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The New England Journal of MedicineSarilumab for Relapse of Polymyalgia Rheumatica during Glucocorticoid Taper

Phase 3 trial reveals sarilumab’s efficacy in achieving sustained remission and reducing glucocorticoid dose.

A recent phase 3 trial has shed light on the potential of sarilumab, a human monoclonal antibody, in treating patients with polymyalgia rheumatica. The study focused on patients experiencing a relapse during glucocorticoid tapering, a common occurrence in more than half of polymyalgia rheumatica patients.

HCN Medical Memo
This study underscores the potential of sarilumab as an effective treatment for polymyalgia rheumatica, particularly for patients experiencing a relapse during glucocorticoid tapering. Although the results are promising, healthcare professionals should be mindful of the increased risk of adverse events and treatment discontinuations associated with sarilumab.

Study Design

  • The trial involved 118 patients randomly assigned to receive either sarilumab (200 mg) plus a 14-week prednisone taper or placebo plus a 52-week prednisone taper.
  • The primary outcome was sustained remission at 52 weeks, defined as resolution of signs and symptoms by week 12 and sustained normalization of the C-reactive protein level, absence of disease flare, and adherence to the prednisone taper from weeks 12 through 52.

Polymyalgia rheumatica typically presents in people over age 50, with the incidence increasing with age. The annual incidence varies from 12 to 60 cases per 100,000 in different populations, with the highest rate in those of Northern European descent. Women are more often affected than men.

Key Findings

  • Sustained remission occurred in 28% (17 of 60 patients) in the sarilumab group and in 10% (6 of 58 patients) in the placebo group.
  • The median cumulative glucocorticoid dose at 52 weeks was significantly lower in the sarilumab group than in the placebo group (777 mg vs. 2044 mg).
  • Adverse events were more common with sarilumab, including neutropenia (15% vs. 0%), arthralgia (15% vs. 5%), and diarrhea (12% vs. 2%). More treatment-related discontinuations were observed in the sarilumab group than in the placebo group (12% vs. 7%).

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