University of Oxford, Oxford, UK.
Swedish Medical Centre and University of Washington, Seattle.
Arthritis Care Res (Hoboken). 2018 Oct;70(10):1529-1535. doi: 10.1002/acr.23537. Epub 2018 Sep 1.
To evaluate minimal disease activity (MDA) among psoriatic arthritis (PsA) patients receiving secukinumab through 2 years in the FUTURE 2 study.
Patients with active PsA were randomized to receive subcutaneous secukinumab 300, 150, or 75 mg or placebo. MDA was assessed in the overall population (anti-tumor necrosis factor [anti-TNF]-naive and inadequate responders [anti-TNF-IR]) and in patients stratified by prior anti-TNF exposure and by time since diagnosis at weeks 16, 24, 52, and 104. Function and patient-reported outcomes (PROs), including health-related quality of life (QoL) and work productivity, were assessed in MDA responders versus nonresponders.
Overall, 28% of patients (27 of 98) and 23% (23 of 100) achieved MDA at week 16 with secukinumab 300 and 150 mg, respectively, versus 10% (9 of 94) with placebo. In the anti-TNF-naive cohort, a higher proportion of patients achieved MDA at week 16 with secukinumab 300 and 150 mg (34% and 32%, respectively) versus placebo (13%). The corresponding value in the anti-TNF-IR cohort was 15% and 8% with secukinumab 300 and 150 mg, respectively, versus with placebo (3%). At week 16, 27.1% of MDA responders (16 of 59) achieved a very low disease activity (VLDA) response, with the percentage being numerically greater with secukinumab 300 and 150 mg (30% [8 of 27] and 26% [6 of 23], respectively) versus placebo (22% [2 of 9]). The MDA and VLDA responses with secukinumab 300 and 150 mg were sustained through 2 years. MDA responders showed greater improvements in QoL outcomes compared to nonresponders through 2 years.
A greater proportion of patients achieved MDA with secukinumab versus placebo at week 16, with response rates sustained through 2 years. MDA was associated with improved PROs, including QoL, through 2 years.
在 FUTURE 2 研究中评估接受司库奇尤单抗治疗的银屑病关节炎（PsA）患者的最小疾病活动度（MDA）。
活动性 PsA 患者被随机分配接受皮下注射司库奇尤单抗 300mg、150mg 或 75mg 或安慰剂。在总体人群（未接受过抗肿瘤坏死因子[anti-TNF]和应答不足的患者[anti-TNF-IR]）以及根据先前抗 TNF 暴露和诊断后时间分层的患者中评估 MDA，时间点为第 16、24、52 和 104 周。在 MDA 应答者和无应答者中评估功能和患者报告的结局（PRO），包括健康相关生活质量（QoL）和工作生产力。
总体而言，分别有 28%（98 例中的 27 例）和 23%（100 例中的 23 例）的患者在第 16 周时达到 MDA，司库奇尤单抗 300mg 和 150mg 组分别为 10%（94 例中的 9 例）安慰剂组。在抗 TNF 初治队列中，司库奇尤单抗 300mg 和 150mg 组达到 MDA 的患者比例更高（分别为 34%和 32%），而安慰剂组为 13%。在抗 TNF-IR 队列中，司库奇尤单抗 300mg 和 150mg 组的相应值分别为 15%和 8%，而安慰剂组为 3%。在第 16 周，27.1%（59 例中的 16 例）的 MDA 应答者达到极低疾病活动度（VLDA）应答，司库奇尤单抗 300mg 和 150mg 组的应答率在数值上更高（分别为 30%[27 例中的 8 例]和 26%[23 例中的 6 例]），而安慰剂组为 22%（9 例中的 2 例）。通过 2 年，司库奇尤单抗 300mg 和 150mg 的 MDA 和 VLDA 应答持续。通过 2 年，MDA 应答者与非应答者相比，在 QoL 结局方面的改善更为显著。
与安慰剂相比，更多的患者在第 16 周时达到 MDA，应答率持续到 2 年。MDA 与 PRO 改善相关，包括 QoL，持续到 2 年。
