Evidence map›Paper›PMID 40676373›Full record

ArticleNeurology and therapy2025

Incidence and Risk Factors for Serious Infections in Patients with Neuromyelitis Optica Spectrum Disorder: A Claims Database Study in Japan.

Noriko Isobe, Tetsuro Oda, Tomohiro Yamaguchi, Yuta Kamei, Takahiko Tsumuraya, Akinori Yuri, Ayako Nakasone, Keiko Asao, Shinichi Matsuda

Abstract read
In one paragraph

Article in Neurology and therapy, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing 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.

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

3 citing papers in PubMed.

  1. Article
  2. Article
  3. 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

9 authors.

Noriko IsobeDepartment of Neurology, Graduate School of Medical Sciences, Kyushu University, 3-1-1 Maidashi, Higashi-Ku, Fukuoka, 812-8582, Japan. isobe.noriko.342@m.kyushu-u.ac.jp.ORCID http://orcid.org/0000-0001-9525-4254
Tetsuro OdaDrug Safety Division, Chugai Pharmaceutical Co., Ltd, Tokyo, Japan.
Tomohiro YamaguchiDrug Safety Division, Chugai Pharmaceutical Co., Ltd, Tokyo, Japan.
Yuta KameiDrug Safety Division, Chugai Pharmaceutical Co., Ltd, Tokyo, Japan.
Takahiko TsumurayaDrug Safety Division, Chugai Pharmaceutical Co., Ltd, Tokyo, Japan.
Akinori YuriDrug Safety Division, Chugai Pharmaceutical Co., Ltd, Tokyo, Japan.
Ayako NakasoneDrug Safety Division, Chugai Pharmaceutical Co., Ltd, Tokyo, Japan.
Keiko AsaoIQVIA Solutions Japan G.K, Tokyo, Japan.
Shinichi MatsudaDrug Safety Division, Chugai Pharmaceutical Co., Ltd, Tokyo, Japan.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionSerious infection is a leading cause of mortality in patients with neuromyelitis optica spectrum disorder (NMOSD). We assessed the incidence of and risk factors for serious infections in patients with NMOSD.

methodsThis observational, retrospective cohort study included patients with a first NMOSD diagnosis (index date) between January 2016 and August 2022 in Japan. Data were extracted between April 2008 and August 2022 from the Medical Data Vision database. A serious infection was defined as an infection diagnosed during hospitalization. We described the incidence rate, cumulative incidence, and estimated hazard ratios (HRs) of potential risk factors using a Cox proportional hazard model with time-fixed and time-varying covariates.

resultIn this study (n = 4231), the incidence rate of serious infections was 5.77 [95% confidence interval (CI) 5.23-6.35] per 100 person-years, and the cumulative incidence ranged from 2.87% (95% CI 2.33-3.49%) at 6-month follow-up to 12.48% (95% CI 10.62-14.50%) at 5-year follow-up. Age [≥ 75 years (ref. 18-35 years); HR 2.48, 95% CI 1.36-4.53], cancer (HR 1.91, 95% CI 1.11-3.29), diabetes mellitus (HR 1.43, 95% CI 1.04-1.96), neurogenic bladder (HR 1.97, 95% CI 1.46-2.66), urolithiasis (HR 1.97, 95% CI 1.02-3.78), the number of NMOSD relapses (HR 1.27, 95% CI 1.03-1.56) and a low daily dose of oral glucocorticoid (> 0 mg and < 5 mg [ref. 0 mg]; HR 1.80, 95% CI 1.21-2.69) were associated with an increased risk of serious infections.

conclusionThe incidence of serious infections in the NMOSD population, including those mainly treated with conventional therapies in real-world settings, was comparable to that reported in clinical trials or observational studies under specific treatments. Various potential risk factors for serious infections were identified. These results may assist patients and clinicians in better decision-making regarding treatment options.

trial registrationUniversity Hospital Medical Information Network Clinical Trials Registry (UMIN-CTR: UMIN000051151).

Indexed as

Claims dataDatabaseDescriptive analysisEpidemiologyInfectionsNeuromyelitis opticaNMOSDObservational studyReal-world dataRisk factors

Identifiers

PMID40676373
PMCPMC12450173

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

Registered trials

None linked

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.