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https://www.readbyqxmd.com/read/29753532/switching-from-an-originator-anti-tnf-to-a-biosimilar-in-patients-with-inflammatory-bowel-disease-can-it-be-recommended-a-systematic-review
#1
Javier P Gisbert, María Chaparro
AIM: To review the effectiveness and safety of switching from an originator anti-TNF (Remicade® ) to a biosimilar (CT-P13) in patients with inflammatory bowel disease (IBD). METHODS: Electronic and manual search up to September 2017. RESULTS: We identified 24 studies evaluating switching between Remicade® and CT-P13 in 1326 patients. Disease control (no worsening after switching) was confirmed in most of the patients (weighted mean, 88%; 95% CI=86-89%)...
May 9, 2018: Gastroenterología y Hepatología
https://www.readbyqxmd.com/read/29732144/evaluation-of-the-physicochemical-and-biological-stability-of-reconstituted-and-diluted-sb2-infliximab
#2
Jihyun Kim, Jihyun Chung, Sujin Park, Saem Jung, Dukwon Kang
Objectives: To evaluate the critical quality attributes that might affect the stability of an infliximab biosimilar (SB2, Flixabi) when reconstituted or diluted and stored under refrigeration and at room temperature. Methods: We largely adhered to the UK's National Health Service guidance requirements for the design of a robust stability study and for robust testing methods. Protocol components included evaluation of visual appearance, chemical stability, physical stability, pH, particle sizes and biological activity...
May 2018: European Journal of Hospital Pharmacy. Science and Practice
https://www.readbyqxmd.com/read/29697550/use-of-infliximab-biosimilar-versus-originator-in-a-paediatric-united-kingdom-inflammatory-bowel-disease-induction-cohort
#3
Neil Chanchlani, Kajal Mortier, Linda J Williams, Rafeeq Muhammed, Marcus K H Auth, Mike Cosgrove, Andrew Fagbemi, John Fell, Sonny Chong, Veena Zamvar, Warren Hyer, W Michael Bisset, Mary-Anne Morris, Astor Rodrigues, Sally G Mitton, Su Bunn, R Mark Beattie, Anne Willmott, David C Wilson, Richard K Russell
OBJECTIVES: To summarize short-term effectiveness, safety, and cost of using infliximab biosimilar (IFX-B) drugs, (Inflectra™ and Remsima™) compared to originator infliximab (IFX-O) (Remicade®) in biologic naive pediatric inflammatory bowel disease in the United Kingdom. METHODS: Prospective audit of patients starting anti-TNF therapy. Disease severity, response to treatment, and remission rate was measured by Pediatric Crohn's Disease Activity Index (PCDAI) and/or Physician Global Assessment (PGA)...
April 23, 2018: Journal of Pediatric Gastroenterology and Nutrition
https://www.readbyqxmd.com/read/29696196/remission-induction-by-raising-the-dose-of-remicade-in-ra-rrrr-study-rationale-and-study-protocol-for-a-randomized-controlled-trial-comparing-for-sustained-clinical-remission-after-discontinuation-of-infliximab-in-patients-with-rheumatoid-arthritis
#4
Koji Oba, Nao Horie, Norihiro Sato, Kazuyoshi Saito, Tsutomu Takeuchi, Tsuneyo Mimori, Nobuyuki Miyasaka, Takao Koike, Yoshiya Tanaka
Infliximab, an inhibitor of TNF-α, is one of the most widely used biological disease-modifying antirheumatic drugs. Recent studies indicated that baseline serum TNF-α could be considered as a key indicator for optimal dosing of infliximab for RA treatment to achieve the clinical response and its sustained remission. The Remission induction by Raising the dose of Remicade in RA (RRRR) study is an open-label, parallel group, multicenter randomized controlled trial to compare the proportions of clinical remission based on the simplified disease activity index (SDAI) after 1 year of treatment and its sustained remission rate after another 1 year between the investigational treatment strategy (for which the dose of infliximab was chosen based on the baseline serum TNF) and the standard strategy of 3 mg/kg per 8 weeks of infliximab administration in infliximab-naïve patients with RA showing an inadequate response to MTX...
