Increases in physical, emotional, and cognitive functioning were more common in patients receiving natalizumab than in patients receiving other disease modifying therapies.
John Foley, MD
Data from a patient-centric survey study presented at the 2020 Annual Meeting of the Consortium of Multiple Sclerosis Centers (CMSC) suggests that treatment with natalizumab (Tysabri; Biogen) is associated with a greater “feel-good” experience compared with other disease modifying therapies (DMTs) for patients with relapsing-remitting multiple sclerosis (RRMS).1
Research conducted by John Foley, MD, neurology specialist, Rocky Mountain MS Clinic, and colleagues showed a significantly higher percentage of natalizumab patients “felt good” while on natalizumab (n = 95; 63%) compared with other DMT-treated patients (45%; n = 252; P = .001).
In total, 78% of natalizumab-treated patients self-reported physical benefits compared with 67% of other-DMT patients (P = .017). Additionally, significantly higher rates of improved energy (23% vs 12%; P = .011) and coordination (22% vs 12%; P = .017) were observed in natalizumab compared with other-DMT patients.
Improvements in organizing thoughts, a cognitive component of the assessment, was significantly higher for natalizumab patients versus other-DMT patients (24% vs 14%; P = .021). Associations of “feel-good” experiences such as increased physical, emotional, and cognitive functioning, which were more commonly observed in natalizumab patients, were consistent with qualitative interviews.
In previous studies, patients had self-reported a “feel-good” experience while receiving natalizumab treatment. This study aimed to confirm previous reports by comparing surveys results of “feel-good” experiences in adult patients with RRMS who were on either natalizumab or other DMTs . The surveys asked patients about their current DMT use and its “feel-good” effect assessed by self-reported improvements in physical, emotional, and cognitive domains.
Time since RRMS diagnosis was <6 years in 29% of natalizumab patients and 35% of other-DMT patients. More notably, a time period of >15 years since RRMS diagnosis was observed in 29% of natalizumab patients and 27% of patients on other DMTs.
Natalizumab versus other-DMT patient responses were corrected for multiple measures and compared using t test and log-rank tests. Foley and colleagues acknowledged that the results of this study are limited by the subjective nature of the survey responses.
The FDA approved natalizumab in November 2004 as a treatment for relapsing forms of MS to reduce the frequency of clinical relapses. The therapy was also granted accelerated approval following priority review designation based on 1-year data from 2 phase 3 studies.2
A recent study cohort study of over 6000 patients showed incidence rates of progressive multifocal leukoencephalopathy (PML) in patients with MS treated with natalizumab decrease by 23% each year since risk-reduction guidelines were implemented in January 2013. The significant number is compared with a yearly increase of 45% prior to their implementation.3
Research presented at ECTRIMS 2019 showed that natalizumab was associated with patients with MS achieving overall clinical no evidence of disease activity (NEDA) status at a high rate, among other clinical benefits. At Year 4, 75.4% of 134 patients (n = 101) had overall NEDA status. Additionally, 59.2% of 169 patients (n = 100) had achieved cumulative clinical NEDA status, while 50.4% of 143 (n = 72) had magnetic resonance imaging (MRI) activity free status.4
In a recent Peer Exchange from NeurologyLive, a panel of key opinion leaders, including Fred D. Lublin, MD, and Patricia K. Coyle, MD, discussed the use of natalizumab for MS and the JCV antibody blood test to determine the risk of developing PML. Watch below to hear their insight.
For more coverage of CMSC 2020, click here.
1. Foley J, Berkovich R, Gudesblatt M, et al. Natalizumab-treated patients with relapsing-remitting multiple sclerosis report better “feel-good” outcomes in key physical, emotional, and cognitive domains compared to other disease-modifying therapies. Int J MS Care. 2020;22(2 Suppl).
2. FDA grants approval of Tysabri, formerly Antegren, for the treatment of multiple sclerosis [news release]. San Diego, CA: Biogen. Published November 23, 2004. Accessed May 27, 2020. drugs.com/newdrugs/tysabri-approved-multiple-sclerosis-16html
3. Vukusic S, Rollot F, Case R, et al. Progressive Multifocal Leukoencephalopathy Incidence and Risk Stratification Among Natalizumab Users in France. JAMA Neurol. Published online September 3, 2019. doi:10.1001/jamaneurol.2019.2670.
4. Perumal J, Fox RJ, Balabanov R, et al. Natalizumab is associated with no evidence of disease activity and with improvement in disability and cognitive performance in anti-JC virus seronegative patients with early relapsing-remitting multiple sclerosis: STRIVE 4-year results. Presented at: ECTRIMS 2019. September 11-13, 2019; Stockholm, Sweden. Poster P1348.