Review
Medicine, General & Internal
Benjamin L. Gordon, Robert Battat
Summary: Therapeutic drug monitoring (TDM) is a useful strategy in ulcerative colitis (UC), particularly in acute severe UC (ASUC). While there is limited data available for the use of TDM of infliximab in ASUC, observational data suggest that higher serum infliximab concentrations and lower clearance are associated with better clinical outcomes and decreased rates of colectomy. However, more studies are needed to evaluate optimal dosing and TDM targets in this population.
JOURNAL OF CLINICAL MEDICINE
(2023)
Article
Gastroenterology & Hepatology
Peter M. Irving, Krisztina B. Gecse
Summary: Therapeutic drug monitoring (TDM) is an optimization strategy in the treatment of inflammatory bowel diseases, aiming to achieve maximal treatment benefits by monitoring drug concentrations. There are variations in optimal drug concentrations based on treatment targets, disease phenotypes, inflammatory burden, and sampling timing. This review discusses the role of TDM in biologic and oral small molecule therapies, the differences between reactive and proactive TDM, and the areas where evidence is lacking. Future adaptations in TDM usage may contribute to personalized treatment for patients with IBD.
Article
Gastroenterology & Hepatology
Hideki Tawa, Kazuki Kakimoto, Keijiro Numa, Naohiko Kinoshita, Yuka Kawasaki, Yoshihiro Tatsumi, Ryoji Koshiba, Satoshi Nakata, Yuki Hirata, Kazuhiro Ota, Naokuni Sakiyama, Yuichi Kojima, Eiko Koubayashi, Hiroki Nishikawa, Toshihisa Takeuchi, Takuya Inoue, Shinya Fukunishi, Takako Miyazaki, Shiro Nakamura, Kazuhide Higuchi
Summary: This study aimed to evaluate the impact of early serum golimumab (GLM) concentrations on long-term outcomes in patients with ulcerative colitis (UC) and to identify the target GLM concentrations for better outcomes. The results showed that the GLM concentration at week 14 was significantly associated with clinical remission at week 54, and a GLM concentration of 1.1 μg/mL at week 14 was identified as the target threshold for achieving clinical remission at week 54.
Article
Pharmacology & Pharmacy
Merve Sivridas, Rob H. Creemers, Dennis R. Wong, Paul J. Boekema, Tessa E. H. Romkens, Lennard P. L. Gilissen, Adriaan A. van Bodegraven, Floris C. Loeff, Theo Rispens, Luc J. J. Derijks
Summary: The aim of this study was to determine the association between vedolizumab (VDZ) trough concentration and clinical and biochemical remission in the maintenance phase. The results showed no statistically significant correlation between VDZ concentration and clinical remission in all patient groups. However, patients in biochemical remission had higher VDZ trough concentrations. Therefore, there is an association between VDZ concentration and biochemical remission, but not with clinical remission.
Article
Medicine, General & Internal
Naohiko Kinoshita, Kazuki Kakimoto, Hikaru Shimizu, Koji Nishida, Keijiro Numa, Yuka Kawasaki, Hideki Tawa, Kei Nakazawa, Ryoji Koshiba, Yuki Hirata, Naokuni Sakiyama, Eiko Koubayashi, Toshihisa Takeuchi, Takako Miyazaki, Kazuhide Higuchi, Shiro Nakamura, Hiroki Nishikawa
Summary: This study evaluated the role of serum biomarkers in predicting the efficacy of golimumab in bio-naive patients with UC. The results suggest that IL-13 may be a potential biomarker to predict the response to golimumab treatment.
JOURNAL OF CLINICAL MEDICINE
(2022)
Article
Biochemistry & Molecular Biology
Karoline Soares Garcia, Matheus Freitas Cardoso de Azevedo, Alexandre de Sousa Carlos, Luisa Leite Barros, Jane Oba, Carlos Walter Sobrado Junior, Aytan Miranda Sipahi, Olivia Duarte de Castro Alves, Tomas Navarro-Rodriguez, Rogerio Serafim Parra, Julio Maria Fonseca Chebli, Liliana Andrade Chebli, Cristina Flores, Andrea Vieira, Christianne Damasceno Arcelino do Ceara, Natalia Sousa Freitas Queiroz, Aderson Omar Mourao Cintra Damiao
Summary: Therapeutic drug monitoring (TDM) is important in optimizing response to anti-tumor necrosis factor drugs and preventing inadequate drug exposure. This study aimed to describe the remission rates of Brazilian inflammatory bowel disease (IBD) patients at six months using a proactive TDM algorithm guided by IFX trough levels (ITL) and antibodies to IFX (ATI) levels. The results showed that proactive TDM was associated with a high persistence rate of 82.9% and favorable remission rates at six months.
