The Food and Drug Administration (FDA) has approved Kevzara® (sarilumab) for the treatment of adults with polymyalgia rheumatica (PMR) who have had an inadequate response to corticosteroids or who cannot tolerate corticosteroid taper.
The approval was based on data from the phase 3 SAPHYR study (ClinicalTrials.gov Identifier: NCT03600818) that evaluated the efficacy and safety of sarilumab in patients 50 years of age and older with steroid-resistant active PMR who flared on at least 7.5mg per day of prednisone or equivalent during taper. Patients were randomly assigned 1:1 to receive either sarilumab 200mg every 2 weeks plus a 14-week taper of prednisone or placebo every 2 weeks plus a 52-week taper of prednisone.
Results showed that 28.3% of patients in the sarilumab arm achieved sustained remission of PMR at week 52 (primary endpoint) compared with 10.3% of patients in the placebo arm (proportion difference from placebo, 18% [95% CI, 4.2-31.8]; P =.0193). Moreover, an analysis was conducted removing all acute phase reactants (CRP and ESR) criteria and confirmed the primary analysis. The sarilumab arm also had a lower total actual cumulative prednisone equivalent corticosteroid dose compared with the placebo arm (777mg vs 2044mg, respectively).
As for safety, sarilumab carries a Boxed Warning associated with a risk of serious infections that may lead to hospitalization or death. Health care providers are advised to interrupt treatment if a serious infection develops, and closely monitor patients for infection during treatment. The most common adverse reactions (incidence greater than or equal to 5%) for sarilumab were neutropenia, leukopenia, and injection site pruritus.
George D. Yancopolous, MD, PhD, President and CSO at Regeneron, commented: “With the approval of Kevzara for polymyalgia rheumatica, patients now have an FDA-approved treatment to help offer relief from the disabling symptoms of this disease and long-term dependence on steroids.”
Kevara is also indicated for the treatment of adults with moderately to severely active rheumatoid arthritis who have had an inadequate response or intolerance to one or more disease-modifying antirheumatic drugs (DMARDs).
Kevzara is supplied as single-dose prefilled syringes and single-dose prefilled pens containing 150mg or 200mg of sarilumab.
- Kevzara® (sarilumab) approved by FDA as first and only biologic indicated for patients with polymyalgia rheumatica. News release. Sanofi-aventis. February 28, 2023. Accessed March 1, 2023. https://www.news.sanofi.us/2023-03-01-Kevzara-R-sarilumab-approved-by-FDA-as-first-and-only-biologic-indicated-for-patients-with-polymyalgia-rheumatica.
- Kevzara. Package insert. Sanofi-aventis; 2023. Accessed March 1, 2023. https://products.sanofi.us/kevzara/kevzara.pdf.