Interleukin inhibitors approved for palmoplantar pustulosis

in Korea

Tremfya first to receive approval…can be prescribed with reimbursement in Korea

Skyrizi approved to expand indication in Korea this month

(From upper side) Tremfya, Skyrizi

Interleukin (IL)-23 inhibitors, which are mainly used for psoriasis, are making their way into the field of palmoplantar pustulosis in Korea.

 

Following the approval of Janssen Korea’s ‘Tremfya (guselkumab), AbbVie Korea’s Skyrizi (risankizumab) has also added an indication for palmoplantar pustulosis and has signaled competition in the area.

 

In the case of Tremfya, its reimbursement standard was extended to cover palmoplantar pustulosis as well.

 

Currently, Tremfya is reimbursed for: ▲patients with a PPPASI score of 12 or higher, who have been treated with acitretin or methotrexate or cyclosporine at therapeutic doses for at least 3 months but are unable to continue treatment due to no response or side effects, or ▲ patients who were treated with phototherapy for at least 3 months but is unable to continue treatment due to no response or side effects.

 

The drug was approved as a treatment for adult patients with plague psoriasis in April 2018 and as a treatment for adult patients with active psoriatic arthritis in March 2021, and the indications were applied insurance benefits in September 2018 and May 2022, respectively.

 

Skyrizi was recently approved by the Ministry of Food and Drug Safety for the treatment of moderate to severe palmoplantar pustulosis in adults who have had an inadequate response to, or are intolerant of, standard therapy.

 

Skyrizi was initially approved in Korea in June 2019 for the treatment of moderate-to-severe plaque psoriasis and its indication was later expanded as a treatment for active psoriatic arthritis in adults in January 2022.

 

The approval for palmoplantar pustulosis was based on the results of the JumPPP study, a Phase 3 clinical trial conducted in Japan to evaluate the efficacy and safety of Skyrizi.

 

The study analyzed 119 patients and showed that from baseline to week 16, the PPPASI (Palmoplantar Pustulosis Area and Severity Index) index decreased by an average of 11.96 in the Skyrizi treatment group, which was significantly greater than the 8.48 point decrease in the placebo group.

 

Yong-Beom Choe, President of the Korean Society of Psoriasis (Konkuk University), said “Palmoplantar pustulosis is a cutaneous immune disease characterized by an eruption of sterile pustules on the palms and soles.

 

As it is often accompanied by itching and pain, it severely affects the quality of life of patients.

 

And due to frequent relapses, it needs to be constantly managed with correct diagnosis and effective treatment.”