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Short-term laboratory and related safety outcomes for the multiple sclerosis oral disease-modifying therapies: an
Elaine Kingwell1,2, Tingting Zhang3, Feng Zhu1
1Department of Medicine, Division of Neurology and Djavad Mowafaghian Centre for Brain Health, University of British Columbia, Vancouver, Canada.
Background:
Real-world safety data for the oral multiple sclerosis (MS) disease-modifying therapies (DMTs), dimethyl fumarate (DMF), fingolimod, and teriflunomide are important. We examined laboratory test abnormalities and adverse health conditions in new users.
Methods:
Linked laboratory and administrative health data were accessed for all persons with MS (PwMS) filling their first oral DMT prescription in two Canadian provinces. PwMS were followed from first prescription fill until discontinuation, death, emigration or study end. Proportions of PwMS, and incidence rates (IR)/100 person-years, were calculated for ≥1 event of elevated alanine aminotransferase (ALT) (>the upper limit of normal [ULN]; all DMTs), liver toxicity (ALT>3xULN; fingolimod); lymphopenia and proteinuria (DMF), and cardiac arrhythmia, hypertension and pneumonia (all DMTs).
Results:
Overall, 1,140 PwMS were followed for up to 2 years. De novo elevated alanine aminotransferase affected 13.2% (DMF), 12.4% (teriflunomide), and 30.0% (fingolimod) of users. Liver toxicity affected 2.8% of fingolimod, lymphopenia 3.1% of DMF, and proteinuria 2.9% of DMF users. The incidences of cardiac arrhythmia, pneumonia and hypertension ranged from <1 to 1.86/100 person-years depending on the DMT.
Conclusions:
The short-term, real-world incidences of abnormal laboratory results or adverse events were consistent with the pivotal clinical trial findings. Longer-term safety data are still needed.
Insights
Real-world safety of oral multiple sclerosis (MS) therapies dimethyl fumarate (DMF), fingolimod, and teriflunomide showed short-term results aligning with clinical trials. Longer-term safety data for these MS disease-modifying therapies are still needed.
Area of Science:
- Neurology
- Pharmacology
- Public Health
Background:
- Real-world safety data for oral multiple sclerosis (MS) disease-modifying therapies (DMTs) are crucial for clinical decision-making.
- Key oral DMTs include dimethyl fumarate (DMF), fingolimod, and teriflunomide.
Purpose of the Study:
- To examine laboratory test abnormalities and adverse health conditions in new users of oral MS DMTs.
- To provide real-world safety insights beyond pivotal clinical trial data.
Main Methods:
- Utilized linked laboratory and administrative health data from two Canadian provinces.
- Followed persons with MS (PwMS) from their first oral DMT prescription until study end.
- Calculated incidence rates (IR)/100 person-years for elevated alanine aminotransferase (ALT), liver toxicity, lymphopenia, proteinuria, cardiac arrhythmia, hypertension, and pneumonia.
Main Results:
- Elevated ALT (>ULN) affected 13.2% (DMF), 12.4% (teriflunomide), and 30.0% (fingolimod) of users.
- Liver toxicity (ALT>3xULN) occurred in 2.8% of fingolimod users; lymphopenia in 3.1% and proteinuria in 2.9% of DMF users.
- Incidences of cardiac arrhythmia, pneumonia, and hypertension ranged from <1 to 1.86/100 person-years.
Conclusions:
- Short-term, real-world incidences of laboratory abnormalities and adverse events align with pivotal clinical trial findings.
- The safety profiles observed in this real-world cohort are consistent with established trial data.
- Longer-term safety monitoring and data collection for these oral MS DMTs remain essential.
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