Baricitinib Effective in Holistic Responses Among Patients with Alopecia Areata

New findings suggest that the severity of eyebrow or eyelash alopecia areata involvement parallels alopecia severity observed on the scalp, in addition to demonstrating that baricitinib treatment was effective in achieving a holistic response across all 3 hair-bearing sites.1

These data resulted from a new analysis authored by a team led by Arash Mostaghimi, MD, MPH, vice chair of Clinical Trials and Innovation at the Brigham & Women's Hospital Department of Dermatology. Mostaghimi and colleagues looked at the integrated results from BRAVE-AA1 and BRAVE-AA2 trials that had characterized eyebrow and eyelash involvement at the point of baseline in those with alopecia areata and responses to baricitinib therapy.2

“Herein, we detail the relationship between [eyebrow or eyelash] involvement and scalp severity at baseline and report responses across these hair-bearing sites following baricitinib treatment through 52 weeks in the 1200 patients in the BRAVE-AA clinical trials,” Mostaghimi and colleagues wrote.1

BRAVE-AA1 and BRAVE-AA2 were randomized, double-blind, placebo-controlled, parallel-group analyses that their investigative teams carried out across 169 sites within 10 countries. The studies were conducted to evaluate baricitinib as a medication for alopecia in terms of efficacy and safety.

BRAVE-AA1 patient enrollment began in March 2019, whereas BRAVE-AA2 enrollment began in July 2019. Each study's final participants were recruited in June 2020 and May 2020, respectively. Those who would be considered eligible for trial inclusion were required to have a Severity of Alopecia Tool (SALT) score of 50 or greater, which would suggest at least 50% scalp hair loss.

This was required along with their current episode of alopecia areata persisting for over 6 months but lasting under 8 years. They were also required to have shown no signs of spontaneous regrowth (defined as ≤10-point improvement in SALT score) over the previous 6-month period in order to be involved. The investigators highlighted a lack of criteria for inclusion based on eyebrow or eyelash involvement.

There were 1,200 participants who the team randomized in a 2:2:3 ratio to receive be provided with a placebo, with baricitinib at a 2 mg dose, or baricitinib 4 mg for a 36-week course. Those who finished the placebo-controlled period of this research were then entered into an extension phase of up to 68 additional weeks of treatment.

Those in the baricitinib 4 mg arm who did not respond by the 52-week mark (defined as having a SALT score over 20 and less than a 2-point improvement in Clinician-Reported Outcome [ClinRO] scores for eyebrow and eyelash involvement) were shifted to the placebo arm. Subjects in the 2 mg arm who did not have a response were raised to the 4 mg cohort.

Individuals who were non-responders (SALT >20) at the 36-week mark were shifted to baricitinib, while those shown to be responders with a SALT score <20 continued with the placebo through the 52-week mark. This analysis included information through Week 52 for subjects on continuous baricitinib treatment, and data through the 36-week mark for those in the placebo arm.

An evaluation of loss of scalp hair loss was done via the SALT score, and changes in eyebrow and eyelash involvement were determined through the utilization of the ClinRO tool. By the study's beginning, participants showing more extensive eyebrow and eyelash involvement were also shown to have more severe scalp involvement, with baseline SALT scores ranging from 70.6 among those with minimal eyebrow or eyelash gaps to 96.0 in those with complete loss of hair at these areas.

Significantly more subjects at the 36-week mark attained eyebrow and eyelash responses, which they defined as ClinRO scores of 0 or 1 with a 1-point improvement at minimum, with both of the dosing regiments of baricitinib versus placebo. In specific, the investigators concluded that response rates were:

• Baricitinib 2 mg: 28.2% (OR=3.27) for eyebrows and 25.1% (OR=2.95) for eyelashes.
• Baricitinib 4 mg: 44.3% (OR=6.84) for eyebrows and 46.4% (OR=8.21) for eyelashes.
• Placebo: 12.6% for eyebrows and 12.4% for eyelashes.

Strong agreement was highlighted by the investigative team in outcomes for both eyelashes and eyebrows. Around 80% of trial participants in the baricitinib 4 mg cohort who reported regrowth in a single region also saw regrowth in the other.1

The investigators added that among scalp responders with a SALT score <20 at the 52-week mark who had been in the 4 mg baricitinib cohort, 78.5% were found to have attained an eyebrow response, 82.6% attained an eyelash response, and 71.1% reported regrowth in both of the areas. Among those labeled as scalp nonresponders (SALT >20 at the 52-week mark), the team found that 46.7% and 48.7% showed eyebrow and eyelash responses, respectively.

The investigators highlighted that 35.4% responded in both regions. Similar patterns were noted by the researchers among those in the 2 mg dose group. However, such response rates were generally shown to be lower.

“[Eyebrows and eyelashes] are important hair-bearing sites and their involvement in [alopecia areata] must be considered in clinical severity assessment,” they concluded.1 “In this analysis, we identified that severity of [eyebrow or eyelash] involvement in patients with [alopecia areata] parallels the severity of scalp hair loss at baseline.”

References

1. Arash Mostaghimi, Brittany Craiglow, Brett King, Jerry Shapiro, Justin Ko, Antonella Tosti, Manabu Ohyama, Yiying Brogan, Guanglei Yu, Angelina Sontag, Najwa Somani, Understanding Eyebrow and Eyelash Involvement in Patients with Alopecia Areata and Responsiveness to Treatment with Baricitinib, British Journal of Dermatology, 2025;, ljaf088, https://doi.org/10.1093/bjd/ljaf088.

2. King B, Ohyama M, Kwon O, et al. Two Phase 3 Trials of Baricitinib for Alopecia Areata. N Engl J 21 Med. 05 05 2022;386(18):1687-1699. doi:10.1056/NEJMoa2110343.