Article
Medicine, General & Internal
Jose Maria Huguet, Xavier Cortes, Marta Maia Bosca-Watts, Marian Aguas, Nuria Maroto, Lidia Marti, Cirilo Amoros, Jose Maria Paredes
Summary: This study analyzed clinical response rates and adverse events in IBD patients treated with CT-P13 in real-life practice. The results showed that CT-P13 is an effective and safe infliximab biosimilar for the treatment of IBD, with sustained clinical remission and response rates over 12 months.
WORLD JOURNAL OF CLINICAL CASES
(2021)
Article
Gastroenterology & Hepatology
Stefan Schreiber, Shomron Ben-Horin, Jaroslaw Leszczyszyn, Robert Dudkowiak, Adi Lahat, Beata Gawdis-Wojnarska, Aldis Pukitis, Marek Horynski, Katalin Farkas, Jaroslaw Kierkus, Maciej Kowalski, Sang Joon Lee, Sung Hyun Kim, Jee Hye Suh, Mi Rim Kim, Seul Gi Lee, Byong Duk Ye, Walter Reinisch
Summary: This study demonstrated the pharmacokinetic noninferiority of CT-P13 SC to CT-P13 IV, with comparable clinical remission rates between the two formulations.
Article
Gastroenterology & Hepatology
Noemie Trystram, Vered Abitbol, Jenny Tannoury, Mahaut Lecomte, Julie Assaraf, Georgia Malamut, Charlotte Gagniere, Amelie Barre, Iradj Sobhani, Stanislas Chaussade, Aurelien Amiot
Summary: The study demonstrated that double switching from the originator Infliximab to CT-P13 and then to SB2 did not impair patient beliefs, while the effectiveness, immunogenicity, and safety of anti-TNF therapy remained stable after 54 weeks of follow-up. Patient perspectives remained focused on effectiveness and safety after the switch, rather than on molecular differences between the originator and biosimilars or socioeconomic benefits.
ALIMENTARY PHARMACOLOGY & THERAPEUTICS
(2021)
Review
Biotechnology & Applied Microbiology
Tommaso Lorenzo Parigi, Ferdinando D'Amico, Laurent Peyrin-Biroulet, Silvio Danese
Summary: Biologic drugs have significantly improved the treatment of ulcerative colitis (UC) and Crohn's disease (CD), but their high cost limits availability. CT-P13, a biosimilar of infliximab, has shown promising results in phase I and II trials for both CD and UC, with stable serum drug doses and potential availability as a subcutaneous version in the future.
EXPERT OPINION ON BIOLOGICAL THERAPY
(2021)
Article
Gastroenterology & Hepatology
Rosa Lovero, Giuseppe Losurdo, Rosa Federica La Fortezza, Fulvia Terracciano, Giuseppe Biscaglia, Giuseppina Martino, Marianna Nardella, Alfredo Di Leo, Mariabeatrice Principi, Angelo Andriulli, Fabrizio Bossa
Summary: Switching from CT-P13 to SB2 is safe and effective for patients with inflammatory bowel diseases, whether they undergo a single switch or multiple switches between different infliximab compounds.
EUROPEAN JOURNAL OF GASTROENTEROLOGY & HEPATOLOGY
(2021)
Article
Gastroenterology & Hepatology
Shintaro Sagami, Kiyohiro Nishikawa, Fumika Yamada, Yasuo Suzuki, Mamoru Watanabe, Toshifumi Hibi
Summary: This study evaluated the safety and efficacy of CT-P13 compared to originator IFX in real-world data in Japan. The results showed no significant differences in treatment persistence, tuberculosis incidence, and hepatic injury between the two biologics, suggesting comparable usefulness in clinical practice.
JOURNAL OF GASTROENTEROLOGY AND HEPATOLOGY
(2021)
Article
Gastroenterology & Hepatology
Shaden Mahmmod, Johannes P. D. Schultheiss, Ad A. van Bodegraven, Gerard Dijkstra, Lennard P. L. Gilissen, Frank Hoentjen, Maurice W. M. D. Lutgens, Nofel Mahmmod, Andrea E. Van der Meulen-de Jong, Lisa J. T. Smits, Adriaan C. I. T. L. Tan, Bas Oldenburg, Herma H. Fidder
Summary: In a retrospective multicenter cohort study, about 9.9% of IBD patients who were switched from originator infliximab to biosimilar CT-P13 experienced reverse switching, predominantly due to biosimilar-attributed adverse effects. Some patients showed symptom improvement after reverse switching, with a good response seen in those who had lost response to CT-P13.
