This protocol applies to adults aged 18 or older in the initial (acute) phase of rapidly progressive alopecia areata with scalp involvement of 25% or more (severity grade S2 or higher), in whom spontaneous cure is not expected.
The preceding treatment step — corticosteroid therapy (intravenous methylprednisolone pulse therapy, or oral prednisolone in patients resistant to corticosteroid application or injection) — aimed for at least 75% hair recovery of the scalp at 6 months. When that goal is not achieved, escalation to the next protocol is indicated.
The primary target is a SALT score of 20 or less — corresponding to alopecia area of 20% or less of the scalp — assessed at 36 weeks.
DOI: 10.14924/dermatol.134.2491
It may be performed in adults with rapidly progressive S2 or higher initial-phase AA.
Rapidly progressive AA patients with spontaneous cure tendency are excluded.
Patients with a high possibility of spontaneous cure should be excluded.
In Japan, 2-mg/4-mg baricitinib (Olumiant: Eli Lilly Japan K.K) tablets and 50-mg ritlecitinib tosilate (Litfulo: Pfizer Japan Inc.) 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.
Of these, 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 oral administration was 35.9% in the 4-mg-treated group (difference from the placebo group: 32.6%, 95% CI: 25.6 to 39.6) and 19.4% in the 2-mg-treated group (difference from the placebo group: 16.1%, 95% CI: 9.1 to 23.2); in the two groups, significant hair growth was observed in comparison with the placebo group (3.3%).
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