Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Observational Study
. 2025 Nov;42(11):5481-5498.
doi: 10.1007/s12325-025-03338-w. Epub 2025 Aug 29.

Effectiveness of Mepolizumab in Patients with OCS-Dependent Severe Asthma: A Real-World Study

Sevim Bavbek  1 , Mona Al-Ahmad  2   3 , Hala Samaha  4 , Pooran Chand Kathuria  5 , Patricia Fernandez  6 , Nasser Al Busaidi  7 , Tayseer Ibrahim  8 , Bassam Mahboub  9 , Seema Haider  10 , Saeed Noibi  11 , Gur Levy  12 , Riyad Omar Al-Lehebi  13   14
Affiliations
Observational Study

Effectiveness of Mepolizumab in Patients with OCS-Dependent Severe Asthma: A Real-World Study

Sevim Bavbek et al. Adv Ther. 2025 Nov.

Abstract

Introduction: Before the availability of biologic therapies, the main treatment for patients with severe asthma in Asia, Latin America, and the Middle East was oral corticosteroids (OCS), despite long-term use causing serious adverse effects. This post hoc analysis of the NUCALA Effectiveness Study (NEST) evaluated the effectiveness of mepolizumab, an anti-interleukin-5 monoclonal antibody, in patients with severe asthma and OCS dependence from regions with limited representation in real-world studies.

Methods: NEST was a multicountry, observational cohort study in adults with severe asthma from Colombia, Chile, India, Türkiye, Saudi Arabia, United Arab Emirates, Kuwait, Oman, and Qatar. Patients received ≥ 1 dose of 100 mg mepolizumab. OCS dependence was defined as receiving maintenance OCS at mepolizumab initiation or for ≥ 26 weeks during the 12 months prior. Data were collected 12 months pre- and post-initiation. Outcomes included OCS use, rate of clinically significant exacerbations (CSEs), and level of asthma symptom control.

Results: Of 524 patients with OCS use data, 58.4% (n = 306) had OCS dependence pre-initiation. Mean (standard deviation) age was 49.2 (13.4) years; 73.9% (n = 226) were women. Of 251 patients with available data, 87.6% (n = 220) received lower OCS doses post-initiation and 68.9% (n = 173) stopped OCS use altogether. CSEs were reduced by 76.9% post-initiation. Of 222 patients with available data, 72.5% (n = 161) had improvements in Asthma Control Test scores post-initiation.

Conclusion: In patients with severe asthma and OCS dependence from the countries studied, mepolizumab reduced OCS use and dose, asthma exacerbations, and improved symptom control.

Keywords: Clinically significant exacerbations; Corticosteroid burden; Interleukin-5 inhibition; Mepolizumab; Oral corticosteroids; Severe asthma.

Plain language summary

Severe asthma is a long-term disorder of the lungs. Symptoms can be difficult to control, despite treatment. Asthma treatment can differ depending on the healthcare services and treatments available, with some countries having more extensive research and access to asthma medications than others. People with severe asthma often receive high doses of oral corticosteroids (OCSs) over prolonged time periods which can cause side effects and affect quality of life. Mepolizumab is a medication used to treat severe asthma. Studies show that mepolizumab treatment can reduce the use of OCS, as well as the risk of major asthma attacks, and improve control of symptoms. The NUCALA Effectiveness Study was carried out to see how well mepolizumab works in real-life clinical practice for treatment of severe asthma in patients living in Colombia, Chile, India, Türkiye, Saudi Arabia, United Arab Emirates, Kuwait, Oman, and Qatar. Here, we looked at how effective mepolizumab was at reducing OCS use for people who required OCS consistently before they started taking mepolizumab (OCS dependence). We found that fewer people relied on OCS following mepolizumab treatment, with nearly 90% receiving a lower dose following treatment with mepolizumab. Almost 70% of these people had their dose reduced entirely so they no longer needed OCS. Additionally, mepolizumab treatment significantly reduced the number of major asthma attacks people experienced and led to better asthma symptom management. These results suggest that mepolizumab could be beneficial for people with severe asthma, in regions where asthma symptoms and the use of OCS are high.