INFLAMMATORY BOWEL DISEASES
(2021)
Article
Medicine, Research & Experimental
Jae Hee Cheon, Seongsu Nah, Hyoun Woo Kang, Yun Jeong Lim, Sang-Hoon Lee, Sang Joon Lee, Sung Hyun Kim, Na Hyun Jung, Jeong Eun Park, Yeo Jin Lee, Da Bee Jeon, Yeon Mi Lee, Jong Min Kim, Sung-Hwan Park
Summary: This analysis evaluated long-term safety and effectiveness data of infliximab biosimilar CT-P13 in patients with RA, IBD, and AS over 5 years, finding no new safety concerns and an increase in treatment effectiveness over time.
ADVANCES IN THERAPY
(2021)
Article
Biotechnology & Applied Microbiology
Bernd Bokemeyer, Tibor Hlavaty, Matthieu Allez, Pamela Selema, Shahrzad Moosavi, Mary Jane Cadatal, Heather Fowler, Markus Mueller, Katherine F. Liau, Javier P. Gisbert
Summary: This study investigated the use of CT-P13 in the treatment of patients with Crohn's disease and ulcerative colitis. The results showed that the safety information for CT-P13 was consistent with the known safety profile for IFX and did not alter the established benefit-risk profile of CT-P13.
EXPERT OPINION ON BIOLOGICAL THERAPY
(2023)
Article
Biochemistry & Molecular Biology
Jose M. Huguet, Victor Garcia-Lorenzo, Lidia Marti, Jose Maria Paredes, Jose Joaquin Ramirez, Miguel Pastor, Lucia Ruiz, Ana Sanahuja, Pilar Timoneda, Laura Sanchis, Gloria Alemany Perez, Marta Maia Bosca-Watts
Summary: This study evaluated the efficacy and safety of subcutaneous infliximab in patients with inflammatory bowel disease. The results showed that subcutaneous administration of infliximab has the potential to maintain treatment stability and increase drug levels. This is of great significance for the management of patients with inflammatory bowel disease.
Article
Medicine, General & Internal
Anna Pekala, Rafal Filip, David Aebisher
Summary: This study aimed to determine the frequency of ADA in IBD patients during therapy with CT-P13, finding ADA in 50% of patients with undetectable levels of the drug. The analysis showed no relationship between response to treatment and antibody titers, but a significant relationship between undetectable levels of CT-P13 and the presence of ADA at week 6 of therapy was found. Patients with undetectable levels of CT-P13 before the third induction dose were at high risk of anti-drug antibodies and primary non-response.
JOURNAL OF CLINICAL MEDICINE
(2021)
Article
Health Care Sciences & Services
Hyun Kyeong Yoo, Han Geul Byun, Flavio Caprioli, Mathurin Fumery, Laurent Peyrin-Biroulet, Subramanian Sreedhar, James Potter, Minyoung Jang
Summary: This article presents a budget impact analysis on the introduction of infliximab SC to European markets. The results show that the use of infliximab SC for the treatment of inflammatory bowel disease can lead to budget savings in the UK, Germany, France, and Italy.
BMC HEALTH SERVICES RESEARCH
(2022)
Article
Gastroenterology & Hepatology
Jurij Hanzel, Laura H. Bukkems, Krisztina B. Gecse, Geert R. D'Haens, Ron A. A. Mathot
Summary: The study characterized the pharmacokinetics of subcutaneous CT-P13 through population PK modeling, identifying body weight, presence of anti-drug antibodies, and serum albumin concentration as clinically relevant covariates affecting drug clearance. Simulated drug exposure demonstrated differences between routes of administration in patients of varying body weights.
ALIMENTARY PHARMACOLOGY & THERAPEUTICS
(2021)
Article
Medicine, Research & Experimental
Bincy Abraham, Bertus Eksteen, Khan Nedd, Hrishikesh Kale, Dipen Patel, Jennifer Stephens, Ahmed Shelbaya, Richard Chambers, Arif Soonasra
Summary: Limited real-world studies have been conducted on the use of infliximab-dyyb, a biosimilar to reference product infliximab in North America. This study examined the utilization patterns and effects of infliximab-dyyb on clinical outcomes, patient-reported outcomes, and healthcare resource use in IBD patients in a real-world setting. The results showed significant improvements in clinical outcomes and patient-reported outcomes for biologic-naive users of infliximab-dyyb.
ADVANCES IN THERAPY
(2022)
Article
Oncology
Krishneel Dutt, Ashish Srinivasan, Daniel Van Langenberg
Summary: This study evaluated the nocebo effect in patients with inflammatory bowel disease (IBD) who switched from originator to biosimilar medicines. The study found a temporary nocebo effect in the first 16 weeks following non-medical switching, but it was not sustained at week 32. Overcoming negative patient perceptions can be achieved through a patient-inclusive approach to non-medical switching, along with close clinical follow-up and disease monitoring.
