Johnson & Johnson said on Monday that the U.S. Food and Drug Administration approved the company's psoriasis drug, Stelara® (ustekinumab), for use in adults with Crohn's disease. The drug is currently approved in the United States to treat the skin condition scaly plaque psoriasis and a type of arthritis associated with psoriasis. According to recently released data, Stelara (ustekinumab) significantly reduced symptoms in Crohn's disease with just one infusion.
Crohn’s disease and ulcerative colitis (collectively called inflammatory bowel disease, or IBD) result from a hyperactive immune system that attacks the gastrointestinal system. The immune system’s attack leads to inflammation of the intestines causing abdominal pain, diarrhea, rectal bleeding, and other symptoms. Immunotherapies for IBD aim to suppress the excessive, inappropriate immune response that is causing the inflammation.
More than five million people worldwide are living with IBD. Crohn’s disease affects approximately 700,000 Americans.2 The cause of Crohn’s disease is not known, but the disease is associated with abnormalities of the immune system that could be triggered by a genetic predisposition or diet and other environmental factors. There is currently no cure for Crohn’s disease.2
The first drugs to treat Crohn’s disease (Remicade® (infliximab) work by blocking tumor necrosis factor (TNF—a mediator of inflammation) and were approved in 1998. Since then several other drugs targeting TNF have come on the market. They are given by injection, either into a vein or under the skin.
Stelara blocks the activity of some types of interleukins (another substance that helps immune cells communicate), and has been undergoing evaluation as a treatment for Crohn’s disease in late-stage clinical trials. Stelara is already FDA approved for other inflammatory disorders and will be considered for use in Crohn’s in the near future.
In a recent study Stelara was first given as an "induction" treatment designed to bring Crohn's under control. Overall, 628 patients were divided into three groups. Two groups received a single infusion of Stelara at one of two different doses and a third group received a placebo infusion. Eight weeks later, 47 percent of patients getting a low Stelara dose and 58 percent getting a high dose had major symptom improvement, compared with 32 percent of those receiving placebo.
Several other soon-to-be-completed Crohn's studies are evaluating Stelara maintenance doses administered every 12 weeks to see how they fare longer term.