Summary of safety analyses for CLASSIC II patients to the end of week 56
| Variable | Randomised cohort | Patients who received open-label treatment or discontinued by week 4 | Safety set total (n = 276) | ||
|---|---|---|---|---|---|
| Placebo (n = 18) | Adalimumab 40 mg eow (n = 19) | Adalimumab 40 mg weekly (n = 18) | Adalimumab 40 mg every other | ||
| week* (n = 221) | |||||
| *All patients entered the open-label period receiving adalimumab 40 mg every other week. Patients who flared or showed continued non-response could have their dosages increased to 40 mg weekly. | |||||
| †Squamous cell carcinoma. | |||||
| eow, every other week. | |||||
| Adverse events (n (%)) | 18 (100) | 15 (79) | 14 (78) | 207 (94) | 254 (92) |
| Adverse events leading to discontinuation of study drug (n (%)) | 2 (11) | 1 (5) | 1 (6) | 39 (18) | 43 (16) |
| Most frequently reported treatment-emergent adverse events (⩾5% of patients) | |||||
| Nasopharyngitis | 7 (39) | 5 (26) | 2 (11) | 37 (17) | 51 (19) |
| Crohn’s disease aggravated | 5 (28) | 4 (21) | 2 (11) | 48 (22) | 59 (21) |
| Sinusitis | 1 (6) | 4 (21) | 1 (6) | 20 (9) | 26 (9) |
| Patients with any type of injection-site reactions (n (%)) | 2 (12) | 1 (5) | 0 (0) | 26 (12) | 29 (12) |
| Patients with treatment-emergent infectious adverse events (n (%)) | 15 (83) | 14 (74) | 6 (33) | 127 (58) | 162 (59) |
| Malignancies (n (%)) | 1 (5)† | 0 (0) | 0 (0) | 0 (0) | 1 (0.4) |
| Serious adverse events (n (%)) | 2 (11) | 1 (5) | 0 (0) | 37 (17) | 40 (15) |
| Serious infections (n (%)) | 0 (0) | 0 (0) | 0 (0) | 9 (4) | 0 (0) |