Table 2.
Investigator-reported treatment-emergent AEs in the double-blind study and the open-label extension combined
| AE | nE (nE/100 PY) | ||
| Sarilumab 150 mg initial dose + MTX | Sarilumab 200 mg initial dose*+ MTX | Any sarilumab dose†+ MTX | |
| Summary ‡ | |||
| Any AE | 299 (182.3) | 668 (142.0) | 1041 (137.7) |
| SAE | 36 (10.3) | 183 (9.9) | 313 (9.1) |
| AE leading to discontinuation | 56 (16.1) | 172 (8.4) | 318 (8.4) |
| AE leading to death | 2 (0.6) | 7 (0.3) | 16 (0.4) |
| AEs with incidence rate ≥ 5 per 100 PY in any dose group § | |||
| Cumulative total AE observation period, PY | 355.5 | 2082.5 | 3826.0 |
| Injection-site erythema | 77 (21.7) | 267 (12.8) | 518 (13.5) |
| Neutropenia | 64 (18.0) | 235 (11.3) | 491 (12.8) |
| Upper respiratory tract infection | 47 (13.2) | 145 (7.0) | 289 (7.6) |
| Accidental overdose¶ | 30 (8.4) | 137 (6.6) | 220 (5.8) |
| Urinary tract infection | 24 (6.8) | 124 (6.0) | 213 (5.6) |
| ALT increased | 43 (12.1) | 108 (5.2) | 211 (5.5) |
| Viral upper respiratory tract infection | 32 (9.0) | 84 (4.0) | 172 (4.5) |
| Bronchitis | 19 (5.3) | 104 (5.0) | 173 (4.5) |
| Injection-site pruritus | 28 (7.9) | 75 (3.6) | 132 (3.5) |
| Influenza | 19 (5.3) | 53 (2.5) | 111 (2.9) |
| Headache | 22 (6.2) | 41 (2.0) | 83 (2.2) |
*Including placebo patients from the double-blind phase who switched to sarilumab 200 mg in the open-label extension.
†Any dose includes exposure on all sarilumab doses.
‡Incidence rate (nE/100 PY) for summary is over time to first event.
§Incidence rate (nE/100 PY) is over cumulative total AE observation period.
¶Administration of two or more doses of study drug during an interval <11 days.
AE, adverse event; ALT, alanine aminotransferase; MTX, methotrexate; nE, number of events; nE/100 PY, number of events per 100 PY; PY, patient-years; SAE, serious adverse event.