Temporal variation in the effectiveness of biologics in asthma: Effect modification by changing patient characteristics.

The underlying population of patients selected for each respiratory monoclonal antibody might change as other biologics are approved. To evaluate effect modification by calendar time of the effectiveness of each respiratory biologics in asthma. The Effectiveness of Respiratory biologics in Asthma (ERA) is a retrospective cohort of severe asthma patients from the Mass General Brigham clinics between January 2013 and September 2023. Periods were pre-specified as the anti-IgE (2013-2015), anti-IL5 (2016-2018), anti-IL4/13 (2019-2021) or anti-alarmin (2022-2023) era. We evaluated each biologic's effect on asthma-related exacerbations comparing the one-year period before and after therapy initiation using Poisson regression and Cox regression for time-to-first exacerbation. Of 647 biologic-naïve patients, 165 initiated omalizumab, 235 anti-IL5, 227 dupilumab, and 20 tezepelumab. Omalizumab's effectiveness improved as more biologics were approved: incidence rate ratio (IRR) 1.16 [0.94-1.43] anti-IgE era vs. 0.54 [0.37-0.80] anti-IL4/13-alarmin era. Omalizumab patients in the anti-IL4/13-alarmin era had lower blood eosinophil counts and less chronic rhinosinusitis with nasal polyps (CRSwNP). For anti-IL5s, effectiveness peaked in the anti-IL4/13 era (IRR 0.52 [0.42-0.64]) when patients had higher BMI and less concomitant CRSwNP. Dupilumab was most effective in the anti-IL4/13 era (IRR 0.60 [0.50-0.72]). There were fewer current smokers in dupilumab patients in the anti-IL4/13 era. Results were similar in time-to-event analyses and in sensitivity analyses accounting for the COVID-19 pandemic. There are temporal variations in the effectiveness of biologics partly explained by the shift in the underlying population, particularly for omalizumab. Though having more choices was associated with better patient selection for omalizumab, this was inconsistent for other biologics.

Nopsopon T ，Brown A ，Hahn G ，Rank M ，Huybrechts KF ，Akenroye A ... -  《-》

Results of personalized biological therapy in patients with chronic rhinosinusitis with nasal polyps and severe uncontrolled bronchial asthma - real-life study.

Jura-Szoltys E ，Niemiec-Gorska A ，Glȕck J ，Rozlucka L ，Branicka O ，Rymarczyk B ，Gawlik R ... -  《-》

Comparative Effectiveness of Mepolizumab, Benralizumab, and Dupilumab among Patients with Difficult-to-Control Asthma: A Multicenter Retrospective Propensity-matched Analysis.

Kearney CM ，Sangani R ，Shankar D ，O'Connor GT ，Law AC ，Walkey AJ ，Bosch NA ... -  《-》

Comparative effectiveness of dupilumab and omalizumab on asthma exacerbations and systemic corticosteroid prescriptions: Real-world US ADVANTAGE study.

In the United States, dupilumab is approved for moderate-to-severe eosinophilic or oral corticosteroid-dependent asthma, and omalizumab is approved for managing moderate-to-severe allergic asthma uncontrolled by inhaled corticosteroids. However, limited comparative effectiveness data exist for these biologics due to differing patient characteristics and treatment histories. This study assessed the real-world effectiveness of dupilumab and omalizumab for asthma in patients in the United States. In this retrospective observational study, TriNetX Dataworks electronic medical record data were used to identify patients with asthma age ≥12 years who initiated (index) dupilumab or omalizumab between November 2018 and September 2020 and who had at least 12 months of pre- and post-index clinical information. Inverse probability of treatment weighting was applied to balance potential confounding in treatment groups. Asthma exacerbation rates and systemic corticosteroid (SCS) prescriptions were compared using a doubly robust negative binomial regression model, adjusting for baseline exacerbation/SCS rates and patient characteristics with ≥10% standardized differences after inverse probability of treatment weighting. All inclusion and exclusion criteria were met by 2138 dupilumab patients and 1313 omalizumab patients. After weighting, the majority of baseline characteristics were balanced (standard difference <10%) between the 2 groups. Dupilumab was associated with a 44% lower asthma exacerbation rate (P < .0001) versus omalizumab. Additionally, dupilumab treatment significantly (P < .05) reduced SCS prescriptions by 28% during the follow-up period compared with omalizumab treatment. The US ADVANTAGE real-world study demonstrated a significant reduction in severe asthma exacerbations and SCS prescriptions for patients prescribed dupilumab compared with patients prescribed omalizumab during 12 months of follow-up.

Bleecker E ，Blaiss M ，Jacob-Nara J ，Huynh L ，Duh MS ，Guo T ，Ye M ，Stanford RH ，Wang Z ，Soler X ，Nag A ，Nair R ，Borsos K ... -  《-》

A real-world study to evaluate effectiveness of mepolizumab in treating severe asthma in Taiwan (REMIT).

Cheng SL ，Lin SM ，Peng CK ，Chan MC ，Shen SY ，Kuo PH ，Lai CH ，Lan CC ，Chen CY ，Lin CH ，Liao KM ，Feng PH ，Wu JT ，Wei YF ，Xu X ，Alfonso-Christancho R ，Lai T ，Navarro A ，Milea D ，Perng DW ... -  《-》