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of Amgen versus Alder, and there are always different variables that make it difficult to compare one clinical trial with another.
But to get an idea of how strong the Alder data are, I looked at the FDA-approved prescribing information for the Amgen drug. As you can see in the table below, the Amgen drug showed in what it calls Study 1 that can help about 40 percent of patients get to that same benchmark of effectiveness, after a longer period of treatment—six months. To be fair though, the Amgen drug has been around since 1998, and has reams of long-term data to show that it is safe and effective over the long haul, and even can help halt progressive joint damage.
|Month 3||Enbrel 25 mg twice-weekly||Placebo|
|ACR50||41 percent||8 percent|
|ACR70||15 percent||4 percent|
|Month 6||Enbrel 25 mg twice-weekly||Placebo|
|ACR50||40 percent||5 percent|
|ACR70||15 percent||1 percent|
And there are definitely caveats in the Alder data that must be pointed out. First, the Alder drug was given in an IV formulation every eight weeks, meaning that patients had to come in to see the doctor. That’s not really competitive with drugs from Amgen and Abbott Laboratories, which patients can give via self-administered injections just under the skin. So Alder and Bristol are reformulating ALD518 into a more convenient and competitive package, in what is known as a subcutaneous form. That’s the version that Alder and Bristol will need to take into a pivotal, Phase III clinical trial in many more patients, which the FDA will want to see before it will consider clearing the Alder drug for sale in the U.S. The pivotal trial will also have to be longer, following FDA guidelines that ask for six months of observation, Schatzman says.
“This was a small study, really a scientific proof of principle,” Schatzman says. “We need to do a much larger trial and see whether we can repeat the results.”
Mease, who has a lot of experience studying the other rheumatoid arthritis drugs, says that the Alder results are still early. Still, the results thus far are “certainly as good as any early anti-TNF data,” Mease said in an e-mail. “Significant development program from [Bristol-Myers Squibb] is to follow.”
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