Evidence map›Paper›PMID 36724181›Full record

Trial reportNeurology(R) neuroimmunology & neuroinflammation2023

Long-term Efficacy of Satralizumab in AQP4-IgG-Seropositive Neuromyelitis Optica Spectrum Disorder From SAkuraSky and SAkuraStar.

Ingo Kleiter, Anthony Traboulsee, Jacqueline Palace, Takashi Yamamura, Kazuo Fujihara, Albert Saiz, Adil Javed, David Mayes, H-Christian von Büdingen, Gaelle Klingelschmitt and 2 more

2 registry-linked trialsOpen access · goldAbstract readRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Neurology(R) neuroimmunology & neuroinflammation, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 32 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
32citing papers in PubMed, 1 pooled it
8.4field-weighted citation impact, top 1% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT02028884 phase3completednot on this map

A Multicenter, Randomized, Addition to Baseline Treatment, Double-Blind, Placebo-Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of Satralizumab (SA237) in Patients With Neuromyelitis Optica (NMO) and NMO Spectrum Disorder (NMOSD)

TypeinterventionalSponsorHoffmann-La RocheRan2014 to 2021Enrolled85ConditionsNeuromyelitis Optica (NMO), NMO Spectrum Disorder (NMOSD)ArmsSatralizumab, Placebo, Baseline Treatment
NCT02073279 phase3completednot on this map

A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of Satralizumab (SA237) as Monotherapy in Patients With Neuromyelitis Optica (NMO) and Neuromyelitis Optica Spectrum Disorder (NMOSD)

TypeinterventionalSponsorHoffmann-La RocheRan2014 to 2022Enrolled95ConditionsNeuromyelitis Optica (NMO), NMO Spectrum Disorder (NMOSD)ArmsSatralizumab, Placebo
3 · Its place in the literature

Who cites it

32 citing papers in PubMed, 1 synthesis or guideline pooled it, 63 citations in OpenAlex.

  1. Guideline
  2. Trial
  3. Trial
  4. Article
  5. Article
  6. Review
  7. Article
  8. Review
  9. Article
  10. Review
  11. Autoimmune encephalitis.Nature reviews. Disease primers · 2025
    Review
  12. Emerging Role of Targeted Monoclonal Antibodies in Neuromyelitis Optica Spectrum Disorders.BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy · 2025
    Review
  13. Article
  14. Review
  15. Article
  16. Article
  17. Article
  18. Advances in the treatment of neuromyelitis optic spectrum disorder.Therapeutic advances in neurological disorders · 2025
    Review
  19. Review
  20. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

12 authors at 1 institution in 5 countries.

