Comparison of Long-term Response and Remission to Omalizumab and Anti-IL-5/IL-5R Using Different Criteria in a Real-life Cohort of Severe Asthma Patients

Background: Evaluation of biologic therapy response is vital to monitor its effectiveness. Authors have proposed various response criteria including good responder, super -responder, non -responder, and clinical remission. Objectives: To ascertain the prevalence of response and clinical remission after long -term treatment (> 6 months) of antiIgE and anti-IL-5/IL-5Rot biologics, compare these results with existing criteria, and identify predictors for non-responders and clinical remission. Methods: A multicenter, real-life study involving severe asthma patients in Spain. Various outcomes were assessed to gauge response and clinical remission against established criteria. Results: The study included 429 patients, 209 (48.7%) omalizumab, 112 (26.1%) mepolizumab, 19 (4.4%) reslizumab and 89 (20.7%) benralizumab, with a mean treatment duration of 55.3 +/- 38.8 months. In the final year of treatment, 218 (50.8%) were super -responders, 173 (40.3%) responders, 38 (8.9%) nonresponders, and clinical remission in 116 (27%), without differences among biologics. The short-term non -responders (< 6 months) were 25/545 (4.6%). Substantial variations in response and clinical remission were observed when applying different published criteria. Predictors of non -response included higher BMI (OR:1.14; 95% CI:1.06-1.23; p < 0.001), admissions at ICU (2.69; 1.30-5.56; p = 0.01), high count of SAE (1.21; 1.03-1.42; p = 0.02) before biologic treatment. High FEV1% (0.96; 0.95-0.98; p < 0.001), a high ACT score (0.93; 0.88-0.99; p = 0.01) before biologic treatment or NSAID-ERD (0.52; 0.29-0.91; p = 0.02) showed strong associations with achieving clinical remission. Conclusion: A substantial proportion of severe asthma patients treated long-term with omalizumab or anti-IL5/IL-5Rot achieved a good response. Differences in response criteria highlight the need for harmonization in defining response and clinical remission in biologic therapy to enable meaningful cross -study comparisons. (c) 2023 SEPAR. Published by Elsevier Espan similar to a, S.L.U. All rights reserved.