Literature DB >> 30535885

Implementation of CT-P13 via a Managed Switch Programme in Crohn's Disease: 12-Month Real-World Outcomes.

Nikolas Plevris1, Gareth R Jones2, Philip W Jenkinson2, Mathew Lyons2, Cher S Chuah2, Lynne M Merchant2, Rebecca J Pattenden3, Eleanor F Watson2, Gwo-Tzer Ho2, Colin L Noble2, Shahida Din2, Alan G Shand2, Ian D Arnott2, Charlie W Lees2.   

Abstract

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. All adverse events during follow-up were also recorded.
RESULTS: One hundred and ten patients on Remicade switched to CT-P13. No significant difference was observed between the Harvey-Bradshaw Index (p = 0.07), CRP (p = 0.13), faecal calprotectin (p = 0.25) or trough infliximab levels (p = 0.47) comparing before and at 6 and 12 months after the switch to CT-P13. Seven patients developed new infliximab antibodies after switching from Remicade to CT-P13. The majority of patients remained on CT-P13 at 12 months (84.5%) and the rate of adverse events and serious adverse events was 53.8 and 13.5 per 100 patient-years of follow-up, respectively. Switching to CT-P13 resulted in a cost saving of approximately 46.4%.
CONCLUSION: The transition to CT-P13 from Remicade for the treatment of Crohn's disease is safe and has no negative effect on clinical outcomes at 12 months.

Entities:  

Keywords:  Biosimilar; CT-P13; Crohn’s disease; Infliximab

Mesh:

Substances:

Year:  2018        PMID: 30535885     DOI: 10.1007/s10620-018-5406-8

Source DB:  PubMed          Journal:  Dig Dis Sci        ISSN: 0163-2116            Impact factor:   3.487


  22 in total

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2.  Switching from originator to biosimilar infliximab - real world data of a prospective 18 months follow-up of a single-centre IBD population.

Authors:  Marte L Høivik; Lydia C T Buer; Milada Cvancarova; David J Warren; Nils Bolstad; Bjørn A Moum; Asle W Medhus
Journal:  Scand J Gastroenterol       Date:  2018-05-31       Impact factor: 2.423

3.  The PROSIT-BIO Cohort: A Prospective Observational Study of Patients with Inflammatory Bowel Disease Treated with Infliximab Biosimilar.

Authors:  Gionata Fiorino; Natalia Manetti; Alessandro Armuzzi; Ambrogio Orlando; Angela Variola; Stefanos Bonovas; Fabrizio Bossa; Giovanni Maconi; Renata DʼIncà; Paolo Lionetti; Laura Cantoro; Walter Fries; Maria L Annunziata; Francesco Costa; Maria M Terpin; Livia Biancone; Claudio C Cortelezzi; Arnaldo Amato; Sandro Ardizzone; Silvio Danese; Luisa Guidi; Giulia Rizzuto; Arianna Massella; Angelo Andriulli; Alessandro Massari; Greta Lorenzon; Silvia Ghione; Anna Kohn; Agostino Ventra; Vito Annese
Journal:  Inflamm Bowel Dis       Date:  2017-02       Impact factor: 5.325

4.  Switching maintenance infliximab therapy to biosimilar infliximab in inflammatory bowel disease patients.

Authors:  Anja Eberl; Saara Huoponen; Tapio Pahikkala; Marja Blom; Perttu Arkkila; Taina Sipponen
Journal:  Scand J Gastroenterol       Date:  2017-08-24       Impact factor: 2.423

5.  Infliximab, azathioprine, or combination therapy for Crohn's disease.

Authors:  Jean Frédéric Colombel; William J Sandborn; Walter Reinisch; Gerassimos J Mantzaris; Asher Kornbluth; Daniel Rachmilewitz; Simon Lichtiger; Geert D'Haens; Robert H Diamond; Delma L Broussard; Kezhen L Tang; C Janneke van der Woude; Paul Rutgeerts
Journal:  N Engl J Med       Date:  2010-04-15       Impact factor: 91.245

6.  Short article: Switching to a infliximab biosimilar: short-term results of clinical monitoring in patients with inflammatory bowel disease.

Authors:  Lisette Binkhorst; Annemieke Sobels; Rogier Stuyt; Elsbeth M Westerman; Rachel L West
Journal:  Eur J Gastroenterol Hepatol       Date:  2018-07       Impact factor: 2.566

7.  Maintenance infliximab for Crohn's disease: the ACCENT I randomised trial.

Authors:  Stephen B Hanauer; Brian G Feagan; Gary R Lichtenstein; Lloyd F Mayer; S Schreiber; Jean Frederic Colombel; Daniel Rachmilewitz; Douglas C Wolf; Allan Olson; Weihang Bao; Paul Rutgeerts
Journal:  Lancet       Date:  2002-05-04       Impact factor: 79.321

8.  Efficacy and Safety of the Biosimilar Infliximab CT-P13 Treatment in Inflammatory Bowel Diseases: A Prospective, Multicentre, Nationwide Cohort.

