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
Rheumatology Research, Providence Swedish Medical Center and University of Washington School of Medicine, Seattle, Washington.
University of Pennsylvania, Philadelphia, Pennsylvania.
ACR Open Rheumatol. 2024 May;6(5):304-311. doi: 10.1002/acr2.11657. Epub 2024 Feb 28.
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.
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).
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).
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.
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。
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)。
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)。
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。