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Lydia C T Buer, Bjørn A Moum, Milada Cvancarova, David J Warren, Asle W Medhus, Marte Lie Høivik
BACKGROUND AND AIMS: A biosimilar version of infliximab (CT-P13/Remsima®) recently entered the European market. The clinical data on its use in inflammatory bowel disease are sparse, especially on switching from the originator Remicade®. In this study, we aimed to prospectively investigate the feasibility, safety and immunogenicity of switching from Remicade® to Remsima® in a real-life IBD population. METHODS: All adult patients who were treated with Remicade® in the Department of Gastroenterology at Oslo University Hospital were switched to Remsima®...
September 22, 2016: Journal of Crohn's & Colitis
Hannah A Blair, Emma D Deeks
Infliximab biosimilar (CT-P13/infliximab-dyyb; Remsima(®), Inflectra(®)) is approved in several countries for use in all indications for which reference infliximab (Remicade(®)) is approved, including rheumatoid arthritis (RA), ankylosing spondylitis (AS), psoriatic arthritis, psoriasis, Crohn's disease, and ulcerative colitis. Clinical data contributing to the EU approval of infliximab biosimilar were obtained from two pivotal double-blind clinical trials in patients with AS (PLANETAS) or RA (PLANETRA)...
October 2016: BioDrugs: Clinical Immunotherapeutics, Biopharmaceuticals and Gene Therapy
Joseph C Marini, Jocelyn Sendecki, Freddy Cornillie, John W Popp, Shawn Black, Marion Blank, Ann Gils, Thomas Van Stappen, Dörte Hamann, Theo Rispens, Lina Thérien, Kelly Chun, Gopi Shankar
Monitoring infliximab (IFX) concentrations and antibodies-to-IFX (ATI) titers during inflammatory bowel disease treatment may allow more informed decisions in assessing exposure/response and determining appropriate dosing. To aid in interpreting results from different commercial tests in the context of Janssen's published Remicade® results, the reliability of Janssen's IFX and ATI assays was compared with commercial assays from KU Leuven, Sanquin, Dynacare, and LabCorp. Test results were independently reported to Janssen...
September 6, 2016: AAPS Journal
Mazin Derzi, Theodore R Johnson, Ahmed M Shoieb, Hugh D Conlon, Penny Sharpe, Andrew Saati, Sarah Koob, Michael W Bolt, Leslie G Lorello, Jim McNally, Carol F Kirchhoff, Teresa A Smolarek, Michael W Leach
INTRODUCTION: PF-06438179, a potential biosimilar to Remicade(®) (infliximab, Janssen Biotech, Inc.), is a chimeric mouse-human monoclonal antibody targeting human tumor necrosis factor alpha (TNF). METHODS: Analytical (small subset reported here) and nonclinical studies compared the structural, functional, and in vivo nonclinical similarity of PF-06438179 with Remicade sourced from the United States (infliximab-US) and/or European Union (infliximab-EU). RESULTS: The peptide map profiles were superimposable, and peptide masses were the same, indicating identical amino acid sequences...
September 1, 2016: Advances in Therapy
Kornelius Schulze, Nadine Koppka, Frederik Lutter, Gunnar Brandhorst, Stefan Schreiber, Ulf Helwig
The approval of infliximab biosimilars Remsima™ and Inflectra™ (CT-P13) for patients with inflammatory bowel disease (IBD) is a promising step to reduce treatment costs. Since monitoring of Remicade™ serum trough levels and anti-Remicade™ immunogenicity hold an important significance in treatment modalities, no data about monitoring of drug serum trough levels or anti-drug antibody levels in IBD patients treated with Remsima™ or Inflectra™ are present to date. Therefore, in this study we applied a Remicade™-validated ELISA to determine drug serum levels of Remsima™ or Inflectra™...
