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Zohra Layegh, Jill Ruwaard, Renske C F Hebing, Merel J L' Ami, Wilfred van der Weele, Mike T Nurmohamed, Charlotte Krieckaert, Gertjan Wolbink
OBJECTIVES: To evaluate the transition from reference infliximab Remicade to biosimilar Remsima in patients with rheumatoid arthritis (RA) or psoriatic arthritis (PsA). METHODS: Patients were informed through a letter about the transition to a biosimilar and were subsequently contacted for possible additional questions and whether they agreed upon the transition. Once agreed, Remsima was administered at the same dosage and interval as previous treatment with Remicade...
February 14, 2019: International Journal of Rheumatic Diseases
#2
Guro L Goll, Kristin K Jørgensen, Joe Sexton, Inge C Olsen, Nils Bolstad, Espen A Haavardsholm, Knut Ea Lundin, Kåre S Tveit, Merete Lorentzen, Ingrid P Berset, Bjørg Ts Fevang, Synøve Kalstad, Kristin Ryggen, David J Warren, Rolf A Klaasen, Øivind Asak, Somyeh Baigh, Ingrid M Blomgren, Øystein Brenna, Trude J Bruun, Katrine Dvergsnes, Svein O Frigstad, Inger M Hansen, Ingvild S H Hatten, Gert Huppertz-Hauss, Magne Henriksen, Sunniva S Hoie, Jan Krogh, Irina P Midtgard, Pawel Mielnik, Bjørn Moum, Geir Noraberg, Armin Poyan, Ulf Prestegård, Haroon Ur Rashid, Eldri K Strand, Kristine Skjetne, Kathrine A Seeberg, Roald Torp, Carl M Ystrøm, Cecilia Vold, Camilla C Zettel, Kenneth Waksvik, Bjørn Gulbrandsen, Jon Hagfors, Cato Mørk, Jørgen Jahnsen, Tore K Kvien
BACKGROUND AND OBJECTIVES: The 52-week, randomized, double blind, non-inferiority, government funded NOR-SWITCH trial demonstrated that switching from infliximab originator to less expensive biosimilar CT-P13 was not inferior to continued treatment with infliximab originator. The NOR-SWITCH extension trial aimed to assess efficacy, safety and immunogenicity in patients on CT-P13 throughout the 78-week study period (maintenance group) vs patients switched to CT-P13 at week 52 (switch group)...
February 14, 2019: Journal of Internal Medicine
#3
Quentin Riller, Camille Cotteret, Helga Junot, Neila Benameur, Julien Haroche, Alexis Mathian, Miguel Hie, Makoto Miyara, Patrick Tilleul, Zahir Amoura, Fleur Cohen Aubart
OBJECTIVES: Infliximab is increasingly used to treat neurosarcoidosis. We aimed to determine the efficacy and tolerance of an infliximab biosimilar for treating neurosarcoidosis. METHODS: We conducted a retrospective single-center study to describe the efficacy, safety and immunogenicity of an infliximab biosimilar in neurosarcoidosis patients. We compared the survival time without relapse while receiving the biosimilar or previous originator-infliximab treatment...
February 9, 2019: Journal of Neurology
#4
Toshihiro Inokuchi, Sakuma Takahashi, Sakiko Hiraoka, Tatsuya Toyokawa, Shinjiro Takagi, Koji Takemoto, Jiro Miyaike, Tsuyoshi Fujimoto, Reiji Higashi, Yuki Morito, Toru Nawa, Seiyuu Suzuki, Mamoru Nishimura, Masafumi Inoue, Jun Kato, Hiroyuki Okada
BACKGROUND AND AIM: Although previous studies compared the efficacy of infliximab (IFX) versus adalimumab (ADA) as the first-line biologics for Crohn's disease (CD), the difference in long-term prognosis based on which biologic was used first has scarcely been reported. In particular, the clinical courses after loss of response (LOR) of the first-line biologics are largely unknown. METHODS: A multicenter, retrospective study was performed. Disease courses of biologic-naïve CD patients who were started on IFX or ADA treatment were evaluated, even after LOR of the initial biologics...
