Long-Term Safety of Sarilumab Confirmed in Open-Label Study

Rheumatoid arthritis
Rheumatoid arthritis
Investigators found data that showed the superiority of sarilumab monotherapy over adalimumab in both clinical and functional domains.

The long-term efficacy and safety of sarilumab was confirmed in a 48-week open-label extension of a phase 3 study that evaluated patients with rheumatoid arthritis (RA), according to findings published in RMD Open.

The researchers conducted a 48-week open-label extension study of 320 patients with active RA. The double-blinded phase of the randomized placebo-controlled phase 3 MONARCH (Efficacy and Safety of Sarilumab and Adalimumab Monotherapy in Patients With Rheumatoid Arthritis [SARIL-RA-MONARCH]; ClinicalTrials.gov Identifier: NCT02332590) study included 369 patients who were methotrexate-ineligible who received either sarilumab or adalimumab for a total of 24 weeks. At the completion of this phase, patients who were treated with adalimumab were switched to subcutaneous sarilumab 200 mg every 2 weeks. Study patients in the sarilumab arm continued on open-label sarilumab at the same dose and on the same administration schedule. Previous results from the double-blinded phase of the study showed superiority of sarilumab monotherapy over adalimumab in both clinical and functional domains.

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After analysis, the researchers found that the safety profile of sarilumab was similar in the switch and continuation arms, with no new safety signals detected, and a similar rate of treatment-emergent adverse events between the groups.

With respect to efficacy, the team reported that patients treated with sarilumab who were in the switch group had lower disease activity score-erythrocyte sedimentation rate and C-reactive protein score at 12 weeks (47.1%; 95% CI, 39.2%-55.0%; 34.8%; 95% CI, 27.3%-42.3%) than patients in the continuation cohort. In addition, improvements in patient-reported outcome scores were observed at 24 weeks.

The researchers acknowledged 2 key limitations of the analysis: the open-label design and small sample size.

“These findings address a real issue where patients who are no longer tolerant to methotrexate but are maintained on adalimumab monotherapy can safely and effectively be switched to sarilumab monotherapy when treatment targets have not been reached or are not maintained,” they concluded.

Disclosure: Several study authors declared affiliations with the pharmaceutical industry.

Please see the original reference for a full list of authors’ disclosures.


Burmester GR, Strand V, Rubbert-Roth A, et al. Safety and efficacy of switching from adalimumab to sarilumab in patients with rheumatoid arthritis in the ongoing MONARCH open-label extension [published online October 18, 2019]. RMD Open. doi:10.1136/rmdopen-2019-001017