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Published on: December 9, 2015
Teriflunomide in relapsing-remitting multiple sclerosis: outcomes by age and pre-treatment status
Boris A Kallmann1, Stefan Ries2, Jennifer S Kullmann3
1Multiple-Sclerosis-Center Bamberg, Bamberg, Germany.
Background And Aims:
To investigate effectiveness and safety of teriflunomide (14 mg once daily) in association with age and pre-treatment in unselected MS patients.
Methods:
Prespecified analysis of a non-interventional, prospective, real-world study in Germany.
Results:
A total of 558 (49.5%) patients were above 45 years old, and 593 patients (52.6%) had been pre-treated within 6 months prior to teriflunomide. Baseline Expanded Disability Status Scale (EDSS) was higher with older age, with lower number of relapses. Relapse rate decreased in all age groups, and in both treatment-naïve (0.82 ± 0.73 at baseline; 0.25 ± 0.55 under teriflunomide) and pre-treated (from 0.48 ± 0.76; 0.22 ± 0.50) patients after 12 months compared with the year before teriflunomide initiation. EDSS remained stable in patients of all age groups as well as in therapy-naïve and pre-treated patients over 24 months. The percentage of patients with adverse events (AEs) ranged between 29.2% (age group >25-35) and 38.9% (age group >55-65), with an increased discontinuation rate (most commonly due to diarrhoea, alopecia and nausea) in the higher age groups. AE rates were lower in pre-treated compared with treatment-naïve patients.
Conclusion:
Overall, patients of all age groups including older patients, and irrespective of pre-treatment, benefit from teriflunomide treatment in routine clinical practice.
Registration:
BfArM public study database number 2075.
Insights
Teriflunomide (14 mg once daily) is effective and safe for multiple sclerosis (MS) patients of all ages, regardless of prior treatment. Real-world data show reduced relapse rates and stable disability scores, confirming its clinical utility.
Area of Science:
- Neurology
- Immunology
- Pharmacology
Background:
- Multiple Sclerosis (MS) is a chronic autoimmune disease affecting the central nervous system.
- Teriflunomide is an immunomodulatory drug used for treating relapsing forms of MS.
- Understanding teriflunomide's effectiveness and safety in diverse patient populations, including older adults and those with prior treatments, is crucial for real-world clinical practice.
Purpose of the Study:
- To evaluate the effectiveness and safety of teriflunomide (14 mg once daily) in unselected multiple sclerosis (MS) patients.
- To analyze the impact of patient age and prior treatment history on teriflunomide's outcomes.
- To assess changes in relapse rates and Expanded Disability Status Scale (EDSS) scores.
Main Methods:
- A prespecified analysis of a non-interventional, prospective, real-world study conducted in Germany.
- Inclusion of 558 patients over 45 years old and 593 pre-treated patients.
- Assessment of relapse rates and EDSS scores at baseline, 12 months, and 24 months.
Main Results:
- Teriflunomide treatment led to a significant decrease in relapse rates in all age groups and both treatment-naïve and pre-treated patients.
- Expanded Disability Status Scale (EDSS) scores remained stable across all age groups and treatment histories over 24 months.
- Adverse event rates varied by age, with higher discontinuation rates in older patients, primarily due to gastrointestinal and hair-related side effects; pre-treated patients showed lower AE rates.
Conclusions:
- Teriflunomide demonstrates effectiveness and safety in routine clinical practice for multiple sclerosis patients across all age groups, including older individuals.
- Treatment outcomes are positive irrespective of prior treatment status, supporting its broad applicability.
- The study confirms teriflunomide's benefit in managing MS in a real-world setting.
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