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REVIEW
Sanjay K Murthy, Adam V Weizman, M Ellen Kuenzig, Joseph W Windsor, Gilaad G Kaplan, Eric I Benchimol, Charles N Bernstein, Alain Bitton, Stephanie Coward, Jennifer L Jones, Kate Lee, Juan-Nicolás Peña-Sánchez, Noelle Rohatinsky, Sara Ghandeharian, Nasruddin Sabrie, Sarang Gupta, Gurmun Brar, Rabia Khan, James H B Im, Tal Davis, Jake Weinstein, Joëlle St-Pierre, Roxana Chis, Saketh Meka, Eric Cheah, Quinn Goddard, Julia Gorospe, Jack Kerr, Kayla D Beaudion, Ashley Patel, Sophia Russo, Jonathan Blyth, Stephanie Blyth, Diane Charron-Bishop, Laura E Targownik
The therapeutic landscape for inflammatory bowel disease (IBD) has changed considerably over the past two decades, owing to the development and widespread penetration of targeted therapies, including biologics and small molecules. While some conventional treatments continue to have an important role in the management of IBD, treatment of IBD is increasingly moving towards targeted therapies given their greater efficacy and safety in comparison to conventional agents. Early introduction of these therapies-particularly in persons with Crohn's disease-combining targeted therapies with traditional anti-metabolite immunomodulators and targeting objective markers of disease activity (in addition to symptoms), have been shown to improve health outcomes and will be increasingly adopted over time...
September 2023: Journal of the Canadian Association of Gastroenterology
#22
JOURNAL ARTICLE
Shubha Bhat, Ruishen Lyu, Mitali Agarwal, Michelle Becker, Richard Bloomfeld, David H Bruining, Benjamin L Cohen, Marina Ivanov, Jonathan A Leighton, Alyssa P Stewart, Lindsay Trocke, Stacy S Tse, Ryan C Ungaro, Byron P Vaughn, Miguel Regueiro, Erick Sokn, Florian Rieder
BACKGROUND: Given the complexity of inflammatory bowel disease (IBD) care, utilization of multidisciplinary teams is recommended to optimize outcomes. There is a growing recognition that clinical pharmacists should be an integral part of this care model. We sought to define the roles of IBD clinical pharmacists in the United States. METHODS: A national multidisciplinary expert panel of 12 gastroenterologists and clinical pharmacists practicing in IBD clinics was assembled...
August 31, 2023: Inflammatory Bowel Diseases
#23
JOURNAL ARTICLE
Ulf Müller-Ladner, Axel Dignass, Karl Gaffney, Deepak Jadon, Marco Matucci-Cerinic, Triana Lobaton, Philippe Carron, Javier P Gisbert, Ira Pande, Maximilian Utzinger, Janet Addison
BACKGROUND: The non-interventional PROPER study generated real-world evidence on clinical outcomes following transition in routine practice from reference adalimumab to the EMA-approved SB5 biosimilar adalimumab in patients with immune-mediated inflammatory disease. METHODS: Adults with rheumatoid arthritis (RA), axial spondyloarthritis (axSpA), psoriatic arthritis (PsA), Crohn's disease (CD), or ulcerative colitis (UC) were enrolled at 63 sites across Europe. Eligible patients received ≥ 16 weeks of routine treatment with reference adalimumab before transitioning to SB5, and were followed for 48 weeks post-transition...
November 2023: BioDrugs: Clinical Immunotherapeutics, Biopharmaceuticals and Gene Therapy
#24
JOURNAL ARTICLE
Panu Wetwittayakhlang, Khaled Karkout, Arti Wongcha-Um, Paraskevi Tselekouni, Reem Al-Jabri, Waqqas Afif, Gary Wild, Alain Bitton, Talat Bessissow, Peter L Lakatos
BACKGROUND: We aimed to evaluate clinical efficacy, biomarker activity, therapeutic drug monitoring (TDM), adverse events (AEs), and nocebo effect in inflammatory bowel disease (IBD) patients who underwent non-medical biosimilar switching. METHODS: A prospective observational study of consecutive IBD patients who underwent biosimilar switch. Disease activity, biomarkers, TDM, and AEs, including the nocebo effect were captured 8 weeks before switch, at the time of switch (baseline),12 and 24 weeks after the switch...
