Ultomiris demonstrated improvements with generalised myasthenia gravis through 60 weeks
Ultomiris demonstrated sustained improvements in functional activities and quality of life with generalised myasthenia gravis through 60 weeks
New, prolonged follow-up results from the Phase III CHAMPION-MG trial open-label extension (OLE) showed that Ultomiris (ravulizumab-cwvz) demonstrated long-term efficacy in adults with anti-acetylcholine receptor (AChR) antibody-positive generalised myasthenia gravis (gMG), with improvements in activities of daily living, muscle strength and quality of life, sustained through 60 weeks. Ultomiris was also well tolerated throughout this analysis.
Results from the trial were presented on 5 April at the 2022 American Academy of Neurology (AAN) Annual Meeting.
Upon completion of the randomised control period (RCP) of the CHAMPION-MG trial, 99.4% of participants (n=161) entered the OLE, during which all patients received Ultomiris. At the time of data cut off, 113 patients had reached 60 weeks. Efficacy analysis included all patients who received at least 1 dose of Ultomiris in the OLE. Ultomiris demonstrated statistically significant improvements from baseline (defined as initiation of Ultomiris therapy) in measures of functional activity, muscle strength and quality of life at 60 weeks of the OLE, including Myasthenia Gravis-Activities of Daily Living (MG-ADL) total score (-4.0 [95% CI -4.8, -3.1], p<0.0001). additionally, patients transitioning from placebo (n="83)" showed rapid response at a similar magnitude and time course as those who received ultomiris during the rcp.
The safety and tolerability were consistent with the known safety profile of Ultomiris observed in the RCP of CHAMPION-MG and other approved indications. The most common adverse events (AEs) (occurring in greater than or equal to 10% of 169 patients treated with Ultomiris in the RCP and/or OLE) were headache (16.6%) and diarrhoea (13.6%).Additional results from the CHAMPION-MG trial and pharmacokinetics and pharmacodynamics of Ultomiris in gMG were also presented at the 2022 AAN Annual Meeting.
Regulatory submissions for Ultomiris for the treatment of gMG are currently under review with multiple health authorities, including in the United States (US), European Union (EU) and Japan..
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