AI Article Synopsis
Article Abstract
Background And Objectives: Satralizumab, 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.
Methods: Following 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).
Results: Forty-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.
Download full-text PDF |
Source |
|---|---|
| http://www.ncbi.nlm.nih.gov/pmc/articles/PMC9756307 | PMC |
| http://dx.doi.org/10.1212/NXI.0000000000200071 | DOI Listing |
Publication Analysis
Top Keywords
Similar Publications
Case report: Satralizumab as an adjunctive therapy for AQP-4 antibody and MOG antibody dual-negative optic neuritis in a third-trimester pregnancy case.
Front Med (Lausanne)
December 2024
Department of Ophthalmology, Zhejiang Provincial People's Hospital, People's Hospital of Hangzhou Medical College, Hangzhou, China.
The treatment of demyelinating optic neuritis (DON) in pregnant patients is challenging, especially when there is poor or no response to intravenous methylprednisolone pulse (IVMP) therapy or adjunctive treatments such as intravenous immunoglobulin (IVIG) therapy. We herein report a case of a 28-year-old pregnant woman who experienced sequential severe vision loss in both eyes. She presented to a local hospital with the main complaint of sudden, painless vision loss in the left eye and was diagnosed with DON in the left eye.
View Article and Find Full Text PDFCase report: Satralizumab therapy for bilateral refractory optic neuritis following the first dose of bivalent human papilloma virus vaccine.
Front Immunol
December 2024
Eye Center, Second Affiliated Hospital of Zhejiang University School of Medicine, Hangzhou, China.
Demyelinating optic neuritis (DON) is a rare but sight-threatening ophthalmic condition which occasionally occurs after human papilloma virus (HPV) vaccination. We herein report a case of previously healthy 13-year-old girl who developed a bilateral refractory DON three days after the first dose of bivalent HPV vaccine. The patient experienced bilateral severe visual loss three days after HPV vaccination, and her vision was quickly deteriorated to no light perception one day after the onset of DON.
View Article and Find Full Text PDFUsage status of biologics for the chronic treatment of optic neuritis in neuromyelitis optica spectrum disorders in Japan.
Jpn J Ophthalmol
October 2024
Department of Orthoptics and Visual Science, Kitasato University School of Allied Health Sciences, Kanagawa, Japan.
Purpose: To investigate the usage status of biologics for the chronic treatment of optic neuritis including neuromyelitis optica spectrum disorders in Japan.
Design: Multicenter retrospective case series.
Methods: Patients diagnosed with anti-aquaporin 4 antibody (AQP4-Ab) positive optic neuritis and had been initiated on biologics (satralizumab, eculizumab, and inebilizumab) between January 2020 and August 2022 were identified at 30 facilities in Japan.
An evaluation of ravulizumab for the treatment of neuromyelitis optica spectrum disorder.
Expert Opin Biol Ther
November 2024
Department of Neurology, Massachusetts General Hospital and Harvard Medical School, Boston, MA, USA.
Introduction: Following the CHAMPION-NMOSD trial, the FDA recently granted approval for ravulizumab, a humanized monoclonal antibody against complement C5 protein in AQP-4 seropositive neuromyelitis optica spectrum disorder (NMOSD). Similar to eculizumab, ravulizumab offers near-complete prevention of NMOSD relapses, but has a longer half-life, providing decreased infusion frequency and increased convenience for patients. While targeting the complement pathway has clear advantages, patients are at risk for infection with encapsulated organisms, in particular .
View Article and Find Full Text PDFPediatric MOG-Ab-Associated Encephalitis: Supporting Early Recognition and Treatment.
Neurol Neuroimmunol Neuroinflamm
December 2024
From the Department of Neurology (N.N.K., O.A.-M., Y.H.), Great Ormond Street Hospital for Children NHS Foundation Trust; Department of Neuroinflammation (N.N.K., D.C., O.A.-M., C.H., O.C., Y.H.), Institute of Neurology, University College London; Children's Neurosciences (M.E., V.L., M.L., T.R.), Evelina London Children's Hospital, Guy's and St Thomas NHS Foundation Trust; Department of Women and Children's Health (M.E., M.L., T.R.), School of Life Course Sciences (SoLCS), King's College London; Department of Paediatrics (A.S., S.R., J.P.), Children's Hospital, John Radcliffe Hospital, Oxford University Hospitals NHS Foundation Trust; Department of Paediatric Neurology (M.V.C.), Addenbrooke's Hospital, Cambridge University Hospitals NHS Foundation Trust; Translational and Clinical Research Sir James Spence Institute (R.F.), University of Newcastle, Royal Victoria Infirmary; Department of Neurology (R.F.), Great North Children's Hospital, Newcastle upon Tyne Hospitals NHS Foundation Trust; Department of Neurology (R.K.), Alder Hey Children's Hospital, Alder Hey Children's NHS Foundation Trust, Liverpool; Department of Paediatric Neurology (D.R., Siobhan West), Royal Manchester Children's Hospital, Manchester University NHS Foundation Trust; Department of Neurology (E.W., Sukhvir Wright), Birmingham Children's Hospital, Birmingham Women's and Children's NHS Foundation Trust; Department of Neuroradiology (A.B., K.M.), Great Ormond Street Hospital, Great Ormond Street Hospital Trust, London, United Kingdom; Department of Neurology (E.P.F.), Laboratory Medicine and Pathology and Center for Multiple Sclerosis and Autoimmune Neurology, Rochester, MN; NIHR University College London Hospitals Biomedical Research Centre (O.C.); and Department of Neuroinflammation (O.C.), National Hospital for Neurology and Neurosurgery, University College London Hospitals NHS Foundation Trust, United Kingdom.
Article Synopsis
- A study assessed children under 18 with antibodies to myelin oligodendrocyte glycoprotein (MOG-Ab), focusing on those with encephalitis who didn’t fit the criteria for acute disseminated encephalitis (ADEM), comparing them to those with ADEM.
- Out of 235 MOG-Ab positive patients, 33 had encephalitis and 74 had ADEM, with common symptoms including headache, seizures, and fever; 24% had a normal initial brain MRI.
- Findings indicated that children with encephalitis were generally older, more often admitted to intensive care, and had a delayed start of steroid treatment, suggesting MOG-Ab testing is essential for suspected encephalitis
Want AI Summaries of new PubMed Abstracts delivered to your In-box?
Enter search terms and have AI summaries delivered each week - change queries or unsubscribe any time!