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在活动性银屑病关节炎患者中,使用古塞库单抗治疗六个月后患者报告结局的改善:来自CorEvitas银屑病关节炎/脊柱关节炎注册中心的真实世界数据。

Improvements in Patient-Reported Outcomes Through Six Months of Guselkumab Treatment in Patients With Active Psoriatic Arthritis: Real-World Data From the CorEvitas Psoriatic Arthritis/Spondyloarthritis Registry.

作者信息

Mease Philip J, Ogdie Alexis, Tesser John, Shiff Natalie J, Zhao Ruizhi Sophia, Chakravarty Soumya D, Kelleman Michael, Dodge Rhiannon, McLean Robert R, Broadwell Aaron, Kavanaugh Arthur, Merola Joseph F

机构信息

Rheumatology Research, Providence Swedish Medical Center and University of Washington School of Medicine, Seattle, Washington.

University of Pennsylvania, Philadelphia, Pennsylvania.

出版信息

ACR Open Rheumatol. 2024 May;6(5):304-311. doi: 10.1002/acr2.11657. Epub 2024 Feb 28.

Abstract

OBJECTIVE

Evaluate patient-reported outcomes after 6 months of on-label guselkumab use in patients with rheumatologist-diagnosed active psoriatic arthritis (PsA) enrolled in the CorEvitas PsA/Spondyloarthritis Registry.

METHODS

This analysis includes registry participants who initiated and persisted with on-label guselkumab (after US Food and Drug Administration approval for PsA; 100 mg at weeks 0, 4, and every 8 weeks) at their 6-month follow-up visit (On-Label Persisters). Among patients not meeting response criteria at baseline, responses at 6 months were determined for patient-reported outcomes, including patient-reported pain (0-100 mm visual analog scale), patient global assessment of arthritis + psoriasis (PtGA; 0-100 visual analog scale), and Health Assessment Questionnaire-Disability Index (HAQ-DI; 0-3). Unadjusted, nominal P values were calculated via single-proportion, one-sided test (H = 0%; α = 0.05).

RESULTS

Of 90 On-Label Persisters, most had treatment-resistant PsA (92.2% and 73.3% previously received ≥1 and ≥2 biologic/targeted synthetic disease-modifying antirheumatic drugs, respectively), with mean (SD) baseline patient-reported pain, PtGA, and HAQ-DI scores of 57.0 (24.6), 50.3 (24.4), and 0.9 (0.6), respectively. Among those with patient-reported pain and PtGA scores of at least 15 at baseline, 40.2% (33/82) and 46.8% (36/77), respectively, achieved at least 15-mm reductions at 6 months; among those with HAQ-DI scores of at least 0.35 and more than 0.5 at baseline, respectively, 30.4% (21/69) achieved improvements of at least 0.35 and 10.3% (6/58) achieved scores of 0.5 or lower at 6 months (all nominal P < 0.001).

CONCLUSION

Pain and physical function are important contributors to health-related quality of life. In this real-world population of patients with treatment-resistant PsA and 6 months of persistent guselkumab treatment, clinically meaningful improvements in pain and physical function were achieved by approximately 40% and 30% of patients, respectively.

摘要

目的

在CorEvitas银屑病关节炎/脊柱关节炎注册研究中,评估经风湿病学家诊断为活动性银屑病关节炎(PsA)的患者使用标签上规定剂量的古塞库单抗6个月后的患者报告结局。

方法

该分析纳入了在6个月随访时开始并持续使用标签上规定剂量的古塞库单抗(在美国食品药品监督管理局批准用于PsA后;第0、4周各100mg,之后每8周100mg)的注册研究参与者(标签上规定剂量持续使用者)。在基线时未达到反应标准的患者中,确定6个月时患者报告结局的反应情况,包括患者报告的疼痛(0 - 100mm视觉模拟量表)、患者对关节炎 + 银屑病的整体评估(PtGA;0 - 100视觉模拟量表)以及健康评估问卷残疾指数(HAQ - DI;0 - 3)。通过单比例单侧检验计算未经调整的名义P值(H = 0%;α = 0.05)。

结果

在90名标签上规定剂量持续使用者中,大多数患有难治性PsA(分别有92.2%和73.3%的患者之前接受过≥1种和≥2种生物制剂/靶向合成改善病情抗风湿药),患者报告的基线疼痛、PtGA和HAQ - DI评分的均值(标准差)分别为57.0(24.6)、50.3(24.4)和0.9(0.6)。在基线时患者报告的疼痛和PtGA评分至少为15的患者中,分别有40.2%(33/82)和46.8%(36/77)在6个月时实现了至少15mm的降低;在基线时HAQ - DI评分分别至少为0.35和超过0.5的患者中,分别有30.4%(21/69)在6个月时实现了至少0.35的改善,10.3%(6/58)的患者在6个月时评分降至0.5或更低(所有名义P < 0.001)。

结论

疼痛和身体功能是影响健康相关生活质量的重要因素。在这个难治性PsA的真实世界患者群体中,经过6个月持续使用古塞库单抗治疗后,分别约有40%和30%的患者在疼痛和身体功能方面取得了具有临床意义的改善。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/edfe/11089443/013128eefff9/ACR2-6-304-g002.jpg

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