A Phase 3 interventional study of adalimumab in Uveitis, sponsored by AbbVie. Completed. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-07-12.
Sponsored by AbbVie · Phase 3, Interventional, and Treatment
The purpose of this study is to evaluate the long term efficacy and safety of adalimumab participants with non-infectious intermediate-, posterior- or pan-uveitis.
This study was initially planned to run for 78 weeks but was extended for ethical reasons, to avoid leaving participants untreated who had responded well to adalimumab treatment, so that participants were allowed to remain in the study until regulatory and/or reimbursement approval for the treatment of uveitis in adults was obtained for their respective countries. Data were collected through Week 366 (maximum), but because of decreasing sample size that became too small toward the end of the study to allow for meaningful conclusion, data cut off for efficacy analyses (intent to treat [ITT] population) occurred at Week 246, as less than 10% of participants in the ITT set had visits beyond this timepoint.
299 studies on the registry are indexed under Uveitis; 32 are open to participants now.
This study's enrollment of 424 is above the median of 30 across 175 interventional studies indexed under Uveitis.
Browse Uveitis studies →AbbVie is the lead sponsor of 973 studies on the registry; 133 are open to participants now.
Of its 357 completed or terminated interventional studies of FDA-regulated products, 214 (60%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants received open label (OL) adalimumab 40 mg by subcutaneous (SC) injection every other week (eow) until the final visit.
Drug: adalimumab
Adalimumab, pre-filled syringe, administered by SC injection
Also known as: ABT-D2E7, Humira
Number of Participants With Adverse Events
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.
Time frame: Baseline to Final Visit (up to 366 weeks)
Hematology: Number of Participants With Potentially Clinically Significant (PCS) Values
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 used include g=grams; L=liters.
Time frame: Baseline to Final Visit (Up to 366 weeks)
Chemistry: Number of Participants With PCS Values
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.
Time frame: Baseline to Final Visit (Up to 366 weeks)
Pulse (Sitting): Mean Change (Beats Per Minute) From Baseline To Final Visit
Heart rate (beats per minute) was measured while the participant was sitting.
Time frame: Baseline to Final Visit (Up to 366 weeks)
Respiratory Rate (Sitting): Mean Change (Respirations Per Minute) From Baseline To Final Visit
Respiratory rate (respirations per minute) was measured while the participant was sitting.
Time frame: Baseline to Final Visit (Up to 366 weeks)
Temperature (Sitting): Mean Change (Centigrade) From Baseline To Final Visit
Temperature was measured while the participant was sitting.
Time frame: Baseline to Final Visit (Up to 366 weeks)
Diastolic and Systolic Blood Pressure (Sitting): Mean Change (mmHg) From Baseline To Final Visit
Blood pressure was measured while the participant was sitting. Abbreviations used include mmHg=millimeters of mercury.
Time frame: Baseline to Final Visit (Up to 366 weeks)
Percentage of Participants in Quiescence Over Time
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.
Time frame: 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
Percentage of Participants With Uveitis Flare Among Participants With Inactive Uveitis at Study Start
Uveitis flare is defined as no quiescence (active inflammatory lesions and AC cell grade \> 0.5+ and/or VH grade \>0.5+).
Time frame: 366 Weeks
Percentage of Participants With Uveitis Flare From Week 8 Through Last Visit Among Participants With Active Uveitis at Study Start
Uveitis flare is defined as no quiescence (active inflammatory lesions and AC cell grade \> 0.5+ and/or VH grade \>0.5+).
Time frame: Weeks 8 to 246 (238 Weeks)
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
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.
Time frame: 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
Percentage of Participants With Steroid-free Quiescence Over Time
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.
Time frame: 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
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
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.
Time frame: 366 Weeks
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
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.
Time frame: 366 Weeks
Percentage of Participants Who Started Uveitis-related Systemic Corticosteroids During the Study
Percentage of participants who started uveitis-related systemic corticosteroids during the study.
Time frame: 366 Weeks
Mean Daily Dose in Milligrams (mg) of Uveitis-related Systemic Corticosteroids in Participants With Active Uveitis Over Time
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.
Time frame: 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
Mean Daily Dose (mg) of Uveitis-related Systemic Corticosteroids in Participants With Inactive Uveitis Over Time
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.
Time frame: 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
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
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. Data not presented after Week 198 as no participants remained on study as of Week 198.
Time frame: Weeks 0, 2, 4, 8, 12, 18, 30, 42, 54, 66, 78, 90, 102, 114, 126, 138, 150, 162, 174, 186, and 198
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
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.
Time frame: 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
Percentage of Participants Not Using Systemic Corticosteroids Over Time
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. Data presented for participants not using systemic corticosteroids at each timepoint.
Time frame: 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
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
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.
Time frame: 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
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
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.
Time frame: Weeks 12, 18, 30, 42, 54, 66, 78, 90, 102, 114, 126, 138, 150, 162, 174, 186, 198, 210, 222, 234, and 246
Mean of Both Eyes of the Logarithm of the Minimum Angle of Resolution (LogMAR) BCVA Over Time
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.
Time frame: 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
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
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.
Time frame: 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
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
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.
Time frame: 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
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
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.
Time frame: 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
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
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.
Time frame: 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
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
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.
Time frame: 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
Percentage of Participants Achieving a ≥50% Reduction in Immunosuppression Load Relative to Baseline Over Time Among Participants With Inactive Uveitis at Study Entry
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.
Time frame: 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
Percentage of Participants Achieving a ≥50% Reduction in Immunosuppression Load Relative to Week 8 Over Time Among Participants With Active Uveitis at Study Entry
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.
Time frame: Weeks 12, 18, 30, 42, 54, 66, 78, 90, 102, 114, 126, 138, 150, 162, 174, 186, 198, 210, 222, 234, and 246
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
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.
Time frame: 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
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
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.
