June 2022
Volume 63, Issue 7
Open Access
ARVO Annual Meeting Abstract  |   June 2022
Long-term efficacy and safety of satralizumab in adults with AQP4-IgG-seropositive neuromyelitis optica spectrum disorder (NMOSD): results from the Phase 3 SAkura studies
Author Affiliations & Notes
  • Shervin Gholizadeh Moghaddam
    Genentech, Inc.,, South San Francisco, California, United States
  • Jeffrey L Bennett
    University of Colorado School of Medicine, Aurora, Colorado, United States
  • Edward Fox
    Central Texas Neurology Consultants, Round Rock, Texas, United States
  • Benjamin Greenberg
    University of Texas Southwestern Medical Center, Dallas, Texas, United States
  • Brian G Weinshenker
    Mayo Clinic, Rochester, Minnesota, United States
  • Anthony Traboulsee
    University of British Columbia, Vancouver, British Columbia, Canada
  • Michael R Yeaman
    David Geffen School of Medicine at UCLA, Los Angeles, and Division of Molecular Medicine, Harbor-UCLA Medical Center, Torrance, California, United States
  • Kathleen Blondeau
    F. Hoffmann-La Roche Ltd, Basel, Switzerland
  • Kristina Weber
    F. Hoffmann-La Roche Ltd, Basel, Switzerland
  • Ivana Vodopivec
    F. Hoffmann-La Roche Ltd, Basel, Switzerland
  • Michael Levy
    Massachusetts General Hospital and Harvard Medical School, Boston, Massachusetts, United States
    Harvard Medical School, Boston, Massachusetts, United States
  • Footnotes
    Commercial Relationships   Shervin Gholizadeh Moghaddam Genentech Inc., Code E (Employment); Jeffrey Bennett Mallinckrodt, Novartis, and the National Institutes of Health, Code F (Financial Support), Aquaporumab, Code P (Patent), Chugai Pharmaceutical,Viela Bio, Mitsubishi-Tanabe, Reistone Bio, Abbvie, Clene Neuroscience, Alexion, Genentech, and Roche, Code R (Recipient); Edward Fox AbbVie, Biogen, Celgene, Chugai, EMD Serono, Genentech/Roche, MedDay , Novartis, Sanofi Genzyme, and TG, Code C (Consultant/Contractor), AbbVie, Biogen, Celgene, Chugai, EMD Serono, Genentech/Roche, MedDay , Novartis, Sanofi Genzyme, and TG, Code R (Recipient); Benjamin Greenberg Alexion, Novartis, EMD Serono, Viela Bio, Genentech/Roche, Greenwich Biosciences, Axon Advisors, Rubin Anders, ABCAM, Signant, IQVIA, Sandoz, Druggability Technologies, Genzyme, and Immunovant, Code C (Consultant/Contractor), Clene Nanomedicine, Code F (Financial Support), UpToDate, Code R (Recipient); Brian Weinshenker UCB Biosciences, Mitsubishi Tanabe, Genentech, and Roche, Code C (Consultant/Contractor), NMO-IgG for diagnosis of neuromyelitis optica, Code P (Patent), Genentech, Roche, and Novartis, Code R (Recipient), Chugai, Code R (Recipient), RSR Ltd., Oxford University, Hospices Civils de Lyon, and MVZ Labor PD Dr. Volkmann und Kollegen GbR, Code R (Recipient), Attack Adjudication Committee for Alexion and Horizon Therapeutics (formerly MedImmune/Viela Bio), Code S (non-remunerative); Anthony Traboulsee Genzyme, Roche, and Novartis , Code C (Consultant/Contractor), Genzyme and Roche, Code R (Recipient); Michael Yeaman Roche and Alexion, Code C (Consultant/Contractor), NIH and DoD, Code F (Financial Support), NovaDigm Therapeutics, Inc. and Metacin, Inc, Code O (Owner), Genentech-Roche Strategic Scientific Committee for NMOSD, Chair Medical Advisor to the Guthy-Jackson Charitable Foundation for NMO, Code S (non-remunerative); Kathleen Blondeau F. Hoffmann-La Roche Ltd., Code E (Employment); Kristina Weber F. Hoffmann-La Roche Ltd., Code E (Employment); Ivana Vodopivec F. Hoffmann-La Roche Ltd., Code E (Employment); Michael Levy Alexion, Viela Bio, Genentech/Roche, UCB Pharmaceuticals, Mitsubishi Pharmaceuticals and Sanofi, Code C (Consultant/Contractor), NIH, Alexion, Bluerock, Siegel Rare Neuroimmune Association, Sumaira Foundation, and Genentech, Code F (Financial Support)
  • Footnotes
    Support  None
Investigative Ophthalmology & Visual Science June 2022, Vol.63, 1585 – A0374. doi:
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      Shervin Gholizadeh Moghaddam, Jeffrey L Bennett, Edward Fox, Benjamin Greenberg, Brian G Weinshenker, Anthony Traboulsee, Michael R Yeaman, Kathleen Blondeau, Kristina Weber, Ivana Vodopivec, Michael Levy; Long-term efficacy and safety of satralizumab in adults with AQP4-IgG-seropositive neuromyelitis optica spectrum disorder (NMOSD): results from the Phase 3 SAkura studies. Invest. Ophthalmol. Vis. Sci. 2022;63(7):1585 – A0374.

