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5 results on '"Guido Lupinacci"'

1. Safety and clinical efficacy of the double switch from originator infliximab to biosimilars CT‐P13 and SB2 in patients with inflammatory bowel diseases (SCESICS): A multicenter cohort study

Author

Stefano Mazza, Nicole Piazza O. Sed, Francesco Simone Conforti, Alberto Fascì, Alessandro Rimondi, Beatrice Marinoni, Valentina Casini, Chiara Ricci, Francesca Munari, Lorena Pirola, Pietro Invernizzi, Carlo Girelli, Guido Lupinacci, Luca Pastorelli, Flaminia Cavallaro, Luca Ferraris, Alice Colucci, Arnaldo Amato, Gian Eugenio Tontini, Maurizio Vecchi, Gionata Fiorino, and Flavio Caprioli

Subjects
Therapeutics. Pharmacology, RM1-950, Public aspects of medicine, RA1-1270
Abstract

Abstract Data regarding double switching from originator infliximab (IFX) to IFX biosimilars in inflammatory bowel diseases (IBDs) are lacking. The purpose of this study was to evaluate the safety and efficacy of switching from originator IFX to CT‐P13 and subsequently to SB2 (double switch) in patients with IBD. Patients undergoing IFX‐double switch in eight Centers in Lombardy (Italy) from November 2018 to May 2019 were retrospectively analyzed. The IFX discontinuation rate, incidence and type of adverse events (AEs), and clinical remission rate were recorded. A comparison with a control group of patients with IBD single‐switched from originator IFX to CT‐P13 was performed, before and after an inverse probability of treatment weighting (IPTW)‐based propensity score analysis. Fifty‐two double‐switched patients with IBD were enrolled. The 24‐ and 52‐week proportions of patients continuing on IFX therapy following the second switch (CTP13 → SB2) were 98% (95% confidence interval [CI] 94%–100%) and 90% (95% CI 81%–99%), respectively. Four patients experienced a total of five AEs, all graded 1–3 according to Common Terminology Criteria for Adverse Events (CTCAE). No infusion reactions were observed. The 24‐week and follow‐up end clinical remission rates following the second switch were 94% and 88%, respectively. No differences were observed in the safety and efficacy outcomes by comparing the double‐switch group with a single‐switch group of 66 patients with IBD; all these results were confirmed by IPTW‐adjusted analysis. The study suggests both the safety and efficacy of the double switch from originator IFX to CT‐P13 and SB2 in patients with IBD is maintained. This strategy may be associated with potential cost implications.

Published
2022
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2. Imatinib and Dasatinib-induced Ulcerative Colitis: Case Report

Author

Rachele Del Sordo, Gabrio Bassotti, Vincenzo Villanacci, Guido Lupinacci, and Giulia Tanzi

Subjects
medicine.medical_specialty, business.industry, Dasatinib, Gastroenterology, Imatinib, medicine.disease, Ulcerative colitis, Pyrimidines, Leukemia, Myelogenous, Chronic, BCR-ABL Positive, Internal medicine, Imatinib Mesylate, medicine, Humans, Immunology and Allergy, Colitis, Ulcerative, business, medicine.drug
Published
2021

3. Incidence and initial disease course of inflammatory bowel diseases in 2011 in Europe and Australia: Results of the 2011 ECCO-EpiCom inception cohort

Author

I. Kaimakliotis, Ebbe Langholz, A. De Padova, Sally Bell, Alberto Fernandez, I Mihu, Søren Avnstrøm, Adrian Goldis, Limas Kupčinskas, Daniela Lazăr, L. Barros, Svetlana Turcan, O Niewiadomski, EpiCom-group, Z. Vegh, K.H. Katsanos, J. Olsen, K R Nielsen, Shmuel Odes, Martin Bortlik, Laimas Virginijus Jonaitis, E.V. Tsianos, Peter L. Lakatos, Pia Munkholm, O Tighineanu, K. Kofod Vinding, Dana Duricova, Guido Lupinacci, Laszlo Lakatos, Vicent Hernandez, Fernando Magro, Johan Burisch, Niels C Pedersen, and Doron Schwartz

Subjects
Adult, Male, medicine.medical_specialty, Adolescent, Constriction, Pathologic, Rate ratio, Severity of Illness Index, Inflammatory bowel diseases, Epidemiology, Europe, Australia, Inflammatory bowel disease, Gastroenterology, Cohort Studies, Young Adult, Crohn Disease, Internal medicine, Humans, Medicine, Mesalamine, Aged, Aged, 80 and over, Crohn's disease, business.industry, Incidence, Incidence (epidemiology), Anti-Inflammatory Agents, Non-Steroidal, Smoking, Colonoscopy, General Medicine, Middle Aged, medicine.disease, Ulcerative colitis, 616.34-002 [udc], digestive system diseases, Cohort, Colitis, Ulcerative, Female, Steroids, business, Immunosuppressive Agents, Cohort study
Abstract

