In two phase III trials (ADvocate1 and ADvocate2), adult and adolescent patients with moderate-to-severe atopic dermatitis (AD) maintained similar improvements with investigational lebrikizumab at 1 year whether they stayed on every-2-week dosing or switched to every-4-week dosing.
While the FDA appears poised to approve the interleukin (IL)-13 inhibitor based on its efficacy and safety data, the agency recently issued a complete response letter, citing problems at a third-party manufacturing facility.
In this exclusive MedPage Today video, study investigator Emma Guttman-Yassky, MD, PhD, of the Icahn School of Medicine at Mount Sinai in New York City, discusses the data and how they should change practice.
Following is a transcript of her remarks:
I think lebrikizumab — that is a drug that we are all awaiting [FDA] approval and we were hoping it’ll be in October, but now it was pushed a little bit — and I’m saying it because I have some patients that I told them ‘Oh, come back, see me in early November with the new drug being approved.’
But it showed very promising results both on the clinical efficacy, but also I think what patients want is to try to space out their treatments. And we do see that the responders to the treatment were able — so basically what was done here, the responders were randomized to either every 2 weeks, every 4 weeks, or nothing — basically placebo. Of course, it’s kind of a real-life situation so topicals were allowed — were monitored — but allowed. And what was seen, and that’s very hopeful, is that every 4 weeks shows very, very similar results to every 2 weeks.
So that tells a patient that once you achieved response, you likely not need to give the drug every 2 weeks. You can be maintained on every 4 weeks.
Now, there were also patients that after they achieved response, were put on placebo with some, probably, topicals that they used. But we don’t know exactly what happened. And not all of them, but many of them, maintained responses on placebo. That needs to be still looked at in other studies.
But for me, the more important take-home message is that every 2 weeks and every 4 weeks look very similar. So I can confidently tell my patients: ‘Once we achieve response, we will be able to space out your drug to every 4 weeks.’ And I think that’s an important point for patients that are looking to have less jabs in reality.