported by the participant.
Infections and infestations DEVICE RELATED INFECTION	0.24% 1/424 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until either 70 days after the last dose of study drug or until the first dose of commercially available drug (up to 370 weeks). TEAEs and SAEs are defined as any AE or SAE with onset or worsening reported by a participant from the time first dose of adalimumab is administered in Study M11-327 until 5 half-lives (70 days) have elapsed following discontinuation of adalimumab or until first dose of commercially available adalimumab post regulatory and/or reimbursement approval for treatment of uveitis in adults in their respective countries. TEAEs were collected whether elicited or spontaneously reported by the participant.
Infections and infestations DIVERTICULITIS	0.47% 2/424 • Number of events 3 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until either 70 days after the last dose of study drug or until the first dose of commercially available drug (up to 370 weeks). TEAEs and SAEs are defined as any AE or SAE with onset or worsening reported by a participant from the time first dose of adalimumab is administered in Study M11-327 until 5 half-lives (70 days) have elapsed following discontinuation of adalimumab or until first dose of commercially available adalimumab post regulatory and/or reimbursement approval for treatment of uveitis in adults in their respective countries. TEAEs were collected whether elicited or spontaneously reported by the participant.
Infections and infestations ESCHERICHIA URINARY TRACT INFECTION	0.24% 1/424 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until either 70 days after the last dose of study drug or until the first dose of commercially available drug (up to 370 weeks). TEAEs and SAEs are defined as any AE or SAE with onset or worsening reported by a participant from the time first dose of adalimumab is administered in Study M11-327 until 5 half-lives (70 days) have elapsed following discontinuation of adalimumab or until first dose of commercially available adalimumab post regulatory and/or reimbursement approval for treatment of uveitis in adults in their respective countries. TEAEs were collected whether elicited or spontaneously reported by the participant.
Infections and infestations GASTROENTERITIS	0.24% 1/424 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until either 70 days after the last dose of study drug or until the first dose of commercially available drug (up to 370 weeks). TEAEs and SAEs are defined as any AE or SAE with onset or worsening reported by a participant from the time first dose of adalimumab is administered in Study M11-327 until 5 half-lives (70 days) have elapsed following discontinuation of adalimumab or until first dose of commercially available adalimumab post regulatory and/or reimbursement approval for treatment of uveitis in adults in their respective countries. TEAEs were collected whether elicited or spontaneously reported by the participant.
Infections and infestations INFECTION	0.24% 1/424 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until either 70 days after the last dose of study drug or until the first dose of commercially available drug (up to 370 weeks). TEAEs and SAEs are defined as any AE or SAE with onset or worsening reported by a participant from the time first dose of adalimumab is administered in Study M11-327 until 5 half-lives (70 days) have elapsed following discontinuation of adalimumab or until first dose of commercially available adalimumab post regulatory and/or reimbursement approval for treatment of uveitis in adults in their respective countries. TEAEs were collected whether elicited or spontaneously reported by the participant.
Infections and infestations LATENT TUBERCULOSIS	0.24% 1/424 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until either 70 days after the last dose of study drug or until the first dose of commercially available drug (up to 370 weeks). TEAEs and SAEs are defined as any AE or SAE with onset or worsening reported by a participant from the time first dose of adalimumab is administered in Study M11-327 until 5 half-lives (70 days) have elapsed following discontinuation of adalimumab or until first dose of commercially available adalimumab post regulatory and/or reimbursement approval for treatment of uveitis in adults in their respective countries. TEAEs were collected whether elicited or spontaneously reported by the participant.
Infections and infestations MENINGITIS	0.24% 1/424 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until either 70 days after the last dose of study drug or until the first dose of commercially available drug (up to 370 weeks). TEAEs and SAEs are defined as any AE or SAE with onset or worsening reported by a participant from the time first dose of adalimumab is administered in Study M11-327 until 5 half-lives (70 days) have elapsed following discontinuation of adalimumab or until first dose of commercially available adalimumab post regulatory and/or reimbursement approval for treatment of uveitis in adults in their respective countries. TEAEs were collected whether elicited or spontaneously reported by the participant.
Infections and infestations OPHTHALMIC HERPES ZOSTER	0.24% 1/424 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until either 70 days after the last dose of study drug or until the first dose of commercially available drug (up to 370 weeks). TEAEs and SAEs are defined as any AE or SAE with onset or worsening reported by a participant from the time first dose of adalimumab is administered in Study M11-327 until 5 half-lives (70 days) have elapsed following discontinuation of adalimumab or until first dose of commercially available adalimumab post regulatory and/or reimbursement approval for treatment of uveitis in adults in their respective countries. TEAEs were collected whether elicited or spontaneously reported by the participant.
Infections and infestations PERITONSILLAR ABSCESS	0.24% 1/424 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until either 70 days after the last dose of study drug or until the first dose of commercially available drug (up to 370 weeks). TEAEs and SAEs are defined as any AE or SAE with onset or worsening reported by a participant from the time first dose of adalimumab is administered in Study M11-327 until 5 half-lives (70 days) have elapsed following discontinuation of adalimumab or until first dose of commercially available adalimumab post regulatory and/or reimbursement approval for treatment of uveitis in adults in their respective countries. TEAEs were collected whether elicited or spontaneously reported by the participant.
Infections and infestations PNEUMONIA	0.71% 3/424 • Number of events 3 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until either 70 days after the last dose of study drug or until the first dose of commercially available drug (up to 370 weeks). TEAEs and SAEs are defined as any AE or SAE with onset or worsening reported by a participant from the time first dose of adalimumab is administered in Study M11-327 until 5 half-lives (70 days) have elapsed following discontinuation of adalimumab or until first dose of commercially available adalimumab post regulatory and/or reimbursement approval for treatment of uveitis in adults in their respective countries. TEAEs were collected whether elicited or spontaneously reported by the participant.
Infections and infestations PYELONEPHRITIS	0.47% 2/424 • Number of events 2 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until either 70 days after the last dose of study drug or until the first dose of commercially available drug (up to 370 weeks). TEAEs and SAEs are defined as any AE or SAE with onset or worsening reported by a participant from the time first dose of adalimumab is administered in Study M11-327 until 5 half-lives (70 days) have elapsed following discontinuation of adalimumab or until first dose of commercially available adalimumab post regulatory and/or reimbursement approval for treatment of uveitis in adults in their respective countries. TEAEs were collected whether elicited or spontaneously reported by the participant.
Infections and infestations PYONEPHROSIS	0.24% 1/424 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until either 70 days after the last dose of study drug or until the first dose of commercially available drug (up to 370 weeks). TEAEs and SAEs are defined as any AE or SAE with onset or worsening reported by a participant from the time first dose of adalimumab is administered in Study M11-327 until 5 half-lives (70 days) have elapsed following discontinuation of adalimumab or until first dose of commercially available adalimumab post regulatory and/or reimbursement approval for treatment of uveitis in adults in their respective countries. TEAEs were collected whether elicited or spontaneously reported by the participant.
Infections and infestations SEPTIC SHOCK	0.24% 1/424 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until either 70 days after the last dose of study drug or until the first dose of commercially available drug (up to 370 weeks). TEAEs and SAEs are defined as any AE or SAE with onset or worsening reported by a participant from the time first dose of adalimumab is administered in Study M11-327 until 5 half-lives (70 days) have elapsed following discontinuation of adalimumab or until first dose of commercially available adalimumab post regulatory and/or reimbursement approval for treatment of uveitis in adults in their respective countries. TEAEs were collected whether elicited or spontaneously reported by the participant.
Infections and infestations SINUSITIS	0.47% 2/424 • Number of events 2 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until either 70 days after the last dose of study drug or until the first dose of commercially available drug (up to 370 weeks). TEAEs and SAEs are defined as any AE or SAE with onset or worsening reported by a participant from the time first dose of adalimumab is administered in Study M11-327 until 5 half-lives (70 days) have elapsed following discontinuation of adalimumab or until first dose of commercially available adalimumab post regulatory and/or reimbursement approval for treatment of uveitis in adults in their respective countries. TEAEs were collected whether elicited or spontaneously reported by the participant.
