Ivarmacitinib ‘potential new option’ for adults with severe alopecia areata

Key takeaways:

• A phase 3 study compared two doses of ivarmacitinib with placebo in 330 adults.
• At week 24, about 35% in the 4 mg group and 40% in the 8 mg group had a SALT score of 20 or less vs. 9% in the placebo group.

ORLANDO — Oral ivarmacitinib, administered 4 mg or 8 mg once daily, significantly induced hair regrowth at 24 weeks vs. placebo in adults with severe alopecia areata, according to phase 3 data presented here.

“Severe alopecia areata has a significant impact on patients’ quality of life and rarely improves without treatment,” Jianzhong Zhang, MD, professor and chair of dermatology at Peking University People’s Hospital in China, said during the late-breaking session at the American Academy of Dermatology Annual Meeting. “Several JAK inhibitors, including baricitinib and ritlecitinib, have been successfully used in the clinic for the treatment of severe alopecia areata. Ivarmacitinib is a new oral, highly selective [Janus kinase (JAK)] 1 inhibitor.”

Zhang and colleagues randomly assigned 330 adults across 31 clinics in China in a 1:1:1 ratio to receive 4 mg ivarmacitinib (Jiangsu Hengrui Pharmaceuticals), 8 mg ivarmacitinib or placebo for 24 weeks. After that, patients in the placebo group then were randomly assigned in a 1:1 ratio to receive either dose of ivarmacitinib through week 52.

The primary endpoint was the proportion of patients with a Severity of Alopecia Tool (SALT) score of 20 or less by week 24.

According to the results, the primary endpoint occurred in 34.9% of patients in the 4 mg group, 40.6% in the 8 mg group and 9% in the placebo group. The difference in response rate was 25.6% (95% CI, 15.4%-35.7%) for the 4 mg group vs. placebo and 31.6% (95% CI, 21.5%-41.8%) for the 8 mg group vs. placebo.

Among patients who switched to ivarmacitinib from placebo, about 47% of those who received 4 mg and 63% who received 8 mg had a SALT score of 20 or less at week 52.

When looking at safety, Zhang and colleagues found that 77.1% of patients in the 4 mg group, 84.7% in the 8 mg group and 75.5% in the placebo group had treatment-emergent adverse events during the first 24 weeks. The safety data through week 52 were similar, Zhang said.

Few patients experienced a treatment-emergent serious adverse event, and all were considered unrelated to treatment except for a case of stage 3 follicular lymphoma in the 4 mg group. In that case, “the relationship between study drug is undetermined,” Zhang said.

Overall, the safety profile was similar to that of other JAK inhibitors, with no new safety signals, thromboembolic events, major cardiovascular events or deaths.

“The results above support ivarmacitinib as a potential new option for adults with severe alopecia areata,” Zhang concluded.