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Improvement of Severe Fatigue Following Nuclease Therapy in Patients With Primary Sjögren's Syndrome: A Randomized Clinical Trial

Lookup NU author(s): Dr Jessica Tarn, John CasementORCiD, Dr Peter GallagherORCiD, Dr Deborah Wilson, Dr Francesca Barone, Professor Fai NgORCiD

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Abstract

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.

Publication metadata

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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