Satralizumab efficacious in AQP4-IgG-positive patients with NMOSD

In adults with AQP4-IgG-seropositive neuromyelitis optica spectrum disorder (NMOSD), satralizumab significantly reduced relapse risk, was well tolerated and showed a favourable safety profile compared with placebo. This was shown by efficacy and safety results from the phase 3 SAkura studies.

SAkuraSky (NCT02028884) tested satralizumab in combination with baseline immunosuppressants; SAkuraStar (NCT02073279) tested satralizumab as monotherapy. In both placebo-controlled studies, satralizumab reduced the risk of protocol-defined relapse. In a pooled subgroup analysis, efficacy and safety of satralizumab in adults with AQP4-IgG-positive NMOSD were assessed [1]. Between-group comparisons were made for time to first relapse, rates of adverse events (AEs), serious AEs, infections, and serious infections that occurred during the double-blind period. To assess safety, data from the overall satralizumab treatment periods were evaluated, including open-label extension periods.

The analysis included 116 adult AQP4-IgG-positive NMOSD patients. Compared with placebo, satralizumab significantly reduced protocol-defined relapse risk by 78% in SAkuraSky and by 74% in SAkuraStar. The percentages of patients who were relapse free after 96 weeks were 91.1% in the satralizumab group and 56.8% in the placebo group in SAkuraSky (HR 0.22; 95% CI 0.06–0.82; P=0.014). These percentages were 76.5% and 41.1%, respectively, in SAkuraStar (HR 0.26; 95% CI 0.11–0.63; P=0.001).

In both studies, rates of AEs and serious AEs were similar in the experimental and placebo groups (see Table). Risk of infection or serious infection was not elevated by satralizumab in the double-blind nor in the overall treatment period. Decreases in neutrophil and platelet counts and elevations in liver enzymes were more frequently observed with satralizumab, but were not associated with serious infections or bleeding events.

Table: Adverse event rates in the double-blind and overall treatment periods of the SAkura studies [1]

1. Bennett J, et al. Satralizumab in adults with AQP4-IgG seropositive NMOSD: Efficacy and safety results from the phase 3 SAkura studies. OPR-163, EAN 2021 Virtual Congress, 19–22 June.

 

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Posted on 18 August 202116 February 2024