The SHAMAL study has achieved a significant breakthrough in the treatment of severe asthma. It demonstrates that benralizumab, a biologic therapy, provides patients with a viable alternative to high-dose inhaled steroids, known for their serious side effects. This development could potentially revolutionize the management of severe asthma, a condition affecting nearly 300 million individuals worldwide, by mitigating the risks associated with steroid usage. Credit: SciTechPost.com
The SHAMAL study unveils the potential of benralizumab, a biologic therapy, as a safer approach to addressing severe asthma without relying on high-dose steroids.
A groundbreaking investigation has revealed that severe asthma can be effectively controlled through the use of biologic therapies, eliminating the need for regular high-dose inhaled steroids, which often carry significant side effects.
The outcomes of the multinational SHAMAL study, as published in The Lancet, indicate that 92% of patients receiving benralizumab as a biologic therapy were able to safely reduce their inhaled steroid dosage, and over 60% were able to discontinue usage altogether.
This study’s findings have the potential to significantly benefit severe asthma patients by reducing or even eliminating the unpleasant and frequently severe side effects associated with inhaled steroids. These side effects include conditions such as osteoporosis, which increases the risk of fractures, diabetes, and cataracts.
The Global Impact of Asthma
Asthma stands as one of the most prevalent respiratory conditions globally, affecting nearly 300 million individuals, with approximately 3 to 5% of them experiencing severe asthma. This severe form of the disease results in daily symptoms such as breathlessness, chest tightness, and coughing, often necessitating frequent hospitalizations due to recurrent asthma attacks.
The SHAMAL study was led by Professor David Jackson, the head of the Severe Asthma Centre at Guy’s and St Thomas’, and a Professor of Respiratory Medicine at King’s College London.
Professor Jackson commented, “Biological therapies like benralizumab have brought about revolutionary changes in the care of severe asthma patients. The results of this study demonstrate, for the first time, that the majority of patients utilizing this therapy can avoid the harmful effects associated with steroid use.”
Benralizumab is a biologic therapy designed to reduce the number of inflammatory cells called eosinophils, which are produced in excessive quantities in the airways of severe asthma patients and play a crucial role in the development of asthma attacks. Administered through injections every four to eight weeks, benralizumab is available at specialized NHS asthma centers.
The SHAMAL study was conducted across 22 sites in four countries: the UK, France, Italy, and Germany.
Of the 208 patients involved, they were randomly assigned to taper their high-dose inhaled steroid usage by varying degrees over 32 weeks, followed by a 16-week maintenance period. Remarkably, nearly 90% of the patients did not experience any worsening of asthma symptoms and remained free of exacerbations throughout the 48-week study.
Further investigations akin to the SHAMAL study will be imperative before definitive recommendations can be made regarding the safety and efficacy of reducing or eliminating high-dose steroid usage 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
This study was funded by AstaZeneca and conducted by researchers from prestigious institutions, including Queens University Belfast, Université Paris-Saclay, and Trinity College Dublin.
Frequently Asked Questions (FAQs) about Biologic Asthma Treatment
What is the significance of the SHAMAL study in severe asthma treatment?
The SHAMAL study is highly significant as it demonstrates that benralizumab, a biologic therapy, provides a safer alternative to high-dose inhaled steroids, reducing or eliminating their serious side effects for severe asthma patients.
How does benralizumab work in treating severe asthma?
Benralizumab is a biologic therapy that reduces eosinophil levels, which play a critical role in severe asthma. By inhibiting eosinophils, it helps prevent asthma attacks and improve patient outcomes.
How many patients participated in the SHAMAL study, and what were the key findings?
The SHAMAL study involved 208 patients across four countries. The key findings indicate that 92% of patients on benralizumab were able to reduce their inhaled steroid dose, with over 60% discontinuing usage. This suggests a significant reduction in steroid-related side effects.
What are the potential benefits of reducing high-dose steroid usage in severe asthma treatment?
Reducing or eliminating high-dose steroids can minimize serious side effects like osteoporosis, diabetes, and cataracts, improving the overall quality of life for severe asthma patients.
Is benralizumab readily available for severe asthma patients?
Benralizumab is available in specialized NHS asthma centers and is administered through injections every four to eight weeks.
What are the global implications of severe asthma, and how many people does it affect?
Severe asthma affects nearly 300 million individuals worldwide, causing daily symptoms and frequent hospitalizations. It poses a significant global health challenge.
Who led the SHAMAL study, and what does it signify for severe asthma care?
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. It signifies a revolutionary change in severe asthma care by offering a safer treatment option.
Are there other biologic therapies like benralizumab being studied for severe asthma treatment?
Further investigations are needed to assess the safety and efficacy of reducing high-dose steroid use with other biologic therapies, as this study specifically focused on benralizumab.
More about Biologic Asthma Treatment
- The Lancet Article – The original research article published in The Lancet detailing the SHAMAL study’s findings.
- SciTechPost – The source of the initial report on the SHAMAL study and its significance in severe asthma treatment.
- AstraZeneca – The pharmaceutical company that funded the study and contributed to its research.
- Queens University Belfast, Université Paris-Saclay, Trinity College Dublin – Institutions whose researchers were involved in conducting the SHAMAL study.