Background And Aims: Biosimilar infliximab CT-P13 is approved for all indications of the originator product in Europe. Prospective data on its efficacy, safety, and immunogenicity in inflammatory bowel diseases are lacking.
Methods: A prospective, nationwide, multicentre, observational cohort was designed to examine the efficacy, safety, and immunogenicity of CT-P13 infliximab biosimilar in the induction treatment of Crohn's disease [CD] and ulcerative colitis [UC]. Demographic data were collected and a harmonised monitoring strategy was applied. Early clinical remission, response, and early biochemical response were evaluated at Week 14, steroid-free clinical remission was evaluated at Week 30. Therapeutic drug level was monitored using a conventional enzyme-linked immunosorbent assay.
Results: In all, 210 consecutive inflammatory bowel disease [126 CD and 84 UC] patients were included in the present cohort. At Week 14, 81.4% of CD and 77.6% of UC patients showed clinical response and 53.6% of CD and 58.6% of UC patients were in clinical remission. Clinical remission rates at Week 14 were significantly higher in CD and UC patients who were infliximab naïve, compared with those with previous exposure to the originator compound [p < 0.05]. Until Week 30, adverse events were experienced in 17.1% of all patients. Infusion reactions and infectious adverse events occurred in 6.6% and 5.7% of all patients, respectively.
Conclusions: This prospective multicentre cohort shows that CT-P13 is safe and effective in the induction of clinical remission and response in both CD and UC. Patients with previous infliximab exposure exhibited decreased response rates and were more likely to develop allergic reactions.
Download full-text PDF |
Source |
|---|---|
| http://dx.doi.org/10.1093/ecco-jcc/jjv220 | DOI Listing |
Publication Analysis
Top Keywords
Similar Publications
Introduction: Although maintenance treatment is recommended for the prevention of relapse, in real-world settings, a subset of patients discontinue antipsychotics while having a good prognosis. The prediction of functional remission in patients with schizophrenia after antipsychotic discontinuation (FURSAD) study aims to obtain real-world knowledge regarding the characteristics of schizophrenia (SCZ) patients who achieve functional remission after antipsychotic discontinuation for 1 year or more. This study also aims to establish a prediction model to identify patients likely to benefit from antipsychotic discontinuation.
View Article and Find Full Text PDFChronic spontaneous urticaria remission definition and therapy stepping-down. WAO Position Paper.
J Allergy Clin Immunol
December 2024
Department of Internal Medicine, Division of Rheumatology, Allergy and Immunology, University of Cincinnati, USA.
Background: There is no global agreement on the definition of Chronic Spontaneous Urticaria (CSU) remission.
Objective: To generate a consensus for clinical definitions in CSU focused on remission.
Methods: The World Allergy Organization (WAO) Urticaria Committee systematically reviewed current available longitudinal articles.
Enhancing predictive accuracy for antidepressant response in depressive disorders: The additive value of interleukin-1β and interleukin-6 alongside hsCRP.
J Affect Disord
December 2024
Department of Psychiatry, Chonnam National University Medical School, Gwangju, Republic of Korea.
Background: This study aimed to evaluate the potential additive effects of measuring serum interleukin-1 beta (IL-1β) and interleukin-6 (IL-6) on enhancing the predictive value of baseline serum high-sensitivity C-reactive protein (hsCRP) levels for predicting 12-week antidepressant treatment responses in patients with depressive disorders.
Methods: Serum levels of hsCRP, IL-1β, and IL-6 were measured at baseline in 1086 outpatient participants diagnosed with depressive disorders. Participants initially received monotherapy with antidepressants for the first three weeks, followed by a naturalistic, stepwise pharmacotherapy regimen administered every three weeks up to 12 weeks.
Modified Crohn's Disease Exclusion Diet Maintains Remission in Pediatric Crohn's Disease; Randomized Controlled Trial.
Clin Gastroenterol Hepatol
December 2024
Department of Pediatrics, University of Alberta, Edmonton, AB, Canada; Department of Physiology, University of Alberta, Edmonton, AB, Canada. Electronic address:
Background & Aims: The Crohn's Disease (CD) Exclusion Diet (CDED)+Partial Enteral Nutrition (PEN) is effective for inducing remission in mild-moderate CD. We assessed whether a 2-week course of Exclusive Enteral Nutrition (EEN), followed by CDED+PEN is superior to 8 weeks of EEN in sustaining clinical remission at week 14 in mild-to-severe CD and if CDED+PEN can maintain remission to week 24.
Methods: This international, multicenter, randomized-controlled trial compared 2-weeks of EEN (Modulen®IBD) followed by 3 phases of the CDED+PEN (henceforth CDED) to 8 weeks of EEN, followed by PEN with free diet up to week 24 (henceforth EEN).
Differential Efficacy of Advanced Therapies in Inducing Remission in Ulcerative Colitis Based on Prior Exposure to TNF Antagonists.
Clin Gastroenterol Hepatol
December 2024
Division of Gastroenterology, Department of Medicine, University of California San Diego, La Jolla, California, USA; Division of Biomedical Informatics, Department of Medicine, University of California San Diego, La Jolla, California, USA. Electronic address:
Background And Aims: We sought to ascertain how prior exposure to TNF antagonists impacts treatment response with various classes of advanced therapies in patients with ulcerative colitis (UC), through a systematic review and meta-analysis.
Methods: Through a systematic review of multiple databases through June 30, 2024, we identified 17 RCTs in 8871 adults with moderate-severe UC who were treated with different advanced therapies vs. placebo, and reported efficacy in induction of clinical remission, stratified by prior exposure to TNF antagonists.
Want AI Summaries of new PubMed Abstracts delivered to your In-box?
Enter search terms and have AI summaries delivered each week - change queries or unsubscribe any time!