What trials do and do not tell us about treatments for severe asthma

• Published in: The Lancet (British edition) Vol. 403; no. 10423; pp. 224 - 226
• Main Authors: Quint, Jennifer K, Shah, Pallav L
• Format: Journal Article
• Language: English
• Published: England Elsevier Ltd 20.01.2024; Elsevier Limited
• Subjects: Asthma; Clinical medicine; Clinical trials; Drug dosages; Health services; Immunoglobulin E; Medical research; Monoclonal antibodies; Patients; Quality of life; Reduction; Remission; Steroids
• ISSN: 0140-6736; 1474-547X; 1474-547X
• DOI: 10.1016/S0140-6736(23)02409-1

Secondary endpoints included reduction in daily ICS dose, improvement in quality of life, forced expiratory volume in 1 s (FEV1), and asthma remission. Once initiated, patients are maintained on treatment and there are no registered studies investigating when to stop benralizumab,9 although other studies have shown worsening in exacerbations and asthma control when omalizumab or mepolizumab are withdrawn.10 By contrast, for some patients, bronchial thermoplasty can achieve a clinical effect after two treatments, reduces exacerbations, hospitalisation, health-care use, and improves asthma control.11 Bronchial thermoplasty is recommended by the National Institute for Health and Care Excellence for the treatment of severe asthma and observed benefits are maintained over 10 years; however, exactly which patients might benefit most is unclear.6,12 Although recruiting and running a trial throughout a pandemic is commendable, asthma natural history was not typical during this period, with a natural reduction in exacerbations occurring.13,14 People were also increasingly vigilant about disease management and treatment adherence and more evidence is needed around the secondary exacerbation reduction endpoint in routine practice.15 As with all randomised controlled trials, the run-in period and follow-up time were also fairly short. JKQ has been supported by institutional research grants from the Industrial Strategy Challenge Fund, the Medical Research Council, Health Data Research, GSK, Boehringer Ingelheim, Asthma + Lung UK, and AstraZeneca, and has received personal fees for advisory board participation, consultancy, or speaking fees from GlaxoSmithKline, Evidera, Chiesi, AstraZeneca, and Insmed, unrelated to the topic of this Comment.