McLean Robert R, Sima Adam P, Beaty Silky, Jones Eric A, Eckmann Thomas, Low Robert, McClung Laura, Spitzer Rebecca L, Stark Jeffrey, Armstrong April
CorEvitas, LLC, 1440 Main Street, Waltham, MA, 02130, USA.
UCB Pharma, Smyrna, GA, USA.
Dermatol Ther (Heidelb). 2023 Nov;13(11):2753-2768. doi: 10.1007/s13555-023-01028-5. Epub 2023 Sep 27.
Near-complete skin clearance has become a rapidly achievable treatment goal for patients with psoriasis receiving systemic biologic therapies. However, real-world evidence for durability of near-complete skin clearance and risk factors associated with loss of near-complete skin clearance is limited.
This study described durability of near-complete skin clearance (≥ 90% improvement in Psoriasis Area and Severity Index from initiation; PASI90) and identified clinical factors or patient characteristics associated with loss of PASI90 among patients with psoriasis from the CorEvitas Psoriasis Registry (April 2015-August 2021). Included patients had PASI > 5 at biologic initiation and achieved PASI90 at approximately 6 months from initiation (index). A Kaplan-Meier estimate described time to loss of treatment response over 24 months follow-up from index. Proportional hazards regression was used to identify independent predictors of loss of treatment response.
This study included 687 patient initiations (instances of patients initiating a biologic). Following achievement of PASI90, treatment response was maintained in more than half of patient initiations (54%). Treatment response was maintained at 6, 12, and 18 months from index in an estimated 73% (95% [confidence interval] CI 70-77%), 60% (95% CI 56-63%), and 50% (95% CI 47-54%) of patient initiations, respectively. Adjusted hazards regression suggested non-White race, full-time employment, greater body weight, concomitant psoriatic arthritis, prior use of biologics, and clinically meaningful skin symptoms were associated with loss of treatment response.
Among real-world patients with psoriasis who achieved PASI90 with biologic therapy, about one-quarter lost response at 6 months, and half lost response at 18 months. Prior use of a biologic therapy and clinically meaningful skin symptoms at index, including itch and skin pain, were associated with loss of treatment response. Therefore, dermatologists may consider focusing on patient-reported symptoms as part of any intervention designed to reduce the likelihood of loss of response to biologic therapies.
ClinicalTrials.gov identifier, NCT02707341.
对于接受系统性生物疗法的银屑病患者而言,近乎完全清除皮肤病变已成为一个可快速实现的治疗目标。然而,关于近乎完全清除皮肤病变的持久性以及与近乎完全清除皮肤病变丧失相关的危险因素的真实世界证据有限。
本研究描述了近乎完全清除皮肤病变(自开始治疗起银屑病面积和严重程度指数改善≥90%;PASI90)的持久性,并从CorEvitas银屑病登记处(2015年4月至2021年8月)的银屑病患者中确定了与PASI90丧失相关的临床因素或患者特征。纳入的患者在开始使用生物制剂时PASI>5,并在开始治疗后约6个月达到PASI90(指数)。采用Kaplan-Meier估计法描述从指数开始随访24个月内治疗反应丧失的时间。使用比例风险回归来确定治疗反应丧失的独立预测因素。
本研究纳入了687例患者开始使用生物制剂的情况(患者开始使用生物制剂的实例)。在达到PASI90后,超过一半的患者开始使用生物制剂(54%)维持了治疗反应。从指数开始计算,在6、12和18个月时,分别估计有73%(95%[置信区间]CI 70-77%)、60%(95%CI 56-63%)和50%(95%CI 47-54%)的患者开始使用生物制剂维持了治疗反应。校正后的风险回归表明,非白种人、全职工作、体重较大、合并银屑病关节炎、既往使用过生物制剂以及具有临床意义的皮肤症状与治疗反应丧失相关。
在通过生物疗法达到PASI90的真实世界银屑病患者中,约四分之一的患者在6个月时丧失反应,一半的患者在18个月时丧失反应。既往使用过生物疗法以及指数时具有临床意义的皮肤症状,包括瘙痒和皮肤疼痛,与治疗反应丧失相关。因此,皮肤科医生在设计任何旨在降低生物疗法反应丧失可能性的干预措施时,可考虑将患者报告的症状作为其中一部分。
ClinicalTrials.gov标识符,NCT02707341。