Long-Term Treatment with Ritlecitinib for Alopecia Areata, With Brett King, MD, PhD

New 3-year data from the ALLEGRO clinical trial program, presented at the European Academy of Dermatology and Venereology (EADV) 2025 Congress, highlight the sustained efficacy and safety of ritlecitinib (Litfulo) for alopecia areata in both adults and adolescents.

“We see retention of clinical benefit achieved at month 12 maintained at month 36 in approximately 90% of patients, but, again, we see achievement of SALT score zero, so 0% terminal scalp hair loss in about 30% of patients out at month 36,” said study presenter Brett King, MD, PhD, associate professor of Dermatology in the Department of Dermatology at Yale University School of Medicine, in an interview with HCPLive. “So really, really important data and tells us a lot about what we can do or what we can expect with treatment with ritlecitinib, for our patients with severe alopecia areata.”

Ritlecitinib is part of a wave of JAK inhibitors transforming the treatment landscape for alopecia areata, a disease that had no US Food and Drug Administration (FDA)-approved therapies until 2022. Since then, baricitinib (Olumiant), ritlecitinib, and deuruxolitinib (Leqselvi) have all gained regulatory approval, marking a rapid revolution in therapeutic options.1,2,3,4

The analysis at EADV 2025 demonstrated that 65.1% of patients (observed) and 47.1% (LOCF) maintained a SALT score ≤20 at 36–38 months. Among those achieving this threshold at 12 months, nearly 90% maintained response through three years, underscoring the durability of treatment. Importantly, 29.8% of patients achieved complete scalp hair regrowth (SALT = 0), with more than 60% of this group maintaining regrowth without relapse at later visits.1

Additional endpoints presented at EADV Congress 2025 reinforced the findings. Among patients who achieved complete regrowth at least once during the study, 84.2% sustained a SALT score ≤5 at later time points. Improvements were also observed in eyebrow and eyelash regrowth, with approximately 60% of patients demonstrating response at 36–38 months.1

The long-term safety profile of ritlecitinib was consistent with earlier reports, with no new safety signals emerging during the follow-up period.1

For more on the significance of these findings, check out our interview with King from the floor at EADV Congress 2025.

Relevant disclosures for King include AbbVie, AltruBio Inc, Almirall, Amgen, AnaptysBio, Apogee Therapeutics, Arena Pharmaceuticals, Aslan Pharmaceuticals, BiologicsMD, Bristol Meyers Squibb, Concert Pharmaceuticals, Eli Lilly, Equillium, Horizon Therapeutics, Eli Lilly and Company, Incyte, Janssen Pharmaceuticals, LEO Pharma, Merck, Otsuka/Visterra, Pfizer, Q32 Bio, Regeneron, Sanofi Genzyme, Sun Pharma, Takeda, TWi Biotechnology, and Ventyx Biosciences.

References:

1. King B. Long-term efficacy and complete scalp hair regrowth in patients with alopecia areata receiving ritlecitinib 50 mg QD up to 3 years in the ALLEGRO clinical trial program. Presented at the European Academy of Dermatology and Venereology (EADV) 2025 Congress. Paris, France. September 17-20, 2025.

2. Pfizer Inc. FDA Approves Pfizer’s LITFULOTM (Ritlecitinib) for Adults and Adolescents With Severe Alopecia Areata | Pfizer. www.pfizer.com. Published June 23, 2023. Accessed September 19, 2025. https://www.pfizer.com/news/press-release/press-release-detail/fda-approves-pfizers-litfulotm-ritlecitinib-adults-and

3. Eli Lilly and Company. FDA Approves Lilly and Incyte’s OLUMIANT® (baricitinib) As First and Only Systemic Medicine for Adults with Severe Alopecia Areata | Eli Lilly and Company. Eli Lilly and Company. Published June 13, 2022. Accessed September 19, 2025. https://investor.lilly.com/news-releases/news-release-details/fda-approves-lilly-and-incytes-olumiantr-baricitinib-first-and

4. National Alopecia Areata Foundation. FDA Approves LEQSELVITM for Adults with Severe Alopecia Areata - National Alopecia Areata Foundation | NAAF. National Alopecia Areata Foundation | NAAF. Published July 26, 2024. Accessed September 19, 2025. https://www.naaf.org/news/fda-approves-leqselvi-deuruxolitinib-for-adults-with-severe-alopecia-areata/