. 2025 Sep 23.

doi: 10.1111/jdv.70067. Online ahead of print.

Effectiveness and safety of baricitinib in severe alopecia areata: 48-week results

Bianca Maria Piraccini^{1

2}, Stephano Cedirian^{1

2}, Francesca Pampaloni^{1

2}, Luca Rapparini^{1

2}, Federico Quadrelli^{1

2}, Francesca Bruni^{1

2}, Lorenzo Ala³, Maria Cristina Acri³, Alfredo Rossi³, Giovanni Pellacani³, Francesco Lacarrubba⁴, Federica Dall'Oglio⁴, Giuseppe Micali⁵, Luciano Foggia⁶, Mariateresa Cantelli⁶, Paola Nappa⁶, Laura Diluvio⁷, Luca Bianchi⁷, Naldi Luigi⁸, Anna Bolzon⁸, Ketty Peris^{9

10}, Giacomo Caldarola^{9

10}, Giampiero Girolomoni¹¹, Francesca Marangoni¹¹, Francesco Bellinato¹¹, Paolo Gisondi¹¹, Gianmarco Silvi¹², Francesca Prignano¹², Nicola Pimpinelli¹², Carlo Tomasini^{13

14}, Stefania Barruscotti^{13

14}, Oriana Simonetti¹⁵, Edoardo de Simoni¹⁵, Francesca Ambrogio¹⁶, Caterina Foti¹⁶, Valeria Boccaletti¹⁷, Alessandro Fraghì¹⁷, Angelo Valerio Marzano^{18

19}, Maria Alessandra Mattioli¹⁹, Silvia Ferrucci¹⁸, Andrea Sechi¹⁸, Luca Valtellini¹⁹, Mauro Barbareschi¹⁹, Giuseppe Gallo²⁰, Simone Ribero²⁰, Pietro Quaglino²⁰, Isotta Giunipero Di Corteranzo²⁰, Riccardo Balestri²¹, Calogero Pagliarello²¹, Raffaele Dante Caposiena²², Iris Zalaudek²², Emanuele Vagnozzi²³, Maria Concetta Fargnoli²³, Chiara Caponio²⁴, Pietro Rubegni²⁵, Elisa Cinotti²⁵, Emanuele Trovato²⁵, Marco Romanelli²⁶, Valentina Dini²⁶, Flavia Manzo Margiotta²⁶, Claudio Feliciani²⁷, Maria Beatrice De Felici Del Giudice²⁷, Laura Atzori²⁸, Silvia Sanna²⁸, Serena Lembo²⁹, Annunziata Raimondo²⁹, Michela Magnano³⁰, Giuseppe Argenziano³¹, Graziella Babino³¹, Elisabetta Fulgione³¹, Franco Rongioletti³², Nazario Pesce³², Stefania Guida³², Alba Guglielmo³³, Natale Schettini³³, Michela Starace^{1

