Infliximab for pediatric patients with Crohn’s disease: A Phase 3, open-label, uncontrolled, multicenter trial in Japan (original) (raw)
57.1% (12/21), and "nasopharyngitis" having an incidence rate of 33.3% (7/21). The SOCs of ADRs having a high incidence rate were "investigations" having an incidence rate of 57.1% (12/21), and the ADR having a high incidence rate was "double stranded DNA antibody positive" having an incidence rate of 57.1% (12/21). (2) The incidence rates of serious AEs and serious ADRs were 14.3% (3/21) and 4.8% (1/21), respectively. "Colitis ulcerative" (recorded as "worsened ulcerative colitis" by the investigator) occurred in 2 patients, but a causal relationship of this event with the study drug was ruled out. Since serious ADR, "enterocolitis" was observed. This event was moderate and recovery occurred without any treatment. (3) The incidence rate of AEs leading to discontinuation of the study was 4.8% (1/21), and the event was "colitis ulcerative" (recorded as "worsened ulcerative colitis" by the investigator). No ADRs leading to discontinuation of the study were observed. (4) The incidence rates of infections and infections (ADRs) were 61.9% (13/21) and 23.8% (5/21), respectively. The event having the highest incidence rate was "nasopharyngitis" having an incidence rate of 33.3% (7/21). The incidence rate of serious infections was 4.8% (1/21), and the only one event was "enterocolitis." No infections leading to discontinuation of treatment were observed. (5) The incidence rates of infusion reactions and infusion reactions (ADRs) were both 9.5% (2/21). The events were moderate and mild, each observed in one patient, but in both of the events recovered occurred on the same day that the reactions occurred. No serious infusion reactions and infusion reactions leading to discontinuation of treatment were observed.
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Gastroenterología y hepatología
BACKGROUND: Efficacy of infliximab in Crohn's disease (CD) showed by randomized controlled trials must be confirmed in clinical practice. We aimed to evaluate efficacy and safety of infliximab in CD patients of the Madrid area, looking for clinical predictors of response. METHODS: Multicenter retrospective survey of all CD patients treated with infliximab in 8 University hospitals of the Madrid area (Spain) with a minimum follow up of 14wks. RESULTS: 169 patients included (48%males, mean age 39 ± 12 yrs). 64% of them had perianal disease. 82% were under immunosuppressants. 1355 infliximab infusions administered (mean 8, range 1-30). 90% response rate and 4 8 % remission rate were obtained with induction therapy. 73% followed maintenance treatment, and 78% of them maintained or improved the response after a mean follow up of 28 months (range 3.5-86). 24 patients lost response during the follow up, after a mean of 41wks (range 6-248). Only the prescription of maintenance therapy was predictive factor for favourable response (p < 0.01). 17 infusion reactions were reported (10% of the patients, 1.2% of the infusions; only one case was severe) and were the cause of treatment withdrawal in 7 patients. Co-treatment with immunosuppressive drugs and maintenance infliximab therapy were protective factors for infusion reactions (p < 0.05). Other adverse events occurred in 26% of the patients, and were cause of treatment withdrawal in 7 patients. CONCLUSIONS: Infliximab is effective and safe for CD management but concomitant immunosuppressive drugs and maintenance treatment should be prescribed to obtain the best outcome. That confirms in a real life clinical setting the favourable results obtained in randomized clinical trials.
Gastroenterology & hepatology, 2007
Infusion reactions have been associated with infliximab therapy, but no study has assessed how physicians treat and manage this common adverse event. To determine how gastroenterologists manage infusion reactions, identify prophylactic pretreatment protocols, and determine infliximab treatment persistence in the presence of infusion reactions. This retrospective multicenter chart review analyzed data from adults younger than 90 years at the time of their first infliximab infusion from 9 academic or community-based gastroenterology practices. Infusion reaction rates were compared using a Chi-square test with Yates' correction. Kaplan-Meier methods assessed infliximab treatment persistency. Among 6,468 infusions with known infusion reaction status administered to 447 patients, 3.5% (226/6,468) of infusions resulted in an infusion reaction, and less than 0.1% (2/6,468) were associated with a serious infusion reaction. Among all patients, 19.7% (88/447) experienced at least 1 infusi...
Infliximab for Crohn's disease in clinical practice at the Mayo clinic: The first 100 patients
Gastroenterology, 2000
The aim of this study was to report the clinical outcome and adverse events in the first 100 patients with refractory inflammatory and/or fistulizing Crohn's disease treated with infliximab at the Mayo Clinic. METHODS: Patient data was abstracted from medical records. Clinical response was classified as complete response, partial response, and nonresponse. RESULTS: Indications for infliximab therapy were: inflammatory disease (61 patients), fistulizing disease (26 patients), or both (13 patients). Patients received one to seven infusions of infliximab (5 mg/kg) for a total of 242 infusions. In all, 50 patients had complete response, 22 had partial response, and 28 had nonresponse. Median time to response was 7 days (range 1-21 days). Median duration of response was 10.3 weeks (range 3-25 wk). A total of 95 patients received concomitant treatment with immune modifiers. Steroid withdrawal was possible in 29/40 patients (73%). Median time of follow-up was 34 wk (range 14-48 wk). Clinically significant adverse events after infliximab included: abscess formation in two patients (perianal, peristomal), pneumonia in two patients, varicella zoster in three patients, candida esophagitis in one patient, and infusionrelated reactions in 19 patients. A total of 23 patients were continued on infliximab as maintenance treatment.
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