AI Article Synopsis
- - The study investigates the effectiveness and safety of anti-TNF-α monoclonal antibodies (adalimumab and infliximab) combined with proactive therapeutic drug monitoring (TDM) for patients with inflammatory bowel disease (IBD).
- - Results from 13 included studies showed that proactive TDM significantly improved clinical remission rates, reduced surgery needs, and decreased adverse events among patients, particularly those treated with adalimumab.
- - The authors conclude that proactive TDM is especially beneficial for IBD patients treated with adalimumab, suggesting a need for tailored monitoring strategies based on the patient's treatment type.
Article Abstract
Background: The efficacy and safety of anti-tumor necrosis factor-α (TNF-α) monoclonal antibody therapy [adalimumab (ADA) and infliximab (IFX)] with therapeutic drug monitoring (TDM), which has been proposed for inflammatory bowel disease (IBD) patients, are still controversial.
Aim: To determine the efficacy and safety of anti-TNF-α monoclonal antibody therapy with proactive TDM in patients with IBD and to determine which subtype of IBD patients is most suitable for proactive TDM interventions.
Methods: As of July 2023, we searched for randomized controlled trials (RCTs) and observational studies in PubMed, Embase, and the Cochrane Library to compare anti-TNF-α monoclonal antibody therapy with proactive TDM with therapy with reactive TDM or empiric therapy. Pairwise and network meta-analyses were used to determine the IBD patient subtype that achieved clinical remission and to determine the need for surgery.
Results: This systematic review and meta-analysis yielded 13 studies after exclusion, and the baseline indicators were balanced. We found a significant increase in the number of patients who achieved clinical remission in the ADA [odds ratio (OR) = 1.416, 95% confidence interval (CI): 1.196-1.676] and RCT (OR = 1.393, 95%CI: 1.182-1.641) subgroups and a significant decrease in the number of patients who needed surgery in the proactive reactive (OR = 0.237, 95%CI: 0.101-0.558) and IFX + ADA (OR = 0.137, 95%CI: 0.032-0.588) subgroups, and the overall risk of adverse events was reduced (OR = 0.579, 95%CI: 0.391-0.858) according to the pairwise meta-analysis. Moreover, the network meta-analysis results suggested that patients with IBD treated with ADA (OR = 1.39, 95%CI: 1.19-1.63) were more likely to undergo TDM, especially in comparison with patients with reactive TDM (OR = 1.38, 95%CI: 1.07-1.77).
Conclusion: Proactive TDM is more suitable for IBD patients treated with ADA and has obvious advantages over reactive TDM. We recommend proactive TDM in IBD patients who are treated with ADA.
Download full-text PDF |
Source |
|---|---|
| http://www.ncbi.nlm.nih.gov/pmc/articles/PMC10921189 | PMC |
| http://dx.doi.org/10.4240/wjgs.v16.i2.571 | DOI Listing |
Publication Analysis
Top Keywords
Similar Publications
Long-Term Effectiveness and Safety of Proactive Therapeutic Drug Monitoring of Infliximab in Paediatric Inflammatory Bowel Disease: A Real-World Study.
Pharmaceutics
December 2024
Pharmacy Department, Hospital Universitari Vall d'Hebron, Vall d'Hebron Barcelona Hospital Campus, 08035 Barcelona, Spain.
Background: This study evaluated the long-term effectiveness and safety of a multidisciplinary early proactive therapeutic drug monitoring (TDM) program combined with Bayesian forecasting for infliximab (IFX) dose adjustment in a real-world dataset of paediatric patients with inflammatory bowel disease (IBD).
Methods: A descriptive, ambispective, single-centre study of paediatric patients with IBD who underwent IFX serum concentration measurements between September 2015 and September 2023. The patients received reactive TDM before September 2019 (n = 17) and proactive TDM thereafter (n = 21).
Tumour necrosis factor inhibitors in Ulcerative colitis: real-world data on Therapeutic drug monitoring and evaluation of current treatment targets (STRIDE II).
Ann Med
December 2025
Department of Gastroenterology, Oslo University Hospital.
Background: The benefit of therapeutic drug monitoring (TDM) and implementation of recommendations from the Selection of Therapeutic Targets in Inflammatory Bowel Disease (IBD, STRIDE) are discussed in the IBD community. We report real-world data in ulcerative colitis patients receiving first-line tumour necrosis factor inhibitor (TNFi) treatment followed by TDM, and assess how implementation of the STRIDE II recommendations might affect clinical practice.
Methods: Adult, biologically naïve UC patients starting TNFi between 2014 and 2021 at Oslo University Hospital were included in a medical chart review study, and data were collected at three and twelve months after the start of treatment.
Therapeutic Drug Monitoring in Patients with Ulcerative Colitis on Infliximab: A Cost-Effectiveness Analysis.
Dig Dis Sci
December 2024
Division of Gastroenterology and Hepatology, Stanford University School of Medicine, Stanford, CA, USA.
Background And Aims: Ulcerative colitis (UC) can be treated with infliximab (IFX). Therapeutic drug monitoring (TDM) can yield superior outcomes, but its cost-effectiveness is unknown.
Methods: We used a decision analytic Markov model to conduct a cost-effectiveness analysis comparing proactive TDM, reactive TDM, no TDM, and combinations of proactive and reactive TDM in 25-year-old patients with UC started on IFX.
Proactive therapeutic drug monitoring of biologic drugs in adult patients with inflammatory bowel disease, inflammatory arthritis, or psoriasis: a clinical practice guideline.
BMJ
October 2024
MAGIC Evidence Ecosystem Foundation, Oslo, Norway.
Clinical Question: In adult patients with inflammatory bowel disease, inflammatory arthritis (rheumatoid arthritis, spondyloarthritis, psoriatic arthritis), or psoriasis taking biologic drugs, does proactive therapeutic drug monitoring (TDM) improve outcomes as compared with standard care?
Context And Current Practice: Standard care for immune mediated inflammatory diseases includes prescribing biologic drugs at pre-determined doses. Dosing may be adjusted reactively, for example with increased disease activity. In proactive TDM, serum drug levels and anti-drug antibodies are measured irrespective of disease activity, and the drug dosing is adjusted to achieve target serum drug levels, usually within pre-specified therapeutic ranges.
Is therapeutic drug monitoring a dancing partner for TNF-α inhibitors in real-world practice? Answers from an updated systematic review and meta-analysis.
Expert Rev Clin Pharmacol
October 2024
Department of Pharmacy, Peking University Third Hospital, Beijing, China.
Article Synopsis
- This systematic review examined the impact of therapeutic drug monitoring (TDM) for TNF-α inhibitors in immune-mediated inflammatory diseases (IMIDs) using real-world evidence, as previous meta-analyses from randomized controlled trials might not reflect actual clinical practices.
- The review included 24 cohort studies, primarily focusing on infliximab, showing that proactive TDM significantly improved clinical remission and reduced complications for inflammatory bowel diseases (IBDs), while the benefits for rheumatic diseases were inconclusive.
- The findings suggest that proactive TDM for TNF-α inhibitors, especially infliximab, enhances treatment effectiveness, safety, and reduces risk of immunogenicity in IBDs, though its advantages in
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!