Letter
Gastroenterology & Hepatology
Joshua Quan, Christopher Ma, Remo Panaccione, Lindsay Hracs, Nastaran Sharifi, Michelle Herauf, Ante Makovinovic, Stephanie Coward, Joseph W. Windsor, Lea Caplan, Richard J. M. Ingram, Jamil N. Kanji, Graham Tipples, Jessalyn K. Holodinsky, Charles N. Bernstein, Douglas J. Mahoney, Sasha Bernatsky, Eric Benchimol, Gilaad G. Kaplan
Article
Gastroenterology & Hepatology
Pauline Riviere, Caitlyn Kanters, Gauthier Pellet, Alexander Ni, Marianne Hupe, Nesrine Aboulhamid, Florian Poullenot, Alain Bitton, Frank Zerbib, Peter L. Lakatos, Waqqas Afif, David Laharie, Talat Bessissow
Summary: This study aimed to compare the efficacy of anti-tumor necrosis factor agents and ustekinumab in patients with Crohn's disease. The results showed that anti-tumor necrosis factor agents as first-line biological therapy were associated with higher response rates at 3 months compared to ustekinumab.
INFLAMMATORY BOWEL DISEASES
(2023)
Article
Gastroenterology & Hepatology
Lorant Gonczi, Laszlo Lakatos, Zsuzsanna Kurti, Petra Golovics, Tunde Pandur, Gyula David, Zsuzsanna Erdelyi, Istvan Szita, Peter L. Lakatos
Summary: This study conducted a prospective study on Crohn's disease patients in Hungary and found a high incidence rate, reflecting the era of biologic therapy in treatment strategies. The progression of disease behavior was low and long-term surgery rates had decreased.
JOURNAL OF CROHNS & COLITIS
(2023)
Article
Gastroenterology & Hepatology
Zsuzsanna Kurti, Lorant Gonczi, Laszlo Lakatos, Petra Golovics, Tunde Pandur, Gyula David, Zsuzsanna Erdelyi, Istvan Szita, Peter L. Lakatos
Summary: This study analyzed the incidence, prevalence, disease phenotype, treatment strategy, disease course, and colectomy rates of ulcerative colitis (UC) patients in Hungary from 2007 to 2018. The results showed a high incidence of UC in Hungary, similar to high-incidence areas in Western Europe. Treatment strategies were consistent with the biological era, and the probability of disease progression and colectomy rates were lower compared to data from Western European centers.
JOURNAL OF CROHNS & COLITIS
(2023)
Article
Gastroenterology & Hepatology
Livia Lontai, Zsuzsanna Kurti, Lorant Gonczi, Nora Komlodi, Fruzsina Balogh, Akos Ilias, Peter L. Lakatos
Summary: This study aimed to evaluate the value of objective disease monitoring in inflammatory bowel disease. The results showed that objective monitoring strategy led to early optimization of medical therapy and frequent specialist follow-up visits, which improved patient outcomes.
TURKISH JOURNAL OF GASTROENTEROLOGY
(2023)
Article
Gastroenterology & Hepatology
Panu Wetwittayakhlang, Christine Verdon, Michael Starr, Gustavo Drugg Hahn, Petra A. Golovics, Talat Bessissow, Waqqas Afif, Gary Wild, Alain Bitton, Peter L. Lakatos
Summary: This study aimed to investigate small bowel mucosal healing and clinical efficacy of adalimumab therapy by video capsule endoscopy in patients with endoscopically active upper gastrointestinal Crohn's disease. The results showed that adalimumab induced endoscopic healing and clinical remission in approximately half of the patients.
TURKISH JOURNAL OF GASTROENTEROLOGY
(2023)
Article
Medicine, General & Internal
Lena Royston, Stephane Isnard, Carolina A. Berini, Simeng Bu, Peter L. Lakatos, Talat Bessissow, Nicolas Chomont, Marina Klein, Bertrand Lebouche, Alexandra de Pokomandy, Nadine Kronfli, Cecilia T. Costiniuk, Rejean Thomas, Cecile Tremblay, Guy Boivin, Jean-Pierre Routy
Summary: This study aims to assess whether letermovir, a novel anti-CMV drug, can inhibit CMV subclinical replication in HIV patients receiving ART, and subsequently reduce CMV-associated gut damage and inflammation. The study will conduct a 14-week open-label, randomized, controlled clinical trial with 60 CMV-seropositive ART-treated HIV patients. The effects of letermovir on gut damage, microbial translocation, inflammation, and HIV reservoir size will be evaluated.
