Resumen de 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
Marcela Valverde Monge, Patricia Sánchez Carrasco, Diana Betancor, Blanca Barroso García, José Manuel Rodrigo Muñoz, I. Mahillo Fernández, Ebymar Arismendi Núñez, I. Bobolea, Blanca Cárdaba, María Jesús Cruz, Victoria del Pozo Abejón, F. Javier Domínguez Ortega, Francisco Javier González Barcala, José María Olaguíbel Rivera, Juan Alberto Luna Porta, Carlos Martínez Rivera, Joaquim Mullol i Miret, Javier Muñoz, Lorena Peleteiro Pedraza, César Picado Vallés, Joaquín Sastre Merlín
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 anti-IgE and anti-IL-5/IL-5Rα 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%) non-responders, 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-5Rα 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.
