The development of new treatments for Crohn’s disease and other inflammatory conditions continues at a remarkable pace. Selective Interleukin-23 inhibition may be the next great advance in the treatment of inflammatory bowel disease (IBD). A recent clinical trial evaluating risankizumab (anti-IL-23) has demonstrated that it is more effective than placebo in patients with moderately-to-severely active Crohn's disease.
IBD is an immune-mediated chronic inflammation of the gastrointestinal tract. There are two types of IBD, Crohn’s disease and ulcerative colitis; both manifest as chronic immune-mediated inflammation of the gastrointestinal system. While they both cause similar symptoms, they are managed differently. Crohn’s disease may affect any part of the gastrointestinal system, from the mouth to the anus. Ulcerative colitis, however, is limited to the colon, otherwise known as the large intestine. It is estimated that 1.4 million Americans have IBD, which tends to run in families and affects males and females equally.
Normally, the cells and proteins that make up the immune system protect individuals from infection. In people with IBD, however, the immune system mistakes food, bacteria, and other materials in the intestine for foreign or invading substances. When this happens, the body sends white blood cells into the lining of the intestines, where they produce chronic inflammation and ulcerations—called an autoimmune response.
Risankizumab selectively blocks IL-23, a key protein involved in inflammatory processes that has been linked to a number of chronic immune-mediated diseases. The therapeutic potential of risankizumab is being evaluated in immunological disorders, including Crohn's disease, psoriasis and psoriatic arthritis. Risankizumab is not currently approved for use by regulatory authorities, and its safety and efficacy are being investigated in ongoing clinical trials.
Recently the results of a comparative, placebo controlled clinical trial showed clinical remission in 24% and 37% of those receiving 200 mg and 600 mg of risankizumab, respectively, compared with only 15% in the placebo control group. Endoscopic remission (normalization of the lining of bowel as seen during an endoscopy) was also achieved by 15% and 20% of patients receiving 200 mg and 600 mg risankizumab, respectively, compared with 3% of patients receiving placebo. Risankizumab was well tolerated in this clinical trial, the most frequently reported adverse events were nausea, worsening of Crohn`s disease, abdominal pain, vomiting, arthralgia, anemia and headache.
Reference: B Feagan et al. Efficacy and safety of induction therapy with the selective IL-23 inhibitor risankizumab (BI 655066), in patients with moderate-to-severe Crohn's disease: Results of a randomized, double-blind, placebo-controlled Phase II study. Digestive Disease Week, San Diego, USA, 21–24th May 2016. [Abstract ID 2483687]