Patient Profile and Treatment Characteristics of Early Ritlecitinib Initiators in the US

Abstract

Introduction: Alopecia Areata (AA) is an autoimmune disease characterized by unpredictable, non-scarring hair loss. In the ALLEGRO phase 2b/3 randomized, placebo-controlled clinical trial, ritlecitinib 50mg demonstrated a significantly greater proportion of patients achieving 80% or more scalp hair coverage at 24 weeks compared to placebo. In June 2023, the FDA approved ritlecitinib (50mg) for treatment of severe AA in adults and adolescents 12 years and older. This study aims to address how ritlecitinib is being integrated into real-world practice by assessing the characteristics of patients prescribed ritlecitinib within the first three months following approval. Methods: This was a retrospective observational study analyzing data from the Komodo Healthcare Map (TM) dataset (Jan 2016-Sept 2023). Komodo Healthcare Map is comprised of open and closed claims for more than 330M lives in the US. The sample included patients aged ≥12 years with ≥1 prescription for ritlecitinib on or after June 23, 2023 (first prescription date defined the index date), ≥1 diagnoses of AA on or before the index date, and ≥12 months of continuous enrollment/eligibility proxy prior to study entry. Clinical characteristics, comorbidities, and AA treatment history were assessed over the 12-month pre-index period. All variables were analyzed descriptively and stratified by age (adolescent: 12-17, adult: ≥18). Results: Among the 150 patients included, 72% were prescribed ritlecitinib by a dermatologist. Over half were female, 52% were adolescents, and 78% were commercially insured. Approximately 30% of patients had alopecia totalis/alopecia universalis (AT/AU); 11% had ≥1 other autoimmune disorder, 23% had ≥1 atopic disorder, and 21% had ≥1 mental/emotional disorders. In the 12 months prior to receiving ritlecitinib, 34% of adolescents received no AA treatments, 30% received systemic immunomodulators (19% Janus kinase inhibitors [JAKi], 13% other systemic immunomodulators), and 20% received topical corticosteroids. Among adults, 24% had no evidence of prior AA treatments, 35% received injectable corticosteroids, and 35% received systemic immunomodulators (21% baricitinib, 13% other JAKi, and 7% other systemic immunomodulators) during the pre-index period. Of those who had received a prior treatment, the mean time between the last days’ supply of the prior therapy and the start of ritlecitinib was 51 days. Conclusion: In the first 3 months following the US approval, ritlecitinib was prescribed to a broad range of patients; including adolescent and adults; those with and without prior treatments; and those with and without various comorbidities. This suggests that ritlecitinib may provide new opportunities to (re)engage in AA-directed care. Funding: this study was funded by Pfizer Inc.