Long-term therapy with Tysabri (natalizumab) significantly improved the mental state of people with secondary progressive multiple sclerosis (SPMS), according to results of a Biogen-supported study with patients taking the drug for almost two years.
Biogen presented the study, “The Impact of Natalizumab on Health-Related Quality of Life in Patients with Secondary Progressive Multiple Sclerosis,” at the 2017 Annual Meeting of the Consortium of Multiple Sclerosis Centers (CMSC), taking place May 24-27 in New Orleans.
Tysabri, which is recommended for the treatment of “highly active” relapsing MS, belongs to a class of medications that act on the immune system – called immune-modulators. It has been shown to slow worsening disability in patients with relapsing forms of MS.
Such patients suffer an impaired health-related quality of life. In the AFFIRM clinical trial (NCT00027300), Tysabri had a significant positive effect on the mental and physical health-related quality of life of RRMS patients. The ASCEND trial (NCT01416181) aimed to see if Tysabri had a similar effect on people with SPMS.
The team used the 36-item Short Form Health Status Survey (SF-36), a generic patient-reported outcome aimed at quantifying health status. Other parameters included the SF-36 Physical Component Summary and Mental Component Summary scores, assessed at baseline and week 96.
ASCEND participants with SPMS scored an average 33.3 on the SF-36 Physical Component Summary at baseline, compared to 43.9 for RRMS patients. Both groups scored similarly on the Mental Component Summary.
At week 96, while the Mental Component Summary score in SPMS patients treated with Tysabri remained stable, those on placebo scored significantly lower. Those on placebo scored lower on the Physical Component Summary than did Tysabri-treated patients, though the differences were not significant.
“Health-related quality of life worsening in SPMS patients over 2 years was driven by Mental Component Summary decline,” researchers concluded. “Though there was no significant difference in Physical Component Summary scores, treatment with natalizumab over approximately two years demonstrated a significant treatment effect in mental health-related quality of life in secondary progressive MS patients compared to placebo.”