CONFERENCE UPDATE: AAN 2024

Updated long-term efficacy of satralizumab in relapse prevention for AQP4-IgG+ NMOSD patients in the SAkuraMoon study

NEUROLOGY
15 Jul 2024

STUDY DESIGN 

Satralizumab is a monoclonal recycling antibody that targets the interleukin-6 receptor (IL-6R).1 Two randomized, placebo-controlled, phase 3 clinical trials, SakuraSky and SAkuraStar, had demonstrated the significant reductive effect and favorable safety and tolerability profile of 120mg satralizumab subcutaneous (SC) administration in the risk of relapse in patients with aquaporin-4 immunoglobulin G seropositive (AQP4-IgG+) neuromyelitis optica spectrum disorder (NMOSD).1

This open-label extension (OLE) SAkuraMoon study aimed to assess the long-term efficacy of satralizumab in patients with AQP4-IgG+ NMOSD.1 Participants who completed SAkuraSky and SAkuraStar, were invited to the OLE period where they received 120mg satralizumab SC every 4 weeks, with or without concomitant immunosuppressive therapy (IST).1 There were 111 patients with AQP4-IgG+ NMOSD in this study.1 In this female-dominant (90.1%) study population, patients averaging 43.2 years of age were treated with satralizumab for a median duration of 5.9 years.1 Approximately one-third of the patients were from Asia and the remaining were from Europe or other regions.1

Efficacy analyses were conducted based on data collected in the overall satralizumab treatment (OST) period, from patients’ first dose of satralizumab in the double-blind period (DBP) or OLE period to the clinical cut-off date of January 31, 2023.1 Assessments of efficacy included time to the first protocol-defined relapses (iPDRs), severe relapse (iPDR associated with a ≥2-point increase in Expanded Disability Status Scale [EDSS]), sustained EDSS worsening (if baseline score=0: increase ≥2 points; if baseline= 1-5: increase ≥1 point; if baseline ≥5.5: increase ≥0.5 points) and annualized iPDR rate (ARR).1

 

 

FINDINGS

Efficacy outcomes:
  • The efficacy outcomes assessed included the time to the first iPDR, severe relapse, sustained EDSS worsening and ARR over 288 weeks1
  • Overall, satralizumab remained clinically effective in patients with AQP4-IgG+ NMOSD over 5.5 years of long-term relapse preventive treatment1
  • 72% (95% CI: 62%-80%) of satralizumab-treated patients were free from iPDR, relapses were mild and associated with good recovery1
  • 91% (95% CI: 83%-95%) of patients were severe relapse-free1
  • No evidence of EDSS worsening was found in 83% (95% CI: 74%-90%) of patients1
  • The overall AAR of 0.08 (95% CI: 0.06-0.10) was low with no significant change over 5-year exposure to satralizumab (Y1: 0.17 [0.10–0.28]; Y2: 0.10 [0.05–0.19]; Y3: 0.04 [0.01–0.14]; Y4: 0.08 [0.02–0.25]; Y5: 0.05 [0.01–0.17])1

Safety:
  • The favorable safety profile of satralizumab observed in the DBP was maintained with long-term treatment (up to 8.9 years), with no new safety concerns reported1

 

“Efficacy of satralizumab ± IST in patients with AQP4-IgG+ NMOSD observed in the DBPs was sustained with long-term treatment”

Dr. Jeffery L. Bennett
University of Colorado School of Medicine,
Aurora, United States

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