Infections and infestations SINUSITIS FUNGAL	0.24% 1/424 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until either 70 days after the last dose of study drug or until the first dose of commercially available drug (up to 370 weeks). TEAEs and SAEs are defined as any AE or SAE with onset or worsening reported by a participant from the time first dose of adalimumab is administered in Study M11-327 until 5 half-lives (70 days) have elapsed following discontinuation of adalimumab or until first dose of commercially available adalimumab post regulatory and/or reimbursement approval for treatment of uveitis in adults in their respective countries. TEAEs were collected whether elicited or spontaneously reported by the participant.
Infections and infestations SOFT TISSUE INFECTION	0.24% 1/424 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until either 70 days after the last dose of study drug or until the first dose of commercially available drug (up to 370 weeks). TEAEs and SAEs are defined as any AE or SAE with onset or worsening reported by a participant from the time first dose of adalimumab is administered in Study M11-327 until 5 half-lives (70 days) have elapsed following discontinuation of adalimumab or until first dose of commercially available adalimumab post regulatory and/or reimbursement approval for treatment of uveitis in adults in their respective countries. TEAEs were collected whether elicited or spontaneously reported by the participant.
Infections and infestations SUBCUTANEOUS ABSCESS	0.24% 1/424 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until either 70 days after the last dose of study drug or until the first dose of commercially available drug (up to 370 weeks). TEAEs and SAEs are defined as any AE or SAE with onset or worsening reported by a participant from the time first dose of adalimumab is administered in Study M11-327 until 5 half-lives (70 days) have elapsed following discontinuation of adalimumab or until first dose of commercially available adalimumab post regulatory and/or reimbursement approval for treatment of uveitis in adults in their respective countries. TEAEs were collected whether elicited or spontaneously reported by the participant.
Infections and infestations TOOTH ABSCESS	0.24% 1/424 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until either 70 days after the last dose of study drug or until the first dose of commercially available drug (up to 370 weeks). TEAEs and SAEs are defined as any AE or SAE with onset or worsening reported by a participant from the time first dose of adalimumab is administered in Study M11-327 until 5 half-lives (70 days) have elapsed following discontinuation of adalimumab or until first dose of commercially available adalimumab post regulatory and/or reimbursement approval for treatment of uveitis in adults in their respective countries. TEAEs were collected whether elicited or spontaneously reported by the participant.
Infections and infestations TUBERCULOSIS	0.24% 1/424 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until either 70 days after the last dose of study drug or until the first dose of commercially available drug (up to 370 weeks). TEAEs and SAEs are defined as any AE or SAE with onset or worsening reported by a participant from the time first dose of adalimumab is administered in Study M11-327 until 5 half-lives (70 days) have elapsed following discontinuation of adalimumab or until first dose of commercially available adalimumab post regulatory and/or reimbursement approval for treatment of uveitis in adults in their respective countries. TEAEs were collected whether elicited or spontaneously reported by the participant.
Infections and infestations URINARY TRACT INFECTION	1.2% 5/424 • Number of events 5 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until either 70 days after the last dose of study drug or until the first dose of commercially available drug (up to 370 weeks). TEAEs and SAEs are defined as any AE or SAE with onset or worsening reported by a participant from the time first dose of adalimumab is administered in Study M11-327 until 5 half-lives (70 days) have elapsed following discontinuation of adalimumab or until first dose of commercially available adalimumab post regulatory and/or reimbursement approval for treatment of uveitis in adults in their respective countries. TEAEs were collected whether elicited or spontaneously reported by the participant.
Infections and infestations UROSEPSIS	0.24% 1/424 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until either 70 days after the last dose of study drug or until the first dose of commercially available drug (up to 370 weeks). TEAEs and SAEs are defined as any AE or SAE with onset or worsening reported by a participant from the time first dose of adalimumab is administered in Study M11-327 until 5 half-lives (70 days) have elapsed following discontinuation of adalimumab or until first dose of commercially available adalimumab post regulatory and/or reimbursement approval for treatment of uveitis in adults in their respective countries. TEAEs were collected whether elicited or spontaneously reported by the participant.
Injury, poisoning and procedural complications COMMINUTED FRACTURE	0.24% 1/424 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until either 70 days after the last dose of study drug or until the first dose of commercially available drug (up to 370 weeks). TEAEs and SAEs are defined as any AE or SAE with onset or worsening reported by a participant from the time first dose of adalimumab is administered in Study M11-327 until 5 half-lives (70 days) have elapsed following discontinuation of adalimumab or until first dose of commercially available adalimumab post regulatory and/or reimbursement approval for treatment of uveitis in adults in their respective countries. TEAEs were collected whether elicited or spontaneously reported by the participant.
Injury, poisoning and procedural complications CORNEAL ABRASION	0.24% 1/424 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until either 70 days after the last dose of study drug or until the first dose of commercially available drug (up to 370 weeks). TEAEs and SAEs are defined as any AE or SAE with onset or worsening reported by a participant from the time first dose of adalimumab is administered in Study M11-327 until 5 half-lives (70 days) have elapsed following discontinuation of adalimumab or until first dose of commercially available adalimumab post regulatory and/or reimbursement approval for treatment of uveitis in adults in their respective countries. TEAEs were collected whether elicited or spontaneously reported by the participant.
Injury, poisoning and procedural complications ELSCHNIG'S BODIES	0.24% 1/424 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until either 70 days after the last dose of study drug or until the first dose of commercially available drug (up to 370 weeks). TEAEs and SAEs are defined as any AE or SAE with onset or worsening reported by a participant from the time first dose of adalimumab is administered in Study M11-327 until 5 half-lives (70 days) have elapsed following discontinuation of adalimumab or until first dose of commercially available adalimumab post regulatory and/or reimbursement approval for treatment of uveitis in adults in their respective countries. TEAEs were collected whether elicited or spontaneously reported by the participant.
Injury, poisoning and procedural complications EPICONDYLITIS	0.24% 1/424 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until either 70 days after the last dose of study drug or until the first dose of commercially available drug (up to 370 weeks). TEAEs and SAEs are defined as any AE or SAE with onset or worsening reported by a participant from the time first dose of adalimumab is administered in Study M11-327 until 5 half-lives (70 days) have elapsed following discontinuation of adalimumab or until first dose of commercially available adalimumab post regulatory and/or reimbursement approval for treatment of uveitis in adults in their respective countries. TEAEs were collected whether elicited or spontaneously reported by the participant.
Injury, poisoning and procedural complications FALL	0.24% 1/424 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until either 70 days after the last dose of study drug or until the first dose of commercially available drug (up to 370 weeks). TEAEs and SAEs are defined as any AE or SAE with onset or worsening reported by a participant from the time first dose of adalimumab is administered in Study M11-327 until 5 half-lives (70 days) have elapsed following discontinuation of adalimumab or until first dose of commercially available adalimumab post regulatory and/or reimbursement approval for treatment of uveitis in adults in their respective countries. TEAEs were collected whether elicited or spontaneously reported by the participant.
Injury, poisoning and procedural complications FOREARM FRACTURE	0.24% 1/424 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until either 70 days after the last dose of study drug or until the first dose of commercially available drug (up to 370 weeks). TEAEs and SAEs are defined as any AE or SAE with onset or worsening reported by a participant from the time first dose of adalimumab is administered in Study M11-327 until 5 half-lives (70 days) have elapsed following discontinuation of adalimumab or until first dose of commercially available adalimumab post regulatory and/or reimbursement approval for treatment of uveitis in adults in their respective countries. TEAEs were collected whether elicited or spontaneously reported by the participant.
Injury, poisoning and procedural complications JOINT DISLOCATION	0.24% 1/424 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until either 70 days after the last dose of study drug or until the first dose of commercially available drug (up to 370 weeks). TEAEs and SAEs are defined as any AE or SAE with onset or worsening reported by a participant from the time first dose of adalimumab is administered in Study M11-327 until 5 half-lives (70 days) have elapsed following discontinuation of adalimumab or until first dose of commercially available adalimumab post regulatory and/or reimbursement approval for treatment of uveitis in adults in their respective countries. TEAEs were collected whether elicited or spontaneously reported by the participant.
Injury, poisoning and procedural complications LACERATION	0.24% 1/424 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until either 70 days after the last dose of study drug or until the first dose of commercially available drug (up to 370 weeks). TEAEs and SAEs are defined as any AE or SAE with onset or worsening reported by a participant from the time first dose of adalimumab is administered in Study M11-327 until 5 half-lives (70 days) have elapsed following discontinuation of adalimumab or until first dose of commercially available adalimumab post regulatory and/or reimbursement approval for treatment of uveitis in adults in their respective countries. TEAEs were collected whether elicited or spontaneously reported by the participant.