December 2017: Contemporary Clinical Trials Communications
https://www.readbyqxmd.com/read/29538037/switching-to-a-infliximab-biosimilar-short-term-results-of-clinical-monitoring-in-patients-with-inflammatory-bowel-disease
#5
Lisette Binkhorst, Annemieke Sobels, Rogier Stuyt, Elsbeth M Westerman, Rachel L West
OBJECTIVE: Currently, a biosimilar of Remicade is available (CT-P13). Switching patients from Remicade to a biosimilar is still under debate, especially for patients with inflammatory bowel disease (IBD). In a retrospective study, we investigated the feasibility and safety of switching patients with IBD from Remicade to a biosimilar infliximab. PATIENTS AND METHODS: At two large general hospitals in The Netherlands, adult patients with a diagnosis of Crohn's disease or ulcerative colitis being treated with Remicade were asked to switch to the biosimilar infliximab (CT-P13)...
March 13, 2018: European Journal of Gastroenterology & Hepatology
https://www.readbyqxmd.com/read/29518978/structural-biology-of-the-tnf%C3%AE-antagonists-used-in-the-treatment-of-rheumatoid-arthritis
#6
REVIEW
Heejin Lim, Sang Hyung Lee, Hyun Tae Lee, Jee Un Lee, Ji Young Son, Woori Shin, Yong-Seok Heo
The binding of the tumor necrosis factor α (TNFα) to its cognate receptor initiates many immune and inflammatory processes. The drugs, etanercept (Enbrel® ), infliximab (Remicade® ), adalimumab (Humira® ), certolizumab-pegol (Cimzia® ), and golimumab (Simponi® ), are anti-TNFα agents. These drugs block TNFα from interacting with its receptors and have enabled the development of breakthrough therapies for the treatment of several autoimmune inflammatory diseases, including rheumatoid arthritis, Crohn's disease, and psoriatic arthritis...
March 7, 2018: International Journal of Molecular Sciences
https://www.readbyqxmd.com/read/29504427/a-randomized-study-comparing-the-pharmacokinetics-of-the-potential-biosimilar-pf-06438179-gp1111-with-remicade%C3%A2-infliximab-in-healthy-subjects-reflections-b537-01
#7
Ramesh Palaparthy, Chandrasekhar Udata, Steven Y Hua, Donghua Yin, Chun-Hua Cai, Stephanie Salts, Muhammad I Rehman, Joseph McClellan, Xu Meng
BACKGROUND: To demonstrate pharmacokinetic (PK) similarity of PF-06438179/GP1111, a potential biosimilar to Remicade®, to Remicade® sourced from European Union (infliximab-EU) and United States (infliximab-US), and of infliximab-EU to infliximab-US. METHODS: In this phase I, parallel-group, three-arm trial, healthy adult subjects were randomized to receive a single 10-mg/kg intravenous infusion of PF-06438179/GP1111, infliximab-EU, or infliximab-US. PK, and safety and immunogenicity evaluations were performed over 8 and 12 weeks, respectively...
April 2018: Expert Review of Clinical Immunology
https://www.readbyqxmd.com/read/29496351/efficacy-and-safety-of-infliximab-biosimilar-inflectra-%C3%A2-in-severe-sarcoidosis
#8
Milou C Schimmelpennink, Adriane D M Vorselaars, Frouke T van Beek, Heleen A Crommelin, Vera H M Deneer, Ruth G M Keijsers, Marcel Veltkamp
BACKGROUND: Infliximab, a monoclonal antibody against tumor necrosis factor alpha (TNF-α) is effective third-line therapy in severe sarcoidosis. The originator product of Infliximab, Remicade® , is expensive, limiting universal access. Recently, a less expensive biosimilar of infliximab, Inflectra® , has become available, but the efficacy and tolerability has not been studied in sarcoidosis. METHODS: In this retrospective cohort study, 29 patients treated with the infliximab biosimilar Inflectra® , were analysed...