Article
Medical Laboratory Technology
Maartje M. van de Meeberg, Elwin R. Verheij, Herma H. Fidder, Gerd Bouma, Alwin D. R. Huitema, Bas Oldenburg
Summary: The measurement of fecal (N-acetyl-)5-ASA does not correlate with disease activity in patients with ulcerative colitis, making it unsuitable for therapeutic drug monitoring of mesalazine.
THERAPEUTIC DRUG MONITORING
(2023)
Review
Medicine, General & Internal
Sanket Patel, Andres Yarur
Summary: Therapeutic drug monitoring (TDM) plays a crucial role in optimizing treatment for patients with inflammatory bowel disease (IBD), especially those receiving combination therapy of biologics and immunomodulators. Through rigorous monitoring and therapy optimization, TDM significantly improves treatment outcomes and reduces adverse events.
JOURNAL OF CLINICAL MEDICINE
(2023)
Review
Gastroenterology & Hepatology
Scott D. Lee, Raina Shivashankar, Daniel Quirk, Haiying Zhang, Jean-Baptiste Telliez, John Andrews, Amy Marren, Arnab Mukherjee, Edward V. Loftus
Summary: Therapeutic drug monitoring (TDM) is recommended for guiding treatment decisions in inflammatory bowel disease (IBD) treatments, but challenges remain in its implementation due to the lack of uniform assay methods and guidance for interpreting results. TDM can help guide individual patient treatment and dose decisions by monitoring metabolite levels or serum drug concentrations for certain drugs.
JOURNAL OF CLINICAL GASTROENTEROLOGY
(2021)
Review
Medicine, General & Internal
Byron P. Vaughn
Summary: Therapeutic drug monitoring (TDM) is a useful strategy for optimizing biologic medications for inflammatory bowel disease, but the focus on serum drug concentration may limit its effectiveness. Physicians need to consider drug concentration in conjunction with inflammatory status and understand the limitations of TDM when making therapeutic decisions with imperfect information.
JOURNAL OF CLINICAL MEDICINE
(2021)
Article
Gastroenterology & Hepatology
Carlos Taxonera, Maria Jesus Fernandez-Acenero, David Olivares, Marta Calvo, Begona Casis, Fernando Bermejo, Pilar Lopez Serrano, Marisa Iborra, Francisco Mesonero, Maia Bosca Watts, Cristina Diaz del Arco, Isabel Vera, Sonsoles Olivares, Alicia Algaba, Cristina Alba
Summary: This study investigated the association between golimumab trough concentrations during maintenance and outcomes such as endoscopic healing, histologic remission, and long-term persistence in UC patients. The results showed that golimumab concentrations were associated with favorable treatment outcomes.
ALIMENTARY PHARMACOLOGY & THERAPEUTICS
(2022)
Review
Medicine, General & Internal
Camilla de Almeida Martins, Karoline Soares Garcia, Natalia Sousa Freita Queiroz
Summary: This review assesses the role of therapeutic drug monitoring (TDM) in inflammatory bowel disease (IBD), focusing on its implementation in different scenarios. TDM can help optimize the use of immunobiologics in the treatment of IBD patients, and is of great significance in clinical practice.
FRONTIERS IN MEDICINE
(2022)
Article
Immunology
Xue Lyu, Zhe Zhang, Xia Liu, Li Geng, Muhan Zhang, Baisui Feng
Summary: This study aimed to predict potential therapeutic targets for non-responders in ulcerative colitis (UC) patients by analyzing gene expression data and validating with biopsies from the GEO database. IL-6, IL1B, CXCL8, and CCL2 were identified as potential targets for non-responders.
JOURNAL OF INFLAMMATION RESEARCH
(2023)
Review
Gastroenterology & Hepatology
Mathilde Barrau, Manon Duprat, Pauline Veyrard, Quentin Tournier, Nicolas Williet, Jean Marc Phelip, Louis Waeckel, Adam S. Cheifetz, Konstantinos Papamichael, Xavier Roblin, Stephane Paul
Summary: This study systematically reviewed the feasibility of using drug-tolerant assays to monitor patients treated with anti-TNFs. Most ADAb detection methods are drug-sensitive and cannot be used close to drug administration, but several drug-tolerant techniques have been developed to overcome this limitation.