Meeting Abstract
Gastroenterology & Hepatology
P. Bacsur, P. Wetwittayakhlang, T. Resal, M. Rutka, T. Bessissow, W. Atif, A. Balint, A. Fabian, R. Bor, Z. Szepes, K. Farkas, P. L. Lakatos, T. Molnar
JOURNAL OF CROHNS & COLITIS
(2023)
Meeting Abstract
Gastroenterology & Hepatology
J. Burisch, M. Zhao, S. Odes, P. De Cruz, S. Vermeire, C. N. Bernstein, G. G. Kaplan, D. Duricova, D. Greenberg, H. O. Melberg, M. Watanabe, H. S. Ahn, L. Targownik, V. E. H. Pittet, V. Annese, K. Park, K. H. Konstantinos H, M. L. Hoivik, Z. Krznaric, M. Chaparro, E. V. Loftus, P. L. Lakatos, J. P. Gisbert, W. Bemelman, B. Moum, R. B. Gearry, M. D. Kappelman, A. Hart, M. Pierik, J. Andrews, S. Ng, R. D'Inca, P. Munkholm
JOURNAL OF CROHNS & COLITIS
(2023)
Meeting Abstract
Gastroenterology & Hepatology
L. Gonczi, L. Lakatos, P. A. Golovics, T. Pandur, G. David, Z. Erdelyi, I. Szita, P. L. Lakatos
JOURNAL OF CROHNS & COLITIS
(2023)
Meeting Abstract
Gastroenterology & Hepatology
T. Resal, P. Bacsur, R. Bor, A. Balint, K. Katsanos, G. Michalopoylos, D. G. Ribaldone, M. Attauabi, Z. Mirabella, H. Yanai, C. Bezzio, F. Castiglione, A. Bar-Gil Shitrit, D. Pugliese, P. L. Lakatos, E. Savarino, M. Lukas, M. Franko, E. Chashkova, P. Molander, S. Nancey, L. Bannon, Z. Krznaric, R. Filip, T. Szamosi, K. Kastylova, P. Sarlos, H. Ami-Barak, A. Rispo, J. Limdi, A. Kagramanova, Z. Szepes, K. Farkas, T. Molnar
JOURNAL OF CROHNS & COLITIS
(2023)
Meeting Abstract
Gastroenterology & Hepatology
B. Siegmund, K. Patel, E. A. Torres, P. L. Lakatos, J. Seidelin, M. Fleisher, S. Ford, V. Remple, A. P. Lacerda, S. Anyanwu, A. Garrison, J. Panes
JOURNAL OF CROHNS & COLITIS
(2023)
Article
Gastroenterology & Hepatology
Dana Kablawi, Faisal Aljohani, Chiara Saroli Palumbo, Sophie Restellini, Alain Bitton, Gary Wild, Waqqas Afif, Peter L. Lakatos, Talat Bessissow, Giada Sebastiani
Summary: This study found that nonalcoholic fatty liver disease (NAFLD) is more frequent in patients with inflammatory bowel disease (IBD) and is strongly associated with cardiovascular risk, particularly in patients with longer IBD duration and ulcerative colitis.
CROHNS & COLITIS 360
(2023)
Article
Gastroenterology & Hepatology
Courtney Heisler, Noelle Rohatinsky, Raza M. Mirza, Olga Kits, Sandra Zelinsky, Sander Veldhuyzen van Zanten, Geoffrey Nguyen, Jeffrey McCurdy, Mark MacMillan, Peter L. Lakatos, Laura Targownik, Sharyle Fowler, Kevin Rioux, Jennifer Jones
Summary: This study aimed to understand the experiences and perspectives of patients living with inflammatory bowel disease (IBD) in accessing healthcare. The findings revealed that IBD patients face numerous challenges including issues related to timely access to specialty care. It is crucial to have a comprehensive understanding of healthcare system structures, processes, and their impact on accessing care.
CROHNS & COLITIS 360
(2023)
Review
Medicine, General & Internal
Reem Al-jabri, Panu Wetwittayakhlang, Peter L. Lakatos
Summary: Understanding the relationship between Inflammatory Bowel Disease (IBD) and pregnancy is crucial, and monitoring IBD activity during pregnancy involves various methods. Small Intestine Ultrasound (IUS) has gained popularity as a noninvasive and reliable option for monitoring. However, trained staff is necessary for optimal usage due to its technique-sensitive nature.
JOURNAL OF CLINICAL MEDICINE
(2023)