Kavanaugh Arthur, Mease Philip, Gossec Laure, Ranza Roberto, Tsuji Shigeyoshi, Douglas Kevin, Lane Michael, Lippe Ralph, Mittal Manish, Gao Tianming, Setty Arathi, Ciecinski Sandra, Aletaha Daniel, Nash Peter
University of California San Diego.
Swedish Medical Center/Providence St. Joseph Health and University of Washington, Seattle.
ACR Open Rheumatol. 2024 Nov;6(11):736-745. doi: 10.1002/acr2.11714. Epub 2024 Aug 1.
We explored the relationship between achievement of clinical disease control and improvements in and normative values for patient-reported outcomes (PROs), including quality of life (QoL) measures, in patients with psoriatic arthritis (PsA).
This was a post hoc analysis of 104-week data from the SELECT-PsA 1 and 2 trials in adults with PsA and inadequate response to one or more conventional synthetic (SELECT-PsA 1) or biologic (SELECT-PsA 2) disease-modifying antirheumatic drug. Patients were initially randomized to upadacitinib 15 mg once daily (QD) to placebo switched to upadacitinib 15 mg QD at week 24 or to adalimumab 40 mg every other week (SELECT-PsA 1 only), and data were pooled across treatments and analyzed. We evaluated several clinical disease control measures (minimal disease activity [MDA]; very low disease activity [VLDA]; and low disease activity [LDA] and/or remission by Disease Activity in Psoriatic Arthritis [DAPSA], Psoriatic Arthritis Disease Activity Score [PASDAS], and Routine Assessment of Patient Index Data 3 [RAPID3]) and examined their associations with improvements and normative values for various PROs.
A total of 1,069 and 317 patients were analyzed for SELECT-PsA 1 and 2, respectively. In both studies, responders (patients who achieved MDA or VLDA, and DAPSA, PASDAS, and RAPID3 LDA or remission) at week 104 achieved more marked changes from baseline, and more responders achieved normative values in PROs compared with nonresponders (most nominal P < 0.0001). Furthermore, numerically larger proportions of responders achieved minimal clinically important differences across PROs compared with nonresponders in both studies. In addition, patients who achieved MDA or VLDA were more likely to achieve DAPSA, PASDAS, and RAPID3 LDA or remission (all nominal P < 0.0001) for upadacitinib 15 mg QD and when treatment arms were pooled.
Patients with PsA who achieve clinical disease control are more likely to achieve improvements and normative values in PROs and QoL measures, which reinforces disease control as a treatment target.
我们探讨了银屑病关节炎（PsA）患者临床疾病控制的达成情况与患者报告结局（PROs）的改善及规范值之间的关系，PROs包括生活质量（QoL）指标。
这是一项对SELECT-PsA 1和2试验104周数据的事后分析，试验对象为成年PsA患者，这些患者对一种或多种传统合成（SELECT-PsA 1）或生物（SELECT-PsA 2）抗风湿药物反应不足。患者最初被随机分为每日一次服用15 mg乌帕替尼（QD）或安慰剂，安慰剂组在第24周换为每日一次服用15 mg乌帕替尼，或每两周服用40 mg阿达木单抗（仅SELECT-PsA 1），汇总各治疗组数据并进行分析。我们评估了几种临床疾病控制指标（最小疾病活动度[MDA]；极低疾病活动度[VLDA]；低疾病活动度[LDA]和/或通过银屑病关节炎疾病活动度[DAPSA]、银屑病关节炎疾病活动评分[PASDAS]和患者指数数据3常规评估[RAPID3]实现缓解），并研究了它们与各种PROs的改善及规范值之间的关联。
SELECT-PsA 1和2分别共分析了1069例和317例患者。在两项研究中，第104周时的缓解者（达到MDA或VLDA以及DAPSA、PASDAS和RAPID3 LDA或缓解的患者）与未缓解者相比，从基线的变化更为显著，更多缓解者在PROs方面达到了规范值（大多数名义P<0.0001）。此外，在两项研究中，与未缓解者相比，缓解者在各项PROs中达到最小临床重要差异的比例在数值上更大。此外，对于每日一次服用15 mg乌帕替尼以及汇总各治疗组时，达到MDA或VLDA的患者更有可能达到DAPSA、PASDAS和RAPID3 LDA或缓解（所有名义P<0.0001）。
实现临床疾病控制的PsA患者更有可能在PROs和QoL指标方面实现改善并达到规范值，这强化了疾病控制作为治疗目标的地位。
