Adverse events over 24 weeks (safety set)
| b-RELIEVED | b-RELIEVED-II | Pooled | ||||
|---|---|---|---|---|---|---|
| Variable, patients n (%) | Canakinumab 150 mg (n=113) | Triamcinolone acetonide 40 mg (n=115) | Canakinumab 150 mg (n=112) | Triamcinolone acetonide 40 mg (n=114) | Canakinumab 150 mg (n=225) | Triamcinolone acetonide 40 mg (n=229) |
| Any AE | 71 (62.8) | 56 (48.7) | 78 (69.6) | 65 (57.0) | 149 (66.2) | 121 (52.8) |
| Infection AEs | 25 (22.1) | 18 (15.7) | 21 (18.8) | 10 (8.8) | 46 (20.4) | 28 (12.2) |
| Any severe AE | 5 (4.4) | 7 (6.1) | 8 (7.1) | 3 (2.6) | 13 (5.8) | 10 (4.4) |
| Any SAE (non-fatal) | 11 (9.7)* | 5 (4.3)† | 6 (5.4)‡ | 2 (1.8)§ | 17 (7.6) | 7 (3.1) |
| Infection SAEs | 2 (1.8) | 0 | 2 (1.8) | 0 | 4 (1.8) | 0 |
| Death | 0 | 1 (0.9)¶ | 1 (0.9)†† | 0 | 1 (0.4) | 1 (0.4) |
| Injection-site reaction** | ||||||
| Subcutaneous | 0 | 0 | 2 (1.8) | 1 (0.9) | 2 (0.9) | 1 (0.4) |
| Intramuscular | 3 (2.7) | 0 | 6 (5.4) | 2 (1.8) | 9 (4.0) | 2 (0.9) |
| AEs reported in > 5% of patients in any treatment group | ||||||
| Headache | 7 (6.2) | 2 (1.7) | 4 (3.6) | 6 (5.3) | 11 (4.9) | 8 (3.5) |
| Hypertension | 7 (6.2) | 8 (7.0) | 5 (4.5) | 5 (4.4) | 12 (5.3) | 13 (5.7) |
| GGT increase | 6 (5.3) | 2 (1.7) | 2 (1.8) | 2 (1.8) | 8 (3.6) | 4 (1.7) |
| Arthralgia | 5 (4.4) | 1 (0.9) | 4 (3.6) | 9 (7.9) | 9 (4.0) | 10 (4.4) |
| Back pain | 5 (4.4) | 0 | 8 (7.1) | 2 (1.8) | 13 (5.8) | 2 (0.9) |
| Muscle spasms | 0 | 1 (0.9) | 3 (2.7) | 6 (5.3) | 3 (1.3) | 7 (3.1) |
↵* SAEs in the canakinumab group in β-RELIEVED were: angina pectoris; arrhythmia; myocardial ischaemia and renal artery occlusion; glaucoma; gastritis and chronic renal failure; spondylolisthesis, spinal cord ischaemia and lumbar spinal stenosis; jaw abscess; increased prostate-specific antigen; hyperglycaemia; device dislocation; and pneumonia.
↵† SAEs in the triamcinolone acetonide group in β-RELIEVED were: meniscus lesion; vertebrobasilar insufficiency; ischaemic stroke; and gouty arthritis.
↵‡ SAEs in the canakinumab group in β-RELIEVED-II were: gastroenteritis; convulsion; abscessed limb; atrial fibrillation; pancreatitis; and back pain and intervertebral disc protrusion.
↵§ SAEs in the triamcinolone acetonide group in β-RELIEVED-II were: diarrhoea, nausea, and vomiting; and aortic valve incompetence, aortic stenosis, worsening bicuspid aortic valve, and cardiomyopathy.
↵¶ Patient died from pulmonary embolism.
↵** Physicians assessed local tolerability at injection sites at 3 and 7 days postdose (for initial treatment and each retreatment) and at weeks 4, 8 and 12 after initial treatment.
↵†† Patient died from intracranial haemorrhage.
AE, adverse event; GGT, γ-glutamyltransferase; SAE, serious AE.