Real-world experience with switching from originator to biosimilar natalizumab
Hogestol, E. A.; Brustad, A. W.; Celius, E. G.; Meling, M.; Berg-Hansen, P.; Kro, G. B.; König, M.; Warren, D.; Gehin, J. E.; Bolstad, N.; Nygaard, G. O.
Show abstract
In January 2024, all persons with multiple sclerosis (pwMS) treated with natalizumab (NTZ) at Oslo University Hospital switched from originator to biosimilar NTZ. We prospectively monitored 39 pwMS during the first year of treatment with biosimilar NTZ and evaluated change in disease activity, side effects, serum NTZ levels, anti-drug antibodies (ADAb), and anti-John Cunningham virus (JCV) antibody levels. Serum NTZ levels and ADAb were measured using in-house assays, while JCV antibody levels were evaluated using Stratify (Biogen) and Immunowell (Sandoz) platforms. One new relapse occurred during the first year and 11 pwMS (28%) reported new side effects after switching to the biosimilar; whereof fatigue, headache, and muscle pain were most frequent. Serum NTZ levels were similar between pwMS on originator (15.1 mg/L, SD 8.9) and biosimilar NTZ (14.9 mg/L, SD 9.0; p = 0.63). We identified ADAb in one pwMS, present both before and after switching. The proportion of pwMS with positive JCV antibody levels increased from 13% in 2023 (Stratify) to 52% in 2024 (Immunowell). Four pwMS discontinued NTZ due to high anti-JCV antibody levels (in the Immunowell assay) in the first 10 months.
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