Injury, poisoning and procedural complications POST PROCEDURAL HAEMORRHAGE	0.24% 1/424 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until either 70 days after the last dose of study drug or until the first dose of commercially available drug (up to 370 weeks). TEAEs and SAEs are defined as any AE or SAE with onset or worsening reported by a participant from the time first dose of adalimumab is administered in Study M11-327 until 5 half-lives (70 days) have elapsed following discontinuation of adalimumab or until first dose of commercially available adalimumab post regulatory and/or reimbursement approval for treatment of uveitis in adults in their respective countries. TEAEs were collected whether elicited or spontaneously reported by the participant.
Injury, poisoning and procedural complications SPINAL COMPRESSION FRACTURE	0.47% 2/424 • Number of events 2 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until either 70 days after the last dose of study drug or until the first dose of commercially available drug (up to 370 weeks). TEAEs and SAEs are defined as any AE or SAE with onset or worsening reported by a participant from the time first dose of adalimumab is administered in Study M11-327 until 5 half-lives (70 days) have elapsed following discontinuation of adalimumab or until first dose of commercially available adalimumab post regulatory and/or reimbursement approval for treatment of uveitis in adults in their respective countries. TEAEs were collected whether elicited or spontaneously reported by the participant.
Injury, poisoning and procedural complications STRESS FRACTURE	0.24% 1/424 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until either 70 days after the last dose of study drug or until the first dose of commercially available drug (up to 370 weeks). TEAEs and SAEs are defined as any AE or SAE with onset or worsening reported by a participant from the time first dose of adalimumab is administered in Study M11-327 until 5 half-lives (70 days) have elapsed following discontinuation of adalimumab or until first dose of commercially available adalimumab post regulatory and/or reimbursement approval for treatment of uveitis in adults in their respective countries. TEAEs were collected whether elicited or spontaneously reported by the participant.
Injury, poisoning and procedural complications TIBIA FRACTURE	0.24% 1/424 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until either 70 days after the last dose of study drug or until the first dose of commercially available drug (up to 370 weeks). TEAEs and SAEs are defined as any AE or SAE with onset or worsening reported by a participant from the time first dose of adalimumab is administered in Study M11-327 until 5 half-lives (70 days) have elapsed following discontinuation of adalimumab or until first dose of commercially available adalimumab post regulatory and/or reimbursement approval for treatment of uveitis in adults in their respective countries. TEAEs were collected whether elicited or spontaneously reported by the participant.
Injury, poisoning and procedural complications UPPER LIMB FRACTURE	0.24% 1/424 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until either 70 days after the last dose of study drug or until the first dose of commercially available drug (up to 370 weeks). TEAEs and SAEs are defined as any AE or SAE with onset or worsening reported by a participant from the time first dose of adalimumab is administered in Study M11-327 until 5 half-lives (70 days) have elapsed following discontinuation of adalimumab or until first dose of commercially available adalimumab post regulatory and/or reimbursement approval for treatment of uveitis in adults in their respective countries. TEAEs were collected whether elicited or spontaneously reported by the participant.
Investigations CARDIAC MURMUR	0.24% 1/424 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until either 70 days after the last dose of study drug or until the first dose of commercially available drug (up to 370 weeks). TEAEs and SAEs are defined as any AE or SAE with onset or worsening reported by a participant from the time first dose of adalimumab is administered in Study M11-327 until 5 half-lives (70 days) have elapsed following discontinuation of adalimumab or until first dose of commercially available adalimumab post regulatory and/or reimbursement approval for treatment of uveitis in adults in their respective countries. TEAEs were collected whether elicited or spontaneously reported by the participant.
Investigations HEPATIC ENZYME INCREASED	0.24% 1/424 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until either 70 days after the last dose of study drug or until the first dose of commercially available drug (up to 370 weeks). TEAEs and SAEs are defined as any AE or SAE with onset or worsening reported by a participant from the time first dose of adalimumab is administered in Study M11-327 until 5 half-lives (70 days) have elapsed following discontinuation of adalimumab or until first dose of commercially available adalimumab post regulatory and/or reimbursement approval for treatment of uveitis in adults in their respective countries. TEAEs were collected whether elicited or spontaneously reported by the participant.
Investigations INTRAOCULAR PRESSURE INCREASED	0.24% 1/424 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until either 70 days after the last dose of study drug or until the first dose of commercially available drug (up to 370 weeks). TEAEs and SAEs are defined as any AE or SAE with onset or worsening reported by a participant from the time first dose of adalimumab is administered in Study M11-327 until 5 half-lives (70 days) have elapsed following discontinuation of adalimumab or until first dose of commercially available adalimumab post regulatory and/or reimbursement approval for treatment of uveitis in adults in their respective countries. TEAEs were collected whether elicited or spontaneously reported by the participant.
Investigations MYCOBACTERIUM TUBERCULOSIS COMPLEX TEST POSITIVE	0.24% 1/424 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until either 70 days after the last dose of study drug or until the first dose of commercially available drug (up to 370 weeks). TEAEs and SAEs are defined as any AE or SAE with onset or worsening reported by a participant from the time first dose of adalimumab is administered in Study M11-327 until 5 half-lives (70 days) have elapsed following discontinuation of adalimumab or until first dose of commercially available adalimumab post regulatory and/or reimbursement approval for treatment of uveitis in adults in their respective countries. TEAEs were collected whether elicited or spontaneously reported by the participant.
Investigations TUBERCULIN TEST POSITIVE	0.24% 1/424 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until either 70 days after the last dose of study drug or until the first dose of commercially available drug (up to 370 weeks). TEAEs and SAEs are defined as any AE or SAE with onset or worsening reported by a participant from the time first dose of adalimumab is administered in Study M11-327 until 5 half-lives (70 days) have elapsed following discontinuation of adalimumab or until first dose of commercially available adalimumab post regulatory and/or reimbursement approval for treatment of uveitis in adults in their respective countries. TEAEs were collected whether elicited or spontaneously reported by the participant.
Metabolism and nutrition disorders HYPOGLYCAEMIA	0.24% 1/424 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until either 70 days after the last dose of study drug or until the first dose of commercially available drug (up to 370 weeks). TEAEs and SAEs are defined as any AE or SAE with onset or worsening reported by a participant from the time first dose of adalimumab is administered in Study M11-327 until 5 half-lives (70 days) have elapsed following discontinuation of adalimumab or until first dose of commercially available adalimumab post regulatory and/or reimbursement approval for treatment of uveitis in adults in their respective countries. TEAEs were collected whether elicited or spontaneously reported by the participant.
Metabolism and nutrition disorders OBESITY	0.71% 3/424 • Number of events 3 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until either 70 days after the last dose of study drug or until the first dose of commercially available drug (up to 370 weeks). TEAEs and SAEs are defined as any AE or SAE with onset or worsening reported by a participant from the time first dose of adalimumab is administered in Study M11-327 until 5 half-lives (70 days) have elapsed following discontinuation of adalimumab or until first dose of commercially available adalimumab post regulatory and/or reimbursement approval for treatment of uveitis in adults in their respective countries. TEAEs were collected whether elicited or spontaneously reported by the participant.
Musculoskeletal and connective tissue disorders ARTHRALGIA	0.47% 2/424 • Number of events 2 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until either 70 days after the last dose of study drug or until the first dose of commercially available drug (up to 370 weeks). TEAEs and SAEs are defined as any AE or SAE with onset or worsening reported by a participant from the time first dose of adalimumab is administered in Study M11-327 until 5 half-lives (70 days) have elapsed following discontinuation of adalimumab or until first dose of commercially available adalimumab post regulatory and/or reimbursement approval for treatment of uveitis in adults in their respective countries. TEAEs were collected whether elicited or spontaneously reported by the participant.
Musculoskeletal and connective tissue disorders MUSCULOSKELETAL PAIN	0.24% 1/424 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until either 70 days after the last dose of study drug or until the first dose of commercially available drug (up to 370 weeks). TEAEs and SAEs are defined as any AE or SAE with onset or worsening reported by a participant from the time first dose of adalimumab is administered in Study M11-327 until 5 half-lives (70 days) have elapsed following discontinuation of adalimumab or until first dose of commercially available adalimumab post regulatory and/or reimbursement approval for treatment of uveitis in adults in their respective countries. TEAEs were collected whether elicited or spontaneously reported by the participant.
