Phase III SAkuraSky Study shows SA 237 cuts risk of relapse in neuromyelitis optica.- Chugai Pharma.
Chugai Pharmaceutical announced new results from the phase III study of SA 237 (satralizumab) SAkuraSky Study (NCT02028884) for the treatment of neuromyelitis optica spectrum disorder (NMOSD), which currently has no approved treatments. The phase III study results for SAkuraSky study showed that satralizumab on top of immunosuppressive therapy significantly reduced the risk of relapse by 62% (hazard ratio = 0.38 [95% confidence interval: 0.16-0.88], p=0.0184 [stratified log-rank test]) in patients with NMOSD including anti-aquaporin-4 (AQP4) antibody positive (AQP4 Ab positive) and negative (AQP4 Ab negative) patients, achieving the primary endpoint of time to first protocol-defined relapse (PDR) in the double-blind period.
The proportion of relapse free at weeks 48 and 96 was 88.9% and 77.6% with satralizumab and 66.0% and 58.7% with placebo, respectively. In a prespecified subgroup analysis, satralizumab showed a 79% risk reduction (N=55, hazard ratio=0.21 [95% confidence interval: 0.06-0.75]) of PDR compared to placebo in the NMOSD AQP4 Ab positive subgroup. The proportion of relapse free at weeks 48 and 96 was 91.5% and 91.5% with satralizumab and 59.9% and 53.3% with placebo, respectively. For the NMOSD AQP4 Ab negative subgroup, satralizumab showed a 34% risk reduction (N= 28, hazard ratio= 0.66 [95% confidence interval: 0.20-2.23]) of PDR compared to placebo, and the proportion of relapse free at weeks 48 and 96 was 84.4% and 56.3% with satralizumab, and 75.5% and 67.1% with placebo, respectively. Throughout the mean treatment duration of approximately 2 years, satralizumab showed a favorable safety profile.
The proportion of patients experiencing serious adverse events, including serious infections, was similar in patients treated with satralizumab or placebo. No death or anaphylactic reactions were observed. Data were presented at the Congress of European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) 2018.
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