February 6, 2019: Journal of Gastroenterology and Hepatology
#5
Karen van Hoeve, Erwin Dreesen, Ilse Hoffman, Gert Van Assche, Marc Ferrante, Ann Gils, Séverine Vermeire
BACKGROUND: Rising evidence demonstrates that there are no differences in efficacy and safety between infliximab (IFX) originator and IFX biosimilar CT-P13 in the treatment of inflammatory bowel diseases (IBD). However, most data are derived from adult patients and data on pharmacokinetics are limited. The authors evaluated long-term IFX trough levels, immunogenicity and remission rates in children with IBD who switched from IFX originator to biosimilar CT-P13. METHODS: In this single-center study, all children with Crohn's disease (CD) and ulcerative colitis (UC) receiving maintenance IFX therapy were switched from originator to biosimilar CT-P13...
January 9, 2019: Therapeutic Drug Monitoring
#6
Masataka Umeda, Tomohiro Koga, Kunihiro Ichinose, Ayuko Takatani, Takashi Igawa, Toshimasa Shimizu, Shoichi Fukui, Ayako Nishino, Yoshiro Horai, Yasuko Hirai, Shin-Ya Kawashiri, Naoki Iwamoto, Mami Tamai, Hideki Nakamura, Tomoki Origuchi, Toshiyuki Aramaki, Yukitaka Ueki, Akitomo Okada, Keita Fujikawa, Naoki Matsuoka, Atsushi Kawakami
To assess the efficacy and safety of switching to infliximab (IFX) from other biological disease-modifying anti-rheumatic drugs (bDMARDs) among Japanese patients with rheumatoid arthritis (RA) in daily practice. We examined 24 consecutive RA patients who had not achieved low disease activity (LDA) as the disease activity score-28 for rheumatoid arthritis with erythrocyte sedimentation rate (DAS28-ESR) despite previous bDMARD therapy in this cohort study. We attempted to determine predictive variables that are associated with achieving DAS28-ESR LDA at 22 weeks post-IFX introduction, by performing univariate analysis...
January 11, 2019: Immunological medicine
#7
Akos Ilias, Kata Szanto, Lorant Gonczi, Zsuzsanna Kurti, Petra Anna Golovics, Klaudia Farkas, Eszter Schafer, Zoltan Szepes, Balázs Szalay, Aron Vincze, Tamas Szamosi, Tamas Molnar, Peter Laszlo Lakatos
BACKGROUND & AIMS: There is evidence that it is safe and effective for patients with inflammatory bowel diseases (IBD) to switch from maintenance therapy with an original infliximab drug to a biosimilar, but little is known about outcomes of reverse switches and/or multiple switches. We aimed to evaluate the effects of a reverse switch (from a biosimilar to Remicade) in a real-life cohort. METHODS: We performed a prospective observational study of 174 unselected and consecutive patients with IBD (136 with Crohn's disease [CD] and 38 with ulcerative colitis [UC]) who received maintenance therapy with the biosimilar in Hungary...
January 7, 2019: Clinical Gastroenterology and Hepatology
#8
Gionata Fiorino, Daniela Gilardi, Carmen Correale, Federica Furfaro, Giulia Roda, Laura Loy, Marjorie Argollo, Mariangela Allocca, Laurent Peyrin-Biroulet, Silvio Danese
Introduction Biosimilars represent great potential in cost saving and re-investment opportunities in healthcare and allow patients greater access to effective mAbs. Infliximab biosimilars are successfully used in all indications for whom the reference product (RP) was approved. Areas covered In late 2018, adalimumab biosimilars will also be available in patients with inflammatory bowel disease (IBD). ABP501, BI 695501, GP2017, and SB5 have been approved by the EMA for the same indications of the reference product (RP, Humira®)...
January 2, 2019: Expert Opinion on Biological Therapy
#9
María Fernanda Guerra Veloz, Federico Argüelles-Arias, Luisa Castro Laria, Belén Maldonado Pérez, Antonio Benítez Roldan, Raúl Perea Amarillo, Vicente Merino Bohórquez, Miguel Angel Calleja, Ángel Caunedo Álvarez, Ángel Vilches Arenas
BACKGROUND: Infliximab original has changed the natural history of inflammatory bowel diseases (IBD) over the past two decades. However, the recent expiration of its patent has allowed the entry of the first Infliximab biosimilar into the European and Spanish markets. Currently switching drugs data in IBD are limited. AIM: To compare the efficacy of infliximab biosimilar, CT-P13, against infliximab original, analyzing the loss of response of both at the 12 mo follow-up in patients with IBD...
