KEVZARA EFFICACY

SIGNS AND SYMPTOMS

CONTROL OF IL-6–RELATED SIGNS AND SYMPTOMS

RELEVANT TRIALS: MOBILITY, TARGET, MONARCH

Pivotal Trial Study Designs

MONARCH data are not included in the KEVZARA US full Prescribing Information. Please see Study Context and Limitations for details.

RAPIDLY NORMALIZED CRP LEVELS1,2

CRP levels returned to normal (<10 mg/L) as early as 2 weeks after the first dose of KEVZARA.3,4*

mobility (mtx-ir)
target (tnf-ir)
monarch (mtx-ir)
Changes in CRP levels over a 24 week period with KEVZARA® (sarilumab)
  • *CRP levels were not a prespecified endpoint. Studied as part of the ACR20/50/70 response endpoints in MOBILITY, TARGET, MONARCH.3,5
  • CRP=C-reactive protein; MTX-IR=methotrexate inadequate response; TNF-IR=tumor necrosis factor inhibitor inadequate response or intolerant; LS=least squares; MTX=methotrexate; q2w=once every 2 weeks; DMARDs=disease-modifying antirheumatic drugs; ACR20=American College of Rheumatology 20% improvement criteria.

REDUCTIONS IN MORNING STIFFNESS5,6

target (tnf-ir)
monarch (mtx-ir)
Reductions in morning stiffness with KEVZARA® (sarilumab)
  • Morning stiffness was not assessed in MOBILITY.
  • TNF-IR=tumor necrosis factor inhibitor inadequate response or intolerant; MTX-IR=methotrexate inadequate response; LS=least squares; VAS=visual analogue scale; DMARDs=disease-modifying antirheumatic drugs; q2w=once every 2 weeks.

REDUCTIONS IN PAIN2,5,7

mobility (mtx-ir)
target (tnf-ir)
monarch (mtx-ir)
Reductions in pain with KEVZARA® (sarilumab)
  • MTX-IR=methotrexate inadequate response; TNF-IR=tumor necrosis factor inhibitor inadequate response or intolerant; LS=least squares; VAS=visual analogue scale; MTX=methotrexate; q2w=once every 2 weeks; DMARDs=disease-modifying antirheumatic drugs.

References:

  • Data on file, Sanofi/Regeneron. Integrated summary. October 25, 2019.
  • 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.
  • KEVZARA [prescribing information]. Bridgewater, NJ: Sanofi/Regeneron Pharmaceuticals, Inc.
  • Center for Devices and Radiological Health. Guidance for industry and FDA staff: review criteria for assessment of C-reactive protein (CRP), high sensitivity C-reactive protein (hsCRP) and cardiac C-reactive protein (cCRP) assays. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/review-criteria-assessment-c-reactive-protein-crp-high-sensitivity-c-reactive-protein-hscrp-and-0. Accessed September 3, 2020.
  • Strand V, Reaney M, Chen CI, et al. Sarilumab improves patient-reported outcomes in rheumatoid arthritis patients with inadequate response/intolerance to tumour necrosis factor inhibitors. RMD Open. 2017;3(1):e000416. doi:10.1136/rmdopen-2016-000416.
  • Strand V, Gossec L, Proudfoot CWJ, et al. Patient-reported outcomes from a randomized phase III trial of sarilumab monotherapy versus adalimumab monotherapy in patients with rheumatoid arthritis. Arthritis Res Ther. 2018;20(1):129. doi:10.1186/s13075-018-1614-z.
  • Strand V, Kosinski M, Chen CI, et al. Sarilumab plus methotrexate improves patient-reported outcomes in patients with active rheumatoid arthritis and inadequate responses to methotrexate: results of a phase III trial. Arthritis Res Ther. 2016;18:198. doi:10.1186/s13075-016-1096-9.