- Dupilumab, a fully human anti–interleukin-4 receptor α monoclonal antibody, appears to offer safe and effective treatment of severe asthma while significantly reducing oral glucocorticosteroid dependence.
Why this matters
- Oral glucocorticoids are a mainstay of asthma treatment.
- However, they can produce significant multiorgan toxic effects and broad immunosuppression.
- Newer biologic agents appear to offer the promise of improving treatment without the side effects seen with oral glucocorticoid treatment.
- The Evaluation of Dupilumab in Patients With Severe Steroid Dependent Asthma (VENTURE) trial was an international, randomized, double-blind, placebo-controlled, phase 3 trial.
- 210 patients with oral glucocorticoid-treated asthma received add-on dupilumab (at a dose of 300 mg) or placebo every 2 weeks for 24 weeks.
- After a glucocorticoid dose-adjustment period before randomization, glucocorticoid doses were adjusted in a downward trend from week 4 to week 20 and then maintained at a stable dose for 4 weeks.
- The study was funded by Sanofi and Regeneron Pharmaceuticals.
- Dupilumab recipients saw a 70.1% reduction in glucocorticoid use compared with a reduction of 41.9% among placebo recipients (P<.001>
- Dupilumab treatment resulted in a severe exacerbation rate that was 59% lower than that in the placebo group and resulted in an FEV1 that was 0.22 L higher.
- Dupilumab was safe and well-tolerated.
- Dupilumab is very expensive, and healthcare systems may need convincing about the cost-efficacy.