RT Journal Article
SR Electronic
T1 Real-world use of inhaled corticosteroid/formoterol as-needed in adults with mild asthma: The PRIME study
JF ERJ Open Research
JO erjor
FD European Respiratory Society
SP 00174-2024
DO 10.1183/23120541.00174-2024
A1 Brusselle, Guy
A1 Blasi, Francesco
A1 Gessner, Christian
A1 Kuna, Piotr
A1 Wark, Peter
A1 Cappellini, Glauco
A1 Oosterom, Emilie
A1 Van Der Deijl, Marielle
A1 Bucchioni, Enrica
A1 Topole, Eva
YR 2024
UL http://openres.ersjournals.com/content/early/2024/04/11/23120541.00174-2024.abstract
AB Introduction Inhaled corticosteroid/formoterol fumarate (ICS/FF) as-needed is recommended by the Global Initiative for Asthma as sole therapy in adults with mild asthma, with low-dose maintenance ICS plus short-acting β2-agonist (SABA) as an alternative. SABA alone is no longer recommended. Given these changes in recommendations, the observational PRIME study aimed to describe real-world treatment patterns in mild asthma in Europe.Methods Adults with asthma receiving low-dose maintenance ICS, or as-needed ICS/FF or SABA were followed for 6 months. Data collected included Asthma Control Test (ACT), Asthma Control Questionnaire 5 item (ACQ-5), forced expiratory volume in 1 s (FEV1), and asthma exacerbations.Results The study was conducted in Germany, Italy, Poland and Spain, in 883 patients; 833 (94.3%) completed follow-up. At enrolment, 32.2% received maintenance ICS, 56.3% ICS/FF as-needed, and 11.6% SABA as-needed; 57.4%, 61.3%, and 54.9%, respectively, had well controlled asthma (ACQ-5/ACT definition). After 6 months, changes in mean FEV1 were small in the maintenance ICS and ICS/FF as-needed groups, whereas there was a decline in FEV1 in the SABA as-needed group. ACQ-5 total score improved from baseline in all three groups; 0.4%, 0.4% and 2.0% patients, respectively, had a severe exacerbation during the study.Conclusions More patients received ICS/FF as-needed than SABA as-needed, suggesting that physicians are aware of the latest treatment recommendations. This real-world study provides additional support to the use of ICS/FF as-needed as preferred treatment for patients with mild asthma, whereas SABA as-needed was associated with a fall in lung function and more severe exacerbations.FootnotesThis manuscript has recently been accepted for publication in the ERJ Open Research. It is published here in its accepted form prior to copyediting and typesetting by our production team. After these production processes are complete and the authors have approved the resulting proofs, the article will move to the latest issue of the ERJOR online. Please open or download the PDF to view this article.Conflicts of interest: In addition to the medical writing support disclosed above, the authors have the following conflicts of interest.Conflicts of interest: GB declares honoraria for advisory boards and/or lectures from AstraZeneca, Boehringer-Ingelheim, Chiesi, GlaxoSmithKline, Merck Sharp & Dohme, Novartis and Sanofi Regeneron, and that he is President of the Belgian Respiratory Society. All are outside the scope of the current manuscript.Conflicts of interest: FB declares grants or contracts from AstraZeneca, Chiesi, GlaxoSmithKline, and Insmed, consulting fees from GlaxoSmithKline, OM Pharma, and Menarini, and payment or honoraria for lectures, presentations, speakers bureaus, manuscript writing or educational events from AstraZeneca, Chiesi, GlaxoSmithKline, Grifols, Insmed, Menarini, Viatris, OM Pharma, Pfizer, Sanofi, Vertex, and Zambon. All are outside the scope of the current manuscript.Conflicts of interest: CG declares consulting fees and payment or honoraria for lectures, presentations, speakers bureaus, manuscript writing or educational events from GlaxoSmithKline, AstraZeneca, Chiesi, Pfizer, Sanofi, Berlin-Chemie, MSD, BMS, Boehringer Ingelheim, Teva, Roche, Regeneron, and Novartis, support for attending meetings and/or travel from Chiesi and Sanofi, participation in a steering committee for the Regeneron lung cancer program, and that he is chairman of the professional association of pneumologists in Saxony. All are outside the scope of the current manuscript.Conflicts of interest: PK declares honoraria for lectures from Adamed, Boehringer Ingelheim, AstraZeneca, Celon Pharma, Polpharma, Berlin-Chemie Menarini, Glenmark, GlaxoSmithKline, Teva, Novartis, and Sanofi, and support to attend congresses from AstraZeneca, and Berlin-Chemie Menarini. All are outside the scope of the current manuscript.Conflicts of interest: PW has no conflicts to disclose.Conflicts of interest: GC, EO, MVDD, EB and ET are all employees of Chiesi, the study sponsor.