152 153 Intestinal Disease Meeting Berlin 2006 - Dr. Falk Pharma ...

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Session 4 38 Relevance of Biologics Chair: M.A. Kamm, Harrow H. Lochs, Berlin Therapy planning – Step Up or Top Down? The classification of IBD was not the only area that sparked controversy in Berlin. Questions of therapy planning were also a matter of discussion, focusing to a great extent on whether the conventional “Step Up” approach should continue to be applied or whether, by integrating the use of biologics, a “Top Down” approach might have better chances of success. Speaking for this concept, in which biologics, such as infliximab, are used initially, was S.B. Hanauer (Chicago). The early, aggressive therapy with biologics can, he said, result in rapid disease stabilization and mucosal healing, with possible Fig. 27 Crohn’s disease Surgery Infliximab MTX AZA/6-MP Systemic steroids Budesonide Antibiotics 5-ASA Severe Moderate Mild I Current “therapeutic pyramids” (S.B. Hanauer, Chicago) S.B. Hanauer favorable effects on the further clinical course (figure 27). Evidence for this concept has been reported from a first comparison study in which 130 patients with active Crohn’s disease were treated initially with either infliximab plus azathioprine or with budesonide or prednisolone. Patients not responding to infliximab/azathioprine could receive prednisolone, while those not responding to steroids could receive azathioprine with or without infliximab. According to S.B. Hanauer, another piece of evidence underscoring the benefit of the “Top Down” approach was that patients in this group more frequently exhibited mucosal healing than did those in the “Step Up” group. Ulcerative colitis Surgery Cyclosporine Infliximab Systemic steroids 5-ASA
J. Schölmerich Only a minority of patients profits from the “Top Down” concept Not in favor of this concept was J. Schölmerich (Regensburg). In his opinion, the proponents of the “Top Down” concept overlook the fact that only a minority of patients do not benefit from the currently standard “Step Up” paradigm. The more aggressive “Top Down” approach would represent an unnecessary risk for these patients and also burden the medical insurance system with unjustifiable increased costs. According to J. Schölmerich, the goal of treatment of IBD consists of reducing patients’ symptoms, inducing and maintaining disease remission and thus preventing renewed acute disease flares and structural changes. “These objectives,” he said, “are realized in the majority of patients using the standard therapy.” Start with medications of proven efficacy The “Step Up” model begins with medications of proven efficacy, such as mesalazine in ulcerative colitis and, in Crohn’s disease, of this medication together with the locally acting steroid budesonide and, where indicated, antibiotics. Only when these medications do not prove effective, said J. Schölmerich, should patients be started on medications, such as systemic corticosteroids, azathioprine or even methotrexate, Congress Short Report Falk Symposium that are stronger but also are associated with greater risk of side effects. If patients fail to respond to these medications with remission or if they relapse the next step can be administration of the TNF-α inhibitor infliximab or cyclosporine, which is indicated in ulcerative colitis. Very few patients require accelerated therapy This type of accelerated therapy is required in only a small percentage of patients, the gastroenterologist said. A majority of patients, in fact, can be brought to remission during the first therapy step and can be maintained free of disease flares for extended periods. J. Schölmerich cited data according to which 35% of Crohn’s patients and 48% of those with ulcerative colitis remain symptom-free and feel well at four years. The fact that patients with inflammatory bowel diseases exhibit a practically normal life expectancy also confirms the success of the current standard treatment in the majority of cases. In addition, J. Schölmerich said, the exact meaning for an individual patient of endoscopically documented mucosal healing and whether this observation is associated with a better long-term outcome remains completely unclear. “Unlike in rheumatology, where joint destruction can be directly visualized, there are no corresponding endpoints in inflammatory bowel diseases,” J. Schölmerich said. At present, mucosal healing can be considered a surrogate parameter, the long-term meaning of which in achieving a favorable disease course remains unclear. According to J. Schölmerich, the current situation does not justify treating patients with newly diagnosed Crohn’s disease or ulcerative colitis according to the “Top Down” model. This would, in his opinion, represent “overtreatment”. 153 39
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