DOP62 A novel formulation of CT-P13 (infliximab biosimilar) for subcutaneous administration: 1-year result from a Phase I open-label randomised controlled trial in patients with active Crohn’s disease

Reinisch, Walter; Jang, Byeong Ik; Borzan, Vladimir; Lahat, Adi; Puķītis, Aldis; Осипенко, М. Ф.; Mostovoy, Yuriy; Schreiber, Stefan; Ben‐Horin, Shomron; Lee, S J; Suh, Jee Hye; Lee, S G; Lee, J H; Ye, B D

doi:10.1093/ecco-jcc/jjy222.096

Cited by 18 publications

(16 citation statements)

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“…During CT-P13 SC clinical development in IBD, Part 1 of the CT-P13 SC 1.6 study compared 54 weeks of treatment with CT-P13 IV (5 mg/kg every 8 weeks [q8w]) with either of 3 doses of CT-P13 SC (120, 180, or 240 mg every 2 weeks [q2w]) in 44 patients with active CD. 23,24 After 1 year of treatment, overall efficacy and safety profiles were comparable between CT-P13 SC and CT-P13 IV, although clinical remission rates were numerically higher in CT-P13 SC cohorts at week (W) 54. 23,24 Mean predose serum concentrations (C trough ) were higher for CT-P13 SC vs CT-P13 IV, and exceeded the 5 mg/mL target therapeutic concentration throughout the study.…”

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confidence: 97%

“…23,24 After 1 year of treatment, overall efficacy and safety profiles were comparable between CT-P13 SC and CT-P13 IV, although clinical remission rates were numerically higher in CT-P13 SC cohorts at week (W) 54. 23,24 Mean predose serum concentrations (C trough ) were higher for CT-P13 SC vs CT-P13 IV, and exceeded the 5 mg/mL target therapeutic concentration throughout the study. 23,24 Based on the proof-of-principle and dose-selection findings in Part 1, Part 2 was initiated: results are presented here.…”

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confidence: 97%

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Randomized Controlled Trial: Subcutaneous vs Intravenous Infliximab CT-P13 Maintenance in Inflammatory Bowel Disease

Schreiber

Ben‐Horin

Leszczyszyn³

et al. 2021

Gastroenterology

124

175

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BACKGROUND & AIMS: This study compared pharmacokinetics, symptomatic and endoscopic efficacy, safety, and immunogenicity of a subcutaneous formulation of the infliximab biosimilar CT-P13 (CT-P13 SC) vs intravenous CT-P13 (CT-P13 IV) in patients with inflammatory bowel disease (IBD). METHODS: This randomized, multicenter, open-label, parallel-group, phase 1 study enrolled tumor necrosis factor inhibitor-naïve patients with active ulcerative colitis (total Mayo score 6-12 points with endoscopic subscore 2) or Crohn's disease (Crohn's Disease Activity Index 220-450 points) at 50 centers. After CT-P13 IV induction at Week (W) 0/ W2, patients were randomized (1:1) to receive CT-P13 SC every 2 weeks (q2w) from W6 to W54 or CT-P13 IV every 8 weeks from W6 to W22. At W30, all patients receiving CT-P13 IV switched to CT-P13 SC q2w until W54. The primary endpoint was noninferiority of CT-P13 SC to CT-P13 IV for observed predose CT-P13 concentration at W22 (C trough,W22 ), concluded if the lower bound of the 2-sided 90% confidence interval (CI) for the ratio of geometric least-squares means exceeded 80%. RESULTS: Overall, 66 and 65 patients were randomized to CT-P13 SC and CT-P13 IV, respectively. The primary endpoint of noninferiority was met with a geometric least-squares means ratio for C trough,W22 of 1154.17% (90% CI 786.37-1694.00; n ¼ 59 [CT-P13 SC]; n ¼ 57 [CT-P13 IV]). W30/W54 clinical remission rates were comparable between arms. Other efficacy,

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confidence: 97%

mentioning

confidence: 97%

Randomized Controlled Trial: Subcutaneous vs Intravenous Infliximab CT-P13 Maintenance in Inflammatory Bowel Disease

Schreiber

Ben‐Horin

Leszczyszyn³

et al. 2021

Gastroenterology

124

175

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“…Gains from biosimilar development could also be extended through the use of innovative approaches, such as the development of more convenient or longer-acting drug formulations, as conducted by RP manufacturers [7]. For example, infliximab biosimilars are currently administered intravenously, but a subcutaneous formulation of CT-P13 that could offer increased convenience for patients is in development [187][188][189]. Adding value to a product and dedication to an evidence-based approach will be key factors in determining the future success and sustainability of a developer in the competitive biosimilars market.…”

