COMPARATIVE EFFICACY OF DUPILUMAB VERSUS BIOLOGICS IN CHINESE PATIENTS WITH UNCONTROLLED SEVERE ASTHMA: A MATCHED-ADJUSTED INDIRECT COMPARISON
Author(s)
Anne-Laure Tardy, PhD1, Chandroday Biswas, MSc2, Olivier Ledanois, MD3, Cong Zheng, MMed4, Joe Yang, PhD5, Yingxin Xu, PharmD, PhD5, Yingrui Xu, MSc4, Patricia Guyot, MSc, PhD1.
1Sanofi, Gentilly, France, 2Sanofi, Hyderabad, India, 3Sanofi, Paris, France, 4Sanofi, Shanghai, China, 5Regeneron Pharmaceuticals, Inc., Sleepy Hollow, NY, USA.
1Sanofi, Gentilly, France, 2Sanofi, Hyderabad, India, 3Sanofi, Paris, France, 4Sanofi, Shanghai, China, 5Regeneron Pharmaceuticals, Inc., Sleepy Hollow, NY, USA.
OBJECTIVES: In China, dupilumab (anti-IL-4/IL-13), mepolizumab and benralizumab (anti-IL-5/IL-5R), and tezepelumab (anti-TSLP) are approved for asthma. Previous indirect treatment comparisons have had limited Chinese population representation. Therefore, we assessed dupilumab’s relative efficacy versus each comparator in Chinese patients with uncontrolled severe asthma using anchored matching-adjusted indirect comparison (MAIC).
METHODS: Four Asia-specific Phase 3, placebo-controlled trials were identified: dupilumab (NCT03782532; 24weeks; N=486) with individual patient data (IPD), and mepolizumab (NCT03562195; 52weeks; N=300), benralizumab (NCT03186209; 48weeks; N=536), and tezepelumab (NCT03927157; 52weeks; N=400) with published aggregate data. Dupilumab ITC cohort was aligned with comparator population by restricting IPD to patients with ≥2 exacerbations in prior year (N=107). Treatment-effect modifiers were identified based on clinical relevance and data availability. When feasible, the following were matched: pre-bronchodilator FEV₁; mean exacerbations in prior year, and proportion with eosinophils (EOS) ≥300 cells/μL for mepolizumab; mean exacerbations in prior year and mean EOS counts for benralizumab; and pre-bronchodilator FEV₁ and mean EOS count for tezepelumab. Endpoints were change from baseline in pre-bronchodilator FEV₁ (mL) at Week 24 and annualized exacerbation rate (AER), compared using mean differences (MDs) and rate ratios (RRs), respectively, with 95% confidence intervals (CI).
RESULTS: Post-matching, effective sample size retention was >60% across comparisons. Dupilumab was associated with greater improvements in pre-bronchodilator FEV₁ (mL) (MD[95%CI]) at Week 24 versus mepolizumab (350[160, 540]; p<0.001), benralizumab (280[70, 490]; p<0.01), and tezepelumab (180[-10, 370]; p=0.07). Dupilumab was associated with numerically lower AERs (RR[95%CI]) versus mepolizumab (0.49[0.17, 1.42]; p=0.187), benralizumab (0.35[0.11, 1.08]; p=0.067), and tezepelumab (0.58[0.18, 1.87]; p=0.359).
CONCLUSIONS: Based on MAIC, dupilumab demonstrated statistically significant lung function improvements versus mepolizumab and benralizumab, and numerical improvement versus tezepelumab. AER results numerically favored dupilumab. Findings were consistent with global evidence, albeit not statistically significant, likely due to small sample sizes. This supports dupilumab as an effective biologic option; however, residual confounding cannot be excluded.
METHODS: Four Asia-specific Phase 3, placebo-controlled trials were identified: dupilumab (NCT03782532; 24weeks; N=486) with individual patient data (IPD), and mepolizumab (NCT03562195; 52weeks; N=300), benralizumab (NCT03186209; 48weeks; N=536), and tezepelumab (NCT03927157; 52weeks; N=400) with published aggregate data. Dupilumab ITC cohort was aligned with comparator population by restricting IPD to patients with ≥2 exacerbations in prior year (N=107). Treatment-effect modifiers were identified based on clinical relevance and data availability. When feasible, the following were matched: pre-bronchodilator FEV₁; mean exacerbations in prior year, and proportion with eosinophils (EOS) ≥300 cells/μL for mepolizumab; mean exacerbations in prior year and mean EOS counts for benralizumab; and pre-bronchodilator FEV₁ and mean EOS count for tezepelumab. Endpoints were change from baseline in pre-bronchodilator FEV₁ (mL) at Week 24 and annualized exacerbation rate (AER), compared using mean differences (MDs) and rate ratios (RRs), respectively, with 95% confidence intervals (CI).
RESULTS: Post-matching, effective sample size retention was >60% across comparisons. Dupilumab was associated with greater improvements in pre-bronchodilator FEV₁ (mL) (MD[95%CI]) at Week 24 versus mepolizumab (350[160, 540]; p<0.001), benralizumab (280[70, 490]; p<0.01), and tezepelumab (180[-10, 370]; p=0.07). Dupilumab was associated with numerically lower AERs (RR[95%CI]) versus mepolizumab (0.49[0.17, 1.42]; p=0.187), benralizumab (0.35[0.11, 1.08]; p=0.067), and tezepelumab (0.58[0.18, 1.87]; p=0.359).
CONCLUSIONS: Based on MAIC, dupilumab demonstrated statistically significant lung function improvements versus mepolizumab and benralizumab, and numerical improvement versus tezepelumab. AER results numerically favored dupilumab. Findings were consistent with global evidence, albeit not statistically significant, likely due to small sample sizes. This supports dupilumab as an effective biologic option; however, residual confounding cannot be excluded.
Conference/Value in Health Info
2026-11, ISPOR Europe 2026, Vienna, Austria
Value in Health, Volume 29, Issue 12S
Code
CO37
Topic
Clinical Outcomes
Topic Subcategory
Comparative Effectiveness or Efficacy
Disease
Biologics & Biosimilars, Respiratory-Related Disorders (Allergy, Asthma, Smoking, Other Respiratory)