Sarilumab, the first biologic treatment for polymyalgia rheumatica gains US FDA approval

Painful disease flares noted in polymyalgia rheumatica significantly impair the quality of life of affected subjects. Now, the US Food and Drug Administration (FDA) has approved sarilumab (Kevzara®), an interleukin-6 receptor antagonist, for the treatment of polymyalgia rheumatica in adult patients with inadequate response to corticosteroids or those intolerant to corticosteroid taper. The first and only biologic treatment approved by FDA has been conjointly developed by Sanofi and Regeneron.

The FDA approval was based on the results of the SAPHYR phase 3 randomized clinical trial in patients with steroid-resistant active PMR and who had experienced flare on ≥7.5 mg/day prednisone or equivalent during taper. The follow-up conducted at 52 weeks revealed the attainment of sustained remission by around 28% of sarilumab-treated patients compared to 10% for placebo (P=0.0193). Adverse reactions were noted only in ≥5% of patients treated with sarilumab (n=59) and the commonly noted events were neutropenia (15%), leukopenia (7%), constipation (7%), pruritic rash (5%), myalgia (7%), fatigue (5%), and injection site pruritus (5%).

In 2017, the drug gained US FDA approval for managing moderate-to-severe rheumatoid arthritis in adults refractory to treatment or intolerant to DMARDs. Sarilumab acts by binding specifically to the IL-6 receptors and inhibiting IL-6-mediated signalling. The drug has also shown comparable clinical efficacy as that of other biologic DMARDs or Janus kinase (JAK) inhibitors in previously treated moderate or severe rheumatoid arthritis.


  1. Kevzara® (sarilumab) Approved by FDA as First and Only Biologic Indicated for Patients with Polymyalgia Rheumatica | Regeneron Pharmaceuticals Inc. [Internet]. [cited 2023 Mar 4]. Available from: