Sustained long-term efficacy and safety of satralizumab in NMOSD

The favourable efficacy and safety profile of satralizumab was sustained with long-term treatment of neuromyelitis optica spectrum disorder (NMOSD) in the open-label extensions (OLE) of the controlled SAkuraSky and SAkuraStar trials. High proportions of AQP4-IgG+ patients remained free from relapse and worsening disability after 3.7 years. Safety was also sustained over a median exposure of 4 years.

Two separate presentations assessed the long-term efficacy and safety, respectively, of satralizumab in patients with aquaporin-4-IgG-seropositive (AQP4-IgG+) NMOSD. Prof. Jeffrey Bennett (University of Colorado Hospital, CO, USA) presented the efficacy results [1]. He explained that participants from the SAkuraySky (NCT02028884) and SAkuraStar (NCT02073279) trials could enter the OLE, in which they were all treated with satralizumab 120 mg. In SAkuraSky, participants had received satralizumab + baseline immunosuppressants; in SAkuraStar, satralizumab monotherapy.

Overall, 111 AQP4-IgG+ patients were evaluated, 49 from SAkuraSky and 62 from SAkuraStar. These analyses assessed the annualised investigator-reported protocol-defined relapse (iPDR) rate (ARR), as well as the proportion of patients who remained free from iPDR, severe iPDR, and sustained Expanded Disability Status Scale (EDSS) score worsening. Severe iPDR was defined as a ≥2 point increase in the EDSS score; sustained EDSS worsening was an EDSS increase of ≥2, ≥1, or ≥0.5 points for patients with baseline scores of 0, 1–5, or ≥5.5, respectively.

Efficacy of satralizumab was sustained in the long term, with high proportions of AQP4-IgG+ patients free from iPDR (71% in SAkuraSky and 73% in SAkuraStar) and free from severe iPDR (91% and 90%, respectively) at week 192 (3.7 years). Percentages of patients free from sustained EDSS worsening were 90% and 86%, respectively. ARR remained consistently low in satralizumab-treated patients. The overall adjusted ARR was low at week 192: in SAkuraSky, it was 0.12 (95% CI 0.08–0.18); in SAkuraSky, 0.08 (95% CI 0.05 to -0.13). The yearly ARR was never above 0.20, with a range of 0.02–0.20. Prof. Bennett mentioned that satralizumab will also be tested as a treatment of myasthenia gravis.

The long-term safety outcomes of satralizumab in the OLE of the SAkura studies were presented by Prof. Benjamin Greenberg (UT Southwestern Medical Center, TX, USA) [2]. The OLE included 75 participants of the SAkuraSky and 91 of the SAkuraStar trial. Median treatment exposure in the overall treatment period (DBP + OLE) was 4 years. Rates of (serious) adverse events, including (serious) infection, in the overall treatment period were comparable to those in the double-blind periods of both studies. No deaths or anaphylactic reactions related to satralizumab treatement were reported.

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. S25.009, AAN 2022, 02–07 April, Seattle, USA.


2. Greenberg B, et al. Long-term Safety of Satralizumab in Neuromyelitis Optica Spectrum Disorder (NMOSD): Results from the Phase 3 SAkuraSky and SAkuraStar Studies. S25.010, AAN 2022, 02–07 April, Seattle, USA.

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Posted on 2 June, 2022