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Observational Study
. 2023 Jan-Dec:17:17534666231202749.
doi: 10.1177/17534666231202749.

Improvement in severe asthma patients receiving biologics and factors associated with persistent insufficient control: a real-life national study

Laurent Guilleminault  1   2   3 , Claire Camus  3 , Chantal Raherison-Semjen  3   4 , Audrey Capdepon  5 , Arnaud Bourdin  3   6 , Philippe Bonniaud  3   7 , Stéphanie Fry  3   8 , Gilles Devouassoux  3   9 , François-Xavier Blanc  3   10 , Christophe Pison  3   11 , Clairelyne Dupin  3   12 , Naji Khayath  3   13 , Joelle Courdeau  14 , Judith Valcke-Brossollet  15 , Cécilia Nocent-Ejnaini  16 , Fabien Rolland  17 , Carmen Lamandi  18 , Alain Proust  19 , Anaig Ozier  20 , Laurent Portel  21 , Wanda Gaspard  22 , Pauline Roux-Claude  3   23 , Antoine Beurnier  3   24 , Stéphanie Martinez  25 , Jean-Marc Dot  26 , Florence Hennegrave  27 , Guillaume Vignal  28 , Etienne Auvray  29 , Nicolas Paleiron  30 , Nicolas Just  31 , Jean Miltgen  32 , Maud Russier  33 , Cécile Olivier  34 , Camille Taillé  3   12 , Alain Didier  1   2   3
Affiliations
Observational Study

Improvement in severe asthma patients receiving biologics and factors associated with persistent insufficient control: a real-life national study

Laurent Guilleminault et al. Ther Adv Respir Dis. 2023 Jan-Dec.

Abstract

Background: Biological therapies have revolutionized the treatment of severe asthma with type 2 inflammation. Although such treatments are very effective in reducing exacerbation and the dose of oral steroids, little is known about the persistence of symptoms in severe asthma patients treated with biologics.

Purpose: We aim to describe asthma control and healthcare consumption of severe asthma patients treated with biologics.

Design: The Second Souffle study is a real-life prospective observational study endorsed by the Clinical Research Initiative in Severe Asthma: a Lever for Innovation & Science Network.

Methods: Adults with a confirmed diagnosis of severe asthma for at least 12 months' duration were enrolled in the study. A self-administered questionnaire including the Asthma Control Questionnaire (ACQ), Asthma Quality of Life Questionnaire (AQLQ) and a compliance evaluation test was given to the patients. Healthcare consumption within 12 months prior to enrolment was documented. In patients receiving biologics, doctors indicated whether the patients were biologic responders or non-responders.

Results: The characteristics of 431 patients with severe asthma were analysed. Among them, 409 patients (94.9%) presented asthma with type 2 inflammation (T2 high) profile, and 297 (72.6%) patients with a T2 high phenotype were treated with a biologic. Physicians estimated that 88.2% of patients receiving biologics were responders. However, asthma control was only achieved in 25.3% of those patients (ACQ > 0.75). A high proportion of patients (77.8%) identified as responders to biologics were not controlled according to the ACQ score. About 50% of patients continue to use oral corticosteroids either daily (25.2%) or more than three times a year for at least three consecutive days (25.6%). Gastro-oesophageal Reflux Disease (GERD) and Obstructive Sleep Apnoea syndrome (OSA) were identified as independent factors associated with uncontrolled asthma.

Conclusion: Although a high proportion of severe asthma patients respond to biologics, only 25.3% have controlled asthma. GERD and OSA are independent factors of uncontrolled asthma.

Keywords: biologics; healthcare; oral corticosteroid; quality of life; severe asthma.

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Conflict of interest statement

LG has participated or is participating as an investigator in clinical trials for AstraZeneca, MSD and Novartis, and hereby declares receipt of a research grant or consultancy fees from AstraZeneca, Chiesi, GlaxoSmithKline, Novartis and Sanofi-Regeneron. He also declares receipt of consultancy fees from Bayer, MSD and outside the submitted work. AC is an employee of AstraZeneca. CN declares receipt of consultancy fees from declares AstraZeneca, GSK, Sanofi, Chiesi, Novartis, ALK, Boehringer Ingelheim, Menarini and Mundipharma. SF declares receipt of consultancy fees from AstraZeneca, Sanofi, GlaxoSmithKline and Novartis. FR declares receipt of consultancy fees from GSK, Chiesi and AstraZeneca. NK has participated or is participating as an investigator in clinical trials for GlaxoSmithKline, Chiesi and Sanofi, and declares receipt of consultancy fees from AstraZeneca, Chiesi, GlaxoSmithKline, Sanofi and Novartis. CD declares receipt of consultancy fees from AstraZeneca, Sanofi, Chiesi, GlaxoSmithKline and Novartis. WG declares receipt of consultancy fees from AstraZeneca, Sanofi, Chiesi, GlaxoSmithKline and Novartis. NJ declares receipt of consultancy fees from Chiesi, AstraZeneca, GlaxoSmithKline. JM declares receipt of consultancy fees from AstraZeneca and non-financial support from ALK-Abello, Menarini, GSK, Boehringer-Ingelheim, Chiesi, Astra-Zeneca, Sanofi, Novartis, Stallergènes, Vitalaire, LVL Arard and AJR médical. CL declares receipt of consultancy fees or non-financial support from AstraZeneca, Sanofi, Novartis, Boehringer Ingelheim, Chiesi, GSK, Menarini, Asten, France Oxygène, SOS oxygène. AP declares receipt of consultancy fees from AstraZeneca, GSK, Chiesi, Novartis, Menarini, Sanofi. AB declares receipt of consultancy fees from Sanofi and AstraZeneca. CT declares research grants or receipt of consultancy fees from AstraZeneca, Sanofi, GlaxoSmithKline and Novartis. AD declares receipt of consultancy fees from ALK, AstraZeneca, Chiesi, GlaxoSmithKline, Menarini, Novartis, Sanofi and Zambon. The other co-authors declare no conflict of interests.

Figures

Figure 1.
Figure 1.
Comorbidity characteristics of severe asthma patients (n = 431).
Figure 2.
Figure 2.
Study design and overall population analysed.
Figure 3.
Figure 3.
Impact of biologic treatment among T2 patients receiving biologics based on therapeutic response defined by a pulmonologist (a), asthma control score (b), OCS consumption (c), patient satisfaction with treatment (d), healthcare consumption (e) and the proportion of super-responders among responders to biologics (f). ACQ, asthma control questionnaire; OCS, oral corticosteroid; NA, number of patients with missing data.
Figure 4.
Figure 4.
Asthma control and quality of life scores for T2 high patients: comparison between patients receiving (n = 297) and not receiving biologics (n = 112). Radar graphs illustrate comparison between patients groups for (a) asthma control using ACQ scores and (b) quality of life using Mini-AQLQ score Values * indicates a statistical difference between T2 high patients receiving biologics versus those not receiving biologics, p < 0.0001. ACQ, asthma control questionnaire; AQLQ, asthma quality of life questionnaire.
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