DX72
The Impact of Natalizumab on Health-Related Quality of Life in Patients with Secondary-Progressive Multiple Sclerosis

Thursday, May 25, 2017
B2 (New Orleans Convention Center)
Mark S Freedman, MD , 1University of Ottawa, Ottawa Hospital Research Institute, Ottawa, ON, Canada
Douglas Jeffery, MD, PhD , Piedmont HealthCare, Mooresville, NC
Aaron E Miller, MD , Icahn School of Medicine at Mount Sinai, New York, NY
Eva Havrdova, MD, PhD , First Faculty of Medicine and General University Hospital, Charles University in Prague, Prague, Czech Republic
Finn Sellebjerg, MD, PhD, DMSci , Danish Multiple Sclerosis Center, Ringshospitalet, University of Copenhagen, Copenhagen, Denmark
Hans-Peter Hartung, MD , Department of Neurology, Medical Faculty, Heinrich-Heine University, Dusseldorf, Germany
Ih Chang, PhD , Biogen, Cambridge, MA
Sarah Naoshy, MPH , Biogen, Cambridge, MA
Nolan Campbell, PhD , Biogen, Cambridge, MA
Christina Eavis, BS , Infusion, an Ashfield company, part of UDG Healthcare, San Bruno, CA



Background: Patients with multiple sclerosis (MS) report diminished health-related quality of life (HRQoL). Previous analyses of natalizumab treatment in relapsing-remitting MS (RRMS) patients in the AFFIRM study have shown a significant effect of natalizumab on mental and physical HRQoL; however the impact on secondary-progressive MS (SPMS) patients has not been reported.

Objectives: To assess the impact of natalizumab on HRQoL, as measured by the Short Form-36 (SF-36), in SPMS patients from the ASCEND trial.

Methods: ASCEND was a randomized, double-blind, placebo-controlled phase 3 study of natalizumab in SPMS patients. The study (placebo n=448; natalizumab n=439) included assessments of the SF-36 Health Survey, an HRQoL measure (range 0–100; higher scores indicate better HRQoL). SF-36 Physical Component Summary (PCS) and Mental Component Summary (MCS) scores were assessed at baseline and week 96. PCS and MCS changes from baseline were analyzed by summary statistics, and treatment comparisons were analyzed by ANCOVA.

Results: At baseline, ASCEND SPMS patients had lower mean PCS scores (33.3) than RRMS patients (43.9) (as assessed at baseline in the AFFIRM study), but generally similar mean MCS scores (44.3 vs 46.1, respectively). Natalizumab-treated SPMS patients (n=429) remained stable at week 96, while placebo-treated patients demonstrated a statistically significant reduction in MCS scores (mean [SD] change from baseline: natalizumab 0.18 [10.81] vs placebo –1.81 [11.84]; P=0.027). PCS showed numerical worsening (mean [SD] change from baseline: placebo –0.35 [7.32] vs natalizumab –0.17 [7.10]; P=0.803). In SPMS placebo-treated patients (n=426), MCS worsening was greater in magnitude than PCS worsening (mean [SD] change from baseline: –1.81 [11.84] vs –0.35 [7.32], respectively).

Conclusions: As would be expected, SPMS patients have lower PCS scores compared to RRMS patients, but similar MCS scores. HRQoL worsening in SPMS patients over 2 years was driven by MCS decline. Though there was no significant difference in PCS scores, treatment with natalizumab over approximately 2 years demonstrated a significant treatment effect in mental HRQoL in SPMS patients compared to placebo.