Notable Findings on Lebrikizumab in ADmirable Study Assessing Patients with Skin of Color

Revolutionizing Atopic Dermatitis (RAD) Conference

 highlighted the efficacy of lebrikizumab (Ebglyss) for atopic dermatitis in adult and adolescent patients with skin of color, with improvements observed by the phase 3b ADmirable study’s investigators over 24 weeks.

 editorial team, Andrew Alexis, MD, MPH, ADmirable investigator, professor of clinical dermatology, and vice-chair for diversity and inclusion at Weill Cornell Medicine, spoke about 

 on lebrikizumab in patients with skin of color.

He described some of the study's most notable findings, highlighting that the study gives those in the field of dermatology greater insight into what the change over time in pigmentary alterations is when treating with lebrikizumab. Alexis noted that almost 2 thirds of patients in the analysis demonstrated improvement in hyperpigmented lesions on the recently-developed PDCA-Derm assessment.

Alexis further expressed that almost a quarter of patients who had hyperpigmentation improved to their normal skin tone by Week 24 in the ADmirable study. 

Alexis has reported advisory/consulting fees from companies including Lilly.

Alexis A, Moiin A, Waibel J, et al. Efficacy and safety of lebrikizumab in adult and adolescent patients with skin of color and moderate-to-severe atopic dermatitis: final 24-wWeek results from the phase 3b, open-label ADmirable study. Presented at: 2025 Revolutionizing Atopic Dermatitis (RAD) Conference; June 6-7, 2025; Nashville, TN.

FDA Approves Lilly's EBGLYSS™ (lebrikizumab-lbkz) for Adults and Children 12 Years and Older with Moderate-to-Severe Atopic Dermatitis. September 13, 2024. Accessed June 18, 2025. 

https://investor.lilly.com/news-releases/news-release-details/fda-approves-lillys-ebglysstm-lebrikizumab-lbkz-adults-and

This interview with Andrew Alexis, MD, MPH, highlights his team’s findings in the phase 3b ADmirable trial on lebrikizumab for atopic dermatitis in patients with skin of color.

Andrew F Alexis, MD, MPH

Dermatological experts discuss challenges that are associated with the use of standard and emerging treatments in special patient population.

Patient Subgroups and Educational Opportunities in Rare Dermatological Disorders

Carly Elston, MD

New data from the ADORING program demonstrate patients with 

 can discontinue use of tapinarof cream 1% (Vtama) for nearly 80 days without recurrence after achieving completely clear skin.

2025 American Academy of Dermatology (AAD) Annual Meeting

, results of the study offer insight into the long-term effects and can help guide use in real-world settings, according to study investigators.

“For patients with atopic dermatitis, the benefits of many topical treatments are often short-lived, and for some patients, their disease rapidly reappears after taking a break from topical treatments,” said Jonathan Silverberg, MD, PhD, MPH, George Washington University School of Medicine and Health Sciences.

 “As a physician, I’m encouraged that at the end of a break from treatment with [tapinarof cream 1%] cream, patients’ [atopic dermatitis] remained mild. I’m excited to see these data support the use of [tapinarof cream 1%] cream to potentially provide lasting results for itch, which is the universal and most burdensome symptom of [atopic dermatitis].”

Initially approved for treatment of moderate to severe plaque psoriasis in adults in 2022, tapinarof cream 1% received approval for moderate to severe atopic dermatitis in patients aged 2 years or older in December 2024 based on data from the ADORING program. A long-term extension study, ADORING 3 aggregated patients from the ADORING 1 and ADORING 2 trials, patients from a 4-week maximal usage pharmacokinetics study, and VTAMA cream-naive patients 2 to 17 years of age with either mild, moderate, or severe atopic dermatitis that did not meet inclusion criteria in ADORING 1 and ADORING 2.

Per study protocol, 378 patients achieving completely clear skin, which was defined as a score of 0 on the validated Investigator Global Assessment for AD (vIGA-AD), discontinued use of tapinarof cream 1% and were assessed for maintenance of vIGA-AD of 0 or 1 off-treatment.