Ingo KleiterFrom the Ruhr University Bochum (I.K.), Bochum, Germany, and Marianne-Strauß-Klinik, Behandlungszentrum Kempfenhausen für Multiple Sklerose Kranke gGmbH, Berg, Germany; University of British Columbia (A.T.), Vancouver, Canada; John Radcliffe Hospital (J.P.), Oxford, United Kingdom; National Institute of Neuroscience (T.Y.), National Center of Neurology and Psychiatry, Tokyo, Japan; Fukushima Medical University School of Medicine (K.F.), Japan; Service of Neurology (A.S.), Hospital Clinic and Institut d'Investigació Biomèdica August Pi i Sunyer (IDIBAPS), University of Barcelona, Spain; University of Chicago Department of Neurology (A.J.), IL; ApotheCom (D.M.), London, United Kingdom; F. Hoffmann-La Roche Ltd (H.-C.B., G.K., D.S.), Basel, Switzerland; and Departments of Neurology and Ophthalmology (J.L.B.), Programs in Neuroscience and Immunology, University of Colorado School of Medicine, Aurora. ingo.kleiter@ms-klinik.de.ORCID 0000-0002-8249-4408
Anthony TraboulseeFrom the Ruhr University Bochum (I.K.), Bochum, Germany, and Marianne-Strauß-Klinik, Behandlungszentrum Kempfenhausen für Multiple Sklerose Kranke gGmbH, Berg, Germany; University of British Columbia (A.T.), Vancouver, Canada; John Radcliffe Hospital (J.P.), Oxford, United Kingdom; National Institute of Neuroscience (T.Y.), National Center of Neurology and Psychiatry, Tokyo, Japan; Fukushima Medical University School of Medicine (K.F.), Japan; Service of Neurology (A.S.), Hospital Clinic and Institut d'Investigació Biomèdica August Pi i Sunyer (IDIBAPS), University of Barcelona, Spain; University of Chicago Department of Neurology (A.J.), IL; ApotheCom (D.M.), London, United Kingdom; F. Hoffmann-La Roche Ltd (H.-C.B., G.K., D.S.), Basel, Switzerland; and Departments of Neurology and Ophthalmology (J.L.B.), Programs in Neuroscience and Immunology, University of Colorado School of Medicine, Aurora.ORCID 0000-0002-0351-9639
Jacqueline PalaceFrom the Ruhr University Bochum (I.K.), Bochum, Germany, and Marianne-Strauß-Klinik, Behandlungszentrum Kempfenhausen für Multiple Sklerose Kranke gGmbH, Berg, Germany; University of British Columbia (A.T.), Vancouver, Canada; John Radcliffe Hospital (J.P.), Oxford, United Kingdom; National Institute of Neuroscience (T.Y.), National Center of Neurology and Psychiatry, Tokyo, Japan; Fukushima Medical University School of Medicine (K.F.), Japan; Service of Neurology (A.S.), Hospital Clinic and Institut d'Investigació Biomèdica August Pi i Sunyer (IDIBAPS), University of Barcelona, Spain; University of Chicago Department of Neurology (A.J.), IL; ApotheCom (D.M.), London, United Kingdom; F. Hoffmann-La Roche Ltd (H.-C.B., G.K., D.S.), Basel, Switzerland; and Departments of Neurology and Ophthalmology (J.L.B.), Programs in Neuroscience and Immunology, University of Colorado School of Medicine, Aurora.
Takashi YamamuraFrom the Ruhr University Bochum (I.K.), Bochum, Germany, and Marianne-Strauß-Klinik, Behandlungszentrum Kempfenhausen für Multiple Sklerose Kranke gGmbH, Berg, Germany; University of British Columbia (A.T.), Vancouver, Canada; John Radcliffe Hospital (J.P.), Oxford, United Kingdom; National Institute of Neuroscience (T.Y.), National Center of Neurology and Psychiatry, Tokyo, Japan; Fukushima Medical University School of Medicine (K.F.), Japan; Service of Neurology (A.S.), Hospital Clinic and Institut d'Investigació Biomèdica August Pi i Sunyer (IDIBAPS), University of Barcelona, Spain; University of Chicago Department of Neurology (A.J.), IL; ApotheCom (D.M.), London, United Kingdom; F. Hoffmann-La Roche Ltd (H.-C.B., G.K., D.S.), Basel, Switzerland; and Departments of Neurology and Ophthalmology (J.L.B.), Programs in Neuroscience and Immunology, University of Colorado School of Medicine, Aurora.
Kazuo FujiharaFrom the Ruhr University Bochum (I.K.), Bochum, Germany, and Marianne-Strauß-Klinik, Behandlungszentrum Kempfenhausen für Multiple Sklerose Kranke gGmbH, Berg, Germany; University of British Columbia (A.T.), Vancouver, Canada; John Radcliffe Hospital (J.P.), Oxford, United Kingdom; National Institute of Neuroscience (T.Y.), National Center of Neurology and Psychiatry, Tokyo, Japan; Fukushima Medical University School of Medicine (K.F.), Japan; Service of Neurology (A.S.), Hospital Clinic and Institut d'Investigació Biomèdica August Pi i Sunyer (IDIBAPS), University of Barcelona, Spain; University of Chicago Department of Neurology (A.J.), IL; ApotheCom (D.M.), London, United Kingdom; F. Hoffmann-La Roche Ltd (H.-C.B., G.K., D.S.), Basel, Switzerland; and Departments of Neurology and Ophthalmology (J.L.B.), Programs in Neuroscience and Immunology, University of Colorado School of Medicine, Aurora.
Albert SaizFrom the Ruhr University Bochum (I.K.), Bochum, Germany, and Marianne-Strauß-Klinik, Behandlungszentrum Kempfenhausen für Multiple Sklerose Kranke gGmbH, Berg, Germany; University of British Columbia (A.T.), Vancouver, Canada; John Radcliffe Hospital (J.P.), Oxford, United Kingdom; National Institute of Neuroscience (T.Y.), National Center of Neurology and Psychiatry, Tokyo, Japan; Fukushima Medical University School of Medicine (K.F.), Japan; Service of Neurology (A.S.), Hospital Clinic and Institut d'Investigació Biomèdica August Pi i Sunyer (IDIBAPS), University of Barcelona, Spain; University of Chicago Department of Neurology (A.J.), IL; ApotheCom (D.M.), London, United Kingdom; F. Hoffmann-La Roche Ltd (H.-C.B., G.K., D.S.), Basel, Switzerland; and Departments of Neurology and Ophthalmology (J.L.B.), Programs in Neuroscience and Immunology, University of Colorado School of Medicine, Aurora.
