Janssen's ulcerative colitis treatment to receive reimbursement

The Janssen Pharmaceutical, a subsidiary of Johnson & Johnson, said Tuesday that the Ministry of Health and Welfare would begin to reimburse Stelara, its active ulcerative colitis (UC) treatment, from this month.

Janssen's ulcerative colitis treatment Stelara has gained insurance benefits from January. (Janssen)

Patients eligible for reimbursement include those who have failed or were intolerant to or have medical contraindications to one or more anti-TNFα or integrin inhibitor treatments.

The ministry based its approval on a phase 3 UNIFI global clinical trial and two maintenance trials designed to evaluate the drug's efficacy and safety on moderate to severe active UC patients.

During Week 8 of the UNIFI-I study, the percentages of patients in clinical remission were higher in the Stelara group compared to the placebo group. In the maintenance study, the share of patients in clinical remission at Week 44 among patients who had a clinical response to induction treatment with the drug was significantly higher in the groups that received 90mg of Stelara every 12 weeks compared to those that received the drug every eight weeks or the placebo group.

"UC is a chronic, progressive inflammatory bowel disease that requires lifelong and ongoing care," said Professor Kim Joo-sung of the Department of Gastroenterology at Seoul National University Hospital. "The rapid onsite of action and chance of long-term clinical remission combined with a consistent safety profile make Stelara an alternative biologic option for patients with moderately to severely active ulcerative colitis."

Janssen Korea Managing Director Jenny Zheng also said, "We are pleased that Stelara, which is the first and only biologic treatment in Korea that targets IL-12 and IL-23, is available for Korean UC patients."

Stelara is the first and only biologic treatment approved in Korea that blocks the action of two proteins (cytokines) in the body called interleukin (IL)-12 and IL-23.

According to the company, IL-12 and IL-23 are essential contributors to chronic inflammation, which are the hallmark of immune-mediated bowel diseases like UC.

In November last year, the ministry approved Stelara to treat Korean adults with moderately to severely active UC.

Adults with UC receive the first dose of Stelara via an intravenous infusion weight-based dosage. Eight weeks after the induction dose, patients receive 90mg through a subcutaneous injection and continue treatment with a maintenance injection every 12 weeks after that.

For patients who do not respond enough or have lost response to the drug eight weeks after the first subcutaneous dose, hospitals can continue treatment on an eight-week treatment cycle instead of the original 12 weeks.