Niels Teich1, Michael Bläker2, Frank Holtkamp-Endemann3, Eric Jörgensen4, Andreas Stallmach5, Susanne Hohenberger6. 1. Internistische Gemeinschaftspraxis für Verdauungs- und Stoffwechselkrankheiten Leipzig und Schkeuditz, Leipzig, Germany. 2. Gastroenterologie/Gastropraxis Eppendorfer Baum, Hamburg, Germany. 3. Gastroenterologische Gemeinschaftspraxis am Germania-Campus, Münster, Germany. 4. Magen-Darm-Zentrum Remscheid, Remscheid, Germany. 5. Klinik für Innere Medizin IV, Gastroenterologie, Hepatologie, Infektiologie, Interdisziplinäre Endoskopie, Universitätsklinikum Jena, Jena, Germany. 6. Medical Affairs, MSD Sharp & Dohme GmbH, Haar, Germany.
Abstract
INTRODUCTION: Infliximab (IFX) therapy is efficacious for inducing and maintaining symptomatic remission in patients with Crohn's disease (CD), but whether this benefit results in reduced hospitalization rates and therefore may improve patients' quality of life in an economically sensible way is conflicting so far. METHODS: We conducted a noninterventional, multicenter, open-label, prospective study to evaluate the effect of originator IFX treatment on patient-reported outcomes and disease-related hospitalizations in adult CD patients in Germany treated for the first time with IFX according to label. RESULTS: Two hundred and ninety-four patients were included in the study. We observed a statistically significant reduction in the number of CD-related hospitalizations from the year before baseline (mean 1.00 per patient, SD ± 0.93) to the mean value of the 1st (0.62, SD ± 0.95) and 2nd year (0.32, SD ± 0.75) of the observation period (p < 0.0001). After 3 months of IFX therapy, work productivity and activity increased by an average of 12.6 and 17.1%, respectively. Patient's clinical outcome was markedly improved as the total CD activity index (CDAI) sum score continuously decreased from baseline to month 24 and the mean score of the total inflammatory bowel disease questionnaire (IBDQ) changed substantially from 141 at baseline to 172 after 24 months of IFX treatment. Additionally, the number of work incapacity days declined. Recently, no new safety issues of IFX have been identified. CONCLUSION: In this large, prospective, multicenter study on disease-related hospitalization rates, work productivity, capacity for daily activities, and HRQoL in patients with CD, IFX significantly reduces their hospitalization rates and improves work productivity, daily activity, and quality of life over 24 months.
INTRODUCTION: Infliximab (IFX) therapy is efficacious for inducing and maintaining symptomatic remission in patients with Crohn's disease (CD), but whether this benefit results in reduced hospitalization rates and therefore may improve patients' quality of life in an economically sensible way is conflicting so far. METHODS: We conducted a noninterventional, multicenter, open-label, prospective study to evaluate the effect of originator IFX treatment on patient-reported outcomes and disease-related hospitalizations in adult CD patients in Germany treated for the first time with IFX according to label. RESULTS: Two hundred and ninety-four patients were included in the study. We observed a statistically significant reduction in the number of CD-related hospitalizations from the year before baseline (mean 1.00 per patient, SD ± 0.93) to the mean value of the 1st (0.62, SD ± 0.95) and 2nd year (0.32, SD ± 0.75) of the observation period (p < 0.0001). After 3 months of IFX therapy, work productivity and activity increased by an average of 12.6 and 17.1%, respectively. Patient's clinical outcome was markedly improved as the total CD activity index (CDAI) sum score continuously decreased from baseline to month 24 and the mean score of the total inflammatory bowel disease questionnaire (IBDQ) changed substantially from 141 at baseline to 172 after 24 months of IFX treatment. Additionally, the number of work incapacity days declined. Recently, no new safety issues of IFX have been identified. CONCLUSION: In this large, prospective, multicenter study on disease-related hospitalization rates, work productivity, capacity for daily activities, and HRQoL in patients with CD, IFX significantly reduces their hospitalization rates and improves work productivity, daily activity, and quality of life over 24 months.
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