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CHEST pulmonary Pub Date : 2025-03-01 DOI:10.1016/j.chpulm.2024.100107

Cristiano Caruso MD, PhD , G. Walter Canonica MD , Manish Patel MBChB, PhD , Andrew Smith MBChB, PhD , Mark C. Liu MD , Rafael Alfonso-Cristancho MD, PhD , Robert G. Price MSc , Rupert W. Jakes PhD , Lydia Demetriou MSc , Antonio Valero MD , Thomas C. Köhler MD , Charles Pilette MD, PhD , Geoffrey Chupp MD , Guy Brusselle MD , Peter Howarth DM

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摘要

研究设计与方法REALITI-A是一项为期2年的国际前瞻性研究，研究对象为新开始皮下注射甲泼尼单抗100毫克（由医生决定）的成人哮喘患者。使用前 1 年与随访 2 年的结果包括临床上严重的哮喘加重（CSEs）率（病情恶化需要使用全身皮质类固醇和/或去急诊科就诊/住院）、需要去急诊科就诊/住院的加重率、需要住院的加重率、需要去急诊科就诊/住院的加重率、需要去急诊科就诊/住院的加重率、需要去急诊科就诊/住院的加重率、需要去急诊科就诊/住院的加重率、结果经过 2 年的随访后，该研究发现了哮喘控制问卷-5 评分、FEV1 和不良事件 (AEs)。结果随访2年后，73%的患者（822人中有599人）没有停用美泊利珠单抗的记录。在2年随访期间与使用美泊珠单抗前相比（N = 822），CSE、需要急诊室就诊/住院治疗的病情加重或仅住院治疗的比率分别降低了74%、79%和73%（无CSE的几率比为10.0；95% CI为7.55-13.25）。mOCS 每日中位剂量从第 0 周的 10.0（四分位 1，5.0；四分位 3，14.7）毫克（n = 297）降至第 101-104 周的 0.0（四分位 1，0.0；四分位 3，5.0）毫克（n = 168），停用 mOCS 的患者比例逐渐增加，1 年时达到 43%，2 年时达到 57%。2 年时，哮喘控制问卷-5 评分比基线降低了 1.53 分。在第 21 至 24 个月，最小平方平均 FEV1 比基线提高了 142 毫升。在随访期间，分别有90例（11%）和7例（< 1%）患者出现甲泼尼单抗相关不良反应和严重不良反应。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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Prospective REALITI-A Study

Background

Mepolizumab, a monoclonal antibody targeting IL-5, is of proven clinical benefit in severe asthma; however, prospective, long-term, real-world data in severe asthma are required.

Research Question

What is the real-world benefit of 2 years of mepolizumab treatment in severe asthma?

Study Design and Methods

REALITI-A was a 2-year, international, prospective study enrolling adults with asthma on newly initiated mepolizumab 100 mg subcutaneously (physician decision). Outcomes in the 1-year premepolizumab vs 2-year follow-up periods included rates of clinically significant asthma exacerbations (CSEs) (deterioration requiring systemic corticosteroids and/or emergency department [ED] visit/hospitalization), exacerbations requiring ED visit/hospitalization, exacerbations requiring hospitalization, proportion of patients with no exacerbations, median daily maintenance oral corticosteroids (mOCSs) dose, proportion of patients discontinuing mOCSs completely, Asthma Control Questionnaire-5 score, FEV₁, and adverse events (AEs).

Results

After 2 years’ follow-up, 73% of patients (599 of 822) had no record of mepolizumab discontinuation. During the 2-year follow-up vs premepolizumab period (N = 822), rates of CSEs, exacerbations requiring ED visit/hospitalization, or hospitalization only were reduced by 74%, 79%, and 73%, respectively (odds ratio for no CSEs, 10.0; 95% CI, 7.55- 13.25). Median daily mOCS dose decreased from 10.0 (quartile 1, 5.0; quartile 3, 14.7) mg at week 0 (n = 297) to 0.0 (quartile 1, 0.0; quartile 3, 5.0) mg at weeks 101 to 104 (n = 168), and the proportion of patients discontinuing mOCSs increased progressively to 43% at 1 year and 57% at 2 years. There was a 1.53-point reduction in Asthma Control Questionnaire-5 scores from baseline at 2 years. At months 21 to 24, least square mean FEV₁ improved by 142 mL from baseline. Ninety (11%) and 7 (< 1%) patients experienced mepolizumab-related AEs and serious AEs during the follow-up period, respectively.

Interpretation

In patients with severe asthma, real-world mepolizumab treatment for 2 years was well tolerated and was associated with sustained reductions in exacerbations and progressive reductions in mOCS use.

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CHEST pulmonary

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