Sarilumab Examined for Effects on Physical Function in RA
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SAN DIEGO—Sarilumab administered every 2 weeks is associated with improvements in physical function in adult patients with rheumatoid arthritis (RA) that are similar to those with adalimumab, according to results from a randomized clinical trial presented at the American College of Rheumatology 2017 Annual Meeting, held November 3-8.
In the initial MONARCH trial (ClinicalTrials.gov identifier: NCT02332590), study participants were “intolerant of, inappropriate for, or inadequate responders to methotrexate” and were given sarilumab (200 mg subcutaneously) or adalimumab (40 mg) every 2 weeks for a total of 24 weeks. In the current study, an open-label extension of the MONARCH trial, patients either switched from adalimumab to sarilumab (n=155; “switch” group), or continued with sarilumab monotherapy (n=165; “continuation” group).
At 24 weeks, a greater — yet not significant — percentage of patients in the continuation vs switch group achieved a Disease Activity Score 28-joint count erythrocyte sedimentation rate (DAS28-ESR) ≤3.2 (58.8% vs 49.7%; P =.1033), Clinical Disease Activity Index remission (18.8% vs 12.3%; P =.1054), and a Health Assessment Questionnaire without Disability Index ≥0.3 (66.7% vs 63.9%; P =.6004).
Treatment-emergent adverse events (63.9% vs 57.9%) and serious treatment-emergent adverse events (9.0% vs 1.2%) were less prevalent in the switch vs continuation group at 24 weeks. Only 3.6% of patients in the continuation group discontinued therapy vs 5.8% of patients in the switch group. One death was reported in the switch group as the result of malignancy.
Although sarilumab showed greater improvements in physical function as well as in the signs and symptoms of RA, the benefits were not statistically significant in this open-label extension study.
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Burmester GR, Fiore S, Hu C-C, 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. Presented at: ACR/ARHP 2017 Annual Meeting; November 3-8, 2017; San Diego, CA. Poster 2482.