Results of the AAD 2025 analysis suggested 84% of patients had a vIGA-AD score of 2 at the end of the first treatment-free interval, which lasted an average of 79.8 consecutive days. Further analysis demonstrated this patient population achieved a mean weekly Peak Pruritus Numerical Rating Scale score of 2.9 and a mean Eczema Area and Severity Index score of 3.4.

With an interest in learning more about how these new data might influence the treatment landscapes and unmet need within management of atopic dermatitis, particularly in pediatric patients, the editorial team of HCPLive Dermatology caught up with study presenter David Rosmarin, MD, chair of dermatology at Indiana University School of Medicine, and that conversation is the subject of the following Q&A.

Rosmarin on Tapinarof Cream 1% in Atopic Dermatitis

HCPLive: How does this new data add to the comfortability that clinicians and patients can have when it comes to using tapinarof cream 1%, particularly in such a young patient population?

 This late breaker is giving some of the results from the ADORING 3 long-term extension evaluating tapinarof cream for atopic dermatitis in patients 2 years of age and up. Just for a background, tapinarof is a nonsteroidal arrow hydrocarbon receptor agonist approved, first for adults in psoriasis, but now also FDA approved for atopic dermatitis in patients 2 years of age and older. The long-term extension basically accumulates patients from the pivotal phase 3 studies for of ADORING 1 and ADORING 2, the maximal use PK study, as well as a few people who were directly enrolled into the long-term extension as well.

So, it's a somewhat heterogeneous population. When they first started in the pivotal phase 3 program most of the patients had either moderate or severe atopic dermatitis and a majority of these patients were also pediatric patients. We know that tapinarof is effective at treating these patients, but the question we're trying to answer with the long-term extension is: What happens when you discontinue the treatment after achieving clearance?

So, what is the disease-free interval for these patients? In practical terms, it's helpful for patients to want to take a drug holiday and not be worried that their symptoms or their itch and their disease is going to immediately recur or rebound. That's what makes tapinarof a little bit unique in that nature.

The top line result is that it's about 80 days on average for the first disease-free interval for patients. So, quite a while, making this drug particularly unique. Additionally, when patients do get their disease back it's usually very mild in nature, meaning they're not super itchy—they're not getting a rip-roaring flare. It's usually coming back in a milder nature. The fact that this medicine as a monotherapy and being used once a day can achieve not only great efficacy results, but also this ability to have a long-term holiday.

HCPLive: How unique is this benefit among current management options and what type of impact could this have on quality of life?

 I think it's an added bonus there, and it is important information to have. I think in many ways more critical is the fact that it's once a day, which is fantastic for patients. It's nonsteroidal, which worry patients. There are no restrictions on an antibody surface area or locations or combining with other treatments. I think all of those really combine to make this treatment very advantageous to many of our atopic dermatitis patients and again, with a very favorable safety profile and no Boxed Warnings.

So, I think it's just an added bonus for some patients and it's nice to not have that burden of doing disease. Now there are some topicals, for example, corticosteroids, that can rebound and can do so rather quickly. So, to me, this is rather unique.

One of our strategies, with our current practices, is giving maintenance. So, we may give maintenance of a calcineurin inhibitor, such as tacrolimus, twice a week to maintain. Well, these are patients who were off treatment altogether. To me, it's a quite a nice feature, and it's unique amongst our topicals.

HCPLive: Are we able to further identify what baseline characteristics might predispose someone to see a greater benefit with tapinarof cream 1%?

So, subgroup analysis has not been done. We don't know if there are certain prognostic factors that will lead to a longer disease-free interval. However, the fact that the population entering the study was heterogeneous—there were patients between the age of 2 all the way up to 81 years and so many pediatric patients in different disease severities, different body surface areas, different locations of disease—I think has me optimistic that it seems like many patients can experience this disease free interval, even though we don't yet know if there are particular differences amongst the population dependent on baseline characteristics.

HCPLive: What unmet needs still exist related to management of atopic dermatitis in pediatric patients?

Well, right now we have data for two years of age and older, but it would be great if we had more options for below that that age because we have many patients who start to get atopic dermatitis at just a few months of age. So, given what we're seeing in the safety for the 2 years of age and up range, I'd love to have more data to give me confidence that I can use it in under 2 years of age.

