Remission from Crohn's disease is promising if patients adopt a treatment of biologic therapy combined with immune-suppressing drugs rather than using immune-suppressing drugs alone.
The study has been published in the April 15, 2010 issue of the New England Journal of Medicine. It found treatment of moderate to severe Crohn's disease with infliximab plus azathioprine allows more patients to achieve remission and mucosal healing than therapy with azathioprine alone.
"These study results are strong enough to change clinical practice," says William Sandborn, M.D., (http://www.mayoclinic.org/bio/10948686.html) gastroenterologist and vice chair of the Division of Gastroenterology and Hepatology, Mayo Clinic, Rochester. "They have certainly changed mine."
The researchers in the international, multi-center SONIC (Study of Biologic and Immunomodulator Naive Patients in Crohn's Disease) study recruited 508 patients with Crohn's disease who were naive to immunomodulator drugs. The patients were then randomized to treatment: 169 infliximab monotherapy, 170 azathioprine monotherapy, or 169 infliximab plus azathioprine combination therapy. Patients underwent colonoscopies at baseline and again at week 26. Patients still in the trial at week 30 were given the option of continuing in a blinded extension trial for another 20 weeks.
Researchers found that 57 percent of patients who received combination therapy with infliximab and azathioprine achieved steroid-free remission after 26 weeks. This is compared to 44 percent of patients who achieved remission with infliximab monotherapy and 30 percent with azathioprine alone. Both the infliximab combination therapy and infliximab monotherapy groups were statistically superior to the azathioprine group. These results were durable through week 50 and overall results show comparable safety in the three groups.