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Clinical Trial
. 2025 Jun;39(6):1163-1173.
doi: 10.1111/jdv.20547. Epub 2025 Feb 17.

Patterns of clinical response in patients with alopecia areata treated with ritlecitinib in the ALLEGRO clinical development programme

B King  1 , P Mirmirani  2 , K Lo Sicco  3 , Y Ramot  4   5 , R Sinclair  6 , L Asfour  7 , K Ezzedine  8 , C Paul  9 , M Ohyama  10 , R A Edwards  11 , G Bonfanti  12 , U Kerkmann  13 , D Wajsbrot  14 , R Ishowo-Adejumo  15 , S H Zwillich  16 , A Lejeune  17
Affiliations
Clinical Trial

Patterns of clinical response in patients with alopecia areata treated with ritlecitinib in the ALLEGRO clinical development programme

B King et al. J Eur Acad Dermatol Venereol. 2025 Jun.

Abstract

Background: 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.

Objectives: 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.

Methods: 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.

Results: 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.

Conclusions: 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.

Gov registration: ALLEGRO phase 2b/3 study (NCT03732807); ALLEGRO-LT study (NCT04006457).

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Conflict of interest statement

BK has served on advisory boards, is a consultant, is a clinical trial investigator and/or is on a data monitoring committee for AbbVie, AltruBio, Inc., Almirall, AnaptysBio, Arena Pharmaceuticals, Aslan Pharmaceuticals, Bioniz Therapeutics, Bristol Meyers Squibb, Concert Pharmaceuticals, Inc., Equillium, Horizon Therapeutics, Eli Lilly and Company, Incyte Corp, Janssen Pharmaceuticals, LEO Pharma, Merck, Otsuka/Visterra, Inc., Pfizer, Inc., Q32 Bio, Inc., Regeneron, Sanofi Genzyme, Sun Pharmaceutical, TWi Biotechnology, Inc., Viela Bio and Ventyx Biosciences, Inc.; and has served on speakers bureaus for AbbVie, Incyte, Eli Lilly, Pfizer, Regeneron and Sanofi Genzyme. PM received investigator grants and/or research funding from Concert Pharmaceuticals, Pfizer, Inc. and Eli Lilly. KL served as an investigator, advisory board member and consultant for Pfizer, received educational grant funding from Pfizer and has been a consultant for Aquis. YR served as consultant, speaker, or investigator for AbbVie, Bristol Myers Squibb, Boehringer Ingelheim, Pfizer, Pepticom, Novartis, Janssen, Neopharm, Giuliani S.p.A, Dexcel Pharma, Eli Lilly, Sanofi, Taro and Monasterium Laboratory; and serves as the CMO of MII Labs. RS has provided professional services to Aerotech, AbbVie, AstraZeneca, Akesobio, Amgen, Arcutis, Arena, Ascend, Bayer, BMS, Boehringer Ingelheim, Celgene, Coherus BioSciences, Connect, Cutanea, Demira, Eli Lilly, Galderma, GSK, Janssen, LEO Pharma, MedImmune, Merck, MSD, Novartis, Oncobiologics, Pfizer, Regeneron, Reistone, Roche, Samson Clinical, Sanofi, Sun Pharma and UCB. LA has served as a consultant for AbbVie and L'Oreal. KE has served as a consultant for and/or received investigator grants from Abbvie, Almirall, Incyte, L'Oreal, La Roche Posay, Pfizer, Pierre Fabre, Sanofi and Viela Bio. CP has served as a consultant for Almirall, Amgen, AbbVie, Apogee Therapeutics, BMS, Boehringer Ingelheim, Celgene, Galderma, GSK, Eli Lilly, IQVIA, Janssen, Leo Pharma, Merck, Mylan, Novartis, Pfizer, Pierre Fabre, Sanofi and UCB Pharma. MO is a medical advisor for and receives advisory fees from Pfizer Japan, Inc., Taisho Pharmaceutical Co, Eli Lilly Japan KK, ROHTO Pharmaceutical Co, Bristol Myers Squibb Japan and AbbVie GK; receives lecture fees from Eli Lilly Japan KK and Pfizer Japan, Inc.; and receives research grants for projects not related to this study from Maruho Co, Sun Pharma Japan Ltd., Advantest Corp and Shiseido Co. RAE is an employee of Health Services Consulting Corporation and received consultancy fees from Pfizer in connection with this study. GB is an employee of Engineering Ingegneria Informatica, a paid sub‐contractor to Health Services Consulting Corporation, in conjunction with this analysis. UK, DW, RIA, SHZ and AL are employees of and hold stock or stock options in Pfizer, Inc.

Figures

FIGURE 1
FIGURE 1
Analysis populations. Data while patients were receiving placebo were not included in this analysis; data from patients in Group G were re‐baselined from the start of treatment with ritlecitinib.
FIGURE 2
FIGURE 2
SALT score trajectories in the rollover cohort treated with ritlecitinib 50 mg QD (N = 191). QD, once daily; SALT, Severity of Alopecia Tool. Red lines indicate the median SALT score trajectory. Trajectories that do not extend to Month 24 reflect patients who had not reached this time point at the data cut‐off (February 2022) or who were discontinued from the study. Data are as‐observed. SALT score trajectories are shown in the Interactive dynamic plot.
FIGURE 3
FIGURE 3
Proportions of rollover patients treated with ritlecitinib 50 mg QD who achieved SALT score ≤20 and (a) sustained response and (b) complete response. QD, once daily; SALT, Severity of Alopecia Tool. Percentages are based on n/N1, where n = the number of patients with sustained or complete response, and N1 = total number of patients who were classed as responders. Patients with sustained response achieved and then maintained a SALT score ≤20 at all subsequent available time points through Month 24, where ‘available’ indicates that the SALT value was not missing. Patients who never achieved SALT score ≤20 and patients who achieved SALT score ≤20 but a score of >20 at subsequent time points were excluded. Patients classed as complete responders achieved a SALT score 0 at ≥1 time point through Month 24. Data are as‐observed.
FIGURE 4
FIGURE 4
Association of patient demographics, baseline disease characteristics and comorbidities with treatment response in rollover patients treated with ritlecitinib 50 mg QD. CI, confidence interval; OR, odds ratio; QD, once daily; SALT, Severity of Alopecia Tool. Multivariable logistic regression models evaluated the non‐responder and responder (SALT score ≤20, irrespective of early, middle and late response) populations only; patients in the relapser and partial responder groups were excluded from this analysis. Independent covariates of interest that were significant in the stepwise models are shown. *Continuous variable in which a change in the variable (1 year for age, duration of significant [≥50%] scalp hair loss, episode duration and disease duration; 1 unit for baseline SALT score) is associated with the likelihood of response. †The latter is the reference category.
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