Abstract
BackgroundTo date, no specific scales have been developed to explore the impact of neuromyelitis optica spectrum disorder (NMOSD)-related disability on quality of life (QoL). The Expanded Disability Status Scale (EDSS) and the EuroQol 5-dimensions (EQ-5D) have been used to assess disability and QoL, respectively, in patients with NMOSD. However, there is limited evidence surrounding their use in this condition. We compared EDSS and EQ-5D data across two clinical trials to quantify the relationship between disability and QoL in patients with NMOSD. MethodsSAkuraSky (NCT02028884) and SAkuraStar (NCT02073279) were Phase 3, multicenter, randomized, international, double-blind, placebo-controlled, parallel-assignment studies of satralizumab, administered in combination with baseline immunosuppressants (SAkuraSky) or as monotherapy (SAkuraStar). EDSS and EQ-5D were assessed at baseline and at 24-week intervals thereafter. The relationship between disability and QoL was assessed by estimating EQ-5D utilities (UK tariff) for each incremental EDSS category. A repeated-measures linear model was used to regress health utilities on EDSS score-derived health states. ResultsOverall, 176 patients underwent at least one EDSS assessment and completed an EQ-5D survey and were included in this analysis. There was a clear association between mean EQ-5D score and EDSS score, with decreases in QoL being observed at each incremental increase in disability. The relationship between EDSS and EQ-5D score remained consistent across the different treatment groups. ConclusionsThese results, generated from high-quality clinical trial data, demonstrated a strong and consistent relationship between disability and QoL in patients with NMOSD.
Highlights
Neuromyelitis optica spectrum disorder (NMOSD) is a rare, lifelong, debilitating autoimmune disease that primarily affects the optic nerves and spinal cord (Borisow et al, 2018; Mealy et al, 2012; Oh and Levy, 2012)
The Expanded Disability Status Scale (EDSS) was obtained at every relapse event, the EuroQol 5-dimensions (EQ-5D) questionnaire was not administered at the time of a relapse
Other studies have shown that patient quality of life (QoL) in neuromyelitis optica spectrum disorder (NMOSD) is directly correlated with relapse (Beekman et al, 2019; Mutch et al, 2014); because the EQ-5D was not administered at the time of relapse, such an impact could not be assessed here
Summary
Neuromyelitis optica spectrum disorder (NMOSD) is a rare, lifelong, debilitating autoimmune disease that primarily affects the optic nerves and spinal cord (Borisow et al, 2018; Mealy et al, 2012; Oh and Levy, 2012). A minority of patients meeting NMOSD criteria are AQP4-IgG seronegative. These individuals experience the hallmark symptoms of NMOSD but show a more heterogeneous disease course, with a number of differences in their clinical features (Fujihara, 2019; Palace et al, 2019). No specific scales have been developed to explore the impact of neuromyelitis optica spectrum disorder (NMOSD)-related disability on quality of life (QoL). We compared EDSS and EQ-5D data across two clinical trials to quantify the relationship between disability and QoL in patients with NMOSD. The relationship between disability and QoL was assessed by estimating EQ-5D utilities (UK tariff) for each incremental EDSS category. Conclusions: These results, generated from high-quality clinical trial data, demonstrated a strong and consistent relationship between disability and QoL in patients with NMOSD
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