ULTOMIRIS Was Proven to Provide Lasting
Control Over gMG Symptoms
Symptom improvements over 26 weeks:
More than 2x greater improvement in activities of daily living such as*:
- Brushing teeth
- Combing hair
- Rising from a chair
More than 3x greater reduction in muscle weakness, improving physical functions such as†:
- Eye and facial movements
- Hand gripping
- Head lifting
- Limb stretching
*Versus placebo from baseline to Week 26 of the clinical trial, according to the Myasthenia Gravis Activities of Daily Living (MG-ADL) scale. The MG-ADL scale is a patient-reported symptom improvement scale that was used in the ULTOMIRIS study to measure the difficulty of everyday activities. MG-ADL total scores range from 0 to 24, with higher scores indicating more severe gMG symptoms. In the study, the average baseline total score for the 86 people receiving ULTOMIRIS was 9.1; for the 89 people receiving placebo, it was 8.9. At Week 26, the average change in score from baseline was -3.1 for people receiving ULTOMIRIS and -1.4 for those receiving placebo. Many patients continued taking other medicines throughout the study.
†Versus placebo from baseline to Week 26 of the clinical trial, according to the Quantitative Myasthenia Gravis (QMG) scale. The QMG scale is a doctor-reported symptom improvement scale. It was used in the ULTOMIRIS study to measure muscle weakness and the difficulty of certain movements. QMG total scores can range from 0-39, with higher scores indicating more severe gMG symptoms. In the study, the average baseline total score for the 86 people receiving ULTOMIRIS was 14.8; for the 89 people receiving placebo, it was 14.5. At Week 26, the average change in score from baseline was -2.8 for people receiving ULTOMIRIS and -0.8 for those receiving placebo. Many patients continued taking other medicines throughout the study.
ULTOMIRIS was studied in a 26-week clinical trial that included adults with varying degrees of severity of anti-AChR antibody-positive gMG
See How ULTOMIRIS Was Studied
The trial (CHAMPION-MG) measured the impact of ULTOMIRIS (ravulizumab-cwvz) on daily activities and muscle weakness. It included 175 people who were randomly split into 2 groups: those taking ULTOMIRIS (86 people) and those receiving placebo (89 people)*
- A patient-reported questionnaire measured the effects of gMG symptoms on activities of daily living and physical functions
- A doctor-reported questionnaire measured muscle weakness
- After Week 26 of the trial, all study participants were eligible to receive ULTOMIRIS for up to an additional 4 years
- Over 90% of people in the trial had mild or moderate gMG†
- Study participants were allowed to continue taking immunosuppressive therapies if they were receiving them prior to the start of the initial study period. In fact, at their first dose of ULTOMIRIS, most people were taking an immunosuppressive therapy. If people were receiving immunosuppressive therapies at the start of the study, they were required to continue taking them throughout the initial study period
*Placebo is an inactive substance or treatment that looks the same as, and is given in the same way as, the investigational medication being studied.
†As defined by Myasthenia Gravis Foundation of America (MGFA) clinical classification.
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