Evidence map›Paper›PMID 41782198›Full record

Trial reportMultiple sclerosis (Houndmills, Basingstoke, England)2026

Safety and efficacy of ravulizumab in patients with NMOSD previously treated with rituximab: A post hoc analysis of the CHAMPION-NMOSD trial.

J L Bennett, S Bhattacharyya, A Zabeti, M Levy, J de Sèze, M J Taney, B Parks, K Allen, U Akpoji, S J Pittock

Registry-linked trialAbstract readClinical Trial, Phase IIIMulticenter Study
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Multiple sclerosis (Houndmills, Basingstoke, England), 2026. 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. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing papers in PubMed
–field-weighted citation impact
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

0 citing papers in PubMed.

No citing paper in PubMed yet.

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.

J L BennettDepartments of Neurology and Ophthalmology, Programs in Neuroscience and Immunology, University of Colorado School of Medicine, Anschutz Medical Campus, Aurora, CO, USA.
S BhattacharyyaDepartment of Neurology, Mass General Brigham, Boston, MA, USA; Harvard Medical School, Boston, MA, USA.
A ZabetiUniversity of Cincinnati, Cincinnati, OH, USA.
M LevyDepartment of Neurology, Mass General Brigham, Boston, MA, USA; Harvard Medical School, Boston, MA, USA.ORCID 0000-0002-7969-8346
J de SèzeHôpital Civil, Service de Neurologie, Strasbourg, France.ORCID 0000-0002-7197-7578
M J TaneyAlexion, AstraZeneca Rare Disease, Boston, MA, USA.
B ParksAlexion, AstraZeneca Rare Disease, Boston, MA, USA.
K AllenAlexion, AstraZeneca Rare Disease, Boston, MA, USA.
U AkpojiAlexion, AstraZeneca Rare Disease, Boston, MA, USA.ORCID 0000-0003-4611-5869
S J PittockDepartment of Neurology, Mayo Clinic, Rochester, MN, USA; Center for Multiple Sclerosis and Autoimmune Neurology, Mayo Clinic, Rochester, MN, USA; Department of Laboratory Medicine and Pathology, Mayo Clinic, Rochester, MN, USA.ORCID 0000-0002-8387-6491

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveThis post hoc analysis of the CHAMPION-NMOSD trial evaluated the safety and efficacy of ravulizumab in patients with aquaporin-4 antibody-positive (AQP4-Ab+) neuromyelitis optica spectrum disorder (NMOSD) previously exposed or naïve to rituximab (RTX).

methodsPatients received weight-based intravenous ravulizumab with a loading dose followed by maintenance dosing every 8 weeks. Patients were stratified by prior RTX exposure: no RTX exposure (RTX-naïve) vs RTX exposure > 3 months before initiating ravulizumab (RTX-exposed). Key outcomes included treatment-emergent adverse events (TEAEs), serious TEAEs (TESAEs), relapse rates, and vaccination timing from the last RTX dose.

resultsOf the 58 patients enrolled, 89.7% were female, with a mean age of 47.4 years, and 21/58 (36.2%) were RTX-exposed. Relapses occurred in 12/21 (57.1%) RTX-exposed patients between their first RTX dose and study entry. The safety profile of ravulizumab was generally similar between RTX-exposed and RTX-naïve groups. Common TEAEs included COVID-19, headache, urinary tract infection, and upper respiratory tract infection. UTIs were more frequent in RTX-exposed individuals. One patient in each group experienced a meningococcal infection. No adjudicated on-trial relapses were reported while on ravulizumab.

conclusionsFollowing initiation of ravulizumab, RTX-exposed and RTX-naïve patients with AQP4-Ab+ NMOSD achieved sustained disease control and demonstrated a manageable safety profile. CLINICAL TRIAL INFORMATION: The CHAMPION-NMOSD Trial; ClinicalTrials.gov identifier: NCT04201262 (registered October 06, 2020).

Indexed as

Immunologic FactorsNeuromyelitis OpticaRituximabAdultAquaporin 4FemaleHumansMaleMiddle AgedTreatment OutcomeAQP4 protein, humanAquaporin 4Immunologic FactorsRituximabAquaporin-4 antibody-positivemeningococcal vaccinationneuromyelitis optica spectrum disorderravulizumabrituximabsafety profile

Identifiers

PMID41782198
PMCPMC13036264

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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.