July 5, 2023: Digestive and Liver Disease
#25
JOURNAL ARTICLE
Vincent Chow, Daniel T Mytych, Shyamal Das, Janet Franklin
ABP 654 is a proposed biosimilar to ustekinumab reference product (RP) which works through antagonism of interleukin-12 and interleukin-23. Ustekinumab RP is used for the treatment of chronic inflammatory conditions, including some forms of plaque psoriasis, psoriatic arthritis, Crohn's disease, and ulcerative colitis. A randomized, double-blinded, single-dose, 3-arm, parallel-group study was conducted to assess the pharmacokinetic (PK) similarity of ABP 654 with ustekinumab RP sourced from the United States (US) and the European Union (EU); the PK similarity of ustekinumab US versus ustekinumab EU; and the comparative safety, tolerability, and immunogenicity of all 3 products...
July 7, 2023: Clinical Pharmacology in Drug Development
#26
JOURNAL ARTICLE
Yoram Bouhnik, Franck Carbonnel, Mathurin Fumery, Mathurin Flamant, Anne Buisson, Armelle Camoin, Janet Addison
BACKGROUND: SB5 is an EMA-approved adalimumab biosimilar, having demonstrated bioequivalence, equivalent efficacy, and similar safety and immunogenicity to the reference product. AIMS: Describe patient training and satisfaction using patient-reported outcome measures (PROMs) and assess their impact on 12-month persistence on SB5. METHODS: The observational PERFUSE study included 318 Crohn's disease (CD) patients and 88 ulcerative colitis (UC) patients in 27 sites across France between October 2018 and December 2020...
June 10, 2023: Digestive and Liver Disease
#27
JOURNAL ARTICLE
Amie Hinshaw, Kristen Cares, Ron Thomas, Mohammad El-Baba
UNLABELLED: The safety, efficacy, and cost-effectiveness of Infliximab biosimilar agents in the management of inflammatory bowel disease in adults have been shown. These agents have been recommended for pediatric inflammatory bowel disease, and although institutions are initiating therapy with the biosimilar agents (IFX-B), few are switching maintenance therapy from the originator (IFX-O). The aim was to compare biochemical markers of disease activity of children with inflammatory bowel disease on maintenance therapy with IFX-B to their previous markers on IFX-O...
November 2022: JPGN reports
#28
JOURNAL ARTICLE
María José Casanova, Óscar Nantes, Pilar Varela, Milagros Vela-González, Montserrat Rivero, Olivia Sierra-Gabarda, Sabino Riestra, Manuel Barreiro-de Acosta, María Del Mar Martín-Rodríguez, Carla Jerusalén Gargallo-Puyuelo, Cristina Reygosa, Roser Muñoz, Irene García de la Filia-Molina, Andrea Núñez-Ortiz, Lilyan Kolle, Margalida Calafat, José María Huguet, Eva Iglesias-Flores, Teresa de Jesús Martínez-Pérez, Orencio Bosch, José María Duque-Alcorta, Santiago Frago-Larramona, Manuel Van Domselaar, Víctor Manuel González-Cosano, Luis Bujanda, Saioa Rubio, Alejo Mancebo, Beatriz Castro, Santiago García-López, Ruth de Francisco, Laura Nieto-García, Viviana Laredo, Ana Gutiérrez-Casbas, Francisco Mesonero, Eduardo Leo-Carnerero, Fiorella Cañete, Lucía Ruiz, Beatriz Gros, María Del Moral-Martínez, Cristina Rodríguez, María Chaparro, Javier P Gisbert
BACKGROUND AND AIMS: Data on the outcomes after switching from adalimumab (ADA) originator to ADA biosimilar are limited. The aim was to compare the treatment persistence, clinical efficacy, and safety outcomes in inflammatory bowel disease patients who maintained ADA originator vs. those who switched to ADA biosimilar. METHODS: Patients receiving ADA originator who were in clinical remission at standard dose of ADA originator were included. Patients who maintained ADA originator formed the non-switch cohort (NSC), and those who switched to different ADA biosimilars constituted the switch cohort (SC)...
July 2023: Alimentary Pharmacology & Therapeutics
#29
JOURNAL ARTICLE
Bernd Bokemeyer, Tibor Hlavaty, Matthieu Allez, Pamela Selema, Shahrzad Moosavi, Mary Jane Cadatal, Heather Fowler, Markus Mueller, Katherine F Liau, Javier P Gisbert
BACKGROUND: The objective of this non-interventional, observational prospective cohort study (CONNECT-IBD) was to assess the use of CT-P13 (Inflectra®) in the treatment of patients with Crohn's disease (CD) and ulcerative colitis (UC) in the context of treatment with reference infliximab (IFX; Remicade®). METHODS: Patients (recruited April 2015 to October 2018) at 150 sites across 13 European countries were followed for up to 2 years. Primary outcomes were safety, population characteristics, and drug utilization patterns...
