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Switching infliximab

Evripidis Kaltsonoudis, Eleftherios Pelechas, Paraskevi V Voulgari, Alexandros A Drosos
OBJECTIVES: To estimate the size of unmet needs in the treatment of early Rheumatoid Arthritis (eRA), using all the conventional synthetic disease-modifying antirheumatic drugs (csDMARDs) and/or biological DMARDs (bDMARDs) in a long-term observational study. MATERIALS AND METHODS: 538 patients with eRA were evaluated. The 2010 ACR/EULAR classification criteria were used. All patients were csDMARDs and bDMARDs-naive with disease duration less than one year. They were treated according to EULAR and ACR recommendations for RA...
June 22, 2018: Seminars in Arthritis and Rheumatism
Akos Ilias, Lorant Gonczi, Zuszsanna Kurti, Peter L Lakatos
The introduction of biological agents has revolutionized the management of ulcerative colitis (UC). Biosimilars are considered to be equivalent to the reference biologic products in terms of pharmacokinetic properties, clinical effectiveness and safety and have now been approved in inflammatory bowel diseases (IBD). CT-P13 was the first biosimilar to infliximab that obtained regulatory approval by the EMA and US FDA. Accumulating data on biosimilars led to an increased acceptance amongst practicing gastroenterologists and their use can be associated with a potential reduction in healthcare costs...
February 2018: Best Practice & Research. Clinical Gastroenterology
Vance J Bray, Aaron Broadwell, Herbert S B Baraf, Shawn Black, Brenna L Brady, Joseph Tkacz, Lorraine Yarngo, Raphael J DeHoratius
PURPOSE: For patients with rheumatoid arthritis (RA) who do not respond or lose response to anti-tumor necrosis factor (TNF) biologics, switching to a different anti-TNF can be an effective means to manage symptoms and disease progression. This study examined the utilization and effectiveness of intravenous golimumab within a real-world population of patients with RA switching directly from infliximab, a potent anti-TNF. METHODS: Patient charts (n = 113) were collected from five US-based rheumatology practices...
July 28, 2018: Drugs in R&D
Tao Gu, Alex Mutebi, Bradley S Stolshek, Hiangkiat Tan
OBJECTIVES: To estimate total costs among patients with rheumatoid arthritis (RA) who persisted on or switched from newly initiated biologic therapy. STUDY DESIGN: A retrospective claims database analysis. METHODS: This analysis included adults in the HealthCore Integrated Research Database with RA who initiated treatment with a biologic for RA (abatacept, adalimumab, certolizumab pegol, etanercept, golimumab, infliximab, rituximab, or tocilizumab) between January 2009 and November 2014...
July 2018: American Journal of Managed Care
Bente Glintborg, Jan Sørensen, Merete Lund Hetland
Objectives: National Danish guidelines in May 2015 dictated a mandatory switch from originator infliximab (INX) to biosimilar CT-P13 in patients with inflammatory rheumatic disease. We investigated if this non-medical switch changed use of outpatient hospital resources. Methods: Observational cohort study. Switchers were identified in DANBIO. Rheumatic outpatient contacts, visits and services were identified in the National Patient Registry. The 6-month rate for (1) number of visits (or services) and (2) days with ≥1 visit (or service) were compared before/after switching (paired t-tests)...
2018: RMD Open
Elena Nikiphorou, Pekka Hannonen, Juha Asikainen, Jelena Borodina, Arto Kokko, Kirsi Paalanen, Tuomas Rannio, Tuulikki Sokka
OBJECTIVES: Reports to-date indicate similarity between infliximab biosimilar (IB) and infliximab bio-original (IO) in clinical efficacy and safety. This study examines the survival of IB and IO using routinely collected data over a 2-year period. METHODS: Routinely collected clinical data inputted directly in an electronic database at a large rheumatology centre were analysed. Adult patients taking IO or IB for any rheumatological diagnosis were included. Kaplan-Meier survival analyses were used to examine IB and IO survival, with a sub-group analysis among those starting infliximab from 2008 onwards...
June 7, 2018: Clinical and Experimental Rheumatology
Lisa Gervais, Luke L McLean, Michelle L Wilson, Carol Cameron, Lee Curtis, Vikki Garrick, Kat Armstrong, Rachel Tayler, Paul Henderson, Richard Hansen, Iain Chalmers, David C Wilson, Richard K Russell
The safety, clinical efficacy and cost-effectiveness of biosimilar infliximab in adult inflammatory bowel disease (IBD) have now been extensively shown. Limited data has been collected in the paediatric setting. We report nationwide, prospective, clinical safety and effectiveness data for patients from all three Scottish paediatric IBD (PIBD) networks switching from originator to biosimilar infliximab.Prospective clinical data was collected for 33 patients. Information was collected from electronic patient records, laboratory reports and patient case notes...
