Impact of natalizumab on quality of life in a real-world cohort of patients with multiple sclerosis: Results from MS PATHS

Abstract

Background Optimizing multiple sclerosis treatment warrants understanding of changes in physical, mental, and social health. Objective To assess the impact of natalizumab on Quality of Life in Neurological Disorders (Neuro-QoL) scores. Methods Annualized change in T-scores and likelihood of ≥5-point improvement over baseline were calculated for each Neuro-QoL domain after natalizumab initiation. Comparisons with ocrelizumab-treated patients were conducted after propensity score weighting and adjustment for relevant co-medications, year, and drug-year interaction. Results Among 164 natalizumab patients analyzed, 8 of 12 Neuro-QoL domains improved significantly, with greater improvement in patients with abnormal baseline Neuro-QoL. In the subgroup comparison of natalizumab-treated ( n = 145) and ocrelizumab-treated ( n = 520) patients, significant improvement occurred in 9 of 12 and 4 of 12 domains, respectively. The difference between groups was statistically significant for positive affect and well-being ( p = 0.02), sleep ( p = 0.003), and satisfaction with social roles and activities (SRA) ( p = 0.03) in the overall population and for emotional and behavioral dyscontrol ( p = 0.01), participation in SRA ( p = 0.0001), and satisfaction with SRA ( p = 0.02) in patients with abnormal baseline Neuro-QoL. Conclusions Natalizumab can produce clinically meaningful improvements in mental and social health. Such improvements are unlikely to be primarily driven by expectation bias, as their magnitude exceeded improvements with another high-efficacy therapy, ocrelizumab.

Improvements in Cognitive Processing Speed, Disability, and Patient-Reported Outcomes in Patients with Early Relapsing-Remitting Multiple Sclerosis Treated with Natalizumab: Results of a 4-year, Real-World, Open-Label Study

“…MSIS-29 physical and psychological scores were significantly lower at all 4-yearly time points during natalizumab treatment than at screening in both the ITT population and the 4-year natalizumab completers. These findings, which demonstrate an improvement in QoL, support and extend the results of other shorter clinical and real-world studies examining the effect of natalizumab treatment on various QoL measures, including MSIS-29 [ 11 , 17 , 27 ], Short Form-36 or Short-Form-12 [ 4 , 11 , 27 ], and NeuroQoL [ 28 ].…”

Correction to: Improvements in Cognitive Processing Speed, Disability, and Patient‑Reported Outcomes in Patients with Early Relapsing‑Remitting Multiple Sclerosis Treated with Natalizumab: Results of a 4‑year, Real‑World, Open‑Label Study

“…MSIS-29 physical and psychological scores were significantly lower at all 4-yearly time points during natalizumab treatment than at screening in both the ITT population and the 4-year natalizumab completers. These findings, which demonstrate an improvement in QoL, support and extend the results of other shorter clinical and real-world studies examining the effect of natalizumab treatment on various QoL measures, including MSIS-29 [11,17,27], Short Form-36 or Short-Form-12 [4,11,27], and NeuroQoL [28].…”

“…The MSIS-29 yields two separate scores (physical and psychological) on a scale of 0-100, with lower scores representing better QoL. Scores on the MSIS-29 can also be divided into five categories: "no problems" (0-19), "few problems" (20)(21)(22)(23)(24)(25)(26)(27)(28)(29)(30)(31)(32)(33)(34)(35)(36)(37)(38)(39), "moderate problems" (40-59), "quite a few problems" (60-79), and "extreme problems" (80-100). A change in the MSIS-29 physical or psychological score resulting in a downward or upward move of at least one category was considered an improvement or worsening, respectively, as described previously [11].…”

Updates and Advances in Multiple Sclerosis Neurotherapeutics

“…Results from phase III clinical trials demonstrated that natalizumab reduces clinical relapses by 67%, new brain MRI lesions by 83% and risk of CDP by 42% [ 65 , 71 ]. These results have been further validated in real-world, long-term observational studies [ 72 , 73 , 74 , 75 , 76 ]. Natalizumab is a generally well-tolerated agent.…”