Τρίτη 22 Ιανουαρίου 2019

Efficacy and safety of reslizumab in severe asthma patients with inadequate response to omalizumab: a multicentre, open-label, pilot study

Publication date: Available online 21 January 2019

Source: The Journal of Allergy and Clinical Immunology: In Practice

Author(s): Luis A. Pérez de Llano, Borja García-Cosío, Christian Domingo, Isabel Urrutia, Irina Bobolea, Antonio Valero, Luis M. Entrenas Costa, Santiago Quirce, Pilar Barranco, Nuria Marina Malanda, Luis Prieto Andrés

Abstract
Background

Patients with severe allergic and eosinophilic asthma could qualify for different biologic therapies.

Objective

The aim of this study was to evaluate the efficacy and safety of weight-based dosing reslizumab iv in patients who have previously failed with omalizumab.

Methods

We carried out a 24-weeks prospective, multicenter, open-label, single-group, self-controlled study in severe eosinophilic asthma patients 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 (IQR: 8.0-18.0) at baseline to 21.0 (IQR: 14.0-24.0) at 24 weeks (p = 0.002). Only 2 out of 29 patients developed at least one severe exacerbation during follow-up and none of them required hospitalization. Overall, fifteen out of 25 patients (60%) were considered as being controlled (ACT ≥ 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 = 0.019). 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 previous omalizumab failure.



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