Proven Safety Profile



Common adverse reactions in pre-rescue, placebo-controlled trials with KEVZARA® (sarilumab) combination therapy
  • *Adverse reactions occurring in ≥2% of patients administered KEVZARA 200 mg or KEVZARA 150 mg + DMARD(s) and greater than observed in patients on placebo + DMARD(s).
  • Medically relevant AE occurring at an incidence of less than 2% in patients with RA treated with KEVZARA in controlled studies was oral herpes1
  • Decrease in ANC was not associated with higher incidence of infections, including serious infections1
  • In the long-term safety population, the overall rates of serious infections, GI perforations, neutrophil counts, platelet counts, and lipid parameters were consistent with what was observed in the placebo-controlled trials1

ANC=absolute neutrophil count; GI=gastrointestinal.


Mean duration of treatment in the safety population (N=2887) was 2.8 years (max 7.3 years), representing 8188 cumulative PY of observation

  • 773 patients (27%) were treated for ≥240 weeks (4.6 years)
  • 36 patients (1.2%) were treated for >360 weeks (7 years)

Incidence rate of AEs was generally stable over time, with no indication of increased incidence rate in serious AEs and serious infections.4

MOBILITY (MTX-IR), TARGET (TNF-IR), and long term safety populations2,3,5

MOBILITY (MTX-IR), TARGET (TNF-IR) and long-term safety populations treated with KEVZARA® (sarilumab) combination therapy

In the long-term safety population, the rate of thromboembolic events (MedDRA high-level group term "embolism and thrombosis") were 0.8 per 100 PY (as reported and evaluated post hoc; not a prespecified AESI)3

  • Rate of DVT was 0.2 per 100 PY; rate of PE was 0.2 per 100 PY3

Safety observations in the open-label extension population were consistent with those in the placebo-controlled trials.5,6

  • *Incidence rate per 100 PY at risk of first event.5
  • TEAE period, period from day of first treatment dose to 60 days after the last treatment dose.
  • Injection site reactions (including erythema and pruritis) were mild in severity for the majority of patients and necessitated drug discontinuation in 3 (<0.5%) patients receiving KEVZARA.5

MTX-IR=methotrexate inadequate response; TNF-IR=tumor necrosis factor inhibitor inadequate response or intolerant; PY=patient-years; AE=adverse event; IR=incidence rate; DMARDs=disease-modifying antirheumatic drugs; q2w=every 2 weeks; TEAE=treatment-emergent adverse event; ALT=alanine aminotransferase; AESI=adverse event of special interest; DVT=deep vein thrombosis; PE=pulmonary embolism.



KEVZARA monotherapy safety was studied in 471 patients, with more than 798 patient-years of exposure3

Mean exposure in the long-term safety population was 1.7 years (max 3.5 years)

  • 384 patients (82%) were treated for ≥60 weeks

Incidence rate of AEs was generally stable over time, with no indication for increased incidence rate3,6

MONARCH (MTX-IR) and MONARCH long-term safety populations and monotherapy long-term safety populations6-8

MONARCH (MTX-IR) and monotherapy long-term safety populations treated with KEVZARA® (sarilumab) monotherapy

In MONARCH, the safety profiles of KEVZARA and adalimumab were generally comparable, except for neutropenia and injection site erythema for KEVZARA and headache and RA for adalimumab7

Safety observations in the long-term population were generally consistent with those in the randomized, controlled population.6

  • *Adverse events reported for the long-term safety population were selected based on occurrence in ≥3% of patients in the randomized, controlled population in any treatment group.7
  • One patient was randomized, but not treated, in the adalimumab group and was not included in the safety population.7
  • In the randomized trial, 1 patient in the KEVZARA group died of acute cardiac failure secondary to aortic dissection and papillary muscle rupture on day 36.
  • §In the randomized trial, 1 patient receiving KEVZARA was diagnosed with infective bursitis and another patient was diagnosed with mastitis, and 1 patient receiving adalimumab was diagnosed with bacterial arthritis and another patient was diagnosed with a respiratory tract infection.7
  • ||Protocol defined as ≥2 doses within 11 calendar days or within 6 days for adalimumab-treated patients who switched to weekly dosing.7
  • Dyslipidemia was defined by standardized MedDRA query.7


  • KEVZARA [prescribing information]. Bridgewater, NJ: Sanofi/Regeneron Pharmaceuticals, Inc.
  • Data on file. Sanofi/Regeneron. ISS long-term safety pool 2_table 1.3.1.
  • Fleischmann R, Genovese M, Lin Y, et al. Long-term safety of sarilumab in rheumatoid arthritis: an integrated analysis with up to 7 years’ follow-up. Rheumatology (Oxford). 2019. doi:10.1093/rheumatology/kez265. (Epub ahead of print].
  • Data on file. Sanofi/Regeneron. EULAR poster SAT0172.
  • Data on file, Sanofi/Regeneron. EXTEND Integrated Summary of Safety. October 2015.
  • Data on file, Sanofi/Regeneron. Fleischmann ACR poster 2527. October 2018.
  • Burmester GR, Lin Y, Patel R, et al. Efficacy and safety of sarilumab monotherapy versus adalimumab monotherapy for the treatment of patients with active rheumatoid arthritis (MONARCH): a randomised, double-blind, parallel-group phase III trial. Ann Rheum Dis. 2017;76(5):840-847.
  • Data on file. Sanofi/Regeneron. Integrated summary of safety_appendix1-4. 2018.