This protocol addresses patients aged 12 years or older with refractory alopecia areata in whom the affected area covers at least 50% of the scalp and no spontaneous hair regeneration has occurred over the preceding 6 months.
For patients meeting these criteria, the protocol involves targeted therapy with selective JAK inhibitors, with agent eligibility informed by patient age. Flexible supportive management may also be considered for those with a prolonged course.
The primary target is a SALT score of 20 or less — corresponding to alopecia affecting 20% or less of the scalp — assessed at 36 weeks.
DOI: 10.14924/dermatol.134.2491
Are Oral JAK Inhibitors or a JAK3/TEC Family Kinase Selective Inhibitor Useful for Treating Refractory AA Involving an Extensive Area?
The alopecia area is ≥ 50% of the scalp, and there was no spontaneous regeneration of hair in the past 6 months.
Baricitinib should be administered to pharmaceutical adults (aged ≥ 15 years; however, patients aged < 18 years were not included in the BRAVE-AA studies), and ritlecitinib tosilate to patients aged ≥ 12 years.
In Japan, baricitinib tablets and ritlecitinib tosilate capsules were approved for the treatment of severe refractory AA and are covered by health insurance.
Baricitinib is a JAK1/2 selective inhibitor. Ritlecitinib tosilate is a JAK3/TEC (tyrosine kinase expressed in hepatocellular carcinoma) family kinase selective inhibitor.
For the treatment of AA with a prolonged course, flexible management, such as the confirmation of a will to continue treatment and a proposal for the use of a wig, is necessary.
The BRAVE-AA2 study involving Japanese patients showed that the rate of patients achieving a SALT score of ≤ 20 (extent of alopecia: ≤ 20% of the scalp) after 36-week administration was 35.9% in the 4-mg-treated group (difference from placebo: 32.6%, 95% CI: 25.6 to 39.6) and 19.4% in the 2-mg-treated group (difference from placebo: 16.1%, 95% CI: 9.1 to 23.2); significant hair growth was observed in both groups versus placebo (3.3%).
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