Ritlecitinib shows promise in alopecia areata treatment
WAILEA, Hawaii — Ritlecitinib was efficacious for patients with alopecia areata, with clinician-assessed efficacy and patient perception of improvement highly correlated, according to a poster presented at Maui Derm for Dermatologists.
“Alopecia areata is a disease that has a huge unmet need. In my view it is the highest unmet need we have in dermatology because there is nothing approved,” Emma Guttman-Yassky, MD, PhD, the Waldman Professor and system chair of the Kimberly and Eric J. Waldman Department of Dermatology at the Icahn School of Medicine at Mount Sinai, told Healio. “It changes your body image and has so many effects on quality of life.”
Ritlecitinib, an inhibitor of Janus kinase 3 (JAK3) and the tyrosine kinase expressed in hepatocellular carcinoma kinase family, is being studied in alopecia areata patients with at least 50% scalp hair loss.
The randomized, double-blind, placebo-controlled, 48-week, phase 2b/3 ALLEGRO trial evaluated the safety and efficacy of five ritlecitinib doses compared with placebo. Two dosing groups received a 4-week loading dose of 200 mg before 50 mg or 30 mg doses. The other groups received 50 mg, 30 mg or 10 mg.
After 24 weeks of treatment, those in the placebo group were switched to active therapy.
Mean changes in Severity of Alopecia Tool (SALT) score and Patient Global Impression of Change (PGI-C) score were recorded with those in the highest dosing regimens having the greatest change.
At week 24, of the two dosing groups with the 200 mg loading dose, the group that followed with a 50 mg dose had a mean SALT score change of –36.5, while those that followed with a 30 mg dose had a mean change of –29.2. The 50 mg, 30 mg and 10 mg groups had mean changes of –33.3, –23.6 and –4.2, respectively. The placebo group’s mean change was –5.1.
The proportion of PGI-C response was 53.2% in the group with the 200 mg loading dose followed by a 50 mg dose and 47.1% in the 200 mg group that followed with a 30 mg dose. The proportion of PGI-C response was 49.6%, 42.2% and 11.7% in the remaining treatment groups, compared with 9.2% in the placebo group.
Ritlecitinib was well tolerated. Treatment-emergent adverse events were reported in 60% to 75% of patients, with serious adverse events in 0.8% to 3.2%. During the study’s initial 24 weeks, 14 patients discontinued use due to adverse events.
“We really need more treatments for alopecia areata and I’m very excited this one is now in phase 3,” Guttman-Yassky said. “I’m excited about the potential of this drug for our patients.”