Long-term efficacy of satralizumab for NMOSD

New, long-term data shows that more than 70% of patients with aquaporin-4 IgG-seropositive neuromyelitis optica spectrum disorder (AQP4-IgG+ NMOSD) treated with satralizumab remained relapse-free after 4 years, with a favourable safety profile [1].

Satralizumab, a subcutaneously administered, IL-6 receptor antagonist, significantly reduced the risk of relapse in patients with AQP4-IgG+ NMOSD in the 2 double-blind, randomised-controlled, phase 3 SAkuraSky (NCT02028884) and SAkuraStar (NCT02073279) trials. In both trials, a favourable safety profile was observed in the double-blind phase [2,3]. The current study, presented by Dr Ingo Kleiter (Ruhr-Universität Bochum, Germany), assessed the long-term efficacy of satralizumab. Patients who received ≥1 dose of satralizumab in the double-blind phase or the open-label extension (OLE) period were included in the analysis (n=111). Satralizumab dose in the OLE period was 120 mg, administered every 4 weeks. Efficacy endpoints were investigator-assessed protocol-defined relapses (iPDRs), severe iPDRs (≥2-point increase on the Expanded Disability Status Scale (EDSS), and sustained EDSS score worsening (≥24 weeks) at week 192. Dr Kleiter said: “Just one NMOSD relapse can lead to lifelong disability. An early accurate diagnosis followed by effective treatment is vital to conserving the quality of life of people with this chronic disease.”

At a median duration of 3.7 years (192 weeks) exposure to satralizumab, 71% (SAkuraSky) and 73% (SAkuraStar) of the patients were free from relapse. This corresponded to a mean annualised iPDR rate of 0.20. In addition, most patients were free from severe relapse (SAkuraSky 90%; SAkuraStar 91%). Sustained EDSS worsening was observed in 10% (SAkuraSky) and 14% (SAkuraStar) of the patients. These results demonstrate that the robust efficacy observed in the studies’ double-blind periods is sustained long-term for satralizumab, as both a monotherapy and in combination with immunosuppressive therapy.

The data also demonstrated a favourable safety and tolerability profile for satralizumab in the overall treatment period of up to 7 years, comparable to the double-blind treatment periods in both SAkuraStar and SAkuraSky studies. Rates of adverse events (AEs) and serious AEs during the overall treatment periods were consistent with satralizumab and placebo in the double-blind periods. The most common AEs observed were headache, arthralgia, white blood cell count decrease, hyperlipidemia, and injection-related reactions. No new safety signals were observed.

1. Kleiter I, et al. Long-term efficacy of satralizumab in aquaporin-4-IgG seropositive neuromyelitis optica spectrum disorder (NMOSD). Results from the open-label extension periods of SAkuraSky and SAkuraStar. P024, ECTRIMS 2021 Virtual Congress, 13–15 October.
2. Yamamura T, et al. N Engl J Med 2019;381(22):2114–2124.
3. Traboulsee A, et al. Lancet Neurol. 2020;19(5):402–412.

 

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Posted on 9 December 2021