Early combination therapy best for new Crohn's disease patients 

Last Updated: 2008-02-21 18:30:01 -0400 (Reuters Health)                    

NEW YORK (Reuters Health) - Early combined immunosuppression is more effective than standard therapy in achieving remission and reducing steroid use in patients with newly diagnosed Crohn's disease, new research indicates.

Corticosteroid therapy is the recommended initial treatment for patients with active disease, according to the report in the February 23rd issue of The Lancet. While this treatment is effective in controlling symptoms, many patients become dependent on or resistant to these agents. Moreover, long-term exposure to corticosteroids is linked to increased mortality.

Research in patients with rheumatoid arthritis, which is pathophysiologically similar to Crohn's disease, has shown that early treatment with TNF antagonists plus methotrexate achieves better outcomes than monotherapy with either agent. Earlier work has also shown that adding the TNF antagonist infliximab to azathioprine therapy improved outcomes for patients with steroid-dependent Crohn's disease.

In the current study, the Belgian Inflammatory Bowel Disease Research Group and the North-Holland Gut Club, led by Dr. Geert D'Haens at the Imelda Gastrointestinal Clinical Research Centre in Bonheiden, Belgium, randomized 133 patients with newly diagnosed Crohn's disease to receive either early treatment with infliximab and azathioprine, or conventional therapy.

The study group received three infusions of infliximab (5 mg/kg) at weeks 0, 2, and 6 with azathioprine. Steroids were given as needed. In the control group, steroids were given first, followed in sequence by azathioprine and infliximab.

At 26 weeks, the remission rate was 60.0% with combined immunosuppression versus 35.9% with conventional therapy (p=0.0062). At 52 weeks, the corresponding rates were 61.5% and 42.2% (p = 0.0278).

Serious adverse events were more common with combination therapy than with conventional therapy, but the difference was not statistically significant.

Dr. William J. Sandborn of the Mayo Clinic in Rochester, Minnesota comments in a related editorial that in line with results in rheumatoid arthritis, the current findings provide "preliminary evidence" that initial treatment with infliximab and azathioprine may be useful for early Crohn's disease.

Dr. Sandborn notes that the results of ongoing SONIC trial (Study of Biologic and Immunomodulator Naïve Patients in Crohn's Disease), expected in the second half of 2008, should provide definitive answers to whether treatment with azathioprine, infliximab, is best for patients with early Crohn's disease.

Lancet 2008;371:635-636,660-667.