Article
Ophthalmology
Noopur Kumar, Turid Follestad, H. Nida Sen, Dordi Austeng
Summary: The study compared the efficacy of biosimilar infliximab to originator infliximab in treating chronic non-infectious uveitis, finding no significant differences in achieving quiescence or flare rates between the two treatments.
AMERICAN JOURNAL OF OPHTHALMOLOGY
(2021)
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)
Article
Ophthalmology
Jordan D. Deaner, Sunil K. Srivastava, Rula A. Hajj-Ali, Careen Y. Lowder, Arthi G. Venkat, Kimberly Baynes, Sumit Sharma
Summary: This study investigated the frequency of ocular flares in patients with noninfectious uveitis switched from originator infliximab to biosimilar infliximab. Results showed that patients experienced more flares after switching to infliximab-abda, with a higher probability of flares within the first 90 days.
AMERICAN JOURNAL OF OPHTHALMOLOGY
(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
Rheumatology
Ilaria Maccora, Niccolo Lombardi, Giada Crescioli, Alessandra Bettiol, Roberto Bonaiuti, Ilaria Pagnini, Valerio Maniscalco, Edoardo Marrani, Maria Vincenza Mastrolia, Claudia Ravaldi, Rita Consolini, Marco Cattalini, Alfredo Vannacci, Gabriele Simonini
Summary: This study aimed to evaluate the long-term efficacy and safety of switching from originators ETA and ADA to their biosimilars in children with JIA. The results showed no significant difference in efficacy and safety between the originators and biosimilars at 3, 6, and 12 months after the switch.
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
Gastroenterology & Hepatology
Lauranne A. A. P. Derikx, Heather W. Dolby, Nikolas Plevris, Laura Lucaciu, Caitlin S. Rees, Mathew Lyons, Spyros Siakavellas, Nathan Constantine-Cooke, Philip Jenkinson, Shanna Su, Claire O'Hare, Laura Kirckpatrick, Lynne M. Merchant, Colin Noble, Ian D. Arnott, Gareth-Rhys Jones, Charlie W. Lees
Summary: The study found that switching from the ADA originator to SB5 is effective and safe for patients with inflammatory bowel disease. Over 12 months of follow-up, most patients remained stable on SB5 treatment. The most frequently reported adverse event was injection site pain.
JOURNAL OF CROHNS & COLITIS
(2021)
Article
Rheumatology
Andrew R. Melville, Md Yuzaiful Md Yusof, John Fitton, Leticia Garcia-Montoya, Lynda Bailey, Shouvik Dass, Paul Emery, Maya H. Buch, Benazir Saleem
Summary: The study evaluated the impact of non-medical switch from rituximab originator (RTX-O) to biosimilar (RTX-B) in patients with rheumatoid arthritis. The results showed that non-medical switch to RTX-B was largely effective, with factors like comorbidities, previous biologic DMARDs, and RTX-O treatment history influencing switch decisions.
Article
Rheumatology
Juliette Petit, Marie Antignac, Rose-Marie Poilverd, Regine Baratto, Sylvie Darthout, Sandra Desouches, Karine Louati, Nathalie Deparis, Francis Berenbaum, Catherine Beauvais
Summary: The objective of this study was to evaluate an intervention to reduce the nocebo effect when switching from the originator infliximab to the infliximab biosimilar SB2 in chronic inflammatory rheumatic disease. Results showed that tailored communication and training led to higher retention and continuation rates of SB2 after switching from OI, compared to historical and other European cohorts.
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
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.
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
Medicine, General & Internal
Craig Haifer, Ashish Srinivasan, Yoon-Kyo An, Sherman Picardo, Daniel van Langenberg, Shankar Menon, Jakob Begun, Simon Ghaly, Lena Thin
Summary: The study found that switching patients with IBD from originator infliximab to a biosimilar is safe and clinically non-inferior. Additionally, the introduction of biosimilar infliximab has led to significant cost savings for the Pharmaceutical Benefits Scheme by increasing market competition.
MEDICAL JOURNAL OF AUSTRALIA
(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
Medicine, General & Internal
Corrado Campochiaro, Alessandro Tomelleri, Silvia Sartorelli, Camilla Sembenini, Maurizio Papa, Federico Fallanca, Maria Picchio, Giulio Cavalli, Francesco De Cobelli, Elena Baldissera, Lorenzo Dagna
Summary: In this study, the use of IFX-biosimilar CT-P13 in patients with refractory TAK showed satisfying efficacy and safety profile.
