Pooled analysis of the safety of IL-1 and IL-6 inhibition in systemic juvenile idiopathic arthritis and adult-onset Still’s disease
| Intervention | SAE | Infectious AE | Infectious SAE | Grades 3–4 neutropenia | Abnormal liver function tests | Macrophage activation syndrome | Infusion reactions | Injection site reactions | |
| Number of patient-years rate/100 patient-year (95% CI) | |||||||||
| IL-6 inhibition | TCZ | 1141 36.5 (33.1 to 40.2) | 855 104.6 (97.9 to 111.8) | 1083 12.9 (10.9 to 15.3) | 688 6.7 (4.9 to 8.9) | 687 10.3 (8.1 to 13.0) | 1141 2.7 (1.8 to 3.9) | 1094 4.8 (3.6 to 6.2) | NA |
| IL-1 inhibition | ALL | 1447 22.6 (20.2 to 25.2) | 1447 94.5 (89.5 to 99.6) | 1399 4.1 (3.1 to 5.3) | 1447 1.9 (1.3 to 2.8) | 1399 2.6 (1.8 to 3.6) | 1447 3.2 (2.3 to 4.2) | NA | 604 9.4 (7.1 to 12.2) |
| IL-1 inhibition | ANK | 739 10.4 (8.2 to 13.0) | 739 18.1 (15.2 to 21.5) | 739 3.2 (2.1 to 4.8) | 739 0.9 (0.4 to 2.0) | 739 0.9 (0.4 to 2.0) | 739 2.2 (2.4 to 3.5) | NA | 526 9.9 (7.4 to 13.0) |
| IL-1 inhibition | CAM | 605 38.9 (34.0 to 44.1) | 605 190.2 (179.3 to 201.4) | 605 4.8 (3.2 to 6.9) | 605 3.3 (2.2 to 5.1) | 605 4.6 (3.1 to 6.7) | 605 4.8 (3.2 to 6.9) | NA | 31 16.2 (5.2 to 37.6) |
| IL-1 inhibition | RIL | 103 14.6 (8.2 to 24.0) | 103 80.6 (64.2 to 99.9) | 103 3.9 (1.1 to 9.9) | 103 1.0 (0.3 to 5.4) | 103 1.9 (2.4 to 7.0) | 103 2.9 (0.6 to 8.5) | NA | 48 29.2 (16.0 to 48.9) |
AE, adverse events; ANK, anakinra; CAM, canakinumab; IL, interleukin; NA, not applicable; RIL, rilonacept; SAE, serious adverse events.