The FDA has in adults, said manufacturer Janssen Biotech.
"Crohn's disease is a complex condition to treat, and not all therapies work for every patient," said , of the University of California San Diego School of Medicine, in a statement issued by the company.
"This therapy offers an alternate mechanism of action to induce and maintain clinical remission over time," said Sandborn, who a lead investigator for the Crohn's disease clinical trials.
Ustekinumab blocks interleukins 12 and 23, proinflammatory cytokines upregulated in inflammatory bowel disease, through their common p40 subunit. It has previously been approved for use in plaque psoriasis and psoriatic arthritis.
Clinical studies have found that ustekinumab was effective both in patients who had previously failed conventional therapies and in those who had failed anti-tumor necrosis factor (TNF) treatment.
In a study known as , among 741 patients with longstanding disease (mean duration 10 years) and a history of TNF failure -- meaning inadequate response or the inability to tolerate the medication -- 34% achieved a clinical response at 6 weeks compared with 22% of those given placebo.
In a second study, UNITI-2, among 628 patients whose median disease duration was 6 years and who had been treated unsuccessfully with immunosuppressives and corticosteroids but not TNF inhibitors, 56% achieved clinical responses at week 6 compared with 29% of those given placebo.
Then, in an additional phase III study, , which included 388 patients with moderate to severe disease, 53% of patients who received 90 mg of ustekinumab subcutaneously every 8 weeks were in clinical remission, defined as a Crohn's Disease Activity Index below 150, after a year compared with 36% of those given placebo (P=0.005).
Ustekinumab is given as a a one-time, weight-based intravenous infusion of 260 mg for patients weighing 55 kg or less, 390 mg for those weighing 55 to 85 kg, or 520 mg for those weighing more than 85 kg. This is then followed by subcutaneous maintenance injections of 90 mg every 8 weeks. The maintenance injections can be administered by a healthcare professional or self-injected by the patient.
Safety concerns with ustekinumab include risks of serious infections, malignancies, reversible posterior leukoencephalopathy syndrome, and allergic reactions.