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This systematic review and meta-analysis evaluated the safety of intrathecal tofersen in SOD1-associated ALS across 6 studies comprising 179 tofersen-treated patients and 48 placebo controls. Any adverse event occurred in 98.0% of patients (95% CI, 95.6–100), while serious adverse events occurred in 10.0% (95% CI, 0–22.1). The most common events were procedural pain (56.2%), headache (54.1%), back pain (38.4%), and extremity pain (35.9%). CSF pleocytosis occurred in 44.1%, while nausea and fatigue occurred in 17.0% and 21.6%, respectively. Respiratory failure was reported in 9.2%. Most events were mild to moderate and manageable, although rare serious complications including meningitis, myelitis, and intracranial hypertension were reported.
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This systematic review and meta-analysis evaluated the safety of intrathecal tofersen in SOD1-associated ALS across 6 studies comprising 179 tofersen-treated patients and 48 placebo controls. Any adverse event occurred in 98.0% of patients (95% CI, 95.6–100), while serious adverse events occurred in 10.0% (95% CI, 0–22.1). The most common events were procedural pain (56.2%), headache (54.1%), back pain (38.4%), and extremity pain (35.9%). CSF pleocytosis occurred in 44.1%, while nausea and fatigue occurred in 17.0% and 21.6%, respectively. Respiratory failure was reported in 9.2%. Most events were mild to moderate and manageable, although rare serious complications including meningitis, myelitis, and intracranial hypertension were reported.
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