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• W2000645384 abstract "Reply: We would like to thank Heuschkel et al for their comments on our case report (1). These comments enable an interesting debate on first-line infliximab therapy. We fully agree with the authors that the use of infliximab at diagnosis in Crohn disease (CD) is not the routine way to treat patients with CD, and we want to stress that our case presentation does not intend to change the current treatment guidelines. This does not mean, however, that a discussion on the ideal initial treatment policy in pediatric CD should be avoided. The use of biological therapy (eg, infliximab) early in the disease process may eventually prove to be more advantageous than waiting for conventional therapy to fail. Moreover, it may alter the natural course of the disease (2). Therefore, a top-down strategy may turn out to be the way to go in a specific group of pediatric patients with CD. Heuschkel et al describe mucosal healing by exclusive enteral nutrition and azathioprine in their pediatric patients with inflammatory bowel disease, by now considered as an important therapeutic target. However, a recent study showed that isolated colonic CD in children did not respond well to treatment with enteral nutrition (3). Endoscopic and histological colonic mucosal assessment did not show posttreatment improvement in the colonic group. Apparently, colonic mucosal healing is somewhat more unusual than the authors suggest in their comments. Conventionally, newly diagnosed CD patients are treated with enteral nutrition or corticosteroids for remission induction, in some cases azathioprine is started immediately; however, our patient was severely ill and had multiple severe deep ulcerations throughout the whole colon without ileal disease. Because our experience confirms the finding by Afzal et al (3) that isolated colonic CD in children does not respond well to treatment with enteral nutrition, first-line infliximab therapy was started. As the authors state, there is no published evidence that the severity of endoscopic lesions predicts treatment response. So far, the only known predictors of infliximab efficacy are not smoking, absence of stricturing disease, and concomitant immune modulation, all of which were applicable to our patient (4). Another approach to achieve remission induction is corticosteroid therapy, but this does not result in mucosal healing. Moreover, corticosteroids have many side effects such as Cushing syndrome, osteoporosis, growth failure, and infection. Moreover, in the Crohn's Therapy, Resource, Evaluation and Assessment Tool registry corticosteroid use was associated with increased mortality (5). Recently, a randomized controlled trial in 130 adults with CD compared top-down treatment with 3 infusions of infliximab and azathioprine to step-up treatment with corticosteroids. A statistically higher efficacy of infliximab, if started according to the top-down strategy (remission attained in 74.5% [top-down] vs 48.1% [step-up], P = 0.006), was shown. Infliximab as first-line therapy seemed to promote long-term remission and seemed to change the course of disease (6). The remission rates in the combined immune suppression arm in this study were remarkably higher than what has been observed in other therapeutic trials in CD, most likely because of the early stage at which treatment was initiated, and patients who received combined immunosuppression in this study were less likely to have mucosal ulceration at 24 months. The authors suggest that our patient was led to become prejudiced against or even prevented from later infliximab use. However, our patient was pretreated with hydrocortisone infusions immediately before the 2 first infliximab infusions, received infliximab infusions of 5 mg/kg at week 0, 2, and 6 and then maintenance every 8 weeks, and immediately started azathioprine 2 mg/kg once daily. This should minimize the risk of human anti-chimeric antibody formation. We disagree that an effect of therapy should always be proven in adults before offering this to children. A child is not a small adult, and both efficacy and safety may be different in a pediatric population. Our patient was prone to growth retardation, pubertal delay, and psychosocial problems, so reaching clinical remission was of the utmost importance. At present, 18 months after the start of infliximab therapy, she still is in clinical remission and taking methotrexate and infliximab. The interval between the infusions is now being stretched and infliximab will be discontinued if she maintains her remission. However, we fully share the grave concern of Heuschkel et al about the development of lymphomas. By now, 8 cases of hepatosplenic T cell lymphomas are reported to the US Food and Drug Administration in young patients with inflammatory bowel disease after exposure to infliximab combined with a purine analogue, almost uniformly with a fatal outcome (7). These reports are of high importance in the decision-making process of treatment guidelines and should be taken into account when designing future studies on top-down strategies. We agree with the authors that international collaboration is necessary to perform randomized controlled studies to evaluate the optimal treatment therapeutic strategies of infliximab therapy in pediatric CD. Only then will the optimal long-term outcome in pediatric CD patients as concerns disease activity, number of relapses, hospital admissions, surgical intervention, growth, and quality of life be answered." @default.
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• W2000645384 date "2007-07-01" @default.
• W2000645384 modified "2023-09-25" @default.
• W2000645384 title "Authors' Response to Letter" @default.
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• W2000645384 doi "https://doi.org/10.1097/mpg.0b013e318058ca95" @default.
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