Ritlecitinib is promising for the treatment of adults and adolescents over the age of 12 years with severe alopecia areata, according to the results of a clinical trial led by Yale researchers. The treatment was approved for use in the U.S. in late June for patients 12 years of age and older with severe alopecia areata.
The Phase 3 trial of ritlecitinib, a Janus kinase (JAK) inhibitor, followed 718 patients—including more than 100 adolescent patients—at 118 hospitals and clinics in 18 countries including Canada (Dr. Charles Lynde, Markham, Ont.). All participants, regardless of age, had at least 50% scalp hair loss caused by alopecia areata.
According to the study published in The Lancet, patients were randomly assigned to oral ritlecitinib or placebo once-daily for 24 weeks, with or without a four-week loading dose (50 mg, 30 mg, 10 mg, 200 mg loading dose followed by 50 mg, or 200 mg loading dose followed by 30 mg). In a 24-week extension period, the ritlecitinib groups continued with their assigned doses and patients on placebo were switched to ritlecitinib 50 mg or 200 mg loading dose followed by 50 mg. A total of 446 (62%) of the patients were female and 272 (38%) were male; 488 (68%) were White, 186 (26%) were Asian, and 27 (4%) were Black or African American. The primary endpoint was Severity of Alopecia Tool (SALT) score 20 or less at week 24.
At week 24, 38 (31%) of 124 patients in the ritlecitinib 200 mg + 50 mg group, 27 (22%) of 121 patients in the 200 mg + 30 mg group, 29 (23%) of 124 patients in the 50 mg group, 17 (14%) of 119 patients in the 30 mg group, and two (2%) of 130 patients in the placebo group had a response based on SALT score 20 or less.
“This new work is a huge advancement for treating alopecia areata because the clinical trial involved adolescents in addition to adults,” said Dr. Brett King, an associate professor of dermatology at Yale School of Medicine and first author of the study, in a press release.
“Because alopecia areata frequently affects children and adolescents, it is groundbreaking to advance a medicine that shows safety and effectiveness in the treatment of younger patients,” Dr. King said. He noted the results were consistent among all age groups, including younger patients.
Ritlecitinib (LITFULO, Pfizer) therapy is under review by Health Canada for this indication.