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Switching infliximab

Yusuf Yazici, Lin Xie, Adesuwa Ogbomo, Lorie A Ellis, Kavitha Goyal, Amanda Teeple, Ismail Simsek
Purpose: This study compared treatment patterns of Turkish patients with a diagnosis of rheumatoid arthritis (RA) who were treated with innovator Remicade® (infliximab [IFX]) and either continued IFX or switched to CT-P13. Materials and methods: Adult RA patients with ≥1 IFX claim were identified from the Turkish Ministry of Health database. Eligible patients initiated and continued IFX treatment (continuers cohort [CC]) or initiated IFX and switched to CT-P13 (switchers cohort [SC]) during the study period...
2018: Biologics: Targets & Therapy
Anna Viola, Daniela Pugliese, Sara Renna, Federica Furfaro, Flavio Caprioli, Renata D'Incà, Fabrizio Bossa, Stefano Mazza, Giuseppe Costantino, Massimo Fantini, Gionata Fiorino, Angela Alibrandi, Ambrogio Orlando, Alessandro Armuzzi, Walter Fries
BACKGROUND: Anti-TNF therapies infliximab (IFX), adalimumab (ADA), and golimumab (GOL) are approved for treating moderate to severe ulcerative colitis (UC). In UC, only the switch from IFX to ADA has been investigated, reaching no more than 10-43% remission rates at 12 months. AIM: Of the present study was to investigate disease outcome after a switch from subcutaneous (SC) agents to the intravenous (IV) agent (IFX). METHODS: In this retrospective multicentre study, we analysed the charts of UC patients unresponsive/intolerant or with secondary loss of response (LOR) to ADA or GOL who were switched to IFX...
October 28, 2018: Digestive and Liver Disease
Machaon M K Bonafede, Donna McMorrow, Clare Proudfoot, Shraddha Shinde, Andreas Kuznik, Chieh-I Chen
Background: Targeted disease-modifying antirheumatic drug (DMARD) options for rheumatoid arthritis (RA) include tumor necrosis factor (TNF) inhibitors (adalimumab, certolizumab, etanercept, golimumab, infliximab) or alternative mechanisms of action (MOAs), such as a T-cell co-stimulation modulator (abatacept), Janus kinase inhibitor (tofacitinib), or interleukin-6 inhibitor (tocilizumab). Objective: To examine treatment persistence and healthcare costs in patients with RA who changed therapy by cycling therapy (ie, switching within the same drug class), or switching between, the TNF inhibitors and alternative MOA medication classes...
June 2018: American Health & Drug Benefits
Mohammed Ibrahim Aladul, Raymond William Fitzpatrick, Stephen Robert Chapman
OBJECTIVE: To investigate UK healthcare professionals' perceptions and perspectives towards biosimilar infliximab, etanercept and insulin glargine and the potential barriers and facilitators to their prescribing. DESIGN: A cross-sectional qualitative study design was used. SETTING: Five hospitals within the West Midlands area in UK. INTERVENTIONS: 30 min face-to-face, semistructured interviews of healthcare professionals...
November 18, 2018: BMJ Open
Carson Van Sanford, Ahmed Z Obeidat, Matthew Hagen, Aram Zabeti
INTRODUCTION: CNS involvement in sarcoidosis is seen in 5-10% of cases. Long term treatment involves steroids and other immunomodulatory agents, including infliximab. Chronic immunosuppression can result in increased patient susceptibility to opportunistic infections. We present a case of fatal aspergillosis in a patient with neurosarcoidosis treated with infliximab. CASE REPORT: A 55-year-old woman with neurosarcoidosis on infliximab (started 4 months prior) and dexamethasone, presented with progressive cognitive decline...
November 15, 2018: International Journal of Neuroscience
Brian G Feagan, Gordon Lam, Christopher Ma, Gary R Lichtenstein
BACKGROUND: Biosimilar versions of widely prescribed drugs, including the tumour-necrosis factor antagonist infliximab, are becoming increasingly available. As biosimilars are not identical copies of reference products, evidence may be required to demonstrate that switching between a reference biologic and biosimilars is safe and efficacious. To establish interchangeability, US Food and Drug Administration guidance states that studies must demonstrate that biosimilars remain equivalent or non-inferior to a reference product after multiple switches between products...
November 8, 2018: Alimentary Pharmacology & Therapeutics
Fernando Magro, Rosa Coelho, Armando Peixoto
Immune-mediated inflammatory diseases share several pathogenic pathways and this pushes sometimes to extrapolate from one disease or indication to others. A biosimilar can be defined as a biotherapeutic product which is similar in terms of quality, safety, and efficacy to an already licensed reference biotherapeutic product. We review the substrate for extrapolation, the current approval process for biosimilars and the pioneering studies on biosimilars performed in rheumatoid arthritis patients. A biosimilar has the same amino acid sequence as its innovator product...
