Tysabri (natalizumab) is superior to other disease-modifying therapies (DMTs) at improving balance and vision, easing bladder problems and sexual dysfunction, and alleviating anxiety in people with multiple sclerosis (MS), according to data from an Australian study.
The study’s findings were presented at MSVirtual2020 by Ingrid van der Mei, PhD, associate professor at the University of Tasmania’s Menzies Institute for Medical Research, in an oral presentation titled “Effects of natalizumab on patient-reported MS outcomes using prospective data from the Australian MS longitudinal study.” The 8th joint meeting of the Americas Committee for Treatment and Research in Multiple Sclerosis (ACTRIMS) and its European counterpart (ECTRIMS) was held online Sept. 11–13.
Marketed by Biogen, Tysabri is an antibody-based therapy approved for the treatment of relapsing MS. The therapy is thought to work by preventing immune cells from entering the brain, damaging neurons and causing inflammation.
Although the safety and efficacy of Tysabri and other DMTs have been well-documented in clinical trials, the effects these medications have on the symptoms, quality of life, and employment status of people with MS are still poorly described.
To learn more, van der Mei and her colleagues compared the effects of Tysabri with those of other DMTs over the previous year on patients’ MS symptoms and their quality of life, work status, and self-perceived disease progression.
Analyses were based on data from patient-reported outcomes collected as part of the Australian MS Longitudinal Study (AMSLS), a survey-based study that currently has more than 3,000 active participants filling in disease questionnaires every year.
Medication and disease-course surveys conducted from 2015 to 2017 in AMSLS were used to extract information on DMT use, severity of MS symptoms, disability, health-related quality of life —assessed by the European Quality of Life with five dimensions, or EQ-5D — and work productivity.
Statistical models were then used to estimate the effects of Tysabri on these parameters, and to compare them to other types of DMTs. Specifically, those therapies included classic injectable DMTs such as interferon-beta-1a (sold as Rebif, among others) and glatiramer acetate (sold as Copaxone, among others); oral therapies like Aubagio (teriflunomide) and Tecfidera (dimethyl fumarate); and high-efficacy DMTs like Gilenya (fingolimod), alemtuzumab (sold as Lemtrada, among others), and Novantrone (mitoxantrone).
A total of 2,817 observations were included in the study. Most patients who completed the surveys were taking classic injectable DMTs (35.3%), followed by high-efficacy DMTs (33.5%), oral therapies (19.0%), and Tysabri (12.2%).
Analyses showed that, compared with any other DMT, Tysabri was better at improving patients’ balance and vision, as well as in alleviating their bladder, sexual and sensory problems, and in easing their feelings of anxiety over time.
However, the team found no evidence suggesting that Tysabri had a positive effect over time at improving patients’ quality of life. There also was no evidence that it alleviated spasticity (muscle stiffness), fatigue, or pain, or eased feelings of depression.
According to van der Mei, a trend toward fewer bowel problems, walking difficulties and cognitive symptoms was observed in those treated with Tysabri; however, these results were not statistically significant.
Researchers also found that treatment with Tysabri was associated with a mild reduction in self-reported disease progression in the previous year.
“What is also important to note is that for none of the analyses natalizumab [Tysabri] actually performed worse, compared to the comparators [other DMTs],” van der Mei said in the presentation.
Regarding work-related parameters, Tysabri was found to be associated with higher productivity, as absenteeism (being absent from work) decreased more over time in patients taking this medication compared with those using other DMTs.
No particular patterns emerged regarding the positive effects of Tysabri over specific classes of other DMTs, van der Mei also noted.
In conclusion, “we basically found that compared to any other DMT, natalizumab [Tysabri] was associated with superior effects in eight of the 22 patient-reported outcomes,” van der Mei said.
These were: difficulty with balance, vision symptoms, sensory symptoms, bladder symptoms, sexual dysfunction, feelings of anxiety, absenteeism, and total work productivity.
“Also, we found that the direction of effect was similar, but not significant for another six of the 22 patient-reported outcomes,” she said.
“Overall, the use of natalizumab was associated with superior effects over time for a number of MS symptoms, self-assessed progression in the previous 12 months, and work productivity loss,” van der Mei concluded.
The researcher emphasized, however, that future studies to confirm these findings are needed, as at the moment data on the effectiveness of DMTs in terms of patient-reported outcomes is very limited.
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