Switching from Dupilumab to Abrocitinib in Patients with Moderate-to-Severe Atopic Dermatitis: A Podcast Article

Abstract

As the number of systemic agents available for the treatment of moderate-to-severe atopic dermatitis (AD) continues to increase, it is likely that patients may need or want to switch from one treatment to another. Owing to differences in the mechanism of action, the systemic agents abrocitinib (an oral Janus kinase 1-selective inhibitor) and dupilumab (an injectable interleukin 4 alpha antagonist) are associated with distinct efficacy and safety profiles. Two recent publications have examined the efficacy and safety of long-term abrocitinib in patients previously treated with dupilumab. In this podcast article, two dermatologists discuss the management of moderate-to-severe AD and highlight factors to consider before changing therapies in the context of these recent studies, focusing on switching from dupilumab to abrocitinib treatment.

Below is the link to the electronic supplementary material.

Download video file ^{(169.8MB, mp4)}

Supplementary file1 (MP4 173881 KB)

Supplementary Information

The online version contains supplementary material available at 10.1007/s13555-025-01491-2.

Key Points

Patients with moderate-to-severe AD may require switching between systemic therapies due to intolerance, inadequate response, adverse events, lack of access, or preference; this podcast will discuss the management of AD and factors to consider before switching treatment, focusing on abrocitinib and dupilumab, in the context of two recent studies.

The JADE DARE and COMPARE trials reported significantly greater improvements in AD signs and symptoms in patients with moderate-to-severe AD treated with abrocitinib versus dupilumab.

In clinical practice, response to treatment is assessed by the extent and rapidity of improvements in itch, skin clearance, quality of life, and other patient-reported outcomes.

A large proportion of patients who achieved an itch-free state (PP-NRS 0/1) with abrocitinib or dupilumab in JADE DARE also achieved a DLQI 0/1 response, highlighting the value of reaching an itch-free state for patients.

Clinicians should consider the unique benefit and risk profiles prior to switching therapies, inform their patients and make a shared treatment decision.

Podcast Audio

The podcast audio can be downloaded from the article’s Figshare page here: 10.6084/m9.figshare.29477951.

Alternatively, the podcast can be found by searching “Adis Journal Podcast” with your preferred podcast platform.

00:00:00–00:00:45

Dr. Shi

Hello everyone, and welcome to this podcast for Dermatology and Therapy. I’m Dr. Vivian Shi from the University of Washington School of Medicine in Seattle. And today, I’m joined by Dr. Jonathan Silverberg from The George Washington University School of Medicine and Health Sciences in Washington, DC.

Now, in this podcast, we’re going to talk about switching from dupilumab to abrocitinib in patients with moderate-to-severe atopic dermatitis, or AD, in the context of our own clinical experience, as well as describing some recent publications which have examined this issue.

This podcast is sponsored by Pfizer Inc.

00:00:45–00:01:03

Dr. Silverberg

Hi, Vivian. I’m looking forward to a great discussion. And it’s really been an amazing time in the field. I’ve had the opportunity of watching the field evolve over the past 10–15 years. And what an amazing renaissance now that we have in treating atopic dermatitis. I look forward to a great discussion.

00:01:04–00:01:20

Dr. Shi

You are absolutely right. It’s really an amazing time to practice. I can’t imagine how it’s been 20 years ago, and we are just riding the wave. Every day is a different day, so we’re really excited to talk about treatment options.

Now, why don’t you get us started with what is moderate-to-severe AD?

00:01:20–00:02:07

Dr. Silverberg

Sure. So atopic dermatitis is a chronic inflammatory skin disease [1]. We know that the universal symptom, the defining symptom, is itch, which obviously can be very severe in many patients [1–4]. And of course, the eczematous lesions, and, putting those together, you get impaired quality of life and downstream effects on sleep and pain, and other issues that happen within the disease state [1].

Now many patients with refractory disease, typically it’s those patients with more moderate-to-severe atopic dermatitis; they’re just not going to do well with topicals alone [5–7], and they’re going to require a systemic therapy in order to achieve control of the disease [5]. And now with respect to systemic therapies, we now have options to use, including biologics as well as small molecule inhibitors such as abrocitinib.

