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| Item Type: | Article |
|---|---|
| Title: | Serum glial fibrillary acidic protein: a neuromyelitis optica spectrum disorder biomarker |
| Creators Name: | Aktas, O. and Smith, M.A. and Rees, W.A. and Bennett, J.L. and She, D. and Katz, E. and Cree, B.A.C. |
| Abstract: | OBJECTIVE: Blood tests to monitor disease activity, attack severity, or treatment impact in neuromyelitis optica spectrum disorder (NMOSD) have not been developed. This study investigated the relationship between serum glial fibrillary acidic protein (sGFAP) concentration and NMOSD activity and assessed the impact of inebilizumab treatment. METHODS: N-MOmentum was a prospective, multicenter, double-blind, placebo-controlled, randomized clinical trial in adults with NMOSD. sGFAP levels were measured by single-molecule arrays (SIMOA) in 1,260 serial and attack-related samples from 215 N-MOmentum participants (92% aquaporin 4-immunoglobulin G-seropositive) and in control samples (from healthy donors and patients with relapsing-remitting multiple sclerosis). RESULTS: At baseline, 62 participants (29%) exhibited high sGFAP concentrations (≥170 pg/ml; ≥2 standard deviations above healthy donor mean concentration) and were more likely to experience an adjudicated attack than participants with lower baseline concentrations (hazard ratio [95% confidence interval], 3.09 [1.6-6.1], p = 0.001). Median (interquartile range [IQR]) concentrations increased within 1 week of an attack (baseline: 168.4, IQR = 128.9-449.7 pg/ml; attack: 2,160.1, IQR = 302.7-9,455.0 pg/ml, p = 0.0015) and correlated with attack severity (median fold change from baseline [FC], minor attacks: 1.06, IQR = 0.9-7.4; major attacks: 34.32, IQR = 8.7-107.5, p = 0.023). This attack-related increase in sGFAP occurred primarily in placebo-treated participants (FC: 20.2, IQR = 4.4-98.3, p = 0.001) and was not observed in inebilizumab-treated participants (FC: 1.1, IQR = 0.8-24.6, p > 0.05). Five participants (28%) with elevated baseline sGFAP reported neurological symptoms leading to nonadjudicated attack assessments. INTERPRETATION: Serum GFAP may serve as a biomarker of NMOSD activity, attack risk, and treatment effects. ANN NEUROL 2021;89:895-910. |
| Keywords: | Biomarkers, Double-Blind Method, Glial Fibrillary Acidic Protein, Humanized Monoclonal Antibodies, Kaplan-Meier Estimate, Neuromyelitis Optica, Prospective Studies, Relapsing-Remitting Multiple Sclerosis, Risk Assessment, Survival Analysis, Treatment Outcome |
| Source: | Annals of Neurology |
| ISSN: | 0364-5134 |
| Publisher: | Wiley |
| Volume: | 89 |
| Number: | 5 |
| Page Range: | 895-910 |
| Date: | May 2021 |
| Additional Information: | Friedemann Paul is a member of the N-MOmentum Scientific Group. |
| Official Publication: | https://doi.org/10.1002/ana.26067 |
| PubMed: | View item in PubMed |
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