Resolve Therapeutics, St. Petersburg, Florida.
Case Western Reserve University, Cleveland, Ohio.
Arthritis Rheumatol. 2021 Jan;73(1):143-150. doi: 10.1002/art.41489. Epub 2020 Nov 22.
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).
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).
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).
Administration of RSLV-132 improved severe fatigue, as determined by 4 independent patient-reported measures of fatigue, in patients with primary SS.
评估 RSLV-132（一种 RNase Fc 融合蛋白）在原发性干燥综合征（SS）患者中进行的一项 II 期随机、双盲、安慰剂对照临床试验的安全性和疗效。
30 名原发性 SS 患者随机接受 RSLV-132 或安慰剂静脉注射治疗，每周 1 次，持续 2 周，然后每 2 周 1 次，持续 12 周。8 名患者接受安慰剂，20 名患者接受 10mg/kg 的 RSLV-132。临床疗效评估指标包括欧洲抗风湿病联盟（EULAR）干燥综合征疾病活动指数、EULAR 干燥综合征患者报告指数（ESSPRI）、慢性疾病治疗疲劳功能评估（FACIT-F）、疲劳概况（ProF）和数字符号替代测试（DSST）。
接受 RSLV-132 治疗的患者在 ESSPRI 评分（P=0.27）、FACIT-F 评分（P=0.05）、ProF 评分（P=0.07）和 DSST（P=0.02）方面从基线到第 99 天均出现有临床意义的改善，而接受安慰剂的患者在这些临床疗效评估指标方面均无变化。这种改善与选定的干扰素诱导基因的表达增加显著相关（Pearson 相关性，每个 P<0.05）。
RSLV-132 治疗可改善原发性 SS 患者的严重疲劳，这可通过 4 项独立的患者报告疲劳评估指标来确定。
