Satralizumab is a new medication being used to treat NMOSD. This study examines whether it is safe and effective for use in long-term therapy.
Satralizumab is a medication used to treat neuromyelitis optica spectrum disorder (NMOSD). Two phase 3 trials are described in this study, SAkuraSky, which used satralizumab in combination with baseline immunosuppressive therapy, and SAkuraStar, which used satralizumab monotherapy. Both are international, multicenter, randomized, placebo-controlled, phase 3 studies, which consisted of a double-blind period followed by an open-label extension. This study, published in Multiple Sclerosis and Related Disorders, provides the results of these studies as well as implications for these forms of treatment.
In the SAkuraSky double-blind period, 41 patients received satralizumab, while 42 received a placebo, in addition to stable baseline immune suppression therapy. In the SAkuraStar double-blind period, 63 patients received satralizumab monotherapy, while 32 received a placebo. Overall rates of infections, including serious infections, were consistent during the overall satralizumab treatment period. Longer exposure to satralizumab was not associated with a higher risk of severe laboratory changes, and no deaths or anaphylactic reactions to treatment with satralizumab were reported during the overall treatment period of both studies. Median satralizumab exposure in the double-blind period was 2.1 years in SAkuraSky and 1.8 years in SAkuraStar, and the median exposure time in the overall satralizumab treatment period was 4.4 years and 4.0 years, respectively.
The authors conclude that according to their data, satralizumab has a favorable safety profile as well as good tolerability in long-term therapy. They also note that combination with immunosuppressive therapy does not significantly change either of these factors. The ongoing safety of satralizumab continues to be monitored, but the current data show favorable results.
Yamamura, T., Weinshenker, B., Yeaman, M. R., De Seze, J., Patti, F., Lobo, P., von Büdingen, H. C., Kou, X., Weber, K., & Greenberg, B. (2022). Long-term safety of satralizumab in neuromyelitis optica spectrum disorder (NMOSD) from SAkuraSky and SAkuraStar. Mult Scler Relat Disord, 66, 104025. https://doi.org/10.1016/j.msard.2022.104025