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Latest & greatest articles for infliximab
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Remsima (infliximab biosimilar) for subcutaneous injection for managing rheumatoid arthritis Remsima (infliximab biosimilar) for subcutaneous injection for managing rheumatoid arthritis Evidence summary Published: 21 July 2020 www.nice.org.uk/guidance/es29 pathways Product overview Product overview The content of this evidence summary was up-to-date in July 2020. See summaries of product characteristics (SPCs), British National Formulary (BNF) or the Medicines and Healthcare products Regulatory (...) Agency (MHRA) or NICE websites for up-to-date information. Remsima for subcutaneous injection (Celltrion Healthcare Hungary Kft) is a biosimilar monoclonal antibody of infliximab that inhibits the activity of tumour necrosis factor (TNF)-alpha. It has a marketing authorisation for managing rheumatoid arthritis in combination with methotrexate. Likely place in therapy Likely place in therapy As with all biologic disease-modifying antirheumatic drugs (DMARDs) for rheumatoid arthritis, Remsima
Infliximab (Avsola) Search Page - Drug and Health Product Register Language selection Search and menus Search Search website Search Topics menu You are here: Summary Basis of Decision - - Health Canada Expand all Summary Basis of Decision (SBD) for Contact: Summary Basis of Decision (SBD) documents provide information related to the original authorization of a product. The for is located below. Recent Activity for SBDs written for approved after September 1, 2012 will be updated to include post
Risk of Tuberculosis in Patients With Inflammatory Bowel Disease on Infliximab or Adalimumab Is Dependent on the Local Disease Burden of Tuberculosis: A Systematic Review and Meta-Analysis. Infliximab (IFX) or adalimumab (ADA) use in patients with inflammatory bowel disease (IBD) leads to increased risk of tuberculosis (TB). This meta-analysis evaluated the factors which determine this risk, with special focus on local TB incidence.All studies until January 31, 2019, which reported
Efficacy of infliximab in treatment-resistant depression: A systematic review and meta-analysis. Treatment-resistant depression (TRD) denotes the therapeutic failure of at least two evidence-based, dose-based, and time-appropriate treatment regiments for major depressive disorder (MDD). Studies have suggested that alterations in proinflammatory cytokines play an important role in the pathophysiology of TRD, as well as a significant relationship between the number of failed treatment (...) and the levels of tumor necrosis factor-alpha (TNF-α).Performed a systematic review and meta-analysis to evaluate the potential effect of the TNF-inhibitor Infliximab adjunct treatment in MDD, through randomized controlled trials (RCT).A search in the electronic databases was proceeded, on MEDLINE, EMBASE, Scopus, Cochrane Central Register of Controlled Trials (CENTRAL), Biomed Central, Web of Science, IBECS, LILACS, PsycINFO, Congress Abstracts, and Grey literature (Google Scholar and the British Library
Systematic Review: Efficacy and Safety of Accelerated Induction Regimes in Infliximab Rescue Therapy for Hospitalized Patients with Acute Severe Colitis. Pharmacokinetic data suggest that standard induction dosing schedules may not be sufficient in patients with acute severe colitis (ASUC). Hence, intensified induction regimes are increasingly used in the rescue treatment of hospitalized patients with ASUC to avoid the need for colectomy although the evidence for this is uncertain.To conduct (...) a systematic review of short- and long-term efficacy outcomes from accelerated infliximab induction studies.Systematic search of relevant databases (MEDLINE, EMBASE, Cochrane Database of Systematic Reviews) and relevant conference proceedings (Digestive Diseases Week, European Colitis and Crohn's Organisation Congress, United European Gastroenterology Week) was done.We identified ten relevant studies with a total of 705 patients, of whom 308 received an intensified infliximab regime. Pooled analysis showed
