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Additional Efficacy Findings from the LIBERTY-AD Four-Year Open-Label Extension Study

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Continuing their discussion about efficacy, Andrew F. Alexis, MD, MPH, and Benjamin N. Lockshin, MD, review long-term results on pruritus. Additionally, they explore data for patients who switched from weekly to every-other-week dupilumab treatment.

Andrew F. Alexis, MD, MPH: Let’s look at other aspects of efficacy. We know how important itch is in the management of atopic dermatitis, and the burden of itch and the impact it has on patients. Would you like to walk us through some of the efficacy on itch?

Benjamin N. Lockshin, MD: Absolutely. In this table, we see it is actually a composite of both the mean EASI [score; Eczema Area and Severity Index] represented by the darker golden bars, and the light-yellow bars represent the mean weekly pruritus NRS [Numerical Rating Scale] score, which is a score of 0 to 10, and looking at that mean change, 0 reflects no itch, and 10 is the worst itch reported. It should be noted that baseline enrollment numbers for patients in all the parent studies tended to be around 7 or 8 out of 10 in severity. That’s pretty consistent with what we see in most of the clinical trials for AD [atopic dermatitis]. What we see here is the mean weekly pruritus score is hovering a little north of 2, and it should be noted that a score of less than 4 is categorized as mild, and severity [is] far past the minimal clinically significant reduction of itch that we see. These in my practice are very happy patients. We see more than a 4-point mean reduction from the baseline characteristics of these patients. Over time, we see the same story, maintenance of that durability of response. This is almost the telltale sign of how patients are doing in terms of the impact on their life, in terms of sleep and attention and work and school. Are there any components on the itch change that you see over time? Does this reflect what you see in your normal patient population?

Andrew F. Alexis, MD, MPH: This is very consistent with what I see in my practice, that we see robust reductions in itch that are maintained. I think this is one of the key benefits of treating with this biologic. Moving on to other efficacy data, what are your thoughts on this cut of the data, which is patients who switch from dupilumab weekly dosing to the more standard approved dose of every 2-week dosing, 300 mg? Any quick takeaways from this, Ben?

Benjamin N. Lockshin, MD: Well, I will say when you look at large populations in general in this study as well, you see not a major difference from the patients who made that switch. About 80% of those patients were able to maintain their EASI scores. In my clinical practice and in some of my patients who actually rolled out of the study who were on weekly dosing I felt did do better on weekly dosing, but the lion’s share of the patients were able to convert from the weekly dosing and that dose-ranging study. If they rolled into 1 of the studies on Q week, they continued until a protocol mandated changing to that every 2-week dosing. I don’t know if this was intentional or unintentional, but it was a nice added benefit to really show us how patients did at that lower dose from that transition at different points in time. What’s your takeaway? Do you have any thoughts? Do you have any patients who require off-label weekly dosing, or would you like the opportunity to be able to put them on weekly dosing? It certainly for me was something that in those tough-to-treat patients was the only option when I didn’t have any other treatments. Now that we do have an array of options, this is less of a frequent issue that I encounter.

Andrew F. Alexis, MD, MPH: I would agree with you, Ben. It’s a very infrequent encounter these days for me to have to go off-label with once-weekly dosing for my moderate to severe AD patients. For the vast majority of my patients, every 2 weeks dosing—the approved, label dosing—is sufficient. But if there are some persistent areas, some breakthrough areas, I’m able to combine with a topical agent or phototherapy if needed, another modality to get them through. But I’ve not had to move to every week dosing in a very long time.

Benjamin N. Lockshin, MD: You make a really good point talking about the adjuvant therapies. And what Regeneron [Pharmaceuticals] did do in their Kronos study was, a unicorn event where they were able to have 52 weeks of a blinded study with concomitant topical steroids. That’s more of a real-world approach. What I like in the open-label extension was that patients were able to use steroids as adjuvant treatments, which really reflects what we do in clinical practice. Very rarely in the real world do I wash patients out of medications, and certainly I don’t stop them from topical medications when I add on biologic therapies. This data really gives me the information that I need to explain to patients what the real-world expectations are because I think these patients really mirror what our patients look like.

Andrew F. Alexis, MD, MPH: It’s reassuring to see these data that more than 80% of patients achieved a response when switched from the weekly dose to the every-2-week dose. We all know that from a patient’s perspective, injecting themselves every 2 weeks vs every week is a major plus, and frequency of injection is important to a lot of patients. Would you agree with that, Ben?

Benjamin N. Lockshin, MD: Yes. I’ve been living in the Washington, DC area. We have a number of state department patients as well as patients who work in the corporate world who travel a lot. Dosing every 2 weeks doesn’t seem to disrupt travel much or inconvenience patients. Once you get into injections on a more frequent basis, it really does make itself somewhat of an onerous burden and task. You get less buy-in for patients in terms of making this a lifestyle decision. Most patients can work around that 2-week dosing window easily enough for most of their trips. I think every 2 weeks is a nice frequency. I know that in the psoriasis world, we have a lot of other options with less frequent dosing. I think they present themselves with benefits and drawbacks. Most of us remember paydays, and a lot of people are paid every 2 weeks so they can remember when to take their shots. Many people can remember the first day of the month if it’s a monthly dosing. But if it’s off-cycle dosing where it’s every 2 or 3 months, I have a very hard time remembering events that don’t happen with a very predictable cycle of events; 2 weeks is a good number for me.

Andrew F. Alexis, MD, MPH: Agreed.

TRANSCRIPT EDITED FOR CLARITY

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