Definitions of non-response and response to biological therapy for severe asthma: a systematic review
Year: 2023
Type: review
Study design: Systematic Review
Abstract: Background: Biologics have proven efficacy for patients with severe asthma but there is lack of consensus on defining response. We systematically reviewed and appraised methodologically developed, defined and evaluated definitions of non-response and response to biologics for severe asthma. Methods: Two reviewers screened references, extracted data, and assessed methodological quality of development, measurement properties of outcome measures and definitions of response based on COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN). A modified GRADE (Grading of Recommendations Assessment, Development and Evaluation) approach and narrative synthesis were undertaken. Results: 13 studies reported three composite outcome measures, three asthma symptoms measures, one asthma control measure and one quality of life measure. Only four measures were developed with patient input; none were composite measures. Studies utilised 17 definitions of response: 10 out of 17 (58.8%) were based on minimal clinically important difference (MCID) or minimal important difference (MID) and 16 out of 17 (94.1%) had high-quality evidence. Results were limited by poor methodology for the development process and incomplete reporting of psychometric properties. Most measures rated "very low" to "low" for quality of measurement properties and none met all quality standards. Conclusions: This is the first review to synthesise evidence about definitions of response to biologics for severe asthma. While high-quality definitions are available, most are MCIDs or MIDs, which may be insufficient to justify continuation of biologics in terms of cost-effectiveness. There remains an unmet need for universally accepted, patient-centred, composite definitions to aid clinical decision making and comparability of responses to biologics.
Source: ERJ Open Research
Authors: Ekaterina Khaleva, Anna Rattu, Chris Brightling, Andrew Bush, Arnaud Bourdin, Apostolos Bossios, Kian Fan Chung, Rekha Chaudhuri, Courtney Coleman, Ratko Djukanovic, Sven-Erik Dahlén, Andrew Exley, Louise Fleming, Stephen J. Fowler, Atul Gupta, Eckard Hamelmann, Gerard H. Koppelman, Erik Melén, Vera Mahler, Paul Seddon, Florian Singer, Celeste Porsbjerg, Valeria Ramiconi, Franca Rusconi, Valentyna Yasinska, Graham Roberts
Institutions: University of Southampton, University of Leicester, NIHR Leicester Biomedical Research Centre, Royal Brompton Hospital, Imperial College London, Inserm, Université de Montpellier, Physiologie et Médecine Expérimentale du Coeur et des Muscles, Hôpital Arnaud de Villeneuve, Karolinska University Hospital, Karolinska Institutet, University of Glasgow, European Lung Foundation, University Hospital Southampton NHS Foundation Trust, NIHR Southampton Biomedical Research Centre, University of Manchester, Manchester University NHS Foundation Trust, NIHR Manchester Biomedical Research Centre, King's College Hospital, Bielefeld University, University Medical Center Groningen, University of Groningen, Beatrix Kinderziekenhuis, Stockholm South General Hospital, Paul Ehrlich Institut, Royal Alexandra Children's Hospital, Medical University of Graz, University Children's Hospital Zurich, Bispebjerg Hospital, European Federation of Allergy and Airways Diseases Patients Associations, Azienda USL Toscana Nord Ovest
Language: English
Subfield: Physiology
Field: Medicine
Domain: Health Sciences
Open Access status: gold
Estimated APC paid: $808
Funders: Pfizer, AstraZeneca, GlaxoSmithKline, Sanofi, Teva Pharmaceutical Industries, Chiesi Farmaceutici, European Respiratory Society, Regeneron Pharmaceuticals, European Federation of Pharmaceutical Industries and Associations, Aimmune Therapeutics, National Institute for Health and Care Research, University of Southampton, European Commission, Bundesministerium für Bildung und Forschung, Shionogi, Innovative Medicines Initiative, National Institute for Health Research Southampton Biomedical Research Centre, Genentech, Horizon 2020 Framework Programme, Medical Research Council
Awards: G1652857658, G3088432854, G355649893, NIHR Senior Investigator Award, Identification of the Molecular Mechanisms of non-response to Treatments, Relapses and Remission in Autoimmune, Inflammatory, and Allergic Conditions, G434337789, G4637685055, G4937468798, MICA: Korea-UK PRISM consortium: Establishing Precision Medicine in severe asthma, G574669212, G5985173317, CHAMP- Allergie und Toleranz im Kindesalter: Biomarker und Prädiktoren, TP 5: Schweregrad und Ko-Morbiditäten bei allergischen Krankheiten, G8456596083
OpenAlex ID: W4318070595