AbbVie's JAK inhibitor Rinvoq (upadacitinib) is expected to enter the market competition following successful clinical trials for alopecia areata.

AbbVie recently announced positive topline results from the No.2 study of the Phase 3 clinical program (UP-AA program) for Rinvoq in adult and adolescent patients with severe alopecia areata.

In this trial, the primary endpoint has been met, with a significant increase in the proportion of patients achieving 80% or more scalp hair regrowth (the primary endpoint) at Week 24 compared to the placebo group.

Based on these results, Rinvoq emerged as a strong candidate to join the alopecia areata treatment market. Specifically, 44.6% of patients in the Rinvoq 15mg arm and 54.3% in the Rinvoq 30mg group achieved 80% or more scalp hair regrowth (SALT score ≤20) at Week 24, compared to only 3.4% in the placebo group.

Key secondary endpoints, including improved eyebrow and eyelash hair growth, achieving ≥90% scalp hair regrowth (SALT ≤10), and attaining complete scalp hair regrowth (SALT=0), were also met in both Rinvoq dose groups.

The safety profile was largely consistent with what has been observed in existing Rinvoq indications, with no new safety signals identified.

Arash Mostaghimi, Professor of Dermatology at Harvard Medical School and Brigham and Women's Hospital, said, "The sudden and often unpredictable hair loss experienced by patients with alopecia areata severely impacts their self-esteem and mental health," and added, "There is a desperate need for more therapies that help hair regrowth on the scalp and other areas. These results, showing the potential for upadacitinib to be an important new treatment option, are very favorable."

Kori Wallace, the Vice President and Global Head of Immunology Clinical Development at AbbVie, stated, "UP-AA is the first pivotal clinical study to establish and achieve high goals such as SALT=0. These study results demonstrate AbbVie's commitment to advancing new therapies with the potential to improve the lives of patients with immune-mediated diseases."

AbbVie plans to initiate global regulatory procedures based on these results. The clinical trial results announced included patients from Korea, suggesting that a swift approval process is anticipated.

Third alopecia areata treatment is expected to emerge, and competition is anticipated

If Rinvoq receives marketing authorization, it will become the third JAK inhibitor available in the domestic alopecia areata treatment market.

Currently, two oral JAK inhibitors, Eli Lilly Korea's Olumiant (baricitinib) and Pfizer Korea's 'Litfulo (ritlecitinib),' can be used for the treatment of severe alopecia areata in Korea.

Olumiant, approved by the Ministry of Food and Drug Safety (MFDS) in March 2023, became the first treatment for severe alopecia areata in adults in Korea.

This drug was approved based on the results of the BRAVE-AA clinical trial, which showed that at 36 weeks, approximately 38.8% of patients receiving the 4 mg dose achieved 80% or more scalp hair regrowth, demonstrating superior efficacy compared to the placebo group (6.2%).

Litfulo, the first alopecia areata treatment to gain an indication for adolescents aged 12 and older, received MFDS approval in September 2024 and was launched in Korea in March this year.

In terms of mechanism of action, Olumiant simultaneously inhibits JAK1 and JAK2, while Litfulo selectively acts on JAK3 and TEC family kinases.

The prevailing view in clinical settings is that sufficient data on treatment outcomes is needed for these two therapies, as a direct comparison is currently challenging.

However, for adult patients, Olumiant could be considered for faster hair regrowth, while Litfulo might be preferred if safety concerns, such as the risk of infection, are prioritized.

Compared to Olumiant, Litfulo is in the stage of accumulating prescription experience since its domestic launch, and its efficacy and safety profile in real-world patient populations will need further observation.


The late entrant Rinvoq is expected to join the market competition, backed by strong Phase 3 data.

Rinvoq, as a selective inhibitor of JAK1, has a distinct target profile from existing drugs and is expected to appeal based on its proven efficacy and accumulated safety data from previous immune disease indications, such as atopic dermatitis.

Notably, the high response rate of approximately half of the patients at week 24, confirmed in this trial, is expected to be a distinct strength in terms of short-term efficacy compared to competing drugs.

Furthermore, adolescent patients were included in Rinvoq's global clinical trials, suggesting a high probability of securing an indication for ages 12 and older, similar to Litfulo, if approved in the future.

This indicates that, in competition with Olumiant, which is limited to adult patients, Rinvoq will have a broader patient population. In competition with Litfulo, the experience accumulated in various indications, such as atopic dermatitis, will be a differentiating point.

AbbVie has already successfully established Rinvoq as a treatment for atopic dermatitis in the dermatology field, leading to observations that it will effectively expand the alopecia areata indication to dermatology specialists, who are in the same prescribing group.

In terms of treatment accessibility, the successive emergence of Olumiant and Litfulo in the field of alopecia areata, which previously had no approved treatments, marked a turning point in the treatment paradigm. With Rinvoq being introduced, the range of treatment options is expected to broaden further.

However, the fact that alopecia areata cannot be reimbursed with the National Health Insurance and remains as the non-reimbursed drug is expected to be a barrier to market expansion.