Tu2018 - Novel Formulation of CT-P13 (Infliximab Biosimilar) for Subcutaneous Administration: Initial Results from a Phase I Open-Label Randomized Controlled Trial in Patients with Active Crohn's Disease

Schreiber, Stefan; Jang, Byung Ik; Borzan, Vladimir; Lahat, Adi; Puķītis, Aldis; Осипенко, М. Ф.; Mostovoy, Yuriy; Ben‐Horin, Shomron; Ye, Byong Duk; Lee, Sang Joon; Lee, Sung Young; Kim, Mi Rim; Reinisch, Walter

doi:10.1016/s0016-5085(18)34477-9

Cited by 13 publications

(13 citation statements)

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“…Rates of dose escalation are in line with current literature [4–60% 12 over 12 months], with lower rates observed for patients on vedolizumab compared to those on anti-TNFα treatments. 13 Although research supports dose escalations being used to recapture response following SLOR, 14 rates of escalation for this study may have been impacted by the bias that vedolizumab treatment labels did not include escalation instructions [USA or Canada].…”

Section: Discussionsupporting

confidence: 86%

Vedolizumab and Anti-Tumour Necrosis Factor α Real-World Outcomes in Biologic-Naïve Inflammatory Bowel Disease Patients: Results from the EVOLVE Study

Bressler

Yarur

Silverberg

et al. 2021

Journal of Crohn's and Colitis

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Background and aims This study aimed to compare real-world clinical effectiveness and safety of vedolizumab, an α4β7-integrin inhibitor, and anti-tumour necrosis factor-α (anti-TNFα) agents in biologic-naïve ulcerative colitis (UC) and Crohn’s disease (CD) patients. Methods This was a 24-month retrospective medical chart study in adult UC and CD patients treated with vedolizumab or anti-TNFα in Canada, Greece and the United States. Inverse probability weighting was used to account for differences between groups. Primary outcomes were cumulative rates of clinical effectiveness (clinical response, clinical remission, mucosal healing) and incidence rates of serious adverse events (SAEs) and serious infections (SIs). Secondary outcomes included cumulative rates of treatment persistence (patients who did not discontinue index treatment during follow-up) and dose escalation and incidence rates of disease exacerbations and disease-related surgeries. Adjusted analyses were performed using inverse probability weighting. Results A total of 1095 patients (604 UC, 491 CD) were included. By 24 months, rates of clinical effectiveness were similar between groups, but incidence rates of SAEs (HR=0.42 [0.28-0.62]) and SIs (HR=0.40 [0.19-0.85]) were significantly lower in vedolizumab vs anti-TNFα patients. Rates of treatment persistence (p<0.01) by 24 months were higher in vedolizumab patients with UC. Incidence rates of disease exacerbations were lower in vedolizumab patients with UC (HR=0.58 [0.45-0.76]). Other outcomes did not significantly differ between groups. Conclusion In this real-world setting, first-line biologic therapy in biologic-naïve patients with UC and CD demonstrated that vedolizumab and anti-TNFα treatments were equally effective at controlling disease symptoms, but vedolizumab has a more favourable safety profile.

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Section: Discussionsupporting

confidence: 86%

Vedolizumab and Anti-Tumour Necrosis Factor α Real-World Outcomes in Biologic-Naïve Inflammatory Bowel Disease Patients: Results from the EVOLVE Study

Bressler

Yarur

Silverberg

et al. 2021

Journal of Crohn's and Colitis

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“…A subcutaneous formulation of the IFX biosimilar (BS) CT-P13 (Celltrion) may soon be available for phase 3 clinical studies in the rheumatoid arthritis population [38], and a phase 1 study in the CD population has been recently conducted [39].…”

Section: Tnf Inhibitors Used In Ibdsmentioning

confidence: 99%

TNF-Alpha Blockers in Inflammatory Bowel Diseases: Practical Recommendations and a User’s Guide: An Update

Vulliemoz¹,

Brand

Juillerat

et al. 2020

Digestion

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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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Tu2018 - Novel Formulation of CT-P13 (Infliximab Biosimilar) for Subcutaneous Administration: Initial Results from a Phase I Open-Label Randomized Controlled Trial in Patients with Active Crohn's Disease

Cited by 13 publications

References 0 publications

Vedolizumab and Anti-Tumour Necrosis Factor α Real-World Outcomes in Biologic-Naïve Inflammatory Bowel Disease Patients: Results from the EVOLVE Study

Vedolizumab and Anti-Tumour Necrosis Factor α Real-World Outcomes in Biologic-Naïve Inflammatory Bowel Disease Patients: Results from the EVOLVE Study

TNF-Alpha Blockers in Inflammatory Bowel Diseases: Practical Recommendations and a User’s Guide: An Update

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

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