NMOSD Attack Adjudication Procedure Used in N-MOmentum Clinical Trial of Uplizna May Provide Template for Clinical Assessment

The neuromyelitis optica spectrum disorder (NMOSD) attack adjudication procedure utilized in the N-MOmentum clinical trial (NCT02200770) was robust, according to a study published in Multiple Sclerosis Journal. N-MOmentum was a randomized, placebo-controlled, double-blind, phase 2/3 clinical trial evaluating the safety and efficacy of Uplizna (inebilizumab-cdon, Horizon Therapeutics PLC, Dublin, Ireland) for reducing the risk of NMOSD attacks compared with a placebo.

In N-MOmentum, 230 adult participants with NMOSD reported potential attacks to an on-site investigator. Then, both investigator-determined attacks and non-attacks were evaluated by an adjudication committee (AC) consisting of 2 neurologists and 1 neuro-opthamologist. The on-site investigator and AC evaluated patient-reported attacks according to 18 predefined criteria for the optic neuritis, myelitis, and brain/brainstem domains, including clinical and magnetic resonance imaging (MRI)-dependent data. The robustness of the N-MOmentum adjudication process was evaluated by analysis of additional MRI measurements, as well as serum glial fibrillary acidic protein (sGFAP) concentrations. Of the 64 total patient-reported events, 51 (80%) were deemed attacks by investigators. The AC found that 43 (84%) of the investigator-determined attacks were NMOSD attacks, while none of the investigator-determined non-attacks were attacks. MRI confirmed 33% of AC-adjudicated attacks where clinical findings were inconclusive, and new domain-specific lesions were found in 90% of AC-adjudicated attacks. More participants with AC-adjudicated attacks had elevated concentrations of sGFAP (78%) vs non-AC-adjudicated attacks (46%), and 56% of participants with AC-adjudicated attacks had increased sGFAP concentrations compared to baseline, reinforcing the potential role of sGFAP as a biomarker for astrocytic damage in the evaluation of NMOSD attack.

“The adjudication process provided an accurate, reliable understanding of the nature of NMOSD attacks, with MRI correlates and biomarker elevations found in the vast majority of adjudicated attacks,” said study author Brian Weinshenker, MD.

In the future, the adjudication process utilized in N-MOmentum could be applied in the clinical setting to provide increased consistency and accuracy when assessing NMOSD attacks.