December 14, 2018: World Journal of Gastroenterology: WJG
#10
Sean E Mazloom, Di Yan, Jeffery Z Hu, Jason Ya, M Elaine Husni, Christine B Warren, Anthony P Fernandez
BACKGROUND: TNF-α inhibitor-induced psoriasis (TNFi-psoriasis) remains poorly understood despite being described 15 years ago. As TNF-α inhibitors (TNFis) often provide life-changing patient benefits, understanding effective treatments for TNFi-psoriasis is important. OBJECTIVE: We characterized a cohort of TNFi-psoriasis patients specifically diagnosed and (co)managed by dermatologists at a single tertiary care institution over a ten-year period. METHODS: Retrospective review of patients diagnosed with TNFi-psoriasis between 2003-2013...
December 18, 2018: Journal of the American Academy of Dermatology
#11
Mercedes Gimeno-Gracia, Carla J Gargallo, Fernando Gomollón
Biosimilars, as defined by the European Medicines Agency, have been used in Europe since 2006. The landscape was considerably expanded when the first biosimilar of a monoclonal was approved and introduced in the European market. CT-P13 was developed by Celltrion as an infliximab biosimilar in 2013, not without controversy. As these complex molecules cannot be completely identical, some experts, clinicians, and even patients were skeptical regarding the real bioequivalence of the drugs. Currently, several new infliximab and adalimumab biosimilars are available or will reach the market in a few months Areas covered: Our goal is to review, mainly from a clinical perspective, the available evidence for bioequivalence of anti-TNF biosimilars...
December 21, 2018: Expert Opinion on Biological Therapy
#12
REVIEW
Morton Scheinberg, Valderilio Azevedo
INTRODUCTION: The upcoming of biosimilars in rheumatic diseases have generated considerable interest throughout the past five years among pharmaceutical industries and regulatory agencies, their development is associated with considerable variation and heterogeneity on the variable requirements for license and marketing throughout the various continents. AIM: In this article we reviewed the contents of the conference presented on the last XI International Conference in Autoimmunity in Lisbon...
December 18, 2018: Autoimmunity Reviews
#13
Steven R Feldman, Haijun Tian, Xinyue Wang, Rebecca Germino
BACKGROUND: Discontinuation or switching of biologic treatment among patients with psoriasis imposes a great economic burden. OBJECTIVE: To assess the health care utilization and costs associated with nonswitchers, switchers, and discontinuers of biologics among patients with moderate to severe psoriasis. METHODS: Patients aged ≥ 18 years with ≥ 1 pharmacy claim for a biologic (adalimumab, etanercept, infliximab, and ustekinumab) between January 1, 2012, and June 30, 2015 (identification period), were identified in the Truven Health Analytics MarketScan Commercial and Medicare Supplemental databases...
December 17, 2018: Journal of Managed Care & Specialty Pharmacy
#14
REVIEW
Georgios Bakalos, Elias Zintzaras
PURPOSE: In observational studies of patients switched from stable treatment with an originator monoclonal antibody (mAb) to a biosimilar, higher rates of biosimilar discontinuation versus those observed in blinded switching studies have been reported. Because this observation relates to the real-world setting, it has been suggested that switching outside of clinical trials may be associated with nocebo effects. However, real-world data on drug discontinuation and nocebo effects after switching to mAb biosimilars remain limited...
December 11, 2018: Clinical Therapeutics
#15
Nikolas Plevris, Gareth R Jones, Philip W Jenkinson, Mathew Lyons, Cher S Chuah, Lynne M Merchant, Rebecca J Pattenden, Eleanor F Watson, Gwo-Tzer Ho, Colin L Noble, Shahida Din, Alan G Shand, Ian D Arnott, Charlie W Lees
BACKGROUND: Switching from Remicade to CT-P13 allows for significant cost savings and has been shown to be non-inferior to continued therapy with Remicade for the treatment of Crohn's disease. AIM: The aim of this work was to prospectively evaluate clinical outcomes in a cohort of patients with Crohn's disease switching from Remicade to CT-P13. METHODS: A prospective service evaluation was performed. The Harvey-Bradshaw index, CRP, faecal calprotectin and serum for infliximab/antibody levels were collected prior to patients' final Remicade infusion and at 6 and 12 months after switching to CT-P13 as part of routine clinical care...
December 7, 2018: Digestive Diseases and Sciences
#16
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
#17
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
#18
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
#19
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
#20
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
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