Teriflunomide under the microscope in studies and practice
Not always do the conclusions from clinical studies fully confirm in real clinical practice. Does this also apply to teriflunomide? Is its efficacy and safety consistent across age groups and individual studies?
Post hoc Analysis
Teriflunomide is a relatively well-established disease-modifying drug (DMD) used in the treatment of multiple sclerosis (MS) worldwide. Its safety and efficacy have already been the subject of numerous studies. Are their conclusions consistent with each other and with real clinical practice observations? This question was addressed by renowned authors in an article published last year in the Journal of Central Nervous System Disease.
Many works point to the possibility of different responses and safety profiles of DMD across different age categories. The aim of this post hoc analysis was to elucidate the safety and efficacy of teriflunomide across the age spectrum based on the evaluation of conclusions from major clinical studies and real clinical practice data.
Evaluated Data
Data from the clinical studies TEMSO, TOWER, TENERE, and TOPIC, including their extensions (a total of 1978 patients), as well as from real clinical practice − from the Teri-PRO projects (928 patients) and TAURUS-MS I (1126 patients) were analyzed. The data were stratified based on the age of the patients: groups up to 25 years inclusive, 25−35 years inclusive, 35−45 years inclusive, 45−55 years inclusive, and those older than 55 years.
Findings
In terms of the annual relapse rate, compared to placebo, patients on teriflunomide therapy showed a decline across all clinical studies. The same was observed in the extension of the TOPIC study and in real clinical practice data across all age categories. The baseline EDSS (Expanded Disability Status Scale) score was higher in older age groups, but regardless of age, it remained relatively stable during observation.
Regarding adverse events, their incidence was similarly approximately between 78.4 and 90.7% across age categories. The exception was patients in the TAURUS-MS I project, where the incidence of adverse events was lower (29.2−37.7%). The incidence of serious adverse events, however, was consistent across all publications, at ≤ 21.3%.
Conclusion
The safety profile of teriflunomide, as well as its efficacy, appears to be consistent across different age categories, studies, and real clinical practice data. This DMD, thus, thanks to its relatively favorable safety profile and good efficacy, continues to confirm its strong place in the management of MS therapy across all age categories.
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Source: Oh J., Vukusic S., Tiel-Wilck K. et al. Efficacy and safety of teriflunomide in multiple sclerosis across age groups: analysis from pooled pivotal and real-world studies. J Cent Nerv Syst Dis 2021; 13: 11795735211028781, doi: 10.1177/11795735211028781.
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