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Introduction <p>Serious 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.</p> Methods <p>This observational, retrospective cohort study included patients with a first NMOSD diagnosis (index date) between January&#xa0;2016 and August&#xa0;2022 in Japan. Data were extracted between April&#xa0;2008 and August&#xa0;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.</p> Result <p>In this study (<i>n</i>&#xa0;=&#xa0;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 [≥&#xa0;75&#xa0;years (ref. 18–35&#xa0;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 (&gt;&#xa0;0&#xa0;mg and&#xa0;&lt;&#xa0;5&#xa0;mg [ref. 0&#xa0;mg]; HR 1.80, 95% CI 1.21–2.69) were associated with an increased risk of serious infections.</p> Conclusion <p>The 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.</p> Trial Registration <p>University Hospital Medical Information Network Clinical Trials Registry&#xa0;(UMIN-CTR: UMIN000051151).</p>

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

  • 期刊论文

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  • 发表日期：

    2025年7月17日

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

摘要

Introduction

Serious 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.

Methods

This 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.

Result

In 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.

Conclusion

The 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 Registration

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