Journal of neuroimmunology · 2025
The real-world experience of biologics for neuromyelitis optica spectrum disorders as first-line and switched therapy.
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Matsuyoshi Ayano, Shinoda Koji, Takeuchi Hajime, Mizutani Keisuke, Kira Yuu-Ichi, Iwao Kazunori, Watanabe Mitsuru, Masaki Katsuhisa, Isobe Noriko
Аннотация
BACKGROUND: Several biologics have demonstrated the efficacy in reducing relapses of neuromyelitis optica spectrum disorder (NMOSD) with aquaporin-4 immunoglobulin G (AQP4-IgG). However, real-world data on biologics for NMOSD are limited. We aimed to evaluate the efficacy and safety of biologics in clinical practice.
METHODS: We retrospectively reviewed the medical records of 117 patients with AQP4-IgG-positive NMOSD in our hospitals between 2000 and 2024. Patients were classified into Biologics-1st and glucocorticoids/immunosuppressants (GC/IS)-1st by their first-line therapy, and then those who switched from GC/IS to biologics (Switched to Biologics). Annualized relapse rate (ARR) and changes in Expanded Disability Status Scale (EDSS) scores were analyzed, and the safety was assessed in all biologics-treated patients.
RESULTS: Among 45 patients who switched to biologics, significant reductions were observed in ARR [median (interquartile range, IQR), 0.0 (0.0-0.0) vs. 0.4 (0.1-0.6), p < 0.0001] and annual changes in EDSS scores [median (IQR), 0.0 (0.0-0.0) vs. 0.1 (0.0-0.3), p < 0.0001] after switching. No relapses occurred during 24.3 patient-years in Biologics-1st group, while GC/IS-1st group had 330 relapses during 970.3 patient-years (p = 0.0031). The ARR was significantly lower in Biologics-1st than in GC/IS-1st [median (IQR), 0.00 (0.00-0.00) vs. 0.20 (0.10-0.50), p < 0.0001], while the EDSS score change was comparable. The safety profile of biologics was generally consistent with the clinical trial data.
CONCLUSIONS: Biologics were highly efficacious in preventing relapses of NMOSD with AQP4-IgG in real-world clinical practice.
METHODS: We retrospectively reviewed the medical records of 117 patients with AQP4-IgG-positive NMOSD in our hospitals between 2000 and 2024. Patients were classified into Biologics-1st and glucocorticoids/immunosuppressants (GC/IS)-1st by their first-line therapy, and then those who switched from GC/IS to biologics (Switched to Biologics). Annualized relapse rate (ARR) and changes in Expanded Disability Status Scale (EDSS) scores were analyzed, and the safety was assessed in all biologics-treated patients.
RESULTS: Among 45 patients who switched to biologics, significant reductions were observed in ARR [median (interquartile range, IQR), 0.0 (0.0-0.0) vs. 0.4 (0.1-0.6), p < 0.0001] and annual changes in EDSS scores [median (IQR), 0.0 (0.0-0.0) vs. 0.1 (0.0-0.3), p < 0.0001] after switching. No relapses occurred during 24.3 patient-years in Biologics-1st group, while GC/IS-1st group had 330 relapses during 970.3 patient-years (p = 0.0031). The ARR was significantly lower in Biologics-1st than in GC/IS-1st [median (IQR), 0.00 (0.00-0.00) vs. 0.20 (0.10-0.50), p < 0.0001], while the EDSS score change was comparable. The safety profile of biologics was generally consistent with the clinical trial data.
CONCLUSIONS: Biologics were highly efficacious in preventing relapses of NMOSD with AQP4-IgG in real-world clinical practice.