番茄社区

Longer-term use of tralokinumab for treating atopic dermatitis appeared safe and with durable efficacy in an open-label extension study, according to a presentation at the American Academy of Dermatology (AAD) Virtual Meeting Experience 2021.

In this exclusive 番茄社区 video, study author , president of Oregon Medical Research Center in Portland, discusses interim results of the ECZTEND trial.

Following is a transcript of his remarks:

So the clinical study ECZTEND, which I discussed in the recent AAD online meeting, is an open-label extension study with the drug tralokinumab for patients with moderate-to-severe atopic dermatitis. Tralokinumab is an anti-IL-13 blocker, it blocks the cytokine -- this is in contrast to a drug that many of you know, dupilumab [Dupixent], which binds the IL-4 receptor alpha, and it blocks signaling of IL-4 and IL-13 -- so this is a selective IL-13 blocker drug.

The drug had previously been shown in phase III trials to be safe and effective over the course of 1 year. And those studies were published. In ECZTEND, the trial that I discussed the latest results, it is patients coming from parent trials of tralokinumab, the 1-year trials and some other phase III trials that the company did with the drug in atopic dermatitis, and then placing every patient on to [tralokinumab] and over time just looking how well they do with maintenance therapy over the course of years. This is a 5-year planned study in terms of both efficacy and safety. So it's really about long-term use of this new biologic that's being investigated for atopic dermatitis, what patients do over time.

What I presented was the the 1-year data of people who have been in this extension for at least 1 year. Now, the majority of the patients, however, included patients that were in 1-year parent trials. And so we have a subset of patients now in the open-label extension that have been on drug for 2 years, and we call that the 2-year cohort. So I presented data both in patients in the open-label extension for 1 year, and a subset of those who have been on drug for up to 2 years of using tralokinumab. And essentially most of the patients coming into the open-label extension had been doing well, because if you think about it, if they weren't doing well for some reason in the parent trial, either due to poor efficacy or to some safety issue, they wouldn't have gone on to the open-label extension.

So really you can kind of think of this study, ECZTEND, as patients doing well on tralokinumab. What happens over time? Do they continue to do well? Do they lose response, which we sometimes see with biologic therapy, or do safety issues emerge with time that we may not have seen in the earlier trials. And very simply, the bottom line is good. We saw nice results for people continuing on this drug. We saw them continue to have very low EASI [Eczema Area and Severity Index] scores, which is a measurement of the eczema severity. And we saw them have relatively few adverse events and nothing new developing with continued use of this drug. So great durability of efficacy and great safety in this particular trial with these interim results.

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