November 1, 2018: Current Medicinal Chemistry
Vincent Germain, Marc Scherlinger, Thomas Barnetche, Thierry Schaeverbeke
No abstract text is available yet for this article.
October 23, 2018: Annals of the Rheumatic Diseases
Oded Sagiv, Sudip D Thakar, Thomas J Kandl, Joshua Ford, Matthew C Sniegowski, Wen-Jen Hwu, Bita Esmaeli
Importance: Conjunctival melanoma has the potential for regional lymphatic and distant metastasis. There is an urgent need for effective treatment for patients with metastatic or locally advanced conjunctival melanoma. Objective: To describe the use of immune checkpoint inhibitors for the treatment of conjunctival melanoma in 5 adult patients. Design, Setting, and Participants: A retrospective review was conducted of the medical records of 5 patients with conjunctival melanoma who were treated with immune checkpoint inhibitors from March 6, 2013, to July 7, 2017...
November 1, 2018: JAMA Ophthalmology
Ron Goeree, Sima Chiva-Razavi, Praveen Gunda, Minal Jain, Steffen M Jugl
INTRODUCTION: To assess the cost-effectiveness of interleukin (IL)-17A inhibitor secukinumab versus the currently licensed biologic therapies in ankylosing spondylitis (AS) patients from a Canadian healthcare system perspective. METHODS: A decision analytic model (semi-Markov) evaluated the cost-effectiveness of secukinumab 150mg compared to certolizumab pegol, adalimumab, golimumab, etanercept and etanercept biosimilar, and infliximab and infliximab biosimilar in a biologic-naïve population, over 60 years of time horizon (lifetime)...
October 22, 2018: Journal of Medical Economics
Viktoria Bergqvist, Mohammad Kadivar, Daniel Molin, Leif Angelison, Per Hammarlund, Marie Olin, Jörgen Torp, Olof Grip, Stefan Nilson, Erik Hertervig, Jan Lillienau, Jan Marsal
Background: As the patents of originator biologics are expiring, biosimilar versions are becoming available for the treatment of inflammatory bowel disease (IBD). However, published switch studies of the first infliximab biosimilar, CT-P13, have delivered ambiguous results that could be interpreted as showing a trend towards inferior effectiveness in Crohn's disease (CD) compared with ulcerative colitis (UC). The aim of this study was to investigate the effectiveness and safety of switching IBD patients from treatment with Remicade to CT-P13...
2018: Therapeutic Advances in Gastroenterology
Masakazu Kondo, Hisakata Yamada
OBJECTIVES: To assess long-term outcomes for 7 biological disease-modifying antirheumatic drugs (bDMARDs) and one Janus kinase (JAK)-inhibitor in rheumatoid arthritis. METHODS: We retrospectively analyzed data from 801 rheumatoid arthritis patients visiting our rheumatology clinic between 2003 and 2017. We determined drug survival rates, drug discontinuation, and switching rates in these patients. RESULTS: Among the drugs administered to naïve subjects, the drug-survival rate was highest for tocilizumab, at 77...
October 18, 2018: Modern Rheumatology
Yusuf Yazici, Lin Xie, Adesuwa Ogbomo, Lorie A Ellis, Kavitha Goyal, Amanda Teeple, Ece A Mutlu, Ismail Simsek
Purpose: Biosimilar IFX (CT-P13) received marketing approval in Turkey for treatment of rheumatologic diseases, including ankylosing spondylitis, psoriatic arthritis, rheumatoid arthritis (RA), inflammatory bowel disease (IBD), and psoriasis. Population data on real-world treatment patterns of CT-P13 following marketing approval in European countries are largely unreported. This study examined the prescribing and medication utilization patterns of innovator infliximab (IFX) and CT-P13 in Turkey for patients with RA or IBD naïve to either IFX...
2018: Biologics: Targets & Therapy
Hiroaki Matsuno, Tsukasa Matsubara
OBJECTIVES: This study aimed to demonstrate the equivalence of NI-071, an infliximab biosimilar (BS), and the infliximab reference product (RP) for treating Japanese patients with active rheumatoid arthritis (RA) refractory to methotrexate. METHODS: In this multicenter two-period phase III study, patients were treated with BS or RP for 30 weeks (Period I) in a randomized double-blind manner and then with BS for the following 24 weeks (Period II). The efficacy and safety of BS and RP were compared...