April 11, 2023: Expert Opinion on Biological Therapy
#30
JOURNAL ARTICLE
Rosanne W Meijboom, Liese Barbier, Louise C Druedahl, Kati Sarnola, Hanna M Tolonen, Helga Gardarsdottir, Acg Egberts, Thijs J Giezen
BACKGROUND: : Professional associations publish guidance advising gastroenterologists on prescribing biosimilars; however, guidelines differ between countries and change over time. This study aimed to map the presence and content of guidance from European gastroenterology associations on TNFα inhibitor biosimilar use and its development over time. RESEARCH DESIGN AND METHODS: Guidelines on biosimilar prescribing from national gastroenterology associations in the European Economic Area (EEA) partnered with the European Crohn's and Colitis Organisation (ECCO) were collected...
March 22, 2023: Expert Opinion on Biological Therapy
#31
JOURNAL ARTICLE
Yoram Bouhnik, Bruno Fautrel, Laurent Beaugerie, Anne-Laure Pelletier, Christine Martinez-Vinson, Ulrich Freudensprung, Amira Brigui, Janet Addison
BACKGROUND: FlixabiTM (SB2) is a biosimilar of the reference infliximab (IFX), Remicade® . Published evidence on long-term, real-world use of SB2 in patients either IFX naive or transitioned from prior IFX is scarce. OBJECTIVES: We evaluated persistence, effectiveness, and safety of SB2 over 12 months in adults with IBD [Crohn's disease (CD) and ulcerative colitis (UC)], participating in PERFUSE. DESIGN: PERFUSE is a long-term, non-interventional, multicenter study of patients receiving SB2 at specialist sites across France...
2023: Therapeutic Advances in Gastroenterology
#32
REVIEW
Naazish S Bashir, Avery Hughes, Wendy J Ungar
UNLABELLED: Background. Policies mandating the use of lower cost biosimilars in patients with inflammatory bowel disease (IBD) have created concerns for patients who prefer their original biologic. Purpose. To inform the cost-effectiveness of biosimilar infliximab treatment in IBD by systematically reviewing the effect of infliximab price variation on cost-effectiveness for jurisdictional decision making. Data Sources. MEDLINE, Embase, Healthstar, Allied and Complementary Medicine, Joanna Briggs Institute EBP Database, International Pharmaceutical Abstracts, Health and Psychosocial Instruments, Mental Measurements Yearbook citation databases, PEDE, CEA registry, HTA agencies...
2023: MDM Policy & Practice
#33
Jessica Larson, Patrick Twohig, Kathryn Hutchins
Tumor necrosis factor-α inhibitors are monoclonal antibodies that are commonly used in the treatment of inflammatory bowel disease. A rare side effect of these biological agents is chronic inflammatory demyelinating polyneuropathy, which is a debilitating disease characterized by weakness, sensory dysfunction, and diminished or absent reflexes. We present the first reported case of chronic inflammatory demyelinating polyneuropathy after treatment with the tumor necrosis factor-α inhibitor biosimilar, infliximab-dyyp (Inflectra)...
February 2023: ACG Case Reports Journal
#34
REVIEW
Gian Marco Leone, Katia Mangano, Maria Cristina Petralia, Ferdinando Nicoletti, Paolo Fagone
Due to the key role of tumor necrosis factor-alpha (TNF-α) in the pathogenesis of immunoinflammatory diseases, TNF-α inhibitors have been successfully developed and used in the clinical treatment of autoimmune disorders. Currently, five anti-TNF-α drugs have been approved: infliximab, adalimumab, golimumab, certolizumab pegol and etanercept. Anti-TNF-α biosimilars are also available for clinical use. Here, we will review the historical development as well as the present and potential future applications of anti-TNF-α therapies, which have led to major improvements for patients with several autoimmune diseases, such as rheumatoid arthritis (RA), ankylosing spondylitis (AS), Crohn's disease (CD), ulcerative colitis (UC), psoriasis (PS) and chronic endogenous uveitis...