Background and aims: The aim of the present study was to validate the IBD (inflammatory bowel diseases) incidence reported in the 2010 ECCO-EpiCom (European Crohn's and Colitis Organization–Epidemiological Committee) inception cohort by including a second independent inception cohort from participating centers in 2011 and an Australian center to investigate whether there is a difference in the incidence of IBD between Eastern and Western European countries and Australia. Methods: Fourteen centers from 5 Eastern and 9 Western European countries and one center from Australia participated in the ECCO-EpiCom 2011 inception cohort. Patients' data regarding disease type, socio-demographic factors, extraintestinal manifestations and therapy were entered into the Web-based EpiCom database, www.ecco-epicom.eu. Results: A total of 711 adult patients were diagnosed during the inclusion year 2011, 178 (25%) from Eastern, 461 (65%) from Western Europe and 72 (10%) from Australia; 259 (37%) patients were diagnosed with Crohn's disease, 380 (53%) with ulcerative colitis and 72 (10%) with IBD unclassified. The mean annual incidence rate for IBD was 11.3/100,000 in Eastern Europe, 14.0/100,000 in Western Europe and 30.3/100,000 in Australia. Significantly more patients were diagnosed with complicated disease at diagnosis in Eastern Europe compared to Western Europe (43% vs. 27%, p = 0.02). Conclusion: Incidence rates, disease phenotype and initial treatment characteristics in the 2011 ECCO-EpiCom cohort were not significantly different from that reported in the 2010 cohort. * Abbreviations: : IBD : inflammatory bowel diseases CD : Crohn's disease UC : ulcerative colitis IBDU : inflammatory bowel disease unclassified ECCO : European Crohn's and Colitis Organization EpiCom : Epidemiological Committee IRR : incidence rate ratio CI : confidence interval EC-IBD : European Collaborative Study on Inflammatory Bowel Disease ACCESS : Asia-Pacific Crohn's and Colitis Epidemiology Study SE : standard error

Published
2014

4. Costs and Resource Utilization for Diagnosis and Treatment During the Initial Year in a European Inflammatory Bowel Disease Inception Cohort:An ECCO-EpiCom Study

Author

Jens Kjeldsen, Ebbe Langholz, Svetlana Turcan, Sven Almer, Shaji Sebastian, Y. Bailey, Jónger Olsen, Doron Schwartz, Niels Thorsgaard, Selwyn Odes, Daniela Lazăr, Riina Salupere, Susanne Krabbe, Michael Friger, Juan R. Pineda, Adrian Goldis, Konstantinnos H. Katsanos, Her-Hsin Tsai, Vibeke Andersen, Søren Avnstrøm, Hillel Vardi, L. Barros, Laimas Virginijus Jonaitis, I. Kaimakliotis, Angelo De Padova, Limas Kupčinskas, S. Cukovic-Cavka, Dan Greenberg, Jens Frederik Dahlerup, Colm A. OʼMorain, Dana Duricova, Peter L. Lakatos, Epameinondas V. Tsianos, Inna Nikulina, Laszlo Lakatos, Pekka Collin, Alberto Fernandez, Fernando Magro, K. Ladefoged, K R Nielsen, Natalia Pedersen, Johan Burisch, Pia Manninen, Jonas Halfvarson, Marko Brinar, Guido Lupinacci, Pia Munkholm, Elena Belousova, Martin Bortlik, Ida Vind, and Olga Shonová

Subjects
Male, Adult, medicine.medical_specialty, Time Factors, Adolescent, Epidemiology, Population, Inflammatory bowel disease, Gastroenterology, Cohort Studies, Young Adult, Internal medicine, Surveys and Questionnaires, medicine, Immunology and Allergy, Humans, education, Economics of IBD therapies, Aged, Health Resources/statistics & numerical data, Aged, 80 and over, education.field_of_study, Crohn's disease, business.industry, Standard treatment, Inflammatory Bowel Diseases/diagnosis, Health Care Costs, Middle Aged, Inflammatory Bowel Diseases, medicine.disease, Prognosis, Ulcerative colitis, Eastern european, Europe, Outcomes research, Cohort, Health Resources, Female, business, Health Care Costs/trends, Cohort study, Follow-Up Studies
Abstract

BACKGROUND: No direct comparison of health care cost in patients with inflammatory bowel disease across the European continent exists. The aim of this study was to assess the costs of investigations and treatment for diagnostics and during the first year after diagnosis in Europe.METHODS: The EpiCom cohort is a prospective population-based inception cohort of unselected inflammatory bowel disease patients from 31 Western and Eastern European centers. Patients were followed every third month from diagnosis, and clinical data regarding treatment and investigations were collected. Costs were calculated in euros (€) using the Danish Health Costs Register.RESULTS: One thousand three hundred sixty-seven patients were followed, 710 with ulcerative colitis, 509 with Crohn's disease, and 148 with inflammatory bowel disease unclassified. Total expenditure for the cohort was €5,408,174 (investigations: €2,042,990 [38%], surgery: €1,427,648 [26%], biologicals: €781,089 [14%], and standard treatment: €1,156,520 [22%)]). Mean crude expenditure per patient in Western Europe (Eastern Europe) with Crohn's disease: investigations €1803 (€2160) (P = 0.44), surgery €11,489 (€13,973) (P = 0.14), standard treatment €1027 (€824) (P = 0.51), and biologicals €7376 (€8307) (P = 0.31). Mean crude expenditure per patient in Western Europe (Eastern Europe) with ulcerative colitis: investigations €1189 ( €1518) (P < 0.01), surgery €18,414 ( €12,395) (P = 0.18), standard treatment €896 ( €798) (P < 0.05), and biologicals €5681 ( €72) (P = 0.51).CONCLUSIONS: In this population-based unselected cohort, costs during the first year of disease were mainly incurred by investigative procedures and surgeries. However, biologicals accounted for >15% of costs. Long-term follow-up of the cohort is needed to assess the cost-effectiveness of biological agents.