Infliximab clinically treating ulcerative colitis: A systematic review and meta-analysis. This review aimed to evaluate the efficacy and safety of infliximab against ulcerative colitis (UC).Collection of databases: PubMed, Cochrane Library, Medline, Embase, CBM, and CNKI. This meta-analysis included randomized controlled trials comparing infliximab vs. placebo's, steroids, or immunosuppressants.Searching terms were ('infliximab', OR 'anti-tumor necrosis factor', OR 'tumor necrosis factor (...) ', OR 'tumor necrosis factor alpha antibody', OR 'tumor necrosis factor antibody', OR 'IFX') and ('ulcerative colitis' OR 'UC'). Study quality: Independently assessed by two reviewers.Meta-analysis combined the odds ratios (OR).Twenty-two studies (2080 patients) evaluated infliximab therapy in UC, and the patients were randomly assigned into infliximab (1149 cases) and control groups (931 cases). The meta-analysis showed the advantage of infliximab in three endpoints (short/long-term response and long-term
A Meta-Analysis of Efficacy and Safety of Infliximab for Prevention of Postoperative Recurrence in Patients with Crohn's Disease. We sought to investigate the efficacy and safety of Infliximab for prevention of postoperative recurrence in patients with Crohn's disease (CD), in a meta-analysis of clinical trial results.The Medline, Embase, PubMed, and Web of Science databases were systematically searched for suitable studies. A meta-analysis of enrolled studies was performed to analyze (...) the efficacy of Infliximab on outcomes regarding the prevention of postoperative recurrence of CD. A Galbraith radial plot was used to quantify the heterogeneity. Funnel plot and Egger test were performed to describe the bias of publication. A Forest plot was prepared to indicate the efficacy outcomes.A total of 7 prospective trials were included in our meta-analysis (N=455). The Funnel plot and Egger test showed there was no significant bias in the included publications. The Cochrane collaboration tool
An updated systematic review and meta-analysis about the safety and efficacy of infliximab biosimilar, CT-P13, for patients with inflammatory bowel disease. We aimed to evaluate the efficacy and safety of infliximab biosimilar, CT-P13, for patients with inflammatory bowel disease.We searched PubMed, Scopus, Ovid, and Web of Science for relevant clinical trials discussing CT-P31 administration for IBD patients either naïve to biological therapy or switched from IFX therapy. Data of the rates
Safety and Efficacy of Infliximab in Severe Alcoholic Hepatitis: A Systematic Review. Severe alcoholic hepatitis (SAH) is associated with significant morbidity and mortality, yet the treatment options available are very limited. Past studies have evaluated the efficacy of infliximab in such patients; however, they were limited by sample size. Our aim was to perform a systematic review of these studies to assess the role of infliximab in patients with SAH. We conducted a literature search using (...) electronic database engines including Ovid, PubMed, Scopus, MEDLINE and Cochrane Library from inception to October 2018 to identify published articles addressing outcomes in patients treated for alcoholic hepatitis with infliximab. The primary outcome reviewed was one-month mortality. Secondary outcomes included rate and type of infection; cause of mortality; levels of aspartate aminotransferase, alanine aminotransferase, bilirubin and tumor necrosis factor-α; and Maddrey discriminant function. Five
Comparable Long-Term Outcomes of Cyclosporine and Infliximab in Patients With Steroid-Refractory Acute Severe Ulcerative Colitis: A Meta-Analysis. Background: In steroid-refractory acute severe ulcerative colitis (ASUC), cyclosporine (CYS) or infliximab (IFX) may be considered as a second-line alternative to avoid colectomy. There are short-term data reported, but until now, there is no meta-analysis regarding long-term outcomes of CYS and IFX in patients with ASUC. Aim: To compare long-term
Pharmacokinetics, Pharmacodynamics and Immunogenicity of Infliximab in Paediatric Inflammatory Bowel Disease; a Systematic Review and Revised Dosing Considerations. Infliximab (IFX), a monoclonal antibody directed against TNF-α is a potent treatment option for inflammatory bowel disease (IBD). Dosing regimens in children are extrapolated from adult data using a fixed, weight-based dose, which is often not adequate. While clinical trials have focused on safety and efficacy, there is limited data (...) -to infliximab (ATI), (3) full text article or abstract, (4) article in English, and (5) original data.Initial electronic search yielded 2360 potentially relevant articles, with 1831 remaining after removal of duplicates. An additional search yielded another 202 potentially relevant articles. Of the 2033 retrieved articles, 2000 articles were excluded based on title, abstract or eligibility criteria. Clearance of infliximab was increased in young children and children with extensive disease, leading to lower