FRONTIERS IN MEDICINE
(2021)
Article
Medicine, General & Internal
Marthe Kirkesaether Brun, Guro Lovik Goll, Kristin Kaasen Jorgensen, Joseph Sexton, Johanna Elin Gehin, Oystein Sandanger, Inge Christoffer Olsen, Rolf Anton Klaasen, David John Warren, Cato Mork, Tore K. Kvien, Jorgen Jahnsen, Nils Bolstad, Espen A. Haavardsholm, Silje Watterdal Syversen
Summary: This study identified several risk factors for the formation of anti-drug antibodies (ADAb) during early-phase infliximab treatment. Factors such as a diagnosis of rheumatoid arthritis, lifetime smoking, concomitant immunosuppressors, and a diagnosis of spondyloarthritis were associated with increased or reduced risk of ADAb formation. Additionally, higher disease activity and longer drug holidays increased the risk, while higher doses and serum concentrations of infliximab reduced the risk of immunogenicity.
JOURNAL OF INTERNAL MEDICINE
(2022)
Article
Rheumatology
Silje W. Syversen, Ingrid Jyssum, Anne T. Tveter, Trung T. Tran, Joseph Sexton, Sella A. Provan, Siri Mjaaland, David J. Warren, Tore K. Kvien, Gunnveig Grodeland, Lise S. H. Nissen-Meyer, Petr Ricanek, Adity Chopra, Ane M. Andersson, Grete B. Kro, Jorgen Jahnsen, Ludvig A. Munthe, Espen A. Haavardsholm, John T. Vaage, Fridtjof Lund-Johansen, Kristin K. Jorgensen, Guro L. Goll
Summary: This study evaluated the immunogenicity and safety of the standard SARS-CoV-2 vaccination regimen and a third dose in patients with immune-mediated inflammatory diseases (IMIDs) receiving immunosuppressive therapy. The results showed that IMID patients had a weaker response to the standard vaccine regimen, but the serologic response improved after receiving a third dose. These data help identify IMID patients who may benefit from a third vaccine dose.
ARTHRITIS & RHEUMATOLOGY
(2022)
Article
Gastroenterology & Hepatology
Jostein H. Ibsen, Adity Chopra, Eline Benno Vaage, John T. Vaage, Fridtjof Lund-Johansen, Knut E. A. Lundin
Summary: This study investigated the humoral response to SARS-CoV-2 vaccines in patients with celiac disease (CeD) and compared it with healthy controls. The results showed that the humoral response in CeD patients is similar to that observed in healthy controls.
SCANDINAVIAN JOURNAL OF GASTROENTEROLOGY
(2023)
Article
Gastroenterology & Hepatology
Kristin H. Bjorlykke, Jorgen Jahnsen, Jorn Brynskov, Pauliina Molander, Michael Eberhardson, Loa G. Davidsdottir, Taina Sipponen, Henrik Hjortswang, Guro Lovik Goll, Silje Watterdal Syversen, Ebbe Langholz, Kristin K. Jorgensen, Casper Steenholdt
Summary: Therapeutic drug monitoring (TDM) is widely implemented and utilized in Scandinavia to optimize biologic and thiopurine therapies in inflammatory bowel disease (IBD). However, the lack of guidelines and delayed test response time are the main barriers to the use of TDM.
SCANDINAVIAN JOURNAL OF GASTROENTEROLOGY
(2023)
Review
Pharmacology & Pharmacy
Vida Terzic, Lea Levoyer, Melanie Figarella, Elisabetta Bigagli, Noemie Mercier, Lucie De Gastines, Severine Gibowski, Marius Troseid, Jacques Demotes, Inge Christoffer Olsen, Maya Hites, Florence Ader, Jose Ramon Arribas Lopez, France Mentre, Helene Esperou, Dominique Costagliola, John-Arne Rottingen, Julien Poissy, Jean-Christophe Roze, Adilia Warris, Jackie O'Leary, Ricardo M. Fernandes, Lambert Assoumou, Regis Hankard, Mark A. Turner, Yazdan Yazdanpanah, Alpha Diallo
Summary: To ensure the safety of participants and regulatory compliance in academic trials, a centralized pharmacovigilance system was established, allowing sponsors to delegate work. This system consisted of key procedures, a local safety officer network, and centralized safety activities. Lessons learned from four trials demonstrated the ability to manage diverse European requirements and communicate effectively with trial teams.
