Satralizumab for the Treatment of Neuromyelitis Optica Spectrum Disorders.

ABSTRACT

OBJECTIVE: To review the pharmacological characteristics, clinical evidence, and place in therapy of satralizumab for the treatment of neuromyelitis optica spectrum disorders (NMOSDs). DATA SOURCES A comprehensive literature search was conducted in PubMed (January 2000 to October 15, 2020). Key search terms included satralizumab and neuromyelitis optica spectrum disorders. Other sources were derived from product labeling and ClinicalTrials.gov. STUDY SELECTION AND DATA EXTRACTION All English-language articles identified from the data sources were reviewed and evaluated. Phase I, II, and III clinical trials were included. DATA SYNTHESIS: NMOSD is an autoimmune disease characterized by inflammatory lesions in the optic nerves and spinal cord. Interleukin-6 is involved in the pathogenesis of the disorder. Satralizumab is a humanized monoclonal antibody targeting the interleukin-6 receptor. Phase III trials showed that protocol-defined relapse was 30% for satralizumab and 50% for placebo (P = 0.018) when patients with NMOSD were treated with satralizumab monotherapy; protocol-defined relapse was 20% for satralizumab and 43% for placebo (P = 0.02) when satralizumab was added to immunosuppressant treatment. Satralizumab is generally well tolerated, with common adverse effects including injection-related reaction. RELEVANCE TO PATIENT CARE AND CLINICAL PRACTICE Satralizumab has the potential to become a valuable treatment option for patients with NMOSD. CONCLUSION: Satralizumab appears to be safe and effective as monotherapy or in combination with an immunosuppressant for patients with NMOSD and has the potential to become a valuable treatment option for these patients.