Plain language summary of the SHAMAL study in patients with severe eosinophilic asthma treated with benralizumab
- PMID: 39780731
- PMCID: PMC11852735
- DOI: 10.1080/1750743X.2024.2436829
Plain language summary of the SHAMAL study in patients with severe eosinophilic asthma treated with benralizumab
Plain language summary
What is this summary about?This is a plain language summary of an article originally published in The Lancet, presenting results of the SHAMAL study.SHAMAL was the first study to investigate whether it is safe to lower the dose of inhaled corticosteroids, a type of medication used to control asthma, in people with severe eosinophilic asthma controlled with benralizumab (another type of medication that helps to control their asthma symptoms).High-dose inhaled corticosteroids increases the risk of several steroid-related side effects; therefore, asthma treatment guidelines recommend a reduction in inhaled corticosteroids doses in people who respond well to biologic medications such as benralizumab. However, there is currently no evidence to support how safe this is or what the best method is for doing this safely.What were the main results of the SHAMAL study?The group of patients who were chosen to reduce their inhaled corticosteroids/long-acting β2-agonist (LABA) dose were called the ‘reduction arm’: by Week 32, 9 out of every 10 participants in the reduction arm (92%) reduced their daily dose of inhaled corticosteroids/LABA without experiencing any worsening of asthma symptoms. Nearly all participants (96%) continued their Week 32 inhaled corticosteroids/LABA dose for another 16 weeks (until Week 48).Up to Week 32, 9 out of every 10 reduction arm participants (91%) did not experience an asthma flare-up/attack (exacerbation). Over the whole study there was no difference in the rate of exacerbations between the participants who reduced the dose of their inhaled corticosteroids/LABA and those who did not.What do the results of the SHAMAL study mean?The SHAMAL study showed that benralizumab treatment can enable people with severe eosinophilic asthma to reduce the amount of inhaled corticosteroids/LABA they receive per day, whilst controlling asthma symptoms.[Box: see text].
Conflict of interest statement
David J. Jackson has received advisory board and speaker fees from AstraZeneca, Boehringer Ingelheim, Chiesi, GlaxoSmithKline, Novartis, and Sanofi. Liam G. Heaney has received grant funding by Amgen, AstraZeneca, Boehringer Ingelheim, Chiesi, Circassia, Evelo Biosciences, GlaxoSmithKline, Hoffmann-La Roche, Novartis, Sanofi, Teva, and Theravance; he has received grants from Aerocrine, Amgen, AstraZeneca, Genentech/Hoffman-La Roche, GlaxoSmithKline, MedImmune, Novartis UK, Roche/Genentech, and Vitalograph; he has received sponsorship for attending international scientific meetings from AstraZeneca, Boehringer Ingelheim, Chiesi, GlaxoSmithKline, and Napp Pharmaceuticals; he has participated in advisory boards, and given lectures at meetings supported by Amgen, AstraZeneca, Boehringer Ingelheim, Chiesi, Circassia, Evelo Biosciences, GlaxoSmithKline, Hoffmann-La Roche, Novartis, Sanofi, Teva, and Theravance; he has also taken part in asthma clinical trials sponsored by AstraZeneca, Boehringer Ingelheim, GlaxoSmithKline, and Hoffmann-La Roche, for which his institution received remuneration; he is the academic lead for the Medical Research Council Stratified Medicine UK Consortium in Severe Asthma, which involves industrial partnerships with a number of pharmaceutical companies, including Amgen, AstraZeneca, Boehringer Ingelheim, GlaxoSmithKline, Hoffmann-La Roche, and Janssen. Marc Humbert has received consulting fees from AstraZeneca, Chiesi, GlaxoSmithKline, Novartis, and Sanofi. Brian D. Kent has received educational travel bursaries from Boehringer Ingelheim, Chiesi, and Napp Pharmaceuticals; has received research funding from Itamar Medical; has participated in advisory boards and/or received speaker fees from AstraZeneca, Chiesi, GlaxoSmithKline, Novartis, and Teva. Anat Shavit is or was an employee of Ast aZeneca at the time of this study and may be a shareholder/hold stock options in AstraZeneca. Lina Hiljemark is or was an employee of AstraZeneca at the time of this study and may be a shareholder/hold stock options in AstraZeneca. Lynda Olinger is an employee of Cytel Inc. and is or was on contract to AstraZeneca at the time of this study. David Cohen is or was an employee of AstraZeneca at the time of this study and may be a shareholder/hold stock options in AstraZeneca. Andrew Menzies-Gow is or was an employee of AstraZeneca at the time of this study and may be a shareholder/hold stock options in AstraZeneca; has received speaker fees from AstraZeneca, Novartis, Sanofi, and Teva; has attended advisory boards for AstraZeneca, GlaxoSmithKline, Novartis, Regeneron, Sanofi, and Teva; has participated in research with AstraZeneca, for which his institution was remunerated; and has had consultancy agreements with AstraZeneca. Stephanie Korn has received grants and personal fees for lectures and advisory boards from AstraZeneca, GlaxoSmithKline, Novartis, Sanofi-Genzyme, and Teva. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.
Medical writing support was provided by Laura Russell, BMedSci (Hons), and Vernice van der Merwe, MSc, in accordance with GPP 2022 Guidelines. This support was funded by AstraZeneca.
Patient reviewers on this PLSP have received honorarium from Immunotherapy for their review work but have no other relevant financial relationships to disclose.
Comment on
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Reduction of daily maintenance inhaled corticosteroids in patients with severe eosinophilic asthma treated with benralizumab (SHAMAL): a randomised, multicentre, open-label, phase 4 study.Lancet. 2024 Jan 20;403(10423):271-281. doi: 10.1016/S0140-6736(23)02284-5. Epub 2023 Dec 7. Lancet. 2024. PMID: 38071986 Clinical Trial.
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