Janssen Korea said its ulcerative colitis Stelara (ustekinumab) won health insurance benefits as the primary treatment for ulcerative colitis in adults in Korea as of Thursday.

The reimbursement for Stelara will be recognized for moderate-to-severe ulcerative colitis adult patients who do not respond to or tolerate common drugs such as corticosteroids, 6-mercaptopurine or azathioprine, or those who are banned from using those drugs.

In the past, the government recognized reimbursement only in patients who have failed treatment with one or more biologics in the treatment of moderate-to-severe ulcerative colitis.

However, the government on Thursday allowed expanded reimbursement, regardless of whether patients received other existing biologic drugs.

Stelara is a biologic with an interleukin (IL)-12/23 inhibitor.

In the phase 3 UNIFI study, Stelara demonstrated the induction and maintenance treatment of ulcerative colitis and showed a good safety profile.

According to the study, at week 8 of induction therapy, 61.8 percent of the Stelara-treated group showed a clinical response, which was significantly higher than the placebo group with 31.3 percent.

In maintenance therapy, at 44 weeks of administration, 38.4 percent of the Stelara 90mg group administered at 12-week intervals and 43.8 percent of the group administered at 8-week intervals achieved clinical remission, which was significantly higher than that of the placebo group with 24 percent.

Jung Tae-yun, Janssen’s Immunology BU Director, said many physicians and patients are worried about the loss of efficacy and side effects due to the characteristics of ulcerative colitis requiring long-term medication.

“I hope the expanded reimbursement could make Stelara provide therapeutic value to more patients by helping them maintain remission stably,” he said.