Combined immunosuppression (CI) therapy is more effective than conventional treatment using corticosteroids for inducing remission in and management of patients recently diagnosed with Crohn’s disease. Using intensive immunosuppressive therapy early in the course of the disease could result in better outcomes. These are the conclusions of authors of an Article in this week’s edition of The Lancet.
Crohn’s disease is a chronic inflammatory disorder of the gastrointestinal tract. Current practice guidelines recommend that most patients with active disease should be treated initially with corticosteroids. Although this approach is usually effective for control of symptoms, many patients become resistant to, or dependent on, these drugs. Long exposure to corticosteroids are also associated with the complications of Cushing’s syndrome*, and also therefore and increased risk of mortality.
Dr Geert D’Haens, Imelda Gastrointestinal Clinical Research Centre, Imelda General Hospital, Bonheiden, Belgium, and colleagues did a 2-year open-label randomised trial of 133 patients at 18 centres in Belgium, Holland, and Germany. The 67 patients assigned to CI received three infusions of infliximab (5mg/kg of bodyweight) at weeks 0, 2, and 6, with azathioprine. Additional treatment with infliximab and, if necessary, corticosteroids, was given to control disease activity. The 66 patients asigned to conventional management received corticosteroids, followed, in sequence, by azathioprine and infliximab. The primary outcome measures of the study were remission without corticosteroids and without bowel resection at weeks 26 and 52.
The researchers found that, at week 26, 60.0% of the patients in the CI group were in remission without corticosteroids and without surgical resection, compared with 35.9% in the conventional management group. By week 52, the corresponding rates were 61.5% in the CI group and 42.2% in the conventional therapy group. Proportions of patients having serious adverse events were similar in both groups - 30.8% in the CI group, 25.3% in the conventional therapy group.
The authors conclude: “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.”
In an accompanying Comment, Dr William Sandborn, Inflammatory Bowel Disease Clinic, Mayo Clinic, Rochester, MN, USA, says that results from another further study in this area – the SONIC** trial – are eagerly awaited. They are due in the second half of 2008. He says: “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.”
Notes to editors: *Cushing’s syndrome is a condition that results from excess levels of steroid hormones in the blood that are usually produced by the adrenal glands, caused either directly by malfunctioning adrenal glands or a malfunctioning pituitary gland sending too high a signal to the adrenal glands, with the same result.
**SONIC trial: Study of Biologic and Immunomodulator Naïve Patients in Crohn’s Disease
Dr Geert D’Haens, Imelda Gastrointestinal Clinical Research Centre, Imelda General Hospital, Bonheiden, Belgium, T) +3215505161 /+32474987756 E) geert.dhaens@imelda.be
Dr William Sandborn, Inflammatory Bowel Disease Clinic, Mayo Clinic, Rochester, MN, USA T) +1 507-284-5005 E) sandborn.william@mayo.edu
PDF OF ARTICLE: http://multimedia.thelancet.com/pdf/press/Crohn.pdf
Journal
The Lancet