Adolescents with alopecia respond just as well as adults to ritlecitinib treatment

Key takeaways:

• At week 24, 17% to 28% of adolescents treated with ritlecitinib 30 mg and higher achieved the primary endpoint.
• Safety outcomes were consistent except for adolescents experiencing higher acne rates.

Efficacy and safety outcomes in adolescents treated with ritlecitinib for severe alopecia areata were consistent with adults in the same indication, according to a subgroup analysis of a phase 2b/3 trial.

The ALLEGRO study was recently used to support the FDA-approval of Litfulo (ritlecitinib), a selective dual Janus kinase 3 and tyrosine family kinase inhibitor, for the treatment of severe alopecia areata (AA) in adolescents.

Previously, researchers in ALLEGRO evaluated the efficacy and safety of ritlecitinib among 613 adults and 105 adolescents aged 12 years and older with at least 50% hair loss due to AA. These results were published in The Lancet.

Now, in a subgroup analysis of ALLEGRO by Maria Hordinsky, MD, of the department of dermatology at University of Minnesota, and colleagues published in Pediatric Dermatology, researchers have evaluated the efficacy and safety results of this drug among adolescents only.

Patients aged 12 to 17 years were randomly assigned to receive ritlecitinib 50 mg (n = 18), 30 mg (n = 20) or 10 mg (n = 9) once-daily for 24 weeks, or a 4-week, 200 mg loading dose of the study drug followed by 50 mg (n = 20) or 30 mg (n = 19) for the same period.

In a 24-week extension, ritlecitinib groups continued their assigned doses, whereas patients taking placebo were switched to ritlecitinib 50 mg once-daily (n = 9) or a 200 mg loading dose followed by 50 mg once-daily (n = 10).

After 24 weeks of treatment, results showed that 28% of patients in the 50 mg with loading dose group, 18% in the 30 mg plus loading dose group, 25% in the 50 mg group and 17% in the 30 mg group achieved the primary endpoint of a Severity of Alopecia Tool score less than or equal to 20. No patients in the 10 mg groups achieved this endpoint at 24 weeks.

During the 24-week extension, success rates increased across most groups, with 39% in the 30 mg plus loading dose group, 50% in the 50 mg group, 26% in the 30 mg group, 13% in the 10 mg group, 40% in the placebo to 50 mg plus loading dose group and 33% in the placebo to 50 mg group achieving the primary endpoint.

However, success rates among patients receiving ritlecitinib 50 mg plus a loading dose decreased slightly to 25%.

The most common adverse events, including headaches, acne and nasopharyngitis, occurred in 65% to 83% of adolescents across ritlecitinib groups and 79% of adolescents in the placebo groups. No deaths or other serious adverse events were reported.

“Overall, clinician- and patient-reported efficacy outcomes in adolescents were consistent with those in the total study population,” Hordinsky and colleagues wrote. “The safety profile suggests that there are no risks unique to adolescents except for a higher frequency of acne ... which is not unexpected as acne is generally more common in the 12- to 17-year age range than in adults.”