47th Annual Gastroenterology Update: Biologic Therapies for Inflammatory Bowel Disease, Part 1

Cleveland, OH—Ahmed Kandiel, MD, MPH, kicked off the 47th Annual Gastroenterology Update with his lecture "Which Patient/Which Biologic?" Kandiel started his lecture with a thorough review of the current treatment landscape for moderate to severe inflammatory bowel disease, including the potential risks for side effects for each biologic agent.

He began by comparing results from three recent clinical trials: ACCENT 1, CHARM, and PRECiSE, which monitored patients with moderate to severe IBD who received infliximab, adalimumab, or certolizumab pegol, respectively. “For patients who initially responded to anti-TNF therapy, the steroid-free remission rate at either week 26 or 30 ranges from 39% for infliximab to 47.9% for certolizumab pegol,” said Kandiel. However, he noted the overall remission rates for patients with moderate to severe IBD were lower, ranging from 22.8% for infliximab to 30.7% for certolizumab pegol. The steroid-free remission rate at week 26 occurred in 40% of adalimumab-treated patients and overall remission was only 24%.

Kandiel shifted his focus to ENCORE trial which evaluated the efficacy of natalizumab induction therapy in patients with Crohn's disease. Natalizumab is a fully humanized antibody against alpha-4 integrin, and can be used if a patient has failed at least one anti- TNFα therapy. Results from the ENCORE study showed sustained remission occurred in 26% of natalizumab-treated patients. “The results of this trial were comparable to overall remission rates observed in the trials examining the efficacy of anti-TNFα agents,” he said.

Risk of Biologics?

While biologic therapy has led to an improved quality of life and fewer side effects from corticosteroids and/or immunomodulators, several unexpected adverse events have occurred and been recognized as related to biologic agents. Infections, infusion reactions (with inflixmab), liver injury, development of autoantibodies and drug induced lupus, cancer or lymphoma, and congestive heart failure are all potential risks with anti-TNF therapy Kandiel said. “Before starting anti-TNF therapy, it is very important to test the patient for tuberculosis and hepatitis B infection.” Kandiel highlighted the risks of natalizumab therapy, including infections, liver injury, and acute hypersensitivity reactions. “Obviously, the side effect we are most concerned of is progressive multifocal leukoencephallopathy (PML).” Natalizumab was briefly taken off the market due to PML, which is caused by the reactivation of JC virus.