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Improvement of Severe Fatigue Following Nuclease Therapy in Patients With Primary Sjögren’s Syndrome: A Randomized Clinical Trial
Author(s) -
Posada James,
Valadkhan Saba,
Burge Daniel,
Davies Kristen,
Tarn Jessica,
Casement John,
Jobling Kerry,
Gallagher Peter,
Wilson Douglas,
Barone Francesca,
Fisher Benjamin A.,
Ng WanFai
Publication year - 2021
Publication title -
arthritis and rheumatology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 4.106
H-Index - 314
eISSN - 2326-5205
pISSN - 2326-5191
DOI - 10.1002/art.41489
Subject(s) - medicine , placebo , randomized controlled trial , digit symbol substitution test , rheumatism , clinical trial , gastroenterology , physical therapy , pathology , alternative medicine
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 (SS). Methods Thirty patients with primary SS were randomized to receive treatment with RSLV‐132 or placebo intravenously once per week for 2 weeks, and then every 2 weeks for 12 weeks. Eight patients received placebo and 20 patients received RSLV‐132 at a dose of 10 mg/kg. Clinical efficacy measures included the European League Against Rheumatism (EULAR) Sjögren’s Syndrome Disease Activity Index, EULAR Sjögren’s Syndrome Patient Reported Index (ESSPRI), Functional Assessment of Chronic Illness Therapy–Fatigue (FACIT‐F), Profile of Fatigue (ProF), and the Digit Symbol Substitution Test (DSST). Results Patients randomized to receive RSLV‐132 experienced clinically meaningful improvements in the ESSPRI score ( P = 0.27), FACIT‐F score ( P = 0.05), ProF score ( P = 0.07), and DSST ( P = 0.02) from baseline to day 99, whereas patients who received placebo showed no changes in any of these clinical efficacy measures. This improvement was significantly correlated with increased expression of selected interferon‐inducible genes (Pearson’s correlations, each P < 0.05). Conclusion Administration of RSLV‐132 improved severe fatigue, as determined by 4 independent patient‐reported measures of fatigue, in patients with primary SS.