00:02:08–00:02:58

Dr. Shi

You’re right. So a little bit of introduction to the two medications. Abrocitinib is an oral JAK1-selective inhibitor that really targets multiple cytokines we now know are central to AD’s pathogenesis, including but not limited to interleukin-4, -13, -22, and -31, really involving both inflammatory response, but also the itch and scratch response [8, 9]. Now, dupilumab is an injectable interleukin-4 receptor alpha subunit inhibitor that inhibits the activity of both IL-4 and IL-13 [10].

So when you look at these mechanisms of action, they’re quite different, even though they both treat atopic dermatitis. There are also different factors to consider in terms of how fast they work, which is rapidity of response, and duration and so forth.

00:02:59–00:03:53

Dr. Silverberg

Absolutely. And I think really both are important additions to our therapeutic armamentarium. And, certainly, many patients can achieve relief in terms of signs and symptoms of their eczema but with different systemic therapies. But at the same time, some patients can even be refractory to one or more of the different systemic therapies and then need to switch or move to a different systemic therapy. And that can be related to a lack of efficacy, or inadequate efficacy, some kind of side effect, intolerance. And sometimes that’s just really a patient’s preference, even in terms of the modality, injectable versus oral therapies, things like that. So there’s, it’s really great to have options that we can use for patients. And, you know, as I always say to patients, there’s something for everyone now. And so really, we can tailor it, in a sense, to the patient’s individual needs.

00:03:53–00:05:28

Dr. Shi

Absolutely. We love options. When I first started practicing all we had are immunosuppressants. And now we have the option telling people there are different things to choose from. And we get the opportunity to walk them through individualized, you know, treatment options.

So that kind of leads us to looking at data. Let’s nerd out a little bit. There are two phase 3 clinical trials that looked at abrocitinib versus dupilumab for treatment of these patients with moderate-to-severe AD, and they have very catchy names. I love them.

JADE COMPARE is an active comparator trial, which looked at the efficacy and safety of abrocitinib, both 100- and 200-mg doses, and compared it to dupilumab or placebo over 16 weeks of treatment in adults [11]. These people had background topical therapies for their AD [11].

And then the other trial, JADE DARE, is a head-to-head trial which looked at the efficacy and safety of abrocitinib 200 mg versus dupilumab with background topical therapy, as well, over 26 weeks for treatment of adults with moderate-to-severe AD [12].

And we know that both trials reported significantly greater improvement in the participants’ AD signs and symptoms with abrocitinib versus dupilumab [11, 12]. So, the aim of our podcast is to really dive a little bit deeper into managing AD, to kind of look at the factors to consider when we have patients in this context, what to do during switch, and how do we utilize the evidence of these two studies focusing on abrocitinib and dupilumab?

00:05:28–00:08:02

Dr. Silverberg

Yeah. So just to kick off a little bit of this conversation, I think it’s really important for us to think about how we should be assessing patients in the real world and thinking about like, when do we decide a patient is doing well on a systemic therapy in general?

It’s important to assess treatment response by looking at how patients are doing with respect to not just skin clearance, but, importantly, really proactively asking all patients, really at all visits, about how their itch is doing, and understanding how their itch responds to a particular therapy. And of course, how their quality of life is doing. And you could certainly ask other things, patient-reported outcomes, like how’s their sleep doing or whether or not they’re having skin pain and things like that, really trying to keep it feasible.

Importantly, right, rapid responses are really important for many patients, particularly with respect to itch. And itch is, of course, the universal symptom, the most burdensome symptom [2–4]. This is really the one that we should be focusing on, primarily, among the symptom complex of the disease. Now, you can assess itch in a lot of different ways. There’s different tools that are used in sort of the structured clinical trial research setting. But really, what the key thing to know is, we don’t have an objective biomarker or measure of itch. So we’ve got to ask. There’s a lot of different ways to ask this. And I think probably one of the best ones is just a single question asking patients to rate the intensity of their itch over the past week on a scale of 0–10, and assessing itch response is generally a really good measure of treatment efficacy, because when patients get to that itch-free or little or no itch state, that’s really when they’re seeing the downstream benefits of having no sleep impacts and no quality of life impacts. So we really want to try to get patients to that itch-free state wherever possible.

