Highlights
- •Phase-III-trials have shown that dupilumab in severe asthma (SA) is effective and safe. Real-world data on clinical efficacy and safety is limited.
- •This real-world study indicates that dupilumab in SA leads to less asthma exacerbations, decreased oral corticosteroid use, and better asthma control.
- •Most benefits were seen in patients with high eosinophils and FeNO. Dupilumab also proved a safe treatment with infrequent, mild side effects.
- •Therefore, this study implies that the results of the phase-III-trials translate well to daily clinical practice.
Abstract
Background
Dupilumab as add-on treatment for severe uncontrolled asthma (SA) has shown to be
effective and safe by phase-III-trials. Real-world data on clinical efficacy and safety
is limited.
Objective
We aim to investigate the efficacy and safety of dupilumab as add-on therapy for SA
in a real-world cohort.
Material and methods
The primary endpoint was annually exacerbation-rate (AER). Secondary outcomes were
maintenance oral corticosteroid (mOCS) dependency, asthma control (ACQ-5), pulmonary
function (FEV1), quality of life (AQLQ) and frequency of reported adverse events (AEs).
Results
Overall, 148 patients were included. Median AER [IQR] reduced from 4.00 [2.00–5.00]
at baseline to 1.00 [0.00–2.00] at 12 months (p < 0.001). mOCS-dependency reduced
from 39.9% of the patients at baseline, to 20.3% at 6 months and to 14.9% at 12 months
(p < 0.001). Median ACQ improved from 3.00 [2.00–3.80] at baseline to 1.80 [0.60–2.95]
after 6 months and to 1.40 [0.20–2.60] after 12 months (p < 0.001). Median FEV1 (L) improved from 2.21 [1.58–2.85] to 2.50 [2.00–3.06] at 6 months and to 2.51 [1.88–3.04]
after 12 months (p < 0.001). The outcomes improved most in subgroups with high eosinophils
(≥300/μL) or FeNO (≥50 ppb) at baseline. AEs were reported by 45.3% (67/148), of which
headache was most frequent.
Conclusions
This study indicates that dupilumab as add-on therapy for SA is associated with significant
improvements in exacerbation-rate, mOCS-dependency, asthma control, pulmonary function,
and quality of life. These results are in line with those of previous phase-III-trials.
Keywords
To read this article in full you will need to make a payment
Purchase one-time access:
Academic & Personal: 24 hour online accessCorporate R&D Professionals: 24 hour online accessOne-time access price info
- For academic or personal research use, select 'Academic and Personal'
- For corporate R&D use, select 'Corporate R&D Professionals'
Subscribe:
Subscribe to Respiratory MedicineAlready a print subscriber? Claim online access
Already an online subscriber? Sign in
Register: Create an account
Institutional Access: Sign in to ScienceDirect
References
- Global strategy for asthma management and prevention.(Available at:)
- Jaarcijfers aandoeningen - huisartsenregistraties.(Available at:)https://www.nivel.nl/nl/nivel-zorgregistraties-eerste-lijn/jaarcijfers-aandoeningen-huisartsenregistratiesDate accessed: September 18, 2022
- The prevalence of severe refractory asthma.J. Allergy Clin. Immunol. 2015; 135: 896-902
- The prevalence of subtypes of type 2 inflammation in an unselected population of patients with severe asthma.J. Allergy Clin. Immunol. Pract. 2021; 9: 1267-1275
- The prevalence and clinical characteristics of T2-high and T2-low endotype of severe uncontrolled asthma distinguished by combining popular type-2 biomarkers.Eur. Respir. J. 2019; 54: 2749
- Efficacy and safety of treatment with biologicals (benralizumab, dupilumab, mepolizumab, omalizumab and reslizumab) for severe eosinophilic asthma. A systematic review for the EAACI Guidelines - recommendations on the use of biologicals in severe asthma.Allergy. 2020; 75: 1023-1042
- Dupilumab efficacy and safety in moderate-to-severe uncontrolled asthma.N. Engl. J. Med. 2018; 378: 2486-2496
- Dupilumab efficacy and safety in adults with uncontrolled persistent asthma despite use of medium-to-high-dose inhaled corticosteroids plus a long-acting β2 agonist: a randomised double-blind placebo-controlled pivotal phase 2b dose-ranging trial.Lancet. 2016; 388: 31-44
- Efficacy and safety of dupilumab in glucocorticoid-dependent severe asthma.N. Engl. J. Med. 2018; 378: 2475-2485
- Treatment eligibility of real-life mepolizumab-treated severe asthma patients [published correction appears in J allergy clin immunol pract. 2021 jan;9(1):604].J. Allergy Clin. Immunol. Pract. 2020; 8 (2999-3008.e1)
- Real-world effectiveness of omalizumab in severe allergic asthma: a meta-analysis of observational studies.J. Allergy Clin. Immunol. Pract. 2021; 9: 2702-2714
- Real-life effectiveness of mepolizumab in severe asthma: a systematic literature review [published online ahead of print, 2021 Dec 24].J. Asthma. 2021; : 1-17
- ChAracterization of Italian severe uncontrolled Asthmatic patieNts Key features when receiving Benralizumab in a real-life setting: the observational rEtrospective ANANKE study.Respir. Res. 2022; 23 (Published 2022 Feb 19): 36
- Real-world effectiveness of benralizumab in severe eosinophilic asthma.Chest. 2021; 159: 496-506
- Asthma control in patients with severe eosinophilic asthma treated with reslizumab: Spanish real-life data.J. Asthma Allergy. 2022; 15 (Published 2022 Jan 14): 79-88
- Biologics for oral corticosteroid-dependent asthma.Allergy Asthma Proc. 2020; 41: 151-157
- Real-life studies of biologics used in asthma patients: key differences and similarities to trials.Expet Rev. Clin. Immunol. 2019; 15: 951-958
- The Strengthening the Reporting of Observational Studies in Epidemiology (STROBE)statement: guidelines for reporting observational studies.Lancet. 2007 Oct 20; 370: 1453-1457
- Measurement properties and interpretation of three shortened versions of the asthma control questionnaire.Respir. Med. 2005; 99: 553-558https://doi.org/10.1016/j.rmed.2004.10.008
- ERS/ATS technical standard on interpretive strategies for routine lung function tests.Eur. Respir. J. 2022; 602101499
- Effectiveness and safety of dupilumab for the treatment of severe asthma in a real-life French multi-centre adult cohort.Clin. Exp. Allergy. 2020; 50: 789-798
- Dupilumab rapidly improves asthma control in predominantly anti-IL5/IL5R pretreated Austrian real-life severe asthmatics.Immun Inflamm Dis. 2021 Sep; 9: 624-627
- Real-world experience with dupilumab in severe asthma: one-year data from an Italian named patient program.J. Asthma Allergy. 2021; 14: 575-583
Article info
Publication history
Published online: November 26, 2022
Accepted:
November 19,
2022
Received in revised form:
November 17,
2022
Received:
October 3,
2022
Identification
Copyright
© 2022 Elsevier Ltd. All rights reserved.