BRITISH JOURNAL OF CLINICAL PHARMACOLOGY
(2023)
Article
Multidisciplinary Sciences
Marketa Chlubnova, Asbjorn O. Christophersen, Geir Kjetil F. Sandve, Knut E. A. Lundin, Jorgen Jahnsen, Shiva Dahal-Koirala, Ludvig M. Sollid
Summary: 42 wheat gluten-reactive T cell clones with different phenotypes and no reactivity to known epitopes were screened. Synthetic peptides were identified bioinformatically from a wheat gluten protein database and tested against the T cell clones. Reactivity of 10 T cell clones was assigned, and 5 previously uncharacterized gliadin/glutenin epitopes with a 9-nucleotide oligomer core region were identified. This work represents an advance in identifying CeD-driving gluten epitopes.
Article
Nutrition & Dietetics
Frida van Megen, Maria Fossli, Gry I. Skodje, Monica H. Carlsen, Lene F. Andersen, Marit B. Veierod, Knut E. A. Lundin, Christine Henriksen
Summary: A study on women with celiac disease and ongoing symptoms revealed that their dietary intake was unbalanced, with higher intake of fat and lower intake of protein and dietary fiber. This highlights the importance of nutritional follow-up for celiac patients and the development of nutrient-dense gluten-free products.
CLINICAL NUTRITION ESPEN
(2023)
Article
Nutrition & Dietetics
Anne Mari Herfindal, Frida van Megen, Mari K. O. Gilde, Jorgen Valeur, Knut Rudi, Gry I. I. Skodje, Knut E. A. Lundin, Christine Henriksen, Siv Kjolsrud Bohn
Summary: Individuals with CeD often experience gastrointestinal symptoms despite adherence to a GFD. The LFD may lead to changes in the faecal microbiota profile, but does not significantly affect gut integrity and inflammation markers in GFD-treated CeD patients.
BRITISH JOURNAL OF NUTRITION
(2023)
Article
Medicine, General & Internal
Liv Cathrine Heggebo, Ida Maria Henriksen Borgen, Hillevi Rylander, Cecilie Kiserud, Tonje Haug Nordenmark, Taran Paulsen Hellebust, Morten Egeberg Evensen, Magnus Gustavsson, Christina Ramberg, Mette Sprauten, Henriette Magelssen, Hanne Blakstad, Janani Moorthy, Karin Andersson, Ingela Raunert, Thomas Henry, Cecilie Moe, Carin Granlund, Dorota Goplen, Jorunn Brekke, Tor-Christian Aase Johannessen, Tora Skeidsvoll Solheim, Kirsten Marienhagen, Oyvind Humberset, Per Bergstrom, Mans Agrup, Ludvig Dahl, Michael Gubanski, Helene Gojon, Carl-Johan Brahme, Isabelle Ryden, Asgeir S. Jakola, Einar O. Vik-Mo, Hanne C. Lie, Lars Asphaug, Maziar Hervani, Ingrid Kristensen, Corina Silvia Rueegg, Inge C. Olsen, Rolf J. Ledal, Eskil Degsell, Katja Werlenius, Malin Blomstrand, Petter Brandal
Summary: This study is an open-label, multicenter, randomized phase III non-inferiority study comparing proton therapy and photon therapy in the treatment of IDH-mutated diffuse gliomas grade 2-3. The results of this study will provide important information on the safety, cognition, fatigue, and quality of life parameters for this patient population.
