Satralizumab: A Review in Neuromyelitis Optica Spectrum Disorder

<p><strong>Declarations</strong></p> <p><strong>Funding </strong>The preparation of this review was not supported by any external funding.</p> <p><strong>Authorship and Conflict of interest</strong> Simon Fung and Matt Shirley are salaried employees of Adis International Ltd/Springer Nature, and declare no relevant conflicts of interest. All authors contributed to the review and are responsible for the article content.</p> <p><strong>Ethics approval, Consent to participate, Consent to publish, Availability of data and material, Code availability</strong> Not applicable.</p> <p><br></p> <p>Additional information about this Adis Drug Review can be found <a href="http://www.springer.com/gp/adis/products-services/adis-journals-newsletters/adis-drug-reviews" target="_blank"><strong>here.</strong></a></p> <p><br></p> <p><strong>Abstract</strong></p> <p>Satralizumab (Enspryng^®) is a monoclonal antibody that blocks the interleukin-6 (IL-6) receptor and is approved for the treatment of neuromyelitis optica spectrum disorder (NMOSD) in patients who are aquaporin-4 immunoglobulin G (AQP4-IgG) seropositive. Patients with NMOSD are at risk of recurrent autoimmune attacks that primarily target the optic nerves and spinal cord but may also target other regions of the central nervous system; these attacks can lead to life-long disability. In the randomized, placebo-controlled phase III SAkuraSky and SAkuraStar trials, subcutaneous satralizumab as an add-on to immunosuppressive therapy or as a monotherapy, respectively, significantly reduced the risk of relapse compared with placebo in patients who were AQP4-IgG seropositive with NMOSD. Satralizumab was well tolerated; the most common adverse events were infection, headache, arthralgia, decreased white blood cell count, hyperlipidaemia and injection-related reactions. In the EU, satralizumab is the first IL-6 receptor blocker to be approved for treatment of AQP4-IgG-seropositive patients with NMOSD, has the potential advantage of subcutaneous administration, and is the only targeted treatment approved for adolescent patients with this disorder. Thus, satralizumab is a valuable treatment option for patients with NMOSD. </p> <p>^© Springer Nature Switzerland AG 2023</p> <p><br></p> <p>  </p> <p><strong>SAkuraStar and SAkuraSky clinical trials additional information</strong></p> <p>Additional information about NMO and NMOSD and the SAkuraStar and SAkuraSky trials can be found in <a href="https://adisjournals.figshare.com/articles/online_resource/Satralizumab_First_Approval_-_SAkuraStar_and_SAkuraSky_clinical_trial_video_abstracts/12931781" target="_blank"><strong>two peer-reviewed video abstracts</strong></a>, which are sponsored by Roche and were uploaded to Figshare after the satralizumab AdisInsight Report was published.</p> <p><br></p>