Ákos Iliás, K Szántó, Lóránt Gönczi, Zsuzsanna Kürti, Petra A. Golovics, Klaudia Farkas, Eszter Schäfer, Zoltán Szepes, Balázs Szalay, Áron Vincze, Tamás Szamosi, Tamás Molnár, Péter L. Lakatos,
There is evidence that it is safe and effective for patients with inflammatory bowel diseases (IBD) to switch from maintenance therapy with an original infliximab drug to a biosimilar, but little is known about outcomes of reverse switches and/or multiple switches. We aimed to evaluate the effects of a reverse switch (from a biosimilar to Remicade) in a real-life cohort.We performed a prospective observational study of 174 unselected and consecutive patients with IBD (136 with Crohn's disease [CD] and ...
Tópico(s): Microscopic Colitis
2019 - Elsevier BV | Clinical Gastroenterology and Hepatology
Lóránt Gönczi, Zsuzsanna Végh, Petra A. Golovics, Mariann Rutka, K Gecse, Renáta Bor, Klaudia Farkas, Tamás Szamosi, László Bene, Beáta Gasztonyi, Tünde Kristóf, Péter L. Lakatos, Pál Miheller, Károly Palatka, Mária Papp, Árpád Patai, Á Salamon, Gábor Tamás Tóth, Áron Vincze, E Bíró, Barbara D. Lovász, Zsuzsanna Kürti, Zoltán Szepes, Tamás Molnár, Péter L. Lakatos,
Biosimilar infliximab CT-P13 received European Medicines Agency [EMA] approval in June 2013 for all indications of the originator product. In the present study, we aimed to evaluate the predictors of short- and medium-term clinical outcome in patients treated with the biosimilar infliximab at the participating inflammatory bowel disease [IBD] centres in Hungary. Demographic data were collected and a harmonised monitoring strategy was applied. Clinical and biochemical activities were evaluated at Weeks ...
Tópico(s): Microscopic Colitis
2016 - Oxford University Press | Journal of Crohn s and Colitis
Lóránt Gönczi, K Szántó, Klaudia Farkas, Tamás Molnár, T Szamosi, Eszter Schäfer, Petra A. Golovics, László Barkai, Livia Lontai, Barbara D. Lovász, Márk Juhász, Árpád V. Patai, Krisztina Sarang, Áron Vincze, Patrícia Sarlós, Alexandra Farkas, Zsolt Dubravcsik, Tamas G. Toth, Pál Miheller, Ákos Iliás, Péter L. Lakatos,
Introduction Although efficacy of ustekinumab (UST) has been demonstrated through randomized trials, data from real-life prospective cohorts are still limited. Our aim was to evaluate clinical efficacy, drug sustainability, dose intensification and results from therapeutic drug monitoring in UST treated patients with Crohn's disease (CD) using a prospective, nationwide, multicenter cohort. Methods Patients from 10 Inflammatory Bowel Disease centers were enrolled between 2019 January and 2020 May. ...
Tópico(s): Eosinophilic Esophagitis
2021 - Elsevier BV | Digestive and Liver Disease
K Gecse, Zsuzsanna Végh, Zsuzsanna Kürti, Mariann Rutka, Klaudia Farkas, Petra A. Golovics, Barbara D. Lovász, Lóránt Gönczi, J Banai, László Bene, Beáta Gasztonyi, Tünde Kristóf, L. Lakatos, Pál Miheller, Ferenc Nagy, Károly Palatka, Mária Papp, Árpád V. Patai, Á Salamon, T Szamosi, Zoltán Szepes, Gábor Tamás Tóth, Áron Vincze, Tamás Molnár, Péter L. Lakatos,
Table 1.Course of the IFX
Tópico(s): Health Systems, Economic Evaluations, Quality of Life
2017 - Elsevier BV | Gastroenterology
Lóránt Gönczi, K Gecse, Zsuzsanna Végh, Zsuzsanna Kürti, Mariann Rutka, Klaudia Farkas, Petra A. Golovics, Barbara D. Lovász, János Banai, László Bene, Bea Gasztonyi, Tünde Kristóf, L. Lakatos, Pál Miheller, Ferenc Nagy, Károly Palatka, Mária Papp, Árpád Patai, Á Salamon, T Szamosi, Zoltán Szepes, G Tóth, Áron Vincze, Balázs Szalay, Tamás Molnár, Péter L. Lakatos,
It has been previously shown that biosimilar infliximab CT-P13 is effective and safe in inducing remission in inflammatory bowel diseases. We report here the 1-year outcomes from a prospective nationwide inflammatory bowel disease cohort. A prospective, nationwide, multicenter, observational cohort was designed to examine the efficacy and safety of CT-P13 in the induction and maintenance treatment of Crohn's disease (CD) and ulcerative colitis (UC). Demographic data were collected and a harmonized ...
