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    Dermatology

    E-Poster Available

    (99) Long-term efficacy and safety of ritlecitinib in adults and adolescents with alopecia areata: 3-year results from the ALLEGRO-LT phase 3, open-label study

    Wednesday, October 29, 2025

      Co-Author(s)

    • Maryanne Senna, MD

      Dermatologist
      Lahey Hospital and Medical Center, Burlington, MA, USA
      Burlington, Massachusetts, United States

    • Ignasi Figueras, MD

      Dermatologist
      Bellvitge Hospital, University of Barcelona, Barcelona, Spain
      Barcelona, Catalonia, Spain

    • Misaki Kinoshita-Ise, MD

      Lecturer
      Kyorin University School of Medicine, Shinkawa, Mitaka, Tokyo, Japan
      Tokyo, Tokyo, Japan

    • Sameh Hanna, MD

      Dermatologist
      University of Toronto, Toronto, Ontario, Canada
      Toronto, Ontario, Canada

    • Wenyu Wu, MD PhD

      Professor
      Huashan Hospital, Fudan University, Shanghai, China
      Shanghai, Shanghai, China (People's Republic)

    • Dalia Wajsbrot, MSc

      Senior Director
      Pfizer Inc, New York, NY, USA
      New York, New York, United States

    • Deborah Woodworth, MBA

      Study Clinician
      Pfizer Inc, Collegeville, PA, USA
      Collegeville, Pennsylvania, United States

    • Robert Wolk, MD PhD DSc

      Executive Director
      Pfizer Inc, Groton, CT, USA
      Groton, Connecticut, United States

    • Alanna Chaudhry, MSc PhD

      Medical Director
      Pfizer Inc, Collegeville, PA, USA
      Collegeville, Pennsylvania, United States

    • Alexandre Lejeune, PhD

      Global Medical Director
      Pfizer Inc, Paris, France
      Paris, Ile-de-France, France

    • Helen Tran, PharmaD

      Medical Director
      Pfizer Inc, New York, NY, USA
      New York, New York, United States

      • Primary Author(s)

    • Helen Tran, PharmaD

      Medical Director
      Pfizer Inc, New York, NY, USA
      New York, New York, United States

      • Presenter(s)

    • Aaron J. Waltzer, n/a

      Director
      Pfizer Inc, New York, NY, USA
      New York, New York, United States


    Background:     : Alopecia areata (AA) is an autoimmune disease characterized by nonscarring hair loss on the scalp, with or without loss of facial and/or body hair. Ritlecitinib demonstrated efficacy and safety up to 48 weeks in patients with AA in the ALLEGRO phase 2b/3 study (NCT03732807).

    Objective: : This analysis investigated the efficacy and safety of ritlecitinib up to 3 years in patients with AA from the ALLEGRO phase 2b/3 and ongoing, phase 3, open-label ALLEGRO-LT (NCT04006457) studies.

    Methods: : Patients aged ≥12 years with AA and ≥50% scalp hair loss who received daily ritlecitinib 50-mg in ALLEGRO-2b/3 and rolled over to ALLEGRO-LT (continued to receive 50-mg) were included. Patients who received placebo and switched to 50-mg were re-baselined to align time points and across groups. Visits were calculated as time since the first ritlecitinib dose, thus resulting in different months for some visits. Observed and last observation carried forward (LOCF) data are reported at the time of data cutoff (June 25th, 2024).

    Results: : 191 patients were included. At the time of data cutoff, 46.6% of patients were either ongoing or had completed the study. At 3 years, 65.1% (71/109 observed) and 47.1% (90/191 LOCF) of patients had Severity of Alopecia Tool (SALT) score ≤20. SALT score ≤10 response rates were 52.3% (57/109 observed) and 36.7% (70/191) (LOCF). Patients’ Global Impression of Change response (“moderately” or “greatly” improved) rates at 3 years were 68.4% (52/76) (observed) and 55.6% (105/189) (LOCF). Ritlecitinib 50-mg was generally well tolerated up to 3 years in patients with severe AA, and the long-term safety profile was consistent with that reported previously.

    Conclusions: : Ritlecitinib 50-mg demonstrated clinically meaningful clinician- and patient-reported efficacy up to 3 years. These data are the longest duration of ritlecitinib treatment to be reported to date and support the long-term use of ritlecitinib in patients aged ≥12 years with AA.

    Sponsorship:: Pfizer Inc