Published
2015

5. East-West gradient in the incidence of inflammatory bowel disease in Europe:The ECCO-EpiCom inception cohort

Author

I Mihu, Konstantinos Katsanos, K. Ladefoged, I. Kaimakliotis, J. Olsen, Vibeke Andersen, D. Martinez-Ares, Naila Arebi, Ebbe Langholz, Johan Burisch, A. De Padova, L. Barros, Svetlana Turcan, Daniela Lazăr, E.V. Tsianos, Yaroslava Zhulina, Jonas Halfvarson, Veronica Moset Hernandez, O Tighineanu, Shaji Sebastian, Niels Thorsgaard, Ida Vind, Y. Bailey, Silvija Čuković-Čavka, Jens Frederik Dahlerup, Peter L. Lakatos, Adrian Goldis, Olga Shonová, Gediminas Kiudelis, K R Nielsen, Dana Duricova, Niels C Pedersen, Riina Salupere, Matteo Martinato, Pekka Collin, Pia Munkholm, Pekka Manninen, Søren Avnstrøm, Monica Milla, Shmuel Odes, Fernando Magro, Guido Lupinacci, Einar Björnsson, Inna Nikulina, M Beltrami, G. Ragnarsson, Marko Brinar, Laszlo Lakatos, Sven Almer, Doron Schwartz, Simon Laiggard Krabbe, Limas Kupčinskas, Elena Belousova, and Renata D'Incà

Subjects
Adult, Male, medicine.medical_specialty, Adolescent, Colorectal cancer, Inflammatory bowel disease, Young Adult, Crohn Disease, Internal medicine, Epidemiology, Inflammatory bowel disease (IBD), inception cohort, East-West gradient, medicine, Humans, Europe, Eastern, Prospective Studies, skin and connective tissue diseases, Aged, Aged, 80 and over, Crohn's disease, medicine.diagnostic_test, business.industry, Incidence, Incidence (epidemiology), Gastroenterology, Colonoscopy, Middle Aged, Inflammatory Bowel Diseases, medicine.disease, INCEPTION COHORT, Ulcerative colitis, digestive system diseases, Surgery, Endoscopy, Europe, Colitis, Ulcerative, Female, sense organs, business
Abstract

Objective: The incidence of inflammatory bowel disease (IBD) is increasing in Eastern Europe. The reasons for these changes remain unknown. The aim of this study was to investigate whether an East-West gradient in the incidence of IBD in Europe exists. Design: A prospective, uniformly diagnosed, population based inception cohort of IBD patients in 31 centres from 14 Western and eight Eastern European countries covering a total background population of approximately 10.1 million people was created. One-third of the centres had previous experience with inception cohorts. Patients were entered into a low cost, web based epidemiological database, making participation possible regardless of socioeconomic status and prior experience. Results: 1515 patients aged 15 years or older were included, of whom 535 (35%) were diagnosed with Crohn's disease (CD), 813 (54%) with ulcerative colitis (UC) and 167 (11%) with IBD unclassified (IBDU). The overall incidence rate ratios in all Western European centres were 1.9 (95% CI 1.5 to 2.4) for CD and 2.1 (95% CI 1.8 to 2.6) for UC compared with Eastern European centres. The median crude annual incidence rates per 100 000 in 2010 for CD were 6.5 (range 0-10.7) in Western European centres and 3.1 (range 0.4-11.5) in Eastern European centres, for UC 10.8 (range 2.9-31.5) and 4.1 (range 2.4-10.3), respectively, and for IBDU 1.9 (range 0-39.4) and 0 (range 0-1.2), respectively. In Western Europe, 92% of CD, 78% of UC and 74% of IBDU patients had a colonoscopy performed as the diagnostic procedure compared with 90%, 100% and 96%, respectively, in Eastern Europe. 8% of CD and 1% of UC patients in both regions underwent surgery within the first 3 months of the onset of disease. 7% of CD patients and 3% of UC patients from Western Europe received biological treatment as rescue therapy. Of all European CD patients, 20% received only 5-aminosalicylates as induction therapy. Conclusions: An East-West gradient in IBD incidence exists in Europe. Among this inception cohort-including indolent and aggressive cases-international guidelines for diagnosis and initial treatment are not being followed uniformly by physicians.

Published
2014

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