Evolution of infliximab biosimilar in inflammatory bowel disease: from intravenous to subcutaneous CT-P13

Parigi, Tommaso Lorenzo; D’Amico, Ferdinando; Peyrin–Biroulet, Laurent; Danese, Silvio

doi:10.1080/14712598.2020.1811849

Cited by 15 publications

(15 citation statements)

References 53 publications

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“…For CT-P13 SC, two pivotal studies demonstrated non-inferiority to CT-P13 IV in terms of efficacy (in part 2 of the phase I/III CT-P13 SC 3.5 study in patients with RA) [ 18 ] and PK (in part 2 of the phase I CT-P13 SC 1.6 study in patients with IBD) [ 19 ]. CT-P13 SC provided a more stable drug exposure than CT-P13 IV in both trials, with levels consistently higher than the target therapeutic concentration, representing a pharmacological advantage for CT-P13 SC [ 11 , 13 , 18 , 19 ]. While the pivotal studies included CT-P13 IV dose loading prior to week 6, given predicted exposure and efficacy were comparable between the CT-P13 SC and CT-P13 IV arms from week 6 onwards.…”

Section: The Advent Of Sc Infliximabmentioning

confidence: 99%

“…Minimising hospital visits per clinical guidelines reduced both the infection risk for patients [ 16 ] and the burden on overstretched medical facilities. The reduction in healthcare resources concomitant with reduced administration of IV therapies could facilitate reorganisation and redeployment as required during the unprecedented demand on medical services [ 2 , 11 , 42 ]. Experts have agreed that SC biobetters could play an important role during health emergencies, such as the COVID-19 pandemic, although decisions to switch must be shared between patient and physician [ 14 ].…”

Section: Clinical Implications Of Sc Infliximab In the Covid-19 Pandemic Era And Beyondmentioning

confidence: 99%

“…In the current circumstances, clinicians might particularly welcome novel therapeutic options that are based on highly potent and well-studied molecules, thereby expanding treatment choices for patients with rheumatic diseases and IBD [ 11 , 12 ]. Recent technological advances have driven the development of innovation in biologics through other modifications, such as the first subcutaneous (SC) formulation of infliximab, CT-P13 SC.…”

Section: Introductionmentioning

confidence: 99%

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Perspectives on Subcutaneous Infliximab for Rheumatic Diseases and Inflammatory Bowel Disease: Before, During, and After the COVID-19 Era

et al. 2022

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Graphical Abstract The coronavirus disease 2019 (COVID-19) pandemic has prompted significant changes in patient care in rheumatology and gastroenterology, with clinical guidance issued to manage ongoing therapy while minimising the risk of nosocomial infection for patients and healthcare professionals (HCPs). Subcutaneous (SC) formulations of biologics enable patients to self-administer treatments at home; however, switching between agents may be undesirable. CT-P13 SC is the first SC formulation of infliximab that received regulatory approval and may be termed a biobetter as it offers significant clinical advantages over intravenous (IV) infliximab, including improved pharmacokinetics and a convenient mode of delivery. Potential benefits in terms of reduced immunogenicity have also been suggested. With a new SC formulation, infliximab provides an additional option for dual formulation, which enables patients to transition from IV to SC administration route without changing agent. Before COVID-19, clinical trials supported the efficacy and safety of switching from IV to SC infliximab for patients with rheumatoid arthritis and inflammatory bowel disease (IBD), and SC infliximab may have been selected on the basis of patient and HCP preferences for SC agents. During the pandemic, patients with rheumatic diseases and IBD have successfully switched from IV to SC infliximab, with some clinical benefits and high levels of patient satisfaction. As patients switched to SC therapeutics, the reduction in resource requirements for IV infusion services may have been particularly welcome given the pandemic, facilitating reorganisation and redeployment in overstretched healthcare systems, alongside pharmacoeconomic benefits and a reduction in exposure to nosocomial infection. Telemedicine and contactless healthcare have been pushed to the forefront during the pandemic, and a lasting shift towards remote patient management and community/home-based drug administration is anticipated. SC infliximab supports the implementation of this paradigm for future improvements of healthcare value delivered. The accumulation of real-world data during the pandemic supports the high level of confidence, with patients, physicians, and healthcare systems benefitting from its uptake.

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Section: The Advent Of Sc Infliximabmentioning

confidence: 99%

Section: Clinical Implications Of Sc Infliximab In the Covid-19 Pandemic Era And Beyondmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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Perspectives on Subcutaneous Infliximab for Rheumatic Diseases and Inflammatory Bowel Disease: Before, During, and After the COVID-19 Era

et al. 2022

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“…2 Concerning immunogenicity, CT-P13 SC provided a more consistent drug exposure with serum concentration stably higher than the therapeutic concentration. 5 High concentrations of the antigen could lead to reduced immune complex formation and diminished ADA generation. 2 None of the three patients with hypersensitivity reaction had a serious reaction after SC injections.…”

Section: The Higher Incidence Of Localised Isr In the Ct-p13 Sc Vs Ct-p13mentioning

confidence: 99%

Letter: treatment with subcutaneous CT‐P13 in Crohn’s disease patients with intravenous infliximab failure

Caron

Fuméry

Netter

et al. 2022

Aliment Pharmacol Ther

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“…Weiterhin sind von Vedolizumab und dem Infliximab-Biosimilar CT-P13 mittlerweile subkutane Darreichungsformen erhältlich. Diese scheinen eine ähnliche Wirksamkeit wie die i.v.-Formulierungen zu haben[49,50].Die verschiedenen Ansatzpunkte der CED-Medikamente sind in . Abb.…”

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Was ist gesichert in der Therapie chronisch-entzündlicher Darmerkrankungen

2021

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Evolution of infliximab biosimilar in inflammatory bowel disease: from intravenous to subcutaneous CT-P13

Cited by 15 publications

References 53 publications

Perspectives on Subcutaneous Infliximab for Rheumatic Diseases and Inflammatory Bowel Disease: Before, During, and After the COVID-19 Era

Perspectives on Subcutaneous Infliximab for Rheumatic Diseases and Inflammatory Bowel Disease: Before, During, and After the COVID-19 Era

Letter: treatment with subcutaneous CT‐P13 in Crohn’s disease patients with intravenous infliximab failure

Was ist gesichert in der Therapie chronisch-entzündlicher Darmerkrankungen

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