July 6, 2018: Journal of Pediatric Gastroenterology and Nutrition
Jessica A Walsh, Oluwakayode Adejoro, Benjamin Chastek, Jacqueline B Palmer, Peter Hur
BACKGROUND: In patients with psoriatic arthritis (PsA), limited data exist regarding patterns of biologic therapy use. OBJECTIVE: To examine treatment patterns and therapy modifications in U.S. patients with PsA receiving a tumor necrosis factor inhibitor (TNFi) or an anti-interleukin (IL)-12/23 inhibitor. METHODS: Adults with PsA who newly initiated a biologic therapy (index biologic) between January 1, 2013, and January 31, 2015, were included from the Optum Research Database...
July 2018: Journal of Managed Care & Specialty Pharmacy
Wayne P Gulliver, Shane Randell, Susanne Gulliver, Valerie Gregory, Sean Nagle, Olivier Chambenoit
Plaque psoriasis affects approximately 2% to 3% of the global population, with psoriatic arthritis observed in approximately 20% to 30% of these individuals. Upon advances in research pathophysiology and treatment over the past decade, biologic therapies have been used more to treat moderate to severe psoriasis. In Canada, reimbursement bodies have defined prior authorization criteria to determine patient eligibility for funding of biologic treatments in moderate to severe plaque psoriasis. Generally, patients will have been treated with conventional therapies such as topical steroids, phototherapy, or systemic treatments such as methotrexate and cyclosporine before starting a biologic therapy...
June 1, 2018: Journal of Cutaneous Medicine and Surgery
Lisa J T Smits, Aura A J van Esch, Lauranne A A P Derikx, Ronald Boshuizen, Dirk J de Jong, Joost P H Drenth, Frank Hoentjen
Background: The infliximab biosimilar has entered daily inflammatory bowel disease (IBD) practice. However, real-life outcomes beyond 1 year after switching are scarce. We aimed to investigate the long-term drug survival, immunogenicity, and pharmacokinetics 2 years after switching to CT-P13 in IBD patients. Methods: We performed a single-center prospective observational cohort study in all Remicade-treated IBD patients who previously switched to CT-P13. We systematically documented reasons for discontinuation, trough levels, and antidrug antibodies to infliximab (ADAs) at baseline, week 16, week 52, and week 104...
June 27, 2018: Inflammatory Bowel Diseases
María Fernanda Guerra Veloz, Juan María Vázquez Morón, María Belvis Jiménez, Héctor Pallarés Manrique, Teresa Valdés Delgado, Luisa Castro Laria, Belén Maldonado Pérez, Antonio Benítez Roldán, Raúl Perea Amarillo, Vicente Merino, Ángel Caunedo Álvarez, Federico Argüelles Arias
BACKGROUND AND AIMS: infliximab has changed the natural history of inflammatory bowel disease (IBD). The advent of biosimilar treatments such as CT-P13 will hopefully improve the availability of biological therapies. Data with regard to drug switching are currently limited. The objective of the study was to assess the effectiveness and safety of switching from the reference product (RP), infliximab, to CT-P13 in patients with IBD. METHODS: this was a multicenter prospective observational study in patients with Crohn's disease (CD) and ulcerative colitis (UC)...
June 12, 2018: Revista Española de Enfermedades Digestivas
J Goncalves, M Santos, R Acurcio, I Iria, L Gouveia, P Matos Brito, A Catarina Cunha-Santos, A Barbas, J Galvão, I Barbosa, F Aires da Silva, A Alcobia, M Cavaco, M Cardoso, J Delgado Alves, J J Carey, T Dörner, J Eurico Fonseca, C Palmela, J Torres, C Lima Vieira, D Trabuco, G Fiorino, A Strik, M Yavzori, I Rosa, L Correia, F Magro, G D'Haens, S Ben-Horin, P L Lakatos, S Danese
AIM: To test the cross-immunogenicity of anti-CT-P13 IBD patients' sera to CT-P13/infliximab originator and the comparative antigenicity evoked by CT-P13/infliximab originator sera. METHODS: Sera of patients with IBD with measurable anti-CT-P13 antibodies were tested for their cross-reactivity to 5 batches of infliximab originator and CT-P13. Anti-drug antibody positive sera from treated patients were used to compare antigenic epitopes. RESULTS: All 42 anti-CT-P13 and 37 anti-infliximab originator IBD sera were cross-reactive with infliximab originator and CT-P13 respectively...
