Trial reportInternational journal of clinical pharmacology and therapeutics2015
Characterization of the relationship between dose and blood eosinophil response following subcutaneous administration of mepolizumab.
Trial report in International journal of clinical pharmacology and therapeutics, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 41 papers, 4 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
41 citing papers in PubMed, 4 syntheses or guidelines pooled it, 83 citations in OpenAlex.
- Incidence of Anti-Drug Antibodies to Monoclonal Antibodies in Asthma: A Systematic Review and Meta-Analysis.The journal of allergy and clinical immunology. In practice · 2023Pooled it
- The clinical efficacy of type 2 monoclonal antibodies in eosinophil-associated chronic airway diseases: a meta-analysis.Frontiers in immunology · 2023Pooled it
- Anti-IL-5 therapies for asthma.The Cochrane database of systematic reviews · 2022Pooled it
- Anti-IL5 therapies for asthma.The Cochrane database of systematic reviews · 2017Pooled it
- Population Pharmacokinetics and Pharmacodynamics of Depemokimab in People with Asthma and Chronic Rhinosinusitis with Nasal Polyps.Journal of clinical pharmacology · 2026Trial
- Development of Pediatric Dosing for Mepolizumab in Severe Asthma Based on Extrapolation of Data From Adult Patients and a Phase II Open-Label Pediatric Trial.Journal of clinical pharmacology · 2026Trial
- Trial
- A Phase 1 study of the long-acting anti-IL-5 monoclonal antibody GSK3511294 in patients with asthma.British journal of clinical pharmacology · 2022Trial
- The Pharmacokinetics and Relative Bioavailability of Mepolizumab 100 mg Liquid Formulation Administered Subcutaneously to Healthy Participants: A Randomized Trial.Clinical pharmacology in drug development · 2020Trial
- Subcutaneous mepolizumab in children aged 6 to 11 years with severe eosinophilic asthma.Pediatric pulmonology · 2019Trial
- Mepolizumab reduces exacerbations in patients with severe eosinophilic asthma, irrespective of body weight/body mass index: meta-analysis of MENSA and MUSCA.Respiratory research · 2019Trial
- Evaluation of clinical benefit from treatment with mepolizumab for patients with eosinophilic granulomatosis with polyangiitis.The Journal of allergy and clinical immunology · 2019Trial
- Article
- Eosinophilic Myocarditis Treated with IL-5 Blockade: An Integrated Case Report and Literature Review.Journal of clinical medicine · 2025Review
- A model-based approach using GSK3772847, an anti-interleukin-33 receptor monoclonal antibody, as a showcase to predict SC administration PK and free target dynamics based on PK and total target measurements after IV administration.CPT: pharmacometrics & systems pharmacology · 2025Article
- Serum and urine eosinophil-derived neurotoxin (EDN) levels predict biologic response in severe asthma.The World Allergy Organization journal · 2025Article
- Effect of benralizumab on inflammation in skin after intradermal allergen challenge in patients with moderate-to-severe atopic dermatitis.The journal of allergy and clinical immunology. Global · 2024Article
- Asthma Inflammatory Phenotypes: How Can We Distinguish Them?Journal of clinical medicine · 2024Article
- Neutralizing Antibody Validation Testing and Reporting Harmonization.The AAPS journal · 2023Article
- Best Practices in mAb and Soluble Target Assay Selection for Quantitative Modelling and Qualitative Interpretation.The AAPS journal · 2023Article
Corrections and comments
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Authors and funding
5 authors at 2 institutions in 3 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
objectiveMepolizumab is a humanized IgG1 monoclonal antibody that blocks human IL-5 from binding to the IL-5 receptor, which is mainly expressed on eosinophils. Eosinophils are key cells in the inflammatory cascade of various diseases, including asthma. This study investigated the pharmacokinetic (PK)/pharmacodynamic (PD) relationship between exposure of mepolizumab subcutaneous (SC) administration and blood eosinophil reduction compared with intravenous (IV) administration in adult subjects with asthma.
methodsIn this multi-center, randomized, open-label, parallel-group, repeat-dose study, 70 adult subjects received one of four possible treatment regimens: mepolizumab 12.5, 125, or 250 mg SC or 75 mg IV. In addition to analyzing the dose and PK/PD relationship, absolute bioavailability, safety, tolerability, and incidence of anti-mepolizumab antibodies were evaluated.
resultsBlood eosinophil levels decreased in a dose-dependent manner with the lowest (12.5 mg) dose clearly differentiating from the other doses. A non-linear inhibition Imax model based on blood eosinophil levels at week 12 identified that the SC doses providing 50% and 90% of maximal blood eosinophil inhibition were 11 mg (95% confidence interval (CI): 5.19 - 16.85) and 99 mg (95% CI: 47 - 152), respectively. The route of administration did not affect the exposure-response relationship. The estimated mepolizumab SC absolute bioavailability (arm) was 74% (90% CI: 54 - 102%). The safety profile of mepolizumab was favorable.
conclusionsA dose-dependent reduction in blood eosinophils across all mepolizumab doses investigated was observed. The subcutaneous absolute bioavailability was 74%. The route of administration did not affect the mepolizumab exposure eosinophil response relationship.
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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.