Treatment Options for Ulcerative Colitis
Orlando—Clinicians have numerous options to treat patients with ulcerative colitis, a form of inflammatory bowel disease. The therapies include 5-amino-salacylic acid, thiopurine, and anti-tumor necrosis factor (TNF) agents such as infliximab. Surgical options include conventional ileostomy, continent ileostomy, ileal pouch-anal anastomosis, and ileorectal anastomosis.
Regardless of the treatment choice, the goal should be sustained disease control, which should be “the bar we all need to set,” according to Marla C. Dubinsky, MD, director of the Pediatric Irritable Bowel Disease Center at Cedars-Sinai Medical Center in Los Angeles, California. She spoke during a satellite symposium at DDW titled Ulcerative Colitis: Optimizing Treatment Strategies to Improve Patient Outcomes. Takeda Pharmaceutical Company Limited sponsored the session.
When dealing with ulcerative colititis, she suggested physicians aim for a normal endoscopy and mucosal healing and monitor the disease. They also need to focus on avoiding surgery and hopefully leaving patients with minimal or no disability. Dr. Dubinsky added that the combination of an immunomodulator and biologic drug is superior to monotherapy.
There are numerous predictors of poor response or colectomy in ulcerative colitis patients, according to Dr. Dubinsky, including bandemia, prolonged flare, active infection, severe endoscopic lesions, and low hemoglobin. She added that the traditional methods to treat irritable bowel disease are symptom-based and sequential and based on acute severity rather than longitudinal changes. Remission is typically defined by the number of bowel movements, blood, or urgency, while flares are defined by patients as a change in their symptoms.
Dr. Dubinsky cited an Internet-based survey of 451 patients with ulcerative colitis in which 74% said having daily disease symptoms was normal. In addition, only 42% of respondents knew that remission meant patients had no symptoms.
Managing Ulcerative Colitis
Brian G. Feagan, MD, director of Robarts Clinical Trials at the University of Western Ontario, Canada, followed with a discussion of the treatment options. He mentioned the conventional approach is sequential and is based on disease severity.
Dr. Feagan cited a study that found 17.9% of patients who took 9 mg of budesonide extended-release tablets had clinical remission at week 8 compared with 7.6% in a placebo group (P=.01). In the same trial, 13.2% of patients who took 6 mg of budesonide extended-release tablets had clinical remission at week 8, a statistically significant increase compared with the placebo group (P=.01).
Corticosteroids are effective for induction of remission in ulcerative colitis, according to Dr. Feagan, but the effect is not durable and patients can become dependent on the drugs. He said prolonged exposure to corticosteroids is not recommended because they are associated with adverse effects. The most effective available therapy is the combination of a TNF antagonist plus azathioprine, according to Dr. Feagan.
Dr. Feagan also discussed tofacitinib, an oral janus kinase inhibitor. The FDA approved tofacitinib in November 2012 to treat patients with moderately to severely active rheumatoid arthritis. However, the drug is not approved for ulcerative colitis, although a phase 2 trial found the drug was superior to placebo when assessing the clinical response rate at week 8.
Another option is adalimumab, which the FDA approved in September 2012 for moderate-to-severe ulcerative colitis. Dr. Feagan cited a study that found significantly more patients who took adalimumab had clinical remission at weeks 8 and 52 compared with patients who received placebo.