And, we now have data from the real world showing the importance of trying to get patients to that NRS itch threshold of 0 or 1, which I like to call the itch-free state. Others call it little or no itch, but it really is saying the same thing. And there was a particular post hoc analysis done from the JADE DARE study that showed that patients who achieve this itch-free state with abrocitinib and dupilumab are more likely to get to really having little or no effect on their quality of life and, and many other downstream benefits of that [13]. So this is something that we want to ask routinely, but we also want to set the bar high. We really want to try to get patients clear of their itch wherever possible.

00:08:03–00:09:07

Dr. Shi

Yeah, Jon, I love the way that you’re phrasing this. At the end of the day, I think patients and their families really appreciate that we’re asking how they’re feeling rather than just looking at how they’re looking. I always say to, you know, to my trainees and my colleagues, patients are the experts. They live in their own skin. So we’ve really gotta, you know, rely on them to tell us how certain treatments are doing or, you know, if they’re not working.

The current clinical guidelines really warn us against frequent and prolonged use of oral corticosteroids [14]. And as we learn from medical school, there is a huge basket of things that comes with systemic steroids, including, you know, short-term and long-term adverse events, and these people often get rebound flares [14]. So, you know, despite all that, we know that oral systemic steroids are still really commonly given to people with moderate-to-severe AD, especially when they have a flare [14]. And we’ve really got to think hard and deep about what to do with these people who are not adequately controlled and kind of needing multiple courses of reactive systemic steroids.

00:09:08–00:09:41

Dr. Silverberg

Certainly, if they’re going to be used at all, it’s really crucial to recognize this should never, ever, ever, ever be used as that long-term fix for patients. Given that this is a chronic disease, if you’re going to use it for 3 weeks, that’s bad enough. But there has to be a plan for what comes afterwards, and something that is going to be a good steroid–sparing therapy, something that they can switch to where they don’t have to use the systemic steroids. And that’s something that has a good efficacy and safety profile longer term.

00:09:41–00:09:52

Dr. Shi

Why don’t we switch gears a little bit to take a look at these people who’ve been on dupilumab and what is the situation and conversation like when they’re facing a need to switch?

00:09:53–00:10:29

Dr. Silverberg

Absolutely. But before we even jump into the data, you know, once upon a time when there was only one approved option, the patients, where are they going to turn to? There was nothing to switch to. And even after, you know, we had, okay, a second approval for a systemic or biologic in the market, that was something that gave patients an option, but one where they were really nervous to exercise because they’re afraid of using up their last sort of option. But now that we’ve got several options available, this is a reality. And this is something that we’re dealing with on a day-to-day basis, so I think it’s real important for us to understand, like, what do the data show, what is the efficacy, and where do we go from there.

00:10:29–00:12:12

Dr. Shi

Yeah. So, you know, we have data showing that these efficacious therapies may not be the right fit for everybody. So, in my world, when I think when I assess the suitability of a systemic treatment, I think about efficacy, right. So, are they adequately controlled? Are they partial responders, or are they nonresponders still having frequent flares, despite being on the medication like dupilumab? And so they also often say “I have residual symptoms of itch and pain” that’s causing them to have sleep disturbance and interfering with their daily life. So commonly, like, you know, many of us do, like you do, we assess with their symptoms from a scale of 1–10. Tell me how your itch been for the past seven days. What’s the worst itch you’ve had and how has it affected your quality of life? So, the Dermatology Quality Life Index really quickly—they can do it in like a minute, I can calculate it in 30 s. And that gives me somewhat of a sensitive measure of how they’re feeling.

After efficacy, I kind of look at durability, you know, do we lose efficacy? Do they initially have that honeymoon period where they’re doing much better, then over time, for one reason or another, they don’t do as well as they used to? So, you know, without maintenance of response, we start thinking about maybe this is not the right long-term medication for this patient.

