ArticleClinical rheumatology2013
Drug levels, anti-drug antibodies, and clinical efficacy of the anti-TNFα biologics in rheumatic diseases.
Article in Clinical rheumatology, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 55 papers, 2 of them syntheses that pooled it.
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Who cites it
55 citing papers in PubMed, 2 syntheses or guidelines pooled it, 97 citations in OpenAlex.
- T-Cell Dependent Immunogenicity of Protein Therapeutics Pre-clinical Assessment and Mitigation-Updated Consensus and Review 2020.Frontiers in immunology · 2020Pooled it
- Immunogenicity of Biologics in Chronic Inflammatory Diseases: A Systematic Review.BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy · 2017Pooled it
- Associations between certolizumab pegol serum levels, anti-drug antibodies and treatment response in patients with inflammatory joint diseases: data from the NOR-DMARD study.Arthritis research & therapy · 2019Trial
- Trial
- Evaluation of the pharmacokinetic equivalence and 54-week efficacy and safety of CT-P13 and innovator infliximab in Japanese patients with rheumatoid arthritis.Modern rheumatology · 2015Trial
- Response to vaccination and immune status after intrauterine exposure to immunomodulating drugs for maternal IBD.NPJ vaccines · 2026Article
- Anti-emicizumab antibodies and their relevance in clinical practice.Research and practice in thrombosis and haemostasis · 2026Article
- Anti-tumor necrosis factor (aTNF) weaning strategy in juvenile idiopathic arthritis (JIA): does duration matter?Clinical rheumatology · 2024Article
- Psoriatic arthritis: the role of self-reported non-adherence, non-trough drug levels, immunogenicity and conventional synthetic DMARD co-therapy in adalimumab and etanercept response.Rheumatology advances in practice · 2024Article
- Unique challenges required reassessment and alterations to critical reagents to rescue a neutralizing antibody assay.Bioanalysis · 2024Article
- The FDA's New Guideline "Generally Accepted Scientific Knowledge" (GASK): An Opportunity to Expedite the Approval of Biosimilars.Pharmaceuticals (Basel, Switzerland) · 2023Review
- Difficult to treat psoriatic arthritis - how should we manage?Clinical rheumatology · 2023Review
- Do genetics contribute to TNF inhibitor response prediction in Psoriatic Arthritis?The pharmacogenomics journal · 2023Review
- A2M inhibits inflammatory mediators of chondrocytes by blocking IL-1β/NF-κB pathway.Journal of orthopaedic research : official publication of the Orthopaedic Research Society · 2023Article
- Effectiveness and drug retention of biologic disease modifying antirheumatic drugs in Korean patients with late onset ankylosing spondylitis.Scientific reports · 2021Article
- Low immunogenicity of emicizumab in persons with haemophilia A.Haemophilia : the official journal of the World Federation of Hemophilia · 2021Article
- Enzyme Therapy: Current Challenges and Future Perspectives.International journal of molecular sciences · 2021Review
- Recombinant Anti-idiotypic Antibodies in Ligand Binding Assays for Antibody Drug Development.Methods in molecular biology (Clifton, N.J.) · 2021Article
- Anti-adalimumab antibodies kinetics: an early guide for juvenile idiopathic arthritis (JIA) switching.Clinical rheumatology · 2020Article
- Head-to-Head Comparison of Etanercept vs. Adalimumab in the Treatment of Ankylosing Spondylitis: An Open-Label Randomized Controlled Crossover Clinical Trial.Frontiers in medicine · 2020Article
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Authors and funding
3 authors at 3 institutions in 2 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
The objectives of this study are to evaluate the effect of anti-drug antibodies on the clinical efficacy and withdrawal rate of the anti-TNFα biologics in patients with rheumatic diseases. Consecutive patients with rheumatic diseases recently commenced on anti-TNFα biologics were recruited. Serum samples were collected for assay of drug level and antibody titer against the corresponding biologics. Comparison of the clinical efficacy and drug retention rate was performed between patients with and without anti-drug antibodies. Fifty-eight Chinese patients were studied (64 % women; age 47.8 ± 12.9 years; disease duration 6.7 ± 6.4 years). The proportion of patients using infliximab (IFX), adalimumab (ADA), and etanercept (ETN) was 41, 28, and 31 %, respectively. Antibodies against IFX, ADA, and ETN were demonstrated in 12(50 %), 5(31 %) and 0(0 %) patients, respectively. Patients who developed anti-drug antibodies had significantly lower levels of the corresponding drugs (IFX level: 0.004 ± 0.01 vs 3.81 ± 3.49 μg/ml; p = 0.002; ADA level: 0.0 vs 7.6 ± 8.3 μg/ml; p = 0.008). Anti-drug antibody-positive patients had a significantly higher cumulative drug withdrawal rate due to inefficacy (64.7 and 71.8 % vs 10.3 and 10.3 % at month 12 and month 24, respectively; p < 0.001). In rheumatoid arthritis and psoriatic arthritis, non-responders was significantly more frequent in antibody-positive patients (54 vs 13 %; p = 0.01). In spondyloarthritis, the improvement in ankylosing spondylitis disease activity score was significant in patients without antibodies (3.89 ± 0.82 to 2.22 ± 0.86; p = 0.01) but not in those with anti-drug antibodies (3.40 ± 1.67 to 3.23 ± 1.40; p = 0.73). We concluded that the presence of neutralizing antibodies is associated with lower serum levels of the anti-TNFα biologics, leading to lower efficacy and higher withdrawal rate.
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