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  • Presentation

Efficacy and Safety of Baricitinib in the Treatment of Alopecia Areata: Phase 2 Results from a Randomized Controlled Study

Description

The presentation discusses the efficacy and safety of baricitinib in treating alopecia areata, highlighting results from a Phase 2 randomized controlled study. Brett King, previously associated with Yale, emphasizes that the research is a collective effort involving numerous investigators and patients. The discussion reflects on the stagnant treatment landscape for alopecia areata prior to 2021, when a case report on tofacitinib sparked interest in Janus kinase inhibitors for this condition. The study involved over 100 patients with significant scalp hair loss, setting a groundwork for future research and establishing baricitinib dosing. Key findings included a significant percentage of patients achieving substantial improvement in their SALT scores, indicating notable hair regrowth. The study's results contributed to the FDA's approval of baricitinib in 2022, marking the first medication cleared specifically for alopecia areata treatment. King expresses enthusiasm for the transformative impact of this treatment, asserting that it has changed the lives of many patients and represents the start of a new era in managing this challenging condition.

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Conclusions

  • Baricitinib is an effective treatment for alopecia areata, demonstrating significant safety and efficacy in clinical trials.
  • The study results indicated that approximately 51.9% of patients receiving baricitinib achieved a SALT score of 20 or less.
  • Only 3.6% of patients in the placebo group achieved the same outcome, highlighting the drug's impact.
  • Baricitinib became the first FDA-approved treatment specifically for alopecia areata in 2022.
  • The treatment significantly improved hair regrowth in patients who had not responded to previous therapies.
  • Ongoing studies are expected to provide further insights into the long-term effects and optimal dosing regimens of baricitinib.
  • King B, et al. J Am Acad Dermatol 2021;85:847-53.
  • Alkhalifah A, et al. J Am Acad Dermatol 2010;62:191-202; Craiglow BG, King BA. J Invest Dermatol. 2014;134:2988-2990.
  • King B, et al. BRAVE-AA Investigators. Two phase 3 trials of baricitinib for alopecia areata. N Engl J Med. 2022;386:1687-1699.
  • King B, et al. When to expect scalp hair regrowth during treatment of severe alopecia areata with baricitinib: insights from trajectories analyses of patients enrolled in two phase III trials. Br J Dermatol. 2023;189(6):666-673.
  • King B, et al. Baricitinib withdrawal and retreatment in patients with severe alopecia areata: the BRAVE-AA1 randomized clinical trial. JAMA Dermatol. 2024;160:1075-1081.
  • King B, et al. Outcomes of down-titration in patients with severe scalp alopecia areata initially treated with baricitinib 4-mg: Week 152 data from BRAVE-AA2. J Am Acad Dermatol. 2025;92:299-306.
  • Kolodsick J, et al. Continued treatment with baricitinib results in meaningful scalp responses among scalp non-responder patients with eyebrow/eyelash regrowth in the first year. J Eur Acad Dermatol Venereol. 2025 Epub.
  • Passeron T, et al. Baricitinib Provides Significant Hair Regrowth In Adolescents With Severe Alopecia Areata: 36-Week Efficacy and Safety Results From A Phase 3 Randomized, Controlled Trial. AAD 2025 Late Breaking