Musculoskeletal and connective tissue disorders MYOPATHY	0.24% 1/424 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until either 70 days after the last dose of study drug or until the first dose of commercially available drug (up to 370 weeks). TEAEs and SAEs are defined as any AE or SAE with onset or worsening reported by a participant from the time first dose of adalimumab is administered in Study M11-327 until 5 half-lives (70 days) have elapsed following discontinuation of adalimumab or until first dose of commercially available adalimumab post regulatory and/or reimbursement approval for treatment of uveitis in adults in their respective countries. TEAEs were collected whether elicited or spontaneously reported by the participant.
Musculoskeletal and connective tissue disorders OSTEOARTHRITIS	0.47% 2/424 • Number of events 2 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until either 70 days after the last dose of study drug or until the first dose of commercially available drug (up to 370 weeks). TEAEs and SAEs are defined as any AE or SAE with onset or worsening reported by a participant from the time first dose of adalimumab is administered in Study M11-327 until 5 half-lives (70 days) have elapsed following discontinuation of adalimumab or until first dose of commercially available adalimumab post regulatory and/or reimbursement approval for treatment of uveitis in adults in their respective countries. TEAEs were collected whether elicited or spontaneously reported by the participant.
Musculoskeletal and connective tissue disorders OSTEOLYSIS	0.24% 1/424 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until either 70 days after the last dose of study drug or until the first dose of commercially available drug (up to 370 weeks). TEAEs and SAEs are defined as any AE or SAE with onset or worsening reported by a participant from the time first dose of adalimumab is administered in Study M11-327 until 5 half-lives (70 days) have elapsed following discontinuation of adalimumab or until first dose of commercially available adalimumab post regulatory and/or reimbursement approval for treatment of uveitis in adults in their respective countries. TEAEs were collected whether elicited or spontaneously reported by the participant.
Musculoskeletal and connective tissue disorders PATELLOFEMORAL PAIN SYNDROME	0.24% 1/424 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until either 70 days after the last dose of study drug or until the first dose of commercially available drug (up to 370 weeks). TEAEs and SAEs are defined as any AE or SAE with onset or worsening reported by a participant from the time first dose of adalimumab is administered in Study M11-327 until 5 half-lives (70 days) have elapsed following discontinuation of adalimumab or until first dose of commercially available adalimumab post regulatory and/or reimbursement approval for treatment of uveitis in adults in their respective countries. TEAEs were collected whether elicited or spontaneously reported by the participant.
Musculoskeletal and connective tissue disorders SYNOVITIS	0.24% 1/424 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until either 70 days after the last dose of study drug or until the first dose of commercially available drug (up to 370 weeks). TEAEs and SAEs are defined as any AE or SAE with onset or worsening reported by a participant from the time first dose of adalimumab is administered in Study M11-327 until 5 half-lives (70 days) have elapsed following discontinuation of adalimumab or until first dose of commercially available adalimumab post regulatory and/or reimbursement approval for treatment of uveitis in adults in their respective countries. TEAEs were collected whether elicited or spontaneously reported by the participant.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) ADENOCARCINOMA OF COLON	0.24% 1/424 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until either 70 days after the last dose of study drug or until the first dose of commercially available drug (up to 370 weeks). TEAEs and SAEs are defined as any AE or SAE with onset or worsening reported by a participant from the time first dose of adalimumab is administered in Study M11-327 until 5 half-lives (70 days) have elapsed following discontinuation of adalimumab or until first dose of commercially available adalimumab post regulatory and/or reimbursement approval for treatment of uveitis in adults in their respective countries. TEAEs were collected whether elicited or spontaneously reported by the participant.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) B-CELL LYMPHOMA	0.24% 1/424 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until either 70 days after the last dose of study drug or until the first dose of commercially available drug (up to 370 weeks). TEAEs and SAEs are defined as any AE or SAE with onset or worsening reported by a participant from the time first dose of adalimumab is administered in Study M11-327 until 5 half-lives (70 days) have elapsed following discontinuation of adalimumab or until first dose of commercially available adalimumab post regulatory and/or reimbursement approval for treatment of uveitis in adults in their respective countries. TEAEs were collected whether elicited or spontaneously reported by the participant.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) BASAL CELL CARCINOMA	0.47% 2/424 • Number of events 2 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until either 70 days after the last dose of study drug or until the first dose of commercially available drug (up to 370 weeks). TEAEs and SAEs are defined as any AE or SAE with onset or worsening reported by a participant from the time first dose of adalimumab is administered in Study M11-327 until 5 half-lives (70 days) have elapsed following discontinuation of adalimumab or until first dose of commercially available adalimumab post regulatory and/or reimbursement approval for treatment of uveitis in adults in their respective countries. TEAEs were collected whether elicited or spontaneously reported by the participant.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) COLORECTAL CANCER	0.24% 1/424 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until either 70 days after the last dose of study drug or until the first dose of commercially available drug (up to 370 weeks). TEAEs and SAEs are defined as any AE or SAE with onset or worsening reported by a participant from the time first dose of adalimumab is administered in Study M11-327 until 5 half-lives (70 days) have elapsed following discontinuation of adalimumab or until first dose of commercially available adalimumab post regulatory and/or reimbursement approval for treatment of uveitis in adults in their respective countries. TEAEs were collected whether elicited or spontaneously reported by the participant.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) LOBULAR BREAST CARCINOMA IN SITU	0.24% 1/424 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until either 70 days after the last dose of study drug or until the first dose of commercially available drug (up to 370 weeks). TEAEs and SAEs are defined as any AE or SAE with onset or worsening reported by a participant from the time first dose of adalimumab is administered in Study M11-327 until 5 half-lives (70 days) have elapsed following discontinuation of adalimumab or until first dose of commercially available adalimumab post regulatory and/or reimbursement approval for treatment of uveitis in adults in their respective countries. TEAEs were collected whether elicited or spontaneously reported by the participant.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) PANCREATIC CARCINOMA METASTATIC	0.24% 1/424 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until either 70 days after the last dose of study drug or until the first dose of commercially available drug (up to 370 weeks). TEAEs and SAEs are defined as any AE or SAE with onset or worsening reported by a participant from the time first dose of adalimumab is administered in Study M11-327 until 5 half-lives (70 days) have elapsed following discontinuation of adalimumab or until first dose of commercially available adalimumab post regulatory and/or reimbursement approval for treatment of uveitis in adults in their respective countries. TEAEs were collected whether elicited or spontaneously reported by the participant.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) RECTAL ADENOCARCINOMA	0.24% 1/424 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until either 70 days after the last dose of study drug or until the first dose of commercially available drug (up to 370 weeks). TEAEs and SAEs are defined as any AE or SAE with onset or worsening reported by a participant from the time first dose of adalimumab is administered in Study M11-327 until 5 half-lives (70 days) have elapsed following discontinuation of adalimumab or until first dose of commercially available adalimumab post regulatory and/or reimbursement approval for treatment of uveitis in adults in their respective countries. TEAEs were collected whether elicited or spontaneously reported by the participant.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) SQUAMOUS CELL CARCINOMA OF SKIN	0.24% 1/424 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until either 70 days after the last dose of study drug or until the first dose of commercially available drug (up to 370 weeks). TEAEs and SAEs are defined as any AE or SAE with onset or worsening reported by a participant from the time first dose of adalimumab is administered in Study M11-327 until 5 half-lives (70 days) have elapsed following discontinuation of adalimumab or until first dose of commercially available adalimumab post regulatory and/or reimbursement approval for treatment of uveitis in adults in their respective countries. TEAEs were collected whether elicited or spontaneously reported by the participant.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) UTERINE LEIOMYOMA	0.24% 1/424 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until either 70 days after the last dose of study drug or until the first dose of commercially available drug (up to 370 weeks). TEAEs and SAEs are defined as any AE or SAE with onset or worsening reported by a participant from the time first dose of adalimumab is administered in Study M11-327 until 5 half-lives (70 days) have elapsed following discontinuation of adalimumab or until first dose of commercially available adalimumab post regulatory and/or reimbursement approval for treatment of uveitis in adults in their respective countries. TEAEs were collected whether elicited or spontaneously reported by the participant.
