Abstract Rationale Dupilumab is indicated for the treatment of patients with moderate-to-severe asthma with an eosinophilic phenotype in the United States (US). Tezepelumab is indicated for treating severe asthma without any phenotype restrictions. To date, no head-to-head trials between these two biologics have been conducted. Additionally, comparative real-world studies are limited. The present study aimed to compare the real-world effectiveness of dupilumab and tezepelumab in patients with asthma using US administrative claims data. Methods This retrospective claims study used Merative™ MarketScan® data to identify asthma patients (ICD-10: J45.x; J82.83) aged ≥12 years old with ≥ 1 claim for dupilumab or tezepelumab between December 20, 2021, and December 31, 2022 (index date). Patients were required to have ≥12 months of continuous medical and pharmacy benefits before and after the index date, with follow-up extending from one day post-index through index therapy discontinuation, biologic switch, end of data availability, or disenrollment. Exacerbations were assessed during follow-up and were defined as: (i) ≥1 claim with a prescription fill/administration of a systemic corticosteroid (SCS) within ±5 days of an outpatient/emergency room visit with an asthma diagnosis; or (ii) hospitalization with asthma as a primary diagnosis. All events taking place within 14 days of the first qualifying event were considered as one exacerbation episode. Patients were 1:1 propensity score matched on demographics (age, sex, insurance), seasonality, comorbidities (type-2 comorbidities, GERD, obesity), exacerbation history, prior treatments (ICS/dual/triple therapy, non-index biologics), and asthma-related healthcare utilization. Standardized mean differences (SMD ≥ 0.1) assessed balance; residual imbalances were addressed via regression adjustment. Exacerbation rates were compared using incidence rate ratios (IRRs) from negative binomial regression models, with follow-up time as an offset. Sensitivity analysis excluded patients with prior biologic use. Results After matching, 254 patients were included in each cohort. Over the follow-up period (median: 374 vs. 372 days), patients initiating dupilumab demonstrated a 29% lower incidence of exacerbations compared to those initiating tezepelumab (IRR=0.71; 95% CI = 0.55-0.91; p 0.01). Consistent results were observed in the sensitivity analysis (IRR=0.67; 95% CI = 0.48-0.94; p = 0.02) among patients with no prior biologic utilization (Figure). Conclusion This retrospective study demonstrated that dupilumab was associated with a greater reduction in asthma exacerbations compared to tezepelumab. Study limitations include potential residual confounding attributable to unmeasured variables, notably biomarker and lung function parameters unavailable in administrative claims databases. Future, larger prospective real-world studies adjusting for comprehensive clinical and biomarker data are warranted to corroborate these findings. This abstract is funded by: Sanofi and Regeneron Pharmaceuticals, Inc.
Mosnaim et al. (Fri,) studied this question.