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      © ARVO (1962-2015); The Authors (2016-present)

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Abstract

Purpose : Satralizumab reduced the risk of protocol-defined relapse (PDR) vs placebo in the double-blind periods (DBP) of two trials in NMOSD: SAkuraSky (NCT02028884; satralizumab + baseline immunosuppressants [IST]) and SAkuraStar (NCT02073279; satralizumab monotherapy). We present long-term efficacy and safety data from the DBP and open-label extension (OLE) of these studies.

Methods : Satralizumab or placebo was administered in the DBP; patients could then enter the OLE (satralizumab 120 mg Q4W). PDRs in the DBP were adjudicated by a Clinical Endpoint Committee; PDRs in the OLE were determined by the investigator (iPDRs). Current analyses included all aquaporin 4-immunoglobulin G seropositive (AQP4-IgG+) adults who received ≥1 dose of satralizumab in the DBP and/or OLE (overall satralizumab treatment [OST] period, data cutoff: Feb 22, 2021). Efficacy analyses assessed the annualised iPDR rate (ARR), time to first iPDR, severe iPDR (≥2 point increase in the Expanded Disability Status Scale [EDSS] score), and sustained EDSS worsening (EDSS increase of ≥2, ≥1, or ≥0.5 points for patients with baseline scores of 0, 1–5, or ≥5.5, respectively, confirmed ≥24 weeks post-initial-worsening). Safety assessments compared rates of adverse events (AEs) per 100 patient-years (PY) in the OST period vs the DBPs.

Results : 106 AQP4-IgG+ adults were included (SAkuraSky: 44; SAkuraStar: 62). Median (range) duration of satralizumab exposure was 5.4 (0.1–7.0) years in SAkuraSky and 4.0 (0.1–6.0) years in SAkuraStar. The overall ARR (95% CI) in the OST was 0.11 (0.07–0.17) in SAkuraSky and 0.08 (0.05–0.13) in SAkuraStar; the ARR remained stable throughout the studies. At Week 192 (3.7 years) in SAkuraSky and SakuraStar, 74% and 73% of patients had no iPDR, 94% and 90% had no severe iPDR, and 89% and 86% had no sustained worsening of EDSS, respectively. Rates of serious AEs (95% CI) in the OST period were comparable with the DBP (serious AEs: SAkuraSky 13.7 [8.9–20.1]/100 PY; SAkuraStar 10.6 [6.9–15.6]/100 PY). Rates of infections and serious infections in the OST period were comparable with the DBP and did not increase over time. No deaths or anaphylactic reactions to satralizumab were reported in either study.

Conclusions : Satralizumab efficacy and its favorable safety profile are sustained with long-term treatment.

This abstract was presented at the 2022 ARVO Annual Meeting, held in Denver, CO, May 1-4, 2022, and virtually.

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