Oral Corticosteroid Reduction Between Biologics Initiated and Non-Initiated Patients with Severe Asthma

Akihiko Tanaka; Mai Takahashi; Ayako Fukui; Yoshifumi Arita; Masakazu Fujiwara; Naoyuki Makita; Naoki Tashiro

doi:10.2147/JAA.S411404

Oral Corticosteroid Reduction Between Biologics Initiated and Non-Initiated Patients with Severe Asthma

J Asthma Allergy. 2023 Aug 14:16:839-849. doi: 10.2147/JAA.S411404. eCollection 2023.

Authors

Akihiko Tanaka¹, Mai Takahashi², Ayako Fukui³, Yoshifumi Arita³, Masakazu Fujiwara³, Naoyuki Makita³, Naoki Tashiro³

Affiliations

¹ Division of Respiratory Medicine and Allergology, Department of Medicine, School of Medicine, Showa University, Tokyo, Japan.
² Medical, AstraZeneca K.K., Tokyo, Japan.
³ Medical, AstraZeneca K.K., Osaka, Japan.

Abstract

Purpose: The oral corticosteroid (OCS)-sparing effect of several biologics (BIOs) has been shown in clinical trials. To date, no study has evaluated differences in OCS dose reduction between BIO-initiated and BIO-non-initiated patients in real-world clinical practice. We compared dose reductions in maintenance OCS between BIO-initiated and BIO-non-initiated severe asthma patients in a real-world setting.

Patients and methods: This retrospective cohort study used the data from the Diagnosis Procedure Combination database of Medical Data Vision in Japan. Severe asthma patients with continuous use of OCS were selected from December 2015 to February 2020. The primary endpoint was the proportion reduction in daily maintenance OCS dose from Week 0 to Week 24. Analyses were performed using inverse probability treatment weighting.

Results: In total, 2927 patients were included (BIO-initiated: 239 patients, BIO-non-initiated: 2688 patients). Adjusted median (quartile [Q] 1-Q3) proportion reduction in daily maintenance OCS dose at Week 24 from the index date was 25.0% (0.0-100.0%) and 0.0% (0.0-83.3%) in the BIO-initiated and BIO-non-initiated groups, respectively (Hodges-Lehmann estimate [95% confidence interval], 0.0000% [0.0000-0.3365%]). Respective proportions of patients in the BIO-initiated and BIO-non-initiated groups achieving dose reductions from the index date in the daily maintenance OCS dose at Week 24 were >0% reduction, 56.6% and 44.1% (odds ratio [OR] 1.6554); ≥25% reduction, 50.5% and 40.6% (OR 1.4888); ≥50% reduction, 42.8% and 33.7% (OR 1.4714); and 100% reduction, 26.2% and 24.4% (OR 1.1005).

Conclusion: Among severe asthma patients, the daily dose of maintenance OCS was reduced with BIO treatment. Although a higher percentage of patients in the BIO-initiated group had an OCS reduction of ≤75% than the BIO-non-initiated group, we found no clear difference in OCS reduction. Our findings will be justified by further research that incorporates a longer observation period and variables excluded from this study.

Trial registration: ClinicalTrials.gov (NCT05136547).

Keywords: asthma exacerbation; biologics; oral corticosteroid; retrospective cohort study; severe asthma.

Associated data

ClinicalTrials.gov/NCT05136547

Grants and funding

This study was funded by AstraZeneca K.K., Osaka, Japan. AstraZeneca K.K. participated in the study design, analysis, and interpretation of data, writing the report, and deciding to submit the article for publication. Statistical analyses were entrusted to EPS, an external vendor appointed and funded by AstraZeneca K.K.