Evidence map›Paper›PMID 36890354›Full record

Trial reportJournal of neurology2023

Ravulizumab pharmacokinetics and pharmacodynamics in patients with generalized myasthenia gravis.

Tuan Vu, Stephan Ortiz, Masahisa Katsuno, Djillali Annane, Renato Mantegazza, Kathleen N Beasley, Rasha Aguzzi, James F Howard

Registry-linked trialOpen access · hybridAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Journal of neurology, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03920293 (A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Safety and Efficacy of Ravulizumab in Complement-Inhibitor-Naïve Adult Patients With Generalized Myasthenia Gravis), which is not on this map. Cited by 33 papers.

0numbers the graph read from it
0cells of the map it votes in
33citing papers in PubMed
9.9field-weighted citation impact, top 1% of its field
1 · What the graph read from 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.

2 · The registry

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.

NCT03920293 phase3completednot on this map

A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Safety and Efficacy of Ravulizumab in Complement-Inhibitor-Naïve Adult Patients With Generalized Myasthenia Gravis

TypeinterventionalSponsorAlexion Pharmaceuticals, Inc.Ran2019 to 2023Enrolled175ConditionsGeneralized Myasthenia GravisArmsRavulizumab, Placebo
3 · Its place in the literature

Who cites it

33 citing papers in PubMed, 48 citations in OpenAlex.

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  14. Targeting the Neonatal Fc Receptor in Autoimmune Diseases: Pipeline and Progress.BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy · 2025
    Review
  15. Article
  16. Article
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  18. Ravulizumab and Efgartigimod in Myasthenia Gravis: A Real-World Study.Neurology(R) neuroimmunology & neuroinflammation · 2025
    Article
  19. Review
  20. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

8 authors at 6 institutions in 5 countries.

Tuan VuUniversity of South Florida Morsani College of Medicine, Tampa, FL, USA.
Stephan OrtizAlexion, AstraZeneca Rare Disease, Boston, MA, USA. Stephan.Ortiz@alexion.com.
Masahisa KatsunoNagoya University Graduate School of Medicine, Nagoya, Japan.
Djillali AnnaneHôpital Raymond Poincaré, University of Versailles, Garches, France.
Renato MantegazzaFondazione IRCCS Istituto Neurologico Carlo Besta, Milan, Italy.
Kathleen N BeasleyAlexion, AstraZeneca Rare Disease, Boston, MA, USA.
Rasha AguzziAlexion, AstraZeneca Rare Disease, Boston, MA, USA.
James F HowardThe University of North Carolina, Chapel Hill, NC, USA.
Alexion Pharmaceuticals (United States) · USFondazione IRCCS Istituto Neurologico Carlo Besta · ITHôpital Raymond-Poincaré · FRNagoya University · JPUniversity of North Carolina at Chapel Hill · USUniversity of South Florida · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionThe terminal complement C5 inhibitor ravulizumab has a long elimination half-life, allowing maintenance dosing every 8 weeks. In the 26-week, double-blind, randomized, placebo-controlled period (RCP) of the CHAMPION MG study, ravulizumab provided rapid and sustained efficacy and was well tolerated in adults with anti-acetylcholine receptor antibody-positive (AChR Ab+) generalized myasthenia gravis (gMG). This analysis evaluated the pharmacokinetics (PK), pharmacodynamics (PD), and potential immunogenicity of ravulizumab in adults with AChR Ab+ gMG.

methodsData were analyzed from 86 patients who received ravulizumab in the CHAMPION MG RCP. Ravulizumab dosing was weight-based: initial loading dose of 2400/2700/3000 mg on Day 1 and maintenance doses of 3000/3300/3600 mg on Day 15 and then every 8 weeks. PK parameters were estimated from serum ravulizumab concentrations determined pre- and post-dose; PD effects of ravulizumab on serum free C5 concentrations were measured; and immunogenicity was assessed using anti-drug antibody and neutralizing-antibody assays.

resultsTarget serum ravulizumab concentrations (> 175 µg/mL) were achieved immediately after the first ravulizumab dose (within 30 min of infusion completion) and maintained throughout the 26-week treatment period irrespective of patient body weight. Following the final maintenance dose, mean C

conclusionsPK/PD evidence supports the use of ravulizumab every 8 weeks for immediate, complete, and sustained inhibition of terminal complement C5 in adults with AChR Ab+ gMG.

trial registrationClinicalTrials.gov ID: NCT03920293 (April 18, 2019).

Indexed as

Myasthenia GravisAdultAntibodies, Monoclonal, HumanizedComplement C5Complement Inactivating AgentsHumansImmunologic FactorsReceptors, CholinergicAntibodies, Monoclonal, HumanizedComplement C5Complement Inactivating AgentsImmunologic FactorsravulizumabReceptors, CholinergicComplementGeneralized myasthenia gravisPharmacodynamicsPharmacokineticsRavulizumab

Identifiers

PMID36890354
PMCPMC10188401
OpenAlexW4323652072

What OpenQuestion holds

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LicenceCC BY
Read underepoch 390

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.