Comparison of Performances of Infliximab Biosimilars CT-P13 Versus SB2 in the Treatment of Inflammatory Bowel Diseases: A Real-Life Multicenter, Observational Study in Italy

Background Perianal fistulizing Crohn’s disease is one of the most severe phenotypes of inflammatory bowel diseases. Combined therapy with seton placement and anti-TNF therapy is the most common strategy for this condition Objectives The aim of this study was to analyze the rates of complete perianal remission after combined therapy for perianal fistulizing Crohn’s disease. Methods This was a retrospective observational study with perianal fistulizing Crohn’s disease patients submitted to combined therapy from four inflammatory bowel diseases referral centers. We analyzed patients’ demographic characteristics, Montreal classification, concomitant medication, classification of the fistulae, occurrence of perianal complete remission and recurrence after remission. Complete perianal remission was defined as absence of drainage from the fistulae associated with seton removal. Discussion A total of 78 patients were included, 44 (55.8%) females with a mean age of 33.8 (±15) years. Most patients were treated with Infliximab, 66.2%, than with Adalimumab, 33.8%. Complex fistulae were found in 52/78 patients (66.7%). After a medium follow-up of 48.2 months, 41/78 patients (52.6%) had complete perianal remission (95% CI: 43.5%-63.6%). Recurrence occurred in four (9.8%) patients (95% CI: 0.7%-18.8%) in an average period of 74.8 months. Conclusions Combined therapy lead to favorable and durable results in perianal fistulizing Crohn’s disease.

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Predictors and Early Markers of Response to Biological Therapies in Inflammatory Bowel Diseases

Journal of Clinical Medicine ◽

10.3390/jcm10040853 ◽

2021 ◽

Vol 10 (4) ◽

pp. 853

Author(s):

Giuseppe Privitera ◽

Daniela Pugliese ◽

Gian Ludovico Rapaccini ◽

Antonio Gasbarrini ◽

Alessandro Armuzzi ◽

...

Keyword(s):

Inflammatory Bowel Diseases ◽

Current Knowledge ◽

Real Life ◽

Response To Therapy ◽

Significant Heterogeneity ◽

Intestinal Damage ◽

Biological Therapies ◽

Early Markers ◽

Bowel Diseases ◽

Inflammatory Bowel

Inflammatory bowel diseases (IBD) are chronic conditions that primarily affect the gastrointestinal tract, with a complex pathogenesis; they are characterized by a significant heterogeneity of clinical presentations and of inflammatory pathways that sustain intestinal damage. After the introduction of the first biological therapies, the pipeline of therapies for IBD has been constantly expanding, and a significant number of new molecules is expected in the next few years. Evidence from clinical trials and real-life experiences has taught us that up to 40% of patients do not respond to a specific drug. Unfortunately, to date, clinicians lack a valid tool that can predict each patient’s response to therapies and that could help them in choosing what drug to administer. Several candidate biomarkers have been investigated so far, with conflicting results: clinical, genetic, immunological, pharmacokinetic and microbial markers have been tested, but no ideal marker has been identified so far. Based on recent evidence, multiparametric models seemingly hold the greatest potential for predicting response to therapy. In this narrative review, we aim to summarize the current knowledge on predictors and early markers of response to biological therapies in IBD.

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Efficacy, Safety and Immunogenicity of Biosimilars in Inflammatory Bowel Diseases: A Systematic Review

Current Medicinal Chemistry ◽

10.2174/0929867323666161014153346 ◽

2019 ◽

Vol 26 (2) ◽

pp. 270-279 ◽

Cited By ~ 13

Author(s):

Laura Martelli ◽

Laurent Peyrin-Biroulet

Keyword(s):

Inflammatory Bowel Diseases ◽

Patent Protection ◽

Real Life ◽

Cost Savings ◽

High Price ◽

Real World Evidence ◽

Real Life Setting ◽

Bowel Diseases ◽

Post Marketing ◽

Inflammatory Bowel

Background: Anti-tumor necrosis factor (anti-TNF) monoclonal antibodies have revolutionized the treatment of inflammatory bowel diseases (IBD). However, because of their complexity, their production is expensive contributing to their high price. As the patent protection of these therapies has expired in several countries, biosimilars have been developed to reduce the healthcare costs. The aim of this article is to review the literature on the safety, efficacy and immunogenicity of biosimilars in IBD. Methods: A PubMed literature search was performed using the following terms until May 2016: ‘biosimilars’, ‘CT-P13’, ‘infliximab’, ‘Crohn’s disease’, ‘ulcerative colitis’, ‘inflammatory bowel diseases’, ‘efficacy’, ‘safety’, ‘immunogenicity’. Additionally, abstracts from international meetings were also reviewed. Results: A total of eleven studies in IBD patients provided real-world evidence on the efficacy, safety and immunogenicity profile of biosimilars in IBD patients. Based on the available evidence, CT-P13 is efficacious and well tolerated in IBD patients in a real-life setting. The vast majority of studies only included IBD patients who had never received biological therapies. Information regarding the interchangeability between CT-P13 and its originator is currently being investigated in the NOR-SWITCH trial. Otherwise, the immunogenicity profile of CT-P13 seems to be similar to the originator. Conclusion: The infliximab biosimilar seems to be efficacious, safe and with a similar immunogenicity profile as the originator in IBD. Large prospective post-marketing studies are needed to assess the long-term safety profile of CT-P13. The use of infliximab biosimilars may lead to major healthcare cost savings.

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