Janssen Korea said that the Ministry of Health and Welfare would begin to reimburse Tremfya, its psoriatic arthritis treatment, from this month.
According to the current standard, the health authorities will provide reimbursement to patients with active and progressive cases where the response to one or more tumor necrosis factor-alpha inhibitors (TNF-α inhibitor) or interleukin-17 inhibitor (IL-17 inhibitor) was insufficient or in cases where patients had to stop treatment due to side effects or little efficacy.
The ministry based its approval on two phase 3 clinical trials, DISCOVER-1 and DISCOVER-2, which demonstrated the improvement of psoriatic arthritis symptoms, including joint and skin symptoms, in patients with active psoriatic arthritis who have not received a biologic treatment or who have previously received treatment with TNF-α inhibitors.
The DISCOVER-1 study showed that 52 percent of patients treated with Tremfya 100 mg on weeks 0 and four and then every eight weeks achieved an American College of Rheumatology 20 (ACR20) response at 24 weeks, and 50 and 26 percent of patients reached psoriasis area and severity index (PASI) 90 and PASI 100 compared with placebo.
Also, in the group administered with Tremfya every eight weeks, the remission rates for appendicitis and pharyngitis were 40 and 65 percent.
According to the long-term data from the DISCOVER-2 study that further analyzed the results of more than two years (112 weeks), the company confirmed that the 24 weeks and 1-year results related to the improvement effect and safety of Tremfya in psoriatic arthritis symptoms, including joint and skin symptoms, were continuously observed for about two years.
“The company is happy to offer more treatment options to psoriatic arthritis patients with limited treatment options by winning Tremfya’s health insurance benefits,” Janssen Korea CEO Cherry Huang said. “Janssen will do its best to provide innovative solutions to help patients with autoimmune diseases, including psoriasis, recover their lives.”
Psoriatic arthritis is a chronic progressive immune disease accompanied by joint inflammation, appendicitis, pharyngitis, and pain in the hands and feet, commonly seen among people in their 30s and 50s. To date, there is no cure for psoriatic arthritis, and despite available treatment options, many people experience symptoms that affect their ability to perform daily activities.
According to Janssen, about 9 percent of psoriasis patients in Korea develop psoriatic arthritis.
Tremfya is the first interleukin-23 (IL-23) inhibitor approved by the Korean Ministry of Food and Drug Safety to treat active psoriatic arthritis in adults with inappropriate or intolerant responses to DMARDs (disease-modifying anti-rheumatic drugs), and it is the only IL-23 inhibitor covered by insurance.
The drug selectively blocks and inhibits the release of inflammatory cytokines by blocking IL-23, involved in the inflammatory and immune responses associated with the symptoms of psoriatic arthritis.