Ritlecitinib efficacious, safe in patients aged 12 years and older with alopecia areata
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Key takeaways:
- Up to 31% of patients aged as young as 12 years with alopecia areata taking ritlecitinib achieved a Severity of Alopecia Tool score of 20 or less after 24 weeks of treatment.
- The study drug was well-tolerated.
Patients aged 12 years and older with alopecia areata exhibited positive efficacy rates and tolerability when treated with ritlecitinib over a 24-week period, according to a phase 2b-3 trial published in The Lancet.
According to study author Brett King, MD, PhD, FAAD, of the department of dermatology at Yale University School of Medicine in New Haven, Connecticut, the importance of this trial in alopecia areata (AA) "cannot be understated."
“First of all, there is only one FDA-approved treatment for severe AA, and there is need for more treatments,” King told Healio. “Equally important, however, AA commonly affects children and adolescents, and we see these patients in clinic every week. For pediatric patients with severe hair loss, there are no FDA-approved treatments.”
In this multicenter, double-blind, phase 2b-3 trial, King and colleagues evaluated the efficacy and safety of ritlecitinib, a selective dual Janus kinase 3 and tyrosine family kinase inhibitor. The study included 613 adults and 105 adolescents aged 12 years and older with at least 50% hair loss due to AA. Mean Severity of Alopecia Tool (SALT) scores ranged from 88.3 to 93 at baseline.
Patients were randomly assigned to ritlecitinib 50 mg (n = 130), 30 mg (n = 132) or 10 mg (n = 63) once-daily for 24 weeks; a 4-week, 200 mg loading dose of the study drug followed by 50 mg (n = 132) or 30 mg (n = 130) for the same period; or placebo (n = 131).
According to the researchers, of the 718 patients who began the trial, 104 discontinued treatment.
In a 24-week extension, ritlecitinib groups continued their assigned doses while patients taking placebo were switched to ritlecitinib 50 mg once-daily (n = 66) or a 200 mg loading dose followed by 50 mg once-daily (n = 65).
After 24 weeks of treatment, results showed that 31% (n = 38) of patients in the 50 mg with loading dose group, 22% (n = 27) in the 30 mg plus loading dose group, 23% (n =29) in the 50 mg group and 14% (n = 17) in the 30 mg group achieved the primary endpoint of a SALT score less than or equal to 20. Only two patients achieved this endpoint in the placebo group.
Based on the primary endpoint, the difference in response rate between the placebo and ritlecitinib-treated groups was 12.8% (95% CI, 6.7%-20.4%) for the 30 mg group, 21.9% (95% CI, 14.7%-30.2%) for the 50 mg group, 20.8% (95% CI, 13.7%-29.2%) for the loading dose plus 30 mg group and 29.1% (95% CI, 21.2%-37.9%) for the loading dose plus 50 mg group.
King and colleagues concluded that once-daily dosages of 30 mg and 50 mg allowed for the most significant hair regrowth, with or without a loading dose.
Although a majority of patients in each group encountered a similar incidence rate of adverse events, ranging from 86% in the group switched from placebo to ritlecitinib 50 mg to 76% in the ritlecitinib 10 mg group, the researchers found that these events were well-tolerated by patients. Sixteen serious adverse events were reported in 14 patients; however, there were no major events or deaths.
“We desperately need a treatment that is approved in younger patients, and this ritlecitinib data gets us closer to that goal,” King told Healio. “Approval of ritlecitinib can’t come soon enough.”