And then last but not least, very importantly, is the safety. Are our patients experiencing adverse events related to either the medication itself or is it some kind of injection-related adverse event? So, all of these coming together it can be a long discussion, but a very important one for the patients.

00:12:12–14:38

Dr. Silverberg

Yeah. These are all really important points. And that’s one of the, the beautiful parts about shared decision-making is trying to understand all of these different characteristics and and match up the right medication for, for the right patient.

I think you know, with respect to the data, what’s fascinating is when we think about, one patient, let’s say, who had an inadequate response to, to dupilumab and then switching to something like abrocitinib, you would expect that to be a particularly refractory patient population. And yet, even in this inherently more severe, more refractory patient population, we now have multiple either post hoc analyses or, or, you know, straight-up analyses, from secondary analyses coming from like the JADE DARE study, etc., that have shown that those patients who, you know, even our inadequate responders with dupilumab can really do quite well with abrocitinib and do just as well as the, you know, sort of the overall treated population.

I don’t usually go through all of the nuances, but I do discuss at a high level that we have now multiple studies supporting the opportunity, you know, supporting the option of, of switching. And then it’s really about, I think, understanding where the patient’s at in their therapy, and for some patients, they’re so used to having the horrific disease that they, the idea of itch-free for them is like a foreign concept. So when I’m having that shared decision-making conversation, I’ll always say to them, look, my treatment goals—I want you to have 100% clear skin and to be itch free. Question is, how much work do we have to do to get you there? And sometimes the patients will say, “Well, you know, I’m doing well enough.” And other patients like, “Wait, you mean I can actually get to itch free? I’ll take it.” Let’s try it, right? And so, then, it really, you can make that decision based on where the patient is at in their current treatment, you know, response and also based on their preferences and treatment goals. But I think it’s super important for us to be able to educate patients about the potential, the opportunity to be able to achieve more stringent end points, to be able to do well and, again, to know that if they’re on, let’s say, dupilumab as, as their current treatment and they’re not doing so well, to let them know that’s not the final option, that there are other things they can turn to afterwards.

And so for me, it’s really, it’s doing everything you mentioned and it’s asking all these questions and getting that response. But really, again, making sure that patients understand that we have more to offer and seeing where they’re at, in terms of their preferences about exercising that option.

00:14:39–16:19

Dr. Shi

All right. Thinking about offers and exercising our options, why don’t we dive a little bit deeper to look at how do we back our offers with some data. And so we have a couple papers that published between you and I on this very topic.

So let’s take a look at patients who received dupilumab in the JADE COMPARE study and subsequently switched to treatment with abrocitinib 200 or 100 mg in JADE EXTEND [15]. So these people had a 4-week dupilumab washout before switching to abrocitinib [15]. The patients were grouped as dupilumab responders or inadequate responders in JADE EXTEND [15]. This is based on whether they had achieved so-called stringent end points at week 16 of JADE COMPARE, which are IGA 0/1, EASI-75, EASI-90, PP-NRS4, and PP-NRS 0/1 [15].

Now, in the study, most patients who achieved these stringent end points with dupilumab in JADE COMPARE were able to maintain the response when they switched to abrocitinib in JADE EXTEND [15]. A substantial portion of these patients who didn’t achieve the stringent end points with dupilumab ended up achieving the response with abrocitinib treatment [15].

And that is really valuable information because for the longest time we’re like, okay, well, well initially it’s like we only got one option. You don’t mess around; you just add to it. But now when something’s not working or something’s working, you just want more options, you have the option to switch. And now we have data to guide us.

You want to talk to us about your paper that’s recently published?

00:16:20–19:17

Dr. Silverberg

Yeah. And I was alluding to this earlier. But, you know, we have the data now from the JADE DARE study, and the JADE DARE study is a little bit different because we have, specifically, the switch was from those patients who previously had received dupilumab and then were switched to the higher dose of abrocitinib, the 200-mg dose [12]. And as we know, you know, the approved, recommended starting dose would be the 100-mg dose [16]. But in this case, they were switched to the 200-mg dose. And the way the patients were divided were among those, again, previously exposed to dupilumab who either were considered responders or inadequate responders, and then, based on whether or not they hit a variety of different efficacy end points by week 26 at the JADE DARE study [17].