So, I think that's still a need. Also, while this is a great option, there's still some patients who don't respond, and it would be helpful to know if we can predict that in advance? And we're always looking for new options. There are so many patients of ours that have eczema, we'd love to have more options in our armamentarium.

Relevant disclosures for Rosmarin include AbbVie, Abcuro, AltruBio, Boehringer-Ingelheim, Bristol Meyers Squibb, Celgene, Concert, CSL Behring, Dermavant, Dermira, Incyte, Janssen, Kyowa Kirin, Lilly, Novartis, Pfizer, Regeneron, Sanofi, Sun Pharmaceuticals, UCB, and VielaBio.

 Tapinarof Cream 1% Once Daily: Maintenance of Low Disease Activity Including Pruritus Through End of the Treatment-free Interval in a Long-term Extension Trial in Patients Down to 2 Years of Age

Presented at the 2025 American Academy of Dermatology (ADA) Annual Meeting. Orlando, FL. March 07-11, 2025.

Organon. New Analysis of Organon’s VTAMA® (tapinarof) CREAM, 1% phase 3 data shows atopic dermatitis disease activity remained low after treatment-free interval in adults and children 2 years of age and older. Organon. March 8, 2025. Accessed March 8, 2025. 

https://www.organon.com/news/new-analysis-of-organons-vtama-tapinarof-cream-1-phase-3-data-shows-atopic-dermatitis-disease-activity-remained-low-after-treatment-free-interval-in-adults-and-children-2-years-of-ag/

Organon. FDA approves VTAMA® (tapinarof) cream, 1% for the treatment of atopic dermatitis in adults and children 2 years of age and older. Organon. December 16, 2024. Accessed March 8, 2025. 

https://www.organon.com/news/fda-approves-vtama-tapinarof-cream-1-for-the-treatment-of-atopic-dermatitis-in-adults-and-children-2-years-of-age-and-older/

New data from the ADORING program reveal that patients with atopic dermatitis can discontinue tapinarof cream 1% for nearly 80 days without recurrence after achieving clear skin. This finding, presented at the 2025 AAD Annual Meeting, highlights the cream's potential for long-term efficacy and itch relief. Initially approved for psoriasis, tapinarof cream is now FDA-approved for atopic dermatitis in patients aged 2 and older. The study underscores its unique ability to maintain low disease activity during treatment-free intervals, offering a promising option for pediatric patients.

David Rosmarin, MD, discusses results from ADORING 3 presented at AAD 2025.

Tapinarof Cream 1% Maintains Clear Skin for 80 Days in Atopic Dermatitis, with David Rosmarin, MD

David Rosmarin, MD

A pair of authors of a recent scientific statement and the president of the HFSA discuss cognitive impairment in heart failure. 

Role of Screening, Addressing Cognitive Impairment in Heart Failure Management

For some time, the heart failure community has warned of an impending storm brewing under the nose of public health despite their rallying cries and calls for a greater emphasis on management. With the aging US population as a backdrop, the prevalence of 

 is expected to grow in the coming years and, with heart failure fellowships going unfilled at an alarming rate, many in the field are concerned they are heading toward a perfect storm bent on wreaking havoc on public health.

The concern among filling fellowship slots aside, advanced heart failure and transplant specialists currently practicing have been confronting a growing concern associated with the aging population, but that could spell disaster for heart failure in particular: cognitive impairment. In their latest scientific statement, the Heart Failure Society of America has aimed at the issue and how it affects the management of heart failure.

Published on March 12, 2024, the 17-page document cites 142 references and is divided into 5 sections addressing the following subjects: risk factors for cognitive impairment, implications of cognitive impairment, management of cognitive impairment, integration of cognitive impairment into decision-making, and gaps in knowledge and challenges to implementation. In addition to calling attention to the prevalence of cognitive impairment in this patient population, the docuemnt also provides an overview of recommended screening tools and practices based on contemporary literature.

In this HCPLive peer-to-peer discussion, we spotlight perspectives on the subject from 3 subject matter experts in Eiran Gorodeski, MD, MPH, Parag Goyal, MD, MS, and James Fang, MD. In the conversation, Fang, who also serves as the president of the Heart Failure Society of America, acts as a moderator and guides Gorodeski and Goyal, who served as lead co-authors for the statement, through a discussion on the creation process, key takeaways, the complexities of heart failure management in patients with cognitive impairment, and the role of the Heart Failure Society of America and other professional organizations in aiding clinicians with incorporating changes and recommendations within these types of documents.

