ArticleBritish journal of clinical pharmacology2019
Population pharmacokinetic modelling and simulation of fremanezumab in healthy subjects and patients with migraine.
Article in British journal of clinical pharmacology, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 20 papers, 1 of them a synthesis 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.
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Who cites it
20 citing papers in PubMed, 1 synthesis or guideline pooled it, 26 citations in OpenAlex.
- Optimal treatment strategy of fremanezumab in migraine prevention: a systematic review with network meta-analysis of randomized clinical trials.Scientific reports · 2020Pooled it
- A Pharmacokinetic Bioequivalence Study of Fremanezumab Administered Subcutaneously Using an Autoinjector and a Prefilled Syringe.Clinical pharmacology in drug development · 2021Trial
- Trial
- Fremanezumab for the treatment of migraine.Pain management · 2025Review
- Migraine in men.The journal of headache and pain · 2025Review
- Effectiveness and safety of monthly versus quarterly fremanezumab for migraine prevention: An Italian, multicenter, real-life study.European journal of neurology · 2024Article
- Long-Term Outcome After Discontinuation of CGRP-Targeting Therapy for Migraine.Current pain and headache reports · 2024Review
- Anti-calcitonin Gene-Related Peptide Monoclonal Antibodies in Migraine: Focus on Clinical Pharmacokinetics.European journal of drug metabolism and pharmacokinetics · 2024Review
- Retreating migraine patients in the second year with monoclonal antibodies anti-CGRP pathway: the multicenter prospective cohort RE-DO study.Journal of neurology · 2023Observational
- The sense of stopping migraine prophylaxis.The journal of headache and pain · 2023Review
- Review
- Migraine evolution after the cessation of CGRP(-receptor) antibody prophylaxis: a prospective, longitudinal cohort study.Cephalalgia : an international journal of headache · 2022Article
- Alpha-Calcitonin Gene Related Peptide: New Therapeutic Strategies for the Treatment and Prevention of Cardiovascular Disease and Migraine.Frontiers in physiology · 2022Review
- The importance of an early onset of migraine prevention: an evidence-based, hypothesis-driven scoping literature review.Therapeutic advances in neurological disorders · 2022Article
- Deterioration of headache impact and health-related quality of life in migraine patients after cessation of preventive treatment with CGRP(-receptor) antibodies.The journal of headache and pain · 2021Article
- A narrative review of the importance of pharmacokinetics and drug-drug interactions of preventive therapies in migraine management.Headache · 2021Review
- Scaling Approaches for Pediatric Dose Selection: The Fremanezumab (AJOVYPharmaceutics · 2021Article
- Review
- Fremanezumab: a disease-specific option for the preventive treatment of migraine, including difficult-to-treat migraine.Emerging topics in life sciences · 2020Review
- Population pharmacokinetic modelling and simulation of fremanezumab in healthy subjects and patients with migraine.British journal of clinical pharmacology · 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 5 institutions in 3 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
aimsFremanezumab is a fully humanized IgG
methodsNonlinear mixed effects modelling was performed using NONMEM with data from 7 phase 1-3 clinical trials evaluating selected intravenous and subcutaneous dose regimens. The influence of covariates on fremanezumab PK was assessed and model evaluation was performed through visual predictive checks.
resultsA 2-compartment model with first-order absorption and elimination described the PK data well. Typical values for fremanezumab central clearance (0.0902 L/d) and central distribution volume (1.88 L) for a 71-kg subject were consistent with previously reported values for IgG antibodies. Higher body weight was associated with increased central clearance and distribution volume. Effects of other covariates (age, albumin, renal function, sex, race, injection site, and acute, analgesic and preventive medication use for migraine) were not found to statistically significantly influence fremanezumab PK. There was no indication of reduced exposure in participants with positive anti-drug antibody status or with mild to moderate hepatic impairment. Absolute bioavailability was estimated at 0.658.
conclusionsA comprehensive population PK model was developed for fremanezumab following intravenous and subcutaneous administration in healthy subjects and patients with chronic migraine or episodic migraine, which will be used to further evaluate exposure-response relationships for efficacy and safety endpoints.
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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.