Efficacy and predictive markers of response to tofacitinib and baricitinib therapy in alopecia areata: A 52-week comparative cohort study
https://doi.org/10.21518/ms2026-049
Abstract
Introduction. Tofacitinib and baricitinib are key systemic therapies for alopecia areata. However, direct comparative data on their efficacy and predictors of treatment response in real-world practice are limited.
Aim. To compare the efficacy of tofacitinib and baricitinib in alopecia areata and identify predictors of treatment response.
Materials and methods. A 52-week prospective comparative non-randomized cohort study included 45 patients with alopecia areata (SALT >25%). Patients were divided into two groups: tofacitinib (n = 18,10 mg daily) and baricitinib (n = 27,4 mg daily). Efficacy was assessed using SALT score dynamics, SALT30 (≥30% reduction), and SALT ≤20% (clinically significant outcome). Multiple regression models and Cox regression were used to identify predictors.
Results. Groups differed in age and sex (p < 0.05). At week 52, the median hair regrowth was 81.4% for tofacitinib and 100.0% for baricitinib (p = 0.280). Achievement of SALT30 and SALT ≤20% was comparable (p > 0.05). Multivariate analysis identified baseline disease severity (SALT) as the only independent predictor of poorer response (β = -2.6% per 10% SALT, p = 0.047; OR for SALT ≤20% = 0.78, p = 0.038). Drug choice was not associated with efficacy. However, the proportion of early responders (SALT30 by week 12) was significantly higher with baricitinib (51.9% vs. 22.2%, p = 0.041). No serious adverse events occurred.
Conclusions. Tofacitinib and baricitinib demonstrate comparable efficacy and a favorable safety profile in alopecia areata. Baricitinib is associated with a higher rate of early responders. The key predictor of response is the baseline extent of hair loss, which must be considered when planning therapy and evaluating outcomes.
About the Authors
N. N. PotekaevRussian Federation
Nikolay N. Potekaev, Dr. Sci. (Med.), Professor, Head of the Department of Skin Diseases and Cosmetology of the Faculty of Further Professional Education; Director
17, Leninskiy Ave., Moscow, 119071;
1, Ostrovityanov St., Moscow, 117997
A. G. Gadzhigoroeva
Russian Federation
Aida G. Gadzhigoroeva, Dr. Sci. (Med.), Head of the Scientific Department of Clinical Dermatovenerology and Cosmetology; Professor, Department of Dermatovenereology Allergology and Cosmetology
17, Leninskiy Ave., Moscow, 119071;
6, Miklukho-Maklai St., Moscow, 117198
G. P. Tereshchenko
Russian Federation
Galina P. Tereshchenko, Cand. Sci. (Med.), Head of the Consultative and Diagnostic Center; Associate Professor, Department of Dermatovenereology Allergology and Cosmetology
17, Leninskiy Ave., Moscow, 119071;
6, Miklukho-Maklai St., Mos
El Hawi Chaza
Russian Federation
Chaza El Hawi, Resident Doctor, Department of Dermatovenereology Allergology and Cosmetology, Institute of Medicine
6, Miklukho-Maklai St., Mos
O. V. Zhukova
Russian Federation
Olga V. Zhukova, Dr. Sci. (Med.), Professor, Head of the Department of Dermatovenereology Allergology and Cosmetology; Chief Medical Officer
17, Leninskiy Ave., Moscow, 119071;
6, Miklukho-Maklai St., Mos
References
1. Sibbald C. Alopecia Areata: An Updated Review for 2023. J Cutan Med Surg. 2023;27(3):241–259. https://doi.org/10.1177/12034754231168839.
2. Mesinkovska N, King B, Mirmirani P, Ko J, Cassella J. Burden of Illness in Alopecia Areata: A Cross-Sectional Online Survey Study. J Investig Dermatol Symp Proc. 2020;20(1):S62–S68. https://doi.org/10.1016/j.jisp.2020.05.007.
3. Lauron S, Plasse C, Vaysset M, Pereira B, D’Incan M, Rondepierre F, Jalenques I. Prevalence and Odds of Depressive and Anxiety Disorders and Symptoms in Children and Adults With Alopecia Areata: A Systematic Review and Meta-analysis. JAMA Dermatol. 2023;159(3):281–288. https://doi.org/10.1001/jamadermatol.2022.6085.
4. Rudnicka L, Trzeciak M, Alpsoy E, Arenberger P, Alper S, Benakova N et al. Disease burden, clinical management and unmet treatment need of patients with moderate to severe alopecia areata; consensus statements, insights, and practices from CERTAAE (Central/Eastern EU, Russia, Türkiye AA experts) Delphi panel. Front Med. 2024;11:1353354. https://doi.org/10.3389/fmed.2024.1353354.
