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在活动性非节段性白癜风患者中使用或不联合窄谱中波紫外线光疗对利特昔替尼的反应:一项2b期扩展研究的结果

Response to ritlecitinib with or without narrow-band ultraviolet B add-on therapy in patients with active nonsegmental vitiligo: Results from a phase 2b extension study.

作者信息

Yamaguchi Yuji, Peeva Elena, Adiri Roni, Ghosh Pranab, Napatalung Lynne, Hamzavi Iltefat, Pandya Amit G, Shore Ronald N, Ezzedine Khaled, Guttman-Yassky Emma

机构信息

Pfizer Inc, Collegeville, Pennsylvania.

Pfizer Inc, Cambridge, Massachusetts.

出版信息

J Am Acad Dermatol. 2025 Apr;92(4):781-789. doi: 10.1016/j.jaad.2024.11.064. Epub 2024 Dec 19.

Abstract

BACKGROUND

Ritlecitinib demonstrated efficacy in a phase 2b trial of nonsegmental vitiligo.

OBJECTIVE

To evaluate the efficacy and tolerability of ritlecitinib with add-on narrow-band ultraviolet B (nbUVB) phototherapy in patients with nonsegmental vitiligo.

METHODS

Following a 24-week, placebo-controlled, dose-ranging period, patients received ritlecitinib 200 mg for 4 weeks then 50 mg for 20 weeks, with or without nbUVB phototherapy 2x/week. Missing data were handled using last observation carried forward and observed case (OC).

RESULTS

Forty-three patients received ritlecitinib + nbUVB and 187 received ritlecitinib-monotherapy. Nine patients receiving ritlecitinib + nbUVB discontinued due to nbUVB group-specific efficacy criteria requiring >10% improvement in % change from baseline (% change from baseline) in Total-Vitiligo Area Scoring Index at week 12. At week 24, mean % change from baseline in Facial-VASI score was -57.0 vs -51.5 (last observation carried forward; P = .158) and -69.6 vs -55.1 (OC; P = .009), for ritlecitinib + nbUVB vs ritlecitinib-monotherapy, respectively. Mean % change from baseline in Total-Vitiligo Area Scoring Index at week 24 was -29.4 vs -21.2 (last observation carried forward; P = .043) and -46.8 vs -24.5 (OC; P < .001), respectively. nbUVB addition to ritlecitinib was well tolerated with no new safety signals.

LIMITATIONS

Exploratory analysis; discontinuation criterion applied only to the ritlecitinib + nbUVB group; small sample size.

CONCLUSION

Ritlecitinib alone and with nbUVB therapy improved facial and total body repigmentation and was well tolerated. Adding nbUVB may improve ritlecitinib efficacy.

摘要

背景

利特昔替尼在一项非节段型白癜风2b期试验中显示出疗效。

目的

评估利特昔替尼联合窄谱中波紫外线(nbUVB)光疗对非节段型白癜风患者的疗效和耐受性。

方法

在进行了为期24周的安慰剂对照剂量范围试验后,患者接受200mg利特昔替尼治疗4周,然后接受50mg治疗20周,同时每周进行2次nbUVB光疗,或不进行光疗。缺失数据采用末次观察结转法和观察病例法(OC)处理。

结果

43例患者接受利特昔替尼联合nbUVB治疗,187例患者接受利特昔替尼单药治疗。9例接受利特昔替尼联合nbUVB治疗的患者因nbUVB组特定疗效标准而停药,该标准要求在第12周时白癜风总面积评分指数相对于基线的变化百分比(相对于基线的变化百分比)提高>10%。在第24周时,利特昔替尼联合nbUVB组与利特昔替尼单药治疗组相比,面部白癜风面积评分指数相对于基线的平均变化百分比分别为-57.0 vs -51.5(末次观察结转法;P = 0.158)和-69.6 vs -55.1(OC法;P = 0.009)。在第24周时,白癜风总面积评分指数相对于基线的平均变化百分比分别为-29.4 vs -21.2(末次观察结转法;P = 0.043)和-46.8 vs -24.5(OC法;P < 0.001)。利特昔替尼联合nbUVB治疗耐受性良好,未发现新的安全信号。

局限性

探索性分析;停药标准仅适用于利特昔替尼联合nbUVB组;样本量小。

结论

利特昔替尼单药治疗及联合nbUVB治疗均能改善面部和全身色素再生,且耐受性良好。添加nbUVB可能会提高利特昔替尼的疗效。

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