Jacqueline Palace, BM, FRCP, DM
An updated analysis from the open-label SAkuraMoon study (NCT04660539) presented at the 2023 MSMilan, the 9th Joint ECTRIMS-ACTRIMS Meeting, October 11–13, in Milan, Italy, showed treatment with satralizumab (Enspryng; Genentech) had a consistently low annual release rates (ARR) among patients with aquaporin-4-IgG-seropositive (AQP4 IgG+) neuromyelitis optica spectrum disorder (NMOSD) over a 5.5-year period. These findings highlight satralizumab, a humanized monoclonal antibody medication, as a strongly efficacious long-term therapy for NMOSD.1
Among 111 patients with AQP4+ NMOSD, the median duration of satralizumab exposure was 5.9 years (range, 0.1–8.9). In this treated patient population, the overall adjusted ARR was 0.08 (95% CI, 0.06–0.10), and did not increase with additional years of exposure (year 1, 0.17 [95% CI, 0.10–0.28]; year 2, 0.10 [95% CI, 0.05–0.19]; year 3: 0.04 [95% CI, 0.01–0.14]; year 4: 0.08 [95% CI, 0.02–0.25]; year 5: 0.05 [95% CI, 0.01–0.17]).
Conducted by lead author Jacqueline Palace, BM, FRCP, DM, consultant neurologist in Oxford and professor in the Nuffield Department of Clinical Neurosciences at Oxford University, and colleagues, patients who completed the double-blind periods (DBPs) and open-label extensions (OLEs) of SAkuraSky (NCT02028884) and SAkuraStar (NCT02073279) were rolled over into SAkuraMoon. The patients then continued to receive satralizumab at 120 mg every 4 weeks with or without baseline immunosuppressants. Investigators analyzed all adults with AQP4-IgG+ who were at least 18 years old and received at least 1 dose of satralizumab during these studies from first dose to the cut-off on January 31, 20223—defined as the overall satralizumab treatment period.
- Satralizumab continues to show long-term effectiveness in managing neuromyelitis optica spectrum disorder (NMOSD) with consistent low annual relapse rates.
- A 5.5-year study of 111 patients with AQP4-IgG+ NMOSD treated with satralizumab reveals that 72% of patients were free from relapses, 91% were free from severe relapses, and 83% had no sustained EDSS worsening.
- The updated SAkuraMoon study analysis, presented by Jacqueline Palace at MSMilan 2023, demonstrates promising results for satralizumab treatment in NMOSD, with a low dropout rate and minimal treatment discontinuations.
Protocol-defined relapses (PDRs) in the DBPs were adjudicated by an independent Clinical Endpoint Committee; however, PDRs in the OLEs and SAkuraMoon were determined by the investigator. Efficacy analyses assessed the annualized investigator-determined protocol-defined relapse (iPDR) rate, time to first iPDR, severe iPDR (defined as an at least 2-point increase in Expanded Disability Status Scale [EDSS] score), and sustained EDSS worsening (defined as an EDSS increase of at least 2, 1, or 0.5 points for patients with baseline scores of 0, 1-5, or at least 5.5, respectively, confirmed at least 24 weeks post initial worsening).
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After 5.5 years, 72% (95% CI, 62%–80%) of satralizumab-treated patients were free from iPDR, 91% of patients (95% CI, 83%–95%) were free from severe iPDR, and 83% of patients (95% CI, 73%–90%) had no sustained EDSS worsening. The researchers noted that only 3 patients dropped out from SAkuraMoon, 2 patients switched to commercial satralizumab, and 1 patient discontinued treatment because of pregnancy.
An earlier analysis of this study presented at the annual Americas Committee for Treatment and Research in Multiple Sclerosis (ACTRIMS) Forum, held February 23-25, 2023, in San Diego, California, demonstrated a high proportion of adult patients with AQP4-IgG+ NMOSD who remained free of relapse with a consistently low ARR over 4.6 years of satralizumab exposure from SAkuraMoon.2 After 4.6 years, 72% (95% CI, 62-80%) of satralizumab-treated patients were free from iPDR. At the same time, 91% (95% CI, 84-96) of patients were free from severe iPDR, and 85% (95% CI, 75-91%) had no sustained EDSS worsening.
In the previous analysis, the median duration of satralizumab exposure was 5.0 years (range, 0.1-7.9). Rates of adverse events (AEs) and serious AEs in the overall satralizumab treatment period were comparable with the DBPs (AEs, 332.6 per 100 PY [95% CI, 316.7-349.1]; serious AEs: 10.5 per 100 PY [95% CI, 7.8-13.8]). Rates of infections (92.9 per 100 PY; 95% CI, 84.6-101.8) and serious infections (2.4 per 100 PY; 95% CI, 1.3-4.2) in the overall treatment period were comparable with the DBP, with no increases being observed over time. No deaths, anaphylactic reactions related to satralizumab, or injection-related reactions occurred that led to changes in study treatment.
In August 2020, the FDA approved satralizumab, a humanized monoclonal recycling antibody against the IL-6 receptor, for use in adult patients with AQP4-IgG+ NMOSD which is the third targeted treatment for this population and the first eligible for at-home administration.3 The approval was based on robust data from the phase 3 SAkuraStar (NCT02073279) and SAkuraSky (NCT02028884) clinical trials, which combined included more than 170 patients who were randomly assigned to receive satralizumab 120 mg or placebo. In SAkuraSky, patients added treatment to baseline immunosuppressive therapy.
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1. Palace J, Traboulsee A, Saiz A, et al. Long-term efficacy of satralizumab in patients with AQP4-IgG+ NMOSD: Updated analysis from the open-label SAkuraMoon study. Presented at: 2023 MSMilan; October 11-12; Milan, Italy. Abstract P362.
2. Bennett JL, Greenberg B, Weinshenker BG, et al. Long-term Efficacy and Safety of Satralizumab in Adults with AQP4-IgG-seropositive Neuromyelitis Optica Spectrum Disorder (NMOSD): Results from the Roll-over, Open-label Study SAkuraMoon. Presented at ACTRIMS Forum 2023; February 23-25; San Diego, California. Abstract P324.
3. FDA approves Genentech’s Enspryng for neuromyelitis optica spectrum disorder. News release. Genentech. August 14, 2020. Accessed October 11, 2023. https://www.businesswire.com/news/home/20200814005501/en/ADDING-MULTIMEDIA%C2%A0FDA-Approves-Genentech%E2%80%99s-Enspryng-Neuromyelitis-Optica