Study type

Study type

Non-interventional study

Scope of the study

Safety study (incl. comparative)

Data collection methods

Secondary data collection
Non-interventional study

Non-interventional study design

Cohort
Study drug and medical condition

Name of medicine

Uplizna

Study drug International non-proprietary name (INN) or common name

INEBILIZUMAB

Anatomical Therapeutic Chemical (ATC) code

(L04AA47) inebilizumab
(L04AG10) inebilizumab

Medical condition to be studied

Neuromyelitis optica spectrum disorder
Population studied

Short description of the study population

The study population will be identified in national healthcare administrative databases, claim databases and disease-specific registries and will include adult (18 years old or more at the index date) female and male patients diagnosed with NMOSD and initiating inebilizumab during the study period.

Age groups

Adult and elderly population (>18 years)
Adults (18 to < 65 years)
Adults (18 to < 46 years)
Adults (46 to < 65 years)
Elderly (≥ 65 years)
Adults (65 to < 75 years)
Adults (75 to < 85 years)
Adults (85 years and over)
Study design details

Study design

A non-interventional multi-center cohort study of patients initiating inebilizumab conducted with secondary data sources in France, Germany, Italy, the Netherlands, and Spain.

Main study objective

This study aims to characterize patients who initiate inebilizumab, describe treatment patterns and incidence of adverse events of special interest (AESI) in the first 12 months following treatment initiation.