, director of the Advanced Heart Failure & Transplant Center at Harrington Heart & Vascular Institute in the University Hospitals Health System as well as section head of advanced heart failure in the Division of Cardiovascular Medicine and Professor of Medicine at Case Western Reserve University.

, statement co-author, associate professor of Medicine, the Founding Director of the Heart Failure with Preserved Ejection Fraction Program, and the director of the Cardiac Amyloidosis Program at Weill Cornell Medicine.

 president of the Heart Failure Society of America, chief of Cardiovascular Medicine at the University of Utah School of Medicine, and director of the Cardiovascular Service Line at University of Utah Health Care.

Relevant disclosures for Gorodeski include Dynamed Plus. Relevant disclosures for Goyal include Agepha, Axon, and Sensorum Health. Relevant disclosures for Fang include Amgen, AstraZeneca, Boehringer Ingelheim, Novartis, and 

Bozkurt B, Ahmad T, Alexander KM, et al. Heart Failure Epidemiology and Outcomes Statistics: A Report of the Heart Failure Society of America. 

. 2023;29(10):1412-1451. doi:10.1016/j.cardfail.2023.07.006

Goyal P, DiDomenico RJ, Pressler SJ, Allen LA, Gorodeski EZ. Cognitive Impairment in Heart Failure: A Heart Failure Society of America Scientific Statement. 

. Published online March 12, 2024. doi:10.1016/j.cardfail.2024.01.003

Eiran Gorodeski, MD, MPH, Parag Goyal, MD, MSc, and James Fang, MD, discuss the HFSA's recent scientific statement on the prevalence and impact of cognitive impairment on the management of heart failure. 

The Role of Screening, Addressing Cognitive Impairment in Heart Failure Management

James Fang, MD

Panelists discuss how endothelin receptor antagonism addresses resistant hypertension by blocking one of the most potent vasoconstrictors, reducing smooth muscle hypertrophy and fibrosis, with aprocitentan being the only endothelin receptor antagonist approved for resistant hypertension.

Rationale for Targeting the Endothelin Pathway In RH

Video content above is prompted by the following: 

The endothelin pathway represents an innovative therapeutic target in resistant hypertension (RH) management, addressing a potent vasoconstrictor mechanism left unopposed by traditional ACD therapy. Endothelin-1 is one of the most powerful vasoconstrictors in the human body, causing arterial constriction, smooth muscle hypertrophy, reduced vascular compliance, and progressive fibrosis that contributes to both blood pressure elevation and target organ damage.

Aprocitentan represents the first endothelin receptor antagonist specifically approved for resistant hypertension treatment, offering a unique mechanism of action distinct from existing antihypertensive drug classes. Unlike other endothelin receptor antagonists like bosentan and macitentan (used for pulmonary hypertension), aprocitentan is specifically indicated for systemic hypertension and provides both renal and vascular benefits through dual endothelin receptor blockade.

The endothelin pathway’s role in resistant hypertension extends beyond simple vasoconstriction, contributing to microvascular dysfunction, inflammatory processes, and progressive vascular remodeling that perpetuates hypertension despite conventional treatment. By targeting this pathway, aprocitentan addresses fundamental pathophysiologic mechanisms underlying treatment resistance, offering hope for patients who remain uncontrolled despite optimal conventional therapy and providing clinicians with an additional tool in their therapeutic armamentarium.

Javed Butler, MD, MPH, MBA

Expert hepatologists discuss future developments in HCV.

The Future and Resources in HCV Care

 Mark, are you looking into the future? Are you excited about anything in whether treatment of hep[atitis][hepatitis] C or management of hep[atitis][hepatitis] C? Is there anything down the line that's got you excited?

