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 minimising or eliminating the unpleasant, and often serious, side effects of inhaled steroids.
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 hospitalisation.
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.
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.
Sources:
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, Timothy Harrison. Reduction of daily maintenance inhaled corticosteroids in patients with severe eosinophilic asthma treated with benralizumab (SHAMAL): a randomised, multicentre, open-label, phase 4 study. The Lancet, 2023; DOI: 10.1016/S0140-6736(23)02284-5
King’s College London. (2023, December 8). Major breakthrough for severe asthma treatment. ScienceDaily. Retrieved December 11, 2023 from www.sciencedaily.com/releases/2023/12/231208133135.htm
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