Study Design
Methods
A multicenter, longitudinal, retrospective study involving patients with RMS*:
. Age: ≥55 years
. Teriflunomide 14 mg
Assessment of efficacy | |
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Safety assessment | |
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Results
Significantly improved mean ARR
Mean EDSS score
In 87.7% of patients at index
In 93.6% of patients at year 2 post-index
In 96% of patients at year 1 post-index
Lymphopenia
Absolute lymphocyte count in patients switching from oral DMT
Low numbers of infections in patients ≥55 years of age after switching to teriflunomide
of patients reported infection, commonly UTI. None of the infections were related to teriflunomide.
Overall stability of WBC and lymphocyte counts
Conclusion
RMS patients (55 years or older) switching to teriflunomide from other DMTs showed:
Improved ARR
Stable disability
Stable or improved MRI
Stable WBC and lymphocyte count
Acceptable safety results
*RMS included patients with RRMS and active secondary progressive MS.
ARR: Annualized relapse rate; DMT: Disease-modifying therapy; EDSS: Expanded Disability Status Scale; MR: Medical record; MS: Multiple sclerosis; MRI: Magnetic resonance imaging; RMS: Relapsing multiple sclerosis; RRMS: Relapsing-remitting multiple sclerosis; RWD: Real-world data; UTI: Urinary tract infection; US: United States; WBC: White blood cell.
The only licensed dose for Aubagio in Gulf countries and KSA is 14mg, this study has not been reviewed by SFDA
MAT-BH-2300590-V1-Oct.2023