Kaiser study results on ranibizumab and bevacizumab

A Kaiser Permanents Southern California study published in this month’s Ophthalmology , the journal of the American Academy of Ophthalmology, compares ranibizumab (Lucentis) and bevacizumab (Avastin) and found them to be equally effective in halting vision loss.

Lead author Donald S. Fong, MD, MPH, and his Kaiser Permanente colleagues followed 324 newly-diagnosed AMD patients treated with bevacizumab and 128 treated with ranibizumab between 2005 and 2008. Visual acuity improved and stabilized in both patient groups: the proportion of patients who had 20/40 vision or better increased from 13.6 percent at baseline to 22.9 percent at 12 month follow-up in bevacizumab-treated patients and from 11.7 percent to 25.0 percent in ranibizumab-treated patients.

Ranibizumab (Lucentis) was specifically developed to treat the wet (neovascular) form of AMD and received US Food and Drug Administration (FDA) approval in 2006; bevacizumab (Avastin) was originally approved by the FDA as a cancer treatment and was used “off label” by ophthalmologists before Lucentis became available. Since Avastin appears to be beneficial and costs significantly less per dose than Lucentis, ophthalmologists continue to use it. Several comparative studies of the two drugs are underway, in relation to efficacy, safety, treatment protocols and cost-effectiveness. Results of the Comparisons of Age-Related Macular Degeneration Treatments Trials (CATT), a randomized clinical trial involving 44 centers across the U.S. and funded by the National Eye Institute, are likely to be particularly important.

“Some physicians are concerned about the effectiveness of Avastin, but our data did not seem to show any difference between the two drugs,” Dr. Fong said. ,“ Our results illustrate real-world use of AMD treatments: at the time of our study, there was no universal agreement within our 11 centers on optimal protocols, so treatment intervals and the drug selected for use depended on doctor-patient preference, ,” he added.

The blogosphere is busy with comments and on Pharma’s Market with Mike Huckman of CNBC GilBashe said: “Healthcare PR opportunities must be rooted in well-developed peer-reviewed science!

“We can't have it both ways - goodwill your way to secure placement on health formularies and then shrug shoulders when long-term data does not show safety or efficacy. Return medicine to good clinical practice driven by well-designed and powered (numbers of patients) trials. The best PR ultimately finds its foundation in peer-reviewed presentations and papers offered in public forum!

“Social media and sense of reporting urgency are not giving physicians sufficient time to study data before making public comments - soundbites are not the basis for large-scale health practice. Good science is essential! Then build your PR efforts.”

The Retina Eye Doctor

asks what it means and has some criticisms over the numbers: “This study was a retrospective study, that is, the results were determined looking backwards. One weakness of retrospective studies is that there are too many variables between patient groups to allow a true “head to head” comparison. The result, too much bias in the study and it is difficult to make sure, concrete conclusions. It doesn't mean that retrospective studies are worthless, but you must keep in mind there may be flaws in the conclusions.

“A prospective, randomized study is really the gold standard. In these studies, similar patients (similar in age, vision, race, etc.) are treated exactly the same and differ only in the treatments they receive. In this case, similar patients would be randomly treated with either Avastin or Lucentis. The patients are treated with the exact same protocol with respect to dosage, frequency of injection, etc. The groups are then followed for a given length of time.

“The results of prospective studies have far less bias and results are taken to be more meaningful. An NIH sponsored prospective study is underway comparing Avastin vs. Lucentis.

“For now, there seems to be no clinical advantage to either drug.”

Read the study