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Baricitinib Safe in Real-Life Clinical Settings Among Patients with Alopecia Areata
Baricitinib treatment was safe among patients with alopecia areata over 48 weeks in a real-world treatment setting.
Baricitinib for alopecia areata maintains a favorable safety profile in real-life clinical settings, new findings suggest, aligning with prior clinical data and supporting the drug’s implementation in routine clinical practice.1
Such conclusions resulted from a recent analysis conducted by a team of investigators to assess baricitinib’s real-life safety profile over 48 weeks within a clinical setting. The investigators were led, in part, by Isotta Giunipero di Corteranzo, from the section of dermatology at the University of Turin Department of Medical Sciences in Italy.
Baricitinib, an oral, selective, reversible JAK1 and JAK2 inhibitor, was the first treatment globally approved for adult individuals suffering from severe alopecia areata. di Corteranzo and colleagues added that both the drug’s effectiveness and safety had previously been shown in in the phase 3 BRAVE-AA1 and BRAVE-AA2 studies.2
“To date, real-world data on the use of baricitinib for [alopecia areata] remain limited, and further clarification is needed regarding its long-term benefit-risk profile,” di Corteranzo and colleagues wrote. “This real-world prospective observational study aims to describe the baricitinib safety profile outcomes over 48 weeks, highlighting associated [adverse events] and their management.”1,3
Analysis of Baricitinib Safety Over 48 Weeks
The investigative team carried out a prospective observational study within the Dermatology Unit of the Città della Salute e della Scienza University Hospital. The study involved 87 adult patients who suffered from severe alopecia areata, with those participating being treated with baricitinib at either a 2 mg or 4 mg dosing regimen.
The team enrolled all individuals who, by March 2023, had been diagnosed with alopecia areata and met the study’s criteria for eligibility for baricitinib. The criteria used by the team were defined as possession of a Severity of Alopecia Tool (SALT) score of 50 or higher, with a 0 score suggesting no scalp hair loss and 100 representing total hair loss on the patients’ scalps.
At the point of the study’s baseline and again at the 12, 24, 36, and 48-week mark, the investigators gathered disease characteristics and demographic information such as comorbidities, gender, and age. They also carried out a series of routine laboratory tests, looking at participants’ liver enzymes, complete blood counts, lipid profiles, and tests of kidney function.
Both adverse events (AEs) and serious adverse events (SAEs) were monitored by the research team, along with clinical laboratory outcomes throughout the analysis’s observation period.
Among the final population assessed in the study, 83 were treated with a daily dose of 4 mg baricitinib, the team treated 4 with a 2 mg dose. The investigators assessed the results at the Week 0 mark along and with the 12, 24, 36, and 48-week mark.
There were 87 individuals enrolled in the analysis in total, with a mean age of 42 years, 71% being female, and 29% being male. When looking at any comorbid conditions, the main examples included atopic dermatitis among 8 subjects, autoimmune thyroiditis in 8 subjects, vitiligo in 4 subjects, Crohn’s disease in 1 subject, and celiac disease in 1 subject.
The investigative team reported that the mean baseline SALT score had been 76.9. Approximately 45% of the trial participants had alopecia universalis, 11% had alopecia totalis, and 45% were shown to have patchy alopecia areata and a SALT score of 50 or greater.
Overall, the analysis demonstrated that baricitinib was well-tolerated throughout the 48-week trial period, with TEAEs being observed among 22 (25%) of subjects. Two individuals discontinued baricitinib therapy due to lack of efficacy, including one at the 36-week mark and the second at the 48-week mark.
The investigators concluded that the most frequently seen AEs included hypercholesterolemia, which affected 14% of participants, with cholesterol levels exceeding 240 mg/dL. Another frequent AE had been hypertriglyceridemia, observed among 9.2% of participants, with triglyceride levels surpassing 150 mg/dL.
Management of these conditions was addressed via lifestyle shifts, such as dietary adjustments and increased physical activity, without the need for pharmacological interventions during the study. The team noted that 3.4% reported mild upper respiratory tract infections, which resolved spontaneously without necessitating antibiotics or discontinuation of the medication.
The investigative team did note 2 serious AEs that resulted in drug discontinuation at the 24-week mark: 1 case of neutropenia and 1 of recurrent, debilitating upper respiratory infections. The team added, however, that there were no examples of life-threatening AEs.
di Corteranzo and colleagues further highlighted that the most commonly noted AEs—hypertriglyceridemia, hypercholesterolemia, and upper respiratory tract infections—showed consistency with prior data from BRAVE-AA1 and BRAVE-AA2.2
“This article may constitute one of the first real-life experiences evaluating the safety profile of baricitinib in severe [alopecia areata],” they wrote. “Our data support a good risk–benefit ratio of baricitinib in daily clinical practice. Additional prospective studies with a greater sample size are needed to confirm these findings.”1
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References
di Corteranzo, I.G., Bongiovanni, E., Cedirian, S., Starace, M., Piraccini, B.M., Mastorino, L., Quaglino, P., Ribero, S. and Gallo, G. (2025), Safety Profile of Baricitinib in Patients With Severe Alopecia Areata: A Prospective Study. Int J Dermatol. https://doi.org/10.1111/ijd.17732.
O. Kwon, M. M. Senna, R. Sinclair, et al., “Efficacy and Safety of Baricitinib in Patients With Severe Alopecia Areata Over 52 Weeks of Continuous Therapy in Two Phase III Trials (BRAVE-AA1 and BRAVE-AA2),” American Journal of Clinical Dermatology 24, no. 3 (2023): 443–451, https://doi.org/10.1007/s40257-023-00764-w.
B. M. Piraccini, F. Pampaloni, S. Cedirian, et al., “Real-Life Effectiveness and Safety of Baricitinib in Patients With Severe Alopecia Areata: A 24-Week Italian Study,” Journal of the European Academy of Dermatology and Venereology (2024). Epub ahead of print, 1–9, https://doi.org/10.1111/jdv.20312.
