Mepolizumab or Placebo for Eosinophilic Granulomatosis with Polyangiitis



Title: Mepolizumab or Placebo for Eosinophilic Granulomatosis with Polyangiitis

Wechsler, ME et al.


 

What You Need to Know:

Treatment with mepolizumab in patients with eosinophilic granulomatosis with polyangiitis led to significantly more weeks in remission as well as a higher proportion of patients in remission vs. placebo, thus reducing the use of glucocorticoids.

Trial Design:

  • Phase 3, multicenter, double-blind, parallel-group study
  • Study patients with relapsing or refractory eosinophilic granulomatosis with polyangiitis who received treatment ≥4 weeks and were taking stable prednisolone or prednisone dose were enrolled
  • 136 patients randomized to either SC mepolizumab 300mg or placebo given every 4 weeks plus standard care for 52 weeks
  • Primary endpoints: accrued weeks of remission according over study period and proportion of patients in remission at Weeks 36 and 48
  • Secondary endpoints: time to first relapse and average daily glucocorticoid use during Weeks 48–52

Key Outcomes:

  • Mepolizumab treatment resulted in more accrued weeks of remission lasting ≥24 weeks vs. placebo (28% vs. 3%, odds ratio [OR] 5.91, 95% CI: 2.68–13.03; P<0.001)
  • Mepolizumab treatment resulted in higher proportion of patients in remission at Weeks 36 and 48 (32% vs. 3%, OR 16.74, 95% CI: 3.61–77.56; P<0.001)
  • Remission was not reached in 47% of mepolizumab-treated patients vs. 81% of placebo patients
  • Annualized relapse rate was lower in the mepolizumab group vs. placebo (1.14 vs. 2.27, rate ratio [RR] 0.50, 95% CI: 0.36–0.70; P<0.001)
  • More mepolizumab-treated patients used average daily dose of prednisolone or prednisone ≤4mg during Weeks 48–52 vs. placebo (44% vs. 7%; OR 0.20, 95% CI: 0.09–0.41; P<0.001)
  • Safety profile of mepolizumab remained consistent with previous studies