Table 2

Investigator-reported treatment-emergent AEs in the double-blind study and the open-label extension combined

AEnE (nE/100 PY)
Sarilumab 150 mg initial dose + MTXSarilumab 200 mg initial dose*+ MTXAny sarilumab dose†+ MTX
Summary
Any AE299 (182.3)668 (142.0)1041 (137.7)
SAE36 (10.3)183 (9.9)313 (9.1)
AE leading to discontinuation56 (16.1)172 (8.4)318 (8.4)
AE leading to death2 (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, PY355.52082.53826.0
Injection-site erythema77 (21.7)267 (12.8)518 (13.5)
Neutropenia64 (18.0)235 (11.3)491 (12.8)
Upper respiratory tract infection47 (13.2)145 (7.0)289 (7.6)
Accidental overdose¶30 (8.4)137 (6.6)220 (5.8)
Urinary tract infection24 (6.8)124 (6.0)213 (5.6)
ALT increased43 (12.1)108 (5.2)211 (5.5)
Viral upper respiratory tract infection32 (9.0)84 (4.0)172 (4.5)
Bronchitis19 (5.3)104 (5.0)173 (4.5)
Injection-site pruritus28 (7.9)75 (3.6)132 (3.5)
Influenza19 (5.3)53 (2.5)111 (2.9)
Headache22 (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.