Systematic Review: Non-medical Switching of Infliximab to CT-P13 in Inflammatory Bowel Disease. Biosimilar approval, such as Inflectra™ (CT-P13) for treating ulcerative colitis (UC) and Crohn's disease (CD), has reduced direct drug costs. Though clinicians are comfortable with biosimilar use in treatment-naïve patients, there are concerns in some jurisdictions that there are insufficient data from well-controlled trials to support non-medical switching. A systematic review, along (...) with a critical assessment of the study design, was conducted to assess the potential impact of switching stable CD/UC patients from infliximab to CT-P13.A literature search using PubMed and abstracts/posters from 3 major gastroenterology conferences from 2014 to 2018 was completed. Two individual reviewers extracted data from each relevant report and compiled it into evidence tables to facilitate descriptive analyses. Key randomized trial and observational study designs were critically assessed
Etrolizumab versus infliximab in the treatment of induction phase of ulcerative colitis: A systematic review and indirect comparison. There is still a need to develop new effective medications for the treatment of ulcerative colitis, particularly for patients who are intolerant or resistant to first line therapies. This article compared the efficacy and safety of etrolizumab and infliximab in moderate to severe ulcerative colitis.This meta-analysis was performed according to the PRISMA (...) statement protocol. A systematic literature search of three major bibliographic databases (Scopus, PubMed, and Cochran) was performed until June 30, 2018. This review included studies that evaluated the efficacy of etrolizumab or infliximab in ulcerative colitis and were placebo controlled randomized trials. Pooled data from each treatment were indirectly compared using Bucher's method.Seven trials were sufficiently homogeneous to be used for indirect comparison of the induction phase of the treatment
Efficacy and Safety in the Continued Treatment With a Biosimilar Drug in Patients Receiving Infliximab: A Systematic Review in the Context of Decision-Making From a Latin-American Country. Introduction: Biological products, including infliximab (INF), are a therapeutic option for various medical conditions. In the Peruvian Social Security (EsSalud), infliximab is approved for the treatment of rheumatoid arthritis, psoriasis, psoriatic arthropathy, ankylosing spondylitis, ulcerative colitis (...) and Crohn's disease (in cases refractory to conventional treatment). Biosimilars are a safe and effective alternative approved for these diseases in patients who start treatment with infliximab. Nevertheless, there are people in treatment with the biological reference product (BRP), in whom the continuing therapy with a biosimilar biological product (BBP) must be evaluated. Objectives: To synthesize the best available evidence, calculate a preliminary financial impact and conduct technical discussions
Efficacy and Safety of Infliximab in Pediatric Crohn Disease: A Systematic Review and Meta-Analysis. Crohn disease is an inflammatory bowel disease with intermittent symptoms relating to damage to the gastrointestinal tract. Compared with adult-onset Crohn disease, the childhood-onset form is more likely to be severe. Infliximab has shown efficacy in adult patients.To examine the efficacy and safety of infliximab in pediatric Crohn disease, by means of a systematic review.Three databases (...) (MEDLINE, Embase, and Cochrane Central Register of Controlled Trials) and regulatory documents were searched from inception to December 2017. Clinical trial registries, conference abstracts, and reference lists were searched to March 2018.Randomized controlled trials (RCTs) and prospective cohort studies that compared infliximab with active control were included in the analysis. Two reviewers independently performed screening, extracted data, and assessed risk of bias. The primary outcomes were
