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.
Review
Biotechnology & Applied Microbiology
Ferdinando D'Amico, Virginia Solitano, Laurent Peyrin-Biroulet, Silvio Danese
Summary: Using biosimilars for the treatment of chronic inflammatory bowel diseases can reduce healthcare costs, but the nocebo effect is an important limitation that requires strategies for prevention.
EXPERT OPINION ON BIOLOGICAL THERAPY
(2021)
Review
Gastroenterology & Hepatology
Anna M. Buchner, Yecheskel Schneider, Gary R. Lichtenstein
Summary: Biological therapy targeting tumor necrosis factor-alpha has become crucial in treating patients with inflammatory bowel disease, but high costs limit accessibility. Biosimilars offer the potential to reduce expenditures and increase availability, providing more options for patients.
AMERICAN JOURNAL OF GASTROENTEROLOGY
(2021)
Article
Pharmacology & Pharmacy
Michael Crosby, Mina Tadrous, Tara Gomes
Summary: TNF alpha inhibitors were the highest cost drug class for Canadian public drug programs in 2018. In 2019, two provinces announced mandatory nonmedical switching policies to reduce costs. However, the market share of biosimilars remains low despite these policies, indicating the potential for substantial cost savings if biosimilar uptake is successfully increased.
CLINICAL PHARMACOLOGY & THERAPEUTICS
(2021)
Review
Pharmacology & Pharmacy
Nerea Garcia-Beloso, Irene Altabas-Gonzalez, Marisol Samartin-Ucha, Monica Gayoso-Rey, Maria Luisa De Castro-Parga, Angel Salgado-Barreira, Amelia Cibeira-Badia, Maria Guadalupe Pineiro-Corrales, Daniel Gonzalez-Vilas, Jose Maria Pego-Reigosa, Noemi Martinez-Lopez de Castro
Summary: From January 1, 2004 to June 30, 2021, a systematic review of studies on switching between reference adalimumab and biosimilars in different chronic immune-mediated inflammatory diseases found that the efficacy, safety, and immunogenicity were not affected by the switch. The findings were consistent across different adalimumab biosimilars and may be extended to other rheumatic diseases like psoriatic arthritis and ankylosing spondylitis.
BRITISH JOURNAL OF CLINICAL PHARMACOLOGY
(2022)
Article
Gastroenterology & Hepatology
Livia Lontai, Lorant Gonczi, Fruzsina Balogh, Nora Komlodi, Tamas Resal, Klaudia Farkas, Tamas Molnar, Pal Miheller, Petra A. Golovics, Eszter Schafer, Tamas Szamosi, Akos Ilias, Peter L. Lakatos
Summary: This study evaluated the medium-term clinical efficacy, drug sustainability, and safety of non-medical switches between adalimumab biosimilars. The results showed no significant difference in clinical remission rates or drug survival between non-medical switches from the originator to biosimilar ADA or between ADA biosimilars. The study concludes that clinical benefit can be sustained following non-medical switches in adalimumab-treated patients with inflammatory bowel disease.
DIGESTIVE AND LIVER DISEASE
(2022)
Review
Gastroenterology & Hepatology
Seema A. Patil, Shubha Bhat, Jimmy K. Limdi, Francis A. Farraye, Raymond K. Cross
Summary: Biosimilar medications can significantly reduce treatment costs for patients with inflammatory bowel disease. Observational studies have demonstrated similar efficacy and safety between biosimilars and biologic reference products. Shared decision-making is crucial for the successful implementation of these agents.
INFLAMMATORY BOWEL DISEASES
(2022)
Review
Pharmacology & Pharmacy
Valeria Dipasquale, Giuseppe Cicala, Edoardo Spina, Claudio Romano
Summary: This study reviewed the use of biosimilars in pediatric inflammatory bowel disease (IBD) patients and found that the effectiveness of CT-P13, a biosimilar of anti-TNF-alpha, was similar to that of the originator drug IFX in terms of clinical response and remission rates.
