Innovative research

Professor Sven Meuth discusses the phase 3b NOVA study – an interventional study evaluating the efficacy, safety and tolerability of six-week EID of natalizumab compared to four-week SID in relapsing-remitting MS over 72 weeks.

A benefit/risk ratio should take into account the efficacy of a disease modifying therapy. In this video, Professor Sven Meuth introduces the body of evidence for natalizumab treatment outcomes and considers the clinical implications of some of the data obtained in the phase 2 efficacy and dose finding study of natalizumab.

Professor Sven Meuth shares the results of the Tysabri Observational Program (TOP) study, for which most sites are in Europe¹, which assessed the effect of natalizumab in real world use outcomes¹. He focuses on the impact of natalizumab treatment over 10 years on disability, per the expanded disability status scale (EDSS), and delves into individual functional systems. He specifically looks at the effect of natalizumab on visual and bladder function from the AFFIRM Phase 3 and TRUST observational studies, respectively, given the importance these functions have on quality of life.

Professor Sven Meuth shares more data on new readout parameters not commonly used in clinical trials, like fatigue in the ENER-G study, and formal SDMT testing for cognitive function in the Swedish registry.

Returning to the European-based TOP study,¹ Professor Sven Meuth answers the question – does the time between MS symptom onset and natalizumab treatment affect the percentage of treatment naïve patients showing EDSS improvement?

Professor Sven Meuth discusses a US-based analysis,² derived from the MSPT³ using the TOUCH population in MS PATHS, which compared earlier use of natalizumab against later use of natalizumab in patients matched for the duration of treatment with natalizumab.