Clinical monitoring: infliximab biosimilar CT-P13 in the treatment of Crohn’s disease and ulcerative colitis

Radan Keil,Martin Wasserbauer,Zdena Zádorová,Jan Hajer,Pavel Drastich,Pavel Wohl,Marek Beneš,Martina Bojková,Pavel Svoboda,Michal Konečný,Přemysl Falt,Tomáš Vaňásek,Martin Pešta,František Pešek,Luděk Bouchner,Jana Koželuhová,Aleš Novotný,Lucie Bartůsková,Julius Špičák

doi:10.3109/00365521.2016.1149883

Abstract

Objective: The infliximab biosimilar CT-P13 (Remsima®, Inflectra®) was approved in Europe for the treatment of inflammatory bowel disease (IBD) based on extrapolation of data from patients with rheumatic disease. Because there are limited published reports on clinical outcomes for IBD patients treated with CT-P13, we monitored responses to induction treatment with this biosimilar in patients with Crohn’s disease (CD) or ulcerative colitis (UC) in centres across the Czech Republic.Material and methods: Fifty-two patients with CD (n = 30) or UC (n = 22) were treated with 5 mg/kg CT-P13 for up to 14 weeks. Effectiveness of therapy was evaluated with the Crohn’s Disease Activity Index (CDAI) or the Mayo Scoring System (MSS) in patients with CD or UC, respectively, before and after 14 weeks. Additional goals were to evaluate weight changes, serum C-reactive protein (CRP) levels, and complications/adverse events.Results: In patients with CD, remission (CDAI <150) was achieved in 50.0% of cases, and partial response (≥70-point decrease in CDAI score from baseline) in the remaining 50.0%. In patients with UC, remission (total score on partial Mayo index ≤2 points) was achieved in 40.9% of cases, partial response (≥2-point decrease in partial Mayo score from baseline) in 54.5%, and no response in 4.5%. There were statistically significant improvements in CDAI, MSS and CRP serum levels after 14 weeks of therapy, and body weight increased. Four adverse events were identified (n = 1 each): lower-extremity phlebothrombosis, herpes labialis, pneumonia and allergic reaction.Conclusions: This prospective observational study provides evidence of the effectiveness of CT-P13 in IBD.

Highlights

Inflammatory bowel disease (IBD), including ulcerative colitis (UC) and Crohn’s disease (CD), is a chronic inflammatory disorder of the gastrointestinal tract.[1,2] Activation of T cells and a broad spectrum of inflammatory mediators, especially tumour necrosis factor (TNF), results in pathological inflammation of the intestinal mucosa and plays an essential role in the pathogenesis of IBD.[1,2,3] The interference of this inflammatory pathway with biological therapies has revolutionised the treatment of IBD
Fifty-two eligible patients (29 men and 23 women) who had been diagnosed with IBD (30 with CD, 22 with UC) were enrolled (Table 1)
In our group of patients with CD treated with the infliximab biosimilar CT-P13, remission was achieved in 50% of cases and partial response in the other 50%

Summary

Introduction

Inflammatory bowel disease (IBD), including ulcerative colitis (UC) and Crohn’s disease (CD), is a chronic inflammatory disorder of the gastrointestinal tract.[1,2] Activation of T cells and a broad spectrum of inflammatory mediators, especially tumour necrosis factor (TNF), results in pathological inflammation of the intestinal mucosa and plays an essential role in the pathogenesis of IBD.[1,2,3] The interference of this inflammatory pathway with biological therapies has revolutionised the treatment of IBD. While anti-TNF therapy provides undeniable benefits to patients’ health,[4] it significantly increases the cost of treatment. Biosimilars are products that are highly similar to their originator biological drug, or ‘reference medicinal product (RMP)’. Generics have relatively simple chemical structures and can be manufactured to be identical to their originator drug. Biosimilars represent an opportunity to reduce health care costs, while offering a similar level of efficacy and safety to that of their RMPs.[5] Currently, around 20

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