Nervous system disorders ATAXIA	0.24% 1/424 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until either 70 days after the last dose of study drug or until the first dose of commercially available drug (up to 370 weeks). TEAEs and SAEs are defined as any AE or SAE with onset or worsening reported by a participant from the time first dose of adalimumab is administered in Study M11-327 until 5 half-lives (70 days) have elapsed following discontinuation of adalimumab or until first dose of commercially available adalimumab post regulatory and/or reimbursement approval for treatment of uveitis in adults in their respective countries. TEAEs were collected whether elicited or spontaneously reported by the participant.
Nervous system disorders DEMYELINATION	0.24% 1/424 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until either 70 days after the last dose of study drug or until the first dose of commercially available drug (up to 370 weeks). TEAEs and SAEs are defined as any AE or SAE with onset or worsening reported by a participant from the time first dose of adalimumab is administered in Study M11-327 until 5 half-lives (70 days) have elapsed following discontinuation of adalimumab or until first dose of commercially available adalimumab post regulatory and/or reimbursement approval for treatment of uveitis in adults in their respective countries. TEAEs were collected whether elicited or spontaneously reported by the participant.
Nervous system disorders ENCEPHALITIS AUTOIMMUNE	0.24% 1/424 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until either 70 days after the last dose of study drug or until the first dose of commercially available drug (up to 370 weeks). TEAEs and SAEs are defined as any AE or SAE with onset or worsening reported by a participant from the time first dose of adalimumab is administered in Study M11-327 until 5 half-lives (70 days) have elapsed following discontinuation of adalimumab or until first dose of commercially available adalimumab post regulatory and/or reimbursement approval for treatment of uveitis in adults in their respective countries. TEAEs were collected whether elicited or spontaneously reported by the participant.
Nervous system disorders MULTIPLE SCLEROSIS	0.47% 2/424 • Number of events 2 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until either 70 days after the last dose of study drug or until the first dose of commercially available drug (up to 370 weeks). TEAEs and SAEs are defined as any AE or SAE with onset or worsening reported by a participant from the time first dose of adalimumab is administered in Study M11-327 until 5 half-lives (70 days) have elapsed following discontinuation of adalimumab or until first dose of commercially available adalimumab post regulatory and/or reimbursement approval for treatment of uveitis in adults in their respective countries. TEAEs were collected whether elicited or spontaneously reported by the participant.
Nervous system disorders TENSION HEADACHE	0.24% 1/424 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until either 70 days after the last dose of study drug or until the first dose of commercially available drug (up to 370 weeks). TEAEs and SAEs are defined as any AE or SAE with onset or worsening reported by a participant from the time first dose of adalimumab is administered in Study M11-327 until 5 half-lives (70 days) have elapsed following discontinuation of adalimumab or until first dose of commercially available adalimumab post regulatory and/or reimbursement approval for treatment of uveitis in adults in their respective countries. TEAEs were collected whether elicited or spontaneously reported by the participant.
Nervous system disorders TRANSIENT ISCHAEMIC ATTACK	0.24% 1/424 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until either 70 days after the last dose of study drug or until the first dose of commercially available drug (up to 370 weeks). TEAEs and SAEs are defined as any AE or SAE with onset or worsening reported by a participant from the time first dose of adalimumab is administered in Study M11-327 until 5 half-lives (70 days) have elapsed following discontinuation of adalimumab or until first dose of commercially available adalimumab post regulatory and/or reimbursement approval for treatment of uveitis in adults in their respective countries. TEAEs were collected whether elicited or spontaneously reported by the participant.
Pregnancy, puerperium and perinatal conditions ECTOPIC PREGNANCY	0.24% 1/424 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until either 70 days after the last dose of study drug or until the first dose of commercially available drug (up to 370 weeks). TEAEs and SAEs are defined as any AE or SAE with onset or worsening reported by a participant from the time first dose of adalimumab is administered in Study M11-327 until 5 half-lives (70 days) have elapsed following discontinuation of adalimumab or until first dose of commercially available adalimumab post regulatory and/or reimbursement approval for treatment of uveitis in adults in their respective countries. TEAEs were collected whether elicited or spontaneously reported by the participant.
Pregnancy, puerperium and perinatal conditions HYPEREMESIS GRAVIDARUM	0.24% 1/424 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until either 70 days after the last dose of study drug or until the first dose of commercially available drug (up to 370 weeks). TEAEs and SAEs are defined as any AE or SAE with onset or worsening reported by a participant from the time first dose of adalimumab is administered in Study M11-327 until 5 half-lives (70 days) have elapsed following discontinuation of adalimumab or until first dose of commercially available adalimumab post regulatory and/or reimbursement approval for treatment of uveitis in adults in their respective countries. TEAEs were collected whether elicited or spontaneously reported by the participant.
Product Issues DEVICE DISLOCATION	0.24% 1/424 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until either 70 days after the last dose of study drug or until the first dose of commercially available drug (up to 370 weeks). TEAEs and SAEs are defined as any AE or SAE with onset or worsening reported by a participant from the time first dose of adalimumab is administered in Study M11-327 until 5 half-lives (70 days) have elapsed following discontinuation of adalimumab or until first dose of commercially available adalimumab post regulatory and/or reimbursement approval for treatment of uveitis in adults in their respective countries. TEAEs were collected whether elicited or spontaneously reported by the participant.
Renal and urinary disorders ACUTE KIDNEY INJURY	0.24% 1/424 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until either 70 days after the last dose of study drug or until the first dose of commercially available drug (up to 370 weeks). TEAEs and SAEs are defined as any AE or SAE with onset or worsening reported by a participant from the time first dose of adalimumab is administered in Study M11-327 until 5 half-lives (70 days) have elapsed following discontinuation of adalimumab or until first dose of commercially available adalimumab post regulatory and/or reimbursement approval for treatment of uveitis in adults in their respective countries. TEAEs were collected whether elicited or spontaneously reported by the participant.
Renal and urinary disorders BLADDER DIVERTICULUM	0.24% 1/424 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until either 70 days after the last dose of study drug or until the first dose of commercially available drug (up to 370 weeks). TEAEs and SAEs are defined as any AE or SAE with onset or worsening reported by a participant from the time first dose of adalimumab is administered in Study M11-327 until 5 half-lives (70 days) have elapsed following discontinuation of adalimumab or until first dose of commercially available adalimumab post regulatory and/or reimbursement approval for treatment of uveitis in adults in their respective countries. TEAEs were collected whether elicited or spontaneously reported by the participant.
Renal and urinary disorders MICTURITION DISORDER	0.24% 1/424 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until either 70 days after the last dose of study drug or until the first dose of commercially available drug (up to 370 weeks). TEAEs and SAEs are defined as any AE or SAE with onset or worsening reported by a participant from the time first dose of adalimumab is administered in Study M11-327 until 5 half-lives (70 days) have elapsed following discontinuation of adalimumab or until first dose of commercially available adalimumab post regulatory and/or reimbursement approval for treatment of uveitis in adults in their respective countries. TEAEs were collected whether elicited or spontaneously reported by the participant.
Renal and urinary disorders NEPHROLITHIASIS	0.47% 2/424 • Number of events 4 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until either 70 days after the last dose of study drug or until the first dose of commercially available drug (up to 370 weeks). TEAEs and SAEs are defined as any AE or SAE with onset or worsening reported by a participant from the time first dose of adalimumab is administered in Study M11-327 until 5 half-lives (70 days) have elapsed following discontinuation of adalimumab or until first dose of commercially available adalimumab post regulatory and/or reimbursement approval for treatment of uveitis in adults in their respective countries. TEAEs were collected whether elicited or spontaneously reported by the participant.
Renal and urinary disorders RENAL COLIC	0.24% 1/424 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until either 70 days after the last dose of study drug or until the first dose of commercially available drug (up to 370 weeks). TEAEs and SAEs are defined as any AE or SAE with onset or worsening reported by a participant from the time first dose of adalimumab is administered in Study M11-327 until 5 half-lives (70 days) have elapsed following discontinuation of adalimumab or until first dose of commercially available adalimumab post regulatory and/or reimbursement approval for treatment of uveitis in adults in their respective countries. TEAEs were collected whether elicited or spontaneously reported by the participant.
Renal and urinary disorders URETEROLITHIASIS	0.24% 1/424 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until either 70 days after the last dose of study drug or until the first dose of commercially available drug (up to 370 weeks). TEAEs and SAEs are defined as any AE or SAE with onset or worsening reported by a participant from the time first dose of adalimumab is administered in Study M11-327 until 5 half-lives (70 days) have elapsed following discontinuation of adalimumab or until first dose of commercially available adalimumab post regulatory and/or reimbursement approval for treatment of uveitis in adults in their respective countries. TEAEs were collected whether elicited or spontaneously reported by the participant.
