Janssen Pharmaceutical said Wednesday that the Ministry of Health and Welfare has decided to reimburse Stelara (Ingredient: ustekinumab) for the treatment of patients with moderately to severely active Crohn’s disease (CD).
With the insurance coverage, the drug can now treat patients living with moderately to severely active Crohn’s disease, Crohn's Disease Activity Index (CDAI) ≥ 220, who have lost response, had an inadequate response, or were intolerant to conventional therapy, such as immunomodulators or corticosteroids, or have medical contraindications to such treatments.
The American College of Gastroenterology (ACG) clinical guidelines strongly recommended the drug as a treatment for moderately to severely active CD patients who have had no prior exposure to anti-TNF-alpha therapy, according to the company, a subsidiary of Johnson and Johnson.
Stelara is a fully human monoclonal antibody that targets both interleukin (IL)-12 and IL-23, which plays a role in the regulation of immune response and reduces the activation of inflammatory cells that cause the disease.
The recommended dose for the weight-based, one-time IV induction is 260 mg, 390 mg or 520 mg. Doctors then can administer the subsequent maintenance doses of 90mg through a subcutaneous injection at every 12 weeks.
Patients who have lost response after eight weeks from the first subcutaneous injections can benefit by shortening the dosing interval to every eight weeks.
The drug has proved its efficacy and safety as both induction (130 mg and ~6 mg/kg) and maintenance therapy (90mg) in patients with moderately (CDAI ≥ 220) to severely (CDAI ≤ 450) active CD from three pivotal, Phase 3, multicenter, randomized, double-blind, placebo-controlled, parallel group studies -- UNITI-1, UNITI-2 and IM-UNITI.
In the follow-up study through week 96, the drug continued to be well tolerable with a favorable safety profile that did not differentiate from placebo.
The company confirmed the efficacy and safety of the drug as maintenance therapy in adult patients with moderately to severely active CD who had responded to a single intravenous dose of Stelara through the IM-UNITI study.
“Crohn’s disease (CD) is a type of chronic inflammatory bowel disease which is prevalent among adolescents and young adults. It requires lifelong care because the symptoms worsen and improve in a vicious circle,” said Jeen Yoon-tae, president of Korean Association for the Study of Intestinal Diseases.
The drug may provide greater convenience for people with CD because it can be treated by subcutaneous injection every 12 weeks after the initial intravenous infusion, and proved its efficacy and safety as both induction and maintenance therapy from three trials, he added, noting that the drug is expected to become a new treatment option for CD patients.
Managing Director of Janssen Korea Jenny Zheng also said, “We are pleased to provide STELARA®, the first and only treatment in Korea targets IL-12 and IL-23, as a new treatment option for patients with CD in Korea, and we remain committed to working towards a world free of immune diseases.”