Olumiant may be prescribed to adolescents with alopecia areata

Recently concluded reimbursement price negotiations on expanding reimbursement coverage to adults

Phase III data showed improved scalp coverage outcomes

The JAK inhibitor ‘Olumiant’ can now be prescribed to adolescents with alopecia areata.

According to industry sources, Eli Lilly's JAK inhibitor ‘Olumiant (baricitinib)’ recently received approval for an additional indication covering severe alopecia areata in adolescents aged 12 years and older.

Lilly had previously reached an agreement with the National Health Insurance Service (NHIS) on reimbursement pricing to expand reimbursement for Olumiant in adult patients with alopecia areata.

Severe alopecia areata is an autoimmune disease characterized by hair loss affecting more than 50% of the scalp. The condition occurs when immune cells attack hair follicles and can result in the loss of scalp hair, as well as eyebrows and eyelashes.

Unlike adults, there had been no approved systemic treatment options available for adolescents in Korea. As a result, off-label use of topical steroids or immunosuppressants was the only available treatment approach. Despite concerns over long-term steroid-related side effects, the younger patients had no other choice.

There has been persistent criticism that the unmet medical needs of adolescent patients are severe in clinical settings. This is because the period of intensifying hair loss coincides with adolescence, a critical phase of identity formation, making the psychological and social impact of appearance changes significantly greater than in adults. As it is reported that 86% of patients with alopecia areata in Korea experience recurrence, the medical vacuum experienced by adolescent patients has been even more profound in the absence of an evidence-based long-term treatment

The indication expansion for Olumiant was based on data from Phase III BRAVE-AA1 and BRAVE-AA2 trials.

In the two studies involving approximately 1,300 patients, 35% to 39% of patients treated with Olumiant 4mg achieved a SALT score of 20 or lower at Week 36, compared with only 2.6% to 6.2% in the placebo group, demonstrating a clear advantage for Olumiant. One notable aspect is that Korean patients accounted for more than 20% of participants in both studies.

The newly approved dose for adolescents weighing 30 kg or more is 4 mg once daily. If the disease is consistently controlled and a dose reduction is deemed appropriate, it may be adjusted to 2mg. Patients are recommended to maintain treatment for several months or longer, even after achieving a stable response, to prevent recurrence.  Consistent with adult guidelines, treatment discontinuation should be considered if no clinical benefit is observed after 36 weeks of therapy.

Meanwhile, Olumiant was first listed for reimbursement in Korea in 2018 for rheumatoid arthritis and has since expanded its reimbursed indications to include atopic dermatitis. Last year, reimbursement coverage was further extended to pediatric atopic dermatitis patients as well.