Letter
Biochemistry & Molecular Biology
Erica Telford, Beatriz Grinsztejn, Inge Christoffer Olsen, Nicolas Pulik, France Mentre, Skerdi Haviari, Maxime Hentzien, Olivier Segeral, Miquel B. Ekkelenkamp, Dimie Ogoina, Nathalie Strub-Wourgaft, Alpha Diallo, Yazdan Yazdanpanah, Alexandra Calmy
Article
Critical Care Medicine
Marius Troseid, Jose R. Arribas, Lambert Assoumou, Aleksander Rygh Holten, Julien Poissy, Vida Terzic, Fulvia Mazzaferri, Jesus Rodriguez Bano, Joe Eustace, Maya Hites, Michael Joannidis, Jose-Artur Paiva, Jean Reuter, Isabel Puentmann, Thale D. J. H. Patrick-Brown, Elin Westerheim, Katerina Nezvalova-Henriksen, Lydie Beniguel, Tuva Borresdatter Dahl, Maude Bouscambert, Monika Halanova, Zoltan Peterfi, Sotirios Tsiodras, Michael Rezek, Matthias Briel, Serhat Unal, Martin Schlegel, Florence Ader, Karine Lacombe, Cecilie Delphin Amdal, Serge Rodrigues, Kristian Tonby, Alexandre Gaudet, Lars Heggelund, Joy Mootien, Asgeir Johannessen, Jannicke Horjen Moller, Beatriz Diaz Pollan, Anders Aune Tveita, Anders Benjamin Kildal, Jean-Christophe Richard, Olav Dalgard, Victoria Charlotte Simensen, Aliou Balde, Lucie de Gastines, Marta del Alamo, Burc Aydin, Fridtjof Lund-Johansen, Mary-Anne Trabaud, Alpha Diallo, Bente Halvorsen, John-Arne Rottingen, Evelina Tacconelli, Yazdan Yazdanpanah, Inge C. Olsen, Dominique Costagliola
Summary: The study conducted a placebo-controlled trial of baricitinib in severe/critical COVID cases. The results showed that baricitinib did not reduce mortality within 60 days, and there may be safety risks in vaccinated participants, which require further investigation.
Review
Critical Care Medicine
Alain Amstutz, Benjamin Speich, France Mentre, Corina Silvia Rueegg, Drifa Belhadi, Lambert Assoumou, Charles Burdet, Srinivas Murthy, Lori Elizabeth Dodd, Yeming Wang, Kari A. O. Tikkinen, Florence Ader, Maya Hites, Maude Bouscambert, Mary Anne Trabaud, Mike Fralick, Todd C. Lee, Ruxandra Pinto, Andreas Barratt-Due, Fridtjof Lund-Johansen, Fredrik Mueller, Olli P. O. Nevalainen, Bin Cao, Tyler Bonnett, Alexandra Griessbach, Ala Taji Heravi, Christof Schonenberger, Perrine Janiaud, Laura Werlen, Soheila Aghlmandi, Stefan Schandelmaier, Yazdan Yazdanpanah, Dominique Costagliola, Inge Christoffer Olsen, Matthias Briel
Summary: This systematic review and meta-analysis assessed the benefits and harms of remdesivir compared to placebo or usual care in COVID-19 patients hospitalized. The study found that remdesivir reduced mortality in patients who required no or conventional oxygen support but did not have enough evidence for patients on ventilators.
LANCET RESPIRATORY MEDICINE
(2023)
Article
Food Science & Technology
Lisa Garnweidner-Holme, Monica Hellmann, Christine Henriksen, Elisabeth Austad, Solveig Ivara Watters, Line Gaundal, Knut E. A. Lundin, Mari C. W. Myhrstad, Vibeke H. Telle-Hansen, Jana Pexova Kalinova
Summary: This study investigated the experiences of people with coeliac disease (CeD) with gluten-free bread, and found that they preferred fibre-rich gluten-free bread that is satiating and has a good texture.
Meeting Abstract
Gastroenterology & Hepatology
K. Bjorlykke, J. Jahnsen, J. Brynskov, P. Molander, M. Eberhardson, L. G. Davidsdottir, T. Sipponen, H. Hjortswang, E. Langholz, K. K. Jorgensen, C. Steenholdt
JOURNAL OF CROHNS & COLITIS
(2022)
Meeting Abstract
Gastroenterology & Hepatology
K. Bjorlykke, M. K. Brun, M. K. Viken, G. E. Stenvik, R. A. Klaasen, J. E. Gehin, D. J. Warren, J. Sexton, E. A. Haavardsholm, J. Jahnsen, B. A. Lie, G. L. Goll, N. Bolstad, S. W. Syversen, K. K. Jorgensen
JOURNAL OF CROHNS & COLITIS
(2022)