Horizon Therapeutics announced the publication of a new analysis from the N-MOmentum clinical trial of UPLIZNA demonstrating the utility of a robust adjudication process that could improve clinical care decision-making in neuromyelitis optica spectrum disorder, NMOSD, through more accurate and consistent assessment of disease-related attacks. These findings are published in the Multiple Sclerosis Journal. NMOSD is characterized by recurrent disabling attacks, which often lead to permanent disability. Properly defining NMOSD attacks is essential to inform treatment decisions, yet there are no universally accepted criteria for accurate and objective diagnosis of NMOSD attacks. The N-MOmentum pivotal trial, which demonstrated UPLIZNA reduced the risk of attacks associated with the disease, introduced a new approach for a”Together with well-defined review criteria and biomarker analysis, this robust adjudication process could serve as the basis for consistent attack evaluations in future studies and real-world care,” said Kristina Patterson, M.D., Ph.D., senior medical director, neuroimmunology medical affairs, Horizon. “Importantly, the accurate picture of disease-related attack events seen in this analysis further reinforces the efficacy of UPLIZNA in reducing these attacks and improving outcomes for people with NMOSD.” ttack analysis. Attacks were evaluated by an adjudication committee . The approach was revised based on guidance from the U.S. Food and Drug Administration FDA. The process evaluated 18 predefined criteria . Domain-specific MRI review was performed in scenarios where the clinical findings were indeterminant…
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