Quantifying the relationship between disability progression and quality of life in patients treated for NMOSD: Insights from the SAkura studies

• Main Authors: Becker, U. (Author), Costantino, C. (Author), Damonte, E. (Author), Haycox, A.R (Author), Klingelschmitt, G. (Author), Levy, M. (Author), Maio, D.D (Author), Szczechowski, L. (Author), von Büdingen, H.C (Author), Wallenstein, G. (Author)
• Format: Article
• Language: English
• Published: Elsevier B.V. 2022
• Subjects: Association; clinical trial; controlled study; disabled person; Disabled Persons; EDSS; EQ-5D; human; Humans; immunosuppressive agent; Immunosuppressive Agents; multicenter study; myelooptic neuropathy; Neuromyelitis Optica; Neuromyelitis optica spectrum disorder; NMO; quality of life; Quality of Life; questionnaire; randomized controlled trial; Surveys and Questionnaires
• Online Access: View Fulltext in Publisher

 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. © 2021