FRONTIERS IN PHARMACOLOGY
(2022)
Article
Medicine, General & Internal
Rogerio Serafim Parra, Sandro da Costa Ferreira, Vanessa Foresto Machado, Cintia Maura Caseiro Nigro, Jose Joaquim Ribeiro da Rocha, Luiz Ernesto de Almeida Troncon, Omar Feres
Summary: This study aimed to analyze Brazilian patients with inflammatory bowel diseases (IBD) perception regarding access to high-cost drugs in the public health care system. The results showed that most patients were unable to obtain biological drugs within one year. This study highlights the need for improvement in the healthcare system to ensure the correct supply of medication.
JOURNAL OF CLINICAL MEDICINE
(2023)
Article
Rheumatology
Uta Kiltz Kiltz, Jan-Clemens Pudelko, Styliani Tsiam, Xenofon Baraliakos, Jurgen Braun
Summary: The study evaluated the effectiveness and safety of non-medical switching from reference to biosimilar etanercept in patients with rheumatoid arthritis, psoriatic arthritis, or axial spondyloarthritis. The results showed that disease activity and function remained largely unchanged after the switch, and whether or not patients were informed about the switch did not affect outcomes or ADE frequency.
CLINICAL AND EXPERIMENTAL RHEUMATOLOGY
(2021)
Review
Biochemistry & Molecular Biology
HyunTaek Jung, Jae Seok Kim, Keum Hwa Lee, Kalthoum Tizaoui, Salvatore Terrazzino, Sarah Cargnin, Lee Smith, Ai Koyanagi, Louis Jacob, Han Li, Sung Hwi Hong, Dong Keon Yon, Seung Won Lee, Min Seo Kim, Paul Wasuwanich, Wikrom Karnsakul, Jae Il Shin, Andreas Kronbichler
Summary: Inflammatory bowel disease (IBD) is a chronic inflammatory disease of the gastrointestinal tract that mainly affects young people. Recent studies have shown that microRNAs (miRNAs) play an important role in the pathogenesis, diagnosis, and treatment of IBD.
INTERNATIONAL JOURNAL OF BIOLOGICAL SCIENCES
(2021)
Review
Pharmacology & Pharmacy
Paul Enck, Sibylle Klosterhalfen
Summary: This review focuses on the placebo and nocebo responses in gastrointestinal diseases, particularly in Crohn's disease (CD) and ulcerative colitis (UC). The analysis includes over 10,000 patients with CD and UC, discussing the impact of placebo responses on clinical improvement and maintenance of remission, as well as identifying mediators and moderators of the response. Differences and similarities in placebo responses between IBD and IBS are compared, alongside the discussion of the nocebo effect in transitioning from biologics to biosimilars in IBD management.
FRONTIERS IN PHARMACOLOGY
(2021)
Editorial Material
Gastroenterology & Hepatology
Luca Scarallo, Anne M. Griffiths
Summary: Antibodies targeting tumour necrosis factor have improved the treatment of paediatric inflammatory bowel disease. Understanding pharmacokinetics and therapeutic drug monitoring has led to increased efficacy and durability of response. Primary non-response is more common in ulcerative colitis, emphasizing the need for alternative biologic agents and oral small molecules.
NATURE REVIEWS GASTROENTEROLOGY & HEPATOLOGY
(2022)
Article
Dermatology
Gabriele Roccuzzo, Giulia Rozzo, Lorenza Burzi, Federica Repetto, Paolo Dapavo, Simone Ribero, Pietro Quaglino
Summary: The study aimed to assess the safety and efficacy of switching from adalimumab originator to biosimilar in the treatment of hidradenitis suppurativa in 37 patients over 12 months. There were no significant differences in clinical response between the originator and biosimilar after non-medical switch, but high discontinuation rates raised concerns about patient compliance to the new drug regimen.
