Study Reaffirms Efficacy of Baricitinib Treatment for Patients with Alopecia Areata

Baricitinib is efficacious and safe as a treatment for alopecia areata, recent findings suggest, and the performing of a trichoscopy may be helpful to reveal early response to such treatment.¹

These data resulted from a new study in Italy which sought to reaffirm baracitinib’s effectiveness for patients with this skin disorder. It was led by BM Piraccini from the IRCCS Azienda Ospedaliero-Universitaria di Bologna dermatology unit in Bologna, Italy.

Piraccini et al. noted the recent BRAVE-AA1 and BRAVE-AA2 clinical trials which suggested that treatment with 4-mg daily baricitinib resulted in stronger Severity Alopecia Tool (SALT) score results versus a 2-mg dose or placebo by the 36-week mark. To explore findings like these, the investigators conducted their retrospective analysis.²

“By conducting a retrospective study across 23 centres in Italy, we evaluated 118 adult (alopecia areata)-diagnosed patients undergoing treatment with a daily 4 mg dosage of baricitinib,” Piraccini and colleagues wrote. “Our study aimed to evaluate treatment effectiveness and tolerability, adverse events, and overall patient outcomes with this new drug in real life…”¹

Study Design

The investigators carried out their retrospective study in 23 medical centers located around Italy, specifically evaluating 118 individuals with diagnoses of alopecia areata who had also been treated with baricitinib at a 4 mg-per-day dose for 24 weeks minimum. Subjects in the age range of 18 - 60 were included in the analysis, though they were required to have a SALT score of 50 or higher and therefore at least 50% loss of scalp hair.

Participants deemed to be eligible by the research team reported an episode of alopecia lasting over half a year but under 6 years, without spontaneous improvement. Such patients were identified by the team using a SALT score reduction that was shown to be 10 points or less in the pre-screening 6 month period.

These participants’ diagnoses were confirmed through the utilization of both clinical assessments and trichoscopic evaluation. The investigators went through each subject, gathering their demographic and baseline clinical data related to alopecia areata and its treatment.

Several different intervals were used in the research team’s assessment of progress, with the team evaluating several elements at the point of baseline, the 4-week mark, the 12-week mark, and the 24-weeks mark.

The elements evaluated by the investigators were participants’ SALT scores, laboratory results, trichoscopic findings, and quality of life assessments such as the Skindex-16 and the Hospital Anxiety and Depression Scale (HADS).

The research team specifically used trichoscopy for the purposes of monitoring disease progession during treatment. Trichoscopic data, noted by the team at each follow-up interaction, helped gauge responses of the subjects to the treatment.

Findings on Baricitinib

The research team concluded the study having involved 118 participants, noting that there had been an average age of 39 years among the subjects as well as a mean SALT score above 95. Mean SALT scores over the course of the 24-week analysis of treatment were reported to have dropped substantially from 96.6 (±8.23 sd) down to 48 (±35.2 sd).

They also found that 42.3% of subjects by the 24-week mark were shown to have achieved SALT 30, 31.3% achieved SALT 20, and 20.3% achieved SALT 10. In their trichoscopic findings the investigators found that reductions in yellow and black dots on patients had been noticeable earlier compared to regrowth of hair.

The research team also wrote that mld laboratory abnormalities, which they classified as adverse events, had been seen among 12.7% of the study participants. However, they did add that no participants withdrew from the analysis.

“These preliminary data, on the effectiveness and safety of baricitinib in real-life setting among a cohort of over 100 patients are very promising and support the use of this drug in severe forms of (alopecia areata),” they wrote. “Early start of therapy, especially when duration of the disease is short, may be suggested, as well as performing trichoscopy to reveal responses to therapy earlier than clinical examination.”

References

1. ^{Piraccini BM, Pampaloni F, Cedirian S, Quadrelli F, Bruni F, Rapparini L, et al. Real-life effectiveness and safety of baricitinib in patients with severe alopecia areata: A 24-week Italian study. J Eur Acad Dermatol Venereol. 2024; 00: 1–9. https://doi.org/10.1111/jdv.20312.}
2. ^{King B, Ohyama M, Kwon O, Zlotogorski A, Ko J, Mesinkovska NA, et al. BRAVE-AA investigators. Two phase 3 trials of Baricitinib for alopecia areata. N Engl J Med. 2022; 386(18): 1687–1699.}