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Sarilumab is FDA Approved for PMR

Yesterday, the U.S. Food and Drug Administration (FDA) approved sarilumab (Kevzara) for the treatment of adults with active, refractory polymyalgia rheumatica (PMR), stipulating it is indicated in those patients who have had an inadequate response to corticosteroids or who cannot tolerate corticosteroid taper.

The FDA granted a Priority Review of sarilumab in PMR, presumably because there are no approved agents for PMR, an inflammatory disorder that affects over 800,000 Americans.

The package insert information on this agent can be found here; caveats in the PI include:

  • New indication: adult patients with polymyalgia rheumatica (PMR) who have had an inadequate response to corticosteroids or who cannot tolerate corticosteroid taper
  • Dosing in PMR: The recommended dosage is 200 mg subcutaneously, once every two weeks in combination with a tapering course of corticosteroids. Kevzara can be used as monotherapy following discontinuation of corticosteroids  (Lower doses of sarilumab have not yet been studied)
  • Safety: no new safety concerns were observed in the SAPHYR study. Adverse events with an incidence ≥ 5%: neutropenia, leukopenia and injection site pruritus

Regulatory approval is based on the Phase 3 SAPHYR trials that demonstrated nearly three fold greater sustained remission rates compared to placebo.  The SAPHYR trial was presented at the EULAR and ACR annual meetings in 2022 and enrolled 118 active PMR, who flared on ≥7.5 mg/day prednisone or equivalent during taper. Patients were treated with either placebo or sarilumab (200 mg every two weeks) and all patients underwent a a 14-week taper of corticosteroids. The primary endpoint was sustained remission at week 52 - thiw was achieved in 28% of sarilumab-treated vs. 10% for placebo treated patients (p=0.0193). Sustained remission is a more stringent outcome measure, requiring disease remission by week 12 that is sustained till week 52, without disease flare, and requiring C-reactive protein normalization and adherence to the steroid taper protocol between weeks 12 to 52.

Kevzara was previously approved for the treatment of moderately-to-severely active rheumatoid arthritis (RA) in adult patients who have had an inadequate response or intolerance to one or more disease-modifying antirheumatic drugs.


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