Reproductive system and breast disorders CYSTOCELE	0.24% 1/424 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until either 70 days after the last dose of study drug or until the first dose of commercially available drug (up to 370 weeks). TEAEs and SAEs are defined as any AE or SAE with onset or worsening reported by a participant from the time first dose of adalimumab is administered in Study M11-327 until 5 half-lives (70 days) have elapsed following discontinuation of adalimumab or until first dose of commercially available adalimumab post regulatory and/or reimbursement approval for treatment of uveitis in adults in their respective countries. TEAEs were collected whether elicited or spontaneously reported by the participant.
Reproductive system and breast disorders HYDROCELE FEMALE	0.24% 1/424 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until either 70 days after the last dose of study drug or until the first dose of commercially available drug (up to 370 weeks). TEAEs and SAEs are defined as any AE or SAE with onset or worsening reported by a participant from the time first dose of adalimumab is administered in Study M11-327 until 5 half-lives (70 days) have elapsed following discontinuation of adalimumab or until first dose of commercially available adalimumab post regulatory and/or reimbursement approval for treatment of uveitis in adults in their respective countries. TEAEs were collected whether elicited or spontaneously reported by the participant.
Reproductive system and breast disorders RECTOCELE	0.24% 1/424 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until either 70 days after the last dose of study drug or until the first dose of commercially available drug (up to 370 weeks). TEAEs and SAEs are defined as any AE or SAE with onset or worsening reported by a participant from the time first dose of adalimumab is administered in Study M11-327 until 5 half-lives (70 days) have elapsed following discontinuation of adalimumab or until first dose of commercially available adalimumab post regulatory and/or reimbursement approval for treatment of uveitis in adults in their respective countries. TEAEs were collected whether elicited or spontaneously reported by the participant.
Reproductive system and breast disorders VAGINAL HAEMORRHAGE	0.24% 1/424 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until either 70 days after the last dose of study drug or until the first dose of commercially available drug (up to 370 weeks). TEAEs and SAEs are defined as any AE or SAE with onset or worsening reported by a participant from the time first dose of adalimumab is administered in Study M11-327 until 5 half-lives (70 days) have elapsed following discontinuation of adalimumab or until first dose of commercially available adalimumab post regulatory and/or reimbursement approval for treatment of uveitis in adults in their respective countries. TEAEs were collected whether elicited or spontaneously reported by the participant.
Respiratory, thoracic and mediastinal disorders ACUTE RESPIRATORY FAILURE	0.24% 1/424 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until either 70 days after the last dose of study drug or until the first dose of commercially available drug (up to 370 weeks). TEAEs and SAEs are defined as any AE or SAE with onset or worsening reported by a participant from the time first dose of adalimumab is administered in Study M11-327 until 5 half-lives (70 days) have elapsed following discontinuation of adalimumab or until first dose of commercially available adalimumab post regulatory and/or reimbursement approval for treatment of uveitis in adults in their respective countries. TEAEs were collected whether elicited or spontaneously reported by the participant.
Respiratory, thoracic and mediastinal disorders NASAL POLYPS	0.24% 1/424 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until either 70 days after the last dose of study drug or until the first dose of commercially available drug (up to 370 weeks). TEAEs and SAEs are defined as any AE or SAE with onset or worsening reported by a participant from the time first dose of adalimumab is administered in Study M11-327 until 5 half-lives (70 days) have elapsed following discontinuation of adalimumab or until first dose of commercially available adalimumab post regulatory and/or reimbursement approval for treatment of uveitis in adults in their respective countries. TEAEs were collected whether elicited or spontaneously reported by the participant.
Respiratory, thoracic and mediastinal disorders PLEURAL EFFUSION	0.24% 1/424 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until either 70 days after the last dose of study drug or until the first dose of commercially available drug (up to 370 weeks). TEAEs and SAEs are defined as any AE or SAE with onset or worsening reported by a participant from the time first dose of adalimumab is administered in Study M11-327 until 5 half-lives (70 days) have elapsed following discontinuation of adalimumab or until first dose of commercially available adalimumab post regulatory and/or reimbursement approval for treatment of uveitis in adults in their respective countries. TEAEs were collected whether elicited or spontaneously reported by the participant.
Respiratory, thoracic and mediastinal disorders PNEUMOTHORAX	0.24% 1/424 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until either 70 days after the last dose of study drug or until the first dose of commercially available drug (up to 370 weeks). TEAEs and SAEs are defined as any AE or SAE with onset or worsening reported by a participant from the time first dose of adalimumab is administered in Study M11-327 until 5 half-lives (70 days) have elapsed following discontinuation of adalimumab or until first dose of commercially available adalimumab post regulatory and/or reimbursement approval for treatment of uveitis in adults in their respective countries. TEAEs were collected whether elicited or spontaneously reported by the participant.
Respiratory, thoracic and mediastinal disorders PULMONARY EMBOLISM	0.24% 1/424 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until either 70 days after the last dose of study drug or until the first dose of commercially available drug (up to 370 weeks). TEAEs and SAEs are defined as any AE or SAE with onset or worsening reported by a participant from the time first dose of adalimumab is administered in Study M11-327 until 5 half-lives (70 days) have elapsed following discontinuation of adalimumab or until first dose of commercially available adalimumab post regulatory and/or reimbursement approval for treatment of uveitis in adults in their respective countries. TEAEs were collected whether elicited or spontaneously reported by the participant.
Respiratory, thoracic and mediastinal disorders PULMONARY FIBROSIS	0.24% 1/424 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until either 70 days after the last dose of study drug or until the first dose of commercially available drug (up to 370 weeks). TEAEs and SAEs are defined as any AE or SAE with onset or worsening reported by a participant from the time first dose of adalimumab is administered in Study M11-327 until 5 half-lives (70 days) have elapsed following discontinuation of adalimumab or until first dose of commercially available adalimumab post regulatory and/or reimbursement approval for treatment of uveitis in adults in their respective countries. TEAEs were collected whether elicited or spontaneously reported by the participant.
Respiratory, thoracic and mediastinal disorders SLEEP APNOEA SYNDROME	0.24% 1/424 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until either 70 days after the last dose of study drug or until the first dose of commercially available drug (up to 370 weeks). TEAEs and SAEs are defined as any AE or SAE with onset or worsening reported by a participant from the time first dose of adalimumab is administered in Study M11-327 until 5 half-lives (70 days) have elapsed following discontinuation of adalimumab or until first dose of commercially available adalimumab post regulatory and/or reimbursement approval for treatment of uveitis in adults in their respective countries. TEAEs were collected whether elicited or spontaneously reported by the participant.
Skin and subcutaneous tissue disorders INGROWING NAIL	0.24% 1/424 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until either 70 days after the last dose of study drug or until the first dose of commercially available drug (up to 370 weeks). TEAEs and SAEs are defined as any AE or SAE with onset or worsening reported by a participant from the time first dose of adalimumab is administered in Study M11-327 until 5 half-lives (70 days) have elapsed following discontinuation of adalimumab or until first dose of commercially available adalimumab post regulatory and/or reimbursement approval for treatment of uveitis in adults in their respective countries. TEAEs were collected whether elicited or spontaneously reported by the participant.
Vascular disorders AORTIC DILATATION	0.24% 1/424 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until either 70 days after the last dose of study drug or until the first dose of commercially available drug (up to 370 weeks). TEAEs and SAEs are defined as any AE or SAE with onset or worsening reported by a participant from the time first dose of adalimumab is administered in Study M11-327 until 5 half-lives (70 days) have elapsed following discontinuation of adalimumab or until first dose of commercially available adalimumab post regulatory and/or reimbursement approval for treatment of uveitis in adults in their respective countries. TEAEs were collected whether elicited or spontaneously reported by the participant.
Vascular disorders BEHCET'S SYNDROME	0.24% 1/424 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until either 70 days after the last dose of study drug or until the first dose of commercially available drug (up to 370 weeks). TEAEs and SAEs are defined as any AE or SAE with onset or worsening reported by a participant from the time first dose of adalimumab is administered in Study M11-327 until 5 half-lives (70 days) have elapsed following discontinuation of adalimumab or until first dose of commercially available adalimumab post regulatory and/or reimbursement approval for treatment of uveitis in adults in their respective countries. TEAEs were collected whether elicited or spontaneously reported by the participant.