October 5, 2018: Modern Rheumatology
Agnieszka Owczarczyk-Saczonek, Witold Owczarek, Agnieszka Osmola-Mańkowska, Zygmunt Adamski, Waldemar Placek, Adriana Rakowska
Tumor necrosis factor alpha (TNF-α) is a leading inflammatory cytokine that plays a pivotal role in the pathogenesis of psoriasis. In case of a severe course of psoriasis and moderate-to-severe disease in which traditional systemic treatments are ineffective or contraindicated, TNF-α inhibitors (iTNF-α) are used. This class of drugs includes monoclonal antibodies and a fusion protein (etanercept) and can induce a humoral or cell-mediated immune response, leading to formation of anti-drug antibodies (ADAs)...
October 4, 2018: Dermatologic Therapy
Zaina T Al-Salama
PF-06438179/GP1111 (Zessly® ; Ixifi® ) [hereafter referred to as GP1111] is a biosimilar of the reference monoclonal anti-TNF-α antibody infliximab, and is approved in the EU and USA for the same indications as the reference drug, including rheumatoid arthritis (RA), Crohn's disease, ulcerative colitis (including paediatric ulcerative colitis in the EU), ankylosing spondylitis, psoriatic arthritis and plaque psoriasis; GP1111 is also approved in Japan. GP1111 has similar physicochemical characteristics and pharmacodynamic properties to those of reference infliximab, and the pharmacokinetic similarity of the agents has been shown in healthy volunteers and patients with moderate-to-severe RA despite methotrexate therapy...
October 4, 2018: BioDrugs: Clinical Immunotherapeutics, Biopharmaceuticals and Gene Therapy
Jonathan P Segal, Lawrence Penez, Soad Mohsen Elkady, Guy H T Worley, Simon D McLaughlin, Benjamin H Mullish, Mohammed N Quraishi, Nik S Ding, Tamara Glyn, Kesavan Kandiah, Mark A Samaan, Peter M Irving, Omar D Faiz, Susan K Clark, Ailsa L Hart
BACKGROUND: Restorative proctocolectomy with ileal pouch-anal anastomosis is considered the procedure of choice in patients with ulcerative colitis refractory to medical therapy. Subsequent inflammation of the pouch is a common complication and in some cases, pouchitis fails to respond to antibiotics, the mainstay of treatment. In such cases, corticosteroids, immunomodulatory or biologic treatments are options. However, our understanding of the efficacy of anti-tumour necrosis factor medications in both chronic pouchitis and Crohn's-like inflammation is based on studies that include relatively small numbers of patients...
September 2018: Scandinavian Journal of Gastroenterology
F Magro, C Rocha, A I Vieira, H T Sousa, I Rosa, S Lopes, J Carvalho, C C Dias, J Afonso
Background: The advent of Remicade® biosimilars, Remsima®, Inflectra® and, more recently, Flixabi®, has brought along the potential to decrease the costs associated with this therapy, therefore increasing its access to a larger group of patients. However, and in order to assure a soft transition, one must make sure the assays and algorithms previously developed and optimized for Remicade perform equally well with its biosimilars. This study aimed to: (a) validate the utilization of Remicade-optimized therapeutic drug monitoring assays for the quantification of Flixabi; and (b) determine the existence of Remicade, Remsima and Flixabi cross-immunogenicity...
2018: Therapeutic Advances in Gastroenterology
Yunsuek Kim, Suyeon Park, Hyun-Sook Kim
Tumor necrosis factor-α inhibitor (TNFi) therapy has shown to be remarkably effective for treating ankylosing spondylitis (AS); however, nearly 30% of AS patients every year either stop TNFi therapy or switch to a different TNFi due to inefficacy or adverse effects. The goal of this study was to identify predictors of TNFi treatment duration, including extra-articular manifestations, using a nationwide registry in Korea. Data obtained from the Korean College of Rheumatology Biologics (KOBIO) registry, a nationwide, multi-center database representing 58 tertiary care hospitals in Korea...
December 2018: Clinical Rheumatology
Jiyeon Joy Park, Lauren Boutillier, Joseph E Cruz, GaEun Joung, Jeffrey Nemeth
BACKGROUND: Infliximab dose rounding is a commonly accepted practice at many institutions to contain costs. Currently, there is limited data on the clinical and financial implications of infliximab dose rounding standardization. OBJECTIVE: To determine whether standardized infliximab dose rounding is comparable with nonstandardized dosing in patients with Crohn's disease or ulcerative colitis in terms of cost and efficiency, using a cost comparison between the 2 dosing methods at an outpatient infusion center attached to a community teaching hospital...
October 2018: Journal of Managed Care & Specialty Pharmacy
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