Time frame: Weeks 12, 18, 30, 42, 54, 66, 78, 90, 102, 114, 126, 138, 150, 162, 174, 186, 198, 210, 222, 234, and 246
Percentage of Participants With Grade ≤0.5+ in VH in Both Eyes on Indirect Ophthalmoscopy According to NEI/SUN Criteria Over Time
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.
Time frame: 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
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
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.
Time frame: Weeks 0, 8, 18, 30, 42, 54, 66, 78, 90, 102, 114, 126, 138, 150, 162, 174, 186, 198, 210, 222, 234, and 246
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
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 8 for participants with active uveitis.
Time frame: Weeks 0, 8, 18, 30, 42, 54, 66, 78, 90, 102, 114, 126, 138, 150, 162, 174, 186, 198, 210, 222, 234, and 246
| Milestone | Adalimumab |
|---|---|
| Started | 424 |
| Completed | 239 |
| Not completed | 185 |
| Withdrew: Other | 185 |
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.
| participants | Adalimumab |
|---|---|
| Any TEAE | 398 |
| Any TESAE | 101 |
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 used include g=grams; L=liters.
| participants | Adalimumab |
|---|---|
| Hemoglobin (Low: <80-65 g/L) | 3 |
| Neutrophils (Low: <1.0-0.5*10^9/L) | 6 |
| Lymphocytes (Low: <0.5-0.2*10^9/L) | 7 |
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.
| participants | Adalimumab |
|---|---|
| ALT/SGPT (High: >5.0-20.0*ULN) | 2 |
| AST/SGOT (High: >5.0-20.0*ULN) | 3 |
| Bilirubin, Total (High: >3.0-10.0*ULN) | 1 |
| Creatinine (High: >3.0-6.0*ULN) | 2 |
| Phosphate Inorganic (Low:<0.6-0.3 mmol/L) | 5 |
| Sodium (Low: <130-120 mmol/L) | 4 |
| Potassium (Low:<3.0-2.5 mmol/L) | 7 |
| Glucose (High: >13.9-27.8 mmol/L) | 18 |
| Albumin (Low: <20.0 g/L) | 2 |
| Cholesterol (High: >10.34-12.92 mmol/L) | 3 |
| Triglycerides (High: >5.0-10*ULN) | 8 |
Heart rate (beats per minute) was measured while the participant was sitting.
| beats per minute | Adalimumab |
|---|---|
| Pulse (Sitting): Mean Change (Beats Per Minute) From Baseline To Final Visit | -1.0 ± 11.92 |
Respiratory rate (respirations per minute) was measured while the participant was sitting.
| respirations per minute | Adalimumab |
|---|---|
| Respiratory Rate (Sitting): Mean Change (Respirations Per Minute) From Baseline To Final Visit | -0.1 ± 2.94 |
Temperature was measured while the participant was sitting.
| Centigrade | Adalimumab |
|---|---|
| Temperature (Sitting): Mean Change (Centigrade) From Baseline To Final Visit | -0.03 ± 0.516 |
Blood pressure was measured while the participant was sitting. Abbreviations used include mmHg=millimeters of mercury.
| mmHg | Adalimumab |
|---|---|
| Diastolic Blood Pressure (Sitting) | 1.443 ± 10.4373 |
| Systolic Blood Pressure (Sitting) | 1.955 ± 14.6281 |
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.
| percentage of participants | Adalimumab |
|---|---|
| Week 0 | 33.5 (28.7 to 38.6) |
| Week 2 | 56.3 (50.9 to 61.6) |
| Week 4 | 63.8 (58.3 to 69.0) |
| Week 8 | 72.0 (66.9 to 76.7) |
| Week 12 | 72.4 (67.2 to 77.1) |
| Week 18 | 75.2 (70.1 to 79.7) |
| Week 30 | 79.9 (75.1 to 84.2) |
| Week 42 | 81.3 (76.5 to 85.5) |
| Week 54 | 81.1 (76.1 to 85.4) |
| Week 66 | 85.9 (81.3 to 89.7) |
| Week 78 | 86.3 (81.7 to 90.2) |
| Week 90 | 87.4 (82.7 to 91.1) |
| Week 102 | 87.3 (82.5 to 91.2) |
| Week 114 | 87.9 (83.0 to 91.8) |
| Week 126 | 88.4 (83.3 to 92.3) |
| Week 138 | 89.3 (84.1 to 93.2) |
| Week 150 | 85.0 (78.9 to 89.9) |
| Week 162 | 87.0 (80.7 to 91.9) |
| Week 174 | 87.3 (80.7 to 92.3) |
| Week 186 | 90.6 (84.2 to 95.1) |
| Week 198 | 89.4 (82.2 to 94.4) |
| Week 210 | 88.6 (80.1 to 94.4) |
| Week 222 | 92.9 (84.1 to 97.6) |
| Week 234 | 96.1 (86.5 to 99.5) |
| Week 246 | 95.2 (83.8 to 99.4) |
Uveitis flare is defined as no quiescence (active inflammatory lesions and AC cell grade \> 0.5+ and/or VH grade \>0.5+).
| percentage of participants | Adalimumab |
|---|---|
| Percentage of Participants With Uveitis Flare Among Participants With Inactive Uveitis at Study Start | 38.7 (30.1 to 47.9) |
Uveitis flare is defined as no quiescence (active inflammatory lesions and AC cell grade \> 0.5+ and/or VH grade \>0.5+).
| percentage of participants | Adalimumab |
|---|---|
| Percentage of Participants With Uveitis Flare From Week 8 Through Last Visit Among Participants With Active Uveitis at Study Start | 67.7 (61.2 to 73.6) |
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.
