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Real-World Data for Safety Studies: Challenges and Opportunities From the Italian Multiple Sclerosis and Related
Marco Salivetto1,2, Tommaso Guerra3, Pasquale Paletta1
1Public Health Research Area, Italian Multiple Sclerosis Foundation, Genoa, Italy.
Pharmacoepidemiology and Drug Safety
|July 30, 2026
Summary
The Italian Multiple Sclerosis and Related Disorders Register (RISM) tracks disease-modifying therapies (DMTs) safety. Over 18% of patients on DMTs experienced clinical events, highlighting RISM
Area of Science:
- Neurology
- Pharmacovigilance
- Real-world data analysis
Background:
- Limited safety data for multiple sclerosis (MS) disease-modifying therapies (DMTs) in clinical practice.
- Patient registries like the Italian Multiple Sclerosis and Related Disorders Register (RISM) are crucial for pharmacovigilance.
- RISM collects demographic and clinical data for MS patients since 2015.
Purpose of the Study:
- To characterize the Italian Multiple Sclerosis and Related Disorders Register (RISM) as a research platform.
- To evaluate the safety of multiple sclerosis (MS) therapies using real-world data.
- To support pharmacovigilance for disease-modifying therapies (DMTs).
Main Methods:
- Systematic characterization of clinical events in patients treated with DMTs.
- Implementation of high-quality data collection procedures within RISM.
- Descriptive statistical analysis of a cohort initiating DMTs between 2016 and 2025.
Main Results:
- 24,259 subjects received at least one DMT between 2016 and 2025.
- 18.2% of patients (4,419) experienced one or multiple clinical events.
- Infections (29.4%) and malignancies (3.7%) were key clinical events reported.
Conclusions:
- RISM offers a patient-centered perspective for long-term DMT safety evaluation.
- Strengths and limitations of RISM for safety studies are outlined.
- Methodological and legal challenges of data platforms are discussed.
