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. 2023 Dec 14;62(6):2300819.
doi: 10.1183/13993003.00819-2023. Print 2023 Dec.

Clinical remission in severe asthma with biologic therapy: an analysis from the UK Severe Asthma Registry

P Jane McDowell  1   2 , Ron McDowell  3 , John Busby  4 , M Chad Eastwood  1   2 , Pujan H Patel  5 , David J Jackson  6 , Adel Mansur  7 , Mitesh Patel  8 , Hassan Burhan  9 , Simon Doe  10 , Rekha Chaudhuri  11 , Robin Gore  12 , James W Dodd  13 , Deepak Subramanian  14 , Thomas Brown  15 , Liam G Heaney  1   2 ; UK Severe Asthma Registry
Affiliations

Clinical remission in severe asthma with biologic therapy: an analysis from the UK Severe Asthma Registry

P Jane McDowell et al. Eur Respir J. .

Abstract

Background: Novel biologic therapies have revolutionised the management of severe asthma with more ambitious treatment aims. Here we analyse the definition of clinical remission as a suggested treatment goal and consider the characteristics associated with clinical remission in a large, real-world severe asthma cohort.

Methods: This was a retrospective analysis of severe asthma patients registered in the UK Severe Asthma Registry (UKSAR) who met strict national access criteria for biologics. Patients had a pre-biologics baseline assessment and annual review. The primary definition of clinical remission applied included Asthma Control Questionnaire (ACQ)-5 <1.5 and no oral corticosteroids for disease control and forced expiratory volume in 1 s above lower limit of normal or no more than 100 mL less than baseline.

Results: 18.3% of patients achieved the primary definition of remission. The adjusted odds of remission on biologic therapy were 7.44 (95% CI 1.73-31.95)-fold higher in patients with type 2 (T2)-high biomarkers. The adjusted odds of remission were lower in patients who were female (OR 0.61, 95% CI 0.45-0.93), obese (OR 0.49, 95% CI 0.24-0.65) or had ACQ-5 ≥1.5 (OR 0.19, 95% CI 0.12-0.31) pre-biologic therapy. The likelihood of remission reduced by 14% (95% CI 0.76-0.97) for every 10-year increase in disease duration. 12-21% of the cohort attained clinical remission depending on the definition applied; most of those who did not achieve remission failed to meet multiple criteria.

Conclusions: 18.3% of patients achieved the primary definition of clinical remission. Remission was more likely in T2-high biomarker patients with shorter duration of disease and less comorbidity. Further research on the optimum time to commence biologics in severe asthma is required.

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Conflict of interest statement

Conflict of interest: The UK Severe Asthma Registry (UKSAR) does not receive any monetary benefits or benefits-in-kind from any pharmaceutical entity; UKSAR does make limited data contributions to the International Severe Asthma Registry (ISAR) and the European Respiratory Society Clinical Research Collaborative (SHARP), which do receive pharmaceutical funding. P.J. McDowell reports speaker fees from GlaxoSmithKline and scientific meeting support from Chiesi. R. McDowell and M. Patel have no conflicts of interest to declare. M.C. Eastwood reports support to attend meetings from GlaxoSmithKline. J. Busby reports grants from AstraZeneca and personal fees from Nuvoair. P.H. Patel received advisory board fees and lecture fees from AstraZeneca, GlaxoSmithKline, Novartis and Sanofi. D.J. Jackson has received speaker fees and consultancy fees from AstraZeneca, GlaxoSmithKline and Sanofi Regeneron. A. Mansur declares personal and to institution payment for talks, advisory board meetings and sponsorship to attend conferences from AstraZeneca, GlaxoSmithKline, Teva, Sanofi, Novartis and Boehringer Ingelheim; he also declares research grants from GlaxoSmithKline. H. Burhan reports fees for advisory board meetings from AstraZeneca and Novartis, honoraria for lectures from AstraZeneca, Chiesi, GSK and Sanofi, and support for attending conferences from AstraZeneca, Chiesi and GSK. S. Doe has participated on advisory boards for Vertex, Gilead and Novartis, and has received support for travel to meetings from GlaxoSmithKline, AstraZeneca, Gilead, Teva; Sanofi, Chiesi and Forest, and fees for lectures from GlaxoSmithKline, AstraZeneca and Sanofi. R. Chaudhuri has received lecture fees from GlaxoSmithKline, AstraZeneca, Teva, Chiesi, Sanofi and Novartis, honoraria for advisory board meetings from GlaxoSmithKline and AstraZeneca, sponsorship to attend international scientific meetings from Chiesi, Sanofi and GlaxoSmithKline, and a research grant (paid to institute) from AstraZeneca for a UK multicentre study. R. Gore has received fees for lecturing from AstraZeneca, Novartis, Sanofi and GlaxoSmithKline. J.W. Dodd declares he has received honoraria for participating in advisory boards and given lectures at meetings supported by GlaxoSmithKline, Boehringer Ingelheim, Chiesi, AstraZeneca, Fisher & Paykel and Aerogen; he has received sponsorship for attending international scientific meetings from Chiesi; he has also taken part in asthma clinical trials sponsored by Sanofi, AstraZeneca and Chiesi, for which his institution received remuneration; his institution has received funding for research from the MRC, NIHR, SBRI, NHSx, Templeton Foundation and Southmead Hospital research charity. T. Brown has received fees as an external expert from AstraZeneca, speaker fees from AstraZeneca, GlaxoSmithKline, Sanofi, Teva, Novartis and Chiesi, honoraria for advisory board attendance from AstraZeneca, Sanofi and Teva, and sponsorship to attend international scientific meetings from Sanofi, GlaxoSmithKline, Teva, Chiesi and Napp Pharmaceuticals. D. Subramanian is part of the AstraZeneca Precision National Working group and has received speaker fees from Chiesi. L.G. Heaney is academic lead for the Medical Research Council Stratified Medicine UK Consortium in Severe Asthma, which involves industrial partnerships with a number of pharmaceutical companies.

Figures

FIGURE 1
FIGURE 1
Forest plot of variables associated with remission included in the regression analysis, adjusted for time to follow-up and hospital site. Remission definition: Asthma Control Questionnaire (ACQ)-5 <1.5, and no maintenance oral corticosteroids (mOCS) or OCS bursts, and forced expiratory volume in 1 s (FEV1) above lower limit of normal or ≤100 mL less than pre-biologics FEV1. BMI: body mass index; T2: type 2; BEC: blood eosinophil count; FENO: fractional exhaled nitric oxide.
FIGURE 2
FIGURE 2
Receiver operating curve for explanatory variables included in the clinical remission model. Variables in the remission model include gender, age at commencing biologics, symptom duration, ethnicity, body mass index, smoking history, depression/anxiety, composite type 2 status, oral corticosteroid (OCS) bursts in the year prior to biologics, maintenance OCS, biologic mechanism, hospital site, time to follow-up and Asthma Control Questionnaire-5. AUC: area under the curve.
FIGURE 3
FIGURE 3
Reasons for not meeting remission criteria after 1 year on biologic therapy. 30% (202) failed to meet lung function criteria, 74% (500) failed to meet Asthma Control Questionnaire (ACQ)-5 criteria and 83% (562) failed to meet steroid criteria; 67% of those who did not achieve remission failed to meet at least two of the remission criterion. #: ACQ-5 ≥1.5; : at least one exacerbation and/or maintenance oral corticosteroids >5 mg; +: forced expiratory volume in 1 s below lower limit of normal and >100 mL less than baseline.
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