論文No2559
Real-world mepolizumab in the prospective severe asthma REALITI-A study: initial analysis
Tim Harrison, Giorgio Walter Canonica, Geoffrey Chupp, Jason Lee, Florence Schleich, Tobias Welte, Antonio Valero, Kim Gemzoe, Aoife Maxwell, Sandra Joksaite, Shibing Yang, Peter Howarth, Melissa K. Van Dyke
European Respiratory Journal 56 (4) 2000151; DOI: 10.1183/13993003.00151-2020 Published 15 October 2020
＜背景＞
メポリズマブ（抗IL-5モノクローナル抗体）の効果はランダム化コントロール試験で示されたが、
実際の臨床現場におけるリアルワールドのデータは不足している。
我々はリアルワールドでのメポリズマブの有効性、安全性を評価した。
＜方法＞
REALITI-Aはグローバルな前向き観察コホート研究である。
喘息患者でルーチンの外来受診データを収集した。
新たにメポリズマブを投与された重症喘息患者はメポリズマブ前12か月の関連する治療データを収集した。
早期開始者が１年フォローアップ（2019年2月28日まで）を完了した初期解析を行った。
主要な目的は臨床的に有意な増悪（経口ステロイド(OCS)を要する and/or 入院 and/or 救急外来受診）の率を
メポリズマブ前後で比較することである。
その他、入院 and/or 救急外来受診を要する増悪、維持OCS量の変化も検討した。治療関連有害事象も報告した。
＜結果＞
全体で368名のメポリズマブ治療患者を解析した。
臨床的に有意な増悪はメポリズマブ前4.63/人年からメポリズマブ後は1.43/人年に69%減少した(p<0.001)。
入院and/or救急外来受診を要する増悪も同様であった（1.14から0.27に減少；77%に減少）。
維持OCS使用の159名のデータが利用可能であり、
メポリズマブ前の１日量中央値は10.0mg/dayが5.0mg/day(21-24週）に減少し、53-56週まで維持された。
新しい副作用は報告されなかった。
＜感想＞
メポリズマブはリアルワールドの設定でも重症喘息患者の増悪、経口ステロイド量を改善したようです。
Introduction Efficacy of mepolizumab, an anti-interleukin-5 monoclonal antibody, was demonstrated in randomised controlled trials; data on its real-world impact in routine clinical practice are starting to emerge. We assessed the effectiveness and safety of mepolizumab prescribed for patients in the real world.
Methods REALITI-A is a global, prospective, observational cohort study, collecting data from routine healthcare visits from patients with asthma. Patients newly prescribed mepolizumab for severe asthma with 12 months of relevant medical history pre-mepolizumab (collected retrospectively) were enrolled. An initial analysis of data from early initiators who had completed 1 year of follow-up (as of February 28, 2019) was conducted. The primary objective was to compare the rate of clinically significant exacerbations (requiring oral corticosteroids (OCS) and/or hospitalisation and/or emergency department visit) before and after mepolizumab; exacerbations requiring hospitalisation and/or emergency department visit and change in maintenance OCS use were secondary objectives. Treatment-related adverse events were reported.
Results Overall, 368 mepolizumab-treated patients were included. Rates of clinically significant exacerbations were reduced by 69% from 4.63 per person per year pre-treatment to 1.43 per person per year during follow-up (p<0.001), as were those requiring hospitalisation and/or emergency department visit (from 1.14 to 0.27 per person per year; 77% reduction). In 159 patients with maintenance OCS dose data available during the pre-treatment period, median daily dose decreased from 10.0 (pre-treatment) to 5.0 mg·day−1 by week 21–24 of follow-up, sustained until week 53–56. No new safety signals were reported.
Conclusion These data demonstrate that the effectiveness of mepolizumab is consistent with clinical trial results under real-world settings, with significant reductions in exacerbations and daily maintenance OCS dose.