School of Medicine, University of California, Irvine, California, USA.
Yale University School of Medicine, New Haven, Connecticut, USA.
J Dermatol. 2024 Nov;51(11):1414-1424. doi: 10.1111/1346-8138.17442. Epub 2024 Sep 27.
This post-hoc analysis of the ALLEGRO phase 2b/3 study (NCT03732807) evaluated the efficacy and safety of ritlecitinib, an oral Janus kinase 3/TEC family kinase inhibitor, in patients with alopecia totalis (AT) and alopecia universalis (AU). Patients aged ≥ 12 years with alopecia areata (AA) and ≥50% scalp hair loss received once-daily ritlecitinib 50 or 30 mg (± 4-week 200-mg loading dose) or placebo for 24 weeks. In a subsequent 24-week extension period, the ritlecitinib groups continued their doses and patients initially assigned to placebo switched to ritlecitinib (200/50 or 50 mg daily). In this analysis, clinician- and patient-reported hair regrowth outcomes were assessed at weeks 24 and 48 in four AA subgroups: AT/AU, AT, AU, and non-AT/AU. Safety was monitored throughout. Of the 718 randomized patients, 151 (21%) and 147 (20%) were defined as having AT or AU, respectively. At week 24, Severity of Alopecia Tool (SALT) score ≤20 (≤20% scalp hair loss) response rates were higher in the ritlecitinib-treated AT/AU, AT, and AU groups (7%-14%, 7%-21%, and 4%-10%, respectively) vs the placebo group (0% in the AT/AU, AT, and AU groups). The proportions of patients with a SALT score of ≤20 increased through week 48 (AT/AU, 13%-31%; AT, 11%-27%; AU, 6%-41%). Additionally, at week 24, 25%-43%, 32%-42%, and 12%-50% of patients with AT/AU, AT, and AU, respectively, who received ritlecitinib achieved a moderately or greatly improved response based on the Patient Global Impression of Change scale. Response rates generally increased through week 48 and were similar across AA subgroups. In patients with AT/AU, ritlecitinib was well tolerated with a safety profile consistent with that of the overall AA population. Ritlecitinib demonstrated clinical efficacy, patient-reported improvement, and an acceptable safety profile in patients with AT and AU through week 48. A plain language summary of this study is available at https://doi.org/10.25454/pfizer.figshare.26879161. Clinicaltrials.gov: NCT03732807.
这是一项针对 ALLEGRO 期 2b/3 研究（NCT03732807）的事后分析，评估了口服 Janus 激酶 3/TEC 家族激酶抑制剂 ritlecitinib 在全秃（AT）和普秃（AU）患者中的疗效和安全性。年龄≥12 岁的斑秃（AA）患者和≥50%头皮毛发丧失的患者接受了每日一次 ritlecitinib 50 或 30mg（±4 周 200mg 负荷剂量）或安慰剂治疗 24 周。在随后的 24 周扩展期内，ritlecitinib 组继续使用剂量，最初分配给安慰剂的患者转换为 ritlecitinib（每日 200/50 或 50mg）。在这项分析中，在四个 AA 亚组（AT/AU、AT、AU 和非 AT/AU）中，在第 24 周和第 48 周评估了临床医生和患者报告的毛发生长结果。在整个研究过程中监测安全性。在 718 名随机患者中，151 名（21%）和 147 名（20%）分别被定义为 AT 或 AU。在第 24 周时，ritlecitinib 治疗的 AT/AU、AT 和 AU 组（分别为 7%-14%、7%-21%和 4%-10%）的严重度脱发工具（SALT）评分≤20（≤20%头皮毛发丧失）应答率高于安慰剂组（AT/AU、AT 和 AU 组中均为 0%）。通过第 48 周，SALT 评分≤20 的患者比例增加（AT/AU，13%-31%；AT，11%-27%；AU，6%-41%）。此外，在第 24 周时，AT/AU、AT 和 AU 组分别有 25%-43%、32%-42%和 12%-50%的患者根据患者总体变化印象量表获得了中度或极大的改善反应。应答率通常在第 48 周增加，并且在 AA 亚组之间相似。在 AT/AU 患者中，ritlecitinib 的耐受性良好，安全性与总体 AA 人群一致。在第 48 周时，ritlecitinib 在 AT 和 AU 患者中表现出临床疗效、患者报告的改善和可接受的安全性。本研究的通俗语言摘要可在 https://doi.org/10.25454/pfizer.figshare.26879161 获得。Clinicaltrials.gov：NCT03732807。