| percentage of participants | Adalimumab |
|---|---|
| Week 2 | 11.8 (8.6 to 15.6) |
| Week 4 | 8.4 (5.6 to 11.9) |
| Week 8 | 7.6 (5.0 to 10.9) |
| Week 12 | 6.9 (4.4 to 10.2) |
| Week 18 | 3.6 (1.9 to 6.3) |
| Week 30 | 5.3 (3.1 to 8.4) |
| Week 42 | 4.2 (2.3 to 7.1) |
| Week 54 | 4.1 (2.1 to 7.0) |
| Week 66 | 1.4 (0.4 to 3.6) |
| Week 78 | 4.1 (2.0 to 7.1) |
| Week 90 | 4.6 (2.4 to 7.9) |
| Week 102 | 4.1 (2.0 to 7.4) |
| Week 114 | 4.8 (2.4 to 8.4) |
| Week 126 | 3.3 (1.3 to 6.6) |
| Week 138 | 2.0 (0.6 to 5.1) |
| Week 150 | 4.4 (1.9 to 8.6) |
| Week 162 | 3.2 (1.1 to 7.4) |
| Week 174 | 1.4 (0.2 to 5.0) |
| Week 186 | 1.6 (0.2 to 5.5) |
| Week 198 | 0 (0 to 0) |
| Week 210 | 3.4 (0.7 to 9.6) |
| Week 222 | 1.4 (0 to 7.7) |
| Week 234 | 0 (0 to 0) |
| Week 246 | 0 (0 to 0) |
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.
| percentage of participants | Adalimumab |
|---|---|
| Week 0 | 30.5 (25.8 to 35.5) |
| Week 2 | 34.8 (29.8 to 40.0) |
| Week 4 | 35.6 (30.4 to 41.1) |
| Week 8 | 41.4 (36.1 to 46.8) |
| Week 12 | 44.4 (39.0 to 50.0) |
| Week 18 | 47.6 (42.1 to 53.1) |
| Week 30 | 52.4 (46.7 to 57.9) |
| Week 42 | 55.8 (50.1 to 61.4) |
| Week 54 | 55.7 (49.9 to 61.5) |
| Week 66 | 56.7 (50.7 to 62.5) |
| Week 78 | 57.7 (51.6 to 63.7) |
| Week 90 | 60.2 (53.9 to 66.1) |
| Week 102 | 65.7 (59.4 to 71.6) |
| Week 114 | 66.2 (59.7 to 72.3) |
| Week 126 | 66.0 (59.3 to 72.3) |
| Week 138 | 67.9 (60.8 to 74.3) |
| Week 150 | 65.0 (57.6 to 71.9) |
| Week 162 | 63.0 (54.8 to 70.6) |
| Week 174 | 65.5 (57.1 to 73.3) |
| Week 186 | 68.0 (59.1 to 75.9) |
| Week 198 | 64.6 (55.0 to 73.4) |
| Week 210 | 64.0 (53.2 to 73.9) |
| Week 222 | 69.0 (56.9 to 79.5) |
| Week 234 | 78.4 (64.7 to 88.7) |
| Week 246 | 83.3 (68.6 to 93.0) |
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.
| percentage of participants | Adalimumab |
|---|---|
| NQ With CM Change and quiescence at next visit | 10.5 |
| NQ With CM Change and nonquiescence at next visit | 2.4 |
| NQ Without CM Change and quiescence at next visit | 13.7 |
| NQ Without CM Change and NQ at next visit | 8.9 |
| NQ With Premature Discontinuation | 3.2 |
| NQ And Completion | 0.8 |
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.
| percentage of participants | Adalimumab |
|---|---|
| NQ With CM Change and quiescence at next visit | 19.2 |
| NQ With CM Change and nonquiescence at next visit | 10.8 |
| NQ Without CM Change and quiescence at next visit | 15.0 |
| NQ Without CM Change and NQ at next visit | 15.4 |
| NQ With Premature Discontinuation | 6.7 |
| NQ And Completion | 0.4 |
Percentage of participants who started uveitis-related systemic corticosteroids during the study.
| percentage of participants | Adalimumab |
|---|---|
| Percentage of Participants Who Started Uveitis-related Systemic Corticosteroids During the Study | 20.3 (16.3 to 24.8) |
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.
| milligrams | Adalimumab |
|---|---|
| Week 0 | 13.6 ± 19.21 |
| Week 2 | 14.8 ± 17.12 |
| Week 4 | 10.1 ± 12.27 |
| Week 8 | 7.3 ± 9.75 |
| Week 12 | 6.0 ± 9.34 |
| Week 18 | 5.1 ± 8.47 |
| Week 30 | 4.4 ± 7.12 |
| Week 42 | 3.5 ± 5.54 |
| Week 54 | 3.5 ± 6.71 |
| Week 66 | 3.1 ± 6.32 |
| Week 78 | 2.6 ± 5.10 |
| Week 90 | 2.2 ± 4.47 |
| Week 102 | 2.1 ± 4.80 |
| Week 114 | 1.8 ± 4.50 |
| Week 126 | 1.6 ± 4.16 |
| Week 138 | 2.2 ± 5.65 |
| Week 150 | 2.0 ± 4.49 |
| Week 162 | 1.9 ± 4.31 |
| Week 174 | 1.9 ± 4.46 |
| Week 186 | 1.6 ± 4.27 |
| Week 198 | 1.6 ± 4.05 |
| Week 210 | 1.4 ± 3.57 |
| Week 222 | 2.3 ± 8.48 |
| Week 234 | 1.1 ± 3.17 |
| Week 246 | 0.6 ± 1.69 |
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.
