Trial reportBritish journal of clinical pharmacology2021
Comprehensive evaluation of microneedle-based intradermal adalimumab delivery vs. subcutaneous administration: results of a randomized controlled clinical trial.
Trial report in British journal of clinical pharmacology, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 11 papers.
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
11 citing papers in PubMed, 29 citations in OpenAlex.
- Comprehensive evaluation of microneedle-based intradermal adalimumab delivery vs. subcutaneous administration: results of a randomized controlled clinical trial.British journal of clinical pharmacology · 2021Trial
- Impact of Repeated Antigen Exposure on Humoral Tolerance: Antidrug Antibodies After Single-Dose Versus Multi-dose Adalimumab.BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy · 2026Article
- Localized NF-κB Inhibition Reduces Lipid Nanoparticle-Associated Inflammation.Advanced science (Weinheim, Baden-Wurttemberg, Germany) · 2026Article
- Clinical Validation of Imaging Biomarkers in Mycosis Fungoides.Experimental dermatology · 2026Article
- Immunoglobulin G Fc engineering for localized therapy: Eliminating neonatal Fc receptor interactions and ensuring purification using protein A.Protein science : a publication of the Protein Society · 2025Article
- Hollow microneedles as a flexible dosing control solution for transdermal drug delivery.Materials today. Bio · 2025Review
- AI-Driven Innovation in Skin Kinetics for Transdermal Drug Delivery: Overcoming Barriers and Enhancing Precision.Pharmaceutics · 2025Review
- A Review on the Mechanisms, Applications, and Clinical Trials of Advanced Technologies in the Transdermal Drug Delivery System.Current pharmaceutical biotechnology · 2025Review
- Innovative strategies and nanocarrier approaches for enhancing the oral bioavailability of macromolecular therapeutics.Iranian journal of basic medical sciences · 2025Review
- Exploiting Unique Features of Microneedles to Modulate Immunity.Advanced materials (Deerfield Beach, Fla.) · 2023Review
- Promising Strategies for Transdermal Delivery of Arthritis Drugs: Microneedle Systems.Pharmaceutics · 2022Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
22 authors at 4 institutions in 2 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
aimsTo evaluate feasibility of intradermal (i.d.) adalimumab administration using hollow microneedles, and to compare a single i.d. dose of adalimumab using a hollow microneedle with a single subcutaneous (s.c.) dose using a conventional needle.
methodsIn this single-centre double-blind, placebo-controlled, double-dummy clinical trial in 24 healthy adults we compared 40 mg adalimumab (0.4 mL) administered i.d. using a hollow microneedle with a s.c. dose using a conventional needle. Primary parameters were pain, acceptability and local tolerability; secondary parameters safety, pharmacokinetics and immunogenicity. We explored usability of optical coherence tomography, clinical photography, thermal imaging, and laser speckle contrast imaging to evaluate skin reaction after i.d. injections. In vitro protein analysis was performed to assess compatibility of adalimumab with the hollow microneedle device.
resultsWhile feasible and safe, injection pain of i.d. adalimumab was higher compared to s.c. adalimumab (35.4 vs. 7.9 on a 100-point visual analogue scale). Initial absorption rate and relative bioavailability were higher after i.d. adalimumab (time to maximum plasma concentration = 95 h [47-120]; F
conclusionsIntradermal injection of adalimumab using hollowing microneedles was perceived as more painful and less accepted than s.c. administration, but yields a higher relative bioavailability with similar safety and pharmacodynamic effects.
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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.