AbbVie Korea said on Tuesday that its psoriasis drug Skyrizi (ingredient: risankizumab) will be reimbursed as a treatment from March 1, for active and progressive psoriatic arthritis in adult patients who stopped responding to one or more TNF-α inhibitors or interleukin-17 inhibitors.

Skyrizi Prefilled Syringe Inj. was approved by the Ministry of Food and Drug Safety (MFDS) as a treatment for active psoriatic arthritis in adults who did not respond appropriately to disease-modifying antirheumatic drugs (DMARDs) in January 2022. 

Previously, Skyrizi was only covered for the treatment of adult chronic severe plaque psoriasis patients since June 1, 2020.

Skyrizi is a biological drug that inhibits interleukin-23 associated with inflammation induction. It is administered as a maintenance therapy subcutaneously at a dose of 150 mg every 0, 4 weeks, and 12 weeks, and can be administered alone or in combination with non-biological DMARDs.

Psoriatic arthritis mainly occurs in about 15 percent of psoriasis patients in their 30s and 40s and may occur in the peripheral joint or spine.

"Psoriatic arthritis is often accompanied by psoriasis and can occur at the same time as skin symptoms or before," said professor Hong Seung-jae of rheumatology at Kyung Hee University Hospital. "If left untreated, it can significantly reduce the quality of life and eventually lead to disability for some patients.”

Skyrizi was granted the latest insurance coverage based on two phase 3 clinical studies, KEEPsAKE-1 and KEEPsAKE-2, in adult patients with active psoriatic arthritis.

The KEEPsAKE-1 study was conducted in adult patients with active psoriatic arthritis who responded improperly to non-biological DMARDs, and the KEEPsAKE-2 study was conducted in adults with active psoriatic arthritis who did not respond to biological agents and/or DMARDs or were not drug-resistant.

The extended data from KEEPsAKE 1 and 2 studies showed that the primary evaluation variable, the American College of Rheumatology 20 (ACR20) response – a disease activity score to evaluate rheumatoid arthritis -- in patients treated with Skyrizi were 70.0 and 58.5 percent, respectively after one year.

Furthermore, 43.3 and 32.1 percent of patients achieved ACR50 response in KEEPsAKE-1 and 2 while 25 and 16.5 percent respectively achieved ACR70 response, demonstrating long-term safety profiles consistent with those reported in week 24, and no new safety concerns.

AbbVie Korea Medical Advisor Kim Seok-uee said, “We are very pleased that this reimbursement will provide patients with a wider range of treatment opportunities and ease the burden of treatment for patients with psoriatic arthritis along with psoriasis."