Shown to be effective over 10 years
TYSABRI Observational Program: 10 years of results
In a 2-year clinical trial of relapsing MS patients, 627 people were treated with TYSABRI versus 315 with placebo. TYSABRI decreased the average number of relapses per year by 67% compared with placebo (TYSABRI 0.22 vs placebo 0.67).
In addition to the clinical trial, TYSABRI was studied in the ongoing TYSABRI Observational Program (TOP). The TOP study is used to further understand the usage of TYSABRI over an extended length of time. We now have over 10 years of interim results.
What was studied?
- The long-term safety and efficacy of TYSABRI in 6148 people with relapsing MS, each at a different point in their journey
- Each person took 300 mg IV of TYSABRI every 4 weeks
- Participants took TYSABRI for various lengths of time
- 3210 people discontinued TYSABRI
- Not all have reached the end of the 10 year observation period
- Participants had 3 or fewer infusions before enrollment, and data were collected at doctor visits every 6 months
What are the limitations to the study?
- This study may not be as reliable as a controlled clinical trial; findings are not included in the full Prescribing Information
- Unlike the clinical trial, all participants were treated with TYSABRI, so there was no comparison vs placebo
- Patients participated in countries outside of the US, so results may not have been the same in the United States
What was studied?
- The long-term safety and efficacy of TYSABRI in 6148 people with relapsing MS, each at a different point in their journey
- Each person took 300 mg IV of TYSABRI every 4 weeks
- Participants took TYSABRI for various lengths of time
- 3210 people discontinued TYSABRI
- Not all have reached the end of the 10 year observation period
- Participants had 3 or fewer infusions before enrollment, and data were collected at doctor visits every 6 months
What are the limitations to the study?
- This study may not be as reliable as a controlled clinical trial; findings are not included in the full Prescribing Information
- Unlike the clinical trial, all participants were treated with TYSABRI, so there was no comparison vs placebo
- Patients participated in countries outside of the US, so results may not have been the same in the United States
What was discovered?
SHOWN TO BE EFFECTIVE OVER 10 YEARS
- People taking TYSABRI had almost a 90% reduction in average number of relapses in the first year of the study,* and the reduction remained the same through all 10 years
- In the 10 years that TYSABRI was studied, it showed a 72% chance that people's disability would not worsen
- Some patients enrolled after the study started and therefore have been treated for less than 10 years
*Compared to average number of relapses in the year before they started TYSABRI (1.99 vs 0.24).
NO NEW SAFETY CONCERNS WERE IDENTIFIED
Findings were consistent with the previous studies of TYSABRI for up to 10 years of treatment.
- 13.5% (829 of 6148 patients) experienced at least 1 serious adverse event
- The most common adverse events were infection and infestations (pneumonia, urinary tract infection, herpes zoster, and PML) with an incidence of 4.1%
- 4.7% (290 of 6148 patients) had at least 1 serious side effect considered or potentially related to treatment
