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

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:

• severe asthma
• asthma exacerbation
• oral corticosteroid
• biologics
• retrospective cohort study

Abbreviations

BIO, biologics; CI, confidence interval; DPC, Diagnosis Procedure Combination; FAS, full analysis set; ICD, International Statistical Classification of Diseases and Related Health Problems; ICS, inhaled corticosteroid; IL, interleukin; IPTW, inverse probability treatment weighting; IQR, interquartile range; LABA, long-acting β₂-agonist; LTRA, leukotriene receptor antagonist; MDV, Medical Data Vision; OCS, oral corticosteroid; OR, odds ratio; Q, quartile; SABA, short-acting β₂-agonist; SD, standard deviation.

Data Sharing Statement

Data underlying the findings described in this manuscript may be obtained in accordance with AstraZeneca’s data sharing policy described at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

Ethics Approval and Informed Consent

This study was conducted per the Declaration of Helsinki and the Ethical Guidelines for Medical and Health Research Involving Human Subjects. The protocol was reviewed and approved (Approval No. 210229) by the Non-Profit Organization MINS Institutional Review Board (Tokyo, Japan). The data for this study were extracted from a commercially available de-identified claims database. According to the Ethical Guidelines above, informed consent is not required for de-identified data.

Acknowledgments

The authors wish to thank Keyra Martinez Dunn, MD of Edanz, Japan, for providing medical writing support, funded by AstraZeneca K.K.

Author Contributions

All authors made a significant contribution to the work reported, whether that is in the conception, study design, execution, acquisition of data, analysis and interpretation, or in all these areas; took part in drafting, revising or critically reviewing the article; gave final approval of the version to be published; have agreed on the journal to which the article has been submitted; and agree to be accountable for all aspects of the work.

Disclosure

Akihiko Tanaka received support for this article from AstraZeneca K.K. and has received payments or honoraria from AstraZeneca K.K., GSK K.K., Sanofi K.K., Kyorin Pharmaceutical Co., Ltd., and Novartis Pharma K.K. Mai Takahashi, Naoyuki Makita, and Naoki Tashiro are employees of and own stock in AstraZeneca K.K. Ayako Fukui, Yoshifumi Arita, and Masakazu Fujiwara are employees of AstraZeneca K.K. The authors report no other conflicts of interest in this work.

Additional information

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.