Authors:  Krisztina B Gecse; Barbara D Lovász; Klaudia Farkas; János Banai; László Bene; Beáta Gasztonyi; Petra Anna Golovics; Tünde Kristóf; László Lakatos; Ágnes Anna Csontos; Márk Juhász; Ferenc Nagy; Károly Palatka; Mária Papp; Árpád Patai; Lilla Lakner; Ágnes Salamon; Tamás Szamosi; Zoltán Szepes; Gábor T Tóth; Áron Vincze; Balázs Szalay; Tamás Molnár; Péter L Lakatos
Journal:  J Crohns Colitis       Date:  2015-12-10       Impact factor: 9.071

9.  Biosimilar Infliximab in Inflammatory Bowel Disease: Outcomes of a Managed Switching Programme.

Authors:  Violeta Razanskaite; Marion Bettey; Louise Downey; Julia Wright; James Callaghan; Miles Rush; Simon Whiteoak; Sarah Ker; Kim Perry; Caron Underhill; Eren Efrem; Iftikar Ahmed; Fraser Cummings
Journal:  J Crohns Colitis       Date:  2017-06-01       Impact factor: 9.071

10.  The relationship between infliximab concentrations, antibodies to infliximab and disease activity in Crohn's disease.

Authors:  Niels Vande Casteele; Reena Khanna; Barrett G Levesque; Larry Stitt; G Y Zou; Sharat Singh; Steve Lockton; Scott Hauenstein; Linda Ohrmund; Gordon R Greenberg; Paul J Rutgeerts; Ann Gils; William J Sandborn; Séverine Vermeire; Brian G Feagan
Journal:  Gut       Date:  2014-10-21       Impact factor: 23.059

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  12 in total

1.  Biosimilars in IBD: Similarity Breeds Contented Patients.

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Journal:  Dig Dis Sci       Date:  2019-06       Impact factor: 3.199

2.  An updated systematic review and meta-analysis about the safety and efficacy of infliximab biosimilar, CT-P13, for patients with inflammatory bowel disease.

Authors:  Mahmoud Ahmed Ebada; Abdelmagid M Elmatboly; Ahmed Said Ali; Ahmed Mohamed Ibrahim; Notila Fayed; Ahmed Faisal Faisal; Souad Alkanj
Journal:  Int J Colorectal Dis       Date:  2019-09-06       Impact factor: 2.571

3.  Effectiveness of Switching from Reference Product Infliximab to Infliximab-Dyyb in Patients with Inflammatory Bowel Disease in an Integrated Healthcare System in the United States: A Retrospective, Propensity Score-Matched, Non-Inferiority Cohort Study.

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5.  The Economic Impact of Originator-to-Biosimilar Non-medical Switching in the Real-World Setting: A Systematic Literature Review.

Authors:  Erin Hillhouse; Karine Mathurin; Joëlle Bibeau; Diana Parison; Yasmine Rahal; Jean Lachaine; Catherine Beauchemin
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6.  SB5 shows cross-immunogenicity to adalimumab but not infliximab: results in patients with inflammatory bowel disease or rheumatoid arthritis.

Authors:  Joao Goncalves; Gihyun Myung; MinJeong Park; Deokyoon Jeong; Jeehoon Ghil
Journal:  Therap Adv Gastroenterol       Date:  2019-12-04       Impact factor: 4.409

Review 7.  The Challenges of Switching Therapies in an Evolving Multiple Biosimilars Landscape: A Narrative Review of Current Evidence.

Authors:  Brian G Feagan; Mona Marabani; Jashin J Wu; Freddy Faccin; Claire Spronk; Gilberto Castañeda-Hernández
Journal:  Adv Ther       Date:  2020-09-10       Impact factor: 3.845

Review 8.  Barriers to Biosimilar Prescribing Incentives in the Context of Clinical Governance in Spain.

Authors:  Félix Lobo; Isabel Río-Álvarez
Journal:  Pharmaceuticals (Basel)       Date:  2021-03-22

9.  Effectiveness and Safety of Adalimumab Biosimilar SB5 in Inflammatory Bowel Disease: Outcomes in Originator to SB5 Switch, Double Biosimilar Switch and Bio-Naïve SB5 Observational Cohorts.

Authors:  Lauranne A A P Derikx; Heather W Dolby; Nikolas Plevris; Laura Lucaciu; Caitlin S Rees; Mathew Lyons; Spyros I Siakavellas; Nathan Constantine-Cooke; Philip Jenkinson; Shanna Su; Claire O'Hare; Laura Kirckpatrick; Lynne M Merchant; Colin Noble; Ian D Arnott; Gareth-Rhys Jones; Charlie W Lees
Journal:  J Crohns Colitis       Date:  2021-12-18       Impact factor: 9.071

10.  Multiple Switches From the Originator Infliximab to Biosimilars Is Effective and Safe in Inflammatory Bowel Disease: A Prospective Multicenter Cohort Study.

Authors:  Jurij Hanzel; Jeroen M Jansen; Rinze W F Ter Steege; Krisztina B Gecse; Geert R D'Haens
Journal:  Inflamm Bowel Dis       Date:  2022-03-30       Impact factor: 5.325

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