Tópico(s): Microscopic Colitis
2017 - Oxford University Press | Inflammatory Bowel Diseases
Ákos Iliás, K Szántó, Lóránt Gönczi, Zsuzsanna Kürti, Petra A. Golovics, E Schäfer, Klaudia Farkas, T Szamosi, Zoltán Szepes, Tamás Molnár, Áron Vincze, Péter L. Lakatos,
The use of biosimilar infliximab (IFX) is effective and safe in inflammatory bowel disease (IBD). Switching from the originator to a biosimilar in patients with IBD has been successful in multiple IBD cohorts, although scientific and clinical evidence is absent on reverse and/or multiple switching. The aim of the present study was to evaluate short-term drug sustainability, safety and immunogenicity profile of reversed switching from biosimilar to originator IFX in a consecutive multicentre real-life ...
Tópico(s): Pharmaceutical studies and practices
2018 - Oxford University Press | Journal of Crohn s and Colitis
L J Barkai, Lóránt Gönczi, F Balogh, Dorottya Angyal, Klaudia Farkas, Bernadett Farkas, Tamás Molnár, T Szamosi, Eszter Schäfer, Petra A. Golovics, Márk Juhász, Árpád V. Patai, Áron Vincze, Patrícia Sarlós, Alexandra Farkas, Zsolt Dubravcsik, Tamas G. Toth, Hajnal Székely, Pál Miheller, Péter L. Lakatos, Ákos Iliás,
Long-term data on ustekinumab in real-life Crohn's disease patients are still missing, though randomized controlled trials demonstrated it as a favorable therapeutic option. We aimed to evaluate ustekinumab's clinical efficacy, drug sustainability, and safety in a prospective, nationwide, multicenter Crohn's disease patient cohort with a three-year follow-up. Crohn's disease patients on ustekinumab treatment were consecutively enrolled from 9 Hungarian Inflammatory Bowel Disease centers between ...
Tópico(s): Eosinophilic Esophagitis
2024 - Nature Portfolio | Scientific Reports
Barbara D. Lovász, Zsuzsanna Kürti, Mariann Rutka, Zsuzsanna Végh, K Gecse, Klaudia Farkas, J Banai, László Bene, Petra A. Golovics, Lóránt Gönczi, Beáta Gasztonyi, Tünde Kristóf, L. Lakatos, Pál Miheller, Károly Palatka, Árpád Patai, Mária Papp, Á Salamon, T Szamosi, Zoltán Szepes, G Tóth, Áron Vincze, Balázs Szalay, Tamás Molnár, Péter L. Lakatos,
Background: Biosimilar infliximab CT-P13 received EMA approval in June 2013 for all indications of the originator product and its use is mandatory in all anti-TNF naïve IBD patients in Hungary since May 2014. In the present study we aimed to prospectively evaluate the immunogenicity profile of the biosimilar infliximab and predictors of TDM in IBD during the first year of therapy in a nationwide, multicentre cohort. Methods: Demographic data were collected and a harmonized monitoring strategy was ...
Tópico(s): Immunodeficiency and Autoimmune Disorders
2017 - Oxford University Press | Journal of Crohn s and Colitis
K Gecse, Zsuzsanna Végh, Zsuzsanna Kürti, Mariann Rutka, Klaudia Farkas, Petra A. Golovics, Barbara D. Lovász, Lóránt Gönczi, J Banai, László Bene, Beáta Gasztonyi, Tünde Kristóf, L. Lakatos, Pál Miheller, Ferenc Nagy, Károly Palatka, Mária Papp, Árpád Patai, Á Salamon, T Szamosi, Zoltán Szepes, Gábor Tamás Tóth, Áron Vincze, Tamás Molnár, Péter L. Lakatos,
Background: Biosimilar infliximab CT-P13 received positive CHMP recommendation in June 2013 for all indications of the originator product. It has been previously shown that CT-P13 is effective and safe in inducing remission in inflammatory bowel diseases (IBD). We report here final results from a prospective nationwide IBD cohort. Methods: A prospective, nationwide, multicentre, observational cohort was designed to examine the efficacy and safety of CT-P13 infliximab biosimilar in the induction and ...
