Trial reportThe Journal of clinical investigation2018
Neonatal Fc receptor antagonist efgartigimod safely and sustainably reduces IgGs in humans.
Trial report in The Journal of clinical investigation, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 254 papers, 3 of them syntheses that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
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.
A Phase I, Randomized, Double-Blind, Placebo-Controlled, SAD and MAD Intravenous Dose Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Immunogenicity of ARGX-113 in Healthy Males and Female Subjects
Treatment of Myasthenia Gravis Exacerbation or Crisis With Efgartigimod: A Single Arm, Open Label Prospective Cohort Study
Who cites it
254 citing papers in PubMed, 3 syntheses or guidelines pooled it, 345 citations in OpenAlex.
- Comparative efficacy, safety, and functional recovery of neonatal fc receptor inhibitors and conventional immunotherapies for chronic inflammatory demyelinating polyradiculoneuropathy: a systematic review and network meta-analysis.Frontiers in immunology · 2026Pooled it
- The efficacy and safety of efgartigimod for refractory myasthenia gravis: a systematic review and meta-analysis.European journal of medical research · 2025Pooled it
- Comparative efficacy and acceptability of novel biologics in the treatment of myasthenia gravis: systematic review and network meta-analysis of randomized trials.Systematic reviews · 2025Pooled it
- Pathogenic properties of myasthenia gravis AChR autoantibodies associate with clinical response to efgartigimod.Journal of neurology, neurosurgery, and psychiatry · 2026Trial
- Long-Term Safety and Efficacy of Efgartigimod PH20 in Chronic Inflammatory Demyelinating Polyradiculoneuropathy: ADHERE/ADHERE+ Trial Interim Analysis.Journal of the peripheral nervous system : JPNS · 2026Trial
- Clinical effectiveness of efgartigimod in a broad population of patients with generalized myasthenia gravis: subgroup analyses from a randomized, double‑blind, placebo‑controlled, phase 3 trial (ADAPT).Journal of neurology · 2026Trial
- Trial
- BCMA-directed mRNA CAR-T cell therapy for myasthenia gravis: exploratory biomarker analysis of a placebo-controlled phase 2b trial.Nature medicine · 2026Trial
- Humoral immune response to polyvalent pneumococcal vaccine in healthy participants receiving efgartigimod: a randomized, open-label, placebo-controlled, parallel-group phase 1 trial.Frontiers in immunology · 2026Trial
- Efficacy and safety of efgartigimod in the treatment of impending myasthenic crisis.Frontiers in immunology · 2026Trial
- Long-term safety, tolerability, and efficacy of subcutaneous efgartigimod PH20 in generalized myasthenia gravis: final results from a phase 3 open-label extension study (ADAPT-SC+).Frontiers in neurology · 2026Trial
- ADAPT NXT: Fixed Cycles or Every-Other-Week IV Efgartigimod in Generalized Myasthenia Gravis.Annals of clinical and translational neurology · 2025Trial
- Pharmacokinetics, Pharmacodynamics, and Safety of Intravenous Efgartigimod and Subcutaneous Efgartigimod PH20 in Healthy Chinese Participants.Drugs in R&D · 2024Trial
- Subcutaneous efgartigimod PH20 in generalized myasthenia gravis: A phase 3 randomized noninferiority study (ADAPT-SC) and interim analyses of a long-term open-label extension study (ADAPT-SC+).Neurotherapeutics : the journal of the American Society for Experimental NeuroTherapeutics · 2024Trial
- Pharmacokinetics and Pharmacodynamics of Nipocalimab, a Neonatal Fc Receptor Blocker, in Healthy Japanese Volunteers.Clinical drug investigation · 2024Trial
- Trial
- A Novel Sequential Regimen of Efgartigimod and Telitacicept as Fast-Acting Treatment for Impeding Crisis of MuSK-MG.Immunity, inflammation and disease · 2026Article
- Regimen-stratified Bayesian model-based meta-analysis of targeted biologics in generalised myasthenia gravis: efficacy comparison, mechanism-level class contrast, and endpoint sensitivity with model-informed trial design.Naunyn-Schmiedeberg's archives of pharmacology · 2026Article
- Effectiveness and safety of efgartigimod in patients with anti-NMDAR or anti-LGI1 encephalitis and itsNeuroprotection (Chichester, England) · 2026Article
- Antimetabolites synergize with non-genotoxic antibody drug conjugate conditioning in hematopoietic stem cell lentiviral gene therapy.Molecular therapy. Advances · 2026Article
194 more citing papers are in PubMed but not listed here.
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
16 authors at 2 institutions in 2 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundIntravenous Ig (IVIg), plasma exchange, and immunoadsorption are frequently used in the management of severe autoimmune diseases mediated by pathogenic IgG autoantibodies. These approaches modulating IgG levels can, however, be associated with some severe adverse reactions and a substantial burden to patients. Targeting the neonatal Fc receptor (FcRn) presents an innovative and potentially more effective, safer, and more convenient alternative for clearing pathogenic IgGs.
methodsA randomized, double-blind, placebo-controlled first-in-human study was conducted in 62 healthy volunteers to explore single and multiple ascending intravenous doses of the FcRn antagonist efgartigimod. The study objectives were to assess safety, tolerability, pharmacokinetics, pharmacodynamics, and immunogenicity. The findings of this study were compared with the pharmacodynamics profile elicited by efgartigimod in cynomolgus monkeys.
resultsEfgartigimod treatment resulted in a rapid and specific clearance of serum IgG levels in both cynomolgus monkeys and healthy volunteers. In humans, single administration of efgartigimod reduced IgG levels up to 50%, while multiple dosing further lowered IgGs on average by 75% of baseline levels. Approximately 8 weeks following the last administration, IgG levels returned to baseline. Efgartigimod did not alter the homeostasis of albumin or Igs other than IgG, and no serious adverse events related to efgartigimod infusion were observed.
conclusionAntagonizing FcRn using efgartigimod is safe and results in a specific, profound, and sustained reduction of serum IgG levels. These results warrant further evaluation of this therapeutic approach in IgG-driven autoimmune diseases.
trial registrationClinicaltrials.gov NCT03457649.
fundingargenx BVBA.
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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.