Supplementary Material for: Patient-Reported Satisfaction With Hair Regrowth in a Study of Ritlecitinib in Alopecia Areata: Results From ALLEGRO-2b/3

Introduction: Patients with alopecia areata (AA) report high levels of dissatisfaction with commonly used treatments. Patient-reported outcomes are essential to understanding patients’ experiences with AA treatments. The objective of this study was to evaluate patient-reported satisfaction with hair growth among patients with AA receiving ritlecitinib or placebo and the correlation between clinician-assessed efficacy and patient-reported satisfaction.

Methods: In the ALLEGRO-2b/3 (NCT03732807) trial, patients with AA and ≥50% scalp hair loss were randomized to daily ritlecitinib or placebo for 24 weeks, with a 24-week extension of continued ritlecitinib or switch from placebo to ritlecitinib. The Patient Satisfaction with Hair Growth (P-Sat) measure evaluated patients’ satisfaction with hair growth in 3 domains: amount, quality, and overall satisfaction with hair growth. The pre-specified analysis evaluated the proportion of patients who were slightly, moderately, or very satisfied with hair growth. Several post-hoc analyses assessed the proportion of patients who were moderately/very satisfied and moderately/very dissatisfied and calculated polyserial correlations between change from baseline (CFB) in Severity of Alopecia Tool (SALT) and P-Sat scores at Weeks 24 and 48.

Results: At Week 24, the proportion of patients (N=718) reporting satisfaction (slightly, moderately, or very satisfied) overall with their hair growth ranged from 36.4% in the ritlecitinib 10-mg group (evaluated for dose ranging only) to 67.5% in the 200/50-mg group vs 22.6% in the placebo groups. In patients randomized to ritlecitinib, the proportion who were satisfied increased or was maintained at Week 48. A substantially greater proportion of placebo patients who switched to ritlecitinib reported satisfaction at Week 48 than at Week 24. Similar results were observed for patient satisfaction with the amount and quality of hair growth. In the post hoc analyses defining satisfaction as moderately/very satisfied and dissatisfaction as moderately/very dissatisfied, the benefit of ritlecitinib was also observed. All P-Sat domain scores strongly correlated with CFB-SALT scores at Weeks 24 (range 0.73-0.76; P<0.05) and 48 (0.74-0.77; P<0.05).

Conclusions: Patients receiving active ritlecitinib doses reported favorable results vs placebo in satisfaction with hair growth up to Week 48. High concordance was observed between improvement in scalp hair growth evaluated by clinicians and patient-reported satisfaction.

Trial Registration: Clinicaltrials.gov NCT0373280

引言：斑秃（alopecia areata, AA）患者对现有常用治疗方案的满意度普遍偏低。患者报告结局（Patient-reported outcomes）是深入了解斑秃患者治疗体验的核心手段。本研究旨在评估接受利特昔替尼（ritlecitinib）或安慰剂治疗的斑秃患者对毛发生长的满意度，并分析临床医师评估的疗效与患者报告满意度之间的相关性。

方法：本研究依托ALLEGRO-2b/3（临床试验编号NCT03732807）开展，纳入斑秃且头皮毛发脱落≥50%的患者，按随机分组每日接受利特昔替尼或安慰剂治疗，疗程24周；后续设置24周延长期，继续使用利特昔替尼组维持原方案，安慰剂组则换用利特昔替尼治疗。本研究采用毛发生长患者满意度量表（Patient Satisfaction with Hair Growth, P-Sat）从毛发量、毛发质量及整体毛发生长满意度3个维度评估患者对毛发生长的满意程度。预设分析旨在统计对毛发生长达到轻微、中度或极度满意的患者占比；事后分析则分别统计中度/极度满意及中度/极度不满意的患者占比，并计算第24周、第48周时斑秃严重程度评分量表（Severity of Alopecia Tool, SALT）较基线变化值（change from baseline, CFB）与P-Sat评分之间的多系列相关系数。

结果：第24周时，纳入分析的718例患者中，整体对毛发生长达到轻微、中度或极度满意的占比范围为：利特昔替尼10mg组（仅用于剂量范围探索）36.4%、200/50mg组67.5%，而安慰剂组仅为22.6%。在随机分配至利特昔替尼组的患者中，第48周时满意患者占比持续升高或维持稳定；而安慰剂组换用利特昔替尼的患者，第48周时报告满意的占比显著高于第24周。针对毛发生长量与毛发质量的患者满意度分析也得到了一致结果。在将满意度定义为中度/极度满意、不满意定义为中度/极度不满意的事后分析中，同样观察到利特昔替尼的治疗获益。第24周时，所有P-Sat维度评分与CFB-SALT评分均呈强相关性（相关系数范围0.73~0.76；P<0.05）；第48周时相关系数范围为0.74~0.77（P<0.05）。

结论：截至第48周，接受活性剂量利特昔替尼治疗的患者，其毛发生长满意度均优于安慰剂组；临床医师评估的头皮毛发改善情况与患者报告的满意度之间具有高度一致性。

试验注册：Clinicaltrials.gov 编号NCT0373280