Most frequently reported adverse events*
Adverse event | Adalimumab sc | All regimens (n = 434) | Placebo (n = 110) | |||
---|---|---|---|---|---|---|
20 mg | 40 mg | |||||
Every other week (n = 106) | Weekly (n = 112) | Every other week (n = 113) | Weekly (n = 103) | |||
Results are shown as No (%) | ||||||
*Occurring in ⩾10% of patients in any treatment group; †p⩽0.05 v placebo. | ||||||
sc, subcutaneous. | ||||||
Clinical flare reaction | 25 (23.6) | 22 (19.6) | 18 (15.9) | 16 (15.5) | 81 (18.7) | 24 (21.8) |
Rhinitis | 11 (10.4) | 21 (18.8) | 21 (18.6) | 22 (21.4) | 75 (17.3) | 12 (10.9) |
Headache | 22 (20.8) | 20 (17.9) | 24 (21.2) | 21 (20.4) | 87 (20.0)† | 11 (10.0) |
Rash | 15 (14.2) | 18 (16.1) | 23 (20.4) | 12 (11.7) | 68 (15.7)† | 6 (5.5) |
Injection site reaction | 5 (4.7) | 13 (11.6) | 11 (9.7) | 17 (16.5) | 46 (10.6)† | 1 (0.9) |
Sore throat | 14 (13.2) | 4 (3.6) | 11 (9.7) | 5 (4.9) | 34 (7.8) | 7 (6.4) |
Back pain | 9 (8.5) | 4 (3.6) | 7 (6.2) | 13 (12.6) | 33 (7.6) | 4 (3.6) |
Gastrointestinal pain | 13 (12.3) | 5 (4.5) | 5 (4.4) | 3 (2.9) | 26 (6.0) | 5 (4.5) |
Pruritus | 11 (10.4) | 8 (7.1) | 13 (11.5) | 9 (8.7) | 41 (9.4)† | 1 (0.9) |
Nausea | 8 (7.5) | 8 (7.1) | 9 (8.0) | 11 (10.7) | 36 (8.3) | 8 (7.3) |
Diarrhoa | 6 (5.7) | 7 (6.3) | 8 (7.1) | 3 (2.9) | 24 (5.5) | 11 (10.0) |