Trial reportJournal of Crohn's & colitis2016
Higher Adalimumab Drug Levels are Associated with Mucosal Healing in Patients with Crohn's Disease.
Trial report in Journal of Crohn's & colitis, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 33 papers, 5 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.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
33 citing papers in PubMed, 5 syntheses or guidelines pooled it, 83 citations in OpenAlex.
- 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
- Predictive value of blood concentration of biologics on endoscopic inactivity in inflammatory bowel disease: A systematic review.World journal of gastroenterology · 2021Pooled it
- Patient sex does not affect endoscopic outcomes of biologicals in inflammatory bowel disease but is associated with adverse events.International journal of colorectal disease · 2020Pooled it
- Outcomes and Strategies to Support a Treat-to-target Approach in Inflammatory Bowel Disease: A Systematic Review.Journal of Crohn's & colitis · 2020Pooled it
- Pooled it
- Rapid and accessible tumor necrosis factor alpha detection using digital nanoparticle sensors towards point-of-care cytokine monitoring.Sensors and actuators. B, Chemical · 2026Article
- Article
- Higher Ustekinumab Levels in Maintenance Therapy are Associated with Greater Mucosal Healing and Mucosal Response in Crohn's Disease: An Experience of 2 IBD Centers.Inflammatory bowel diseases · 2024Observational
- Precision medicine in inflammatory bowel disease.Precision clinical medicine · 2023Review
- InfliximabWorld journal of gastroenterology · 2023Review
- Adalimumab in Pediatric Inflammatory Bowel Disease.Frontiers in pediatrics · 2022Review
- Noninvasive Targeted Crohn Disease Management by Combining Endoscopic Healing Index and Therapeutic Drug Monitoring.Crohn's & colitis 360 · 2021Article
- Certolizumab Trough Levels and Antibodies in Crohn Disease: A Single-Center Experience.Crohn's & colitis 360 · 2021Article
- Therapeutic Drug Monitoring for Current and Investigational Inflammatory Bowel Disease Treatments.Journal of clinical gastroenterology · 2021Review
- The New Proactive Approach and Precision Medicine in Crohn's Disease.Biomedicines · 2020Review
- Potential Utility of Therapeutic Drug Monitoring of Adalimumab in Predicting Short-Term Mucosal Healing and Histologic Remission in Pediatric Crohn's Disease Patients.Journal of Korean medical science · 2020Article
- Lower adalimumab trough levels are associated with higher bowel wall thickness in Crohn's disease.United European gastroenterology journal · 2020Observational
- Article
- Achieving Mucosal Healing in Inflammatory Bowel Diseases: Which Drug Concentrations Need to Be Targeted?Clinical pharmacology and therapeutics · 2019Review
- Proactive Therapeutic Drug Monitoring of Adalimumab Is Associated With Better Long-term Outcomes Compared With Standard of Care in Patients With Inflammatory Bowel Disease.Journal of Crohn's & colitis · 2019Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
7 authors at 3 institutions in 3 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
BACKGROUND AND
aimsThe current approach to managing the loss of response to anti-tumour necrosis factor (TNF) agents is generally empirical. Prior studies have suggested that adalimumab levels of >4.9 µg/mL are required to achieve clinical remission. Our aim was to identify an optimal adalimumab level to achieve endoscopic healing in Crohn's disease (CD).
methodsA cohort of 60 CD patients treated with adalimumab between 2005 and 2013 were reviewed for the study. Demographic and clinical information was obtained from chart review and patient interview. Disease activity was determined using the Harvey-Bradshaw index (HBI), ileocolonoscopy reports and C-reactive protein (CRP) levels. Clinical remission was defined as HBI <5. Endoscopic remission/mucosal healing (MH) was defined as the absence of any ulceration in all ileocolonic segments. Trough adalimumab levels and adalimumab antibody levels were tested using a liquid-phase mobility shift assay.
resultsLower median CRP was significantly associated with MH 1.2mg/dl vs no MH 14.4mg/dl (p = 6.93×10(-6)). Higher adalimumab trough level was significantly associated with MH (median 14.7 µg/mL in those with MH vs 3.4 µg/mL in those without, p = 6.25×10(-5)). Higher adalimumab trough level was also significantly associated with the combined outcome of clinical and endoscopic remission (median 13.0 vs 4.8 µg/mL, p = 5.36×10(-3)). A cut-off of 8.14 µg/ml best discriminated subjects with MH from those without MH, with sensitivity and specificity of 91.4 and 76.0%, respectively (positive and negative predictive values 84.2 and 86.4%, respectively).
conclusionsHigher adalimumab levels were significantly associated with MH. This study suggests that attaining MH alone or a combined outcome of clinical and endoscopic remission is more likely to occur in those patients who achieve an adalimumab trough level of at least 8.14 μg/mL.
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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.