Long-term efficacy and cost-effectiveness of infliximab as first-line treatment in rheumatoid arthritis: systematic review and meta-analysis. Introduction: Early biological treatment of rheumatoid arthritis (RA) may reverse the autoimmune response in some patients resulting in favorable long-term outcomes. Although the cost-effectiveness of this strategy has been questioned, biosimilar entries warrant the revision of clinical and pharmaco-economic evidence. Areas covered: We conducted (...) a systematic review of randomized controlled trials (RCTs) published up to 24 May 2018 in Pubmed, EMBASE and Cochrane CENTRAL, comparing infliximab with non-biological therapy in patients with RA naïve to methotrexate. We performed meta-analyses for efficacy outcomes at month 6 and years 1 and 2. Six RCTs were identified, involving 1832 patients. At month 6 ACR70 response and remission, and at year 1 ACR20/ACR70 responses and remission were improved significantly with first-line infliximab versus control
Premedication as primary prophylaxis does not influence the risk of acute infliximab infusion reactions in immune-mediated inflammatory diseases: A systematic review and meta-analysis. Up to 25% of patients treated with infliximab experience hypersensitivity reactions. Prophylactic premedication prior to infliximab infusion, comprising corticosteroids and/or antihistamines, is widely used in clinical practice but its efficacy has recently been called into question due to the lack (...) of pathophysiological rationale and validation by controlled trials.We conducted a comprehensive literature search of multiple electronic databases from inception to June 2017 to identify studies reporting the impact of corticosteroid and/or antihistamine premedication on the risk of acute (<24 h) hypersensitivity reaction to infliximab in immune-mediated inflammatory diseases (IMIDs). Random-effects meta-analysis was performed.Ten studies, eight observational studies and two randomized control trials, were
Loss of response to scheduled infliximab therapy for Crohn's disease in adults: A systematic review and meta-analysis. To determine the potential predictors of loss of response (LOR) to infliximab (IFX) maintenance therapy for adult patients with Crohn's disease (CD).We searched for English-language articles published between 1990 and March 2017 in PubMed, Embase, and the Cochrane Library. After identifying eligible studies, data extraction was performed independently by two reviewers
Cost-effectiveness of laparoscopic ileocaecal resection versus infliximab treatment of terminal ileitis in Crohn`s disease: the LIR!C Trial Evaluate the cost-effectiveness of laparoscopic ileocaecal resection compared with infliximab in patients with ileocaecal Crohn's disease failing conventional therapy.A multicentre randomised controlled trial was performed in 29 centres in The Netherlands and the UK. Adult patients with Crohn's disease of the terminal ileum who failed >3 months (...) of conventional immunomodulators or steroids without signs of critical strictures were randomised to laparoscopic ileocaecal resection or infliximab. Outcome measures included quality-adjusted life-years (QALYs) based on the EuroQol (EQ) 5D-3L Questionnaire and the Inflammatory Bowel Disease Questionnaire (IBDQ). Costs were measured from a societal perspective. Analyses were performed according to the intention-to-treat principle. Missing cost and effect data were imputed using multiple imputation. Cost
A cost-utility analysis of biosimilar infliximab compared to reference infliximab in adult switch patients with Crohn’s disease: A Canadian analysis The Hospital for Sick Children Technology Assessment at SickKids (TASK) FULL REPORT A COST-UTILITY ANALYSIS OF BIOSIMILAR INFLIXIMAB COMPARED TO REFERENCE INFLIXIMAB IN ADULT SWITCH PATIENTS WITH CROHN’S DISEASE: A CANADIAN ANALYSIS Authors: Avery Hughes, MSc Child Health Evaluative Sciences, The Hospital for Sick Children, Toronto, Canada Health (...) , Toronto, Ontario Canada Wendy J. Ungar, MSc, PhD Senior Scientist, Child Health Evaluative Sciences, The Hospital for Sick Children, Toronto, Canada Professor, Institute for Health Policy, Management and Evaluation, University of Toronto, Toronto, Canada Report No. 2019-02 Date: February 27, 2019 2 Executive Summary Cost-Utility Analysis of Biosimilar Infliximab Compared to Reference Infliximab in Adult Switch Patients with Crohn’s Disease: A Canadian Analysis Avery Hughes Master of Science Health