June 5, 2018: Alimentary Pharmacology & Therapeutics
Luisa Guidi, Daniela Pugliese, Tommaso Panici Tonucci, Alexandra Berrino, Barbara Tolusso, Michele Basile, Laura Cantoro, Paola Balestrieri, Fortunata Civitelli, Lorenzo Bertani, Manuela Marzo, Carla Felice, Elisa Gremese, Francesco Costa, Franca Viola, Michele Cicala, Anna Kohn, Antonio Gasbarrini, Gian Lodovico Rapaccini, Matteo Ruggeri, Alessandro Armuzzi
Background: Empirical dose intensification and therapeutic drug monitoring (TDM) of infliximab (IFX) trough levels (ITL) and antibody (ATI) assays are recognised approaches for managing the loss of response (LoR) in inflammatory bowel disease (IBD) patients. Aim: To compare these two interventions in a clinical setting, in terms of effectiveness and cost savings. Methods: Consecutive IBD patients, experiencing LoR, were clinically managed according to a TDM algorithm...
May 31, 2018: Journal of Crohn's & Colitis
Ayelet Ollech, Alex Zvulunov, Lev Pavlovsky, Emmilia Hodak, Dan Ben-Amitai
BACKGROUND: There is a paucity of data on the use of biologic therapy in recalcitrant pediatric psoriasis. The current study presents pediatric psoriasis cases treated with biologic agents in a tertiary referral center. METHODS: In this retrospective case series, data were collected on all patients ≤18 years old with severe psoriasis treated with biological therapy from 2010 through 2016 in a tertiary children's hospital. We included demographic data, previous systemic treatments, reason for discontinuation or switch to other systemic treatments, efficacy and side effects...
June 4, 2018: Journal of Dermatological Treatment
Silvio Danese, Gionata Fiorino
Biosimilars of infliximab (CT-P13) are currently approved and available for the same indications as the originator. Some concerns about safety and immunogenicity have risen in the past because of lack of data in IBD. Since 2015, several cohort studies have been conducted in IBD showing that CT-P13 has comparable safety and efficacy profile to the originator, both in adult and pediatric population, either in naïve patients, or even in those who switched from the originator to CT-P13. This review aims to analyze the current literature data in order to define a clear patient profile, to identify those IBD patients who would benefit the most from the use of CT-P13...
May 13, 2018: Current Medicinal Chemistry
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%)...
June 2018: Gastroenterología y Hepatología
M Augustin, D McBride, I Gilloteau, C O'Neill, K Neidhardt, C N Graham
BACKGROUND: Secukinumab, a fully human monoclonal antibody that selectively neutralizes interleukin 17A, has demonstrated strong and sustained efficacy in adults with moderate to severe psoriasis in clinical trials. OBJECTIVE: This analysis compared the cost per responder of secukinumab as first biologic treatment of moderate to severe psoriasis, with adalimumab, infliximab, etanercept and ustekinumab in Germany. METHODS: A 52-week decision-tree model was developed...
May 5, 2018: Journal of the European Academy of Dermatology and Venereology: JEADV
Zsuzsanna Kurti, Lorant Gonczi, Peter L Lakatos
Biological therapies have revolutionized the treatment of inflammatory bowel diseases (IBD) in the last two decades. Though biological drugs are effective, their use is associated with high costs and access to biological agents varies among countries. As the patent for the reference products expired, the advent of biosimilar monoclonal antibodies has been expected. Biosimilars represent less expensive alternatives compared to the reference product. Areas covered: In this review, authors will review the literature on the clinical efficacy, safety and immunogenicity of current and future biosimilar infliximabs...
June 2018: Expert Opinion on Biological Therapy
Raguprakash Ratnakumaran, Natalie To, David J Gracie, Christian P Selinger, Anthony O'Connor, Tanya Clark, Nicola Carey, Katherine Leigh, Lynsey Bourner, Alexander C Ford, P John Hamlin
OBJECTIVES: Recently, the infliximab biosimilar (CT-P13) received market authorisation for inflammatory bowel disease (IBD), allowing cost benefits when switching to CT-P13. We aim to assess the efficacy and safety of switching from originator infliximab to CT-P13 for new and existing patients. MATERIAL AND METHODS: Treatment response, remission, primary and secondary loss of response rates, and adverse events in patients who initiated infliximab originator in the 12 months pre-switch (n = 53) were compared with the patients who initiated CT-P13 in the 12 months post-switch (n = 69)...
June 2018: Scandinavian Journal of Gastroenterology
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