September 2016: Biologicals: Journal of the International Association of Biological Standardization
Jing Fang, Catalin Doneanu, William R Alley, Ying Qing Yu, Alain Beck, Weibin Chen
In this study, we demonstrate the utility of ultra-performance liquid chromatography coupled to mass spectrometry (MS) and ion-mobility spectrometry (IMS) to characterize and compare reference and biosimilar monoclonal antibodies (mAbs) at an advanced level. Specifically, we focus on infliximab and compared the glycan profiles, higher order structures, and their host cell proteins (HCPs) of the reference and biosimilar products, which have the brand names Remicade® and Inflectra®, respectively. Overall, the biosimilar attributes mirrored those of the reference product to a very high degree...
August 2016: MAbs
Rachel Archer, Paul Tappenden, Shijie Ren, Marrissa Martyn-St James, Rebecca Harvey, Hasan Basarir, John Stevens, Christopher Carroll, Anna Cantrell, Alan Lobo, Sami Hoque
BACKGROUND: Ulcerative colitis (UC) is the most common form of inflammatory bowel disease in the UK. UC can have a considerable impact on patients' quality of life. The burden for the NHS is substantial. OBJECTIVES: To evaluate the clinical effectiveness and safety of interventions, to evaluate the incremental cost-effectiveness of all interventions and comparators (including medical and surgical options), to estimate the expected net budget impact of each intervention, and to identify key research priorities...
May 2016: Health Technology Assessment: HTA
Jakob Nørgaard Henriksen, Bengt Oluf Mikael Eriksson
We present a case of a 64-year-old man with Crohn's disease who developed parkinsonism after starting treatment with infliximab (Remicade). The patient had a 30-year history of Crohn's disease with previous surgical procedures and treatment with methotrexate. Treatment was augmented with infliximab, and 3 days after the first dose of 400 mg, a resting tremor began in the left leg. Over 4 months, symptoms progressed and now involved the right leg as well as both hands. There was no clinical effect of infliximab treatment, and the treatment was withdrawn 4 months later...
2016: BMJ Case Reports
Bryce David Beutler, Philip R Cohen
BACKGROUND: Molluscum contagiosum is a benign viral infection of the skin. Lesions typically present as dome-shaped, flesh-colored, umbilicated papules that range in size from 1 to 5 millimeters in diameter. They are usually asymptomatic, but can become tender or pruritic. Children and immunocompromised adults, including individuals being treated with immunosuppressive drugs, are most susceptible to infection. Single or multiple lesions most commonly appear on the extremities, face, genitals, and trunk...
2016: Dermatology Online Journal
Dae Hyun Yoo, Nenad Prodanovic, Janusz Jaworski, Pedro Miranda, Edgar Ramiterre, Allan Lanzon, Asta Baranauskaite, Piotr Wiland, Carlos Abud-Mendoza, Boycho Oparanov, Svitlana Smiyan, HoUng Kim, Sang Joon Lee, SuYeon Kim, Won Park
OBJECTIVES: To assess the efficacy and safety of switching from the infliximab reference product (RP; Remicade) to its biosimilar CT-P13 (Remsima, Inflectra) or continuing CT-P13 in patients with rheumatoid arthritis (RA) for an additional six infusions. METHODS: This open-label extension study recruited patients with RA who had completed the 54-week, randomised, parallel-group study comparing CT-P13 with RP (PLANETRA; NCT01217086). CT-P13 (3 mg/kg) was administered intravenously every 8 weeks from weeks 62 to 102...
April 29, 2016: Annals of the Rheumatic Diseases
Lisa J T Smits, Lauranne A A P Derikx, Dirk J de Jong, Ronald S Boshuizen, Aura A J van Esch, Joost P H Drenth, Frank Hoentjen
BACKGROUND AND AIMS: The biosimilar of Remicade®, CT-P13, recently entered the European market. Clinical data on switching from Remicade® to CT-P13 in inflammatory bowel disease [IBD] are scarce. We aimed to prospectively investigate efficacy, safety, pharmacokinetic profile, and immunogenicity following a switch from Remicade® to CT-P13 in IBD patients. METHODS: Remicade®-treated IBD patients at the Radboud university medical centre who switched to CT-P13 were included in this prospective observational cohort study...
