SIGNS AND SYMPTOMS
RELEVANT TRIALS: MOBILITY, TARGET, MONARCH
MONARCH STUDY DESIGN: A 24-week, randomized, double-blind, double-dummy, phase 3 superiority study to evaluate the efficacy and safety of KEVZARA 200 mg q2w monotherapy (n=184) vs adalimumab 40 mg q2w monotherapy (n=185) in patients who should not continue treatment with MTX due to intolerance or inadequate response.*†‡ The primary endpoint was ΔDAS28-ESR; secondary endpoints included ΔDAS28-ESR <2.6, ACR20/50/70, ΔDAS28-CRP, ΔHAQ-DI.1
PRIMARY ENDPOINT DATA1
q2w=once every 2 weeks; MTX=methotrexate; DAS28-ESR=Disease Activity Score-28 Erythrocyte Sedimentation Rate; ACR20=American College of Rheumatology 20% improvement criteria; DAS28-CRP=disease activity score 28-C-reactive protein; HAQ-DI=Health Assessment Questionnaire-Disability Index; ITT=intent to treat; TJC=tender joint count; SJC=swollen joint count; SC=subcutaneous; qw=once daily.
References: 1. 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. 2. Humira [package insert]. North Chicago, IL: AbbVie Inc; 2019.
MONARCH ADDITIONAL STUDY CONTEXT
USE OF ADALIMUMAB
STUDY LIMITATIONS (MONARCH)
Given the limitations and context described above, caution should be used in interpreting these data.
MONARCH data are not included in the KEVZARA US full Prescribing Information. Please see Study Context and Limitations for details.
CRP levels returned to normal (<10 mg/L) as early as 2 weeks after the first dose of KEVZARA.3,4*
DMARDs=disease-modifying antirheumatic drugs; ALT=alanine aminotransferase; ANC=absolute neutrophil count; GI=gastrointestinal.
Reference: 1. KEVZARA [prescribing information]. Bridgewater, NJ: Sanofi/Regeneron Pharmaceuticals, Inc.
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 adalimumab3
References: 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]. 2. Data on file, Sanofi/Regeneron. Integrated summary. October 25, 2019. 3. 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.