Real-World Data Support Baricitinib Use for Atopic Dermatitis, Alopecia

A systematic literature review of real-world evidence supported the use of baricitinib for the treatment of atopic dermatitis (AD) and alopecia areata (AA), backing similar efficacy and tolerability reported in pivotal clinical trials.1

Across 76 publications matching the inclusion criteria, baricitinib, an oral selective Janus kinase 1/2 inhibitor, was linked to a high level of patient satisfaction, particularly for the treatment of itch in AD. For the treatment of AA of the beard, a form affecting 28% of men with AA, baricitinib was linked to complete or partial beard regrowth for most treated patients.

“Overall, the publications identified in this SLR indicate that the effectiveness and safety of baricitinib in the real-world treatment of adult and paediatric patients with AD and adult patients with AA appear to be similar to that reported in clinical trials,” wrote the investigative team, led by Julien Seneschal, MD, PhD, a professor of dermatology at the National Reference Center for Rare Skin Diseases, University of Bordeaux.

These immune-mediated inflammatory skin diseases often exist concomitantly, with a bidirectional relationship, with a patient with AD experiencing an increased risk of AA diagnosis and a patient with AA experiencing a greater likelihood of AD.2 The US Food and Drug Administration (FDA) has only approved baricitinib to treat severe AA in adults, with AD guidelines highlighting it as a treatment option with qualifiers for adults and adolescents.3 Meanwhile, the European Medicines Agency (EMA) approved baricitinib for use in adults and pediatric patients aged ≥2 years with moderate-to-severe AD and adults with severe AA.4

In this published literature analysis, investigators searched the Ovid MEDLINE, Embase, and Evidence-Based Medicine Reviews (EBMR) and disease- and drug-related keywords from October 2020 to November 2023.1 Eligible studies involved patients receiving baricitinib for AD and/or AA and reporting patient outcomes, treatment patterns, safety, and/or economic outcomes.

Of the 769 identified studies from the databases, 46 were retained for analysis. For the 161 records identified from other sources, 30 conference abstracts were collected. Overall, Seneschal and colleagues included 76 publications for analysis in the study.

Among the included publications, 48 reported studies in patients with AD, of which 6 included patients with comorbid AA. Among 28 publications reporting studies in patients with AA, 5 reported patients with comorbid AD. Overall, 1134 unique patients with AD and 598 patients with AA were included for analysis.

Analysis of baricitinib’s effectiveness for AD revealed notable reductions in Eczema Area and Severity Index (EASI) scores in real-world settings as well as the percentage of patients with severe AD, which were sustained to 16 and 52 weeks.

Seneschal and colleagues noted the high level of treatment satisfaction identified in the study as of particular importance. According to results of a post hoc analysis of the BREEZE-AD7 study, patients with a body surface area (BSA) of ≤ 40%, and an Itch numerical rating scale (NRS) ≥ 7 were more likely to benefit from baricitinib 4 mg per day in combination with topical corticosteroids.

Further analysis of available data showed improvement with baricitinib in difficult-to-treat areas of AD, such as the head and neck and genitalia, and visible areas, including the hands and arms. Evaluation of real-world data in a poster presentation revealed significant clearance in sensitive body areas with baricitinib 4 mg, particularly in highly involved patients.

Baricitinib also demonstrated a substantial improvement in EASI scores, compared with baseline, in patients with AD who were recalcitrant to numerous prior therapies, including dupilumab. Although not yet approved for pediatric use, baricitinib has shown real-world benefits in treating alopecia areata in children, highlighting both a significant unmet need and physician confidence, with its efficacy currently being evaluated in the BRAVE-AA-PEDS study.

“These real-world data offer important insights into baricitinib use in pediatric AA, but further research is necessary to gather more comprehensive data on real-world use of baricitinib in the treatment of AD in pediatric patients,” Seneschal and colleagues wrote.

References

1. Seneschal J, Figueras Nart L, Sabatino S, Papadimitropoulos M, Dabral S, Lampropoulou A. Real-World Evidence for Baricitinib in the Treatment of Atopic Dermatitis and Alopecia Areata: Systematic Literature Review 2020-2023. Dermatol Ther (Heidelb). Published online May 16, 2025. doi:10.1007/s13555-025-01425-y

2. Rudnicka L, Arenbergerova M, Grimalt R, et al. European expert consensus statement on the systemic treatment of alopecia areata. J Eur Acad Dermatol Venereol. 2024;38(4):687-694. doi:10.1111/jdv.19768

3. Butera A. FDA approves baricitinib for alopecia areata in adults. HCP Live. June 13, 2022. Accessed May 23, 2025. https://www.hcplive.com/view/fda-approves-baricitinib-for-alopecia-areata.

4. AAAAI/ACAAI JTF Atopic Dermatitis Guideline Panel, Chu DK, Schneider L, et al. Atopic dermatitis (eczema) guidelines: 2023 American Academy of Allergy, Asthma and Immunology/American College of Allergy, Asthma and Immunology Joint Task Force on Practice Parameters GRADE- and Institute of Medicine-based recommendations. Ann Allergy Asthma Immunol. 2024;132(3):274-312. doi:10.1016/j.anai.2023.11.009