AbbVie Korea’s psoriasis drug Skyrizi approved for pustular psoriasis on hands and feet

AbbVie Korea's psoriatic disease treatment Skyrizi (risankizumab) won approval from the Ministry of Food and Drug Safety (MFDS) on Tuesday for treating moderate-to-severe pustular psoriasis of the hands and feet in adults (18 years and older) who have had an inadequate response to or are intolerant of standard therapies.

This approval allows Skyrizi to be used for treating moderate to severe adult plaque psoriasis, active psoriatic arthritis in adults, as well as palmoplantar pustulosis that requires phototherapy or systemic therapies, including biologic therapies, AbbVie Korea said Thursday.

"Palmar pustulosis is a skin immune disease characterized by sterile pustules on frequently used hands or feet, accompanied by itching and pain, severely affecting patients' quality of life. It is important to correctly diagnose and effectively treat the disease, as it often flares up again," said Professor Choe Yong-beom of the Department of Dermatology at Konkuk University Medical Center and president of the Korean Society for Psoriasis.

Skyrizi, which has demonstrated significant efficacy in moderate-to-severe plaque psoriasis and psoriatic arthritis, will provide a new treatment option for patients with palmar pustulosis, Professor Choi added.

The approval is based on data from a randomized, double-blind, placebo-controlled Phase 3 clinical study (JumPPP) conducted in Japan to evaluate the efficacy, safety and tolerability of Skyrizi. In the study of 119 adult patients with moderate-to-severe palmoplantar pustulosis, the mean reduction in the Palmoplantar Pustulosis Area Severity Index (PPPASI) at week 16 compared to baseline was significantly greater in the Skyrizi group (-11.96) than in the placebo group (-8). The proportion of patients achieving a PPPASI of 50 at Week 16 was 41.4 percent (n=24/58) in the Skyrizi treatment arm and 24.1 percent (n=14/58) in the placebo arm (p<0.05).

"We are pleased to see the approval of Skyrizi in Korea for palmoplantar pustulosis based on studies evaluating its clinical efficacy and safety," said Kim Hyun-jung, vice president for medical affairs at AbbVie Korea. "This approval provides a new treatment option for patients with palmoplantar pustulosis, an unmet need for treatment, and AbbVie will continue its efforts to support patients with psoriasis and other immune system inflammatory diseases."

Skyrizi is a biologic that inhibits interleukin-23 (IL-23), associated with inflammation in immune-mediated inflammatory diseases. In Korea, Skyrizi was approved in June 2019 for treating moderate-to-severe plaque psoriasis and in January 2022 for treating active psoriatic arthritis in adults. As a maintenance therapy, Skyrizi demonstrated high skin improvement and sustained improvement in psoriasis patients with a single 150 mg dose administered every 12 weeks four times yearly.