Tópico(s): Pharmaceutical studies and practices
2017 - Oxford University Press | Journal of Crohn s and Colitis
Ákos Iliás, K Szántó, Lóránt Gönczi, Zsuzsanna Kürti, Petra A. Golovics, T Szamosi, Eszter Schäfer, Klaudia Farkas, Zoltán Szepes, Tamás Molnár, Áron Vincze, Péter L. Lakatos,
Tópico(s): Pharmaceutical Economics and Policy
2018 - Elsevier BV | Gastroenterology
Lóránt Gönczi, Ákos Iliás, K Szántó, Zsuzsanna Kürti, Petra A. Golovics, Klaudia Farkas, E Schäfer, Zoltán Szepes, Balázs Szalay, Áron Vincze, T Szamosi, Tamás Molnár, Péter L. Lakatos,
Switching from the originator to a biosimilar infliximab (IFX) in patients with inflammatory bowel disease (IBD) has proven to be successful, although clinical evidence is lacking on reverse and/or multiple switching. The aim of the present study was to evaluate medium-term drug sustainability, safety and immunogenicity profile of reverse switching from a biosimilar to the originator IFX in a consecutive multi-centre real-life cohort. We performed a prospective observational study of 174 consecutive ...
Tópico(s): Inflammatory Bowel Disease
2019 - Oxford University Press | Journal of Crohn s and Colitis
Lóránt Gönczi, Ákos Iliás, K Szántó, Zsuzsanna Kürti, Petra A. Golovics, Klaudia Farkas, Eszter Schäfer, Zoltán Szepes, Balázs Szalay, Áron Vincze, T Szamosi, Tamás Molnár, Péter L. Lakatos,
Tópico(s): Microscopic Colitis
2019 - Elsevier BV | Gastroenterology
L J Barkai, Lóránt Gönczi, Klaudia Farkas, B Farkas, Tamás Molnár, T Szamosi, E Schäfer, Petra A. Golovics, Márk Juhász, Árpád V. Patai, Áron Vincze, Patrícia Sarlós, Alexandra Farkas, Zsolt Dubravcsik, Tibor Tóth, Pál Miheller, Péter L. Lakatos, Ákos Iliás,
Abstract Background While randomized controlled trials have shown ustekinumab (UST) as an effective therapeutic option for Crohn’s disease (CD), there is a lack of long-term observational data in real-world CD patient settings. This prospective study seeks to evaluate the clinical effectiveness, sustainability, and safety of UST in a nationwide multicentre cohort of CD patients over three years. The aim is to bridge the gap in our understanding of UST's real-world implications for long-term CD management. ...
Tópico(s): Gastrointestinal Tumor Research and Treatment
2024 - Oxford University Press | Journal of Crohn s and Colitis
Lóránt Gönczi, K Szántó, Klaudia Farkas, Tamás Molnár, T Szamosi, E Schäfer, Petra A. Golovics, Barbara D. Lovász, Árpád V. Patai, Áron Vincze, Patrícia Sarlós, Alexandra Farkas, Z Dubrovcsik, Guanglei Tan, Péter L. Lakatos, Pál Miheller, Ákos Iliás,
Abstract Background Although efficacy and safety of ustekinumab (UST) in the treatment of inflammatory bowel disease have been demonstrated through randomized trials, data from real-life prospective cohorts are still of great interest. Our aim was to evaluate the clinical efficacy, drug sustainability, frequency of dose intensification, and results from therapeutic drug monitoring in UST treated Crohn’s disease (CD) patients using a prospective, nationwide, multicenter cohort from Hungary. Methods ...
Tópico(s): Biosimilars and Bioanalytical Methods
2021 - Oxford University Press | Journal of Crohn s and Colitis
Zsuzsanna Kürti, Barbara D. Lovász, Mariann Rutka, Zsuzsanna Végh, K Gecse, Klaudia Farkas, J Banai, László Bene, Petra A. Golovics, Lóránt Gönczi, Beáta Gasztonyi, Tünde Kristóf, L. Lakatos, Pál Miheller, Károly Palatka, Árpád V. Patai, Mária Papp, Á Salamon, T Szamosi, Zoltán Szepes, Gábor Tamás Tóth, Áron Vincze, Balázs Szalay, Tamás Molnár, Péter L. Lakatos,
Tópico(s): Statistical Methods in Clinical Trials
2017 - Elsevier BV | Gastroenterology