Efficacy and Safety of Baricitinib in Patients with Severe Alopecia Areata Over 52 Weeks in Phase III Trials

February 2023 in “ American Journal of Clinical Dermatology ”

Oh Sang Kwon, Maryanne M. Senna, Rodney Sinclair, Taisuke Ito, Yves Dutronc, Chen-Yen Lin, Guanglei Yu, Chiara Chiasserini, Jill Shwed McCollam, Wen‐Chi Wu, Brett King

baricitinib alopecia areata Janus kinase inhibitor SALT score upper respiratory tract infection nasopharyngitis acne urinary tract infection creatine phosphokinase elevation AA JAK inhibitor

From the encyclopedia

Baricitinib →

JAK inhibitor that reduces inflammation and immune attacks on hair follicles, leading to potential hair regrowth, especially in alopecia areata cases

Alopecia Areata →

autoimmune disorder causing patchy hair loss

Studysummary In this study, 40.9% of patients taking 4 mg baricitinib and 21.2% taking 2 mg achieved significant hair regrowth over 52 weeks, indicating potential long-term benefits for adults with severe alopecia areata without introducing new safety concerns.

Our plain-language summary. Not medical advice or a treatment recommendation. Consult a qualified healthcare professional before changing treatment. Full disclaimer

The document presents the results of two Phase III trials, BRAVE-AA1 (465 patients) and BRAVE-AA2 (390 patients), investigating the efficacy and safety of baricitinib, an oral Janus kinase inhibitor, in treating severe alopecia areata (AA) in adults with ≥50% scalp hair loss over 52 weeks. The results showed that 40.9% and 36.8% of patients treated with 4 mg of baricitinib in BRAVE-AA1 and BRAVE-AA2 respectively, achieved a Severity of Alopecia Tool (SALT) score ≤ 20 (≤ 20% scalp hair loss) at Week 52. The most common side effects were upper respiratory tract infection, headache, nasopharyngitis, acne, urinary tract infection, creatine phosphokinase elevation, and COVID-19 infection. The study concluded that the efficacy of baricitinib for adults with severe AA continuously improved over 52 weeks, indicating that long-term treatment may be necessary to observe maximum clinical benefit. No new safety concerns were identified.

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Research cited in this study

6 / 6 results

research Two Phase 3 Trials of Baricitinib for Alopecia Areata

148 citations , March 2022 in “The New England Journal of Medicine”

In two phase 3 trials, this study found that oral baricitinib significantly improved hair regrowth compared to placebo in adults with severe alopecia areata after 36 weeks, though longer trials are needed to ascertain its long-term efficacy and safety.

Development of Clinician-Reported Outcome and Patient-Reported Outcome Measures for Eyebrow, Eyelash, and Nail Assessment in Alopecia Areata

research Development of Clinician-Reported Outcome and Patient-Reported Outcome Measures for Eyebrow, Eyelash, and Nail Assessment in Alopecia Areata

56 citations , August 2020 in “American Journal of Clinical Dermatology”

This study concluded that the ClinRO and PRO measures, along with their photoguides, offer clear and meaningful assessments for patients with alopecia areata concerning eyebrow, eyelash, and nail appearance, as well as eye irritation.

research The Alopecia Areata Investigator Global Assessment Scale: A Measure for Evaluating Clinically Meaningful Success in Clinical Trials

86 citations , January 2020 in “British Journal of Dermatology”

This study developed the Alopecia Areata Investigator Global Assessment (AA-IGA) to measure scalp-hair loss in alopecia areata patients, incorporating perspectives of both patients and clinicians to define treatment success.

research JAK Inhibitors for Alopecia Areata: A Systematic Review and Meta-Analysis

130 citations , February 2019 in “JEADV. Journal of the European Academy of Dermatology and Venereology/Journal of the European Academy of Dermatology and Venereology”

This study found that JAK inhibitors for alopecia areata showed promising response rates, with 72.4% of 289 cases responding, and oral administration achieving better outcomes than topical treatment, but recurrence occurred when treatment stopped. Further large-scale studies are needed to confirm these findings.

research JAK Inhibitors in Dermatology: The Promise of a New Drug Class

355 citations , January 2017 in “Journal of the American Academy of Dermatology”

This review reports no new results and highlights existing research suggesting JAK inhibitors may be effective in treating inflammatory skin conditions like alopecia areata, atopic dermatitis, psoriasis, and vitiligo.

research Alopecia Areata Is Driven by Cytotoxic T Lymphocytes and Is Reversed by JAK Inhibition

701 citations , August 2014 in “Nature medicine”

This study found that JAK inhibitors promote hair regrowth in both mice and human alopecia areata cases by blocking key immune pathways involved in disease development.