And so, similar to the results in your study, most of the dupilumab responders for efficacy in the JADE DARE study were able to maintain those responses 12 weeks after switching to abrocitinib, and a considerable proportion of the dupilumab nonresponders ended up gaining that response after switching to abrocitinib [17].

So I think these are both important subsets, because you may have a patient who’s technically doing well with dupilumab but just doesn’t want to do shots anymore, whatever the reasons are. So for patients who have, you know, residual lesions, residual itch during dupilumab treatment, switching to abrocitinib should be considered as part of the shared clinical decision-making process, something that should be offered to patients. And, you know, although these studies suggest improvements across multiple outcomes for a large subset of patients who are able to achieve these stringent end points after switching from dupilumab to abrocitinib, it’s important just to note that some patients still did not achieve stringent responses with long-term abrocitinib treatment in the EXTEND study [15, 17].

As an additional point for consideration, as important as those robust thresholds are, of trying to get them to itch-free and clear skin, even for some of the patients where they didn’t achieve those end points, many of them were still able to at least achieve partial improvement with abrocitinib, again, even in that refractory patient population to prior dupilumab treatment. So there’s a, a range of responses. But you know, we and this is something I think that needs to be discussed with patients.

So, we also have some small real-world studies now, case reports, case series, etc., showing very clearly that abrocitinib is an effective treatment for patients with atopic derm, who’ve had this inadequate response to other systemic therapies, whether in the literature, we have even more prior exposures to other types of therapies as well [18, 19]. So not just dupilumab, but even other JAK inhibitors like upadacitinib, and tralokinumab [18, 19]. And my own clinical experience has certainly been consistent with this as well.

00:19:17–00:22:05

Dr. Shi

So we’ve been talking a lot about efficacy and how to do shared decision-making. I think, you know, it will be important for us to touch a little bit on safety considerations. So, I wanted to take a look at the data a little bit more in the two studies. So, we looked at safety analysis that’s integrated from both phase 2 and 3 trials for abrocitinib [20, 21]. Safety signals are there, but they’re manageable long-term and short-term safety profiles that we should understand.

And so, the common adverse event in the short term for the abro-treated patients, you know, they get nausea, headache, and acne sometimes [21]. And there is a dose-dependent elevation in cholesterol levels kind of in the short term, up to 16 weeks [21]. And these greater changes are observed with higher doses [21]. In clinical experience, in my experience, they tend to kind of go back to baseline or normalize over time.

Now, in the study, the long-term abrocitinib treatment, the incidence rates were comparable across the doses for serious infections, herpes zoster, herpes simplex, MACE (also known as major adverse cardiovascular event), deep vein thrombosis (DVT), malignancies, thrombocytopenia, and these other lab abnormalities including lymphopenia [20].

Now, we know not all AD patients are designed the same way, and these incidence rates certainly has been shown to be higher in people 65 years and older versus the younger AD patients [20]. So, we should really think about the benefit-to-risk ratio for individualized patients before starting therapy with anything, including abrocitinib, particularly in patients with these high-risk brackets, contraindications, or previous malignancies and cardiovascular issues. So, when you look at the magnitude of risk of malignancies and MACE events with abro, they’re comparable, you know, it’s good to know they’re comparable to these real-world estimates in patients with AD, regardless whether they’re treated with JAKs or a biologic before [22]. Now the magnitude risk of these malignancies and MACE events with abrocitinib treatment are comparable to real-world estimates of the event in patients with AD not previously treated with a JAK inhibitor or other biologics. This was shown by a recent publication based on a US-based retrospective cohort study [22].

So when we think about safety considerations, Jon, and, you know, the context of switching dupi to abrocitinib, what are some of the approaches you have for say, for example, you see a patient who is on dupi but have a history of serious MACE or malignancy. What are some of the things that we should really think about?