| milligrams | Adalimumab |
|---|---|
| Week 0 | 1.5 ± 7.32 |
| Week 2 | 1.6 ± 6.65 |
| Week 4 | 1.4 ± 4.89 |
| Week 8 | 0.9 ± 3.41 |
| Week 12 | 0.9 ± 4.12 |
| Week 18 | 0.8 ± 3.29 |
| Week 30 | 0.7 ± 2.74 |
| Week 42 | 0.7 ± 2.64 |
| Week 54 | 1.8 ± 7.09 |
| Week 66 | 1.3 ± 5.32 |
| Week 78 | 1.1 ± 4.36 |
| Week 90 | 1.2 ± 4.54 |
| Week 102 | 0.6 ± 2.63 |
| Week 114 | 0.6 ± 2.67 |
| Week 126 | 0.7 ± 2.95 |
| Week 138 | 0.5 ± 2.09 |
| Week 150 | 0.5 ± 1.91 |
| Week 162 | 0.2 ± 1.00 |
| Week 174 | 0.2 ± 1.07 |
| Week 186 | 0.3 ± 1.12 |
| Week 198 | 0.3 ± 1.23 |
| Week 210 | 0.4 ± 1.50 |
| Week 222 | 0.5 ± 1.73 |
| Week 234 | 0.5 ± 1.57 |
| Week 246 | 0.0 ± 0.00 |
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. Data not presented after Week 198 as no participants remained on study as of Week 198.
| percent change from baseline | Adalimumab |
|---|---|
| Week 2 | -11.8 (-21.6 to -2.1) |
| Week 4 | -46.6 (-64.2 to -29.0) |
| Week 8 | -64.5 (-88.1 to -40.8) |
| Week 12 | -29.7 (-91.5 to 32.1) |
| Week 18 | -30.8 (-128.4 to 66.7) |
| Week 30 | -25.0 (-159.6 to 109.5) |
| Week 42 | -36.7 (-150.4 to 76.9) |
| Week 54 | -11.9 (-186.2 to 162.5) |
| Week 66 | -25.1 (-156.9 to 106.6) |
| Week 78 | -28.3 (-157.9 to 101.2) |
| Week 90 | -27.5 (-162.6 to 107.6) |
| Week 102 | -78.1 (-120.7 to -35.4) |
| Week 114 | -84.2 (-96.8 to -67.2) |
| Week 126 | -88.9 (-113.9 to -63.9) |
| Week 138 | -95.9 (-148.4 to -43.3) |
| Week 150 | -99.5 (-106.3 to -92.7) |
| Week 162 | -100.0 (-100.0 to -100.0) |
| Week 174 | -100.0 (-100.0 to -100.0) |
| Week 186 | -100.0 (-100.0 to -100.0) |
| Week 198 | -100.0 (-100.0 to -100.0) |
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.
| percent change from baseline | Adalimumab |
|---|---|
| Week 2 | -4.6 (-14.2 to 5.0) |
| Week 4 | -25.0 (-38.6 to -11.4) |
| Week 8 | -41.7 (-55.0 to -28.4) |
| Week 12 | -46.3 (-65.0 to -27.7) |
| Week 18 | -55.1 (-73.1 to -37.1) |
| Week 30 | -62.8 (-78.1 to -47.5) |
| Week 42 | -73.4 (-85.0 to -61.9) |
| Week 54 | -73.2 (-85.3 to -61.0) |
| Week 66 | -77.1 (-89.3 to -64.9) |
| Week 78 | -77.3 (-90.2 to -64.4) |
| Week 90 | -82.1 (-93.3 to -70.9) |
| Week 102 | -78.8 (-95.7 to -62.0) |
| Week 114 | -82.0 (-96.8 to -66.9) |
| Week 126 | -82.8 (-98.6 to -66.9) |
| Week 138 | -87.8 (-94.2 to -81.4) |
| Week 150 | -86.9 (-94.5 to -79.2) |
| Week 162 | -90.7 (-94.9 to -86.4) |
| Week 174 | -91.4 (-95.8 to -86.9) |
| Week 186 | -90.3 (-95.9 to -84.7) |
| Week 198 | -91.0 (-96.6 to -85.5) |
| Week 210 | -89.9 (-96.8 to -82.9) |
| Week 222 | -87.1 (-102.0 to -72.2) |
| Week 234 | -93.8 (-103.8 to -83.9) |
| Week 246 | -98.3 (-101.3 to -95.4) |
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. Data presented for participants not using systemic corticosteroids at each timepoint.
| percentage of participants | Adalimumab |
|---|---|
| Week 0 | 66.3 (61.1 to 71.2) |
| Week 2 | 58.7 (53.4 to 63.8) |
| Week 4 | 60.2 (54.8 to 65.3) |
| Week 8 | 61.9 (56.5 to 67.1) |
| Week 12 | 64.7 (59.3 to 69.8) |
| Week 18 | 68.3 (63.0 to 73.3) |
| Week 30 | 70.2 (64.8 to 75.2) |
| Week 42 | 70.9 (65.5 to 75.9) |
| Week 54 | 71.9 (66.4 to 77.0) |
| Week 66 | 73.1 (67.4 to 78.2) |
| Week 78 | 75.2 (69.5 to 80.3) |
| Week 90 | 77.0 (71.4 to 82.0) |
| Week 102 | 80.8 (75.2 to 85.6) |
| Week 114 | 83.6 (78.1 to 88.1) |
| Week 126 | 84.2 (78.5 to 88.9) |
| Week 138 | 82.1 (75.9 to 87.3) |
| Week 150 | 81.5 (74.9 to 87.0) |
| Week 162 | 80.5 (73.3 to 86.6) |
| Week 174 | 79.4 (71.6 to 85.9) |
| Week 186 | 80.5 (72.4 to 87.1) |
| Week 198 | 80.4 (71.1 to 87.8) |
| Week 210 | 81.7 (71.6 to 89.4) |
| Week 222 | 86.4 (75.0 to 94.0) |
| Week 234 | 89.6 (77.3 to 96.5) |
| Week 246 | 94.1 (80.3 to 99.3) |
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.
