The SHAMAL study reveals that benralizumab, a biologic therapy, offers a new, safer approach to treating severe asthma without relying on high-dose steroids.
A landmark study has shown that severe asthma can be controlled using biologic therapies, without the addition of regular high-dose inhaled steroids which can have significant side effects.
The findings from the multinational SHAMAL study, published in The Lancet, demonstrated that 92% of patients using the biologic therapy benralizumab could safely reduce inhaled steroid dose and more than 60% could stop all use.
The study’s results could be transformative for severe asthma patients by minimizing or eliminating the unpleasant, and often serious, side effects of inhaled steroids. These include osteoporosis which leads to increased risk of fractures, diabetes, and cataracts.
Asthma’s Global Impact
Asthma is one of the most common respiratory diseases worldwide — affecting almost 300 million people — and around 3 to 5% of these have severe asthma. This leads to daily symptoms of breathlessness, chest tightness and cough, along with repeated asthma attacks which require frequent hospitalization.
The SHAMAL study was led by Professor David Jackson, head of the Severe Asthma Centre at Guy’s and St Thomas’ and Professor of Respiratory Medicine at King’s College London.
Professor Jackson said: “Biological therapies such as benralizumab have revolutionized severe asthma care in many ways, and the results of this study show for the first time that steroid related harm can be avoided for the majority of patients using this therapy.”
Understanding Benralizumab
Benralizumab is a biologic therapy that reduces the number of inflammatory cells called eosinophil. This is produced in abnormal numbers in the airway of patients with severe asthma and is critically involved in the development of asthma attacks. Benralizumab is injected every four to eight weeks and is available in specialist NHS asthma centers.
The SHAMAL study took place across 22 sites in four countries — the UK, France, Italy, and Germany.
The 208 patients were randomly assigned to taper their high-dose inhaled steroid by varying amounts over 32 weeks, followed by a 16-week maintenance period. Approximately 90% of patients experienced no worsening of asthma symptoms and remained free of any exacerbations throughout the 48-week study.
Similar studies to SHAMAL will be necessary before firm recommendations can be made regarding the safety and efficacy of reducing or eliminating high-dose steroid use with other biologic therapies.
Reference: “Reduction of daily maintenance inhaled corticosteroids in patients with severe eosinophilic asthma treated with benralizumab (SHAMAL): a randomised, multicentre, open-label, phase 4 study” by David J Jackson, Liam G Heaney, Marc Humbert, Brian D Kent, Anat Shavit, Lina Hiljemark, Lynda Olinger, David Cohen, Andrew Menzies-Gow, Stephanie Korn, Claus Kroegel, Cristiano Caruso, Ilaria Baglivo, Stefania Colantuono, David Jackson, Dirk Skowasch, Fabiano Di Marco, Francis Couturaud, Frank Käßner, Iwona Cwiek, Markus Teber, Kornelia Knetsch, Jasmin Preuß, Gilles Devouassoux, Katrin Milger-Kneidinger, Liam Heaney, Lukas Jerrentrup, Marc Humbert, Margret Jandl, Hartmut Timmermann, Beatrice Probst, Maria D’Amato, Martin Hoffmann, Philippe Bonniaud, Guillaume Beltramo, Pierre-Olivier Girodet, Patrick Berger, Shuaib Nasser, Stéphanie Fry, Stephanie Korn, Sven Philip Aries, Thomas Koehler and Timothy Harrison, 7 December 2023, The Lancet.
DOI: 10.1016/S0140-6736(23)02284-5
The study was funded by AstaZeneca and carried out by researchers at renowned universities including Queens University Belfast, Université Paris-Saclay and Trinity College Dublin.
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1 Comment
A systemic injectable asthma treatment, an antibody attacking the IL-5 receptor for the whole body? That’s a little scary. 73% of patients in the steroid reduction-group of the study had “adverse events”, but it doesn’t mention what those were. It’s exciting that they found a good treatment target and a way to do it. It might be best limited to people with uncontrollable severe asthma, and it seemed to work for them in the study. FDA classifies this as an unprofitable orphan drug.