pe26 schreef op 30 juli 2017 21:54:
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David R. Risinger - Morgan Stanley & Co. LLC
Yes, hi. Thanks very much. I have two questions, one for Mike and one for Bill. So obviously, there have been a lot of questions about your JAK inhibitors PE and DVT rate, but when do you expect to publish percentages the way that we've seen for baricitinib? T
hat was 0.47% (Eli Lily) and Galapagos was 0.16%.Michael E. Severino, M.D. - AbbVie, Inc.
Okay. So, this is Mike. I'll take the first question on upadacitinib and the rates of DVT and PE. So I think, as we've said, it's the overall rates that are really important. We continue to monitor those. We're well within that expected rate for the population. And, of course, one wouldn't expect to see something lower than the background rate for the population in any large clinical trials program.
So when we have the aggregate data, we'll present the whole picture. And we'll show what those rates are. And we'll also show, at an appropriate time, the distribution in the control period. But really right now, we're very early on in un-blinding and reporting out our Phase 3 RA studies.
With respect to those other rates, the rate that you quoted for Gilead, I think we'd have to really understand where that exposure comes from. Gilead is really just getting started in RA. Most of their data comes from Crohn's disease and other inflammatory bowel disease conditions, like UC, where the patient population's very different. They tend to be younger. The risk profile is different.So I think, at this stage, it's hard to use those benchmarks that you quoted as ranges. I think you have to look at the literature. You have to look at other sources of information. And we see a very, very consistent background rate of 0
.3 to 0.8. You see that in the literature. We've done our own work in payer databases and we see that same rate.
And we've seen that same rate across historical RA programs, regardless of mechanism of action. Some are ours. Some are other programs. So we think we have a really good handle on that rate. And what we're seeing right now is very, very consistent with nothing other than that background rate. When we have the data from our Phase 3 program, we'll present that whole picture.