May 2018: Respiratory Medicine
https://www.readbyqxmd.com/read/29462398/full-interchangeability-in-regard-to-immunogenicity-between-the-infliximab-reference-biologic-and-biosimilars-ct-p13-and-sb2-in-inflammatory-bowel-disease
#9
Gionata Fiorino, M Begoña Ruiz-Argüello, Ainara Maguregui, Daniel Nagore, Carmen Correale, Simona Radice, Daniela Gilardi, Mariangela Allocca, Federica Furfaro, Antonio Martínez, Silvio Danese
Background: Infliximab (IFX) biosimilars CT-P13 and SB2 have comparable efficacy, safety, and immunogenicity to the originator Remicade (RMC). However, concerns about cross-switching patients between the 3 brands were raised in the absence of cross reactivity data between them. We aimed to determine whether antibodies to infliximab (ATI) in inflammatory bowel disease (IBD) patients cross-react with RMC, CT-P13, and SB2. Methods: Based on previous ATI status, samples from 34 patients participating in the BIOSIM01 study (13 RMC, 9 CT-P13, and 12 switchers) were selected...
February 15, 2018: Inflammatory Bowel Diseases
https://www.readbyqxmd.com/read/29439320/of-patents-and-patent-disputes-the-tnf%C3%AE-patent-files-part-2-enbrel-remicade-cimzia-and-simponi
#10
Ulrich Storz
This article is the second part of a trilogy that discusses IP issues related to anti-Tumor Necrosis factor α (TNFα) biologics. TNFα is the world's most valuable target, with accumulated sales of TNFα biologics of 34 bn USD in 2014. While in the first part of this trilogy, Humira was discussed, this second parts discusses the patent strategies of Enbrel, Remicade, Cimzia and Simponi.
February 5, 2018: Human Antibodies
https://www.readbyqxmd.com/read/29404425/gut-microbiota-offers-universal-biomarkers-across-ethnicity-in-inflammatory-bowel-disease-diagnosis-and-infliximab-response-prediction
#11
Youlian Zhou, Zhenjiang Zech Xu, Yan He, Yunsheng Yang, Le Liu, Qianyun Lin, Yuqiang Nie, Mingsong Li, Fachao Zhi, Side Liu, Amnon Amir, Antonio González, Anupriya Tripathi, Minhu Chen, Gary D Wu, Rob Knight, Hongwei Zhou, Ye Chen
Gut microbiota dysbiosis contributes to the onset and perpetuation of inflammatory bowel disease (IBD). Given that gut microbiotas vary across geography and ethnicity, it remains obscure whether any universal microbial signatures for IBD diagnosis and prognosis evaluation exist irrespective of populations. Here we profiled the fecal microbiota of a series of Chinese IBD patients and combined them with two Western IBD cohorts, PRISM and RISK, for meta-analyses. We found that the gut microbial alteration patterns in IBD are similar among Chinese and Westerners...
January 2018: MSystems
https://www.readbyqxmd.com/read/29369768/biosimilars-for-rheumatoid-arthritis-don-t-count-them-out-quite-yet
#12
Nicolle Rychlick
Because physicians and health plan members both value choice, the current weak market for Inflectra and Renflexis could be a passing phase. Attitudes could change once there is more data that show people do well after switching from Remicade to the newcomers.
January 2018: Managed Care
https://www.readbyqxmd.com/read/29304271/blau-jabs-syndrome-in-a-tertiary-ophthalmologic-center
#13
Heloisa Nascimento, Jacqueline M Sousa, Délia González Fernández, Gustavo H A Salomão, Elcio H Sato, Cristina Muccioli, Rubens Belfort
In a prospective case series of patients with Blau-Jabs syndrome (BJS) conducted in the Ophthalmology Department/Federal University of Sao Paulo, seven patients with clinical and ophthalmologic manifestations of the disease and a positive genetic test result for the presence of a mutation in the CARD15/NOD2 gene were followed for a minimal period of 1 year. All patients had uveitis, five had nummular corneal subepithelial opacities, and four had multifocal choroiditis. Oral prednisolone was administered to all patients; inflammation was controlled in six patients with at least one immunosuppressive drug...