| percentage of participants | Adalimumab |
|---|---|
| Week 2 | 100 (96.9 to 100) |
| Week 4 | 99.1 (94.9 to 100) |
| Week 8 | 100 (96.8 to 100) |
| Week 12 | 100 (96.8 to 100) |
| Week 18 | 100 (96.8 to 100) |
| Week 30 | 99.1 (95.1 to 100) |
| Week 42 | 98.2 (93.7 to 99.8) |
| Week 54 | 97.2 (92.0 to 99.4) |
| Week 66 | 98.1 (93.2 to 99.8) |
| Week 78 | 97.0 (91.4 to 99.4) |
| Week 90 | 98.9 (94.3 to 100) |
| Week 102 | 97.8 (92.1 to 99.7) |
| Week 114 | 97.6 (91.7 to 99.7) |
| Week 126 | 96.1 (88.9 to 99.2) |
| Week 138 | 96.9 (89.2 to 99.6) |
| Week 150 | 100 (93.7 to 100) |
| Week 162 | 100 (91.0 to 100) |
| Week 174 | 100 (89.7 to 100) |
| Week 186 | 100 (88.8 to 100) |
| Week 198 | 100 (86.8 to 100) |
| Week 210 | 100 (79.4 to 100) |
| Week 222 | 91.7 (61.5 to 99.8) |
| Week 234 | 88.9 (51.8 to 99.7) |
| Week 246 | 85.7 (42.1 to 99.6) |
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.
| percentage of participants | Adalimumab |
|---|---|
| Week 12 | 96.8 (93.5 to 98.7) |
| Week 18 | 96.3 (92.8 to 98.4) |
| Week 30 | 96.6 (93.1 to 98.6) |
| Week 42 | 94.9 (90.8 to 97.5) |
| Week 54 | 94.7 (90.4 to 97.4) |
| Week 66 | 93.3 (88.6 to 96.5) |
| Week 78 | 93.6 (88.8 to 96.8) |
| Week 90 | 96.4 (92.3 to 98.7) |
| Week 102 | 94.8 (90.0 to 97.7) |
| Week 114 | 93.8 (88.6 to 97.1) |
| Week 126 | 95.0 (90.0 to 98.0) |
| Week 138 | 93.9 (88.3 to 97.3) |
| Week 150 | 92.7 (86.6 to 96.6) |
| Week 162 | 93.9 (87.8 to 97.5) |
| Week 174 | 91.6 (84.6 to 96.1) |
| Week 186 | 92.7 (85.6 to 97.0) |
| Week 198 | 95.3 (88.5 to 98.7) |
| Week 210 | 95.8 (88.1 to 99.1) |
| Week 222 | 96.6 (88.1 to 99.6) |
| Week 234 | 95.2 (83.8 to 99.4) |
| Week 246 | 91.2 (76.3 to 98.1) |
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.
| Log (Mar) BCVA Both Eyes | Adalimumab |
|---|---|
| Week 0 | 0.20 ± 0.275 |
| Week 2 | 0.17 ± 0.265 |
| Week 4 | 0.15 ± 0.248 |
| Week 8 | 0.14 ± 0.247 |
| Week 12 | 0.13 ± 0.244 |
| Week 18 | 0.12 ± 0.240 |
| Week 30 | 0.12 ± 0.249 |
| Week 42 | 0.12 ± 0.227 |
| Week 54 | 0.11 ± 0.238 |
| Week 66 | 0.11 ± 0.241 |
| Week 78 | 0.11 ± 0.238 |
| Week 90 | 0.09 ± 0.214 |
| Week 102 | 0.09 ± 0.219 |
| Week 114 | 0.09 ± 0.233 |
| Week 126 | 0.09 ± 0.231 |
| Week 138 | 0.09 ± 0.224 |
| Week 150 | 0.10 ± 0.255 |
| Week 162 | 0.09 ± 0.249 |
| Week 174 | 0.09 ± 0.261 |
| Week 186 | 0.09 ± 0.244 |
| Week 198 | 0.07 ± 0.205 |
| Week 210 | 0.07 ± 0.211 |
| Week 222 | 0.07 ± 0.218 |
| Week 234 | 0.07 ± 0.222 |
| Week 246 | 0.08 ± 0.217 |
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.
| percent change from baseline | Adalimumab |
|---|---|
| Week 2 | 0.3 (-1.41 to 1.97) |
| Week 4 | -0.2 (-2.03 to 1.56) |
| Week 8 | -0.7 (-2.07 to 0.72) |
| Week 12 | -1.0 (-2.27 to 0.23) |
| Week 18 | -0.5 (-2.02 to 1.07) |
| Week 30 | -1.9 (-3.25 to -0.60) |
| Week 42 | -1.3 (-2.83 to 0.17) |
| Week 54 | -2.1 (-3.90 to -0.22) |
| Week 66 | -1.9 (-3.95 to 0.11) |
| Week 78 | -1.4 (-4.54 to 1.70) |
| Week 90 | -2.9 (-4.51 to -1.22) |
| Week 102 | -3.1 (-4.95 to -1.34) |
| Week 114 | -2.8 (-4.44 to -1.14) |
| Week 126 | -3.7 (-5.66 to -1.68) |
| Week 138 | -3.4 (-5.38 to -1.46) |
| Week 150 | -3.5 (-5.48 to -1.58) |
| Week 162 | -3.3 (-6.25 to -0.29) |
| Week 174 | -3.0 (-5.45 to -0.52) |
| Week 186 | -3.8 (-6.69 to -1.00) |
| Week 198 | -3.2 (-5.99 to -0.35) |
| Week 210 | -5.2 (-10.23 to -0.17) |
| Week 222 | -4.6 (-11.17 to 1.93) |
| Week 234 | -3.6 (-13.06 to 5.77) |
| Week 246 | -3.4 (-14.83 to 7.93) |
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.