Vascular disorders HYPERTENSION	0.24% 1/424 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until either 70 days after the last dose of study drug or until the first dose of commercially available drug (up to 370 weeks). TEAEs and SAEs are defined as any AE or SAE with onset or worsening reported by a participant from the time first dose of adalimumab is administered in Study M11-327 until 5 half-lives (70 days) have elapsed following discontinuation of adalimumab or until first dose of commercially available adalimumab post regulatory and/or reimbursement approval for treatment of uveitis in adults in their respective countries. TEAEs were collected whether elicited or spontaneously reported by the participant.

Other adverse events

Other adverse events
Measure	Adalimumab n=424 participants at risk Participants received open label (OL) adalimumab 40 mg by subcutaneous (SC) injection every other week (eow) until the final visit.
Eye disorders CATARACT	7.1% 30/424 • Number of events 38 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until either 70 days after the last dose of study drug or until the first dose of commercially available drug (up to 370 weeks). TEAEs and SAEs are defined as any AE or SAE with onset or worsening reported by a participant from the time first dose of adalimumab is administered in Study M11-327 until 5 half-lives (70 days) have elapsed following discontinuation of adalimumab or until first dose of commercially available adalimumab post regulatory and/or reimbursement approval for treatment of uveitis in adults in their respective countries. TEAEs were collected whether elicited or spontaneously reported by the participant.
Eye disorders CYSTOID MACULAR OEDEMA	10.1% 43/424 • Number of events 70 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until either 70 days after the last dose of study drug or until the first dose of commercially available drug (up to 370 weeks). TEAEs and SAEs are defined as any AE or SAE with onset or worsening reported by a participant from the time first dose of adalimumab is administered in Study M11-327 until 5 half-lives (70 days) have elapsed following discontinuation of adalimumab or until first dose of commercially available adalimumab post regulatory and/or reimbursement approval for treatment of uveitis in adults in their respective countries. TEAEs were collected whether elicited or spontaneously reported by the participant.
Eye disorders DRY EYE	7.1% 30/424 • Number of events 33 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until either 70 days after the last dose of study drug or until the first dose of commercially available drug (up to 370 weeks). TEAEs and SAEs are defined as any AE or SAE with onset or worsening reported by a participant from the time first dose of adalimumab is administered in Study M11-327 until 5 half-lives (70 days) have elapsed following discontinuation of adalimumab or until first dose of commercially available adalimumab post regulatory and/or reimbursement approval for treatment of uveitis in adults in their respective countries. TEAEs were collected whether elicited or spontaneously reported by the participant.
Eye disorders EYE PAIN	5.9% 25/424 • Number of events 27 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until either 70 days after the last dose of study drug or until the first dose of commercially available drug (up to 370 weeks). TEAEs and SAEs are defined as any AE or SAE with onset or worsening reported by a participant from the time first dose of adalimumab is administered in Study M11-327 until 5 half-lives (70 days) have elapsed following discontinuation of adalimumab or until first dose of commercially available adalimumab post regulatory and/or reimbursement approval for treatment of uveitis in adults in their respective countries. TEAEs were collected whether elicited or spontaneously reported by the participant.
Eye disorders IRIDOCYCLITIS	5.2% 22/424 • Number of events 29 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until either 70 days after the last dose of study drug or until the first dose of commercially available drug (up to 370 weeks). TEAEs and SAEs are defined as any AE or SAE with onset or worsening reported by a participant from the time first dose of adalimumab is administered in Study M11-327 until 5 half-lives (70 days) have elapsed following discontinuation of adalimumab or until first dose of commercially available adalimumab post regulatory and/or reimbursement approval for treatment of uveitis in adults in their respective countries. TEAEs were collected whether elicited or spontaneously reported by the participant.
Eye disorders MACULAR OEDEMA	5.7% 24/424 • Number of events 31 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until either 70 days after the last dose of study drug or until the first dose of commercially available drug (up to 370 weeks). TEAEs and SAEs are defined as any AE or SAE with onset or worsening reported by a participant from the time first dose of adalimumab is administered in Study M11-327 until 5 half-lives (70 days) have elapsed following discontinuation of adalimumab or until first dose of commercially available adalimumab post regulatory and/or reimbursement approval for treatment of uveitis in adults in their respective countries. TEAEs were collected whether elicited or spontaneously reported by the participant.
Eye disorders UVEITIS	29.0% 123/424 • Number of events 217 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until either 70 days after the last dose of study drug or until the first dose of commercially available drug (up to 370 weeks). TEAEs and SAEs are defined as any AE or SAE with onset or worsening reported by a participant from the time first dose of adalimumab is administered in Study M11-327 until 5 half-lives (70 days) have elapsed following discontinuation of adalimumab or until first dose of commercially available adalimumab post regulatory and/or reimbursement approval for treatment of uveitis in adults in their respective countries. TEAEs were collected whether elicited or spontaneously reported by the participant.
Eye disorders VISUAL ACUITY REDUCED	7.1% 30/424 • Number of events 36 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until either 70 days after the last dose of study drug or until the first dose of commercially available drug (up to 370 weeks). TEAEs and SAEs are defined as any AE or SAE with onset or worsening reported by a participant from the time first dose of adalimumab is administered in Study M11-327 until 5 half-lives (70 days) have elapsed following discontinuation of adalimumab or until first dose of commercially available adalimumab post regulatory and/or reimbursement approval for treatment of uveitis in adults in their respective countries. TEAEs were collected whether elicited or spontaneously reported by the participant.
Gastrointestinal disorders DIARRHOEA	6.6% 28/424 • Number of events 33 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until either 70 days after the last dose of study drug or until the first dose of commercially available drug (up to 370 weeks). TEAEs and SAEs are defined as any AE or SAE with onset or worsening reported by a participant from the time first dose of adalimumab is administered in Study M11-327 until 5 half-lives (70 days) have elapsed following discontinuation of adalimumab or until first dose of commercially available adalimumab post regulatory and/or reimbursement approval for treatment of uveitis in adults in their respective countries. TEAEs were collected whether elicited or spontaneously reported by the participant.
Gastrointestinal disorders NAUSEA	7.5% 32/424 • Number of events 45 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until either 70 days after the last dose of study drug or until the first dose of commercially available drug (up to 370 weeks). TEAEs and SAEs are defined as any AE or SAE with onset or worsening reported by a participant from the time first dose of adalimumab is administered in Study M11-327 until 5 half-lives (70 days) have elapsed following discontinuation of adalimumab or until first dose of commercially available adalimumab post regulatory and/or reimbursement approval for treatment of uveitis in adults in their respective countries. TEAEs were collected whether elicited or spontaneously reported by the participant.
General disorders FATIGUE	8.5% 36/424 • Number of events 42 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until either 70 days after the last dose of study drug or until the first dose of commercially available drug (up to 370 weeks). TEAEs and SAEs are defined as any AE or SAE with onset or worsening reported by a participant from the time first dose of adalimumab is administered in Study M11-327 until 5 half-lives (70 days) have elapsed following discontinuation of adalimumab or until first dose of commercially available adalimumab post regulatory and/or reimbursement approval for treatment of uveitis in adults in their respective countries. TEAEs were collected whether elicited or spontaneously reported by the participant.
General disorders PYREXIA	5.7% 24/424 • Number of events 28 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until either 70 days after the last dose of study drug or until the first dose of commercially available drug (up to 370 weeks). TEAEs and SAEs are defined as any AE or SAE with onset or worsening reported by a participant from the time first dose of adalimumab is administered in Study M11-327 until 5 half-lives (70 days) have elapsed following discontinuation of adalimumab or until first dose of commercially available adalimumab post regulatory and/or reimbursement approval for treatment of uveitis in adults in their respective countries. TEAEs were collected whether elicited or spontaneously reported by the participant.
Infections and infestations BRONCHITIS	9.0% 38/424 • Number of events 50 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until either 70 days after the last dose of study drug or until the first dose of commercially available drug (up to 370 weeks). TEAEs and SAEs are defined as any AE or SAE with onset or worsening reported by a participant from the time first dose of adalimumab is administered in Study M11-327 until 5 half-lives (70 days) have elapsed following discontinuation of adalimumab or until first dose of commercially available adalimumab post regulatory and/or reimbursement approval for treatment of uveitis in adults in their respective countries. TEAEs were collected whether elicited or spontaneously reported by the participant.
