Baricitinib for the Treatment of Alopecia Areata

May 2023 in “ Drugs ”

Egídio Freitas, Emma Guttman‐Yassky, Tiago Torres

baricitinib Janus kinase pathway alopecia areata SALT score nausea acne upper respiratory tract infection JAK pathway AA

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 This study reports that baricitinib was more effective than placebo in promoting hair growth in adults with severe alopecia areata after 36 weeks of treatment in clinical trials.

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

Baricitinib, a drug that inhibits the Janus kinase (JAK) pathway, has been found to be more effective than a placebo in promoting hair growth in adults with severe alopecia areata (AA) after 36 weeks of treatment. This was demonstrated in a phase 2 trial and two phase 3 trials, BRAVE-AA1 and BRAVE-AA2, which included 654 and 546 patients respectively. At week 36, 38.8% and 35.9% of patients in the baricitinib group achieved a Severity of Alopecia Tool (SALT) score of 20 or less, compared to 6.2% and 3.3% in the placebo group. The most common side effects were nausea, acne, and upper respiratory tract infection. As a result, the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA) have approved baricitinib for the treatment of adults with severe AA. However, the document concludes that longer trials are needed to determine the long-term efficacy and safety of Baricitinib in AA.

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Research cited in this study

29 / 29 results

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

20 citations , February 2023 in “American Journal of Clinical Dermatology”

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.

Systematic Review of Newer Agents for the Management of Alopecia Areata in Adults: Janus Kinase Inhibitors, Biologics and Phosphodiesterase-4 Inhibitors

research Systematic Review of Newer Agents for the Management of Alopecia Areata in Adults: Janus Kinase Inhibitors, Biologics and Phosphodiesterase-4 Inhibitors

12 citations , December 2022 in “JEADV. Journal of the European Academy of Dermatology and Venereology/Journal of the European Academy of Dermatology and Venereology”

This review suggests that oral Janus kinase inhibitors are a promising treatment for alopecia areata in adults, showing significant hair regrowth with fewer side effects than conventional treatments, while PDE-4 inhibitors and biologics show limited efficacy.

research Integrated Safety Analysis of Baricitinib in Adults With Severe Alopecia Areata From Two Randomized Clinical Trials

25 citations , November 2022 in “British journal of dermatology/British journal of dermatology, Supplement”

In this analysis, safety data from two clinical trials showed that baricitinib for severe alopecia areata had predictable side effects like infections and elevated CPK, with some serious adverse events noted at low incidence rates; no deaths were reported.

research Analysis of Alopecia Areata Surveys Suggests a Threshold for Improved Patient-Reported Outcomes

14 citations , June 2022 in “British Journal of Dermatology”

This study found that the Alopecia Areata Symptom Impact Scale (AASIS) is a better tool than the Alopecia Areata Quality of Life Index (AA-QLI) for assessing patient-reported outcomes in alopecia areata.

research Baricitinib in Alopecia Areata

16 citations , May 2022 in “New England Journal of Medicine”

This Italian study observed that one third of patients with 25 to 50% scalp hair loss from alopecia areata still experienced active patchy disease at long-term follow-up, and another third progressed to more severe forms like alopecia totalis or universalis, with limited recovery.

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.

research Maintenance, Withdrawal, and Re-Treatment with Ritlecitinib and Brepocitinib in Patients with Alopecia Areata in a Single-Blind Extension of a Phase 2a Randomized Clinical Trial

20 citations , December 2021 in “Journal of the American Academy of Dermatology”

This study found that the oral JAK inhibitors ritlecitinib and brepocitinib were effective in maintaining hair regrowth in alopecia areata with continuous use, though efficacy decreased after withdrawal.

research Ritlecitinib And Brepocitinib Demonstrate Significant Improvement In Scalp Alopecia Areata Biomarkers

36 citations , December 2021 in “The journal of allergy and clinical immunology/Journal of allergy and clinical immunology/The journal of allergy and clinical immunology”

This study observed that both ritlecitinib and brepocitinib improved scalp biomarkers in patients with alopecia areata, with associations to hair regrowth seen in this phase 2a trial.

Efficacy and Safety of the Oral Janus Kinase Inhibitor Baricitinib in the Treatment of Adults with Alopecia Areata: Phase 2 Results from a Randomized Controlled Study

research Efficacy and Safety of the Oral Janus Kinase Inhibitor Baricitinib in the Treatment of Adults with Alopecia Areata: Phase 2 Results from a Randomized Controlled Study

66 citations , June 2021 in “Journal of The American Academy of Dermatology”

In this phase 2 study, baricitinib at 2 mg and 4 mg doses significantly improved hair regrowth in adults with alopecia areata and ≥50% scalp hair loss compared to placebo, without new safety concerns, although the small sample size limits the results' generalizability.

research A Phase 2a Randomized, Placebo-Controlled Study to Evaluate the Efficacy and Safety of the Oral Janus Kinase Inhibitors Ritlecitinib and Brepocitinib in Alopecia Areata: 24-Week Results

138 citations , March 2021 in “Journal of the American Academy of Dermatology”

This study found that treatment with ritlecitinib or brepocitinib was effective in improving scalp hair loss for patients with alopecia areata over 24 weeks compared to placebo.

research Alopecia Areata: A Complex Cytokine-Driven Disease

3 citations , October 2020 in “The journal of investigative dermatology. Symposium proceedings/The Journal of investigative dermatology symposium proceedings”

This research discusses the complex immune pathogenesis of alopecia areata and highlights the success of Jak inhibitors and IL-4Rα antagonists, while IL-17A and PDE4 inhibitors showed limited efficacy; controlled trials are advocated to better understand cytokine involvement.

