Immunomodulators As Part of Early Therapy in the Treatment of Ulcerative Colitis and Crohn's Disease

Without proper assessment and treatment, a patient with mild colitis or Crohn's disease can easily transition into more severe disease.

The use of immunomodulators in ulcerative colitis or Crohn’s disease usually begins in the “mildest moderate” patient, said Maria T. Abreu, MD, professor of medicine and chair, Division of Gastroenterology, University of Miami, Miller School of Medicine. This is usually when the symptoms of disease begin to affect the patient’s daily life.

“To me, the mildest moderate patients are somewhat symptomatic and have superficial ulcerations,” she said.

Abreu addressed the current clinical use of immunomodulators in the treatment of Crohn’s disease and ulcerative colitis during a presentation at the 2014 American Gastroenterological Association Clinical Congress of Gastroenterology and Hepatology in Miami Beach, FL, on Jan 17.

When colitis or Crohn’s patients say that they have taken immunomodulators before but that they did not help their symptoms, Abreu said she will ask them a series of questions to help determine if she should reconsider immunomodulator therapy. “I want to know what’s been tried, if the immunomodulator was used long enough, if it was the correct or optimized dose, and if the patient actually had a bad side effect,” she said.

Abreu will also assess disease severity by testing C-reactive protein and erythrocyte sedimentation rate, testing for anemia, and reviewing colonoscopy results if performed recently.

Without proper treatment, a patient with mild colitis or Crohn’s disease can easily transition into the moderate disease category, she said.

One guiding principle is that combination therapy is usually more effective than monotherapy for Crohn’s management, Abreu said. Early therapy is better than later therapy, and well-timed surgery can be useful as well, she added.

Although clinicians spend a good deal of time distinguishing ulcerative colitis from Crohn’s disease, the two respond to very similar treatments, including tumor necrosis factor inhibitors, anti-interleukin-12 and -13, adhesion molecule inhibitors, and immunomodulators, Abreu said.

There are an increasing number of immunomodulators available for the treatment of colitis and Crohn’s disease, including the 2013 approval of golumumab and the expected FDA approval of vedolizumab following positive recommendations from the Gastrointestinal Drugs Advisory Committee (GIDAC) and the Drug Safety and Risk Management Advisory Committee (DSaRMAC), Abreu said.

Results from the SONIC trials and continued related research provide landmark data about the effectiveness of immunomodulators and the treatment of Crohn’s disease, Abreu added. “SONIC is one of the most significant studies in the last 15 years of IBD,” she said.