SAE Rate Higher With Nilotinib Versus Placebo in Parkinson Disease

Among patients with moderately severe Parkinson disease, exploratory biomarkers are altered in response to nilotinib, but the rate of serious adverse events (SAEs) is significantly higher in those receiving nilotinib versus placebo, according to a study published online Dec. 16 in JAMA Neurology.

Fernando L. Pagan, M.D., from Georgetown University Medical Center in Washington, D.C., and colleagues conducted a phase 2 randomized trial with 75 patients randomly assigned (1:1:1) to either placebo, nilotinib 150 mg, or nilotinib 300 mg. Nilotinib and placebo were administered orally once daily for 12 months.

The researchers concluded that nilotinib at doses of 150 mg and 300 mg seems to be reasonably safe, although more SAEs were seen in the nilotinib groups compared with the placebo group (24 and 48 percent, respectively, versus 16 percent). An increase in cerebrospinal fluid levels of the dopamine metabolites homovanillic acid and 3,4-dihydroxyphenylacetic acid were seen in the nilotinib 150-mg group, while in the 300-mg nilotinib group, an increase in 3,4-dihydroxyphenylecatic acid was seen. A reduction of α-synuclein oligomers was seen in the nilotinib 150-mg group but not the 300-mg group. In both nilotinib groups, there was a significant reduction noted in hyperphosphorylated tau levels.

"The conclusion that nilotinib is reasonably safe holds poorly to scrutiny," write the authors of an accompanying editorial. "Selected safety end points underscore a dose-related increase in the incidence of serious adverse events."

Several authors disclosed financial ties to pharmaceutical companies, including Novartis, the manufacturer of nilotinib.

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