Satralizumab 120mg/1ml solution for injection pre-filled syringes

IntroductionNeuromyelitis optica spectrum disorder (NMOSD) is a rare antibody-mediated neuro-autoimmune disease. Monoclonal antibodies targeting B cell antigens CD19 and CD20, the interleukin-6 receptor, or the complement cascade are used as preventive therapies to reduce relapse rates. We conducted a network meta-analysis (NMA) to compare the effect of rituximab on time to first relapse with ravulizumab, eculizumab, inebilizumab, and satralizumab in patients with NMOSD who are aquaporin-4 (AQP4)-IgG-positive.MethodsA systematic search was conducted in PubMed, Scopus, CINAHL, EMBASE, Web of Science, the Cochrane Library, and gray literature sources up to October 31, 2024, and updated on November 1, 2025, following PRISMA guidelines. A network meta-analysis of randomized and open-label trials was conducted to compare time to first relapse between rituximab and other monoclonal antibody therapies.ResultsFrom 6337 records, 3825 duplicates were removed; 2512 were screened, 2327 excluded, leaving eight trials. The prior treatment, relapse history, and definitions and adjudication of relapse varied across studies. Rituximab showed higher hazard ratio (HR) point estimates for time to first relapse compared with ravulizumab with or without immunosuppressive therapies (IST) (HR 5.00, 95% CI 0.25, 101.01) and eculizumab ± IST (HR 1.17, 95% CI 0.12, 10.89), but were lower compared with satralizumab ± IST (HR 0.29, 95% CI 0.04, 2.23). In patients not receiving IST, rituximab showed numerically higher HR compared with ravulizumab (HR 3.33, 95% CI 0.13, 83.16) and eculizumab (HR 1.59, 95% CI 0.05, 50.17), but lower point estimates compared with inebilizumab (HR 0.31, 95% CI 0.04, 2.31) and satralizumab (HR 0.27, 95% CI 0.03, 2.21).ConclusionThis NMA showed hazard ratio point estimates favoring eculizumab and ravulizumab over rituximab. However, wide, overlapping confidence intervals and between-study heterogeneity indicate substantial uncertainty. Head-to-head trials or registry-based studies are needed to determine the most effective treatment for AQP4-IgG-positive NMOSD.

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BackgroundThere are numerous immunotherapies that are effective in preventing relapses in neuromyelitis optica spectrum disorder (NMO-SD). With head-to-head clinical trials between immunotherapies lacking, Bayesian network meta-analysis can be used to compare treatment interventions. Previous network meta-analyses have compared monoclonal antibodies but either not included newer complement inhibitors or earlier immunotherapies such as rituximab or tocilizumab.ObjectiveTo compare immunosuppressive treatments used in relapse prevention in NMO-SD.MethodsPubMed, EMBASE and Scopus were searched for randomised controlled trials until 20th September, 2024. Search terms strategy included neuromyelitis optica, antibody and relapse. Randomised controlled trials testing immunotherapies used in relapse reduction in NMO-SD were included. Of 550 studies screened, 8 clinical trials initially met inclusion criteria. The study was performed according to PRISMA guidelines by multiple observers. Bayesian fixed-effect network meta-analysis was conducted. The primary outcome was time to relapse. The secondary outcome was annualised relapse rate. Sensitivity analysis was undertaken in seropositive patients. Treatments were ranked using a probability measure called surface under the cumulative rank curve (SUCRA).ResultsEight studies were included that contained a total 851 patients [716 (84%) seropositive]. There were six treatment interventions-ravulizumab, eculizumab, tocilizumab, rituximab, inebilizumab, satralizumab and the control arm (placebo/azathioprine). Ravulizumab was the ideal treatment (HR 0.00 (95%CrI 0.00-0.03), SUCRA 0.99) with a 98% probability of being the superior treatment in increasing time to relapse in NMO-SD. This was supported by secondary analysis of annualised relapse rate and the sensitivity analysis in seropositive patients.DiscussionThese findings suggest that ravulizumab had the highest probability of being the most superior treatment in decreasing relapse risk in NMO-SD.

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Background and objectivesNeuromyelitis optica spectrum disorder (NMOSD) is a rare debilitating autoimmune disease of the CNS. Three monoclonal antibodies were recently approved as maintenance therapies for aquaporin-4 immunoglobulin G (AQP4-IgG)-seropositive NMOSD (eculizumab, inebilizumab, and satralizumab), prompting the need to consider best practice therapeutic decision-making for this indication. Our objective was to develop validated statements for the management of AQP4-IgG-seropositive NMOSD, through an evidence-based Delphi consensus process, with a focus on recommendations for eculizumab, inebilizumab, and satralizumab.MethodsWe recruited an international panel of clinical experts in NMOSD and asked them to complete a questionnaire on NMOSD management. Panel members received a summary of evidence identified through a targeted literature review and provided free-text responses to the questionnaire based on both the data provided and their clinical experience. Responses were used to generate draft statements on NMOSD-related themes. Statements were voted on over a maximum of 3 rounds; participation in at least 1 of the first 2 rounds was mandatory. Panel members anonymously provided their level of agreement (6-point Likert scale) on each statement. Statements that failed to reach a predefined consensus threshold (≥67%) were revised based on feedback and then voted on in the next round. Final statements were those that met the consensus threshold (≥67%).ResultsThe Delphi panel comprised 24 experts, who completed the Delphi process in November 2021 after 2 voting rounds. In round 1, 23/25 statements reached consensus and were accepted as final. The 2 statements that failed to reach consensus were revised. In round 2, both revised statements reached consensus. Twenty-five statements were agreed in total: 11 on initiation of or switching between eculizumab, inebilizumab, and satralizumab; 3 on monotherapy/combination therapy; 7 on safety and patient population considerations; 3 on biomarkers/patient-reported outcomes; and 1 on research gaps.DiscussionAn established consensus method was used to develop statements relevant to the management of AQP4-IgG-seropositive NMOSD. These international statements will be valuable for informing individualized therapeutic decision-making and could form the basis for standardized practice guidelines.

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