Ritlecitinib in severe alopecia areata: a profile of its use

Ritlecitinib (Litfulo™) is a valuable new option for the treatment of severe alopecia areata in individuals aged ≥ 12 years. Of note, ritlecitinib, a dual selective Janus kinase (JAK)-3/TEC family kinase inhibitor, is the first targeted treatment for severe alopecia areata to be approved for use in adolescents. In the pivotal, randomised, double-blind, placebo-controlled, phase 2b/3 ALLEGRO trial in adults and adolescents with alopecia areata with ≥ 50% scalp hair loss, once-daily oral ritlecitinib 50 mg significantly increased the percentage of patients achieving ≤ 20% scalp hair loss at 24 weeks. Ritlecitinib therapy was also associated with eyebrow and eyelash regrowth. Response rates for key efficacy outcomes in the pivotal trial continued to increase with treatment up to 48 weeks. Longer-term data indicate that responses are sustained with continued treatment. Ritlecitinib is generally well tolerated, with most adverse events being of mild severity and not requiring dose interruption or treatment discontinuation. Alopecia areata is an autoimmune disease characterised by hair loss, including from the scalp, face and/or body. It has a lifetime incidence of approximately 2% globally, affecting both children and adults, and can be associated with a significant psychological burden. For severe disease (generally defined as ≥ 50% scalp hair loss), there are few effective treatments available. Ritlecitinib (Litfulo™) is a valuable new treatment option, approved in the EU, the USA and several other countries for the treatment of severe alopecia areata in individuals aged ≥ 12 years, making it the first targeted treatment to be approved for use in adolescents. As demonstrated in the pivotal ALLEGRO-2b/3 clinical trial, ritlecitinib, taken orally (as a capsule) once daily, provides clinically meaningful hair regrowth (including eyebrow and eyelash regrowth) in patients with alopecia areata with ≥ 50% scalp hair loss. Furthermore, hair regrowth is sustained longer term with continued treatment. Ritlecitinib is generally well tolerated, with most adverse events being of mild severity.