Observational studyRheumatology (Oxford, England)2024
Adalimumab serum levels and anti-drug antibodies: associations to treatment response and drug survival in inflammatory joint diseases.
Observational study in Rheumatology (Oxford, England), 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 14 papers, 2 of them syntheses that pooled it.
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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.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
14 citing papers in PubMed, 2 syntheses or guidelines pooled it.
- Prevalence and clinical relevance of anti-drug antibodies in psoriatic arthritis: a systematic review.RMD open · 2026Pooled it
- Efficacy of pharmacological interventions and therapeutic exercises for rheumatoid arthritis: a systematic review and meta-analysis.Frontiers in pharmacology · 2025Pooled it
- The Effect of Certolizumab Pegol Dose and Dose Changes on Plasma Trough Levels: Data From a Randomized Phase III Trial.Therapeutic drug monitoring · 2026Trial
- Therapeutic serum level for adalimumab in rheumatoid arthritis: explorative analyses of data from a randomised phase III trial.RMD open · 2024Trial
- Impact of high rheumatoid factor levels on treatment outcomes with certolizumab pegol and adalimumab in patients with rheumatoid arthritis.Rheumatology (Oxford, England) · 2024Trial
- Pharmaceutical Industry Perspectives on Exposure-Response Confounding in Large Molecule Therapeutics: Results From an IQ Consortium Survey.CPT: pharmacometrics & systems pharmacology · 2026Article
- Immunological heterogeneity in rheumatoid arthritis: challenges in early-stage stratification, non-response to targeted therapy, and the restoration of immune tolerance.Frontiers in immunology · 2026Review
- Navigating the Therapeutic Landscape of Non-Infectious Uveitis Despite Major Gaps.Biomedicines · 2025Article
- Characteristics of patients who developed transient anti-adalimumab antibodies.Journal of ophthalmic inflammation and infection · 2025Article
- Clinical Implications of Point-of-Care Measurement of Adalimumab Concentration and Anti-Adalimumab Antibodies in Patients with Rheumatoid Arthritis and Ankylosing Spondylitis.International journal of molecular sciences · 2025Article
- Innovative Formulation Strategies for Biosimilars: Trends Focused on Buffer-Free Systems, Safety, Regulatory Alignment, and Intellectual Property Challenges.Pharmaceuticals (Basel, Switzerland) · 2025Review
- 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
- Age as a Predictor of Serum Tumor Necrosis Factor Antagonist Drug and Antidrug Antibody Concentrations in Inflammatory Bowel Disease-A Nationwide Cohort Study.Journal of clinical medicine · 2025Article
- Therapeutic drug monitoring and neutralizing anti-drug antibody detection to optimize TNF-alpha inhibitor treatment for uveitis.Frontiers in ophthalmology · 2025Article
Corrections and comments
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Authors and funding
11 authors.
Funding
Abstract
objectivesTo explore associations between serum adalimumab level, treatment response and drug survival in order to identify optimal drug levels for therapeutic drug monitoring of adalimumab. Also, to assess the occurrence and risk factors of anti-drug antibody (ADAb) formation.
methodsNon-trough adalimumab and ADAb levels were measured by automated fluorescence assays in serum collected after 3 months of adalimumab treatment in patients with RA, PsA or axial SpA (axSpA) included in the observational NOR-DMARD study. Treatment response was evaluated after 3 months and drug survival was evaluated during long-term follow-up.
resultsIn 340 patients (97 RA, 69 PsA, 174 axSpA), the median adalimumab level was 7.3 mg/l (interquartile range 4.0-10.3). A total of 33 (10%) patients developed ADAbs. Findings were comparable across diagnoses. In RA and PsA, adalimumab levels ≥6.0 mg/l were associated with treatment response [odds ratio (OR) 2.2 (95% CI 1.0, 4.4)] and improved drug survival [hazard ratio 0.49 (95% CI 0.27, 0.80)]. In axSpA, a therapeutic level could not be identified, but higher adalimumab levels were associated with response. Factors associated with ADAb formation were previous bDMARD use, no methotrexate comedication and the use of adalimumab originator compared with GP2017.
conclusionHigher adalimumab levels were associated with a better response and improved drug survival for all diagnoses, with a suggested lower threshold of 6.0 mg/l for RA/PsA. This finding, the large variability in drug levels among patients receiving standard adalimumab dose and the high proportion of patients developing ADAbs encourages further investigations into the potential role of therapeutic drug monitoring of adalimumab.
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