“Olumiant rises as a new option for alopecia areata”

...Plans for its reimbursement remain undecided

Lilly holds a press conference to celebrate the indication expansion of Olumiant as a treatment for severe alopecia alopecia

Over half of the patients are in the younger age range...serious hair loss reduces the quality of life

Will have to bear KRW 7.4 million per year as treatment expense...”Patients have shown a strong will to receive treatment”

A new treatment option has emerged in the field of severe alopecia, an area where no option other than local steroid therapy had existed until now.

 

The drug gained attention from patients with severe circular hair loss due to its safe and high therapeutic effect.

 

However, it remains unclear whether the indication for circular hair loss will be able to rise to the right to benefit.

 

Lilly Korea held a press conference at The Plaza Hotel in Jung-gu, Seoul on the 12th and explained the meaning of expanding the indication for severe circular hair loss of the JAK inhibitor 'Olumiant (ingredient: baricitinib)'.

 

Oh-sang Kwon, professor of Dermatology at Seoul National University Hospital, and Bark-Lynn Lew, Professor of dermatology at Kangdong Kyunghee University Hospital, explained the current state of alopecia areata in Korea, the disease burden, and the effects of Olumient.

 

Professor Kwon served as the vice president of the Korean Hair Research Society and Professor Lew serves as the Academic Director of her academic society.

 

Professor Oh-sang Kwon (left) Professor Bark-Lynn Lew (right)

According to Professor Lew, as of 2021, about 170,000 patients visit the hospital with alopecia areata a year in Korea.

 

Young patients in their 20s to 40s account for about 60% of the AA population.

 

Unlike general hair loss caused by hormones, alopecia areata is classified as one of the symptoms of an autoimmune disease.

 

The immune system mistakenly recognizes part of one’s hair as a foreign substance, and the hair falls out.

 

Unlike general hair loss, in which the hair gradually thins, the forehead widens in the shape of an M, and the hair loss expands, in alopecia areata, one or several circular bald areas with clear boundaries occur on the scalp.

 

Bald spots can occur not only on the scalp, but also anywhere on the hair, such as eyebrows, beard, armpit hair, and pubic hair.

 

Professor Lew added, “Most hair loss is naturally cured and responds well to treatment, but about 40% of patients experience recurrence within a year, and in severe cases, all hair on one’s scalp or body falls out and progresses to widespread alopecia.

 

Alopecia areata is a chronic autoimmune disease, which has a high risk of autoimmune disease complications such as atopic dermatitis at the same time and can have a significant impact on the quality of life of patients.

 

Its lifetime prevalence of the psychiatric disorder is up to 74%." he explained.” Before Olumiant, there was no treatment approved for severe alopecia areata.

 

Instead, topical steroids were used off-label for patients with mild symptoms.

 

However, the efficacy evidence was limited on its use while the risk of side effects was high from long-term steroid use.

 

The efficacy of Olumiant was demonstrated through the Phase III BRAVE-AA1 and BRAVE-AA2 trials that were conducted on a total of 1,200 patients with severe alopecia areata.

 

Koreans participated in both studies.

 

The trials’ primary efficacy endpoint was a SALT score of 20 or less.

 

SALT stands for Severity of Alopecia Tool score.

 

41%, and 37% in the group treated with Olumiant for 52 weeks in AA1 and AA2, respectively, achieved the primary efficacy endpoint.

 

At the time, improvements in eyebrow and eyelash coverage were also observed.

 

The company plans to further confirm the effectiveness and safety of Olumiant treatment for up to 200 weeks.

 

Professor Kwon said, "What is noteworthy in the 52-week extension study is that the regrowth effect of scalp, eyebrows, and eyelashes continued to improve for up to 52 weeks when treated with Olumient 4mg.

 

This shows that long-term treatment may be required to achieve maximum benefit in AA patients." Patients’ responses were also positive.

 

Professor Lew said, "Although it is reimbursed yet, about 60% of patients were willing to use Olumiant when it was recommended.

 

This is twice more than my expectations, indicating the high willingness to treat among the patients.” However, it is expected that the AA indication will not be covered for the time being.

 

Lilly Korea said, "It's only been a month since the indication was added, so nothing has been decided or progressed related to reimbursement yet.

 

We will make efforts to expand access to Olumiant in AA patients with high unmet needs.”