Latest news on ritexitinib

Ritlecitinib (Ritlecitinib), an oral JAK3/TEC family kinase inhibitor, demonstrated efficacy and an acceptable safety profile for up to 24 weeks in the ALLEGRO Phase 2a study in adult patients with alopecia areata (AA). In the ALLEGRO Phase 2b/3 study, ritixitinib demonstrated clinical and patient-reported efficacy and an acceptable safety profile for up to 48 weeks.

A post hoc analysis of the ALLEGRO Phase 2b/3 study evaluated the efficacy and safety of the oral Janus kinase 3/TEC family kinase inhibitor ritexitinib in patients with alopecia totalis (AT) and alopecia universalis (AU). Patients aged ≥12 years with ≥50% scalp hair loss and alopecia areata (AA) were treated with ritexitinib 50 or 30 mg once daily (200 mg loading dose for 4 weeks) or placebo for 24 weeks.

During the subsequent 24-week extension period, the ritixitinib arm continued its dosage, and patients initially assigned to placebo were switched to ritixitinib (200/50 or 50 mg daily). In this analysis, clinician- and patient-reported hair regrowth outcomes in four AA subgroups (at/AU, at, AU, and non-at/AU) were assessed at weeks 24 and 48. Monitor safety throughout the entire process.

Among 718 randomized patients, 151 (21%) and 147 (20%) were defined as AT or AU, respectively. At Week 24, response rates with a Severity of Hair Loss Tool (SALT) score ≤20 (≤20% scalp loss) were higher in the AT/AU, AT, and AU groups treated with ritexitinib (7%-14%, 7%-21%, and 4%-10%, respectively) compared with the placebo group (0% in the AT/AU, AT, and AU groups). The proportion of patients with SALT scores ≤20 increased at week 48 (AT/AU, 13%-31%; AT, 11%-27%; AU, 6%-41%).

In addition, at week 24, 25%-43%, 32%-42%, and 12%-50% of patients at/AU, AT, and AU, respectively, who received ritixitinib achieved moderately or significantly improved responses based on the patient's global impression of change scale. At week 48, response rates generally increased and were similar among AA subgroups. In patients with AT/AU, ritexitinib was well tolerated and its safety profile was consistent with that in the overall AA population. At Week 48, ritixitinib demonstrated clinical efficacy, patient-reported improvements, and an acceptable safety profile in patients with AT and AU.