2}

Affiliations

¹ Dermatology Unit, IRCCS Azienda Ospedaliero-Universitaria di Bologna, Policlinico S. Orsola-Malpighi, Bologna, Italy.
² Department of Medical and Surgical Sciences, Alma Mater Studiorum University of Bologna, Bologna, Italy.
³ Department of Clinical, Internal, Anesthesiological and Cardiovascular Science - Dermatology Section, Sapienza University of Rome, Rome, Italy.
⁴ Dermatology Clinic, University of Catania, Catania, Italy.
⁵ Chair, Dermatology Clinic, University of Catania, Catania, Italy.
⁶ Dermatology Unit, Department of Clinical Medicine and Surgery, University of Naples Federico II, Naples, Italy.
⁷ Dermatology Unit, Department of Systems Medicine, University of Rome Tor Vergata, Rome, Italy.
⁸ Dermatology Unit, San Bortolo Hospital, Vicenza, Italy.
⁹ Section of Dermatology, Department of Translational Medicine and Surgery, Catholic University of the S. Heart, Rome, Italy.
¹⁰ Dermatology Unit, Policlinico A. Gemelli, IRCCS, Rome, Italy.
¹¹ Section of Dermatology, Department of Medicine, University of Verona, Verona, Italy.
¹² Section of Dermatology, Department of Health Sciences, University of Florence, Florence, Italy.
¹³ Dermatology Clinic, Fondazione IRCCS Policlinico San Matteo, Pavia, Italy.
¹⁴ Department of Clinical-Surgical, Diagnostic and Pediatric Sciences, University of Pavia, Pavia, Italy.
¹⁵ Dermatological Unit, DISCLIMO, Polytechnic Marche University, Ancona, Italy.
¹⁶ Section of Dermatology and Venereology, Department of Precision and Regenerative Medicine and Ionian Area (DiMePRe-J), University of Bari "Aldo Moro", Bari, Italy.
¹⁷ Dermatology Department, University of Brescia, Brescia, Italy.
¹⁸ Dermatology Unit, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan, Italy.
¹⁹ Department of Pathophysiology and Transplantation, Università Degli Studi di Milano, Milan, Italy.
²⁰ Section of Dermatology, Department of Medical Sciences, University of Turin, Turin, Italy.
²¹ Division of Dermatology, Alopecia Areata Outpatient Service, APSS-Trento Hospital, Trento, Italy.
²² Department of Dermatology and Venerology, University of Trieste, Trieste, Italy.
²³ Department of Biotechnological and Applied Clinical Sciences, University of L'aquila, L'Aquila, Italy.
²⁴ UOSD Dermatologia Generale Ed Oncologica DU, Ospedale San Salvatore, L'Aquila, Italy.
²⁵ Department of Medical, Surgical and Neurological Science, Dermatology Section, University of Siena, S. Maria Alle Scotte Hospital, Siena, Italy.
²⁶ Dermatology Unit, Department of Clinical and Experimental Medicine, University of Pisa, Pisa, Italy.
²⁷ Dermatology Unit, Department of General and Specialist Medicine, University of Parma, Parma, Italy.
²⁸ Dermatology Unit, Department Medical Sciences and Public Health, University of Cagliari, Cagliari, Italy.
²⁹ Department of Medicine, Surgery and Dentistry "Scuola Medica Salernitana", University of Salerno, Salerno, Italy.
³⁰ Unit of Dermatology, Versilia Hospital, Lucca, Italy.
³¹ Dermatology Unit, Department of Mentals and Physical Health and Preventive Medicine, University of Campania Luigi Vanvitelli, Naples, Italy.
³² Dermatology Clinic, Vita-Salute-University, San Raffaele Hospital, Milan, Italy.
³³ Section of Dermatology and Infectious Diseases, Department of Medical Sciences, University of Ferrara, Ferrara, Italy.

PMID: 40985491
DOI: 10.1111/jdv.70067

Effectiveness and safety of baricitinib in severe alopecia areata: 48-week results

Bianca Maria Piraccini et al. J Eur Acad Dermatol Venereol. 2025.

. 2025 Sep 23.

doi: 10.1111/jdv.70067. Online ahead of print.

