Efficacy of the new infliximab biosimilar CT-P13 induction therapy in Crohn’s disease and ulcerative colitis – experiences from a single center

Farkas, Klaudia; Rutka, Mariann; Bálint, Anita; Nagy, Ferenc; Bor, Renáta; Milassin, Ágnes; Szepes, Zoltán; Molnár, Tamás

doi:10.1517/14712598.2015.1064893

Cited by 83 publications

(54 citation statements)

References 14 publications

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“…After the initial concerns about the extrapolation of clinical data from rheumatic indications to IBD, some paper has published on the efficacy and safety of CT-P13 in IBD patients. The increasing data on the comparable efficacy and safety profile may further decrease the fear of using biosimilar IFX routinely [3,[12][13][14].…”

Section: Discussionmentioning

confidence: 99%

“…However, considering the number of full articles published in this topic, experience with the biosimilar IFX, mainly with long-term use, is still limited. We have already published an 8-week data of the efficacy of CT-P13 IFX biosimilar in Crohn's disease (CD) and ulcerative colitis (UC), and the multicenter Hungarian study has also confirmed the effectiveness and safety of CT-P13 therapy in the induction of clinical response and remission on large number of IBD patients very soon afterwards [3,4]. The ACCENT and ACT trials were the landmark randomized controlled trials demonstrating clearly that the originator IFX can maintain remission after inducing response in both diseases [5,6].…”

Section: Introductionmentioning

confidence: 99%

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Infliximab biosimilar CT-P13 therapy is effective and safe in maintaining remission in Crohn’s disease and ulcerative colitis – experiences from a single center

Farkas

Rutka

Ferenci

et al. 2017

Expert Opinion on Biological Therapy

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Background: CT-P13, the first biosimilar monoclonal antibody to infliximab (IFX), has been confirmed to be efficacious in inducing remission in inflammatory bowel diseases (IBD). The aim of this study was to evaluate the long-term efficacy and safety of CT-P13 therapy in Crohn's disease (CD) and ulcerative colitis (UC), and to identify predictors of sustained clinical response during a 54-week CT-P13 treatment period. Patients and methods: Patients with CD and UC, who were administered CT-P13, were prospectively enrolled. Clinical response was assessed at week 14 and week 54. Predictive factors for disease outcome at week 54 were evaluated. Results: 57 CD and 57 UC patients were included; 55 CD and 49 UC patients completed the induction therapy and 50 CD and 46 UC patients completed the 54-week treatment period. Clinical remission was achieved in 65.5% of CD and 75.5% of UC patients at week 14. Rate of continuous clinical response was 51% in both CD and UC at week 54. None of the examined parameters were predictive to the clinical outcome neither in CD, nor in UC. Conclusion: This study confirmed the long-term efficacy and safety of CT-P13 therapy in IBD. Response rates at week 54 were similar in CD and UC.ARTICLE HISTORY

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Section: Discussionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Infliximab biosimilar CT-P13 therapy is effective and safe in maintaining remission in Crohn’s disease and ulcerative colitis – experiences from a single center

Farkas

Rutka

Ferenci

et al. 2017

Expert Opinion on Biological Therapy

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“…After some case series, a large, prospective Hungarian multicenter study has confirmed the efficacy of CT-P13, the first infliximab biosimilar, in inducing and maintaining remission in both Crohn's disease (CD) and ulcerative colitis (UC) [1][2][3][4][5]. However, besides efficacy data, safety assessment is also very important when extrapolating indications for biosimilars.…”

Section: Introductionmentioning

confidence: 99%

Frequency and characteristics of infusion reactions during biosimilar infliximab treatment in inflammatory bowel diseases: results from Central European nationwide cohort

Bálint

Rutka

Végh

et al. 2017

Expert Opinion on Drug Safety

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Background: Safety data of the 'real life' use of an infliximab biosimilar, CT-P13 in inflammatory bowel disease (IBD) are still lacking. Our aim was to assess the frequency and characteristics of infusion reactions during CT-P13 therapy in 13 Hungarian and 1 Czech IBD centres. Methods: Clinical and safety data was registered at fixed appointments. Trough levels and anti-drug antibody (ADA) concentration were measured by ELISA. Association between demographic, clinical, laboratory parameters and infusion reaction rates were evaluated statistically. Results: Three hundred and eighty-four IBD patients were included. Twenty-eight Hungarian IBD patients (9.6%) developed infusion reaction during the treatment, 64.3% of them was previously exposed to anti TNF therapy. No infusion reaction occurred in the Czech population. CT-P13 therapy had to be stopped in 17 patients who developed infusion reaction and was switched to adalimumab in 12 patients. However in 39.3% of patients developing infusion reaction CT-P13 therapy was continued with the use of premedication. Cumulative ADA positivity rates were 8.7%, 19.3%, and 28.0% at weeks 0, 14, and 30. Previous anti-TNF-alpha exposure (30% vs. 3.1%, p < 0.001,) and ADA positivity (32.6% vs. 4.1%, p < 0.001,) during the induction therapy were predictive factors for infusion reactions. Conclusions: Patients with previous exposure to anti-TNF-alpha and ADA positivity during the induction therapy were more likely to develop infusion reactions. ARTICLE HISTORY

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“…10 Similarly, Kang et al reported 1 UC patient experiencing arthralgia and requiring discontinuation of CT-P13. 11 In the study by Keil et al, however, a total of 4 complications were identified during the CT-P13 therapy course, represented by pneumonia in 1 patient, herpes labialis in 1 patient, venous thrombosis in 1 patient and allergic reaction in 1 patient.…”

Section: Safetymentioning

confidence: 96%

The Role of Infliximab Biosimilar CT-P13 in Inflammatory Bowel Disease

Kapuria¹,

Chhabra²

2017

JERP

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The advent of targeted biologic therapies for debilitating disorders such as Crohn's disease (CD) and Ulcerative Colitis (UC) has changed management and significantly improved outcomes. However, biologic agents are expensive, and the introduction of biosimilar medications for the treatment of inflammatory bowel diseases presents a lower-cost alternative. In this review, the mechanism of action, pharmacokinetics, efficacy and adverse effects associated with biosimilar CT-P13 in the treatment of inflammatory bowel disease are discussed.

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Efficacy of the new infliximab biosimilar CT-P13 induction therapy in Crohn’s disease and ulcerative colitis – experiences from a single center

Abstract: This was the first study to prospectively evaluate the outcome of CT-P13 induction therapy in CD and UC. Our results confirm that induction with CT-P13 is safe and effective.

Cited by 83 publications

References 14 publications

Infliximab biosimilar CT-P13 therapy is effective and safe in maintaining remission in Crohn’s disease and ulcerative colitis – experiences from a single center

Infliximab biosimilar CT-P13 therapy is effective and safe in maintaining remission in Crohn’s disease and ulcerative colitis – experiences from a single center

Frequency and characteristics of infusion reactions during biosimilar infliximab treatment in inflammatory bowel diseases: results from Central European nationwide cohort

The Role of Infliximab Biosimilar CT-P13 in Inflammatory Bowel Disease

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