Division of Clinical Immunology and Rheumatology, University of Alabama at Birmingham, 510 20th St South, FOT 802, Birmingham, AL, 35233, USA.
College of Medical Veterinary and Life Sciences, University of Glasgow, Glasgow, UK.
Adv Ther. 2022 Oct;39(10):4613-4631. doi: 10.1007/s12325-022-02270-7. Epub 2022 Aug 10.
The phase 3 DISCOVER-2 trial evaluated the effect of guselkumab on impaired work productivity and nonwork activity in biologic-naïve patients with psoriatic arthritis (PsA).
Adults with active PsA were randomized (1:1:1) to guselkumab 100 mg every 4 weeks (Q4W), guselkumab 100 mg at weeks 0 and 4 and then every 8 weeks (Q8W), or placebo (with crossover to guselkumab Q4W at week 24). Least squares mean change from baseline in Work Productivity and Activity Impairment Questionnaire for PsA (WPAI-PsA) domains and employment were assessed by treatment group. Multivariate analysis of data from weeks 0 through 24 assessed independent associations between PsA clinical features and WPAI-PsA domains.
In total, 738 patients were evaluated (guselkumab Q4W n = 245; guselkumab Q8W n = 248; placebo n = 245). At week 24, improvements (reduced impairment) in presenteeism (Q4W -20.1%, Q8W -19.6%, placebo -10.5%), work productivity (Q4W -20.1%, Q8W -19.2%, placebo -10.6%), and nonwork activity (Q4W -20.5%, Q8W -21.2%, placebo -9.9%) were greater in guselkumab-treated versus placebo-treated patients. At week 52, following placebo crossover at week 24, improvements were similar among groups. Baseline absenteeism was minimal and did not change in any group. By week 52, 23.1-25.9% of guselkumab-treated patients who were unemployed at baseline were employed. All WPAI-PsA domains were positively associated with C-reactive protein level, fatigue, and pain. All domains except absenteeism were positively associated with enthesitis and Psoriasis Area and Severity Index score. Age was negatively associated with presenteeism and work productivity loss, female sex and tender joint count were positively associated with nonwork activity impairment, and dactylitis was positively associated with presenteeism.
Both guselkumab regimens reduced work productivity loss and nonwork activity impairment in patients with active PsA. Association of work productivity loss and nonwork activity impairment with PsA joint and skin features suggests that improvement in both features is beneficial for optimizing improved work productivity loss and nonwork activity impairment.
ClinicalTrials.gov identifier, NCT03158285.
这项 3 期 DISCOVER-2 试验评估了 Guselkumab 在生物制剂初治的银屑病关节炎(PsA)患者中对工作生产力受损和非工作活动的影响。
活动期 PsA 成人患者被随机分为 Guselkumab 100mg 每 4 周(Q4W)组、Guselkumab 100mg 在第 0 周和第 4 周,然后每 8 周(Q8W)组或安慰剂(在第 24 周交叉至 Guselkumab Q4W)组。通过治疗组评估工作生产力和活动障碍问卷在银屑病关节炎(WPAI-PsA)领域和就业方面从基线的最小二乘均数变化。从第 0 周到 24 周的数据分析评估了 PsA 临床特征与 WPAI-PsA 领域之间的独立关联。
共评估了 738 名患者(Guselkumab Q4W n=245;Guselkumab Q8W n=248;安慰剂 n=245)。在第 24 周,与安慰剂相比,Guselkumab 治疗组的出勤(Q4W-20.1%,Q8W-19.6%,安慰剂-10.5%)、工作生产力(Q4W-20.1%,Q8W-19.2%,安慰剂-10.6%)和非工作活动(Q4W-20.5%,Q8W-21.2%,安慰剂-9.9%)都有较大改善。在第 24 周交叉使用安慰剂后,在第 52 周时,各组之间的改善情况相似。基线缺勤率较低,且在任何一组中都没有变化。在第 52 周时,基线时失业的 Guselkumab 治疗患者中有 23.1%-25.9%就业。所有 WPAI-PsA 领域均与 C 反应蛋白水平、疲劳和疼痛呈正相关。除缺勤外,所有领域均与附着点炎和银屑病面积和严重程度指数评分呈正相关。年龄与出勤和工作生产力损失呈负相关,女性和压痛关节计数与非工作活动障碍呈正相关,指(趾)炎与出勤呈正相关。
两种 Guselkumab 方案均能降低活动期 PsA 患者的工作生产力损失和非工作活动障碍。工作生产力损失和非工作活动障碍与 PsA 关节和皮肤特征相关,提示这两个特征的改善均有利于优化工作生产力损失和非工作活动障碍的改善。
ClinicalTrials.gov 标识符,NCT03158285。