Why Was It Approved?
Uplizna was approved based on results from a large clinical study that included adults with gMG who tested positive for either anti-AChR or anti-MuSK antibodies.In the study, people who received Uplizna had better muscle strength and improved daily function compared with those who received a placebo.
The trial included 238 adults with gMG, including both AChR+ (190) and MuSK+ (48) patients.
Patients on steroids at baseline started reducing the dose at week 4, aiming for a specific low dose by week 24.
By week 26, 87% of patients taking Uplizna and 85% of patients taking placebo reached this low steroid dose. At the same time, Uplizna improved daily living activities, with patients showing a 1.9-point greater improvement (-4.2 vs -2.2) on a predefined scoring system (the MG-ADL score) than those taking placebo; AChR+ patients continued to benefit through week 52 with a 2.8-point improvement (-4.7 vs -1.9). Uplizna also reduced muscle weakness as measured by the Quantitative Myasthenia Gravis score (-4.8 vs -2.3).
What Do I Need to Know?
Uplizna is given through an IV infusion. You’ll get two starting doses two weeks apart, followed by one dose every six months. Each infusion takes about 90 minutes, and your health care provider will monitor you for at least an hour afterward to check for any side effects. Before each infusion, you’ll receive medicines like steroids, antihistamines, and fever reducers to help lower the chance of infusion-related reactions. Some people may also get infections like urinary tract infections or colds. Be sure to tell your health care provider about all medicines you take, including prescription drugs, over-the-counter medicines, vitamins, and herbal or natural supplements, especially those that affect your immune system.
