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Weighing the Impact of Long-Term Open-Label Extension Data


Andrew F. Alexis, MD, MPH, and Benjamin N. Lockshin, MD, review the impact of the open-label extension data on the current atopic dermatitis landscape.

Andrew F. Alexis, MD, MPH: We’ve looked at the 4-year data. I’d love to get your thoughts on what impact you think these data might have on the overall treatment landscape of atopic dermatitis [AD], especially considering that we have multiple options and anticipate others in the future. What are your thoughts?

Benjamin N. Lockshin, MD: This is a great question…. Open-label data add another point that we can focus on, in terms of the value of this product in our marketplace. Patients and prescribers are different in terms of their tolerance for risk. I’m a very data-driven individual. When I can present this to a patient, saying that in an open-label manner over 4 years in patients who are on treatment just like you—using topicals, not using topicals—I see no real amplification of safety signals. In fact, many of the signals we saw in the phase 3 studies diminished over time. You did a nice job articulating that rate with conjunctivitis. In addition, there are injection site reactions, which are very limited. On the spectrum of biologic therapies, I rank them 2 or 3 of the 10 of the options we have.

There are common adverse events that we see with many of these drugs. There’s no amplification, and there are no worrisome new signals. There are none of those rare and scariest that pop out over time. All that makes me much more comfortable with the data that I already felt comfortable with. This just gives me the opportunity to add to the data set that I’m delivering to patients explaining this product. How do you digest this information? What do you think about it?

Andrew F. Alexis, MD, MPH: I agree with the way you summarized that, Ben. Let’s face it: For long-term safety data, I’m particularly interested in the safety end. Of course, efficacy is important too, but long-term safety data are key when thinking about a treatment for a disease that we’re going to be treating for a very long time. It’s reassuring to see that there aren’t any new safety signals and there aren’t any signs of cumulative risk for safety issues while being on drug. On the contrary, we saw a reduction in rates of conjunctivitis, particularly with increasing weeks of exposure. Overall, this helps give some reassurance to me as a clinician that I can comfortably and safely treat patients with atopic dermatitis, moderate-severe AD, with dupilumab for the long term without new safety signals.

On the efficacy side, I’m also reassured that we’re seeing efficacy not just in the short term but in the long term. Rapid responses and early responses are important, but I want to make sure I’m controlling this patient longitudinally. These data give me confidence in being able to manage my patients over the long term, giving them what is needed in terms of long-term control but without any increased or cumulative safety concerns.

Transcript edited for clarity

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