5. Dahabreh D, Jung S, Renert-Yuval Y, Bar J, Del Duca E, Guttman-Yassky E. Alopecia Areata: Current Treatments and New Directions. Am J Clin Dermatol. 2023;24(6):895–912. https://doi.org/10.1007/s40257-023-00808-1.
6. Кубанов АА, Кондрахина ИН, Галлямова ЮА, Асоскова АВ. Гнездная алопеция. Клинические рекомендации. Российское общество дерматовенерологов и косметологов, 2024. Режим доступа: https://diseases.medelement.com/disease/гнездная-алопеция-кп-рф-2024/18119.
7. Krzeszowska P, Kujawa A, Krochmal K, Pisarek W, Samoraj A, Zajączkowski J et al. Jak inhibitors in the treatment of alopecia areata – a literature review. J Education, Health and Sport. 2025;82:60104. https://doi.org/10.12775/JEHS.2025.82.60104.
8. Zhang X, Jiang Y. Predictors and Management of Inadequate Response to JAK Inhibitors in Alopecia Areata. Am J Clin Dermatol. 2024;25(6):975–986. https://doi.org/10.1007/s40257-024-00884-x.
9. King BA, Craiglow BG. Janus kinase inhibitors for alopecia areata. J Am Acad Dermatol. 2023;89(2):S29–S32. https://doi.org/10.1016/j.jaad.2023.05.049.
10. Olsen EA, Hordinsky MK, Price VH, Roberts JL, Shapiro J, Canfield D et al. Alopecia areata investigational assessment guidelines – Part II. National Alopecia Areata Foundation. J Am Acad Dermatol. 2004;51(3):440–447. https://doi.org/10.1016/j.jaad.2003.09.032.
11. Samuel C, Cornman H, Kambala A, Kwatra SG. A Review on the Safety of Using JAK Inhibitors in Dermatology: Clinical and Laboratory Monitoring. Dermatol Ther. 2023;13(3):729–749. https://doi.org/10.1007/s13555-023-00892-5.
12. Huang J, Qian P, Tang Y, Li J, Liu F, Shi W. Effectiveness and Predictive Factors of Response to Tofacitinib Therapy in 125 Patients with Alopecia Areata: A Single-centre Real-world Retrospective Study. Acta Derm Venereol. 2023;103:adv12425. https://doi.org/10.2340/actadv.v103.12425.
13. Wyrwich KW, Kitchen H, Knight S, Aldhouse NVJ, Macey J, Nunes FP et al. The alopecia areata investigator global assessment scale: a measure for evaluating clinically meaningful success in clinical trials. Br J Dermatol. 2020;183(4):702–709. https://doi.org/10.1111/bjd.18883.
14. Sun Y, Li Q, Zhang Y, Liu Y. Janus kinase inhibitors for alopecia areata: a review of clinical data. Front Immunol. 2025;16:1577115. https://doi.org/10.3389/fimmu.2025.1577115.
15. Freitas E, Guttman-Yassky E, Torres T. Baricitinib for the Treatment of Alopecia Areata. Drugs. 2023;83(9):761–770. https://doi.org/10.1007/s40265-023-01873-w.
16. Kazmi A, Moussa A, Bokhari L, Bhoyrul B, Joseph S, Chitreddy V et al. Switching between tofacitinib and baricitinib in alopecia areata: A review of clinical response. J Am Acad Dermatol. 2023;89(6):1248–1250. https://doi.org/10.1016/j.jaad.2023.03.041.
17. King B, Zhang X, Harcha WG, Szepietowski JC, Shapiro J, Lynde C et al. Efficacy and safety of ritlecitinib in adults and adolescents with alopecia areata: a randomised, double-blind, multicentre, phase 2b-3 trial. Lancet. 2023;401(10387):1518–1529. https://doi.org/10.1016/s0140-6736(23)00222-2.
18. King B, Shapiro J, Ohyama M, Egeberg A, Piraccini BM, Craiglow 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. https://doi.org/10.1093/bjd/ljad253.
19. AlMarzoug A, AlOrainy M, AlTawil L, AlHayaza G, AlAnazi R, AlIssa A et al. Alopecia areata and tofacitinib: a prospective multicenter study from a Saudi population. Int J Dermatol. 2022;61(7):886–894. https://doi.org/10.1111/ijd.15917.
20. Ko JM, Mayo TT, Bergfeld WF, Dutronc Y, Yu G, Ball SG et al. Clinical outcomes for uptitration of baricitinib therapy in patients with severe alopecia areata: a pooled analysis of the BRAVE-AA1 and BRAVE-AA2 trials. JAMA Dermatol. 2023;159(9):970–976. https://doi.org/10.1001/jamadermatol.2023.2581.
