Baricitinib Maintains Alopecia Hair Regrowth at 2 Years

Maryanne Senna, MD

Credit: Twitter

Oral baricitinib (Olumiant) remained effective for treating severe alopecia areata for 2 years among patients who initially reported a response to the drug at 1 year, according to new data.

In phase 3 findings presented during the final sessions at the American Academy of Dermatology (AAD) 2023 Annual Meeting in New Orleans this weekend, investigators from the BRAVE-AA clinical trial program reported that the landmark drug maintained its efficacy in benefited patients previously with the chronic condition of hair loss.

Less than a year after the US Food and Drug Administration (FDA) approved baricitinib as the first systemic therapy indicated for alopecia areata,2 new 104-week data strengthen the JAK inhibitor’s validity for the previously unmet need for restored scalp hair. .

Led by Maryanne Senna, MD, a dermatologist with Lahey Hospital and Harvard Medical Center and Medical School, investigators sought to evaluate the efficacy of continuous baricitinib in adult patients with alopecia areata over 104 weeks after BRAVE-AA1 and BRAVE- AA2 52-week. judgments.

Relevant data from the main trial program included patients with Severity of Alopecia Tool (SALT) scores ≥50, indicating scalp hair loss of ≥50%. Senna and colleagues randomized these patients to 2 mg or 4 mg baricitinib for up to 104 weeks, then patients with SALT SCORE >20 at week 52 but ≤20 at previous visits to 4 mg baricitinib for up to 104 weeks.

Looking for outcomes important to sustainable hair growth, investigators set key outcomes including the following:

Proportion of patients achieving SALT score ≤20 Clinician-Reported Outcomes (ClinRO) eyebrow and eyelash hair loss scores of 0 or 1, indicating full coverage or minimal gaps≥2 point improvements from baseline in ClinRO

Among the group of patients who responded to baricitinib at week 52, 117 (90.7%) receiving baricitinib 4 mg and 58 (89.2%) receiving baricitinib 2 mg had maintained a SALT score ≤20 at 104 weeks.

At 52-week responders with baseline ClinRO scores of ≥2, 67 (83.8%) and 25 (67.6%) had achieved ClinRO Eyebrow scores of 0 or 1, and 55 (80.9%) and 22 (73.3%) had achieved ClinRO Eyelashes 0 or 1 with 4 mg and 2 mg baricitinib, respectively, at 104 weeks.

In the group with a SALT score >20 at week 52, 4 mg baricitinib resulted in 43 (39.1%) patients achieving a SALT score ≤20 at 104 weeks.

“Efficacy of baricitinib for severe alopecia areata was maintained at 104 weeks in response to week 52,” the investigators concluded. “Efficacy was increased in patients with a SALT score > 20 at week 52, illustrating that long-term treatment may be necessary to observe maximal benefit in some patients.”

In an interview with HCPLive at AAD 2023, Lotus Mallbris, MD, PhD, vice president of US and global immunology development and medical affairs at Lilly, discussed the true value of confirming baricitinib’s “persistence” in combating hair loss of alopecia areata, noting the historically disappointing interaction patients have had with previous treatments.

“Some of my patients, when I was a doctor, would say ‘Don’t bring me to heaven and then to hell,'” Mallbris said. “Not going up and down is very important for patients and their quality of life. And then there are some patients who at week 52 did not respond with full hair coverage, and here comes the most important piece of data: we see their hair grow back—they respond later.

Mallbris also highlighted the company’s ongoing pediatric trial, where there remains a “huge unmet need” to address the psychosocial and development-related burdens of alopecia areata in children and adolescents.

“Patients say that when they lose their eyebrows and eyelashes, they don’t recognize themselves. It goes to the core of who you are as a person. And the burden in pediatrics is that, it’s not only on the patients, but also on the family that cares for that patient. It has more impact on quality of life.”

References

Senna M, Mostaghimi A, Ohyama M, et al. Long-term efficacy of baricitinib in alopecia areata: 104-week results from BRAVE-AA1 and BRAVE-AA2. Paper presented at: American Academy of Dermatology 2023 Annual Meeting; March 17 – 21. New Orleans, LA. Accessed March 18, 2023. Butera A. FDA Approves Baricitinib for Alopecia Areata in Adults. HCPLive. Published June 13, 2022. Accessed March 18, 2023. https://www.hcplive.com/view/fda-approves-baricitinib-for-alopecia-areata