Summary of safety findings
| No. of subjects (%) | ||||
|---|---|---|---|---|
| eoJIA (n=60) | ERA (n=38) | PsA (n=29) | Overall (n=127) | |
| Treatment-emergent AEs* | 21 (35.0) | 16 (42.1) | 8 (27.6) | 45 (35.4) |
| Treatment-emergent AEs leading to withdrawal* | 0 | 2 (5.3) | 0 | 2 (1.6) |
| Treatment-emergent non-infectious AEs in ≥5% subjects | ||||
| Headache | 2 (3.3) | 2 (5.3) | 3 (10.3) | 7 (5.5) |
| Abdominal pain | 0 | 4 (10.5) | 0 | 4 (3.1) |
| Diarrhoea | 1 (1.7) | 3 (7.9) | 0 | 4 (3.1) |
| Fatigue | 0 | 4 (10.5) | 0 | 4 (3.1) |
| Pyrexia | 3 (5.0) | 1 (2.6) | 0 | 4 (3.1) |
| Aspartate aminotransferase increased | 3 (5.0) | 0 | 0 | 3 (2.4) |
| Myalgia | 0 | 3 (7.9) | 0 | 3 (2.4) |
| Decreased appetite | 0 | 2 (5.3) | 0 | 2 (1.6) |
| Back pain | 0 | 0 | 2 (6.9) | 2 (1.6) |
| Epistaxis | 0 | 2 (5.3) | 0 | 2 (1.6) |
| Respiratory disorder | 0 | 0 | 2 (6.9) | 2 (1.6) |
| Allergic rhinitis | 0 | 2 (5.3) | 0 | 2 (1.6) |
| Wheezing | 0 | 2 (5.3) | 0 | 2 (1.6) |
| Treatment-emergent ISRs | 4 (6.67) | 4 (10.53) | 2 (6.90) | 10 (7.87) |
| Treatment-emergent infections | 31 (51.7) | 15 (39.5) | 12 (41.4) | 58 (45.7) |
| Treatment-emergent infections leading to withdrawal | 1 (1.7) | 0 | 1 (3.4) | 2 (1.6) |
| Treatment-emergent infections ≥5% subjects | ||||
| Upper respiratory tract infection | 9 (15.0) | 4 (10.5) | 5 (17.2) | 18 (14.2) |
| Pharyngitis | 9 (15.0) | 4 (10.5) | 2 (6.9) | 15 (11.8) |
| Rhinitis | 4 (6.7) | 2 (5.3) | 2 (6.9) | 8 (6.3) |
| Gastroenteritis | 3 (5.0) | 1 (2.6) | 1 (3.4) | 5 (3.9) |
| Bronchitis | 1 (1.7) | 3 (7.9) | 0 | 4 (3.1) |
| Sinusitis | 3 (5.0) | 0 | 0 | 3 (2.4) |
| Treatment-emergent SAEs* | 0 | 1 (2.6) | 0 | 1 (0.8) |
| Serious treatment-emergent infections | 2 (3.3) | 0 | 1 (3.4) | 3 (2.4) |
| Infections considered preventable by vaccination in subjects not previously vaccinated | 1 (1.7) | 1 (2.6) | 0 | 2 (1.6) |
| Medically important infections | 2 (3.3) | 0 | 1 (3.4) | 3 (2.4) |
| Opportunistic infections | 0 | 1 (2.6) | 0 | 1 (0.8) |
No incidences of serious treatment-emergent injection site reactions (ISRs), infections considered preventable by vaccination in subjects previously vaccinated, autoimmune disorders, demyelinating disorders, malignancies were reported and therefore not included in this table.
*Excluding infections and ISRs.
AEs, adverse events; ERA, enthesitis-related arthritis; eoJIA, extended oligoarticular juvenile idiopathic arthritis; PsA, psoriatic arthritis; SAEs, serious AEs.