JOURNAL OF CROHNS & COLITIS
(2022)
Article
Gastroenterology & Hepatology
Daniela Pugliese, Giuseppe Privitera, Francesca Rogai, Angela Variola, Anna Viola, Lucrezia Laterza, Antonino C. Privitera, Mariangela Allocca, Fabrizio Bossa, Maria Cappello, Marco Daperno, Greta Lorenzon, Silvia Mazzuoli, Mariabeatrice Principi, Renato Sablich, Luisa Moser, Antonio Ferronato, Sara Traini, Gherardo Tapete, Giorgia Bodini, Maria Di Girolamo, Laurino Grossi, Giammarco Mocci, Chiara Ricci, Simone Saibeni, Stefano Festa, Rocco Spagnuolo, Claudio C. Cortelezzi, Filippo Mocciaro, Fernando Rizzello, Alessandro Armuzzi
Summary: This study investigated the long-term outcomes of patients with ulcerative colitis on golimumab therapy. Results showed that being biological-naive and able to discontinue steroids at Weeks 8 and 14 were associated with longer persistence on golimumab therapy. Maintaining continuous clinical response also led to a lower likelihood of golimumab discontinuation.
UNITED EUROPEAN GASTROENTEROLOGY JOURNAL
(2021)
Article
Gastroenterology & Hepatology
William J. Sandborn, Julian Panes, Silvio Danese, Zaineb Sharafali, Azra Hassanali, Rhian Jacob-Moffatt, Christopher Eden, Marco Daperno, John F. Valentine, David Laharie, Carolina Baia, Raja Atreya, Remo Panaccione, Grazyna Rydzewska, Humberto Aguilar, Severine Vermeire
Summary: This study compared the safety and efficacy of two doses of Etrolizumab with placebo in patients with Crohn's disease. The results showed that during the maintenance phase, Etrolizumab significantly improved clinical remission and endoscopic improvement in patients with moderately to severely active Crohn's disease compared to placebo. However, there was no significant difference in the effects of Etrolizumab and placebo on clinical remission and endoscopic improvement during the induction phase.
LANCET GASTROENTEROLOGY & HEPATOLOGY
(2023)
Editorial Material
Gastroenterology & Hepatology
Zhigang Wang, Bram Verstockt, Joao Sabino, Marc Ferrante, Severine Vermeire, Erwin Dreesen
CLINICAL GASTROENTEROLOGY AND HEPATOLOGY
(2023)
Article
Gastroenterology & Hepatology
Julian Panes, Edward Loftus, Peter D. R. Higgins, James O. Lindsay, Wen Zhou, Xuan Yao, Dapo Ilo, Charles Phillips, Jacinda Tran, Yuri Sanchez Gonzalez, Severine Vermeire
Summary: The study evaluated the benefits of UPA on the HRQoL of patients with ulcerative colitis, and found that UPA treatment significantly improved patients' quality of life.
INFLAMMATORY BOWEL DISEASES
(2023)
Article
Gastroenterology & Hepatology
Dotan Yogev, Bram Verstockt, Axel Dignass, Gili Focht, Ohad Atia, Iris Dotan, Severine Vermeire, Dan Turner
Summary: Evaluation of the modified version of the Mucosal Inflammation Noninvasive Index in adult Crohn's disease.
INFLAMMATORY BOWEL DISEASES
(2023)
Article
Gastroenterology & Hepatology
Gary R. Lichtenstein, Brian Bressler, Carlos Francisconi, Severine Vermeire, Nervin Lawendy, Leonardo Salese, Gosford Sawyerr, Hongjiong Shi, Chinyu Su, Donna T. Judd, Thomas Jones, Edward V. Loftus
Summary: Age is considered a risk factor for adverse events in the tofacitinib ulcerative colitis clinical program, with older individuals potentially having a higher risk of herpes zoster, malignancies (excluding nonmelanoma skin cancer), and nonmelanoma skin cancer compared to younger patients.
INFLAMMATORY BOWEL DISEASES
(2023)
Article
Gastroenterology & Hepatology
Wannee Kantasiripitak, Sebastian G. Wicha, Debby Thomas, Ilse Hoffman, Marc Ferrante, Severine Vermeire, Karen van Hoeve, Erwin Dreesen
Summary: The study aimed to develop a multi-model model-based software tool for guiding personalized infliximab induction treatment in pediatric inflammatory bowel disease patients. The study found that using the tool for individualized dosing improved the chances for children to achieve deep remission at 6 months.
