优思明单抗对红皮病型银屑病的长期治疗既有效又安全：日常实践中的多中心研究

JEADV clinical practice Pub Date : 2024-02-17 DOI:10.1002/jvc2.325

Clara Plana, Maria J. Concha-Garzón, Vicen C. Rocamora, Ofelia Baniandrés, Rosa Feltes, Jose L. López-Estebaranz, Joan Garcías-Ladaria, Jose-Manuel Carrascosa, Eva Vilarrasa, Caridad Soria, Belen Navajas, Mar Llamas-Velasco, Esteban Dauden

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引用次数: 0

摘要

红皮病型银屑病（EP）的治疗具有挑战性。为了确定乌司他单抗（UST）在日常治疗条件下治疗红皮病型银屑病的有效性和安全性，我们对在日常治疗条件下接受乌司他单抗治疗的红皮病型银屑病患者进行了一项长达3年的回顾性、观察性、全国多中心队列研究。在治疗期间的第1、4、7、13、19、25、31和37个月对银屑病面积和严重程度指数（PASI）和安全性等结果进行了评估。进行了 "观察结果 "和 "意向治疗最后观察结果结转（ITT-LOCF）"分析。基线平均 PASI 为 43.1。在最初的 7 个月中，平均 PASI 指数急剧下降，达到了一个高点，并一直维持到 37 个月的随访结束。7 个月时，分别有 61% 和 43% 的患者达到 PASI ≤ 2 和 PASI 0。25 个月时，48 名患者（39%）（"观察结果"/ITT-LOCF）实现了完全清除。31 个月时，分别有 95、80 和 45 名患者（79%、64% 和 39%）（"观察结果"/ITT-LOCF）达到 PASI 75、PASI 90 和 PASI 100。有 11 名患者需要通过缩短剂量间隔来加强治疗。四名患者接受了最小化治疗。在随访期间，9 名患者（32%）曾接受过系统的联合治疗。八名患者主要因疗效不佳而中断了治疗。UST 具有良好的安全性。在69.25人/年的随访中，只有3名患者出现了严重的非药物相关不良事件。

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Ustekinumab is effective and safe in the long-term treatment of erythrodermic psoriasis: Multicenter study in daily practice

Background

The treatment of erythrodermic psoriasis (EP) is challenging. Biological therapies have shown promising results in the long-term management of this clinical variant, but most of the current available evidence is based on single case reports and short case series.

Objectives

To determine the effectiveness and safety of ustekinumab (UST) in the treatment of EP under daily practice conditions.

Methods

We conducted a retrospective, observational, nationwide, multicenter cohort study of patients diagnosed with EP treated with UST under daily practice conditions with up to 3 years of follow-up. Outcomes, such as the psoriasis area and severity index (PASI) and safety, were assessed at months 1, 4, 7, 13, 19, 25, 31 and 37 during treatment. “As observed” and “intention-to-treat last observation carried forward (ITT-LOCF)” analyses were performed.

Results

Twenty-eight patients were enroled in the study. Baseline mean PASI was 43.1. A sharp decrease in mean PASI was observed during the first 7 months, reaching a plateau that was maintained until the end of the 37-month follow-up. At 7 months, 61% and 43% of the patients achieved PASI ≤ 2 and PASI 0, respectively. At 25 months, 48 (39%) (“as observed”/ITT-LOCF) of the patients achieved complete clearance. At 31 months, PASI 75, PASI 90 and PASI 100 were achieved in 95, 80 and 45 (79%, 64% and 39%) (“as observed”/ITT-LOCF) of the patients, respectively. Eleven patients required treatment intensification by reducing the interval between doses. Treatment minimisation was performed in four patients. During the follow-up, nine patients (32%) received systemic combination therapy at some point. Eight patients discontinued treatment mainly due to lack of effectiveness. UST presented a good safety profile. With a follow-up of 69.25 patient/years, only three patients exhibited serious nondrug-related adverse events.

Conclusions

Ustekinumab can be a fast, effective and safe alternative for the long-term treatment of erythrodermic psoriasis.

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