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@article{Maher:2023:10.1016/S2213-2600(22)00359-9,
author = {Maher, TM and Tudor, VA and Saunders, P and Gibbons, MA and Fletcher, SV and Denton, CP and Hoyles, RK and Parfrey, H and Renzoni, EA and Kokosi, M and Wells, AU and Ashby, D and Szigeti, M and Molyneaux, PL and RECITAL, Investigators},
doi = {10.1016/S2213-2600(22)00359-9},
journal = {The Lancet Respiratory Medicine},
pages = {45--54},
title = {Rituximab versus intravenous cyclophosphamide in patients with connective tissue disease-associated interstitial lung disease in the UK (RECITAL): a double-blind, double-dummy, randomised, controlled, phase 2b trial},
url = {http://dx.doi.org/10.1016/S2213-2600(22)00359-9},
volume = {11},
year = {2023}
}

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TY  - JOUR
AB  - 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 capacity (FVC) at 24 weeks compared with baseline, analysed using a mixed-effects model with random intercepts, adjusted for baseline FVC and CTD type. Prespecified secondary endpoints reported in this Article were change in FVC at 48 weeks versus baseline; changes from baseline in 6 min walk distance, diffusing capacity of the lung for carbon monoxide (DLCO), physician-assessed global disease activity (GDA) score, and quality-of-life scores on the St George's Respiratory Questionnaire (SGRQ), King's Brief Interstitial Lung Disease (KBILD) questionnaire, and European Quality of Life Five-Dimension (EQ-5D) questionnaire at 24 and 48 weeks; overall survival, progression-free survival, and time to treatment failure; and corticosteroid use. All endpoints were analysed in the modified intention-to-treat population, which comprised all patients who received at least one dose of study drug. This trial is registered with ClinicalTrials.gov (NCT01862926). FINDINGS: Between Dec 1, 2014, and March 31, 2020, we screened 145 participants, of whom 101 participants were randomly allocated
AU  - Maher,TM
AU  - Tudor,VA
AU  - Saunders,P
AU  - Gibbons,MA
AU  - Fletcher,SV
AU  - Denton,CP
AU  - Hoyles,RK
AU  - Parfrey,H
AU  - Renzoni,EA
AU  - Kokosi,M
AU  - Wells,AU
AU  - Ashby,D
AU  - Szigeti,M
AU  - Molyneaux,PL
AU  - RECITAL,Investigators
DO  - 10.1016/S2213-2600(22)00359-9
EP  - 54
PY  - 2023///
SN  - 2213-2600
SP  - 45
TI  - Rituximab versus intravenous cyclophosphamide in patients with connective tissue disease-associated interstitial lung disease in the UK (RECITAL): a double-blind, double-dummy, randomised, controlled, phase 2b trial
T2  - The Lancet Respiratory Medicine
UR  - http://dx.doi.org/10.1016/S2213-2600(22)00359-9
UR  - https://www.ncbi.nlm.nih.gov/pubmed/36375479
UR  - https://www.sciencedirect.com/science/article/pii/S2213260022003599?via%3Dihub
UR  - http://hdl.handle.net/10044/1/100514
VL  - 11
ER  -

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