Efficacy and Safety of Tofacitinib in Patients With Refractory Prurigo Nodularis: A 16-Week, Single-Center, Prospective, Observational Pilot Study

IF 3.7 4区医学 Q1 DERMATOLOGY Dermatologic Therapy Pub Date : 2025-03-24 DOI:10.1155/dth/8988947

Ru Dai, Chao-Cheng Chi, Yuchen Lou, I-Jung Hsieh, Xiao-Yong Man

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Abstract

Background: The current management for prurigo nodularis (PN) is challenging. Tofacitinib may emerge as a promising treatment for PN.

Aim: This study aimed to assess the efficacy and safety of tofacitinib in treating refractory PN.

Design and methods: A 16-week prospective observational pilot study was conducted in patients with moderate-to-severe refractory PN. The enrolled patients received oral tofacitinib. The primary endpoints included improvement in pruritus and quality of life, as measured by investigator’s global assessment (IGA), prurigo activity score (PAS), visual analog scale (VAS), numeric rating scale (NRS), verbal rating scale (VRS), Dermatology Life Quality Index (DLQI), and Itchy Specific Quality of Life (Itchy QoL) at week 12. Secondary endpoints were the proportion of patients with a ≥ 4-point reduction in Worst Itch-Numeric Rating Scale (WI-NRS) from baseline at week 12 and week 16. Safety assessments were conducted through week 16. Besides, historical controls, mixed-effects model (MMRM), and post-hoc analyses were performed to evaluate the efficacy of tofacitinib.

Results: Twenty-four PN patients included demonstrated clinical improvement in terms of skin lesions, pruritus, and quality of life. IGA, PAS items, VAS, NRS, VRS, DLQI, and Itchy QoL significantly improved from the baseline to 12 weeks of tofacitinib treatment (p < 0.05 for all). However, the response to tofacitinib became less pronounced at week 16, with reduced improvement in skin lesions, itch, and quality of life compared to that at week 12. The percentage of patients experiencing a ≥ 4-point WI-NRS reduction decreased from 75% at week 12% to 66.67% at week 16. The results of historical controls, MMRM model, and post hoc analyses supported the clinical efficacy of tofacitinib in PN, with baseline NRS_24h,worst appearing to be a potentially clinical feature impacting treatment efficacy. No severe adverse events were reported up until the end of the study period.

Conclusions: Tofacitinib demonstrates effectiveness in reducing itch and skin infiltration in patients with moderate-to-severe PN, whereas its long-term efficacy requires further observation.

Trial Registration: ClinicalTrials.gov identifier: NCT06201715

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背景：目前对结节性瘙痒症（PN）的治疗极具挑战性。托法替尼可能会成为一种治疗结节性瘙痒症的有效药物。目的：本研究旨在评估托法替尼治疗难治性结节性瘙痒症的疗效和安全性。设计与方法在中重度难治性 PN 患者中开展了一项为期 16 周的前瞻性观察试验研究。入组患者口服托法替尼。主要研究终点包括第12周时瘙痒症状和生活质量的改善情况，通过研究者总体评估（IGA）、瘙痒活动评分（PAS）、视觉模拟量表（VAS）、数字评分量表（NRS）、口头评分量表（VRS）、皮肤科生活质量指数（DLQI）和瘙痒特定生活质量（Itchy QoL）进行测量。次要终点是在第12周和第16周时，最严重瘙痒数字评定量表（WI-NRS）比基线降低≥4分的患者比例。安全性评估持续到第 16 周。此外，还进行了历史对照、混合效应模型（MMRM）和事后分析，以评估托法替尼的疗效。结果24例PN患者在皮损、瘙痒和生活质量方面均有临床改善。从基线到托法替尼治疗 12 周期间，IGA、PAS 项目、VAS、NRS、VRS、DLQI 和瘙痒 QoL 均有显著改善（均为 p < 0.05）。然而，在第16周时，患者对法替尼的反应变得不那么明显，与第12周时相比，皮损、瘙痒和生活质量的改善程度有所下降。WI-NRS降低≥4分的患者比例从第12周的75%降至第16周的66.67%。历史对照、MMRM模型和事后分析的结果支持托法替尼对PN的临床疗效，基线NRS24h,最差似乎是影响疗效的潜在临床特征。直到研究结束，都没有出现严重的不良反应。结论托法替尼能有效减轻中重度PN患者的瘙痒和皮肤浸润，但其长期疗效还需进一步观察。试验注册：ClinicalTrials.gov 标识符：NCT06201715

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来源期刊

Dermatologic Therapy 医学-皮肤病学

CiteScore

7.00

自引率

8.30%

发文量

711

审稿时长

3 months

期刊介绍： Dermatologic Therapy has been created to fill an important void in the dermatologic literature: the lack of a readily available source of up-to-date information on the treatment of specific cutaneous diseases and the practical application of specific treatment modalities. Each issue of the journal consists of a series of scholarly review articles written by leaders in dermatology in which they describe, in very specific terms, how they treat particular cutaneous diseases and how they use specific therapeutic agents. The information contained in each issue is so practical and detailed that the reader should be able to directly apply various treatment approaches to daily clinical situations. Because of the specific and practical nature of this publication, Dermatologic Therapy not only serves as a readily available resource for the day-to-day treatment of patients, but also as an evolving therapeutic textbook for the treatment of dermatologic diseases.