Trial reportJournal of internal medicine2022
Risk factors for anti-drug antibody formation to infliximab: Secondary analyses of a randomised controlled trial.
Trial report in Journal of internal medicine, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 23 papers.
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The trial behind it
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Who cites it
23 citing papers in PubMed, 36 citations in OpenAlex.
- Risk factors for anti-drug antibody formation to infliximab: Secondary analyses of a randomised controlled trial.Journal of internal medicine · 2022Trial
- Advancing Biotherapeutic Treatment of Ulcerative Colitis Using Lipid Mesophases: Formulation Design and Preclinical Validation.Advanced science (Weinheim, Baden-Wurttemberg, Germany) · 2026Article
- Optimisation of in vitro assays for accurate risk assessment of T-cell responses to biologics with potential immune liabilities.Archives of toxicology · 2026Article
- Development and validation of a LASSO-logistic regression model for predicting subtherapeutic infliximab trough concentrations in patients with Crohn's disease.International journal of clinical pharmacy · 2026Article
- Inflammatory and Immune Pathways Driving Tumor Necrosis Factor Inhibitor Resistance in Ulcerative Colitis.Journal of inflammation research · 2026Review
- The prevalence and potential associations of anti-drug antibodies against adalimumab in patients with non-infectious uveitis: a cross-sectional study.Journal of ophthalmic inflammation and infection · 2025Article
- Article
- Development and Validation of a Machine Learning Model to Predict Anti-Drug Antibody Formation During Infliximab Induction in Crohn's Disease.Biomedicines · 2025Article
- Assessing early therapeutic drug monitoring of adalimumab as a predictor of treatment efficacy and immunogenicity in rheumatic diseases: "early therapeutic drug monitoring of adalimumab".Clinical rheumatology · 2025Article
- Therapeutic Drug Monitoring in Patients with Ulcerative Colitis on Infliximab: A Cost-Effectiveness Analysis.Digestive diseases and sciences · 2025Article
- Detection of antibodies to infliximab in routine care: a 4-year French retrospective study.Clinical and experimental immunology · 2025Article
- Review
- Immunogenicity risk assessment for tailored mitigation and monitoring of biotherapeutics during development: recommendations from the European Immunogenicity Platform.Frontiers in immunology · 2025Review
- Adalimumab Autoantibodies in Uveitis Patients: Do We Need Routine Drug Monitoring?Biomedicines · 2024Article
- Subcutaneous infliximab in Crohn's disease patients with previous immunogenic failure of intravenous infliximab.International journal of colorectal disease · 2024Article
- Adalimumab serum levels and anti-drug antibodies: associations to treatment response and drug survival in inflammatory joint diseases.Rheumatology (Oxford, England) · 2024Observational
- Obesity and tobacco smoking are independently associated with poor patient-reported outcomes in SLE: a cross-sectional study.Rheumatology international · 2024Article
- Article
- Precision Dermatology: A Review of Molecular Biomarkers and Personalized Therapies.Current issues in molecular biology · 2024Review
- Harnessing Variability Signatures and Biological Noise May Enhance Immunotherapies' Efficacy and Act as Novel Biomarkers for Diagnosing and Monitoring Immune-Associated Disorders.ImmunoTargets and therapy · 2024Article
Corrections and comments
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Authors and funding
15 authors at 4 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundAnti-drug antibodies (ADAb) frequently form early in the treatment course of infliximab and other tumour necrosis factor (TNF) inhibitors, leading to treatment failure and adverse events.
objectiveTo identify risk factors for ADAb in the early phase of infliximab treatment.
methodsPatients (n = 410) with immune-mediated inflammatory diseases who initiated infliximab treatment were included in the 38-week Norwegian Drug Monitoring Trial (NOR-DRUM) A and randomised 1:1 to therapeutic drug monitoring (TDM) or standard therapy. Serum levels of infliximab and ADAb were measured at each infusion. Possible risk factors for ADAb formation were assessed using logistic regression, adjusting for potential confounders.
resultsADAb were detected in 78 (19%) patients. A diagnosis of rheumatoid arthritis (RA) (odds ratio [OR], 1.9 [95% confidence interval [CI] 1.0-3.6]) and lifetime smoking (OR, 2.0 [CI 1.1-3.6]) were baseline risk factors, while baseline use of concomitant immunosuppressors (OR, 0.4 [CI 0.2-0.8]) and a diagnosis of spondyloarthritis (SpA) (OR, 0.4 [CI 0.2-0.8]) reduced the risk of ADAb. Higher disease activity during follow-up (OR, 1.1 [CI 1.0-1.1]) and "drug holidays" of more than 11 weeks (OR, 4.1 [CI 1.2-13.8]) increased the risk of ADAb, whereas higher infliximab doses (OR, 0.1 [CI 0.0-0.3) and higher serum infliximab concentrations (OR, 0.7 [CI 0.6-0.8]) reduced the risk of immunogenicity.
conclusionSeveral risk factors for ADAb formation during early-phase infliximab treatment were identified. This knowledge provides a basis for treatment strategies to mitigate the formation of ADAb and identify patients in whom these measures are of particular importance.
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