作者
Toby M Maher, Veronica A Tudor, Peter Saunders, Michael A Gibbons, Sophie V Fletcher, Christopher P Denton, Rachel K Hoyles, Helen Parfrey, Elisabetta A Renzoni, Maria Kokosi, Athol U Wells, Deborah Ashby, Matyas Szigeti, Philip L Molyneaux, Mohammed Akil, Daphne Babalis, Nazia Chaudhuri, Felix Chua, Arnab Data, Dhananjay Desai, Shrish Dubey, Natalie Dwyer, Marcus Flather, Richard Fordham, Carlota Grossi Sampedro, Frances Hall, Ira Jakupovic, Gregory Keir, Bipen Patel, Henry Penn, Arvind Rajasekaran, Lisa G Spencer, Vicky Tsipouri, Zhe Wu, Georgio Xydopoulos, Fernando Zanghelini
发表日期
2023/1/1
期刊
The Lancet Respiratory Medicine
卷号
11
期号
1
页码范围
45-54
出版商
Elsevier
简介
Background
Rituximab is often used as rescue therapy in interstitial lung disease (ILD) associated with connective tissue disease (CTD), but has not been studied in clinical trials. This study aimed to assess whether rituximab is superior to cyclophosphamide as a treatment for severe or progressive CTD associated ILD.
Methods
We conducted a randomised, double-blind, double-dummy, phase 2b trial to assess the superiority of rituximab compared with cyclophosphamide. Patients aged 18–80 years with severe or progressive ILD related to scleroderma, idiopathic inflammatory myositis, or mixed CTD, recruited across 11 specialist ILD or rheumatology centres in the UK, were randomly assigned (1:1) to receive rituximab (1000 mg at weeks 0 and 2 intravenously) or cyclophosphamide (600 mg/m2 body surface area every 4 weeks intravenously for six doses). The primary endpoint was rate of change in forced vital …
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TM Maher, VA Tudor, P Saunders, MA Gibbons… - The Lancet Respiratory Medicine, 2023