When treating patients with Crohn’s disease, early use of an intensive combined immunosuppression (CI) in combination with conventional management is more effective than the current standard, treatment with corticosteroids. These outcomes were reported in an Article in the February 23, 2008 issue of The Lancet.
Crohn’s disease is a gastrointestinal disorder which is indicated by chronic inflammation of the wall of the digestive tract, usually in the ileum or large intestines. Current medical guidelines recommend that the active disease should be treated with corticosteroids, which are similar to steroid hormones in the body. These drugs usually treat the symptoms of Crohn’s well, but many patients become resistant to or dependent on them. Prolonged exposure can induce Cushing’s Syndrome and therefore an increased risk of mortality.
This alternative treatment, combined immunosuppression, was investigated by Dr Geert D’Haens, Imelda Gastrointestinal Clinical Research Centre, Imelda General Hospital, Bonheiden, Belgium, and colleagues. In a two year, open label, randomized trial, 133 patients at 18 centers in Europe were divided evenly to receive one of two treatments: one with infliximab with azathioprine initially and after 2 and 6 weeks, with additional infliximab and corticosteriods if necessary; and a second with a conventional treatment, intially with corticosteroids and followed by azathioprine and inflicimab. Primary outcome measures of the study at weeks 26 and 52 were remission without corticosteroids and without bowel resection.
At week 26, 60.0 percent of patients who underwent initial CI were in remission without the use of corticosteroids and without surgical resection. In contrast, 35.9 percent in the conventional management group had this outcome. By week 52, the rates were 61.5 percent and 42.2 percent respectively. Serious adverse events were similar in both groups (30.8 percent for CI, and 25.3 percent in conventional therapy.
The authors conclude, emphasizing the positive potential of this study: “Combined immunosuppression was more effective than conventional management for induction of remission and reduction of corticosteroid use in patients who had recently been diagnosed with Crohn’s disease. Initiation of more intensive treatment early in the course of the disease could result in better outcomes.”
Dr William Sandborn, Inflammatory Bowel Disease Clinic, Mayo Clinic, Rochester, MN, USA, contributed a Comment in the same issue of The Lancet, in which he said that the results of another deep study in this area, known as the SONIC trial, are due soon and much anticipated. He states: “If the
preliminary data on initial combination therapy in early Crohn’s disease reported by D’Haens
and colleagues are confirmed, the treatment algorithm for patients with Crohn’s disease will
change.”
Early combined immunosuppression or conventional management in patients with newly diagnosed Crohn’s disease: an open randomised trial
Geert D’Haens, Filip Baert, Gert van Assche, Philip Caenepeel, Philippe Vergauwe, Hans Tuynman, Martine De Vos, Sander van Deventer, Larry Stitt, Allan Donner, Severine Vermeire, Frank J Van De Mierop, Jean-Charles R Coche, Janneke van der Woude, Thomas Ochsenkühn, Ad A van Bodegraven, Philippe P Van Hootegem, Guy L Lambrecht, Fazia Mana, Paul Rutgeerts, Brian G Feagan, Daniel Hommes.
The Lancet – Vol. 371, Issue 9613, 23 February 2008, Pages 660-667
Written by Anna Sophia McKenney