Luis A Pérez de Llano1, Borja G Cosío2, Christian Domingo3, Isabel Urrutia4, Irina Bobolea5, Antonio Valero5, Luis M Entrenas Costa6, Santiago Quirce7, Pilar Barranco7, Nuria Marina Malanda8, Luis Prieto Andrés9, Francisco J Alvarez-Gutiérrez10. 1. Pneumology Service, Hospital Universitario Lucus Agusti, Lugo, Spain. Electronic address: eremos26@hotmail.com. 2. Department of Respiratory Medicine, Hospital Universitario Son Espases-IdISBa, Palma de Mallorca, Spain; CIBER de Enfermedades Respiratorias (CIBERES), Instituto de Salud Carlos III, Madrid, Spain. 3. Department of Pulmonary Medicine, Corporació Sanitària Parc Taulí, Sabadell, Spain; Department of Medicine, Autonomous University of Barcelona, Barcelona, Spain. 4. Asthma Unit, Department of Pulmonary Medicine, Hospital Galdakao, Bizkaia, Spain. 5. CIBER de Enfermedades Respiratorias (CIBERES), Instituto de Salud Carlos III, Madrid, Spain; Allergy Section, Department of Pulmonology and Allergy, Hospital Clinic Barcelona-Institute for Health Research (IdiBAPS), Madrid, Spain. 6. Pneumology Service, Hospital Universitario Reina Sofía, IMIBIC, Universidad de Córdoba, Córdoba, Spain. 7. CIBER de Enfermedades Respiratorias (CIBERES), Instituto de Salud Carlos III, Madrid, Spain; Department of Allergy, Hospital La Paz Institute for Health Research (IdiPAZ), Madrid, Spain. 8. Department of Pulmonology, Hospital de Cruces, Bilbao, Spain. 9. Allergy Section, Hospital Universitario Dr Peset, Valencia, Spain. 10. Asthma Unit, Hospital Universitario Virgen del Rocío, Seville, Spain.
Abstract
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.
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.
Authors: A Padilla-Galo; RCh Levy-Abitbol; C Olveira; B Valencia Azcona; M Pérez Morales; F Rivas-Ruiz; B Tortajada-Goitia; I Moya-Carmona; A Levy-Naon Journal: BMC Pulm Med Date: 2020-06-29 Impact factor: 3.317
Authors: Luis A Pérez de Llano; Borja G Cosío; Ignacio Lobato Astiárraga; Gregorio Soto Campos; Miguel Ángel Tejedor Alonso; Nuria Marina Malanda; Alicia Padilla Galo; Isabel Urrutia Landa; Francisco J Michel de la Rosa; Ismael García-Moguel Journal: J Asthma Allergy Date: 2022-01-14