00:22:05–00:23:42

Dr. Silverberg

Yeah. So, if I have a patient with a prior heart attack, stroke, etc., that may not be the right patient; I think we have to be extra careful there. But I think when you look at cardiovascular risk factors like hypertension or hypercholesterolemia, etc., there we actually see, even in those patients who have higher risk, the absolute risk of adverse cardiovascular events still remains quite low from an absolute risk perspective [20]. So I think it’s part of that conversation. And we’re going to be confronted with this decision of should we switch to abrocitinib? And I think it’s very reasonable in that case. You have to have a shared decision-making conversation. You want to have that risk–benefit discussion. But at that point, when the patient has already tried and had an inadequate response or intolerance to multiple therapies, right, their willingness to try, you know, another therapy, is much higher, right? And they really want, put efficacy often as a higher priority. And so that’s part of that shared decision-making process.

I think when it comes to using abrocitinib, it’s also it’s not an all-or-nothing question in this respect, right, because we’ve got two approved doses and we can use lower doses there as a, you know, at least, being proactive in a way, of potentially reducing risk for adverse events. And so that’s something that we can build into our own treatment strategies, to try to potentially mitigate risk in patients who may otherwise have a little bit of a higher risk.

00:23:42–00:26:41

Dr. Shi

Yeah, I agree, you know, with the flexibility of the dosing, it’s really helpful. Now, abrocitinib 100-mg starting dose is mandated in the US for patients who may have higher risk for serious adverse events [16, 23]. And then the abrocitinib 200 mg is for inadequate response when approved for patients with no risk factors [16, 23]. And we know the safety risk may be minimized by targeting a flexible dosing strategy to target in order to reach the minimal effective dosing. So, with appropriate patient and dose selection, the safety risk associated with JAK inhibitor treatments may be further mitigated for a majority of our patients. So it’s not just one-size-fits-all like some of the biologic options. So I like the flexibility.

And then kind of looking at safety profiles, Jon, you know, we get asked this question a lot. Like, how do you stratify the risk factors? Who’s a candidate? Who’s not a candidate? My resident and I, we work together and we came up with these buckets. So your green bucket is super low risk; young, male, not able to get pregnant, no history of malignancy. And then you have your like yellow/orange category. These are like, you know, caution, moderate risk; 50 and older, female of childbearing potential, well-controlled blood pressure, for example. And your orange moderate risk category also include, you know, mild kidney or liver insufficiency, remote low-grade cancers that are in remission like skin cancer, cervical cancers, and people who are smokers, on OCPs, or have some early mild heart problems. Then we design this red higher risk category. It’s everything yellow and orange, plus moderate kidney and liver insufficiency. They have some heart issues, but well-compensated and treated, remote history of blood clots and blood thinners, and low-grade cancers. And then, last but not least, you have your category where it’s like you’ve got to be really cautious—people who are actively pregnant, or have a genetic clotting or bleeding disorder, or active serious infections such as HIV with detectable viral load, very recent stroke, untreated active high-grade cancers, and poorly controlled symptomatic heart failure. I feel like once I’ve written these things down, it really helps us have a conversation with our patients to see where the risk factors are and what we’re both comfortable with, with proceeding.

All right. So, we’ve talked about efficacy, dosing, data, and safety. And why don’t we dive a little bit deeper, quickly, about what to do with these patients who really have, you know, low-risk profiles. Once you get them started, how do you counsel them on safety concerns and how do we really monitor? We know we’re supposed to, like, counsel and monitor, so what’s real-life practicality here for low-risk individuals, Jon?

00:26:42–28:28

Dr. Silverberg

Usually what I’ll discuss is, just, in that shared decision-making conversation again, I’ll mention multiple treatment options and I’ll sort of try to give a little bit of a comparison, and I’ll explain in the context of abrocitinib, particularly at the 200-mg dose, that you’re seeing really superior efficacy even to dupilumab across multiple studies and analyses and and then, but, as a once oral daily medication, they love the oral, but are they going to be good with adherence? And, you know, are they going to be able to stick with that, as part of their, sort of, daily routine? If they are, then we’ll talk about the, you know, the risk–benefit discussion. And of course, as always, that’s a personal conversation, because when you’ve got that 20-year-old otherwise healthy patient, the rare risk events that come up in the trials are exceedingly low absolute risk. But low is not zero, and that’s typically how I’ll frame it. You know, there is potential for rare safety concerns to come up. I’ll just mention a little bit about what they are. But understand that it’s a very low risk. But low is not zero, and that’s something they have to be comfortable with.

