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Lien Google trad http://journals.lww.com/neurotodayonlin ... nia.1.aspxEculizumab Found Safe and Effective for Myasthenia Gravis
Neurology Today: January 11, 2018 - Volume 18 - Issue 1 - p 1,27–28
In a post-hoc analysis, eculizumab was found safe and effective for reducing symptoms in patients with generalized myasthenia gravis who have not responded to the standard treatments used in the autoimmune disease
Eculizumab, a drug that blocks the complement cascade, is safe and effective in reducing symptoms in patients with generalized myasthenia gravis (gMG) who have not responded to the standard treatments used in the autoimmune disease, according to the results of a clinical trial published in December in Lancet Neurology.
In October, the U.S. Food and Drug Administration (FDA) approved eculizumab (Soliris), even though the primary endpoint in the phase 3 study narrowly missed statistical significance.
About 10 to 15 percent of patients with gMG continue to have severe disabling muscle weakness and repeated hospitalizations despite multiple therapies. Sometimes, the side effects from these medicines are just too daunting to continue taking them, said the lead author of the new study, said James F. Howard, Jr, MD, professor of neurology, medicine and allied health and chief of the neuromuscular disorders section at the University of North Carolina School of Medicine.
“This is a breakthrough treatment,” Dr. Howard said. “There is no question that the drug works in many of the refractory patients in the phase 3 study.”
Still, he said, 30 to 40 percent of the patients on the drug did not seem to have a significant benefit, and the researchers are still trying to figure out why.
For now, eculizumab can be prescribed when other medications used to treat gMG have failed or patients are dependent on chronic plasma exchange or IV immunoglobulin G (IVIG), he said.