Section: Developers' Perspective: Innovative Approaches To Bring Addimentioning

confidence: 99%

The Future of Biosimilars: Maximizing Benefits Across Immune-Mediated Inflammatory Diseases

Kim

Alten

Avedano³

et al. 2020

Drugs

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Biologics have transformed the treatment of immune-mediated inflammatory diseases such as rheumatoid arthritis (RA) and inflammatory bowel disease (IBD). Biosimilars-biologic medicines with no clinically meaningful differences in safety or efficacy from licensed originators-can stimulate market competition and have the potential to expand patient access to biologics within the parameters of treatment recommendations. However, maximizing the benefits of biosimilars requires cooperation between multiple stakeholders. Regulators and developers should collaborate to ensure biosimilars reach patients rapidly without compromising stringent quality, safety, or efficacy standards. Pharmacoeconomic evaluations and payer policies should be updated following biosimilar market entry, minimizing the risk of imposing nonmedical barriers to biologic treatment. In RA, disparities between treatment guidelines and national reimbursement criteria could be addressed to ensure more uniform patient access to biologics and enable rheumatologists to effectively implement treat-to-target strategies. In IBD, the cost-effectiveness of biologic treatment earlier in the disease course is likely to improve when biosimilars are incorporated into pharmacoeconomic analyses. Patient understanding of biosimilars is crucial for treatment success and avoiding nocebo effects. Full understanding of biosimilars by physicians and carefully considered communication strategies can help support patients initiating or switching to biosimilars. Developers must operate efficiently to be sustainable, without undermining product quality, the reliability of the supply chain, or pharmacovigilance. Developers should also facilitate information sharing to meet the needs of other stakeholders. Such collaboration will help to ensure a sustainable future for both the biosimilar market and healthcare systems, supporting the availability of effective treatments for patients.

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“…More recently available biologic agents with other mode of action, such as vedolizumab, are also delivered with a fixed dose. Recently, phase I/III trials conducted both in rheumatology and gastroenterology have focused on a new CT-P13 (infliximab biosimilar) formulation delivered subcutaneously [22,23]. Importantly, only three infliximab doses have been evaluated: 90, 120 and 180 mg in rheumatoid arthritis and 120, 180 and 240 mg in Crohn's disease.…”

Section: Discussionmentioning

confidence: 99%

Implementation of infliximab standardized doses after pharmacokinetic modelization in a cohort of patients with Crohn’s disease

Poullenot

Ollivier

Rivière

et al. 2020

Digestive and Liver Disease

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Background: According to infliximab (IFX) license in Crohn's disease (CD), infusion doses are based on patient's body-weight. Dose banding providing standardized doses (SD) has been implemented in parenteral chemotherapy in order to optimize aseptic unit capacity and reduce drug expenditure, duration of hospital stay and costs without decreasing efficacy. Material and method: The first part was a single-center retrospective analysis of consecutive CD patients receiving IFX maintenance therapy to determine standardized doses covering more than 50% of infusions. The second part was a prospective cohort study assessing the impact of SD compared to body-weight doses (BWD) on admission duration and costs. Results: Six IFX SD covering more than 90% of infusion doses were implemented for dose banding. According to the Monte-Carlo simulation, there was no significant difference between IFX SD and BWD maintenance regimens. When assessed prospectively in 116 patients (75 patients treated with SD and 41 with BWD) corresponding to 128 infusions, hospitalization duration was shortened by 70 min per patient (p < 0.001). Conclusion:According to a pharmacokinetic model, IFX SD has a pharmacokinetic profile close to BWD and is associated with reduced length of hospitalization in a cohort of patients with CD. IFX SD implementation could optimize infusion units functioning and, save time and costs without decreasing efficacy.

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DOP62 A novel formulation of CT-P13 (infliximab biosimilar) for subcutaneous administration: 1-year result from a Phase I open-label randomised controlled trial in patients with active Crohn’s disease

Cited by 18 publications

References 0 publications

Randomized Controlled Trial: Subcutaneous vs Intravenous Infliximab CT-P13 Maintenance in Inflammatory Bowel Disease

Randomized Controlled Trial: Subcutaneous vs Intravenous Infliximab CT-P13 Maintenance in Inflammatory Bowel Disease

The Future of Biosimilars: Maximizing Benefits Across Immune-Mediated Inflammatory Diseases

Implementation of infliximab standardized doses after pharmacokinetic modelization in a cohort of patients with Crohn’s disease

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