| percent change from baseline | Adalimumab |
|---|---|
| Week 2 | -0.2 (-1.92 to 1.45) |
| Week 4 | -0.8 (-2.99 to 1.39) |
| Week 8 | -1.5 (-3.19 to 0.25) |
| Week 12 | -1.0 (-2.76 to 0.66) |
| Week 18 | -0.4 (-2.73 to 1.84) |
| Week 30 | -2.8 (-4.78 to -0.86) |
| Week 42 | -2.2 (-4.31 to -0.15) |
| Week 54 | -3.7 (-6.00 to -1.44) |
| Week 66 | -3.3 (-5.66 to -0.97) |
| Week 78 | -3.9 (-6.36 to -1.38) |
| Week 90 | -3.8 (-6.47 to -1.08) |
| Week 102 | -5.3 (-7.99 to -2.67) |
| Week 114 | -5.6 (-8.65 to -2.53) |
| Week 126 | -5.4 (-8.57 to -2.21) |
| Week 138 | -4.7 (-7.75 to -1.72) |
| Week 150 | -2.1 (-9.07 to 4.90) |
| Week 162 | -2.9 (-6.06 to 0.36) |
| Week 174 | -2.7 (-5.88 to 0.56) |
| Week 186 | -2.0 (-5.49 to 1.46) |
| Week 198 | -1.2 (-5.91 to 3.48) |
| Week 210 | -2.3 (-6.35 to 1.66) |
| Week 222 | -1.7 (-4.76 to 1.44) |
| Week 234 | -1.3 (-6.32 to 3.78) |
| Week 246 | 1.6 (-0.78 to 3.93) |
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.
| percent change from baseline | Adalimumab |
|---|---|
| Week 12 | 1.0 (-0.50 to 2.42) |
| Week 18 | -0.3 (-2.36 to 1.71) |
| Week 30 | -2.4 (-4.24 to -0.55) |
| Week 42 | -2.8 (-4.62 to -1.00) |
| Week 54 | -3.2 (-5.52 to -0.90) |
| Week 66 | -2.3 (-4.52 to 0.01) |
| Week 78 | -3.5 (-5.99 to -1.02) |
| Week 90 | -4.8 (-7.19 to -2.42) |
| Week 102 | -5.3 (-7.41 to -3.10) |
| Week 114 | -6.6 (-9.15 to -3.95) |
| Week 126 | -5.3 (-8.66 to -1.92) |
| Week 138 | -7.0 (-9.96 to -3.99) |
| Week 150 | -7.3 (-10.22 to -4.48) |
| Week 162 | -7.5 (-11.31 to -3.72) |
| Week 174 | -9.5 (-13.20 to -5.81) |
| Week 186 | -7.6 (-10.21 to -4.93) |
| Week 198 | -8.4 (-11.84 to -4.99) |
| Week 210 | -6.6 (-10.40 to -2.74) |
| Week 222 | -9.3 (-13.42 to -5.17) |
| Week 234 | -8.2 (-11.85 to -4.46) |
| Week 246 | -9.1 (-13.41 to -4.82) |
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.
| percent change from baseline | Adalimumab |
|---|---|
| Week 12 | 0.4 (-1.58 to 2.47) |
| Week 18 | -0.7 (-2.71 to 1.30) |
| Week 30 | -0.7 (-3.36 to 1.90) |
| Week 42 | -2.4 (-4.85 to 0.05) |
| Week 54 | -2.4 (-5.25 to 0.36) |
| Week 66 | -1.3 (-4.81 to 2.27) |
| Week 78 | -2.1 (-5.61 to 1.50) |
| Week 90 | -3.6 (-6.44 to -0.76) |
| Week 102 | -3.4 (-6.98 to 0.13) |
| Week 114 | -2.2 (-6.18 to 1.81) |
| Week 126 | -3.5 (-7.43 to 0.47) |
| Week 138 | -4.6 (-8.22 to -0.92) |
| Week 150 | -6.5 (-9.81 to -3.15) |
| Week 162 | -4.8 (-8.91 to -0.75) |
| Week 174 | -5.4 (-9.46 to -1.27) |
| Week 186 | -7.9 (-12.74 to -3.03) |
| Week 198 | -8.2 (-12.30 to -4.13) |
| Week 210 | -6.6 (-10.76 to -2.43) |
| Week 222 | -9.7 (-13.24 to -6.19) |
| Week 234 | -9.7 (-14.24 to -5.07) |
| Week 246 | -9.9 (-15.43 to -4.35) |
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.
| percentage of participants | Adalimumab |
|---|---|
| Week 0 | 65.4 (60.3 to 70.3) |
| Week 2 | 85.9 (81.8 to 89.4) |
| Week 4 | 90.4 (86.7 to 93.4) |
| Week 8 | 91.5 (88.1 to 94.3) |
| Week 12 | 91.3 (87.7 to 94.1) |
| Week 18 | 90.9 (87.3 to 93.8) |
| Week 30 | 94.7 (91.6 to 96.9) |
| Week 42 | 92.3 (88.7 to 95.0) |
| Week 54 | 92.9 (89.4 to 95.6) |
| Week 66 | 95.1 (91.9 to 97.3) |
| Week 78 | 93.0 (89.3 to 95.7) |
| Week 90 | 94.3 (90.7 to 96.7) |
| Week 102 | 93.5 (89.6 to 96.2) |
| Week 114 | 93.5 (89.5 to 96.3) |
| Week 126 | 94.0 (90.0 to 96.8) |
| Week 138 | 93.4 (89.0 to 96.4) |
| Week 150 | 94.5 (90.1 to 97.3) |
| Week 162 | 95.5 (90.9 to 98.2) |
| Week 174 | 94.4 (89.2 to 97.5) |
| Week 186 | 96.1 (91.1 to 98.7) |
| Week 198 | 94.7 (88.8 to 98.0) |
| Week 210 | 96.6 (90.5 to 99.3) |
| Week 222 | 98.6 (92.4 to 100) |
| Week 234 | 100 (93.0 to 100) |
| Week 246 | 95.2 (83.8 to 99.4) |
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.