February 17, 2023: Journal of Clinical Medicine
#35
JOURNAL ARTICLE
Marieke J Pierik, Andrea E van der Meulen, Klaas Van der Linde, Maurice Lutgens, Johan P Kuijvenhoven, Halil Akol, Ids J Klompmaker, Michelle S G Sikkens, Yvonne J B van Megen, Corinne M Stoop, Joanne P J Bloemsaat-Minekus, Gerard Dijkstra
BACKGROUND: Quality of life (QoL) data for patients with inflammatory bowel disease switched from the reference infliximab to biosimilar CT-P13 is lacking. This study aims to demonstrate noninferiority for QoL and efficacy after switching. METHODS: OoL and clinical efficacy were measured prior to and after 2, 4, and 6 CT-P13 infusions. RESULTS: One hundred seventy-eight patients were included. Noninferiority was established for QoL [ratio 97...
July 2022: Crohn's & colitis 360
#36
JOURNAL ARTICLE
Christine Martinez-Vinson, Anaïs Lemoine, Yoram Bouhnik, Ben Braithwaite, Audrey Fohlen-Weill, Janet Addison
OBJECTIVES: PERFUSE s a non-interventional study of 1233 patients (inflammatory rheumatic disease, n=496; inflammatory bowel disease [IBD], n=737) receiving infliximab (IFX) biosimilar SB2 therapy. This analysis describes response to treatment and persistence on SB2 for up to 12 months in paediatric IBD patients (n=126). METHODS: Paediatric IBD patients with Crohn's disease (CD) or ulcerative colitis (UC), either naïve or switched from originator infliximab, who started SB2 in routine practice after September 2017 were eligible...
December 16, 2022: Journal of Pediatric Gastroenterology and Nutrition
#37
Maria Zachou, Konstantinos Pikramenos, Maria Panoutsakou, Efthimia Lalla, Theodoros Androutsakos
Infliximab (IFX) is a chimeric human-murine monoclonal antibody that prevents tumor necrosis factor alpha (TNF-α) activation by binding to both soluble and transmembrane forms of TNF-α. Antagonists of TNF (anti-TNF agents) can cause drug-induced liver injury (DILI). We present a non-anti-TNF naïve patient suffering from severe Crohn's disease who developed DILI with a hepatocellular pattern, without jaundice, after two infusions of an IFX biosimilar.
December 2022: Curēus
#38
JOURNAL ARTICLE
Dong W Kim, Yousun Lee, Geuntae Kim, Sang H Kim, Dae H Cho, Jeongmin Choi, Yong H Kwon, Younjin Park, Wooree Choi, Dong I Park
INTRODUCTION: SB2 is a biosimilar of infliximab (IFX), which is approved for rheumatoid arthritis (RA), ankylosing spondylitis (AS), adult and pediatric Crohn's disease (CD), adult and pediatric ulcerative colitis (UC), psoriatic arthritis (PsA), and plaque psoriasis (PsO). The drug approval process in Korea includes post-marketing surveillance (PMS) studies to re-examine the safety and effectiveness of approved new medications. METHODS: This was a prospective, multi-center, open-label, observational, phase 4 PMS study of IFX-naïve patients or patients switched from reference IFX or another IFX-biosimilar to SB2 in all approved indications...
January 10, 2023: Advances in Therapy
#39
JOURNAL ARTICLE
Thomas Khoo, Navkiran Sidhu, Franca Marine, Susan Lester, Alannah Quinlivan, Debra Rowett, Rachelle Buchbinder, Catherine L Hill
BACKGROUND: Biologic and targeted synthetic disease modifying agents (b/tsDMARDs) have broadened the treatment landscape for autoimmune diseases particularly in patients refractory to conventional DMARDs. More recently, the introduction of biosimilars has reduced the price of bDMARDs, potentially improving accessibility. Though efficacy and safety have been described, patient attitudes to b/tsDMARDs are not well-understood. We aim to investigate patients' beliefs about biologic and biosimilar therapy, and the factors influencing their perceptions...
December 23, 2022: BMC rheumatology
#40
REVIEW
Stephen Hanauer
WHAT IS THIS SUMMARY ABOUT?: This is a summary of the VOLTAIRE-CD study originally published in The Lancet Gastroenterology and Hepatology . BI 695501 is a medicine being developed to treat people with moderately to severely active Crohn's disease, a chronic inflammatory condition that usually affects the small bowel and colon. BI 695501 is a biosimilar, which means that it is designed to be highly similar to the original drug. The VOLTAIRE-CD study aimed to show whether BI 695501 is just as effective and safe as the original drug, adalimumab (Humira® ) in treating Crohn's disease...
December 2022: Immunotherapy
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