Ondertussen bij de concurrentie...uit de presentatie van abvie. Redelijk kritische vragen van de analisten...
Terence C. Flynn
Okay, great. As we think about, I guess upadacitinib moving on here, maybe again similar question to SKYRIZI, just recap the profile for us what’s most exciting about this? And then how it is compared to some of the other JAKs that are available or either in development and really what's the differentiated feature that you see on the upadacitinib front?
Mike Severino
Well if you are -- turning back to what we said about our strategy of finding an agent that either drives higher levels of response or drives response in patients who have failed of other therapies in RA, we feel that upadacitinib fits that bill very nicely. If you look at performance across our Phase 3 clinical trial program, we uniformly drove very high levels of response. Not just at the ACR20 level, but at much higher levels of response, at ACR50, ACR70, patients who achieved DAS low disease activity or remission, which we believe really should be the standard going forward. Now that there are agents that can drive that level of response, there's really no reason to leave the patient with disease activity that's greater than that. And so we did that across a wide range of settings. We did that very early patients who are new to therapy. We did that in classic methotrexate inadequate responder populations. And we also drove those responses in patients who have failed multiple biologic therapies, not just TNF-inadequate responders, but true biologic inadequate responders. So really across the spectrum we are driving the level of response that we wanted to try. We had a very, very strong benefit on structural endpoints in two different studies, a very strong monotherapy data, so really has rounded out the efficacy profile. And then lastly and I think very importantly, we had very, very strong head-to-head data against HUMIRA, which is of course the gold standard today in that space, where we showed superiority to HUMIRA across every endpoint that was tested. And that sort of broad-based very robust deal, I think is an important demonstration of the profile.
Terence C. Flynn
Do you think -- I mean, I think that’s one of the questions. Do you think you'll be able to get that head-to-head data on the label that had versus HUMIRA?
Mike Severino
Well, typically it takes two head-to-head studies to get a label claim. So it's not necessarily so much about what's in the label.
Terence C. Flynn
Okay.
Mike Severino
It's about the overall profile of the molecule that's broadly presented, I think well understood by the [indiscernible] in a number of settings. They can be used with payers, they can be used in a number of different interactions by different groups. And so it's more about demonstrating the overall profile than about getting a specific claim in the label.
Terence C. Flynn
Okay. Would you consider running a second study though to get that label claim? Because to me, it could be a key advantage relatively to some of the other competitors coming and maybe in a world where we do have HUMIRA biosimilars out there, does that give you increased leverage in terms of position, or do you think having just the one study in, again being able to talk as we did, kind of gives you enough leverage on that front?
Mike Severino
We believe the label have everything that it needs to make us competitive. So we are always committed to ongoing data generation. We will be generating data on all of our products for many years to come. And so, we will do more work with upadacitinib, but we feel very good about what we would expect to be in the initial label and it will have all the information we need. You asked about positioning against other agents. If you look at the program we run with the only JAK inhibitor that’s at the primary endpoint across every study, we are the only JAK inhibitor that shown the kind of head-to-head superiority against HUMIRA that we’re talking about. So we feel that we are going to have the data that we need to be competitive.
Terence C. Flynn
Okay. One other question. I know you guys have gotten is just a potential for an FDA AdCom and then kind of corollary to that is how to think about the label and does the FDA view this as kind of class labeling or do you guys think you can kind of carve out a differentiated label versus some of the other JAK, so maybe just offer your perspective on those two questions here?
Mike Severino
Certainly. So we are reasonably far along in our review process right now. And we don't at this point expect an advisory committee based on all the discussions that we are having with the FDA. So we feel good about the progress we are making in the review. It's a little bit early to make exact predictions about the label. But we think that the data that we've generated, not only the efficacy data, but also the safety data which shows a robust benefit/risk profile, showed rates of DTEs, in particular, which is something that’s been of the interest in this class that were no different between upadacitinib and the comparators. And that's true whether the comparators were adalimumab, methotrexate or true placebo. We feel like that puts us in a very good position for those negotiations.
Terence C. Flynn
Okay. So you feel like there is a possibility that you won't have that blackbox warning for DVT?
Mike Severino
Again, it's a bit early to make predictions about what the label looks like, but we feel that we are in a very strong position. We feel we have a very strong data set. We've looked very carefully for any evidence of increased risk and we haven't demonstrated that. The rates have been the same across upadacitinib both doses and similar in the same in fact compared to all of the different comparators that we included in the programs, we think that puts us in a very strong position.
Terence C. Flynn
Okay. One other thing is just thinking about -- maybe the -- walk us through kind of the education effort that it will take you think to kind of continue to build the JAK class, because some of those historical questions recognizing you guys might have the safest, cleanest profile, but how do you really build the totality of the data to kind of drive uptake of the JAK class, maybe better than what we've seen from some of the prior drugs out there?
Mike Severino
Well it starts with having a very strong data package, which we have. And then if you look at our track record, we are an organization that has a very strong commercial presence, a marketing presence in the space. And we understand how to drive messages that resonate with patients and with physicians. We’ve a very, very strong medical affairs capabilities. We are committed to ongoing data generation, data communication. We’ve shown that we’re very effective there. And we know this space very well. This is a space we’ve been leaders for many years. So we think we understand how to not only develop, but how to commercialize this product and how to make sure that the attributes of the product are well understood by treating physicians and by patients.
Terence C. Flynn
And maybe the last question in this topic. Can you just remind us how we should think about the cadence of label indications building for SKYRIZI and upadacitinib? I think you guys have provided some guidance in terms of where you want to end up relative to HUMIRA over a certain number of years, but again just maybe walk us through kind of the cadence of some of those label [ph]?