King B, Mirmirani P, Lo Sicco K, Ramot Y, Sinclair R, Asfour L, Ezzedine K, Paul C, Ohyama M, Edwards R A, Bonfanti G, Kerkmann U, Wajsbrot D, Ishowo-Adejumo R, Zwillich S H, Lejeune A
Dermatology Physicians of Connecticut, Fairfield, Connecticut, USA.
The Permanente Medical Group, Vallejo, California, USA.
J Eur Acad Dermatol Venereol. 2025 Jun;39(6):1163-1173. doi: 10.1111/jdv.20547. Epub 2025 Feb 17.
Ritlecitinib, an oral JAK3/TEC family kinase inhibitor, demonstrated efficacy over 48 weeks in patients with alopecia areata (AA) in the ALLEGRO phase 2b/3 study.
This post hoc analysis evaluated individual Severity of Alopecia Tool (SALT) score trajectories in patients who received ritlecitinib 50 mg and rolled over from Phase 2b/3 into the ongoing, open-label, Phase 3 ALLEGRO-LT study to describe long-term response patterns and associated baseline disease characteristics.
Patients aged ≥12 years with ≥50% scalp hair loss received ritlecitinib 50 mg once daily in both studies. SALT score trajectories from baseline to Month 24 were used to categorise patients as early (SALT score ≤20 at Week 24 and Months 12 and 24), middle (≤20 at Months 12 and 24) or late responders (≤20 by Month 24) or as partial responders (maintained 30% improvement), relapsers (achieved but did not maintain 30% improvement) or non-responders (did not achieve 30% improvement). The proportions of patients achieving sustained response (achieved and maintained SALT score ≤20 at all subsequent available time points through Month 24) and complete response (SALT score 0 at ≥1 time point through Month 24) were evaluated. Multivariable logistic regression assessed variables associated with response.
Of 191 patients treated with ritlecitinib 50 mg, 87 (45.5%) were responders (SALT score ≤20), 24 (12.6%) were partial responders, 24 (12.6%) were relapsers and 56 (29.3%) were non-responders. Of 87 patients categorised as responders, 81 (93.1%) sustained their clinical response and 47 (46.0%) achieved complete response. Factors associated with treatment response included female sex and less extensive and shorter duration of hair loss.
Approximately 45% of patients were SALT score responders, with up to 11% requiring >1 year of ritlecitinib treatment to achieve response, highlighting the importance of extended treatment duration.
ALLEGRO phase 2b/3 study (NCT03732807); ALLEGRO-LT study (NCT04006457).
芦可替尼是一种口服的JAK3/TEC家族激酶抑制剂，在2b/3期ALLEGRO研究中，对斑秃（AA）患者进行了超过48周的疗效验证。
这项事后分析评估了接受50mg芦可替尼治疗且从2b/3期转入正在进行的开放标签3期ALLEGRO-LT研究的患者的个体脱发严重程度工具（SALT）评分轨迹，以描述长期反应模式及相关的基线疾病特征。
在两项研究中，年龄≥12岁且头皮脱发≥50%的患者每日接受一次50mg芦可替尼治疗。从基线到第24个月的SALT评分轨迹用于将患者分类为早期反应者（第24周、第12个月和第24个月时SALT评分≤20）、中期反应者（第12个月和第24个月时≤20）或晚期反应者（到第24个月时≤20），或分类为部分反应者（维持改善30%）、复发者（实现但未维持30%的改善）或无反应者（未实现30%的改善）。评估了实现持续反应（在第24个月的所有后续可用时间点实现并维持SALT评分≤20）和完全反应（在第24个月的≥1个时间点SALT评分为0）的患者比例。多变量逻辑回归评估与反应相关的变量。
在191例接受50mg芦可替尼治疗的患者中，87例（45.5%）为反应者（SALT评分≤20），24例（12.6%）为部分反应者，24例（12.6%）为复发者，56例（29.3%）为无反应者。在87例被分类为反应者的患者中，81例（93.1%）维持了临床反应，47例（46.0%）实现了完全反应。与治疗反应相关的因素包括女性性别以及脱发范围较小和持续时间较短。
约45%的患者为SALT评分反应者，高达11%的患者需要>1年的芦可替尼治疗才能实现反应，这突出了延长治疗时间的重要性。
ALLEGRO 2b/3期研究（NCT03732807）；ALLEGRO-LT研究（NCT04006457）。
