DENVER — The use of the monoclonal antibody satralizumab for the long-term treatment of anti-aquaporin-4 antibody-positive neuromyelitis optica spectrum disorder provides sustained freedom from relapse with no new safety concerns over 5 years, new research shows.
The drug was approved by the US Food and Drug Administration in 2020 for the treatment of AQP4 antibody-positive NMOSD after favorable results from two key trials: SAkuraSky and SAkuraStar. With a median duration of satralizumab exposure of 5 years, the overall adjusted annualized rate of investigator protocol-defined relapse was 0.09.
Asked if there are potential subgroups of patients who may be more susceptible to the worsening of disability, Traboulsee responded"not that we can tell as of yet." While the use of combination therapy has been an important clinical concern, Traboulsee noted that"this does not appear to be the case with satralizumab when combined with daily prednisone or daily azathioprine."
In addition to its long-term safety and efficacy, satralizumab"is easy for patients to take and does not require access to an infusion center. It's easy for physicians to monitor safety, especially since no additional vaccinations or precautions are required beyond what is done in routine care."