Overview of adverse events (AEs). Results are shown as the number (%) of patients
| Placebo (n = 70) | Adalimumab | ||||
|---|---|---|---|---|---|
| 20 mg (n = 72) | 40 mg (n = 70) | 80 mg (n = 72) | All doses (n = 214) | ||
| *Changes in common toxicity criteria grade automatically generated laboratory AEs irrespective of the investigator’s opinion about their clinical relevance; †erythema and/or itching, haemorrhage, pain, or swelling at injection site. | |||||
| Comparison v placebo (Fisher’s exact test): ‡p⩽0.05; §p⩽0.01; ¶p⩽0.001. | |||||
| Patients with: | |||||
| Serious AE | 7 (10) | 2 (3) | 5 (7) | 9 (13) | 16 (7) |
| Severe or intractable AE | 19 (27) | 8 (11)‡ | 11 (16) | 14 (19) | 33 (15)‡ |
| Serious infection | 0 (0) | 0 (0) | 2 (3) | 2 (3) | 4 (2) |
| Malignancy | 0 (0) | 0 (0) | 0 (0) | 0 (0) | 0 (0) |
| Most frequently reported (10%) AEs | |||||
| Laboratory test abnormal* | 39 (56) | 33 (46) | 35 (50) | 29 (40) | 97 (45) |
| Hypercholesterolaemia (cholesterol >6.21 mmol/l) | 24 (34) | 32 (44) | 29 (41) | 31 (43) | 92 (43) |
| Haemoglobin ↓ | 31 (44) | 23 (32) | 27 (39) | 25 (35) | 75 (35) |
| Haemorrhage | 23 (33) | 16 (22) | 19 (27) | 15 (21) | 50 (23) |
| Hyperlipidaemia (triglycerides >2.26 mmol/l) | 13 (19) | 18 (25) | 22 (31) | 22 (31) | 62 (29) |
| Injection site reaction† | 4 (6) | 21 (29) | 16 (23)§ | 21 (29) | 58 (27) |
| Hyperuricaemia (uric acid 0.42 μmol/l (men), >5.7 μmol/l (women)) | 15 (21) | 13 (18) | 16 (23) | 19 (26) | 48 (22) |
| Haematuria (blood urea >500 mg/l) | 18 (26) | 16 (22) | 17 (24) | 9 (13) | 42 (20) |
| Blood urea nitrogen increased | 6 (9) | 11 (15) | 12 (17) | 12 (17) | 35 (16) |
| Clinical flare | 11 (16) | 5 (7) | 6 (9) | 6 (8) | 17 (8) |
| Rhinitis | 7 (10) | 11 (15) | 11 (16) | 7 (10) | 29 (14) |
| Alkaline phosphatase increased | 10 (14) | 10 (14) | 6 (9) | 10 (14) | 26 (12) |
| Alanine transaminase↑ | 6 (9) | 6 (8) | 1 (1) | 10 (14) | 17 (8) |
| Hypophosphataemia (phosphate <0.8 mmol/l) | 4 (6) | 0 (0) | 9 (13) | 4 (6) | 13 (6) |
| Rash | 6 (9) | 7 (10) | 9 (13) | 8 (11) | 24 (11) |
| Cough increased | 2 (3) | 9 (13) | 5 (7) | 3 (4) | 17 (8) |
| Pruritus | 4 (6) | 9 (13) | 8 (11) | 9 (13) | 26 (12) |
| Headache | 3 (4) | 9 (13) | 8 (11) | 3 (4) | 20 (9) |
| Hyperkalaemia (potassium >5 mmol/l) | 5 (7) | 8 (11) | 4 (6) | 7 (10) | 19 (9) |
| Proteinuria (urine protein 0.15 g/24 h) | 0 (0) | 5 (7) | 7 (10)‡ | 4 (6) | 16 (7)‡ |
| Hyponatraemia (sodium <135 mmol/l) | 7 (10) | 7 (10) | 7 (10) | 5 (7) | 19 (9) |