Nuclease Therapy Improves Severe Fatigue in Primary Sjögren’s Syndrome: A Randomized Clinical Trial

James Posada, Saba Valadkhan, Daniel Burge, Kristen Davies, Jessica Tarn, John Casement, Kerry Jobling, Peter Gallagher, Douglas Wilson, Francesca Barone, Benjamin Fisher, Wan-Fai Ng

Research output: Contribution to journalArticlepeer-review

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.
Original languageEnglish
JournalArthritis and Rheumatology
Publication statusAccepted/In press - 30 Jul 2020

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