Authors

Affiliations

¹ Dermatology Unit, IRCCS Azienda Ospedaliero-Universitaria di Bologna, Policlinico S. Orsola-Malpighi, Bologna, Italy.
² Department of Medical and Surgical Sciences, Alma Mater Studiorum University of Bologna, Bologna, Italy.
³ Department of Clinical, Internal, Anesthesiological and Cardiovascular Science - Dermatology Section, Sapienza University of Rome, Rome, Italy.
⁴ Dermatology Clinic, University of Catania, Catania, Italy.
⁵ Chair, Dermatology Clinic, University of Catania, Catania, Italy.
⁶ Dermatology Unit, Department of Clinical Medicine and Surgery, University of Naples Federico II, Naples, Italy.
⁷ Dermatology Unit, Department of Systems Medicine, University of Rome Tor Vergata, Rome, Italy.
⁸ Dermatology Unit, San Bortolo Hospital, Vicenza, Italy.
⁹ Section of Dermatology, Department of Translational Medicine and Surgery, Catholic University of the S. Heart, Rome, Italy.
¹⁰ Dermatology Unit, Policlinico A. Gemelli, IRCCS, Rome, Italy.
¹¹ Section of Dermatology, Department of Medicine, University of Verona, Verona, Italy.
¹² Section of Dermatology, Department of Health Sciences, University of Florence, Florence, Italy.
¹³ Dermatology Clinic, Fondazione IRCCS Policlinico San Matteo, Pavia, Italy.
¹⁴ Department of Clinical-Surgical, Diagnostic and Pediatric Sciences, University of Pavia, Pavia, Italy.
¹⁵ Dermatological Unit, DISCLIMO, Polytechnic Marche University, Ancona, Italy.
¹⁶ Section of Dermatology and Venereology, Department of Precision and Regenerative Medicine and Ionian Area (DiMePRe-J), University of Bari "Aldo Moro", Bari, Italy.
¹⁷ Dermatology Department, University of Brescia, Brescia, Italy.
¹⁸ Dermatology Unit, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan, Italy.
¹⁹ Department of Pathophysiology and Transplantation, Università Degli Studi di Milano, Milan, Italy.
²⁰ Section of Dermatology, Department of Medical Sciences, University of Turin, Turin, Italy.
²¹ Division of Dermatology, Alopecia Areata Outpatient Service, APSS-Trento Hospital, Trento, Italy.
²² Department of Dermatology and Venerology, University of Trieste, Trieste, Italy.
²³ Department of Biotechnological and Applied Clinical Sciences, University of L'aquila, L'Aquila, Italy.
²⁴ UOSD Dermatologia Generale Ed Oncologica DU, Ospedale San Salvatore, L'Aquila, Italy.
²⁵ Department of Medical, Surgical and Neurological Science, Dermatology Section, University of Siena, S. Maria Alle Scotte Hospital, Siena, Italy.
²⁶ Dermatology Unit, Department of Clinical and Experimental Medicine, University of Pisa, Pisa, Italy.
²⁷ Dermatology Unit, Department of General and Specialist Medicine, University of Parma, Parma, Italy.
²⁸ Dermatology Unit, Department Medical Sciences and Public Health, University of Cagliari, Cagliari, Italy.
²⁹ Department of Medicine, Surgery and Dentistry "Scuola Medica Salernitana", University of Salerno, Salerno, Italy.
³⁰ Unit of Dermatology, Versilia Hospital, Lucca, Italy.
³¹ Dermatology Unit, Department of Mentals and Physical Health and Preventive Medicine, University of Campania Luigi Vanvitelli, Naples, Italy.
³² Dermatology Clinic, Vita-Salute-University, San Raffaele Hospital, Milan, Italy.
³³ Section of Dermatology and Infectious Diseases, Department of Medical Sciences, University of Ferrara, Ferrara, Italy.

PMID: 40985491
DOI: 10.1111/jdv.70067

Abstract

Background: Alopecia areata (AA) is an autoimmune condition leading to hair loss. Baricitinib, a Janus kinase (JAK) inhibitor, has demonstrated efficacy in controlled clinical trials, but real-world data on its long-term effectiveness and safety remain limited.

Objectives: This study aimed to assess the real-life effectiveness and safety of baricitinib 4 mg daily in Italian adult patients with severe AA over a 48-week treatment period.

Methods: We conducted a 48-week retrospective, observational, multicenter study across 27 Italian university hospitals. Adult patients (18-65 years) with severe AA (Severity of Alopecia Tool [SALT] score ≥ 50) who initiated baricitinib 4 mg daily treatment between November 2022 and October 2023 were included. Effectiveness was measured by the percentage of patients achieving SALT ≤20 at week 48. Secondary outcomes included changes in mean SALT score, trichoscopic findings, patient-reported quality of life (Skindex-16, Hospital Anxiety and Depression Scale [HADS]), and Clinician-Reported Outcomes (ClinRO) for eyebrows and eyelashes. Adverse events were also documented.

