N-MOmentum clinical trial of Uplizna shows role of assessment accuracy in neuromyelitis optica spectrum disorder and is published in Multiple Sclerosis Journal

The N-MOmentum pivotal trial, which demonstrated Uplizna reduced the risk of attacks associated with the disease, introduced a new approach for attack analysis. Attacks were evaluated by an adjudication committee (AC, comprised of two neurologists and one neuro-ophthalmologist). The approach was revised based on guidance from the FDA. The process evaluated 18 predefined criteria (covering optic neuritis, myelitis and brain/brainstem domains). Domain-specific MRI review was performed in scenarios where the clinical findings were indeterminant. This analysis assessed the accuracy of the attack adjudication criteria against a retrospective review of MRI (for those attacks where MRI was not reviewed) as well as assess the biomarker serum glial fibrillary acidic protein (sGFAP, a structural filament protein that is released following injury of the central nervous system).

Of the 230 participants in the trial, 64 participant-reported neurological events occurred; 51 of these (80%) were deemed attacks by the trial investigators and of those, 43 (84%) were independently confirmed by the AC. The use of detailed, predefined criteria enabled reliable and reproducible determinations, as only 16% of investigator-determined attacks were rejected following AC review and no investigator-rejected attack decisions were reversed by the AC.

MRI and sGFAP biomarker findings provided additional specificity in the attack adjudication process. New domain-specific lesions were found in 90% of adjudicated attacks for which MRI data were available, and use of MRI allowed for confirmation of 33% of adjudicated attacks for which clinical findings were inconclusive. Further, increased concentrations of sGFAP (>2-fold mean change from baseline) were observed in more than half (56%) of adjudicated attacks, reinforcing the potential role of sGFAP in NMOSD attacks and supporting the use of sGFAP measurements in clinical care. Importantly, sGFAP elevations were notably less common in Uplizna-treated participants than those receiving placebo, consistent with previous findings showing the effectiveness of Uplizna in reducing sGFAP levels. These findings are published in the Multiple Sclerosis Journal.

See: "Attack adjudication in neuromyelitis optica spectrum disorder: Substantiation of criteria by magnetic resonance imaging and biomarkers in N-MOmentum" Brian G Weinshenker et al. Multiple Sclerosis Journal online June 6, 2023 https://doi.org/10.1177/13524585231172145