Noninfectious meningitis related to nusinersen: a pharmacovigilance analysis using the WHO database.

During treatment of spinal muscular atrophy with the antisense oligopeptide nusinersen, rare cases of drug-induced non-infectious meningitis have been reported. Drug-induced non-infectious meningitis is usually diagnosed by exclusion and additional factors, such as the highly variable time to onset might complicate the diagnosis even more. In this retrospective study we analyzed 73 individual case safety reports (ICSR) from the WHO database Vigibase™. The aim of the study was to assess the risk associated with the use of the drug and to discuss potential risk factors for the occurrence of non-infectious meningitis during treatment with nusinersen. A disproportionality analysis was applied to evaluate whether non-infectious meningitis and related reactions associated with nusinersen were reported disproportionately frequently compared to other drugs. Most of the adverse reactions analyzed showed a statistically significant signal for association with nusinersen. Due to the limited data available, we can only speculate about possible risk factors as well as about the underlying mechanism. Awareness of non-infectious meningitis as a potential adverse reaction associated with nusinersen can simplify diagnosis and contribute to timely treatment. The benefits of nusinersen in terms of improving motor function and survival in patients with SMA clearly outweigh the rare risks.