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The relative risk of infection in people with multiple sclerosis using disease-modifying treatment: a systematic
M W Y Leung1, E M W Van de Garde1, B M J Uitdehaag2
1Division Pharmacoepidemiology & Clinical Pharmacology, Department of Pharmaceutical Sciences, Faculty of Science, Utrecht Institute for Pharmaceutical Sciences (UIPS), Utrecht University, Utrecht, The Netherlands.
Background:
Some disease-modifying treatments (DMTs) for multiple sclerosis (MS) increase the risk of infection, but it remains unknown how the risk compares between trials and observational studies.
Objective:
To assess the current state of observational research on the risk of infection in people with MS and using DMTs.
Methods:
PubMed and Embase were searched for observational studies published on or before 4 April 2023 describing infection in people with MS, with a comparison of at least 1 DMT to no DMT or another DMT. We examined which DMT contrasts and types of infection were studied and how often; and compared observational results of the most frequently studied DMT to trial data from a network meta-analysis.
Results:
Out of 5373 search records 22 papers were eligible, of which 5 reported relative risks (RRs). In total, 9 DMTs were studied. Out of 45 possible contrasts, 9 were not studied, and 19 once. The most assessed specific type of infection was neurological (n = 11/22 studies). Natalizumab was the most studied DMT contrasting 7 other DMTs or no DMT, with 12 RRs reported. Point estimates of the RRs (compared to no DMT) for respiratory and urinary tract infections were in opposite direction compared to trial data.
Conclusion:
Observational study data on the risk of infection in people with MS on DMT are sparse. The growing availability of real-world data on MS and DMT use provides an opportunity to study specific infections on DMT, which is particularly valuable to populations underrepresented in trials.
Insights
Observational studies on multiple sclerosis (MS) treatments show sparse infection risk data. Real-world data offers opportunities to study infections in MS patients using disease-modifying therapies (DMTs).
Area of Science:
- Neurology
- Infectious Diseases
- Pharmacovigilance
Background:
- Disease-modifying treatments (DMTs) for multiple sclerosis (MS) can increase infection risk.
- Comparative infection risk between clinical trials and real-world observational studies for MS DMTs is not well-established.
Purpose of the Study:
- To evaluate the current landscape of observational research on infection risk in MS patients using DMTs.
- To identify gaps in the study of specific DMTs and infection types in real-world MS populations.
Main Methods:
- Systematic literature search of PubMed and Embase for observational studies up to April 2023.
- Analysis of studied DMT contrasts, infection types, and frequency.
- Comparison of observational findings for the most studied DMT with existing clinical trial data from a meta-analysis.
Main Results:
- 22 observational studies were identified, with only 5 reporting relative risks (RRs).
- Natalizumab was the most studied DMT, with 12 RRs reported against other DMTs or no DMT.
- Observed infection risks (respiratory, urinary) in observational data contrasted with clinical trial findings.
Conclusions:
- Real-world data on infection risk associated with MS DMTs is currently limited.
- There is a significant opportunity to leverage growing real-world data for robust infection risk assessment in MS.
- Further research is crucial, especially for populations underrepresented in clinical trials.
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