Baricitinib Consistently Safe, Tolerable for Severe Alopecia Areata at 2 Years

Brett King, MD, PhD

Janus kinase inhibitor (JAK) inhibitor baricitinib (Olumniant) was associated with a consistent safety profile among treated patients with severe alopecia areata, according to new findings.¹

In pooled safety data from a pivotal clinical trial program, presented as an abstract at the Maui Derm 2023 NP + PA Summer Conference in Colorado Springs this week, a team of US investigators reported that fewer than 7% of all treatment-emergent adverse events (TEAEs) reported by patients with alopecia areata receiving baricitinib were severe in nature.

The findings from patient data derived from the phase 2/3 BRAVE-AA1 and phase 3 BRAVE-AA2 clinical trials provide further assurance of the JAK inhibitor in treating the chronic hair loss condition.

Led by Brett King, MD, PhD, of the department of dermatology at Yale School of Medicine, investigators sought to interpret collected safety data from patients with severe alopecia areata treated with baricitinib in the BRAVE-AA clinical program, including long-term extension periods.

Two-year findings from the BRAVE-AA trials, presented at the American Academy of Dermatology (AAD) 2023 Annual Meeting in New Orleans this March, showed patients who reported hair regrowth at 52 weeks generally maintained the benefit through 104 weeks.²

“Efficacy increased in patients with (Severity of Alopecia Tool) score >20 at week 52, illustrating that long-term treatment may be needed to observe maximum benefit in some patients,” investigators wrote at the time. With consideration to such extended use of the JAK inhibitor, King and colleagues observed available long-term safety outcomes.

Their assessment included patients treated only with baricitinib from baseline in either trial to the data endpoints of May 24, 2022 (BRAVE-AA1) and May 10, 2022 (BRAVE-AA2)—excluding any patients randomized to placebo. Treatment arms including 1 mg, 2 mg, or 4 mg doses of baricitinib.

The investigators sought endpoints of TEAEs, adverse events of special interest, and observed abnormal changes in laboratory results. They calculated proportion of patients to experience such events and incidence rates.

The final assessment included 1303 patients with severe alopecia areata who received ≥1 dose of baricitinib; median days of patient exposure was 591 days, or a total of 2218 patient-years. King and colleagues observed that 93.2% of TEAEs reported by baricitinib-treated patients were mild to moderate in severity.

The incident rate (IR) of severe adverse events was 2.9 per 100; treatment discontinuation IR was 1.9 per 100. Just 16 patients reported a serious infection during the trial period (IR, 0.7); the most common serious infections were COVID-19 (IR, 0.1) and COVID-related pneumonia (IR, 0.2).

Only 1 opportunistic infection—a case of multi-dermatomal herpes zoster—was reported among treated patients (IR <.05). There were 44 total cases of herpes zoster (IR, 2.0).

Other serious adverse events that were observed briefly in patients included:

• Major adverse cardiovascular event (myocardial infarction [n = 1; IR, <.05])
• Pulmonary embolism (n = 2; IR, 0.1)
• Malignancies other than non-melanoma skin cancer (n = 2; IR, 0.2)
• Appendicitis with perforation (n = 1; IR <.05)

Investigators observed no patient deaths in the assessment period, concluding the agent’s safety profile presented little concern—even without consideration to the significant efficacy observed with baricitinib in the long-term trials.

“This pooled safety analysis in patients with severe alopecia areata is consistent with previously reported data from the baricitinib alopecia area clinical trial program,” they wrote.

References

1. ^{King B, Ko J, Piraccini BM, Shimomura Y, et al. Safey Analysis of Baricitinib in Adult Patients with Severe Alopecia Areata From 2 Randomized Clinical Trials over a Median of 1.6 Years and up to 3.6 Years of Exposure. Poster presented at:Maui Derm 2023 NP + PA Summer Conference. Colorado Springs, CO. June 22 – 25, 2023.}
2. ^{Kunzmann K. Baricitinib Maintains Alopecia Hair Regrowth at 2 Years. HCPLIve. Published May 18, 2023. https://www.hcplive.com/view/baricitinib-maintains-alopecia-hair-regrowth-2-years}