April 19, 2016: Journal of Crohn's & Colitis
Gerassimos J Mantzaris
In the last 20 years, the advent of anti-tumor necrosis factor alpha (TNFα) biologics has revolutionized the treatment of patients with inflammatory bowel disease (IBD) but the cost of biologic therapy now constitutes a large proportion of all healthcare expenditures. Patent expiration has sparked the healthcare industry's interest in the production of biosimilar (BS) versions of first generation biologics (originators [ORGs]) for market sharing. Having no access to the production line of the ORG, the sponsor of a BS needs to develop his own manufacturing process to produce a highly similar version of the reference product...
2016: Digestive Diseases
M Begoña Ruiz-Argüello, Ainara Maguregui, Ainhoa Ruiz Del Agua, Dora Pascual-Salcedo, Ana Martínez-Feito, Teresa Jurado, Chamaida Plasencia, Alejandro Balsa, Francisca Llinares-Tello, José Rosas, Nerea Torres, Antonio Martínez, Daniel Nagore
OBJECTIVES: The aim of this study was to determine whether antibodies to infliximab (IFX) in Remicade-treated patients cross-react with the biosimilar CT-P13. METHODS: 250 consecutive patients with rheumatic diseases under Remicade and 77 controls were retrospectively selected for the study. Anti-IFX antibodies at drug through levels were measured in parallel with three different bridging ELISA assays: Promonitor-ANTI-IFX kit, which uses Remicade to detect antibodies, and two more assays that use either Inflectra or Remsima with the same format...
September 2016: Annals of the Rheumatic Diseases
Ann Gils, Thomas Van Stappen, Erwin Dreesen, Ruth Storme, Séverine Vermeire, Paul J Declerck
BACKGROUND: The availability of an infliximab ELISA for measuring the originator drug Remicade and its biosimilars, such as Remsima and Inflectra (CT-P13), would facilitate the implementation of therapeutic drug monitoring of biosimilars and enhance the extrapolation of treatment stratification algorithms established for Remicade. A universal calibrator for all anti-infliximab antibody bridging assays allows harmonization of anti-drug antibody titers. METHODS: A panel of 55 mouse monoclonal antibodies raised against Remicade, including MA-IFX6B7 and MA-IFX10F9, were evaluated for their reactivity toward the biosimilars using a sandwich-type ELISA and surface plasmon resonance...
April 2016: Inflammatory Bowel Diseases
Won Park, Dae Hyun Yoo, Janusz Jaworski, Jan Brzezicki, Andriy Gnylorybov, Vladimir Kadinov, Irmgadt Goecke Sariego, Carlos Abud-Mendoza, William Jose Otero Escalante, Seong Wook Kang, Daina Andersone, Francisco Blanco, Seung Suh Hong, Sun Hee Lee, Jürgen Braun
BACKGROUND: CT-P13 (Remsima®, Inflectra®) is a biosimilar of the infliximab reference product (RP; Remicade®) and is approved in Europe and elsewhere, mostly for the same indications as RP. The aim of this study was to compare the 54-week efficacy, immunogenicity, pharmacokinetics (PK) and safety of CT-P13 with RP in patients with ankylosing spondylitis (AS), with a focus on patient-reported outcomes (PROs). METHODS: This was a multinational, double-blind, parallel-group study in patients with active AS...
