Study Design

Methods

A multicenter, longitudinal, retrospective study involving patients with RMS*:

.  Age: ≥55 years

.  Teriflunomide 14 mg

Assessment of efficacy
  • ARR
  • EDSS
  • MRI outcomes
Safety assessment
  • Lymphocyte counts
  • Infections
  • Malignancies

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

Aubagio API

MAT-BH-2300590-V1-Oct.2023