重度哮喘患者中启动生物制剂与未启动生物制剂者之间口服皮质类固醇的减量情况
Oral Corticosteroid Reduction Between Biologics Initiated and Non-Initiated Patients with Severe Asthma.
作者信息
Tanaka Akihiko, Takahashi Mai, Fukui Ayako, Arita Yoshifumi, Fujiwara Masakazu, Makita Naoyuki, Tashiro Naoki
机构信息
Division of Respiratory Medicine and Allergology, Department of Medicine, School of Medicine, Showa University, Tokyo, Japan.
Medical, AstraZeneca K.K., Tokyo, Japan.
出版信息
J Asthma Allergy. 2023 Aug 14;16:839-849. doi: 10.2147/JAA.S411404. eCollection 2023.
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).
目的
多项生物制剂（BIO）在临床试验中已显示出具有节省口服糖皮质激素（OCS）的作用。迄今为止，尚无研究评估在实际临床实践中，起始使用BIO与未起始使用BIO的患者在OCS剂量降低方面的差异。我们比较了在实际环境中，起始使用BIO与未起始使用BIO的重度哮喘患者维持性OCS的剂量降低情况。
患者与方法
这项回顾性队列研究使用了日本医疗数据愿景诊断程序组合数据库中的数据。选取2015年12月至2020年2月期间持续使用OCS的重度哮喘患者。主要终点是从第0周至第24周每日维持性OCS剂量的降低比例。采用逆概率处理加权法进行分析。
结果
总共纳入2927例患者（起始使用BIO：239例患者，未起始使用BIO：2688例患者）。从索引日期至第24周，起始使用BIO组和未起始使用BIO组每日维持性OCS剂量调整后的中位（四分位间距[Q]1-Q3）降低比例分别为25.0%（0.0-100.0%）和0.0%（0.0-83.3%）（霍奇斯-莱曼估计值[95%置信区间]，0.0000%[0.0000-0.3365%]）。起始使用BIO组和未起始使用BIO组中，从索引日期至第24周每日维持性OCS剂量实现降低的患者比例分别为：降低>0%，56.6%和44.1%（优势比[OR]1.6554）；降低≥25%，50.5%和40.6%（OR 1.4888）；降低≥50%，42.8%和33.7%（OR 1.4714）；以及降低100%，26.2%和24.4%（OR 1.1005）。
结论
在重度哮喘患者中，BIO治疗可降低维持性OCS的每日剂量。尽管起始使用BIO组中OCS降低≤75%的患者比例高于未起始使用BIO组，但我们发现OCS降低方面无明显差异。我们的研究结果将通过纳入更长观察期和本研究未涉及变量的进一步研究来加以验证。
试验注册
ClinicalTrials.gov（NCT05136547）
Zotero 插件