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