Evidence map›Paper›PMID 38356884›Full record

ArticleFrontiers in neurology2024

Immediate and sustained terminal complement inhibition with ravulizumab in patients with anti-aquaporin-4 antibody-positive neuromyelitis optica spectrum disorder.

Stephan Ortiz, Sean J Pittock, Achim Berthele, Michael Levy, Ichiro Nakashima, Celia Oreja-Guevara, Kerstin Allen, Yasmin Mashhoon, Becky Parks, Ho Jin Kim

Registry-linked trialOpen access · goldAbstract read
In one paragraph

Article in Frontiers in neurology, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04201262 (A Phase 3, External Placebo-Controlled, Open-Label, Multicenter Study to Evaluate the Efficacy and Safety of Ravulizumab in Adult Patients With Neuromyelitis Optica Spectrum Disorder), which is not on this map. Cited by 8 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
8citing papers in PubMed, 1 pooled it
2.5field-weighted citation impact, top 12% 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.

NCT04201262 phase3completednot on this map

A Phase 3, External Placebo-Controlled, Open-Label, Multicenter Study to Evaluate the Efficacy and Safety of Ravulizumab in Adult Patients With Neuromyelitis Optica Spectrum Disorder (NMOSD)

TypeinterventionalSponsorAlexion Pharmaceuticals, Inc.Ran2019 to 2024Enrolled58ConditionsNeuromyelitis Optica, Neuromyelitis Optica Spectrum DisorderArmsRavulizumab
3 · Its place in the literature

Who cites it

8 citing papers in PubMed, 1 synthesis or guideline pooled it, 6 citations in OpenAlex.

  1. Pooled it
  2. Review
  3. Article
  4. Article
  5. Article
  6. Article
  7. Article
  8. Complement updates in optic neuritis.Frontiers in neurology · 2025
    Review
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

10 authors at 8 institutions in 5 countries.

Stephan OrtizAlexion, AstraZeneca Rare Disease, Boston, MA, United States.
Sean J PittockDepartment of Neurology and Center for Multiple Sclerosis and Autoimmune Neurology, Mayo Clinic, Rochester, MN, United States.
Achim BertheleDepartment of Neurology, School of Medicine, Technical University of Munich, Munich, Germany.
Michael LevyDepartment of Neurology, Massachusetts General Hospital and Harvard Medical School, Boston, MA, United States.
Ichiro NakashimaDivision of Neurology, Tohoku Medical and Pharmaceutical University, Sendai, Japan.
Celia Oreja-GuevaraDepartment of Neurology, Hospital Clínico Universitario San Carlos, Instituto de Investigacion Sanitaria San Carlos (IdISSC), Madrid, Spain.
Kerstin AllenAlexion, AstraZeneca Rare Disease, Boston, MA, United States.
Yasmin MashhoonAlexion, AstraZeneca Rare Disease, Boston, MA, United States.
Becky ParksAlexion, AstraZeneca Rare Disease, Boston, MA, United States.
Ho Jin KimDepartment of Neurology, Research Institute and Hospital of National Cancer Center, Goyang, Republic of Korea.
Alexion Pharmaceuticals (United States) · USAstraZeneca (United States) · USMassachusetts General Hospital · USMayo Clinic · USNational Cancer Center · KRTechnical University of Munich · DETohoku Medical and Pharmaceutical University · JPUniversidad Complutense de Madrid · ES

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Objective: To assess the pharmacokinetics and pharmacodynamics of the long-acting terminal complement 5 (C5) inhibitor ravulizumab in adults with anti-aquaporin-4 antibody-positive (AQP4+) neuromyelitis optica spectrum disorder (NMOSD) in the phase 3, open-label CHAMPION-NMOSD trial (NCT04201262). Methods: Patients aged 18 years or older received a weight-based intravenous loading dose of ravulizumab (2,400-3,000 mg) on day 1, followed by weight-based maintenance doses (3,000-3,600 mg) on day 15 and once every 8 weeks thereafter. Pharmacokinetic assessments were maximum observed concentration ( Results: The pharmacokinetic/pharmacodynamic analysis included 58 patients treated with ravulizumab. Serum ravulizumab concentrations at or above the therapeutic threshold (175 μg/mL) were achieved in all patients after administration of the first dose and maintained for 50 weeks. At week 50, the mean (standard deviation) Conclusions: Serum ravulizumab concentrations were maintained above the therapeutic threshold in all patients through 50 weeks of treatment. Ravulizumab achieved immediate and complete terminal complement inhibition that was sustained throughout the treatment period in adults with AQP4+ NMOSD.

Indexed as

autoimmunecomplementexposure-response analysisneuromyelitis optica spectrum disorderpharmacodynamicspharmacokineticsravulizumab

Identifiers

PMID38356884
PMCPMC10865503
OpenAlexW4391387249

What OpenQuestion holds

Textmetadata
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.