Certainly, it's a very exciting time. I mean, we've got opportunity in front of us to really for the first time eliminate hep[atitis][hepatitis] C's[in] public health. We can't lose sight of that. I think it's easy to lose sight of that as we struggle with some of the barriers that we've talked about today. So, what do we need to do? Some of you've heard here, we need to increase access to medications. And although tThese medications are highly cost effective, if not [a form of] cost savings, in a relatively short period of time, meaning society will spend less money over a brief period, say five 5 years, if we treat everyone. Despite that, there's there are still barriers to accessing medication. So, tThe first thing we're excited about is removing those barriers. Nancy mentioned and prior authorization forms. I'm working on one now that's 37 patient pages long. Six months we've been back and forth. I'll leave that where it is because there’s not much more I can say. But [the important point is] ensuring we have access. And tThen to pick up on people'sTipu’s point, it's bringing the medications to the patient. And tThere we really need point-of-care testing. So, the second thing I'm excited about is point-of-care PCR [polymerase chain reaction] testing, or antigen testing is another possibility. We mentioned the antibody shows that your immune system has seen hep[atitis][hepatitis] C, but when you cure someone, they remain antibody-positive. So, it [the testing] becomes less effective as we cure more people.. So gGo into a community,[and do] a point-of-care test, a rapid result that shows they're actively affected. Then you've got access. So, yYou reach into the backpack, pull out the medication, hand them a medication, follow that minimal mileage to actually get their phone number, although I'll make another plug for using social media like WhatsApp because they can lose their phone, but they’ll still have the same access. So tThat's the second thing, is point of care. And you say, well, what about people with bad livers? Well, bBring a mobile elastography or fiber scan machine. And iIf your their score is low, you they don't have liver failure. So, point of care. The third thing I'm excited about is actually the potential to develop long-acting therapies. And iIn the HIV space that I've alluded to a couple of times, they now have medications that can be given at that last eight 8weeks. Huh, eight 8 weeks. Well, iIf we had a hep[atitis][hepatitis] C medication that sustained in the liver for eight 8 weeks after a single injection, that would be a one-shot cure. And tThat is being worked on as we speak., Sso, it's not without the realm of possibility. And give me one more.: It's vaccine. And wWe've talked a lot about trying to treat our way out of the hep[atitis][hepatitis] C epidemic, but this is an incredibly transmissible pathogen. We saw that with healthcare–worker needle sticks. We see that with populations and networks of people who inject drugs,. [It’s]incredibly transmissible. So yYes, we should be treating everybody and taking the path of treatment prevention, but vaccine is essential. And tThere's now a lot of excitement around vaccine development and what's called human challenge studies. That's where you take a volunteer with the appropriate informed consent, you intentionally give them hepatitis C, and vaccinate some and see if the vaccine can clear the infection. And then oOf course, you've got treatment to rescuethem,…those who don't clear. It sounds a bit crazy, but they do this with malaria, they do this with dengue, they do this with shigella, diarrhea, and they did this with COVID-19, intentionally affecting [infecting] people. And wWhy would you do that? Because it allows you to test vaccine candidates very quickly. If they don't work, move on. So tThose are the things I'm excited about as we work our way to 2030. It's only seven 7years away, so we've got a lot of work to do.

 So sSome exciting things [are] on the horizon potentially. For some of our viewers who might not be aware, iIt's really an exciting time around Hep[atitis][hepatitis] C. We have a relatively newly announced federal elimination plan that has been brought forward. This is something that's obviously very fluid and dynamic, but it's in development. . [There are] [It has] the three 3 key components,: iIt would fast track point-of-care tests like Mark has described. It would open access to medications, hopefully eliminating a lot of the barriers that we've discussed. And it would also provide funding for the infrastructure needed to actually carry this work out. So sStay tuned for all of this, there is a lot that'’s happening. We'’ve covered a lot of ground. Nancy, if providers, if viewers [patients] are looking for more information, do you have any go-to sites that they can access to get more infoit?

Well, aAbsolutely. There are tons of them. So I think that Hep[atitis][Hepatitis] CP Live actually has great tools, the American Liver Foundation, [and] you cannot go wrong with things like the CDC or the World Health Organization. Also, I wouldn't discount your industry partners, especially once you [patients] know the agent that you're[they’re] being started on. There are really great resources on those websites when [they] you know what you're[they’re] going to be taking. But I think that misinformation is also prevalent. So yYou want to make sure that you're talking to your patients about what their fears are. There still are websites out there that say that Hep[atitis][hepatitis] C treatment is intolerable, that you're going to end up with depression or some of the interferon-related side [adverse] effects, [or] that you won't be able to work through things, or that these are still experimental. I mean, tThese are not experimental therapies anymore. And so, yYou want to make sure that you're using a tool that's vetted and up-to -date, not archaic.

