Evidence map›Paper›PMID 30635724›Full record

ArticleJournal of neurology2019

Long-term tolerability, safety and efficacy of rituximab in neuromyelitis optica spectrum disorder: a prospective study.

V Shaygannejad, E Fayyazi, S Badihian, O Mirmosayyeb, N Manouchehri, F Ashtari, N Asgari

Abstract read
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In one paragraph

Article in Journal of neurology, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 16 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
16citing papers in PubMed, 1 pooled it
–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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

16 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
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  10. Adverse drug reactions of Rituximab in patients suffering from autoimmune neurological diseases.Daru : journal of Faculty of Pharmacy, Tehran University of Medical Sciences · 2022
    Observational
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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

7 authors.

V ShaygannejadIsfahan Neurosciences Research Center, Alzahra Research Institute, Isfahan University of Medical Sciences, Isfahan, Iran.
E FayyaziIsfahan Neurosciences Research Center, Alzahra Research Institute, Isfahan University of Medical Sciences, Isfahan, Iran.
S BadihianDepartment of Neurology, Johns Hopkins University School of Medicine, Baltimore, MD, USA.
O MirmosayyebIsfahan Neurosciences Research Center, Alzahra Research Institute, Isfahan University of Medical Sciences, Isfahan, Iran.
N ManouchehriDepartment of Neurology and Neurotherapeutics, The University of Texas Southwestern Medical Center, Dallas, TX, USA.
F AshtariIsfahan Neurosciences Research Center, Alzahra Research Institute, Isfahan University of Medical Sciences, Isfahan, Iran.
N AsgariDepartment of Neurobiology, Institute of Molecular Medicine, Institute of Regional Health Research, University of Southern Denmark, Odense, Denmark. nasgari@health.sdu.dk.ORCID http://orcid.org/0000-0001-8551-0947

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundNeuromyelitis optica spectrum disorder (NMOSD) is a B-cell-mediated disease with autoimmunity towards the astrocyte water channel aquaporin-4 (AQP-4) in the central nervous system.

objectiveTo assess the long-term safety and efficacy in NMOSD patients receiving maintenance therapy with B-cell-depleting agent rituximab for more than 2 years.

methodNMOSD patients were included prospectively from 2014 to 2018 and received continuous cycles of rituximab infusions biannually. Incidence of adverse events (AE), serious AEs (SAE), and infusion-related AEs were evaluated through monthly phone calls and neurological examination every 4 months.

resultsA total of 44 NMOSD patients were included, of those 30 were treatment naive (68%). The mean age was 37.2 years with 79.5% females. With overall observation period of 31.6 ± 7.3 months (24-48 months), tolerability was assessed as satisfactory in most cases. We observed infusion reactions (mostly mild) in 31.8% of patients and 31.8% never experienced any AEs after a mean 5.1 cycles of rituximab therapy. Rituximab was also beneficial in terms of improvement in relapse rate (from 0.26 ± 0.54 to 0, P = 0.003) and Expanded Disability Status Scale (from 4.1 ± 1.8 to 3.1 ± 1.8, P < 0.001). Stratification according to AQP4-IgG serostatus showed no difference between groups.

conclusionRituximab treatment is well tolerated, safe, and efficacious with a minor risk of mild infusion reactions for NMOSD patients.

Indexed as

Outcome Assessment, Health CareAdultFemaleHumansImmunologic FactorsMaleMiddle AgedNeuromyelitis OpticaProspective StudiesRituximabSecondary PreventionSeverity of Illness IndexImmunologic FactorsRituximabAdverse drug reactionsEfficacyNeuromyelitis optica spectrum diseaseRituximabSafetyTolerability

Identifiers

PMID30635724

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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.