Session Type: ACR Poster Session C
Session Time: 9:00AM-11:00AM
Background/Purpose: Sarilumab is a human mAb blocking the IL-6Rα. Efficacy and safety of sarilumab as monotherapy and combination therapy have been reported.1-3 In MONARCH (NCT02332590), adults intolerant of, inappropriate for, or inadequate responders to methotrexate received subcutaneous sarilumab (200 mg every 2 weeks [q2w]) or adalimumab (40 mg) monotherapy for 24 weeks.2 Sarilumab monotherapy demonstrated superiority to adalimumab monotherapy in reducing disease activity and improving physical function in patients with active RA.2 Safety profiles of both therapies were consistent with published data. Patients in MONARCH who completed the initial double-blind phase could continue in the open-label extension (OLE) in which all patients received sarilumab 200 mg q2w monotherapy.
Methods: Disease activity, physical function, and safety were assessed regularly (Table). Data were used as observed.
Results: A total of 321 patients completed MONARCH, 320 of whom entered the OLE; 155 switched from adalimumab to sarilumab (switch group), and 165 remained on sarilumab (continuation group). At OLE entry, mean DAS28-ESR was 4.46 and DAS28-ESR ≤3.2 was 16.1% in the switch group vs 3.45 and 47.9%, respectively, in the continuation group (P<0.0001 for both endpoints). By week 24 of the OLE, the proportion of patients in the switch and continuation groups who achieved DAS28-ESR ≤3.2 was 49.7% vs 58.8% (P=0.1033), DAS28-ESR <2.6 was 40.0% and 42.4% (P=0.6586), CDAI remission was 12.3% and 18.8% (P=0.1054), and improvement in HAQ-DI of ≥0.3 was 63.9% and 66.7% (P=0.6004), respectively. At week 24 of the OLE, treatment-emergent adverse events (TEAEs; 63.9% vs 57.9%), serious TEAEs (9.0% vs 1.2%), infections (34.2% vs 23.6%), and serious infections (1.9% vs 0%) were observed in the switch and continuation groups, respectively, with 1 death in the switch group (malignancy) and no deaths in the continuation group. Discontinuations due to TEAEs occurred in 5.8% of patients in the switch group and 3.6% in the continuation group.
Conclusion: In the OLE of a randomized clinical trial, patients switching from adalimumab 40 mg monotherapy to open-label sarilumab 200 mg q2w monotherapy demonstrated improvements in physical function and in the signs and symptoms of RA, which became numerically similar to patients who were initially randomized to sarilumab 200 mg q2w. Safety observations in the OLE were generally consistent with what was observed in the randomized portion of the study.
1. Genovese et al. Arthritis Rheumatol. 2015;67:1424-1437.
2. Burmester et al. Ann Rheum Dis. 2017;76:840-847.
3. Fleischmann et al. Arthritis Rheumatol. 2017;69:277-290.
To cite this abstract in AMA style:Burmester GR, Fiore S, Hu CC, Fay J, Lee EB, Genovese MC. Efficacy and Safety of Switching from Adalimumab to Sarilumab in an Open-Label Extension of a Phase 3 Monotherapy Trial in Patients with Active Rheumatoid Arthritis [abstract]. Arthritis Rheumatol. 2017; 69 (suppl 10). https://acrabstracts.org/abstract/efficacy-and-safety-of-switching-from-adalimumab-to-sarilumab-in-an-open-label-extension-of-a-phase-3-monotherapy-trial-in-patients-with-active-rheumatoid-arthritis/. Accessed August 12, 2020.
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