RESEARCH ARTICLE


Real-life Effectiveness of Omalizumab in Patients with Severe Allergic Asthma: RELIEF Study



Mona Al Ahmad1, Lilia Margarita Borboa Olivares2, Alexandre Pinto Cardoso3, Wagih Djazmati4, Miguel Angel Vinuesa5, María de Jesús García Domínguez6, Alcindo Cerci Neto7, Luis Ugalde Gamboa8, Jason K. Lee9, Nadine Pinho10, Paolo Tassinari11, *
1 Department of Microbiology, Faculty of Medicine, Kuwait University, Kuwait
2 ISSSTEP, Puebla, México
3 Instituto Doenças do Tórax UFRJ, Rio de Janeiro, Brazil
4 Sheikh Khalifa Medical City, Abu Dhabi, UAE
5 Sanatorio Británico, Rosario, Argentina
6 Consultorio Médico de Guadalupe/CHPTR, ISSSTE Campeche, México
7 Hospital Universitário da, Universidade Estadual de Londrina, Londrina, Brazil
8 Clínica Americana, San José, Costa Rica
9 Evidence Based Medical Educator, Toronto, Ontario, Canada
10 Global Drug Development, Novartis Biociencias S.A., Sao Paulo, Brazil
11 Novartis Pharma AG, Basel, Switzerland


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Creative Commons License
© 2022 Al Ahmad et al.

open-access license: This is an open access article distributed under the terms of the Creative Commons Attribution 4.0 International Public License (CC-BY 4.0), a copy of which is available at: https://creativecommons.org/licenses/by/4.0/legalcode. This license permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.

* Address correspondence to this author at the Department of Global Medical Affairs, Novartis Pharma AG, Basel, Switzerland; Tel: +41799407643; E-mail: paolo.tassinari@novartis.com


Abstract

Introduction:

Patients with severe allergic asthma (SAA) are at risk of severe exacerbations. Omalizumab is recommended as an add-on treatment for patients with uncontrolled SAA, despite high-dose inhaled corticosteroids and long acting β2-agonist combination therapy (standard therapy).

RELIEF was a prospective, open label, multicenter study conducted to assess the real-life effectiveness of omalizumab co-administered with standard therapy in patients with SAA for 24 months.

Methods:

A total of 347 patients aged ≥ 6 years with SAA were enrolled, 285 of whom (8 pediatrics and 277 adolescents and adults) completed this 24-month study. Compared with the 12 months prior to baseline, the mean number of exacerbations was reduced in the overall population at any time interval during the study. Proportion of patients with no exacerbations increased to 77.7% at 24 months from 32.6% at 12 months prior to baseline. A reduction in healthcare resource utilization was also observed. The mean number of specialist visits reduced from baseline (5.8 visits) to 2.4 visits at Month 24.

Results:

The mean asthma control test score was >19 at every time-point during the study. The rate of Global Evaluation of Treatment Effectiveness (GETE) for asthma response significantly increased at Months 18 and 24 (P <0.05) compared to baseline. Pulmonary function remained relatively stable for the overall study population. There were no new or unexpected safety findings in the study.

Conclusion:

RELIEF study showed that add-on therapy with omalizumab is effective in reducing exacerbations, healthcare utilization, and improving GETE score in patients with SAA uncontrolled by standard therapy.

Keywords: Exacerbations, Omalizumab, Real-world, Severe allergic asthma, Pulmonary function, Asthma.