Results: A total of 253 patients (66.8% females, mean age 40.0 ± 12.6 years) were included. By week 48, 63.2% achieved SALT ≤20, and 75.5% achieved SALT ≤30. The mean SALT score significantly decreased from 93.7 ± 14.1 at baseline to 26.5 ± 33.0 at week 48 (p < 0.001). Trichoscopic assessment showed a decline in yellow dots (97.6%-50.2%), black dots (43.5%-9.1%), and dystrophic hairs (14.6%-4.3%), whilst regrowing hairs increased (7.1%-80.2%). Skindex-16 scores improved significantly (57.1 ± 25.0 to 30.0 ± 17.8, p < 0.001), as did HADS Anxiety (8.21 ± 9.38 to 4.62 ± 4.21, p < 0.001) and HADS Depression (6.36 ± 4.55 to 3.70 ± 4.11, p < 0.001). Adverse events were reported in 9.4% of patients.

Conclusion: This real-world study confirms the effectiveness of baricitinib in achieving significant hair regrowth and improving psychological well-being in severe AA patients.

Keywords: HADS; Janus kinase inhibitors; SKINDEX‐16; alopecia areata; baricitinib; trichoscopy.

Plain language summary

WHAT IS THE DISEASE?: Alopecia areata (AA) is an autoimmune condition that causes sudden hair loss on the scalp, face, or body. Severe forms can result in complete loss of scalp hair (alopecia totalis) or all body hair (alopecia universalis). It affects both men and women and can significantly impact emotional well‐being.

Location of the study: This study was conducted in Italy, involving 27 university hospitals.

Aim of the study: We wanted to understand how well baricitinib, a medicine that blocks specific immune signals (JAK1/2), works and how safe it is for adults with severe AA in everyday clinical practice over 48 weeks.

Methodology: We reviewed the medical records of 253 adults (aged 18–65 years) with severe AA who started baricitinib 4 mg daily between November 2022 and October 2023. We measured hair regrowth using the Severity of Alopecia Tool (SALT) and assessed eyebrow/eyelash changes, scalp examination with a dermatoscope (trichoscopy), quality of life, mood, and treatment safety.

Key findings: After 48 weeks, 63% of patients had major scalp hair regrowth (SALT ≤20), and over 75% had moderate regrowth (SALT ≤30). Trichoscopy showed more regrowing hairs and fewer disease signs. Quality‐of‐life scores improved, and symptoms of anxiety and depression decreased. Side effects occurred in about 9% of patients, mostly mild.

Conclusions and practical implications: In real‐world settings, baricitinib can restore hair and improve mental health in many people with severe AA. Regular follow‐up is important to monitor progress and detect side effects.

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References

REFERENCES

1. Piraccini BM, Ohyama M, Craiglow B, Bewley A, Ding Y, Chen YF, et al. Scalp hair regrowth is associated with improvements in health‐related quality of life and psychological symptoms in patients with severe alopecia areata: results from two randomized controlled trials. J Dermatolog Treat. 2023;34(1):2227299. https://doi.org/10.1080/09546634.2023.2227299
1. Alessandrini A, Bruni F, Piraccini BM, Starace M. Common causes of hair loss – clinical manifestations, trichoscopy and therapy. J Eur Acad Dermatol Venereol. 2021;35(3):629–640. https://doi.org/10.1111/jdv.17079
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Effectiveness and safety of baricitinib in severe alopecia areata: 48-week results

Affiliations

Effectiveness and safety of baricitinib in severe alopecia areata: 48-week results

Authors

Affiliations

Abstract

Plain language summary

References

REFERENCES

Grants and funding

LinkOut - more resources

Full Text Sources

Research Materials

Miscellaneous