Infections and infestations INFLUENZA	8.5% 36/424 • Number of events 44 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until either 70 days after the last dose of study drug or until the first dose of commercially available drug (up to 370 weeks). TEAEs and SAEs are defined as any AE or SAE with onset or worsening reported by a participant from the time first dose of adalimumab is administered in Study M11-327 until 5 half-lives (70 days) have elapsed following discontinuation of adalimumab or until first dose of commercially available adalimumab post regulatory and/or reimbursement approval for treatment of uveitis in adults in their respective countries. TEAEs were collected whether elicited or spontaneously reported by the participant.
Infections and infestations NASOPHARYNGITIS	24.8% 105/424 • Number of events 214 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until either 70 days after the last dose of study drug or until the first dose of commercially available drug (up to 370 weeks). TEAEs and SAEs are defined as any AE or SAE with onset or worsening reported by a participant from the time first dose of adalimumab is administered in Study M11-327 until 5 half-lives (70 days) have elapsed following discontinuation of adalimumab or until first dose of commercially available adalimumab post regulatory and/or reimbursement approval for treatment of uveitis in adults in their respective countries. TEAEs were collected whether elicited or spontaneously reported by the participant.
Infections and infestations SINUSITIS	7.8% 33/424 • Number of events 43 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until either 70 days after the last dose of study drug or until the first dose of commercially available drug (up to 370 weeks). TEAEs and SAEs are defined as any AE or SAE with onset or worsening reported by a participant from the time first dose of adalimumab is administered in Study M11-327 until 5 half-lives (70 days) have elapsed following discontinuation of adalimumab or until first dose of commercially available adalimumab post regulatory and/or reimbursement approval for treatment of uveitis in adults in their respective countries. TEAEs were collected whether elicited or spontaneously reported by the participant.
Infections and infestations UPPER RESPIRATORY TRACT INFECTION	10.1% 43/424 • Number of events 65 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until either 70 days after the last dose of study drug or until the first dose of commercially available drug (up to 370 weeks). TEAEs and SAEs are defined as any AE or SAE with onset or worsening reported by a participant from the time first dose of adalimumab is administered in Study M11-327 until 5 half-lives (70 days) have elapsed following discontinuation of adalimumab or until first dose of commercially available adalimumab post regulatory and/or reimbursement approval for treatment of uveitis in adults in their respective countries. TEAEs were collected whether elicited or spontaneously reported by the participant.
Infections and infestations URINARY TRACT INFECTION	11.1% 47/424 • Number of events 66 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until either 70 days after the last dose of study drug or until the first dose of commercially available drug (up to 370 weeks). TEAEs and SAEs are defined as any AE or SAE with onset or worsening reported by a participant from the time first dose of adalimumab is administered in Study M11-327 until 5 half-lives (70 days) have elapsed following discontinuation of adalimumab or until first dose of commercially available adalimumab post regulatory and/or reimbursement approval for treatment of uveitis in adults in their respective countries. TEAEs were collected whether elicited or spontaneously reported by the participant.
Investigations INTRAOCULAR PRESSURE INCREASED	5.4% 23/424 • Number of events 30 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until either 70 days after the last dose of study drug or until the first dose of commercially available drug (up to 370 weeks). TEAEs and SAEs are defined as any AE or SAE with onset or worsening reported by a participant from the time first dose of adalimumab is administered in Study M11-327 until 5 half-lives (70 days) have elapsed following discontinuation of adalimumab or until first dose of commercially available adalimumab post regulatory and/or reimbursement approval for treatment of uveitis in adults in their respective countries. TEAEs were collected whether elicited or spontaneously reported by the participant.
Musculoskeletal and connective tissue disorders ARTHRALGIA	17.0% 72/424 • Number of events 94 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until either 70 days after the last dose of study drug or until the first dose of commercially available drug (up to 370 weeks). TEAEs and SAEs are defined as any AE or SAE with onset or worsening reported by a participant from the time first dose of adalimumab is administered in Study M11-327 until 5 half-lives (70 days) have elapsed following discontinuation of adalimumab or until first dose of commercially available adalimumab post regulatory and/or reimbursement approval for treatment of uveitis in adults in their respective countries. TEAEs were collected whether elicited or spontaneously reported by the participant.
Musculoskeletal and connective tissue disorders BACK PAIN	6.1% 26/424 • Number of events 30 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until either 70 days after the last dose of study drug or until the first dose of commercially available drug (up to 370 weeks). TEAEs and SAEs are defined as any AE or SAE with onset or worsening reported by a participant from the time first dose of adalimumab is administered in Study M11-327 until 5 half-lives (70 days) have elapsed following discontinuation of adalimumab or until first dose of commercially available adalimumab post regulatory and/or reimbursement approval for treatment of uveitis in adults in their respective countries. TEAEs were collected whether elicited or spontaneously reported by the participant.
Musculoskeletal and connective tissue disorders PAIN IN EXTREMITY	5.7% 24/424 • Number of events 25 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until either 70 days after the last dose of study drug or until the first dose of commercially available drug (up to 370 weeks). TEAEs and SAEs are defined as any AE or SAE with onset or worsening reported by a participant from the time first dose of adalimumab is administered in Study M11-327 until 5 half-lives (70 days) have elapsed following discontinuation of adalimumab or until first dose of commercially available adalimumab post regulatory and/or reimbursement approval for treatment of uveitis in adults in their respective countries. TEAEs were collected whether elicited or spontaneously reported by the participant.
Nervous system disorders HEADACHE	14.9% 63/424 • Number of events 83 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until either 70 days after the last dose of study drug or until the first dose of commercially available drug (up to 370 weeks). TEAEs and SAEs are defined as any AE or SAE with onset or worsening reported by a participant from the time first dose of adalimumab is administered in Study M11-327 until 5 half-lives (70 days) have elapsed following discontinuation of adalimumab or until first dose of commercially available adalimumab post regulatory and/or reimbursement approval for treatment of uveitis in adults in their respective countries. TEAEs were collected whether elicited or spontaneously reported by the participant.
Respiratory, thoracic and mediastinal disorders COUGH	9.9% 42/424 • Number of events 45 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until either 70 days after the last dose of study drug or until the first dose of commercially available drug (up to 370 weeks). TEAEs and SAEs are defined as any AE or SAE with onset or worsening reported by a participant from the time first dose of adalimumab is administered in Study M11-327 until 5 half-lives (70 days) have elapsed following discontinuation of adalimumab or until first dose of commercially available adalimumab post regulatory and/or reimbursement approval for treatment of uveitis in adults in their respective countries. TEAEs were collected whether elicited or spontaneously reported by the participant.
Respiratory, thoracic and mediastinal disorders OROPHARYNGEAL PAIN	7.5% 32/424 • Number of events 39 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until either 70 days after the last dose of study drug or until the first dose of commercially available drug (up to 370 weeks). TEAEs and SAEs are defined as any AE or SAE with onset or worsening reported by a participant from the time first dose of adalimumab is administered in Study M11-327 until 5 half-lives (70 days) have elapsed following discontinuation of adalimumab or until first dose of commercially available adalimumab post regulatory and/or reimbursement approval for treatment of uveitis in adults in their respective countries. TEAEs were collected whether elicited or spontaneously reported by the participant.
Skin and subcutaneous tissue disorders RASH	5.7% 24/424 • Number of events 30 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until either 70 days after the last dose of study drug or until the first dose of commercially available drug (up to 370 weeks). TEAEs and SAEs are defined as any AE or SAE with onset or worsening reported by a participant from the time first dose of adalimumab is administered in Study M11-327 until 5 half-lives (70 days) have elapsed following discontinuation of adalimumab or until first dose of commercially available adalimumab post regulatory and/or reimbursement approval for treatment of uveitis in adults in their respective countries. TEAEs were collected whether elicited or spontaneously reported by the participant.
Vascular disorders HYPERTENSION	6.4% 27/424 • Number of events 28 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until either 70 days after the last dose of study drug or until the first dose of commercially available drug (up to 370 weeks). TEAEs and SAEs are defined as any AE or SAE with onset or worsening reported by a participant from the time first dose of adalimumab is administered in Study M11-327 until 5 half-lives (70 days) have elapsed following discontinuation of adalimumab or until first dose of commercially available adalimumab post regulatory and/or reimbursement approval for treatment of uveitis in adults in their respective countries. TEAEs were collected whether elicited or spontaneously reported by the participant.

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