Satralizumab is a humanised monoclonal antibody that binds to and blocks the IL-6 receptor and was shown to reduce NMOSD relapse risk in both the SAkuraSky (satralizumab in combination with baseline immunosuppressants), and the SAkuraStar (satralizumab monotherapy) phase 3 trials. The pooled double-blind population included 178 patients (satralizumab, n=104; placebo, n=74); 166 patients received satralizumab in the open-label extension period. The combined double-blind/extension period was defined as the overall satralizumab treatment period, in which mean exposure was around 130 weeks.
In the double-blind period, rates of adverse events (AEs) and serious AEs in the satralizumab arms were comparable to those with placebo. Infection rates were lower with satralizumab. In the double-blind and overall treatment periods, AE, serious AE, and infection rates were comparable (see Table). An AE led 4 patients (3.8%) on satralizumab and 6 (8.1%) on placebo to withdraw from the double-blind period. The injection-related reaction (IRR) rate was higher with satralizumab. IRRs were mostly mild-to-moderate and did not lead to treatment discontinuation.
Table. Pooled adverse event rates across the SAkuraSky and SAkuraStar trials [1]

- Greenberg BM, et al. Abstract EPR2140, EAN 2020.
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