Mosca Marta, Arnaud Laurent, Askanase Anca, Hobar Coburn, Becker Brandon, Singhal Shalabh, Banerjee Subhashis, Pomponi Samantha, Choi Jiyoon, Strand Vibeke
University of Pisa, Pisa, Italy.
Department of Rheumatology, Hôpitaux universitaires de Strasbourg, Strasbourg, France.
Lupus Sci Med. 2025 Jun 1;12(1):e001517. doi: 10.1136/lupus-2025-001517.
In PAISLEY, a 48-week, phase II, randomised controlled trial that assessed deucravacitinib in patients with active SLE, all primary and secondary endpoints were met with the deucravacitinib 3 mg two times per day dose. Changes in patient-reported outcomes, collected as exploratory endpoints, were evaluated in this study.
Patients with SLE (n=363) were randomised to placebo (n=90) or deucravacitinib 3 mg two times per day (n=91), 6 mg two times per day (n=93) or 12 mg once daily (n=89). Patients assessed pain levels on a Numeric Rating Scale and completed the Patient-Reported Outcomes Measurement Information System Fatigue Short Form 7a and 36-Item Short Form Health Survey (SF-36) at scheduled intervals. These outcomes were stratified by Systemic Lupus Erythematosus Responder Index 4 (SRI-4) and British Isles Lupus Assessment Group-based Composite Lupus Assessment (BICLA) response. Missing data were imputed using control-based pattern imputation.
At week 48, greater mean improvement in pain and fatigue scores from day 1 were reported across all deucravacitinib dose groups compared with placebo. Regardless of treatment group, SRI-4 and BICLA responders reported greater improvements in pain and fatigue than non-responders at week 48. Additionally, deucravacitinib-treated patients generally saw greater SRI-4 and BICLA response rates than placebo-treated patients. Pain decreased by 1.3 points vs 2.2-2.3 points and fatigue scores decreased by 3.4 points vs 5.9-7.3 points in the placebo versus deucravacitinib dose groups, respectively. Mean SF-36 physical scores were 41.5 vs ≥44.6 and mean SF-36 mental scores were 45.2 vs ≥46.3 with placebo versus deucravacitinib dose groups, respectively. A greater proportion of patients receiving deucravacitinib also reported clinically meaningful improvements in SF-36 scores compared with placebo.
Patients with SLE experienced greater improvements in pain, fatigue and health-related quality-of-life scores at week 48 with deucravacitinib versus placebo treatment.
NCT03252587.
在PAISLEY这项为期48周的II期随机对照试验中，评估了度普利尤单抗在活动性系统性红斑狼疮（SLE）患者中的疗效，每日两次3毫克度普利尤单抗剂量达到了所有主要和次要终点。本研究评估了作为探索性终点收集的患者报告结局的变化。
SLE患者（n = 363）被随机分为安慰剂组（n = 90）或每日两次3毫克度普利尤单抗组（n = 91）、每日两次6毫克度普利尤单抗组（n = 93）或每日一次12毫克度普利尤单抗组（n = 89）。患者使用数字评分量表评估疼痛程度，并按预定间隔完成患者报告结局测量信息系统疲劳简表7a和36项简明健康调查（SF - 36）。这些结局按系统性红斑狼疮反应指数4（SRI - 4）和基于不列颠群岛狼疮评估小组的综合狼疮评估（BICLA）反应进行分层。使用基于对照的模式插补法对缺失数据进行插补。
在第48周时，与安慰剂相比，所有度普利尤单抗剂量组从第1天起疼痛和疲劳评分的平均改善程度更大。无论治疗组如何，在第48周时，SRI - 4和BICLA反应者报告的疼痛和疲劳改善程度均高于无反应者。此外，度普利尤单抗治疗的患者总体上比安慰剂治疗的患者有更高的SRI - 4和BICLA反应率。安慰剂组与度普利尤单抗剂量组相比，疼痛分别降低1.3分和2.2 - 2.3分，疲劳评分分别降低3.4分和5.9 - 7.3分。安慰剂组与度普利尤单抗剂量组的SF - 36身体评分均值分别为41.5分和≥44.6分，SF - 36心理评分均值分别为45.2分和≥46.3分。与安慰剂相比，接受度普利尤单抗治疗的患者中报告SF - 36评分有临床意义改善的比例也更高。
与安慰剂治疗相比，SLE患者在第48周时使用度普利尤单抗治疗在疼痛、疲劳和健康相关生活质量评分方面有更大改善。
NCT03252587。
