Table 3.
Safety results
| n (%) | Adalimumab 40 mg q2w (n=184)* |
Sarilumab 200 mg q2w (n=184) |
|---|---|---|
| Overall results | ||
| Patients with any AE | 117 (63.6) | 118 (64.1) |
| Patients with any SAE | 12 (6.5) | 9 (4.9) |
| Patients with any AE that led to treatment discontinuation | 13 (7.1) | 11 (6.0) |
| AEs (≥3% in any treatment group) | ||
| Infections | 51 (27.7) | 53 (28.8) |
| Bronchitis | 7 (3.8) | 12 (6.5) |
| Nasopharyngitis | 14 (7.6) | 11 (6.0) |
| Upper respiratory tract infection | 7 (3.8) | 3 (1.6) |
| Neutropenia | 1 (0.5) | 25 (13.6) |
| Headache | 12 (6.5) | 7 (3.8) |
| Rheumatoid arthritis | 7 (3.8) | 1 (0.5) |
| Injection site erythema | 6 (3.3) | 14 (7.6) |
| Alanine aminotransferase increased | 7 (3.8) | 7 (3.8) |
| Accidental overdose† | 11 (6.0) | 6 (3.3) |
| Dyslipidaemia‡ | 8 (4.3) | 3 (1.6) |
| Serious infections | ||
| Patients with at least one serious infection | 2 (1.1) | 2 (1.1) |
| Bursitis, infective | 0 | 1 (0.5) |
| Mastitis | 0 | 1 (0.5) |
| Arthritis, bacterial | 1 (0.5) | 0 |
| Respiratory tract infection | 1 (0.5) | 0 |
| Deaths§ | 0 | 1 (0.5) |
*One patient was randomised but not treated in the adalimumab group and was not included in the safety population.
†Protocol defined as ≥2 doses within 11 calendar days or within 6 days for adalimumab-treated patients who switched to weekly dosing.
‡Dyslipidaemia was defined by standardised MedDRA query.
§One patient in the sarilumab group died of acute cardiac failure secondary to aortic dissection and papillary muscle rupture on day 36.
AE, adverse event; MedDRA, Medical Dictionary for Regulatory Activities; q2w, every 2 weeks; SAE, serious adverse event.