Pooled Phase III open-label extension data reinforce safety of satralizumab in neuromyelitis optica spectrum disorder

Pooled data from the double-blind periods of the SAkuraStar and SAkuraSky studies showed that the rates of adverse events (AEs) and serious AEs were comparable between satralizumab and placebo (serious AEs: 15.0 vs 18.0 events/100 patient years, respectively).

SPS commentary:

The safety profile of satralizumab in the open-label extension was consistent with the double-blind period with respect to the nature and rate of AEs. The most common AEs in both treatment groups were urinary tract infection and upper respiratory tract infection. No deaths or anaphylactic reactions were reported.

Satralizumab is an investigational humanized monoclonal antibody that targets the interleukin-6 (IL-6) receptor. The European Medicines Agency is currently reviewing satralizumab as monotherapy or added to immunosuppressive therapy in the treatment of neuromyelitis optica, and granted it accelerated assessment in November 2019.


Biospace Inc.