Complete response to anti-IL5 biologics in a real-life setting
- Marianne Baastrup Soendergaard1⇑,
- Susanne Hansen1,
- Anne-Sofie Bjerrum2,
- Ole Hilberg3,
- Sofie Lock-Johansson4,
- Kjell Erik Julius Haakansson5,
- Truls Sylvan Ingebrigtsen6,
- Claus Rikard Johnsen7,
- Linda Makowska Rasmussen7,
- Anna von Bülow1,
- Karin Dahl Assing8,
- Johannes Martin Schmid2,
- Charlotte Suppli Ulrik5 and
- Celeste Porsbjerg1,9
- 1Department of Respiratory Medicine, Copenhagen University Hospital - Bispebjerg, Kobenhavn, Denmark
- 2Department of Respiratory Diseases and Allergy, Aarhus University Hospital, Aarhus, Denmark
- 3Sygehus Lillebalt Vejle Sygehus, Vejle, Denmark
- 4Department of Respiratory Medicine, Odense University Hospital, Odense, Denmark
- 5Department of Respiratory Medicine, Copenhagen University Hospital-Hvidovre, Hvidovre, Denmark
- 6Department of Respiratory Medicine, Gentofte University Hospital, Hellerup, Denmark
- 7Gentofte University Hospital, Allergy Clinic, Hellerup, Denmark
- 8Respiratory Medicine, Aalborg Universitetshospital, Aalborg, Denmark
- 9University of Copenhagen, Institute of Clinical Medicine, Kobenhavn, Denmark
- Corresponding author: Marianne Soendergaard (marianne.baastrup.soendergaard{at}regionh.dk)
Abstract
Background Phase III regulatory trials show that anti-IL 5 biologics efficiently reduce exacerbations and use of maintenance oral corticosteroids (mOCS) in patients with severe eosinophilic asthma. However, patients eligible for these trials differ significantly compared to real life severe asthma populations. Therefore, our aim was to explore efficacy in a real-life setting. The Danish Severe Asthma Register (DSAR) is a complete, nationwide register that comprises all Danish patients on biological therapy for severe asthma.
Methods This prospective study identified patients in DSAR who were complete responders to anti IL5 biologics after one year of treatment. A complete response was defined as resolution of the parameter setting the indication, i.e. recurrent exacerbations and/or use of mOCS.
Results A total of 289/502 (58%) were complete responders to anti-IL5 biologics after 12 months. Complete responders had greater improvements in FEV1 and Asthma Control Questionnaire (ACQ) compared to non-complete responders (Δ 210 mL versus Δ 30 mL, p<0.0001) and (Δ-1.04 versus Δ-0.68, p=0.016), respectively. A complete response was predicted by age at onset, less severe disease at baseline (i.e. no mOCS and lower ACQ score) and higher blood eosinophils.
Conclusion More than half of Danish patients treated with anti-IL5 biologics for severe asthma achieve a complete response to treatment thereby becoming free from asthma exacerbations and need for mOCS. Complete responders also achieved superior effects on lung function and symptoms compared to non-complete responders.
Footnotes
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Conflict of interest: Kjell Erik Julius Håkansson has received unrestricted research grant, paid to institution from AstraZeneca and SanofiGenzyme, outside the submitted work. Payment or honoraria for lectures, presentations, speakers bureaus, manuscript writing or educational events from AstraZeneca, TEVA, GSK and SanofiGenzyme, outside the submitted work.
Conflict of interest: Marianne Baastrup Soendergaard has received lecture fees from GSK, outside the submitted work.
Conflict of interest: Susanne Hansen
Conflict of interest: Anne Sofie Bjerrum has received lecture fees from Astra Zeneca and GSK, outside the submitted work.
Conflict of interest: Ole Hilberg
Conflict of interest: Sofie Lock-Johansson
Conflict of interest: Kjell Erik Julius Haakansson
Conflict of interest: Truls Sylvan Ingebrigtsen
Conflict of interest: Claus Rikard Johnsen
Conflict of interest: Linda Makowska Rasmussen has received payment or honoraria for lectures, presentations, speakers bureaus, manuscript writing or educational events from AstraZeneca, GlaxoSmithKline, Teva and ALK, outside the submitted work. Support for attending meetings and/or travel received from AstraZeneca and Chiesi, outside the submitted work. Participation on a Data Safety Monitoring Board or Advisory Board for AstraZeneca, GlaxoSmithKline, Teva and Sanofi, outside the submitted work.
Conflict of interest: Anna von Bülow has done consultancy work for Novartis DK, outside the submitted work. Lectures and speakers fees received from Astra Zenica, Novartis and GSK, outside the submitted work. Attended Advisory Board for Astra Zenica and Novartis, outside the submitted work.
Conflict of interest: Karin Dahl Assing
Conflict of interest: Johannes Martin Schmid
Conflict of interest: Charlotte Suppli Ulrik received payment or honoraria for lectures, presentations, speakers bureaus, manuscript writing or educational events from AZ, GSK, TEVA, Sanofi, Orion Pharma, Novartis, and Chiesi, outside the submitted work.
Conflict of interest: Celeste Porsbjerg has received grants or contracts from AZ, GSK, Novartis, TEVA, Sanofi, Chiesi and ALK, outside the submitted work. Consulting fees from AZ, GSK, Novartis, TEVA, Sanofi, Chiesi and ALK, outside the submitted work. Payment or honoraria for lectures, presentations, speakers bureaus, manuscript writing or educational events, received from AZ, GSK, Novartis, TEVA, Sanofi, Chiesi and ALK, outside the submitted work. Participation on a Data Safety Monitoring Board or Advisory Board for AZ, Novartis, TEVA, Sanofi and ALK, outside the submitted work.
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- Received May 16, 2022.
- Accepted June 15, 2022.
- Copyright ©The authors 2022
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