JOURNAL OF CROHNS & COLITIS
(2023)
Review
Pharmacology & Pharmacy
Angela Elma Edwina, Nada Dia, Erwin Dreesen, Thomas Vanassche, Peter Verhamme, Isabel Spriet, Lorenz van der Linden, Jos Tournoy
Summary: Older adults, who make up almost 50% of DOACs users, lack sufficient pharmacological and clinical data. Understanding the PK/PD of DOACs in older adults is crucial due to the population's unique characteristics. This review highlights the current insights and interindividual variability in DOAC exposure in older adults.
CLINICAL PHARMACOKINETICS
(2023)
Review
Gastroenterology & Hepatology
S. Beysens, J. Wellens, G. De Hertogh, A. Van Laethem, J. Sabino, T. Hillary, S. Vermeire
Summary: This study conducted a retrospective case series of 11 patients with metastatic Crohn's disease (MCD). Skin biopsies showed noncaseating granulomatous inflammation in all cases. Treatment included steroids, biologicals, and surgical excision. Based on the findings and multidisciplinary discussion, a treatment algorithm for MCD was proposed.
SCANDINAVIAN JOURNAL OF GASTROENTEROLOGY
(2023)
Letter
Dermatology
Tom Hillary, Michele Grymonprez, Emma Vanhooren, Canan Guvenc, Maria Garmyn, Severine Vermeire
Summary: Venous thromboembolism is prevalent among patients with psoriasis, especially in older individuals with a history of malignancy and arterial hypertension. Dermatologists should be aware of this comorbidity and consider thromboprophylaxis in at-risk patients with psoriasis.
CLINICAL AND EXPERIMENTAL DERMATOLOGY
(2023)
Letter
Gastroenterology & Hepatology
Bram Verstockt, Maaike Vancamelbeke, Severine Vermeire
Article
Gastroenterology & Hepatology
Gabriele Bislenghi, Julie Van Den Bossch, Steffen Fieuws, Albert Wolthuis, Marc Ferrante, Gert de Hertogh, Severine Vermeire, Andre D'Hoore
Summary: The macroscopic appearance of the bowel and associated mesentery during surgery does not appear to be predictive of postoperative recurrence after ileocecal resection for Crohn's disease. Prospective studies investigating risk factors for Crohn's disease recurrence after surgery are scarce.
INFLAMMATORY BOWEL DISEASES
(2023)
Meeting Abstract
Gastroenterology & Hepatology
E. Schoefs, S. Vermeire, M. Ferrante, J. Sabino, B. Verstockt, L. Avedano, M. S. De Rocchis, M. Sajak-Szczerba, R. Saldana, N. Straetemans, M. Vandebroek, I. Huys, R. Janssens
JOURNAL OF CROHNS & COLITIS
(2023)
Article
Gastroenterology & Hepatology
Marla C. Dubinsky, David B. Clemow, Theresa Hunter Gibble, Xingyuan Li, Severine Vermeire, Tadakazu Hisamatsu, Simon P. L. Travis
Summary: This study analyzed the efficacy of Mirikizumab in reducing bowel urgency in ulcerative colitis patients, and found that the drug is effective in improving this symptom and is associated with other clinical outcomes.
CROHNS & COLITIS 360
(2023)
Article
Gastroenterology & Hepatology
Laurent Peyrin-Biroulet, Severine Vermeire, Geert D'Haens, Julian Panes, Axel Dignass, Fernando Magro, Maciej Nazar, Manuela Le Bars, Marjolein Lahaye, Lioudmila Ni, Ivana Bravata, Frederic Lavie, Marco Daperno, Milan Lukas, Alessandro Armuzzi, Mark Loewenberg, Daniel R. Gaya, Silvio Danese
Summary: The STARDUST LTE study is the first interventional study to investigate the efficacy of ustekinumab in Crohn's disease. The study showed that flexible, algorithm-driven dose adjustment, including dose reduction, preserved clinical and endoscopic outcomes for up to 104 weeks.
ALIMENTARY PHARMACOLOGY & THERAPEUTICS
(2023)
Article
Gastroenterology & Hepatology
Severine Vermeire, Jurij Hanzel, Mark Lowenberg, Marc Ferrante, Peter Bossuyt, Frank Hoentjen, Denis Franchimont, Karoly Palatka, Harald Peeters, Aart Mookhoek, Gert de Hertogh, Tamas Molnar, Wouter van Moerkercke, Triana Lobaton, Esme Clasquin, Melanie S. Hulshoff, Filip Baert, Geert D'Haens
Summary: This study explored the differential efficacy of vedolizumab in early and late ulcerative colitis and evaluated clinical, endoscopic, and histological outcomes. The results showed no significant differences between early and late UC in terms of clinical, endoscopic, and histological improvement.
JOURNAL OF CROHNS & COLITIS
(2023)