January 1, 2018: Ophthalmic Surgery, Lasers & Imaging Retina
https://www.readbyqxmd.com/read/29228558/1-palmitoyl-2-linoleoyl-3-acetyl-rac-glycerol-ameliorates-arthritic-joints-through-reducing-neutrophil-infiltration-mediated-by-il-6-stat3-and-mip-2-activation
#14
Young-Jun Kim, Jae Min Shin, Su-Hyun Shin, Joo Heon Kim, Ki-Young Sohn, Heung-Jae Kim, Jong-Koo Kang, Sun Young Yoon, Jae Wha Kim
The pathogenesis of rheumatoid arthritis (RA) has been implicated neutrophil extracellular traps (NETs) formation which could generate autoantigen. Neutrophil contributes to initiate and maintain the inflammatory process in the joint. In this study, we show that 1-palmitoyl-2-linoleoyl-3-acetyl-rac-glycerol (PLAG) decreases neutrophil migration by regulating the activity of STAT3, a regulator of IL-6 and MIP-2 expression. PLAG caused a decrease in IL-6 production in the RAW264.7 macrophage cell line and in rheumatoid arthritis-fibroblast-like synoviocytes via the regulation of STAT3 signaling without affecting NF-κB signaling...
November 14, 2017: Oncotarget
https://www.readbyqxmd.com/read/29205444/switching-from-infliximab-innovator-to-biosimilar-in-patients-with-inflammatory-bowel-disease-a-12-month-multicentre-observational-prospective-cohort-study
#15
E M H Schmitz, P J Boekema, J W A Straathof, D C van Renswouw, L Brunsveld, V Scharnhorst, M E C van de Poll, M A C Broeren, L J J Derijks
BACKGROUND: Infliximab biosimilars have become available for treatment of inflammatory bowel disease (IBD). However, data showing long-term safety and effectiveness of biosimilars in IBD patients are limited. AIM: To study prospectively the switch from infliximab innovator to biosimilar in an IBD cohort with 12 months follow-up to evaluate safety and effectiveness. METHODS: Adult IBD patients from two hospitals treated with infliximab innovator (Remicade; Janssen Biotech,  Horsham ,  Pennsylvania, USA) were switched to infliximab biosimilar (Inflectra; Hospira, Lake Forest, Illinois, USA) as part of routine care, but in a controlled setting...
February 2018: Alimentary Pharmacology & Therapeutics
https://www.readbyqxmd.com/read/29123576/the-efficacy-and-safety-of-the-biosimilar-product-inflectra-%C3%A2-compared-to-the-reference-drug-remicade-%C3%A2-in-rescue-therapy-in-adult-patients-with-ulcerative-colitis
#16
Magdalena Kaniewska, Andrzej Moniuszko, Grażyna Rydzewska
Introduction: The biosimilar product Inflectra® has been approved by the European Medicine Agency (EMA) for the same indications as its reference drug, infliximab, based on studies in patients with rheumatic diseases. Thus far, there have not been enough data regarding its efficacy and safety in ulcerative colitis (UC). Aim: To assess the efficacy and safety of the biosimilar product Inflectra® in comparison with its reference biological agent (Remicade® ) in rescue therapy in adult patients presenting with severe exacerbation of UC, as well as to evaluate recurrence rate during a 6-month observation after finish of treatment...
