Treatment-emergent adverse events (AE) through Week 20 reported in ≥ 5% of patients in either treatment group.
| MedDRA* Terms | Incidence, n (%) | |
|---|---|---|
| Placebo, n = 330 | Rilonacept 160 mg, n = 985 | |
| Patients with any AE | 195 (59.1) | 656 (66.6) |
| Treatment-related AE | 43 (13.0) | 271 (27.5) |
| Serious AE | 13 (3.9) | 31 (3.1) |
| Serious treatment-related AE | 2 (0.6) | 1 (0.1) |
| Deaths | 3 (0.9) | 3 (0.3) |
| AE resulting in withdrawal | 10 (3.0) | 46 (4.7) |
| Musculoskeletal and connective tissue disorders | 70 (21.2) | 206 (20.9) |
| Musculoskeletal and connective tissue pain and discomfort | 32 (9.7) | 110 (11.2) |
| Pain in extremity | 15 (4.5) | 52 (5.3) |
| Joint-related signs and symptoms | 24 (7.3) | 72 (7.3) |
| Arthralgia | 20 (6.1) | 65 (6.6) |
| Infections and infestations | 63 (19.1) | 198 (20.1) |
| Upper respiratory tract infections | 34 (10.3) | 98 (9.9) |
| General disorders and administration site conditions | 27 (8.2) | 189 (19.2) |
| Injection site reactions | 11 (3.3) | 150 (15.2) |
| Injection site erythema | 1 (0.3) | 61 (6.2) |
| Nervous system disorders | 41 (12.4) | 122 (12.4) |
| Headache NEC | 29 (8.8) | 94 (9.5) |
| Headache | 26 (7.9) | 90 (9.1) |
| Gastrointestinal disorders | 33 (10.0) | 109 (11.1) |
| Injury, poisoning, and procedural complications | 33 (10.0) | 105 (10.7) |
| Overdoses | 21 (6.4) | 55 (5.6) |
| Accidental overdose† | 20 (6.1) | 54 (5.5) |
| Skin and subcutaneous tissue disorders | 17 (5.2) | 66 (6.7) |
| Investigations‡ | 18 (5.5) | 83 (8.4) |
↵* MedDRA: the Medical Dictionary for Regulatory Activities terminology, version 12.0;
↵† Either due to additional injection of study drug following the last scheduled injection, or during the treatment period if a patient administered the injection too soon after the previously scheduled once-weekly injection.
↵‡ Term used for laboratory or other tests listed as an adverse event.