21. King B, Mirmirani P, Lo Sicco K, Ramot Y, Sinclair L, Ezzedine K et al. Patterns of clinical response in patients with alopecia areata treated with ritlecitinib in the ALLEGRO clinical development programme. J Eur Acad Dermatol Venereol. 2025;39(6):1163–1173. https://doi.org/10.1111/jdv.20547.
22. Uchiyama A, Araki T, Kosaka K, Motegi S-I .Real-life effectiveness and safety of baricitinib in 17 Japanese patients with alopecia areata: a 60-week single center study. J Cutan Immunol Allergy. 2025;7:13890. https://doi.org/10.3389/jcia.2024.13890.
23. Wada-Irimada M, Takahashi T, Sekine M, Okazaki T, Takahashi T, Chiba T et al. Predictive factors for treatment responses to baricitinib in severe alopecia areata: A retrospective, multivariate analysis of 70 cases from a single center. J Dermatol. 2025;52(4):701–711. https://doi.org/10.1111/1346-8138.17641.
24. Liu LY, Craiglow BG, Dai F, King BA. Tofacitinib for the treatment of severe alopecia areata and variants: a study of 90 patients. J Am Acad Dermatol. 2017;76(1):22–28. https://doi.org/10.1016/j. jaad.2016.09.007.
25. Numata T, Irisawa R, Mori M, Uchiyama M, Harada K. Baricitinib Therapy for Moderate to Severe Alopecia Areata: A Retrospective Review of 95 Japanese Patients. Acta Derm Venereol. 2024;104:adv18348. https://doi.org/10.2340/actadv.v104.18348.
26. Lima XTV, Bambery M, Alora MB. A retrospective study of oral tofacitinib therapy for alopecia areata. An Bras Dermatol. 2023;98(2):222–522. https://doi.org/10.1016/j.abd.2022.05.002.
27. Pelzer C, Iorizzo M. Alopecia Areata of the Nails: Diagnosis and Management. J Clin Med. 2024;13(11):3292. https://doi.org/10.3390/jcm13113292.
28. Ko J, McMichael A, Hordinsky M, Passeron T et al. Baricitinib Achieved Complete/Near Complete Scalp Coverage in SALT Score ≤20 Responders: 52-Week Findings From BRAVE-AA Trials. SKIN J Cutaneous Med. 2025;9(1):s520. https://doi.org/10.25251/SKIN.9.SUPP.520.
29. Husein-ElAhmed H, Abdulla N, Al-Obaidli A, Ali-Alam M, Steinhoff M. Real-world experience and long-term evaluation of tofacitinib in refractory alopecia areata: A prospective, open-label, single-center study in Asian Arab population. Dermatol Ther. 2022;35(12):e15871. https://doi.org/10.1111/dth.15871.
30. Huang J, Deng S, Li J, Tang Y, Liu F, Liu Y et al. Drug Survival and Long-term Outcome of Tofacitinib in Patients with Alopecia Areata: A Retrospective Study. Acta Derm Venereol. 2023;103:adv13475. https://doi.org/10.2340/actadv.v103.13475.
31. Tembhre MK, Sharma VK. T-helper and regulatory T-cell cytokines in the peripheral blood of patients with active alopecia areata. Br J Dermatol. 2013;169(3):543–548. https://doi.org/10.1111/bjd.12396.
32. Chiricozzi A, Balato A, Fabbrocini G, Di Nardo L, Babino G, Rossi M et al. Beneficial effects of upadacitinib on alopecia areata associated with atopic dermatitis: a multicenter retrospec- tive study. J Am Acad Dermatol. 2023;89(6):1251–3125. https://doi.org/10.1016/j.jaad.2023.05.001.
33. Silverberg JI, Rosmarin D, Chovatiya R, Bieber T, Schleicher S, Beck L et al. The regulatory T cell-selective interleukin-2 receptor agonist rezpegaldesleukin in the treatment of inflammatory skin diseases: two randomized, double-blind, placebo-controlled phase 1b trials. Nat Commun. 2024;15(1):9230. https://doi.org/10.1038/s41467-024-53384-1.
Review
For citations:
Potekaev NN, Gadzhigoroeva AG, Tereshchenko GP, Chaza EH, Zhukova OV. Efficacy and predictive markers of response to tofacitinib and baricitinib therapy in alopecia areata: A 52-week comparative cohort study. Meditsinskiy sovet = Medical Council. 2026;(2):14-23. (In Russ.) https://doi.org/10.21518/ms2026-049
JATS XML

