| percentage of participants | Adalimumab |
|---|---|
| Week 2 | 3.6 (0.4 to 12.5) |
| Week 4 | 9.1 (3.0 to 20.0) |
| Week 8 | 17.3 (8.2 to 30.3) |
| Week 12 | 17.3 (8.2 to 30.3) |
| Week 18 | 21.6 (11.3 to 35.3) |
| Week 30 | 24.5 (13.3 to 38.9) |
| Week 42 | 22.9 (12.0 to 37.3) |
| Week 54 | 17.8 (8.0 to 32.1) |
| Week 66 | 15.0 (5.7 to 29.8) |
| Week 78 | 15.0 (5.7 to 29.8) |
| Week 90 | 13.5 (4.5 to 28.8) |
| Week 102 | 14.7 (5.0 to 31.1) |
| Week 114 | 25.0 (11.5 to 43.4) |
| Week 126 | 25.0 (10.7 to 44.9) |
| Week 138 | 25.0 (9.8 to 46.7) |
| Week 150 | 23.8 (8.2 to 47.2) |
| Week 162 | 18.8 (4.0 to 45.6) |
| Week 174 | 12.5 (1.6 to 38.3) |
| Week 186 | 12.5 (1.6 to 38.3) |
| Week 198 | 0 (0 to 0) |
| Week 210 | 12.5 (0.3 to 52.7) |
| Week 222 | 25.0 (0.6 to 80.6) |
| Week 234 | 50.0 (6.8 to 93.2) |
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.
| percentage of participants | Adalimumab |
|---|---|
| Week 12 | 17.1 (11.3 to 24.4) |
| Week 18 | 27.2 (19.9 to 35.5) |
| Week 30 | 33.6 (25.5 to 42.5) |
| Week 42 | 41.6 (32.9 to 50.8) |
| Week 54 | 44.5 (35.4 to 53.9) |
| Week 66 | 48.7 (39.2 to 58.3) |
| Week 78 | 48.6 (38.9 to 58.4) |
| Week 90 | 53.8 (43.8 to 63.5) |
| Week 102 | 54.1 (43.7 to 64.2) |
| Week 114 | 51.1 (40.3 to 61.8) |
| Week 126 | 52.9 (41.9 to 63.7) |
| Week 138 | 52.5 (41.0 to 63.8) |
| Week 150 | 53.9 (42.1 to 65.5) |
| Week 162 | 53.5 (41.3 to 65.5) |
| Week 174 | 55.6 (42.5 to 68.1) |
| Week 186 | 55.9 (42.4 to 68.8) |
| Week 198 | 52.0 (37.4 to 66.3) |
| Week 210 | 51.2 (35.1 to 67.1) |
| Week 222 | 54.8 (36.0 to 72.7) |
| Week 234 | 56.5 (34.5 to 76.8) |
| Week 246 | 63.2 (38.4 to 83.7) |
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.
| percentage of participants | Adalimumab |
|---|---|
| Week 2 | 100 (96.9 to 100) |
| Week 4 | 99.1 (94.9 to 100) |
| Week 8 | 100 (96.8 to 100) |
| Week 12 | 100 (96.8 to 100) |
| Week 18 | 98.2 (93.7 to 99.8) |
| Week 30 | 100 (96.8 to 100) |
| Week 42 | 98.2 (93.7 to 99.8) |
| Week 54 | 99.1 (94.9 to 100) |
| Week 66 | 100 (96.5 to 100) |
| Week 78 | 100 (96.3 to 100) |
| Week 90 | 98.9 (94.3 to 100) |
| Week 102 | 98.9 (93.9 to 100) |
| Week 114 | 100 (95.7 to 100) |
| Week 126 | 100 (95.2 to 100) |
| Week 138 | 98.4 (91.6 to 100) |
| Week 150 | 96.5 (87.9 to 99.6) |
| Week 162 | 97.4 (86.5 to 99.9) |
| Week 174 | 100 (89.7 to 100) |
| Week 186 | 100 (88.8 to 100) |
| Week 198 | 100 (86.8 to 100) |
| Week 210 | 100 (79.4 to 100) |
| Week 222 | 100 (73.5 to 100) |
| Week 234 | 100 (66.4 to 100) |
| Week 246 | 100 (59.0 to 100) |
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.
| percentage of participants | Adalimumab |
|---|---|
| Week 12 | 97.7 (94.8 to 99.3) |
| Week 18 | 99.1 (96.7 to 99.9) |
| Week 30 | 97.1 (93.8 to 98.9) |
| Week 42 | 99.0 (96.4 to 99.9) |
| Week 54 | 98.9 (96.2 to 99.9) |
| Week 66 | 98.3 (95.2 to 99.7) |
| Week 78 | 97.7 (94.2 to 99.4) |
| Week 90 | 97.6 (93.9 to 99.3) |
| Week 102 | 99.4 (96.5 to 100) |
| Week 114 | 97.3 (93.2 to 99.3) |
| Week 126 | 99.3 (96.1 to 100) |
| Week 138 | 100 (97.2 to 100) |
| Week 150 | 96.7 (91.9 to 99.1) |
| Week 162 | 97.4 (92.6 to 99.5) |
| Week 174 | 100 (96.6 to 100) |
| Week 186 | 99.0 (94.4 to 100) |
| Week 198 | 100 (95.8 to 100) |
| Week 210 | 100 (95.1 to 100) |
| Week 222 | 100 (93.9 to 100) |
| Week 234 | 100 (91.6 to 100) |
| Week 246 | 100 (90.0 to 100) |
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.
