Medically reviewed by Dr. Kimberly Langdon Cull, M.D. on August 5, 2023
The adjudication of attacks in neuromyelitis optica spectrum disorder patients was robust and associated with elevated levels of sGFAP and MRI lesion correlates.
The N-MOmentum trial evaluated the safety and efficacy of inebilizumab in neuromyelitis optica spectrum disorder (NMOSD) patients. In an analysis published in the journal Multiple Sclerosis, the authors aimed to assess the adjudication committee (AC) performance and the attack identification process of this trial in the context of magnetic resonance imaging (MRI) findings and serum glial fibrillary acidic protein (sGFAP) biomarkers.
The participants reported a total of 64 potential NMOSD attacks, and the criteria were fulfilled by 80% of the attacks based on the evaluation of site investigations. Out of these attacks, 84% were confirmed by the AC.
Reliability of Adjudication Committee Performance and Attack Identification
The inter-AC-member agreement was high, and 51/64 decisions about NMOSD attacks were unanimous. The analysis also reported a high degree of reliability in attack identification and adjudication. In 97% of the cases, the concurrence of pre-planned re-adjudication with the initial decision in the assessment of intra-rater agreement was evident. Approximately 88% of the cases indicated good agreement between AC and investigator decisions about potential NMOSD attacks.
MRI Findings and Incidence of NMOSD Attacks
Approximately 90% of the cases demonstrated MRI lesion correlates in adjudicated NMOSD attacks. In such cases, the detection of T1 lesions was greater compared to that of T2 lesions in adjudicated events. New domain-specific MRI lesions were evident in 6/13 participant-reported events.
sGFAP Concentrations and Incidence of NMOSD Attacks
More AC-adjudicated NMOSD attacks demonstrated elevated sGFAP concentrations compared to non-AC-adjudicated attacks. In AC-adjudicated attacks, increased sGFAP concentrations were less frequent in the inebilizumab group compared to the placebo group. Compared to participants without any new symptoms at the end of the randomized controlled period, there was a significant increase in the sGFAP concentration in participants with either participant-reported symptoms or AC-adjudicated attacks.
The AC adjudication of attacks in NMOSD patients is robust and is associated with elevated levels of sGFAP and MRI lesion correlates.
Weinshenker, B. G., Wingerchuk, D. M., Green, A. J., Bennett, J. L., Kim, H. J., Pittock, S. J., Fujihara, K., Paul, F., Cutter, G., Marignier, R., Aktas, O., Hartung, H. P., She, D., Smith, M., Rees, W., Patterson, K., Cimbora, D., Katz, E., & Cree, B. A. (2023). Attack adjudication in neuromyelitis optica spectrum disorder: Substantiation of criteria by magnetic resonance imaging and biomarkers in N-MOmentum. Multiple sclerosis (Houndmills, Basingstoke, England), 29(8), 945–955. https://doi.org/10.1177/13524585231172145