FDA Approves Sarilumab for Adults with Glucocorticoid-Resistant Polymyalgia Rheumatica

At each visit after baseline, the proportion of patients without the signs and symptoms of PMR was higher in patients who received sarilumab than in those who received placebo. A similar trend was noted when patients who received rescue therapy with glucocorticoids were excluded from the analyses.⁵

A higher proportion of patients who received placebo required additional rescue therapy during the study period than those who received sarilumab (58.6% vs. 32.2%; P=0.0053 [Fisher’s exact test]). The cumulative proportion of patients requiring rescue therapy was higher after the baseline visit up to week 52 in the patients who received placebo than in those who received sarilumab.

No new safety signals were found during this study. The adverse events were consistent with the known safety profile of sarilumab. These adverse events included neutropenia (15%), leukopenia (7%), constipation (7%), pruritic rash (5%), myalgia (7%), fatigue (5%) and injection site pruritus (5%). The serious adverse event of neutropenia occurred in two patients (3%) treated with sarilumab and none treated with placebo. In both neutropenia cases, the patients had a neutrophil count less than 500/mm3 without any infections. The neutropenia resolved after the permanent discontinuation of sarilumab.³

Michele B. Kaufman, PharmD, BCGP, is a freelance medical writer based in New York City and a pharmacist at New York Presbyterian Lower Manhattan Hospital.

References

1. Highlights of prescribing information: Kevzara (sarilumab) injection for subcutaneous use. U.S. Food & Drug Administration. 2023 Feb 28. http://tinyurl.com/3udxmets.
2. Kevzara (sarilumab) approved by FDA as first and only biologic indicated for patients with polymyalgia rheumatica. Regeneron. 2023 Feb 28. http://tinyurl.com/4bw6u3nn.
3. Kevzara (sarilumab) injection. U.S. Food & Drug Administration. 2017 Jun 3. http://tinyurl.com/mwavs5pc.
4. Spiera R, Unizony S, Warrington K, et al. Sarilumab in patients with relapsing polymyalgia rheumatica: A phase 3, multicenter, randomized, double blind, placebo-controlled trial (SAPHYR) [abstract: 1676]. Arthritis Rheumatol. 2022 Oct;74(suppl 9).
5. Spiera R, Unizony S, Warrington K, et al. Resolution of PMR signs and symptoms in patients treated with sarilumab: A phase 3, multicenter, randomized, double blind, placebo controlled trial (SAPHYR) in relapsing PMR [abstract: 1543]. Arthritis Rheumatol. 2022 Oct; 74(suppl 9).