Changes from baseline in effectiveness measures at week 12
| Change from baseline at week 12, mean (95% CI) [%] | ||||
|---|---|---|---|---|
| JIA ACR core components | eoJIA n=58 | ERA n=36 | PsA n=29 | Overall n=123 |
| PGA of disease activity | −3.5 (−3.9 to −3.1) [−73.2%] | −3.9 (−4.6 to −3.3) [−70.9%] | −3.0 (−3.5 to −2.5) [−65.0%] | −3.5 (−3.8 to −3.2) [−70.6%] |
| Parent global assessment of child's overall well being | −2.8 (−3.5 to −2.2) [−53.1%] | −2.8 (−3.7 to −1.9) [−47.6%] | −2.4 (−3.1 to −1.6) [−47.7%] | −2.7 (−3.1 to −2.3) [−50.2%] |
| No. of active joints | −5.5 (−6.7 to −4.2) [−69.8%] | −4.3 (−5.4 to −3.1) [−77.7%] | −5.2 (−6.8 to −3.6) [−73.8%] | −5.1 (−5.8 to −4.3) [−73.0%] |
| No. of joints with LOM | −4.5 (−5.6 to −3.3) [−64.1%] | −3.4 (−4.1 to −2.6) [−67.4%] | −4.3 (−5.7 to −2.9) [−71.7%] | −4.1 (−4.8 to −3.4) [−66.9%] |
| CRP*, mg/l | −2.8 (−4.9 to −0.7) [−18.9%] | −13.2 (−20.5 to −5.8) [−36.8%] | −1.3 (−2.8 to −0.20) [−11.0%] | −5.4 (−7.8 to −2.9) [−22.1%] |
| CHAQ | −0.5 (−0.7 to −0.4) [−52.2%] | −0.5 (−0.7 to −0.3) [−57.8%] | −0.4 (−0.6 to −0.2) [−51.3%] | −0.5 (−0.6 to −0.4) [−53.6%] |
| Other assessments | ||||
| Parent global assessment of child's pain VAS | −3.2 (−3.8 to −2.5) [−58.9%] | −3.2 (−4.2 to −2.2) [−44.9%] | −2.6 (−3.4 to −1.8) [−46.6%] | −3.0 (−3.5 to −2.6) [−51.9%] |
| Morning stiffness (min) | −60.3 (−83.6 to −37.0) [−61.5%] | −65.6 (−97.6 to −33.6) [−64.1%] | −47.9 (−67.3 to −28.6) [−77.2%] | −58.9 (−73.7 to −44.1) [−66.0%] |
| JIA category-specific assessments | ||||
| Tender entheseal score | – | −4.4 (−6.3 to −2.4) [−57.8%] | – | – |
| Back pain VAS | – | −12.5 (−21.3 to −3.7) [−21.2%] | – | – |
| Nocturnal back pain VAS | – | −8.9 (−16.7 to −1.2) [−6.8%] | – | – |
| Modified Schober's test† | – | 0.35‡ (−0.02 to 0.72) [9.7%] | – | – |
| BSA, % | – | – | −6.7 (−10.6 to −2.9) [−48.2%] | – |
| PGA of psoriasis§ | – | – | −1.0 (−1.4 to −0.6) [−39.6%] | – |
All values are the mean change from baseline (95% CI) (% change from baseline). mITT population (observed cases).
*For CRP: eoJIA n=58, ERA n=34, PsA n=28 and total n=120.
†ERA n=35.
‡change from baseline calculated after subtracting 10 from the baseline and week 12 scores.
§PsA n=28.
ACR, American College of Rheumatology; BSA, body surface area; CHAQ, Childhood Health Assessment Questionnaire; CRP, C-Reactive Protein; eoJIA, extended oligoarticular Juvenile idiopathic arthritis; ERA, enthesitis-related arthritis; LOM, limitation of motion; mITT, modified intent-to-treat; PGA, physician global assessment; VAS, visual analogue scale.