Table 2.
AEs summary up to 16 weeks
| AEs, n (%) | Placebo | Risankizumab | ||
| (n=40) | 18 mg (n=40) | 90 mg (n=39) | 180 mg (n=40) | |
| Any AE | 26 (65) | 28 (70) | 22 (56.4) | 26 (65) |
| Infections and infestations | 13 (32.5) | 16 (40) | 11 (28.2) | 10 (25) |
| Musculoskeletal and connective tissue disorder | 14 (35) | 6 (15) | 5 (12.8) | 7 (17.5) |
| Severe AEs | 1 (2.5) | 1 (2.5) | 1 (2.6) | 0 |
| Drug-related AEs | 7 (17.5) | 10 (25) | 9 (23.1) | 8 (20) |
| AEs leading to discontinuation | 3 (7.5) | 0 | 0 | 0 |
| Serious infections | 0 | 0 | 0 | 0 |
| Serious AEs | 2 (5) | 0 | 2 (5.1) | 1 (2.5) |
| Common AEs* | ||||
| Nasopharyngitis | 3 (7.5) | 6 (15) | 4 (10.3) | 10 (25) |
| Influenza | 1 (2.5) | 2 (5) | 2 (5.1) | 4 (10) |
| Sinusitis | 1 (2.5) | 0 | 2 (5.1) | 1 (2.5) |
| Arthralgia | 4 (10) | 0 | 2 (5.1) | 1 (2.5) |
| Back pain | 2 (5) | 3 (7.5) | 1 (2.6) | 2 (5.0) |
| Fatigue | 2 (5) | 2 (5) | 1 (2.6) | 4 (10) |
| Diarrhoea | 0 | 2 (5) | 1 (2.6) | 3 (7.5) |
| Headache | 3 (7.5) | 5 (12.5) | 3 (7.7) | 4 (10) |
| Dizziness | 0 | 0 | 2 (5.1) | 1 (2.5) |
| Increased blood CPK | 3 (7.5) | 1 (2.5) | 2 (5.1) | 1 (2.5) |
| Eczema | 1 (2.5) | 0 | 2 (5.1) | 0 |
| Renal colic | 0 | 0 | 2 (5.1) | 0 |
AEs were coded using MedDRA V.19.0. The severity of AEs was graded according to RCTC V.2.0.
*Common AEs were reported in at least 5% of patients in any treatment group.
AE, adverse event; CPK, creatine phosphokinase; MedDRA, Medical Dictionary for Regulatory Activities; RCTC, Rheumatology Common Toxicity Criteria.