Trial reportAnnals of the rheumatic diseases2018
Successful reduction of overexposure in patients with rheumatoid arthritis with high serum adalimumab concentrations: an open-label, non-inferiority, randomised clinical trial.
Trial report in Annals of the rheumatic diseases, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 3 registered trials, which are not on this map. Cited by 31 papers, 6 of them syntheses 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.
Concentration-guided Dose Reduction Versus Standard Dosing in Tocilizumab-treated Rheumatoid Arthritis Patients: a Randomised, Multicenter, Non-inferiority Trial (TODORA)
Adalimumab Drug Optimisation in Rheumatoid Arthritis Using Therapeutic Drug Monitoring (ADDORA): Multi-centre Open Label Randomised Controlled Trail
Adalimumab Dose Reduction Aiming Low Serum Concentration With Control of Disease Activity: a Single Blind, Non-inferiority, Randomised Clinical Trial
Who cites it
31 citing papers in PubMed, 6 syntheses or guidelines pooled it.
- What are the benefits of therapeutic drug monitoring in the optimization of adalimumab therapy? a systematic review and meta-analysis up to 2022.Frontiers in pharmacology · 2024Pooled it
- Pooled it
- Enzyme-linked immunosorbent assays for monitoring TNF-alpha inhibitors and antibody levels in people with rheumatoid arthritis: a systematic review and economic evaluation.Health technology assessment (Winchester, England) · 2021Pooled it
- Reduction of biologics in rheumatoid arthritis: a systematic review and meta-analysis.Rheumatology international · 2020Pooled it
- Efficacy of pharmacological treatment in rheumatoid arthritis: a systematic literature research informing the 2019 update of the EULAR recommendations for management of rheumatoid arthritis.Annals of the rheumatic diseases · 2020Pooled it
- Impact of tapering targeted therapies (bDMARDs or JAKis) on the risk of serious infections and adverse events of special interest in patients with rheumatoid arthritis or spondyloarthritis: a systematic analysis of the literature and meta-analysis.Arthritis research & therapy · 2020Pooled it
- Therapeutic serum level for adalimumab in rheumatoid arthritis: explorative analyses of data from a randomised phase III trial.RMD open · 2024Trial
- Exploring TNFi drug-levels and anti-drug antibodies during tapering among patients with inflammatory arthritis: secondary analyses from the randomised BIODOPT trial.Rheumatology international · 2024Trial
- Trial
- Evaluation of adalimumab tapering regimens in children and adolescents with juvenile idiopathic arthritis in remission: a simulation study.Pediatric rheumatology online journal · 2026Article
- The Association Between Serum Drug Concentration and a Flare in Rheumatoid Arthritis Patients Tapering TNF Inhibitors.Pharmaceuticals (Basel, Switzerland) · 2025Article
- Prospective study to characterize adalimumab exposure in pediatric patients with rheumatic diseases.Pediatric rheumatology online journal · 2024Article
- Development and validation of a novel therapeutic drug monitoring-based nomogram for prediction of primary endoscopic response to anti-TNF therapy in active Crohn's disease.Therapeutic advances in gastroenterology · 2024Article
- Overcoming provider barriers to therapeutic drug monitoring of tumour necrosis factor inhibitors for rheumatoid arthritis: a qualitative analysis.Rheumatology advances in practice · 2024Article
- Assessing Immunogenicity of Biologic Drugs in Inflammatory Joint Diseases: Progress Towards Personalized Medicine.BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy · 2022Review
- Therapeutic drug monitoring of biologics in inflammatory bowel disease: unmet needs and future perspectives.The lancet. Gastroenterology & hepatology · 2022Review
- TNF-α inhibitor ameliorates immune-related arthritis and pneumonitis in humanized mice.Frontiers in immunology · 2022Article
- Switching from TNFα inhibitor to tacrolimus as maintenance therapy in rheumatoid arthritis after achieving low disease activity with TNFα inhibitors and methotrexate: 24-week result from a non-randomized, prospective, active-controlled trial.Arthritis research & therapy · 2021Article
- Therapeutic drug monitoring of anti-TNF drugs: an overview of applicability in daily clinical practice in the era of treatment with biologics in juvenile idiopathic arthritis (JIA).Pediatric rheumatology online journal · 2021Article
- Immunogenicity of biologic agents in rheumatology.Nature reviews. Rheumatology · 2021Review
Corrections and comments
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Authors and funding
7 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
objectiveHigh adalimumab serum concentrations do not result in better response in patients with rheumatoid arthritis (RA), suggesting overexposure. We investigated whether patients with adalimumab concentrations >8 µg/mL can prolong their dosing interval by 50% without a clinically relevant change in disease activity.
methodsConsecutive patients with RA, treated with adalimumab 40 mg every other week for at least 28 weeks, were approached for this randomised, open-label, non-inferiority trial. Patients with adalimumab trough concentrations >8 µg/mL were randomly (1:1) assigned to dose-interval prolongation of once every 3 weeks or continuation of every other week. Primary outcome was the change in disease activity score of 28 joints (ΔDAS28-ESR) after 28 weeks, with a non-inferiority margin of 0.6 points.
resultsIn total, 147 patients were screened. Fifty-five patients had concentrations >8 µg/mL and were randomised. Mean ΔDAS28 after 28 weeks was -0.14±SD 0.61 in the prolongation group and 0.30±0.52 in the continuation group. Mean difference was significantly in favour of the prolongation group: 0.44 (95% CI 0.12 to 0.76, p=0.01).
conclusionsAdalimumab-treated patients with RA with trough concentrations >8 µg/mL can prolong their standard dosing interval to once every 3 weeks without loss of disease control. TRIAL REGISTRATION NUMBER: NTR3509; Results.
Indexed as
Identifiers
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Registered trials
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.