‘You Lose Your Hair, What’s the Big Deal?’ I Was So Embarrassed, I Was So Self-Conscious, I Was So Depressed: A Qualitative Interview Study to Understand the Psychosocial Burden of Alopecia Areata

research ‘You Lose Your Hair, What’s the Big Deal?’ I Was So Embarrassed, I Was So Self-Conscious, I Was So Depressed: A Qualitative Interview Study to Understand the Psychosocial Burden of Alopecia Areata

30 citations , September 2020 in “Journal of Patient-Reported Outcomes”

This study found that alopecia areata significantly impacts emotional and psychological well-being, relationships, and lifestyles, highlighting the need for increased awareness and effective treatments.

research IL-12/IL-23 Neutralization Is Ineffective for Alopecia Areata in Mice and Humans

20 citations , December 2019 in “The journal of allergy and clinical immunology/Journal of allergy and clinical immunology/The journal of allergy and clinical immunology”

In this study, ustekinumab did not promote hair regrowth in human patients with alopecia areata or prevent disease development in an AA mouse model, suggesting limited efficacy for this treatment.

research The Role of Janus Kinase Inhibitors in the Treatment of Alopecia Areata: A Systematic Review

19 citations , August 2019 in “Dermatologic therapy”

This review discusses the use of Janus kinase inhibitors for alopecia areata and reports promising short-term efficacy but low-quality evidence, highlighting the need for further research to confirm long-term safety and effectiveness.

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 Treatment of Alopecia Areata: An Australian Expert Consensus Statement

95 citations , November 2018 in “Australasian journal of dermatology”

This consensus statement outlines a treatment algorithm for alopecia areata, discussing when to consider systemic treatment and how to assess outcomes, without providing new clinical results.

research JAK Inhibitors for Treatment of Alopecia Areata

63 citations , July 2018 in “The journal of investigative dermatology/Journal of investigative dermatology”

In this review, the researchers reported that JAK inhibitors, originally approved by the FDA for other uses, have shown effectiveness in reversing hair loss in patients with moderate to severe alopecia areata, based on current preclinical and clinical studies.

An Open-Label Pilot Study to Evaluate the Efficacy of Tofacitinib in Moderate to Severe Patch-Type Alopecia Areata, Totalis, and Universalis

research An Open-Label Pilot Study to Evaluate the Efficacy of Tofacitinib in Moderate to Severe Patch-Type Alopecia Areata, Totalis, and Universalis

130 citations , February 2018 in “Journal of Investigative Dermatology”

This study found that tofacitinib led to ≥50% hair regrowth in eight out of twelve patients with moderate to severe alopecia areata, suggesting a potential benefit for using JAK inhibitors in treating this condition.

research Tofacitinib for the Treatment of Severe Alopecia Areata in Adults and Adolescents

28 citations , December 2017 in “Journal of Investigative Dermatology Symposium Proceedings”

This review summarizes findings on the long-term use of tofacitinib for severe alopecia areata, reporting its potential as a promising treatment option.

research Alopecia Areata: Treatment Options and Efficacy

182 citations , December 2017 in “Journal of the American Academy of Dermatology”

This article reviews current and emerging treatments for alopecia areata, including Janus kinase inhibitors, highlighting variability in clinical outcomes and the lack of sustained remission.

research The Changing Landscape of Alopecia Areata: The Therapeutic Paradigm

77 citations , June 2017 in “Advances in Therapy”

This review discusses recent advances and ongoing clinical trials in novel therapeutics for alopecia areata, despite the lack of current FDA-approved treatments for severe cases, and reports no new results.

research Tofacitinib for the Treatment of Alopecia Areata and Variants in Adolescents

139 citations , November 2016 in “Journal of the American Academy of Dermatology”

In this retrospective review, tofacitinib treatment was associated with clinically significant hair regrowth in most adolescent patients with alopecia areata, though limitations suggest further studies are needed to confirm these findings.

research Tofacitinib for the Treatment of Severe Alopecia Areata and Variants: A Study of 90 Patients

238 citations , November 2016 in “Journal of The American Academy of Dermatology”

In this study, tofacitinib was reported to improve scalp hair regrowth in patients with severe alopecia areata, alopecia totalis, and alopecia universalis, showing a higher response in alopecia areata.

research Safety and Efficacy of the JAK Inhibitor Tofacitinib Citrate in Patients with Alopecia Areata

222 citations , September 2016 in “JCI insight”

This research overview highlights that although JAK inhibitors show promise as potential treatments for alopecia areata based on recent insights into the disease mechanism, their efficacy has not yet been thoroughly evaluated in a systematic manner.

research Oral Ruxolitinib Induces Hair Regrowth in Patients with Moderate-to-Severe Alopecia Areata

196 citations , September 2016 in “JCI insight”

This study explored the effectiveness of the oral JAK1/2 inhibitor ruxolitinib in treating patients with moderate-to-severe alopecia areata, building on prior success with JAK inhibitors in mice, but results are not reported in this abstract.

research Familial Aggregation of Alopecia Areata

295 citations , May 2016 in “Journal of the American Academy of Dermatology”

This review examines the immunological aspects of alopecia areata, focusing on genetic, neuroimmunological, and immune privilege factors, but does not report new clinical findings.

Epidemiology and Burden of Alopecia Areata: A Systematic Review