Efficacy and Safety of Reslizumab in Patients with Severe Asthma with Inadequate Response to Omalizumab: A Multicenter, Open-Label Pilot Study
Por:
Pérez de Llano LA, García-Cosío B, Domingo C, Urrutia I, Bobolea I, Valero A, Entrenas Costa LM, Quirce S, Barranco P, Malanda NM and Andrés LP
Publicada:
1 sep 2019
Ahead of Print:
21 ene 2019
Categoría:
Immunology and allergy
Resumen:
BACKGROUND: Patients with severe allergic and eosinophilic asthma could qualify for different biologic therapies.
OBJECTIVE: To evaluate the efficacy and safety of weight-based intravenous reslizumab dosing in patients who have previously failed therapy with omalizumab.
METHODS: We carried out a 24-week prospective, multicenter, open-label, single-group, self-controlled study in patients with severe eosinophilic asthma who had previously failed to respond to omalizumab. The main objective was to determine whether treatment with reslizumab significantly improved asthma symptoms assessed by the Asthma Control Test (ACT) at week 24. Secondary objectives were to evaluate symptoms at weeks 4 and 12, change in FEV1 at week 24, and the incidence of severe exacerbations over the study period.
RESULTS: Twenty-nine patients (62.1% women, median age, 50.8 years) were included in the study. The median ACT score significantly increased from 13.0 (interquartile range, 8.0-18.0) at baseline to 21.0 (interquartile range, 14.0-24.0) at 24 weeks (P=.002). Only 2 of 29 patients developed at least 1 severe exacerbation during follow-up and none of them required hospitalization. Overall, 15 of 25 patients (60%) were considered as being controlled (ACT score of >= 20 and no exacerbations) at week 24. The percentage of patients who were receiving daily systemic corticosteroids significantly decreased from 72.4% to 52.0% (P=.019). Adverse events were mostly moderate and within the range of previously reported side effects with reslizumab.
CONCLUSION: Reslizumab is an effective and safe option for patients with severe eosinophilic asthma and a history of omalizumab failure. (C) 2019 The Authors. Published by Elsevier Inc. on behalf of the American Academy of Allergy, Asthma & Immunology.
Filiaciones:
Pérez de Llano LA:
Pneumology Service. Hospital Universitario Lucus Agusti. Lugo. Spain
García-Cosío B:
Department of Respiratory Medicine, Hospital Universitario Son Espases-IdISBa. Palma de Mallorca, Spain
and CIBER de Enfermedades Respiratorias (CIBERES). Instituto de Salud Carlos III, Madrid
Domingo C:
Department of Pulmonary Medicine, Corporació Sanitària Parc Taulí, Sabadell Department of Medicine, Autonomous University of Barcelona ((Spain)
Urrutia I:
Asthma Unit. Department of Pulmonary Medicine. Hospital Galdakao. Bizkaia. Spain
Bobolea I:
Allergy Section, Department of Pulmonology and Allergy, Hospital Clinic Barcelona- Institute for Health Research (IdiBAPS) and CIBER of Respiratory Diseases CIBERES, Madrid, Spain
:
Allergy Section, Department of Pulmonology and Allergy, Hospital Clinic Barcelona- Institute for Health Research (IdiBAPS) and CIBER of Respiratory Diseases CIBERES, Madrid, Spain
Entrenas Costa LM:
Pneumology Service. Hospital Universitario Reina Sofía, Córdoba. IMIBIC. Universidad de Córdoba. Spain
Quirce S:
Department of Allergy, Hospital La Paz Institute for Health Research (IdiPAZ), and CIBER of Respiratory Diseases CIBERES, Madrid, Spain
Barranco P:
Department of Allergy, Hospital La Paz Institute for Health Research (IdiPAZ), and CIBER of Respiratory Diseases CIBERES, Madrid, Spain
Malanda NM:
Department of Pulmonology. Hospital de Cruces. Bilbao. Spain
:
Allergy Section. Hospital Universitario Dr. Peset. Valencia. Spain
Open Access
|