| percentage of participants | Adalimumab |
|---|---|
| Week 0 | 58.0 (52.7 to 63.1) |
| Week 2 | 75.6 (70.7 to 80.0) |
| Week 4 | 77.7 (72.8 to 82.1) |
| Week 8 | 84.2 (79.9 to 87.9) |
| Week 12 | 84.4 (80.0 to 88.1) |
| Week 18 | 87.3 (83.2 to 90.7) |
| Week 30 | 87.1 (83.0 to 90.6) |
| Week 42 | 90.3 (86.5 to 93.4) |
| Week 54 | 89.5 (85.4 to 92.7) |
| Week 66 | 92.2 (88.5 to 95.1) |
| Week 78 | 93.3 (89.7 to 96.0) |
| Week 90 | 93.5 (89.8 to 96.2) |
| Week 102 | 93.9 (90.1 to 96.5) |
| Week 114 | 93.1 (89.0 to 96.0) |
| Week 126 | 94.9 (91.0 to 97.4) |
| Week 138 | 95.4 (91.5 to 97.9) |
| Week 150 | 92.2 (87.3 to 95.7) |
| Week 162 | 91.6 (86.0 to 95.4) |
| Week 174 | 92.3 (86.6 to 96.1) |
| Week 186 | 96.1 (91.1 to 98.7) |
| Week 198 | 93.8 (87.7 to 97.5) |
| Week 210 | 92.0 (84.3 to 96.7) |
| Week 222 | 95.7 (88.0 to 99.1) |
| Week 234 | 96.1 (86.5 to 99.5) |
| Week 246 | 97.6 (87.4 to 99.9) |
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.
| score on a scale | Adalimumab |
|---|---|
| Week 0 | 84.77 (81.93 to 87.62) |
| Week 8 | 84.37 (81.37 to 87.37) |
| Week 18 | 85.21 (82.30 to 88.13) |
| Week 30 | 84.75 (81.91 to 87.59) |
| Week 42 | 84.41 (81.29 to 87.53) |
| Week 54 | 84.87 (81.82 to 87.91) |
| Week 66 | 84.09 (80.97 to 87.21) |
| Week 78 | 83.59 (80.33 to 86.85) |
| Week 90 | 83.66 (80.18 to 87.15) |
| Week 102 | 84.19 (80.62 to 87.76) |
| Week 114 | 84.09 (80.40 to 87.78) |
| Week 126 | 84.44 (80.59 to 88.28) |
| Week 138 | 84.85 (80.56 to 89.14) |
| Week 150 | 83.90 (78.95 to 88.85) |
| Week 162 | 86.60 (81.31 to 91.90) |
| Week 174 | 87.25 (81.51 to 92.99) |
| Week 186 | 87.25 (81.43 to 93.06) |
| Week 198 | 85.30 (78.35 to 92.26) |
| Week 210 | 85.71 (76.61 to 94.82) |
| Week 222 | 85.67 (74.60 to 96.74) |
| Week 234 | 82.90 (68.16 to 97.63) |
| Week 246 | 79.83 (61.00 to 98.66) |
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 8 for participants with active uveitis.
| score on a scale | Adalimumab |
|---|---|
| Week 0 | 72.00 (69.52 to 74.48) |
| Week 8 | 75.77 (73.27 to 78.26) |
| Week 18 | 78.12 (75.65 to 80.58) |
| Week 30 | 78.98 (76.46 to 81.50) |
| Week 42 | 79.77 (77.37 to 82.18) |
| Week 54 | 80.10 (77.69 to 82.50) |
| Week 66 | 80.42 (77.87 to 82.97) |
| Week 78 | 80.98 (78.39 to 83.58) |
| Week 90 | 81.85 (79.32 to 84.37) |
| Week 102 | 81.44 (78.74 to 84.14) |
| Week 114 | 81.76 (78.99 to 84.54) |
| Week 126 | 81.86 (79.11 to 84.61) |
| Week 138 | 81.76 (78.94 to 84.59) |
| Week 150 | 82.41 (79.51 to 85.31) |
| Week 162 | 81.87 (78.90 to 84.85) |
| Week 174 | 81.96 (78.78 to 85.14) |
| Week 186 | 81.27 (78.07 to 84.46) |
| Week 198 | 82.08 (78.82 to 85.34) |
| Week 210 | 80.75 (76.99 to 84.51) |
| Week 222 | 81.65 (77.24 to 86.05) |
| Week 234 | 81.86 (76.32 to 87.40) |
| Week 246 | 81.57 (75.44 to 87.70) |
Collected over 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).. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Adalimumab | 4/424 (0.9%) | 101/424 (23.8%) | 332/424 (78.3%) |
| Event | Adalimumab |
|---|---|
| CATARACTEye disorders | 7/424 |
| UVEITISEye disorders | 5/424 |
| URINARY TRACT INFECTIONInfections and infestations | 5/424 |
| RETINAL DETACHMENTEye disorders | 3/424 |
| VITREOUS HAEMORRHAGEEye disorders | 3/424 |
| CHOLELITHIASISHepatobiliary disorders | 3/424 |
| PNEUMONIAInfections and infestations | 3/424 |
| OBESITYMetabolism and nutrition disorders | 3/424 |
| VISUAL ACUITY REDUCEDEye disorders | 2/424 |
| CROHN'S DISEASEGastrointestinal disorders | 2/424 |
| Event | Adalimumab |
|---|---|
| UVEITISEye disorders | 123/424 |
| NASOPHARYNGITISInfections and infestations | 105/424 |
| ARTHRALGIAMusculoskeletal and connective tissue disorders | 72/424 |
| HEADACHENervous system disorders | 63/424 |
| URINARY TRACT INFECTIONInfections and infestations | 47/424 |
| CYSTOID MACULAR OEDEMAEye disorders | 43/424 |
| UPPER RESPIRATORY TRACT INFECTIONInfections and infestations | 43/424 |
| COUGHRespiratory, thoracic and mediastinal disorders | 42/424 |
| BRONCHITISInfections and infestations | 38/424 |
| FATIGUEGeneral disorders | 36/424 |
Safety population
| Age, Continuous(years) | Adalimumab |
|---|---|
| Mean | 43.44 ± 14.066 |
| Sex: Female, Male(Participants) | Adalimumab |
|---|---|
| Female | 249 |
| Male | 175 |
| Ethnicity (NIH/OMB)(Participants) | Adalimumab |
|---|---|
| Hispanic or Latino | 77 |
| Not Hispanic or Latino | 347 |
| Unknown or Not Reported | 0 |
No study locations are listed for this record.
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Studies of the drug tested here: Adalimumab