DERMATOLOGIC THERAPY
(2022)
Article
Gastroenterology & Hepatology
Antonio Tursi, Giammarco Mocci, Leonardo Allegretta, Giovanni Aragona, Maria Antonia Bianco, Raffaele Colucci, Antonio Cuomo, Nicola Della Valle, Antonio Ferronato, Giacomo Forti, Federica Gaiani, GianMarco Giorgetti, Maria Giovanna Graziani, Katia Lofano, Roberto Lorenzetti, Tiziana Larussa, Antonio Penna, Roberta Pica, Giuseppe Pranzo, Stefano Rodino', Antonella Scarcelli, Costantino Zampaletta, Gabrio Bassotti, Alessia Immacolata Cazzato, Stefania Chiri, Valeria Clemente, Andrea Cocco, Gianluigi de' Angelis, Laura Donnarumma, Roberto Faggiani, Camilla Graziosi, Marco Le Grazie, Francesco Luzza, Costantino Meucci, Rita Monterubbianesi, Cristiano Pagnini, Patrizia Perazzo, Marcello Picchio, Rodolfo Sacco, Ladislava Sebkova, Mariaelena Serio, Daniele Napolitano, Daniela Pugliese, Franco Scaldaferri, Elisa Schiavoni, Laura Turchini, Alessandro Armuzzi, Walter Elisei, Giovanni Maconi, Alfredo Papa
Summary: There is no significant difference in the efficacy and safety of different ADA biosimilars in the treatment of inflammatory bowel disease.
INFLAMMATORY BOWEL DISEASES
(2023)
Review
Medicine, General & Internal
Tommaso Lorenzo Parigi, Elisabetta Mastrorocco, Leonardo Da Rio, Mariangela Allocca, Ferdinando D'Amico, Alessandra Zilli, Gionata Fiorino, Silvio Danese, Federica Furfaro
Summary: Endoscopy is essential for evaluating inflammatory bowel disease and monitoring colorectal cancer. Advances in virtual chromoendoscopy and artificial intelligence are reshaping the field, while tools like endocytoscopy and pCLE enhance inflammation and dysplasia assessment. The combination of pCLE and molecular labeling may lead to personalized medicine.
JOURNAL OF CLINICAL MEDICINE
(2022)
Review
Medicine, General & Internal
Virginia Solitano, Alessandra Zilli, Gianluca Franchellucci, Mariangela Allocca, Gionata Fiorino, Federica Furfaro, Ferdinando D'Amico, Silvio Danese, Sameer Al Awadhi
Summary: Artificial intelligence (AI) is increasingly playing a crucial role in various medical fields, particularly in the detection and classification of gastrointestinal lesions during endoscopy. In the field of inflammatory bowel disease (IBD), AI has the potential to overcome human limitations and serve as a powerful tool for precision medicine decision-making. This review discusses the current state-of-the-art and identifies research gaps in the application of AI in endoscopy for IBD at the beginning of 2022.
JOURNAL OF CLINICAL MEDICINE
(2022)
Review
Medicine, General & Internal
Edoardo Vespa, Ferdinando D'Amico, Mauro Sollai, Mariangela Allocca, Federica Furfaro, Alessandra Zilli, Arianna Dal Buono, Roberto Gabbiadini, Silvio Danese, Gionata Fiorino
Summary: Histological assessment is an important measure of disease activity in inflammatory bowel diseases. For ulcerative colitis, histological activity is associated with relapse rates, corticosteroid use, and long-term complications, making it a potential treatment target. Several histological scoring systems are available, but their use in Crohn's disease is limited by the discontinuous nature of lesions.
JOURNAL OF CLINICAL MEDICINE
(2022)
Article
Gastroenterology & Hepatology
Gaetano Bergamaschi, Fabiana Castiglione, Renata D'Inca, Marco Astegiano, Walter Fries, Monica Milla, Carolina Ciacci, Fernando Rizzello, Simone Saibeni, Rachele Ciccocioppo, Ambrogio Orlando, Fabrizio Bossa, Mariabeatrice Principi, Piero Vernia, Chiara Ricci, Maria L. Scribano, Giorgia Bodini, Dario Mazzucco, Gabrio Bassotti, Gabriele Riegler, Andrea Buda, Matteo Neri, Flavio Caprioli, Fabio Monica, Aldo Manca, Erica Villa, Gionata Fiorino, Michele Comberlato, Nicola Aronico, Cristina Della Corte, Roberta Caccaro, Paolo Gionchetti, Paolo Giuffrida, Paola Iovino, Marco Lenti, Caterina Mengoli, Lucienne Pellegrini, Alberto Pieraccini, Davide Ribaldone, Anna Testa, Cristina Ubezio, Anna Viola, Maurizio Vecchi, Catherine Klersy, Antonio Di Sabatino
Summary: The prevalence of anemia in Italian IBD patients is lower than previously reported, with the majority being caused by iron deficiency and leading to fatigue and decreased quality of life. However, a large proportion of patients with iron and/or vitamin deficiencies remain untreated.
