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 ^[1] ; Patricia Sánchez-Carrasco ^[2] ; Diana Betancor ^[1] ; Blanca Barroso ^[1] ; José Manuel Rodrigo-Muñoz ^[5] ; Ignacio Mahillo-Fernández ^[1] ; Ebymar Arismendi ^[5] ; Irina Bobolea ^[6] ; Blanca Cárdaba ^[5] ; María Jesús Cruz ^[3] ; Victoria Del Pozo ^[5] ; Javier Domínguez-Ortega ^[5] ; Francisco Javier González-Barcala ^[5] ; José María Olaguibel ^[5] ; Juan Alberto Luna-Porta ^[5] ; Carlos Martínez-Rivera ^[5] ; Joaquim Mullo ^[5] ; Xavier Muñoz ^[5] ; Lorena Peleteiro-Pedraza ^[4] ; Cesar Picado Valles ^[5] ; Joaquín Sastre ^[1]
  1. [1] Fundación Jiménez Díaz

     Fundación Jiménez Díaz

     Madrid, España

     
  2. [2] Universidad Autónoma de Madrid

     Universidad Autónoma de Madrid

     Madrid, España

     
  3. [3] Universitat Autònoma de Barcelona

     Universitat Autònoma de Barcelona

     Barcelona, España

     
  4. [4] Complexo Hospitalario Universitario de Santiago

     Complexo Hospitalario Universitario de Santiago

     Santiago de Compostela, España

     
  5. [5] CIBER de Enfermedades Respiratorias (CIBERES), Madrid, Spain
  6. [6] Allergy Unit & Severe Asthma Unit, Pneumonology and Allergy Department, Hospital Clínic, Barcelona, Spain

  Mostrar afiliaciones +
• Localización: Archivos de bronconeumología: Organo oficial de la Sociedad Española de Neumología y Cirugía Torácica SEPAR y la Asociación Latinoamericana de Tórax ( ALAT ), ISSN 0300-2896, Vol. 60, Nº. 1, 2024, págs. 23-32
• Idioma: inglés
• Enlaces
  • Texto completo
• Resumen

  • 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.