Adil JavedFrom the Ruhr University Bochum (I.K.), Bochum, Germany, and Marianne-Strauß-Klinik, Behandlungszentrum Kempfenhausen für Multiple Sklerose Kranke gGmbH, Berg, Germany; University of British Columbia (A.T.), Vancouver, Canada; John Radcliffe Hospital (J.P.), Oxford, United Kingdom; National Institute of Neuroscience (T.Y.), National Center of Neurology and Psychiatry, Tokyo, Japan; Fukushima Medical University School of Medicine (K.F.), Japan; Service of Neurology (A.S.), Hospital Clinic and Institut d'Investigació Biomèdica August Pi i Sunyer (IDIBAPS), University of Barcelona, Spain; University of Chicago Department of Neurology (A.J.), IL; ApotheCom (D.M.), London, United Kingdom; F. Hoffmann-La Roche Ltd (H.-C.B., G.K., D.S.), Basel, Switzerland; and Departments of Neurology and Ophthalmology (J.L.B.), Programs in Neuroscience and Immunology, University of Colorado School of Medicine, Aurora.
David MayesFrom the Ruhr University Bochum (I.K.), Bochum, Germany, and Marianne-Strauß-Klinik, Behandlungszentrum Kempfenhausen für Multiple Sklerose Kranke gGmbH, Berg, Germany; University of British Columbia (A.T.), Vancouver, Canada; John Radcliffe Hospital (J.P.), Oxford, United Kingdom; National Institute of Neuroscience (T.Y.), National Center of Neurology and Psychiatry, Tokyo, Japan; Fukushima Medical University School of Medicine (K.F.), Japan; Service of Neurology (A.S.), Hospital Clinic and Institut d'Investigació Biomèdica August Pi i Sunyer (IDIBAPS), University of Barcelona, Spain; University of Chicago Department of Neurology (A.J.), IL; ApotheCom (D.M.), London, United Kingdom; F. Hoffmann-La Roche Ltd (H.-C.B., G.K., D.S.), Basel, Switzerland; and Departments of Neurology and Ophthalmology (J.L.B.), Programs in Neuroscience and Immunology, University of Colorado School of Medicine, Aurora.
H-Christian von BüdingenFrom the Ruhr University Bochum (I.K.), Bochum, Germany, and Marianne-Strauß-Klinik, Behandlungszentrum Kempfenhausen für Multiple Sklerose Kranke gGmbH, Berg, Germany; University of British Columbia (A.T.), Vancouver, Canada; John Radcliffe Hospital (J.P.), Oxford, United Kingdom; National Institute of Neuroscience (T.Y.), National Center of Neurology and Psychiatry, Tokyo, Japan; Fukushima Medical University School of Medicine (K.F.), Japan; Service of Neurology (A.S.), Hospital Clinic and Institut d'Investigació Biomèdica August Pi i Sunyer (IDIBAPS), University of Barcelona, Spain; University of Chicago Department of Neurology (A.J.), IL; ApotheCom (D.M.), London, United Kingdom; F. Hoffmann-La Roche Ltd (H.-C.B., G.K., D.S.), Basel, Switzerland; and Departments of Neurology and Ophthalmology (J.L.B.), Programs in Neuroscience and Immunology, University of Colorado School of Medicine, Aurora.
Gaelle KlingelschmittFrom the Ruhr University Bochum (I.K.), Bochum, Germany, and Marianne-Strauß-Klinik, Behandlungszentrum Kempfenhausen für Multiple Sklerose Kranke gGmbH, Berg, Germany; University of British Columbia (A.T.), Vancouver, Canada; John Radcliffe Hospital (J.P.), Oxford, United Kingdom; National Institute of Neuroscience (T.Y.), National Center of Neurology and Psychiatry, Tokyo, Japan; Fukushima Medical University School of Medicine (K.F.), Japan; Service of Neurology (A.S.), Hospital Clinic and Institut d'Investigació Biomèdica August Pi i Sunyer (IDIBAPS), University of Barcelona, Spain; University of Chicago Department of Neurology (A.J.), IL; ApotheCom (D.M.), London, United Kingdom; F. Hoffmann-La Roche Ltd (H.-C.B., G.K., D.S.), Basel, Switzerland; and Departments of Neurology and Ophthalmology (J.L.B.), Programs in Neuroscience and Immunology, University of Colorado School of Medicine, Aurora.
Daniela StokmaierFrom the Ruhr University Bochum (I.K.), Bochum, Germany, and Marianne-Strauß-Klinik, Behandlungszentrum Kempfenhausen für Multiple Sklerose Kranke gGmbH, Berg, Germany; University of British Columbia (A.T.), Vancouver, Canada; John Radcliffe Hospital (J.P.), Oxford, United Kingdom; National Institute of Neuroscience (T.Y.), National Center of Neurology and Psychiatry, Tokyo, Japan; Fukushima Medical University School of Medicine (K.F.), Japan; Service of Neurology (A.S.), Hospital Clinic and Institut d'Investigació Biomèdica August Pi i Sunyer (IDIBAPS), University of Barcelona, Spain; University of Chicago Department of Neurology (A.J.), IL; ApotheCom (D.M.), London, United Kingdom; F. Hoffmann-La Roche Ltd (H.-C.B., G.K., D.S.), Basel, Switzerland; and Departments of Neurology and Ophthalmology (J.L.B.), Programs in Neuroscience and Immunology, University of Colorado School of Medicine, Aurora.
Jeffrey L BennettFrom the Ruhr University Bochum (I.K.), Bochum, Germany, and Marianne-Strauß-Klinik, Behandlungszentrum Kempfenhausen für Multiple Sklerose Kranke gGmbH, Berg, Germany; University of British Columbia (A.T.), Vancouver, Canada; John Radcliffe Hospital (J.P.), Oxford, United Kingdom; National Institute of Neuroscience (T.Y.), National Center of Neurology and Psychiatry, Tokyo, Japan; Fukushima Medical University School of Medicine (K.F.), Japan; Service of Neurology (A.S.), Hospital Clinic and Institut d'Investigació Biomèdica August Pi i Sunyer (IDIBAPS), University of Barcelona, Spain; University of Chicago Department of Neurology (A.J.), IL; ApotheCom (D.M.), London, United Kingdom; F. Hoffmann-La Roche Ltd (H.-C.B., G.K., D.S.), Basel, Switzerland; and Departments of Neurology and Ophthalmology (J.L.B.), Programs in Neuroscience and Immunology, University of Colorado School of Medicine, Aurora.
Roche (Switzerland) · CH

