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Lucentis, Avastin show comparable efficacy in treating wet AMD; Avastin yields higher SAE rate

Wednesday, May 02 2012 | Comments
Evidence Grade 0 What's This?
Two-year results from a head-to-head trial of Genentech Inc.'s Avastin (bevacizumab) and Lucentis (ranibizumab) indicate that the drugs have comparable efficacy profiles as treatments for neovascular (wet) age-related macular degeneration (AMD), according to data published in the May 1 issue of the journal Ophthalmology.

In light of these findings, the Cleveland Clinic, which led the research effort, said the cost differences between these treatments "may have implications for both patients and physicians," noting that one dose of Lucentis costs approximately $2,000, while one dose of Avastin costs approximately $50.

At the same time, Novartis AG, the drugmaker that markets Lucentis outside of the United States, underscored safety findings from the trial, which showed a higher incidence of certain adverse events with Avastin.

The trial, known as CATT, was funded by the National Eye Institute and was designed to compare the safety and efficacy of Avastin and Lucentis as treatments for wet AMD and to compare the relative merits of different dosing regimens. The Food and Drug Administration has approved Lucentis as a treatment for wet AMD. Avastin is not approved in this indication, but has been used in an off-label capacity as a treatment for wet AMD, the Cleveland Clinic noted. Avastin is approved for treating certain types of colon, lung, kidney and brain cancers.

During CATT, 1,185 participants with wet AMD were randomized to receive one of two treatments (Avastin or Lucentis) and one of two dosing regimens (monthly or as needed). The primary outcome measure was the mean change from baseline in visual acuity at one year.

After one year of treatment, the data showed that the two drugs "had nearly identical effects on visual acuity and that less-than-monthly, or as-needed dosing, did not compromise vision," according to the study authors.

During the second year of treatment, the participants who were originally randomized to receive monthly dosing were rerandomized to receive either monthly or as-needed dosing.

Among the patients who followed the same dosing regimen for two years, there were no significant differences between the drugs in mean gains in visual acuity.

In a comparison of dosing regimens, the data suggested that monthly dosing was associated with slightly greater gains in vision relative to as-needed dosing, but the final results were similar in all treatment groups, with at least 60 percent of the patients achieving driving vision.

The authors of the study noted that rates of death and arteriothrombotic events were similar for both drugs, but the proportion of patients who experienced at least one systemic serious adverse event (SAE) was significantly higher with Avastin (39.9 percent) than with Lucentis (31.7 percent).

The Cleveland Clinic said the importance of this between-group difference is uncertain, noting that most of the adverse events in the Avastin group were not events that have been linked with Avastin in cancer trials (in which patients receive a much higher dose of the drug) and that the rate of SAEs was actually higher with less-frequent (i.e., as-needed rather than monthly) dosing.

"In 2010, [Lucentis] accounted for nearly 10 percent of the entire Medicare Part B drug budget, its single largest expenditure," the study authors wrote.

"The choice of drug and dosing regimen for patients must balance the comparable effects on vision, the possibility of true differences in adverse events and the 40-fold difference in cost per dose between [Lucentis] and [Avastin]," they concluded.

This information concerns a use that has not been approved by the FDA.

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