Background
Methods
Patients and study design
Efficacy and safety outcomes
Statistical analysis
Results
Patient disposition and baseline characteristics
eoJIA n = 55 | ERA n = 31 | PsA n = 23 | Total n = 109 | |
---|---|---|---|---|
% of CLIPPER | 92% (55/60) | 82% (31/38) | 79% (23/29) | 86% (109/127) |
Age, yearsa | 10.6 (4.6) | 16.2 (1.6) | 15.8 (2.4) | 13.3 (4.5) |
Femalea | 38 (69) | 5 (16) | 18 (78) | 61 (56) |
JIA core set | ||||
Physician Global Assessment of disease activity, 0–100 score | 1.0 (1.4) n = 49 | 0.7 (0.7) n = 30 | 0.8 (1.0) n = 19 | 0.8 (1.2) n = 98 |
Number of active jointsa | 0.6 (1.0) n = 40 | 0.7 (1.2) n = 28 | 1.3 (4.6) n = 19 | 0.8 (2.3) n = 87 |
Number of joints with LOMa | 0.8 (1.1) n = 40 | 1.4 (3.2) n = 28 | 1.7 (5.0) n = 19 | 1.2 (3.0) n = 87 |
C-reactive protein, mg/La (normal < 5 mg/L) | 3.9 (8.5) n = 47 | 2.7 (4.1) n = 27 | 1.1 (0.2) n = 18 | 3.0 (6.5) n = 92 |
PtGA scorea | 1.4 (2.0) | 1.0 (1.3) | 1.3 (1.5) | 1.3 (1.7) |
CHAQ scorea | 0.3 (0.6) n = 47 | 0.1 (0.2) n = 20 | 0.2 (0.3) n = 13 | 0.2 (0.5) n = 80 |
JADAS 73 scorea | 3.5 (4.7) n = 37 | 2.3 (2.2) n = 25 | 3.3 (5.4) n = 18 | 3.1 (4.3) n = 80 |
Additional measures | ||||
Overall back pain VAS, mma | – n = 0 | 2.3 (4.8) n = 26 | – n = 0 | 2.3 (4.8) n = 26 |
Nocturnal back pain VAS, mma | – n = 0 | 2.1 (3.7) n = 26 | – n = 0 | 2.1 (3.7) n = 26 |
Psoriasis BSA, percentagea | – n = 0 | – n = 0 | 1.4 (2.4) n = 19 | 1.4 (2.4) n = 19 |
PGA of psoriasisa | – n = 0 | – n = 0 | 0.6 (0.9) n = 19 | 0.6 (0.9) n = 19 |
Baseline therapiesb | ||||
Any DMARD | 50 (91) | 28 (90) | 19 (83) | 97 (89) |
Methotrexate | 45 (82) | 17 (55) | 16 (70) | 78 (72) |
Oral corticosteroid | 7 (13) | 7 (23) | 1 (4) | 15 (14) |
Oral NSAID | 26 (47) | 19 (61) | 9 (39) | 54 (50) |
Efficacy
Safety
eoJIA n = 60 | ERA n = 38 | PsA n = 29 | Total N = 127 | |
---|---|---|---|---|
Exposure, patient-years | 245.6 | 158.9 | 119.9 | 524.4 |
TEAEs (excluding infections and injection site reactions), n (n/100PY) | 244 (99.4) | 151 (95.0) | 90 (75.0) | 485 (92.5) |
Infections, n (n/100PY) | 351 (142.9) | 93 (58.5) | 117 (97.5) | 561 (107.0) |
TEAEs causing withdrawal (excluding infections and injection site reactions), n (n/100PY) | 5 (2.0) | 8 (5.0) | 0 | 13 (2.5) |
Infections causing withdrawal, n (n/100PY) | 2 (0.8) | 0 | 1 (0.8) | 3 (0.6) |
Serious TEAEs, n (n/100PY) | 11 (4.5) | 17 (10.7) | 4 (3.3) | 32 (6.1) |
Serious infections, n (n/100PY) | 5 (2.0) | 4 (2.5) | 4 (3.3) | 13 (2.5) |
Opportunistic infectionsa, n (n/100PY) | 0 | 1 (0.6) | 1 (0.8) | 2 (0.4) |
Autoimmune disordersb, n (n/100PY) | 4 (1.6) | 4 (2.5) | 2 (1.7) | 10 (1.9) |
Malignancies, n (n/100PY) | 1 (0.4) | 0 | 0 | 1 (0.2) |