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Lookup NU author(s): Dr Jessica Tarn, John CasementORCiD, Dr Peter GallagherORCiD, Dr Deborah Wilson, Dr Francesca Barone, Professor Fai NgORCiD
This work is licensed under a Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International License (CC BY-NC-ND).
Objective. To assess the safety and efficacy of RSLV-132, an RNase Fc fusion protein in a phase II randomized, double-blind, placebo-controlled clinical trial in patients with primary Sjögren’s syndrome (pSS). Methods. Thirty patients were randomized to receive intravenous RSLV-132 or placebo, weekly for two weeks then every two weeks for twelve weeks. Eight subjects received placebo and twenty received RSLV-132, 10 mg/kg. Clinical efficacy measures included the European League Against Rheumatism (EULAR) Sjögren’s syndrome disease activity index (ESSDAI), EULAR Sjögren’s syndrome patient reported index (ESSPRI), FACIT fatigue (FACIT-F), and profile of fatigue (ProF), and the digit symbol substitution test (DSST). Results. Patients randomized to RSLV-132, but not placebo, experienced clinically meaningful improvements in ESSPRI, FACIT-F, ProF, and DSST. This improvement was correlated with increased expression of selected interferon-inducible genes. Conclusion. Administration of RSLV-132 improved severe fatigue in pSS patients as determined by four independent measures of fatigue.
Author(s): Posada J, Valadkhan S, Durge D, Davies K, Tarn J, Casement J, Jobling K, Gallagher P, Wilson D, Barone F, Fisher BA, Ng WF
Publication type: Article
Publication status: Published
Journal: Arthritis and Rheumatology
Year: 2021
Volume: 73
Issue: 1
Pages: 143-150
Print publication date: 01/01/2021
Online publication date: 15/08/2020
Acceptance date: 21/07/2020
Date deposited: 06/08/2020
ISSN (print): 2326-5191
ISSN (electronic): 2326-5205
Publisher: John Wiley & Sons, Inc.
URL: https://doi.org/10.1002/art.41489
DOI: 10.1002/art.41489
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