PubMed Disclaimer

Conflict of interest statement

Declarations. Conflict of Interest: Sevim Bavbek has given lectures at meetings supported by AstraZeneca, GSK, and Novartis, and reports receipt of advisory board fees from AstraZeneca, GSK, and Novartis. Mona Al-Ahmad has received lecture and advisory board honoraria from AstraZeneca, GSK, Novartis, and Sanofi. Hala Samaha has received lecture and advisory board honoraria from AstraZeneca, GSK, and Sanofi. Pooran Chand Kathuria has no conflicts of interest to report. Patricia Fernandez reports having been a speaker for AstraZeneca, GSK, Sanofi, and Teva, and participated in advisory boards with AstraZeneca, GSK, and Sanofi. Nasser Al Busaidi has received lecture and advisory board honoraria from AstraZeneca, GSK, and Sanofi. Tayseer Ibrahim has received lecture honoraria from AstraZeneca, GSK, and Sanofi. Bassam Mahboub has received lecture and advisory board honoraria from AstraZeneca, GSK, and Sanofi. Seema Haider and Gur Levy are employed by and hold financial equities in GSK. Saeed Noibi is employed by GSK. Riyad Omar Al-Lehebi has given lectures at meetings supported by AstraZeneca, Boehringer Ingelheim, GSK, and Sanofi, and received advisory board fees from GSK. Ethical Approval: The study protocol was reviewed and approved by an institutional review board, and the study was conducted in accordance with the International Council on Harmonisation, Good Pharmacoepidemiology Practice, Good Clinical Practice, and all applicable patient privacy requirements and country-specific requirements relevant for an observational study. Data were collected from existing medical records and ethical committee reviews were conducted for all included countries. Informed consent to participate was obtained for patients in countries where a waiver for informed consent was not requested or granted. The data collected were anonymized and non-identifiable.

Figures

Fig. 1
Fig. 1
NEST study design. Figure from Al-Lehebi RO, et al., Real-world effectiveness of mepolizumab in severe asthma: Results from the multicountry, self-controlled NUCALA effectiveness study (NEST). Adv Ther 2024. © 2024 (Creative Commons Attribution Non-Commercial 4.0 International licence). Mo month, NEST NUCALA Effectiveness Study
Fig. 2
Fig. 2
Change in OCS dose from pre- to post-initiation (n = 251)a. aIncludes patients that received OCS pre-initiation. Patients who did not have available, consistent, or valid dosage data were excluded. OCS oral corticosteroids
Fig. 3
Fig. 3
Change in ACT scores from pre- to post-initiation in patients with OCS dependence ACT Asthma Control Test, OCS oral corticosteroid
See this image and copyright information in PMC

References

    1. Global strategy for asthma management and prevention (2024 update). Global Initiative for Asthma (GINA); 2024. https://ginasthma.org/2024-report/. Accessed Nov 11, 2024.
    1. Mortimer K, Reddel HK, Pitrez PM, Bateman ED. Asthma management in low and middle income countries: case for change. Eur Respir J. 2022;60:2103179. - DOI - PMC - PubMed
    1. Caminati M, Morais-Almeida M, Bleecker E, et al. Biologics and global burden of asthma: a worldwide portrait and a call for action. World Allergy Organ J. 2021;14:100502. - DOI - PMC - PubMed
    1. Meghji J, Mortimer K, Agusti A, et al. Improving lung health in low-income and middle-income countries: from challenges to solutions. Lancet. 2021;397:928–40. - DOI - PubMed
    1. Swarnakar R, Dhar R. Call to action: addressing asthma diagnosis and treatment gaps in India. Lung India. 2024;41:209–16. - DOI - PMC - PubMed

Publication types