INFLAMMATORY BOWEL DISEASES
(2023)
Article
Gastroenterology & Hepatology
Ferdinando D'Amico, Olga Tasopoulou, Gionata Fiorino, Alessandra Zilli, Federica Furfaro, Mariangela Allocca, Pierpaolo Sileri, Antonino Spinelli, Laurent Peyrin-Biroulet, Silvio Danese
Summary: This study aimed to investigate the impact of postoperative biological therapy on the incidence of endoscopic recurrence and long-term outcomes in Crohn's disease patients. The results showed that early treatment with biologics decreased the rates of endoscopic recurrence and hospitalization/surgery.
INFLAMMATORY BOWEL DISEASES
(2023)
Article
Gastroenterology & Hepatology
Cristina Bezzio, Gionata Fiorino, Davide G. Ribaldone, Alessandro Armuzzi, Simone Saibeni
Summary: This study investigated the impact of severe acute respiratory syndrome coronavirus 2 infection on inflammatory bowel disease course and found that therapy discontinuation is a risk factor for disease flare.
INFLAMMATORY BOWEL DISEASES
(2023)
Article
Gastroenterology & Hepatology
Fabio Salvatore Macaluso, Mariabeatrice Principi, Federica Facciotti, Antonella Contaldo, Alessia Todeschini, Simone Saibeni, Cristina Bezzio, Fabiana Castiglione, Olga Maria Nardone, Rocco Spagnuolo, Massimo Claudio Fantini, Gaia Riguccio, Flavio Caprioli, Chiara Vigano, Carla Felice, Gionata Fiorino, Carmen Correale, Giorgia Bodini, Monica Milla, Giulia Scardino, Marta Vernero, Federico Desideri, Mariella Mannino, Giuseppe Rizzo, Ambrogio Orlando
Summary: The study investigated the humoral response to COVID-19 vaccines in patients with inflammatory bowel disease (IBD) treated with immunomodulatory or biological drugs. The majority of IBD patients showed seropositivity after COVID-19 vaccination, but the magnitude of the humoral response was significantly lower compared to healthy controls. These findings suggest that the lower response is mostly unrelated to the use of immune-modifying treatments.
DIGESTIVE AND LIVER DISEASE
(2023)
Article
Gastroenterology & Hepatology
Joana Torres, Maria Chaparro, Mette Julsgaard, Konstantinos Katsanos, Zuzana Zelinkova, Manasi Agrawal, Sandro Ardizzone, Marjo Campmans-Kuijpers, Gabriele Dragoni, Marc Ferrante, Gionata Fiorino, Emma Flanagan, Catarina Frias Gomes, Ailsa Hart, Charlotte Rose Hedin, Pascal Juillerat, Annemarie Mulders, Par Myrelid, Aoibhlinn O'Toole, Pauline Riviere, Michael Scharl, Christian Philipp Selinger, Elena Sonnenberg, Murat Toruner, Jantien Wieringa, C. Janneke Van der Woude
JOURNAL OF CROHNS & COLITIS
(2023)
Article
Gastroenterology & Hepatology
Paolo Angelo Cortesi, Gionata Fiorino, Laurent Peyrin-Biroulet, Lorenzo Giovanni Mantovani, Vipul Jairath, Kristine Paridaens, Fredrik L. Andersson, Silvio Danese
Summary: This study assessed the cost-effectiveness of a treat-to-target strategy based on clinical signs and faecal calprotectin levels in patients with mild-moderate ulcerative colitis. The results showed that this approach increased the time spent in clinical remission and reduced the number of relapses compared to a strategy based solely on symptoms. However, it was also associated with higher costs.
