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Video
LIBERTY AD OLE Study in Atopic Dermatitis
Author(s):
Dr Andrew Blauvelt reviews key highlights and clinical implications from the LIBERTY AD OLE study assessing the effect of long-term dupilumab treatment on efficacy improvements in adults with moderate to severe atopic dermatitis.
Andrew Blauvelt, MD, MBA: Very recently, we published a paper looking at patients who initially did not do well with dupilumab [Dupixent]. Now, what I mean by that, is that the criteria for responses in these systemic AD [atopic dermatitis] studies is an EASI [Eczema Area and Severity Index] of 75 or an IGA [Investigator’s Global Assessment] score of 0/1. So EASI is a scoring system for atopic dermatitis, and patients have a baseline score. Then, if they don’t get 75 or more improved on that score, then they’re considered a failure for EASI 75. So EASI 75 means the percentage of patients who are achieving that response. The other measurement is IGA 0/1. IGA is a global score. It’s a simpler score. It goes from clear to almost clear, mild, moderate, severe, and 0/1 scores are clear or almost clear. So it’s a higher bar to get to than EASI 75. It’s really difficult actually to get patients to clear skin or almost clear skin. We see in trials the percentages of patients who achieve this 0/1 rating. In this recent paper, what we looked at is after 16 weeks of dupilumab therapy, that’s the primary end point, we looked at EASI 75 and we looked at IGA 0/1. And what we found is that a certain percentage of patients did not reach those parameters—either EASI 75 or IGA 0/1—but those patients were continued in the trial on dupilumab. In this particular trial, in the phase 3 program, the long-term studies were done with dupilumab 300 mg every week, not every other week. So that’s 1 of the caveats of this data. Then we looked at week 100. So 2 years into therapy, what happened to those people who initially quote-unquote, did not do well or meet those criteria? What happened to them after 2 years of dupilumab therapy? What we found is a very high percentage of them reached those goals. In fact, over 90% of patients achieved EASI 75 at the week 100 point.
In the high 40s, so 45% to 50% or so, patients achieved clear or almost clear skin IGA 0/1. This result is important, I think, because it shows that the initial response is not the whole story, and that 4 months may not do the trick for some patients. With continuing therapy, you’re going to see probably a bump up and some patients start to respond well if they continue on their therapy. For practice, I think at the 4-month time point, you have to decide whether you want to switch or not. If the patient is quote-unquote not doing well, a clear option, at least from this data, is to continue the patients on the drug, and you’re going to, I think, see a percentage of patients eventually respond to dupilumab.
In private practice, when we’re seeing patients back in follow-up, we’re always looking at whether the therapies are working, and it’s different in private practice definitely than in clinical trials. In clinical trials, there are rules for stopping and continuing. Most patients will continue unless there’s some major issue going on. I think for private practice, it’s a little bit different. There are other factors going in, and one of the main factors for me is patient happiness. So obviously if you have a patient, let’s say who’s had a few months of dupilumab and is not happy for whatever reason, even if you think the skin response is doing well, if their expectations are different than yours and they’re unhappy, then I would consider switching. So for the happiness factor of the patient, you don’t want to keep them on a drug that they don’t like and that they don’t have confidence in, even if you think that it’s eventually going to do well. The other thing is insurance coverage. It’s a big thing in private practice. Do the patients continue to have the coverage for the drug? Another thing is competitors. When new drugs are approved in atopic dermatitis patients, many times, we’ll know about that. Doctors know about that. So if a patient’s not doing terrifically on their current choice and a new drug just became available, many times that will push the switch to occur. On the other hand, there’s going to be patients who don’t want to switch, even if they’re not doing terrifically but they’re on a pathway, or there are doctors that don’t want to switch. That’s OK, too, I think, to continue on a drug like dupilumab because we know that over time patients can get better and better if they stay on longer than 4 months. But the actual decision to make a switch is going to be governed by a number of different factors that I went over.
Transcript Edited for Clarity