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

BACKGROUND AND

objectivesSatralizumab, an interleukin 6 receptor inhibitor, reduced the risk of protocol-defined relapse (PDR) vs placebo in 2 independent, double-blind studies in patients with neuromyelitis optica spectrum disorder (NMOSD). We assessed the long-term efficacy of satralizumab in patients with aquaporin-4-immunoglobulin G (IgG)-seropositive (AQP4-IgG+) NMOSD.

methodsFollowing the double-blind periods of SAkuraSky (satralizumab + baseline immunosuppressive treatment [IST]) and SAkuraStar (satralizumab monotherapy), patients could enter the open-label extension (OLE, satralizumab 120 mg Q4W ± IST). This analysis included all AQP4-IgG+ patients who received ≥1 dose of satralizumab in the double-blind and/or OLE periods, from patients' first dose to the data cutoff (February 22, 2021). PDR in the OLE period was determined by the investigator without external adjudication. We evaluated time to first investigator-reported PDR (iPDR), severe iPDR (≥2 point increase in the Expanded Disability Status Scale [EDSS] score), and sustained EDSS worsening (EDSS score 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), plus the annualized iPDR rate (ARR).

resultsForty-six of 55 AQP4-IgG+ patients (84%) in SAkuraSky and 57/64 patients in SAkuraStar (89%) continued from the double-blind periods into the OLEs. In total, 111 AQP4-IgG+ patients received ≥1 dose of satralizumab in the double-blind and/or OLE periods and were included in these analyses (SAkuraSky: 49; SAkuraStar: 62). The median (range) duration of satralizumab exposure was 4.4 (0.1-7.0) years in SAkuraSky and 4.0 (0.1-6.0) years in SAkuraStar, with a combined 440.1 patient-years of treatment. Seventy-one of 111 patients (64%) received satralizumab for ≥192 weeks (3.7 years). At this time point, 71% (SAkuraSky) and 73% (SAkuraStar) of satralizumab-treated patients were free from iPDR, 91% (SAkuraSky) and 90% (SAkuraStar) were free from severe iPDR, and 90% (SAkuraSky) and 86% (SAkuraStar) had no sustained EDSS worsening. The overall adjusted ARR (95% CI) was 0.12 (0.08-0.18) in SAkuraSky and 0.08 (0.05-0.13) in SAkuraStar and remained stable over time. DISCUSSION: These long-term results from the OLE periods of the SAkura studies demonstrate the continued efficacy of satralizumab over more than 3.5 years of treatment. High proportions of patients remained free from relapse, severe relapse, or worsening disease, with a consistently low ARR. TRIAL REGISTRATION INFORMATION: ClinicalTrials.gov registration numbers: NCT02028884 (SAkuraSky) and NCT02073279 (SAkuraStar). CLASSIFICATION OF EVIDENCE: This study provides Class II evidence that satralizumab reduces the risk of relapse in patients with AQP4-IgG+ NMOSD beyond the first 96 weeks of treatment.

Indexed as

Neuromyelitis OpticaAntibodies, Monoclonal, HumanizedAquaporin 4HumansImmunoglobulin GImmunosuppressive AgentsRecurrenceAntibodies, Monoclonal, HumanizedAQP4 protein, humanAquaporin 4Immunoglobulin GImmunosuppressive Agentssatralizumab

Identifiers

PMID36724181
PMCPMC9756307
OpenAlexW4311910797

What OpenQuestion holds

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.