ALIMENTARY PHARMACOLOGY & THERAPEUTICS
(2023)
Editorial Material
Gastroenterology & Hepatology
Paolo Angelo Cortesi, Gionata Fiorino, Lorenzo Giovanni Mantovani, Silvio Danese
ALIMENTARY PHARMACOLOGY & THERAPEUTICS
(2023)
Article
Gastroenterology & Hepatology
Luca Massimino, Orazio Palmieri, Amanda Facoetti, Davide Fuggetta, Salvatore Spano, Luigi Antonio Lamparelli, Silvia D'Alessio, Stefania Cagliani, Federica Furfaro, Ferdinando D'Amico, Alessandra Zilli, Gionata Fiorino, Tommaso Lorenzo Parigi, Daniele Noviello, Anna Latiano, Fabrizio Bossa, Tiziana Latiano, Alessandra Pirola, Luca Mologni, Rocco Giovanni Piazza, Danilo Abbati, Francesco Perri, Chiara Bonini, Laurent Peyrin-Biroulet, Alberto Malesci, Vipul Jairath, Silvio Danese, Federica Ungaro
Summary: This study found that the virome-associated protein encoded by the hepatitis B virus (HBx) is detected in about 45% of patients with ulcerative colitis (UC) and is associated with UC progression. Experimental findings showed that HBx induces colonic inflammation and its silencing reverses the colitis phenotype. HBx acts as a transcriptional regulator in epithelial cells, leading to barrier leakage and altering mucosal immunity. This study provides a new perspective on targeted treatments for the virome composition of the gut microbiota.
Review
Medicine, General & Internal
Sarah Bencardino, Ferdinando D'Amico, Ilaria Faggiani, Francesca Bernardi, Mariangela Allocca, Federica Furfaro, Tommaso Lorenzo Parigi, Alessandra Zilli, Gionata Fiorino, Laurent Peyrin-Biroulet, Silvio Danese
Summary: Ulcerative colitis (UC) is a chronic inflammatory bowel disease (IBD) that affects patients' quality of life. There is a need for new drugs that target new pathways and minimize adverse events. Sphingosine-1-phosphate (S1P) receptor modulators have shown promise in reducing inflammation in UC by controlling the movement of immune cells. Several S1P receptor modulators, including ozanimod, etrasimod, and VTX002, have been developed and tested in UC. Oral administration, rapidity, and safety profile are the advantages of these drugs.
JOURNAL OF CLINICAL MEDICINE
(2023)
Review
Medicine, General & Internal
Laura Cantoro, Rita Monterubbianesi, Giuliano Falasco, Caterina Camastra, Paolo Pantanella, Mariangela Allocca, Rocco Cosintino, Roberto Faggiani, Silvio Danese, Gionata Fiorino
Summary: Delayed diagnosis poses a challenge to managing inflammatory bowel disease (IBD), especially in Crohn's disease (CD). The Red Flags Index score, along with non-invasive biomarkers like fecal calprotectin, can effectively reduce diagnostic delay and aid in early treatment strategies for patients with IBD.
Meeting Abstract
Gastroenterology & Hepatology
Joana Reves, Barbara S. Abreu, Maria Chaparro, Javier P. Gisbert, Mariangela Allocca, Gionata Fiorino, Brigida Barberio, Fabiana Zingone, Anthea Pisani, David Cassar, Georgios Michalopoulos, Gerassimos J. Mantzaris, Katerina Mountaki, Ioannis E. Koutroubakis, Konstantinos Karmiris, Konstantinos Katsanos, Dana Duricova, Johan M. Burisch, Gorm Roager Madsen, Christian Maaser, Naila Arebi, Eleni Orfanoudaki, Vladimir Milivojevic, Anthony Buisson, Luisa Avedano, Salvatore Leone, Joana Torres, Pierre Ellul
Meeting Abstract
Gastroenterology & Hepatology
Mariangela Allocca, Cecilia Dell'Avalle, Simona Radice, Cristiana Bonifacio, Federica Furfaro, Alessandra Zilli, Ferdinando D'Amico, Laurent Peyrin-Biroulet, Silvio Danese, Gionata Fiorino