1. Quantifying the relationship between disability progression and quality of life in patients treated for NMOSD: Insights from the SAkura studies
- Author
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Gene Wallenstein, Gaelle Klingelschmitt, Elisabetta Damonte, Michael J. Levy, Cristina Costantino, D. Di Maio, H. Christian von Büdingen, Ursula Becker, Lech Szczechowski, and Alan Haycox
- Subjects
medicine.medical_specialty ,Neuromyelitis optica ,Expanded Disability Status Scale ,business.industry ,Multiple sclerosis ,Neuromyelitis Optica ,General Medicine ,medicine.disease ,Clinical trial ,Neurology ,Quality of life ,immune system diseases ,Surveys and Questionnaires ,medicine ,Physical therapy ,Quality of Life ,Humans ,Disability progression ,Spectrum disorder ,In patient ,Disabled Persons ,Neurology (clinical) ,business ,Immunosuppressive Agents - Abstract
Background To 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. Methods SAkuraSky (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. Results Overall, 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. Conclusions These results, generated from high-quality clinical trial data, demonstrated a strong and consistent relationship between disability and QoL in patients with NMOSD.
- Published
- 2021