Hospital resource utilization in patients with generalized myasthenia gravis treated with nipocalimab: results from the VIVACITY-MG3 study.

چکیده اصلی

AIMS: Generalized myasthenia gravis (gMG) is a rare, chronic autoimmune disorder with substantial healthcare resource utilization (HRU) and high economic burden. This study evaluated HRU, costs, and predictors of high-cost events in adults with gMG, using data from VIVACITY-MG3. METHODS: Post-hoc analyses used the primary efficacy dataset from VIVACITY-MG3, a randomized, double-blind, placebo-controlled study of nipocalimab and standard-of-care (SoC) versus placebo and SoC in seropositive adults with gMG. HRU endpoints included hospital admissions (HA), emergency department visits (EDV), and hospital days. Logistic regression analysis identified clinical and demographic HA/EDV predictors. Hospital costs per patient per year (PPPY) were estimated using United States (US) cost data from published sources and from a claims database, adjusted to 2024 US dollars. RESULTS: Among 153 patients, nipocalimab numerically reduced the proportion experiencing ≥1 all-cause (9.1% vs 15.8%) and gMG-related (3.9% vs 7.9%) HA/EDV events versus placebo. The incidence rate of HA/EDV events was 51% numerically lower with nipocalimab. Mean hospital stay duration was numerically shorter with nipocalimab for all-cause (8.4 vs 14.6 days) and gMG-related admissions (11.2 vs 17.6 days). All-cause and gMG-related hospital days per 100 patient-years were statistically significantly reduced by 60% and 68% with nipocalimab, respectively. Estimated cost offsets for reduced HRU were $10,860-$13,253 PPPY. Multivariate analysis identified worsening in Myasthenia Gravis-Activities of Daily Living (MG-ADL) total score and higher baseline Quantitative Myasthenia Gravis (QMG) respiratory total score as independent predictors. Patients switching from placebo to nipocalimab in the VIVACITY-MG3 open-label extension experienced a 64% reduction in hospital days PPPY. LIMITATIONS AND CONCLUSION: Study limitations include the post-hoc nature of the analysis and the relatively short study duration. Nipocalimab added to SoC significantly reduces overall HRU and associated costs in adults with gMG, particularly by lowering rates and severity of HA/EDV events. Clinical deterioration and high baseline disease severity independently predict high-cost events.

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