First TYK2i Sotyktu shows effect in Asian psoriasis patients

Effective in improving psoriasis index in specific areas... shows consistent response in long-term treatment

Reimbursement approved in Korea last year, reducing treatment costs and improving patient access

BMS Korea

The psoriatic arthritis treatment Sotyktu, which is jointly marketed in Korea by BMS Korea and Yuhan Corp, has established itself as a personalized oral treatment option for psoriatic arthritis patients in Korea, accumulating data from patients in East Asia.

 

Sotyktu has been proven effective even in difficult-to-treat areas such as the scalp and nails, and is evaluated as having increased patients' access to early treatment through its inclusion in the national health insurance reimbursement list.

 

According to industry sources on the 8th, BMS recently released clinical data of Sotyktu on East Asian patients, which included Koreans.

 

Sotyktu is a first-in-class selective TYK2 inhibitor that, unlike other JAK inhibitors, has an allosteric mechanism that binds to the inactive regulatory domain.

 

Psoriasis is a chronic disease that is difficult to cure and involves repeated improvements and worsening of symptoms, requiring long-term and continuous treatment.

 

In particular, there remained a therapeutic need for new alternatives due to the diverse treatment options required based on individual disease characteristics and treatment preferences.

 

Sotyktu is a once-daily oral treatment that can be taken regardless of meal intake and without dose adjustment, expanding the treatment options for psoriasis patients who previously had only biological agents as an alternative to conventional treatments.

 

Sotyktu has demonstrated its efficacy and safety profile as a psoriasis treatment in numerous global and Asian clinical trials.

 

In the POETYK PSO-3 study, which included Asian patients including Koreans, the proportion of patients who showed a 75% or greater reduction in the Psoriasis Area and Severity Index score (PASI 75) at Week 16 was 68.8%, and the rate of achieving a score of 0/1 on the static Physician’s Global Assessment (sPGA) was 55.6%, showing significant improvement compared to the placebo group.

 

The results of three recent analyses conducted in Japan also supported the efficacy and safety of Sotyktu in East Asian patients.

 

New data was released this year, including a post-hoc analysis of the POETYK PSO-4 Phase III clinical trial, a three-year efficacy and safety analysis of Japanese patients through the POETYK PSO-1, 4, and LTE studies, and an analysis of Japanese patient reports from POETYK PSO-4.

 

In the post-analysis of POETYK PSO-4 in Japanese patients, the PASI 2 or less rate at week 16 of treatment in the Sotyktu group was 46.0%, and at week 52, the PASI 2 or less rate was 68.3% and the PASI 1 or less rate was 47.6%.

 

In the patient-reported outcome (PRO) analysis of the same study, the rate of patients achieving a DLQI (Dermatology Life Quality Index) of 0/1 at week 52 reached 66.1%.

 

Major symptoms such as erythema, scaling thickness, and severity of scaling began to improve from week 1 of treatment, with over 80% improvement by week 16, and approximately 90% of the effect was maintained or improved by week 52.

 

Kiheon Jeong, Professor of Dermatology at Kyung Hee University Hospital (Insurance Director of the Korean Society for Psoriasis (KSP)), stated, “Areas such as the scalp and palms/soles, which are visible and cause daily discomfort, often have low patient satisfaction even with mild symptoms.

 

We anticipate that oral medications with proven efficacy in these special areas will expand treatment options.” Health insurance coverage greatly reduces treatment costs and improves access to the latest treatments Sotyktu showed consistent efficacy even in patients with a variety of previous treatment histories, demonstrating its potential as a long-term treatment option.

 

In a three-year post-hoc analysis including POETYK PSO-1, PSO-4, and long-term extension (LTE) studies, 65.6% of 125 Japanese patients had prior treatment experience, and 20.8% of these had a history of biological agent use.

 

In the analysis of Japanese patients with PSO-1, the PASI achievement rate was 88.9% in the first year and remained at 87.5% in the third year, and the sPGA 0/1 response rate also showed a long-term response, from 74.1% in the first year to 66.7% in the third year.

 

Similar results were observed in patients who switched from placebo to Sotyktu.

 

This suggests that consistent clinical responses are possible over a long period of time, regardless of previous treatment experience.

 

Sotyktu was approved in Korea in 2023 and was reimbursed the following year, greatly improving patient access and reducing their burden of cost compared to existing treatments.

 

According to the health insurance reimbursement criteria, it can be administered to adult patients aged 18 years or older with chronic severe plaque psoriasis that has persisted for at least six months.

 

Sotyktu was approved by the Ministry of Food and Drug Safety in 2023 and became eligible for reimbursement by health insurance eight months later.

 

Reimbursement is available for adult patients aged 18 years or older with chronic severe plaque psoriasis that has persisted for six months or longer and who have ▲symptoms on BSA (body surface area) of 10% or more ▲PASI score of 10 or higher, and who have not responded to or cannot continue treatment with methotrexate or cyclosporine for at least three months due to efficacy or adverse effects, or have not responded to or cannot continue photochemotherapy or narrowband ultraviolet B therapy for at least three months due to efficacy or adverse effects.

 

Professor Jeong said, “The accumulation of evidence from East Asian patients is encouraging for the psoriasis treatment environment in Korea.

 

With reimbursement, the burden of treatment costs has been reduced, enabling quick and economical treatment even for patients who do not qualify for the special calculation benefits.

 

This will provide practical treatment opportunities to more patients.”