Patients characteristics at study treatment onset
| Adalimumab (n=16) | Placebo (n=15) | All patients (n=31) | |
| Demographic features | |||
| Female, n (%) | 15 (94) | 13 (87) | 28 (90) |
| Age, years, median (range) | 10.8 (5.0–20.3) | 9.2 (4.9–29.1) | 9.5 (4.9–29.1) |
| Patients <13 years, n (%) | 12 (75) | 12 (80) | 24 (77) |
| Weight, kg, median (range) | 32.7 (17.9–74) | 29.5 (-62.2) | 31.6 (17.9–74) |
| Juvenile idiopathic arthritis (JIA) features | |||
| JIA duration, years, median (range) | 6.0 (1.8–12.6) | 5.5 (0.4–27.9) | 5.6 (0.4–27.9) |
| Oligoarticular-onset JIA, n (%) | 12 (75) | 13 (87) | 25 (81) |
| Others JIA categories, n (%) | 2* (13) | 2* (13) | 4* (13) |
| Positive antinuclear antibodies | 14 (88) | 13 (87) | 27 (87) |
| Chronic uveitis, no arthritis, n (%) | 2 (13) | 0 (0) | 2 (6) |
| No. of active joints, median (range) | 0 (0–3) | 0 (0–4) | 0 (0–4) |
| No. of joints with LOM, median (range) | 0 (0–9) | 0 (0–1) | 0 (0–9) |
| CHAQ, median (range) | 0 (0–1) | 0 (0–0.625) | 0 (0–1) |
| Physician VAS, median (range) | 0 (0–45) | 0 (0–15) | 0 (0–45 |
| Patient/parent VAS, median (range) | 0 (0–14) | 0 (0–48) | 0 (0–48) |
| ESR, median (range) | 5.5 (2.0–15.0) | 6.5 (2-30) | 6.0 (2-30) |
| CRP, median (range) | 6 (1–30.0) | 6 (1-6) | 6 (1-30) |
| Ophthalmologic features | |||
| Uveitis median duration, years (range) | 4.4 (0.4–8.9) | 4.8 (0.6–24.2) | 4.7 (0.4–24.2) |
| Bilateral uveitis, patients n (%) | 10 (67) | 14 (93) | 24 (80) |
| Band keratopathy, patients n (%) | 13/15 (87) | 10 (67) | 23/30 (77) |
| Cataract, patients n (%) | 9/11 (82) | 5/13 (38) | 14/25 (56) |
| Posterior synechiae, patients n (%) | 12/14 (86) | 10/15 (67) | 22/29 (76) |
| Vitritis, patients n (%) | 8/15 (53) | 9/15 (60) | 17/30 (57) |
| Macular oedema*, patients n (%) | 8/15(53) | 6/15 (40) | 14/30 (47) |
| Visual acuity†, median (range) | 0.1 [−0.2–1.3) | 0.0 (−0.2–1.0) | 0.1 (−0.2–1.3) |
| Main characteristics of the eye evaluated for the primary outcome | |||
| Laser flare (ph/ms), median (range) | 99 (23–322) | 70 (36–265) | 73 (23–322) |
| Slit lamp protein | |||
| SUN 0, patients n (%) | 3 (19) | 1 (7) | 4 (13) |
| SUN 1, patients n (%) | 5 (31) | 5 (33) | 10 (32) |
| SUN 2, patients n (%) | 7 (44) | 8 (53) | 15 (48) |
| SUN 3, patients n (%) | 1 (6) | 1 (7) | 2 (6) |
| Slit lamp cells | |||
| SUN 0, patients n (%) | 3 (19) | 3 (20) | 6 (19) |
| SUN 0.5, patients n (%) | 5 (31) | 4 (27) | 9 (29) |
| SUN 1, patients n (%) | 7 (44) | 3 (20) | 10 (32) |
| SUN 2, patients n (%) | 1 (6) | 4 (27) | 5 (16) |
| SUN 3, patients n (%) | 0 (0) | 1 (7) | 1 (3) |
| Previous treatments | |||
| Oral steroids, patients n (%) | 9 (56) | 8 (53) | 17 (55) |
| MTX, patients n (%) | 16 (100) | 15 (100) | 31 (100) |
| Etanercept, patients n (%) | 2 (13) | 2 (13) | 4 (13) |
| Ongoing treatments at D0 (median doses and range for patients on treatment) | |||
| Patients on steroids eye drops‡, n (%) | 12 (75) | 10 (67) | 22 (71) |
| Dexamethasone eye drops, n (range)‡ | 3 (1-6) | 3 (1-5)= | 3 (1-6) |
| Oral steroids, patients n (%) | 7 (44) | 3 (20) | 10 (32) |
| Predn. daily dose (mg), median (range) | 5 (1-12) | 2 (2-15) | 5 (1-15) |
| MTX, patients n (%) | 15 (94) | 11 (73) | 26 (84) |
| MTX dose in mg/week, median (range) | 12.5 (5-20) | 12.5 (7.5–17.5) | 12.5 (5-20) |
| MTX in mg/m2/week, median (range) | 11.3 (3.4–14.5) | 12.3 (7.2–15.8) | 11.5 (3.4–15.8) |
*Two cases of rheumatoid factor negative polyarticular JIA in the adalimumab group, two cases of unclassified JIA in the placebo group.
†Macular thickness was measured by optical coherence tomography and values superior to 320 microns were considered sufficient to confirm macular oedema.
‡Expressed in log (MAR), most of patients were evaluated using ETDRS charts but Monoyer and Snellen charts had also been used in a few cases.
§Eye evaluated for the primary outcome.
CHAQ, Childhood Health Assessment Questionnaire; CRP, C reactive protein; ESR, erythrocyte sedimentation rate; JIA, juvenile idiopathic arthritis; LOM, joints with limitation of motion; MTX, methotrexate; n, number; Predn., prednisone or prednisolone; SUN, Standardised Uveitis Nomenclature; VAS, visual analogue scale (from 0 to 100) allowing to measure JIA disease activity.