Abstract

RSLV-132, a biological drug consisting of an RNase–IgG1 Fc fusion protein, improved severe fatigue in patients with primary Sjögren's syndrome in a phase 2 randomised trial. James Posada and colleagues randomly assigned 30 patients (3:1) to receive 10 mg/kg intravenous RSLV-132 (n=22) or placebo (n=8) for 12 weeks. Patients in the RSLV-132 group achieved clinically meaningful improvements on the EULAR Sjögren's syndrome patient reported index (ESSPRI), FACIT fatigue, profile of fatigue, and the digit symbol substitution test, which correlated with increases in interferon-inducible gene expression (the primary outcome) via an unclear mechanism.

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