SynthesisBioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy2021
Anti-Drug Antibody Formation Against Biologic Agents in Inflammatory Bowel Disease: A Systematic Review and Meta-Analysis.
Synthesis in BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 46 papers, 1 of them a synthesis that pooled it.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
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Who cites it
46 citing papers in PubMed, 1 synthesis or guideline pooled it, 75 citations in OpenAlex.
- Reactive Immunomodulator Addition to Infliximab Monotherapy Restores Clinical Response in Inflammatory Bowel Disease: A Meta-Analysis.Digestive diseases and sciences · 2024Pooled it
- Risk factors for anti-drug antibody formation to infliximab: Secondary analyses of a randomised controlled trial.Journal of internal medicine · 2022Trial
- Beyond the Prevention of Anti-drug Antibody Formation with Uricase Therapy: Mechanistic Roles of DMARDs in Modifying Gout Flare Risk.BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy · 2026Review
- Decoding Nonlinearities in AAV-Based Gene Therapy Using PBPK Modelling.The AAPS journal · 2026Article
- Article
- Unlocking the Potential of Population Pharmacokinetic Models of Adalimumab in Patients with Crohn's Disease.Pharmaceutics · 2026Article
- Long-term effectiveness and cost-effectiveness of testing for alemtuzumab antidrug antibodies to guide treatment in multiple sclerosis: a modelling study.The European journal of health economics : HEPAC : health economics in prevention and care · 2026Article
- Review
- Redosing of anti-CD3 antibodies in NOD mice with new-onset diabetes does not alter the effect of a single treatment course.Diabetologia · 2026Article
- Anti-tumor necrosis factor-α monotherapy versus combo therapy with immunosuppressant in pediatric inflammatory bowel disease: A real-life study.Journal of pediatric gastroenterology and nutrition · 2026Observational
- Off-Label Ustekinumab and Vedolizumab in Pediatric Anti-TNFα Refractory IBD: Therapeutic Drug Monitoring Insights from a Case Series.Pharmaceuticals (Basel, Switzerland) · 2026Article
- Higher Anti-Drug Antibody Levels to Anti-Tumor Necrosis Factor Therapies Are Associated with Treatment Failure in Patients with Inflammatory Bowel Disease.Journal of clinical medicine · 2026Article
- Discontinuation of advanced therapy in inflammatory bowel disease: Updated evidence, guidelines, and personalized decision-making one year later.World journal of clinical cases · 2026Article
- Therapeutic drug monitoring of adalimumab in hidradenitis suppurativa: a prospective observational study.Frontiers in immunology · 2026Observational
- Therapeutic drug monitoring of biologics in inflammatory bowel disease: An evidence-based multidisciplinary guideline.Acta pharmaceutica Sinica. B · 2026Article
- Finding appropriate timing for the combination of azathioprine and infliximab: propensity score matching and inverse probability of treatment weighting analysis.Clinical and experimental medicine · 2025Article
- Tumour necrosis factor inhibitors in Ulcerative colitis: real-world data on Therapeutic drug monitoring and evaluation of current treatment targets (STRIDE II).Annals of medicine · 2025Article
- Development and Validation of a Machine Learning Model to Predict Anti-Drug Antibody Formation During Infliximab Induction in Crohn's Disease.Biomedicines · 2025Article
- Distinct B Cell Subsets Changes as Potential Biomarkers of Response to Biologic Therapy in Crohn's Disease.International journal of molecular sciences · 2025Article
- Fragment-Based Immune Cell Engager Antibodies in Treatment of Cancer, Infectious and Autoimmune Diseases: Lessons and Insights from Clinical and Translational Studies.Antibodies (Basel, Switzerland) · 2025Review
Corrections and comments
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Authors and funding
9 authors at 3 institutions in 4 countries.
Funding
Abstract
BACKGROUND AND
aimsImmunogenicity with formation of anti-drug antibodies (ADA) to biologics is an important reason for treatment failure in inflammatory bowel disease (IBD). Our aim was to assess the rate of ADA, the effect of combination therapy with immunomodulators on ADA and the influence of ADA on efficacy and safety of biologics for IBD treatment.
methodsMEDLINE, Embase and Cochrane Central Register of Controlled Trials (CENTRAL) were searched from inception to April 2020 for trials of biologics that assessed immunogenicity. The overall certainty of evidence was evaluated using Grading of Recommendations, Assessment, Development and Evaluations (GRADE). The primary outcome was rate of ADA. Secondary outcomes included efficacy and safety outcomes among patients with detectable versus undetectable ADA. For dichotomous outcomes, pooled risk ratios (RR) and 95% confidence intervals (CI) were calculated.
resultsData from 68 studies were analyzed and 33 studies (5850 patients) were included in the meta-analysis. Pooled ADA rates for biologic monotherapy were 28.0% for infliximab, 7.5% for adalimumab, 3.8% for golimumab, 10.9% for certolizumab, 6.2% for ustekinumab and 16.0% for natalizumab. Pooled ADA rates were 8.4% for vedolizumab and 5.0% for etrolizumab for combo- and monotherapy combined. In all biologics, ADA rates were underestimated by use of drug-sensitive ADA assays and higher dose and/or frequency. ADA rate was significantly reduced in patients treated with combination therapy for infliximab (RR 0.52; 95% CI 0.44-0.62), adalimumab (RR 0.31; 95% CI 0.14-0.69), golimumab (RR 0.29; 95% CI 0.10-0.83), certolizumab pegol (RR 0.30; 95% CI 0.14-0.67) and natalizumab (RR 0.20; 95% CI 0.11-0. 39). ADA to infliximab were associated with lower clinical response rates (RR 0.75; 95% CI 0.61-0.91) and higher rates of infusion reactions (RR 2.36; 95% CI 1.85-3.01).
conclusionsDifferences in analytical methods to detect ADA hamper comparison of true ADA rates across biologics in IBD. Use of combination therapy with immunomodulators appeared to reduce ADA positivity for most biologics. For infliximab, ADA were associated with reduced drug efficacy and increased adverse events.
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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.