Patterns of clinical response in patients with alopecia areata treated with ritlecitinib in the <scp>ALLEGRO</scp> clinical development programme
Brett King, Paradi Mirmirani, Kristen Lo Sicco, Yuval Ramot, Rodney Sinclair, Leila Asfour, Khaled Ezzedine, C. Paul, M. Ohyama, Roger Edwards, Gianluca Bonfanti, U. Kerkmann, Dalia Wajsbrot, R. Ishowo‐Adejumo, Samuel H. Zwillich, A. Lejeune
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).