2016: Arthritis Research & Therapy
Ellen M H Schmitz, Daan van de Kerkhof, Dörte Hamann, Joost L J van Dongen, Philip H M Kuijper, Luc Brunsveld, Volkher Scharnhorst, Maarten A C Broeren
BACKGROUND: Therapeutic drug monitoring (TDM) of infliximab (IFX, Remicade®) can aid to optimize therapy efficacy. Many assays are available for this purpose. However, a reference standard is lacking. Therefore, we evaluated the analytical performance, agreement and clinically relevant differences of three commercially available IFX ELISA kits on an automated processing system. METHODS: The kits of Theradiag (Lisa Tracker Infliximab), Progenika (Promonitor IFX) and apDia (Infliximab ELISA) were implemented on an automated processing system...
July 1, 2016: Clinical Chemistry and Laboratory Medicine: CCLM
Donghoon Shin, Youngdoe Kim, Yoo Seok Kim, Thomas Körnicke, Rainard Fuhr
OBJECTIVE: SB2, a biosimilar to infliximab reference product (INF), has an identical amino acid sequence and similar physicochemical functional properties to its reference product. The primary objective of this study is to demonstrate pharmacokinetic (PK) bioequivalence between SB2 and EU-sourced INF (EU-INF), between SB2 and US-sourced INF (US-INF), and between EU-INF and US-INF. METHODS: This study was a randomized, single-blind, three-arm, parallel group study in 159 healthy subjects...
December 2015: BioDrugs: Clinical Immunotherapeutics, Biopharmaceuticals and Gene Therapy
Sabine Kuin, Suzan B Stolte, Gijs R van den Brink, Cyriel Y Ponsioen, Paul Fockens, Geert R D'Haens, Mark Löwenberg
OBJECTIVE: Infliximab maintenance treatment for Crohn's disease (CD) consists of intravenous infusions that are usually given at 6-8-week intervals. We aimed to evaluate whether home-based infliximab infusions could offer a useful and safe alternative for the management of CD patients. METHODS: Adult CD patients receiving infliximab maintenance treatment at the Academic Medical Center in Amsterdam were invited to receive their infusions at home for the duration of 1 year...
February 2016: European Journal of Gastroenterology & Hepatology
Elena Nikiphorou, Hannu Kautiainen, Pekka Hannonen, Juha Asikainen, Arto Kokko, Tuomas Rannio, Tuulikki Sokka
OBJECTIVE: To gain clinical experience on the effectiveness and safety of switching from infliximab-Remicade(INX) to infliximab-biosimilar-CT-P13(INB) in patients with established rheumatic disease. METHODS: Patients receiving INX treatment at a rheumatology clinic consented to switching from INX to INB. Patient reported outcomes (PROs), disease-activity, and inflammatory markers were recorded at every visit. Generalized estimating equation models and time-dependent area under the curve (AUC) before/during INX and INB treatments were employed...
2015: Expert Opinion on Biological Therapy
Clare Oni, Sheryl Mitchell, Katherine James, Wan-Fai Ng, Bridget Griffiths, Victoria Hindmarsh, Elizabeth Price, Colin T Pease, Paul Emery, Peter Lanyon, Adrian Jones, Michele Bombardieri, Nurhan Sutcliffe, Costantino Pitzalis, John Hunter, Monica Gupta, John McLaren, Annie Cooper, Marian Regan, Ian Giles, David Isenberg, Vadivelu Saravanan, David Coady, Bhaskar Dasgupta, Neil McHugh, Steven Young-Min, Robert Moots, Nagui Gendi, Mohammed Akil, Francesca Barone, Ben Fisher, Saaeha Rauz, Andrea Richards, Simon J Bowman
OBJECTIVE: To identify numbers of participants in the UK Primary Sjögren's Syndrome Registry (UKPSSR) who would fulfil eligibility criteria for previous/current or potential clinical trials in primary SS (pSS) in order to optimize recruitment. METHODS: We did a retrospective analysis of UKPSSR cohort data of 688 participants who had pSS with evaluable data. RESULTS: In relation to previous/current trials, 75.2% fulfilled eligibility for the Belimumab in Subjects with Primary Sjögren's Syndrome study (Belimumab), 41...
March 2016: Rheumatology
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