Safety parameters
| Primary system organ class preferred term | Placebo (n=51) N (%) | SAR 100 mg q2w (n=51) N (%) | SAR 150 mg q2w (n=52) N (%) | SAR 100 mg qw (n=50) N (%) | SAR 200 mg q2w (n=51) N (%) | SAR 150 mg qw (n=50) N (%) |
|---|---|---|---|---|---|---|
| (A) Safety overview | ||||||
| Any TEAE | 24 (47.1) | 22 (43.1) | 28 (53.8) | 36 (72.0) | 33 (64.7) | 27 (54.0) |
| Any treatment-emergent SAE | 2 (3.9) | 3 (5.9) | 0 | 3 (6.0) | 0 | 0 |
| Any TEAE leading to treatment discontinuation | 2 (3.9) | 4 (7.8) | 2 (3.8) | 13 (26.0) | 4 (7.8) | 3 (6.0) |
| Deaths | 0 | 1 | 0 | 0 | 0 | 0 |
| (B) Treatment-emergent serious adverse events | ||||||
| Basal cell carcinoma | 1 (2.0) | 0 | 0 | 0 | 0 | 0 |
| Plasmacytoma | 0 | 1 (2.0) | 0 | 0 | 0 | 0 |
| Squamous cell carcinoma | 1 (2.0) | 0 | 0 | 0 | 0 | 0 |
| Neutropenia | 0 | 0 | 0 | 1 (2.0) | 0 | 0 |
| Hypersensitivity | 0 | 0 | 0 | 1 (2.0) | 0 | 0 |
| Cerebrovascular accident | 0 | 1 (2.0) | 0 | 0 | 0 | 0 |
| Acute respiratory distress syndrome | 0 | 1 (2.0) | 0 | 0 | 0 | 0 |
| Alcoholic pancreatitis | 0 | 0 | 0 | 1 (2.0) | 0 | 0 |
| Arthralgia | 1 (2.0) | 0 | 0 | 0 | 0 | 0 |
| RA | 0 | 1 (2.0) | 0 | 0 | 0 | 0 |
| (C) TEAEs occurring in ≥5% of patients | ||||||
| Infections and infestations | 7 (13.7) | 6 (11.8) | 12 (23.1) | 13 (26.0) | 12 (23.5) | 10 (20.0) |
| Nasopharyngitis | 3 (5.9) | 2 (3.9) | 2 (3.8) | 2 (4.0) | 2 (3.9) | 1 (2.0) |
| Upper respiratory tract infection | 2 (3.9) | 0 | 2 (3.8) | 1 (2.0) | 3 (5.9) | 2 (4.0) |
| Urinary tract infection | 1 (2.0) | 1 (2.0) | 1 (1.9) | 3 (6.0) | 1 (2.0) | 0 |
| Blood and lymphatic system disorders | 0 | 1 (2.0) | 1 (1.9) | 9 (18.0) | 11 (21.6) | 6 (12.0) |
| Neutropenia | 0 | 0 | 1 (1.9) | 7 (14.0) | 10 (19.6) | 5 (10.0) |
| Musculoskeletal/connective tissue | 5 (9.8) | 5 (9.8) | 1 (1.9) | 1 (2.0) | 2 (3.9) | 5 (10.0) |
| RA | 1 (2.0) | 2 (3.9) | 0 | 0 | 0 | 3 (6.0) |
| Investigations | 3 (5.9) | 0 | 4 (7.7) | 3 (6.0) | 3 (5.9) | 2 (4.0) |
| ALT increased | 0 | 0 | 3 (5.8) | 2 (4.0) | 2 (3.9) | 2 (4.0) |
| Injury/poisoning/procedural complications | 6 (11.8) | 1 (2.0) | 5 (9.6) | 2 (4.0) | 6 (11.8) | 3 (6.0) |
| Accidental overdose* | 5 (9.8) | 1 (2.0) | 3 (5.8) | 2 (4.0) | 2 (3.9) | 3 (6.0) |
All patients received methotrexate 10–25 mg/week.
*Accidental overdose was defined as the administration of at least twice the treatment dose during an interval of less than 6 days (qw regimen) or less than 11 days (q2w regimen). There were no adverse events associated with these protocol-defined overdoses.
ALT, alanine aminotransferase; q2w, every 2 weeks; qw, every week; RA, rheumatoid arthritis; SAE, serious adverse event; SAR, sarilumab; TEAE, treatment-emergent adverse event.