2017: Przegla̜d Gastroenterologiczny
https://www.readbyqxmd.com/read/29094341/safety-efficacy-and-drug-survival-of-biologics-and-biosimilars-for-moderate-to-severe-plaque-psoriasis
#17
A Egeberg, M B Ottosen, R Gniadecki, S Broesby-Olsen, T N Dam, L E Bryld, M K Rasmussen, L Skov
BACKGROUND: Real-life data on newer biological and biosimilar agents for moderate-to-severe psoriasis are lacking. OBJECTIVES: To examine safety, efficacy and time to discontinuation (drug survival) of biologics (adalimumab, etanercept, infliximab, secukinumab and ustekinumab) and compare originators with biosimilars (i.e. Enbrel with Benepali, and Remicade with Remsima). METHODS: The DERMBIO registry contains data on all Danish patients with moderate-to-severe plaque psoriasis treated with biologics...
February 2018: British Journal of Dermatology
https://www.readbyqxmd.com/read/29045077/subjective-complaints-as-the-main-reason-for-biosimilar-discontinuation-after-open-label-transition-from-reference-infliximab-to-biosimilar-infliximab
#18
Lieke Tweehuysen, Bart J F van den Bemt, Iris L van Ingen, Alphons J L de Jong, Willemijn H van der Laan, Frank H J van den Hoogen, Alfons A den Broeder
OBJECTIVE: To evaluate drug survival, effectiveness, pharmacokinetics, immunogenicity, and safety in daily practice after transitioning treatment from original reference infliximab (Remicade [REM]) to a biosimilar infliximab (CT-P13 [Remsima; Inflectra]) in patients with rheumatoid arthritis, psoriatic arthritis, or ankylosing spondylitis. METHODS: Of the initial 222 REM-treated patients, 192 agreed to transition to CT-P13 and were included in this multicenter prospective cohort study...
January 2018: Arthritis & Rheumatology
https://www.readbyqxmd.com/read/29023386/the-immunogenicity-of-branded-and-biosimilar-infliximab-in-rheumatoid-arthritis-according-to-th9-related-responses
#19
Rossella Talotta, Angela Berzi, Andrea Doria, Alberto Batticciotto, Maria Chiara Ditto, Fabiola Atzeni, Piercarlo Sarzi-Puttini, Daria Trabattoni
Our objective was to evaluate the immunogenicity of branded and biosimilar infliximab by detecting changes in T-helper-9 (Th9) percentages induced by an in vitro stimulation test. METHODS: Peripheral blood mononuclear cells collected from 55 consecutive rheumatoid arthritis (RA) outpatients (15 drug free, 20 successfully treated with branded infliximab, 20 branded infliximab inadequate responders) and 10 healthy controls were cultured, with or without 50 μg/mL of infliximab originator (Remicade® ) or 50 μg/mL of infliximab biosimilar (Remsima® ) for 18 h...
October 12, 2017: International Journal of Molecular Sciences
https://www.readbyqxmd.com/read/28976302/certolizumab-pegol-and-secukinumab-for-treating-active-psoriatic-arthritis-following-inadequate-response-to-disease-modifying-antirheumatic-drugs-a-systematic-review-and-economic-evaluation
#20
Mark Corbett, Fadi Chehadah, Mousumi Biswas, Thirimon Moe-Byrne, Stephen Palmer, Marta Soares, Matthew Walton, Melissa Harden, Pauline Ho, Nerys Woolacott, Laura Bojke
BACKGROUND: Several biologic therapies are approved by the National Institute for Health and Care Excellence (NICE) for psoriatic arthritis (PsA) patients who have had an inadequate response to two or more synthetic disease-modifying antirheumatic drugs (DMARDs). NICE does not specifically recommend switching from one biologic to another, and only ustekinumab (UST; STELARA®, Janssen Pharmaceuticals, Inc., Horsham, PA, USA) is recommended after anti-tumour necrosis factor failure. Secukinumab (SEC; COSENTYX®, Novartis International AG, Basel, Switzerland) and certolizumab pegol (CZP; CIMZIA®, UCB Pharma, Brussels, Belgium) have not previously been appraised by NICE...
October 2017: Health Technology Assessment: HTA
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