Yamaguchi Yuji, Peeva Elena, Adiri Roni, Ghosh Pranab, Napatalung Lynne, Hamzavi Iltefat, Pandya Amit G, Shore Ronald N, Ezzedine Khaled, Guttman-Yassky Emma
Pfizer Inc, Collegeville, Pennsylvania.
Pfizer Inc, Cambridge, Massachusetts.
J Am Acad Dermatol. 2025 Apr;92(4):781-789. doi: 10.1016/j.jaad.2024.11.064. Epub 2024 Dec 19.
Ritlecitinib demonstrated efficacy in a phase 2b trial of nonsegmental vitiligo.
To evaluate the efficacy and tolerability of ritlecitinib with add-on narrow-band ultraviolet B (nbUVB) phototherapy in patients with nonsegmental vitiligo.
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).
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.
Exploratory analysis; discontinuation criterion applied only to the ritlecitinib + nbUVB group; small sample size.
Ritlecitinib alone and with nbUVB therapy improved facial and total body repigmentation and was well tolerated. Adding nbUVB may improve ritlecitinib efficacy.
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。
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。
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。
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。
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。
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。