And then as part of that shared decision-making conversation, the patients will, will, you know, pick, essentially based on what their level of comfort is. And for some patients, you know, they’re like great, let’s do it, let’s get started. Other patients may have a little bit of hesitancy. And so in a sense walking through, but when I have that conversation about risk, I’m totally tailoring it in the tone of how I’m presenting it. And in in the discussion around specific adverse events based on their own, you know, baseline risk factors.

00:28:29–00:28:32

Dr. Shi

All right. I think we should wrap up.

00:28:33–00:28:57

Dr. Silverberg

That sounds like a great idea. So, this was really great conversation. I’d like to thank you, Vivian, for sitting down to discuss, really, these important clinical decisions. And just the tools and some of the different things that we can do in clinical practice, and and how we should work through that process between switching from dupi to abrocitinib for the treatment of moderate-to-severe atopic dermatitis.

00:28:58–00:29:11

Dr. Shi

Always a pleasure, Jon, to have a stimulating discussion on a topic that we both hold near and dear. We want to give a big thanks to our listeners for your interest and time on this very important topic. Have a good day.

Author Contributions

Vivian Y. Shi and Jonathan I. Silverberg contributed to development and critical review of the podcast outline, had full editorial control over the final podcast recording, and provided final approval to submit the podcast. Erman Güler and Brian Esparza contributed to development and critical review of the podcast outline, and provided final approval to submit the podcast.

Funding

This podcast and the studies discussed herein, the Rapid Service Fees, and additional Podcast Fees were funded by Pfizer Inc.

Data Availability

The datasets generated and/or analyzed during the studies discussed in this podcast are available from the corresponding author on reasonable request. Upon request, and subject to review, Pfizer will provide the data that support the findings of the studies discussed in this podcast. Subject to certain criteria, conditions, and exceptions, Pfizer may also provide access to the related individual de-identified participant data. See https://www.pfizer.com/science/clinical-trials/trial-data-and-results for more information.

Declarations

Conflict of Interest

Vivian Y. Shi is a stockholder of Learn Health and has served as an advisory board member or investigator and/or received research funding from Pfizer Inc, Sanofi-Genzyme, Regeneron, AbbVie, Eli Lilly, Novartis, SUN Pharma, LEO Pharma, Menlo Therapeutics, Dermira, Burt’s Bees, Galderma, Kiniksa Pharmaceuticals, UCB, Altus Lab, MYOR, Polyfin, GpSkin, and Skin Actives Scientific. Brian Esparza and Erman Güler are employees and shareholders of Pfizer Inc. Jonathan I. Silverberg served as an investigator for Celgene, Eli Lilly and Company, F. Hoffmann-La Roche, Menlo Therapeutics, Realm Therapeutics, Regeneron Pharmaceuticals, and Sanofi Genzyme; as a consultant for Pfizer Inc., AbbVie, Anacor, AnaptysBio, Arena Pharmaceuticals, Dermavant, Dermira, Eli Lilly and Company, Galderma, GlaxoSmithKline, Glenmark, Incyte, Kiniksa Pharmaceuticals, LEO Pharma, Menlo Therapeutics, Novartis, Realm Therapeutics, Regeneron Pharmaceuticals, and Sanofi Genzyme; and as a speaker for Regeneron Pharmaceuticals and Sanofi Genzyme.

Ethical Approval

Study documents and procedures for the studies discussed in this podcast were approved by the appropriate institutional review boards/ethics committees at each study site. The trials discussed in this podcast were conducted in accordance with the ethical principles from the Declaration of Helsinki, International Ethical Guidelines for Biomedical Research Involving Human Subjects from the Council for International Organizations of Medical Sciences, and International Council for Harmonisation Good Clinical Practice Guidelines. Informed consent was obtained from all individual participants included in both trials discussed in this podcast.