 YeahYes, hcv.com is also another great resource.— A alot of information there, practical information about implementation, and tons of great educational content. Thanks to all of you for this rich and informative discussion. And thank you, our viewers, for joining us during this HCP Live Peer Exchange. If you enjoyed today's content, please subscribe to our e-news letters to receive information regarding upcoming peer exchanges and other great content right to your inbox. Thank you very much.

Transcript was AI-generated and edited for clarity.

Expert hepatologists discuss future developments in HCV that they are excited about and provide resources for new providers to get started on delivering HCV care.

Jordan Mayberry, MPAS, PA-C

Matt, we’ve had this great, enriching conversation this evening. This has just been fantastic; I really appreciate it. What advice or practice pearls do you have for other APPs [advanced practice providers] managing patients with plaque psoriasis?

This is a very global question, and I’m glad that you asked it. My number one pearl for all of the APPs that are out there just getting started, or maybe they’ve been in practice for a few years, is just be a true advocate for your patients. Try to put yourself in their shoes, no matter if it’s a plaque psoriasis patient or not. You need to always consider what is going to be the best for them. It may be best for you now to put them on a certain drug or a certain treatment, but I want you to consider all the variables that go along with the patient’s life. Think about how far it takes that patient to drive to your office, think about what they did to get to your care, if they waited 3 months or 6 months. Spend a little extra time with these people and just be more than what they expect you to be. Often, you’re going to find that these patients have not had a true advocate, they’ve not had a true person to be a fighter in their corner. That’s really where you, as the APP, have an opportunity to change the paradigm, change the treatment of that patient who’s coming to your office with plaque psoriasis. The other thing that I always tell everyone, especially as they’re just starting out, is to find someone who’s going to train you, find someone who’s really going to spend the time to make sure that you become a professional, that you become an expert in dermatology. That’s what you’re expecting from yourself, so don’t accept anything less. Find that person who’s going to take you to the next level in your career and you have a true opportunity, you have a true chance to make a difference in people’s lives. You get to see it because you practice in dermatology, but you’re going to feel it too if you exceed expectations from your patients. Those are my 2 main pearls. I think you and I both, because we’ve been at practice a while, could talk about this all night, but I really think those are the 2 main things that I want to impart upon our group listening.

I agree with you so much, Matt. The one thing is that you continue to educate yourself, and every time I have students, no matter from which university, no matter if they’re MP [nursing director] or PA [physician assistant] students, they want to have a dermatologist experience. I’m more than happy to say, “Come.” In fact, next semester I have 3 students from 3 different universities, and I said, “We just have to arrange this so that everybody can have their time.” It’s crucial to support one another. Regarding those patients, yes, walking in their shoes. It never fails to really break my heart when I have patients who have come to me and they’ve had psoriasis for 10-plus years, they’ve been in several dermatology practices, and nobody has given them a jar of triamcinolone. They’re coming to see you, just like you said. They have driven, they’re hoping that someone will be able to help them to understand their physical, as well as their emotional, burden with this disease, which is a heavy burden disease. If you cannot help them and you don’t know how to help them, then find somebody who does. Resource them, help them because there are people who specialize in psoriasis and those who don’t. Dermatology practice is not always the same, but there are so many ways that we can educate one another and support one another and help these patients.

You’re absolutely right, thank you for sharing that.

Thank you, Matt. It has been an absolute pleasure to be with you here this evening.

You as well. Thank you, Jayme, for having me.

Jayme Heim, MSN, FNP-BC, and Matthew T. Reynolds, PA-C, shares clinical pearls for clinicians managing patients with plaque psoriasis.

Practice Pearls for Advanced Practice Providers Managing Patients With Plaque Psoriasis

Matthew T Reynolds, PA-C

Nicole Bundy is a board-certified rheumatologist and the Medical Director at Mymee, a pioneer in self-evidence-based research for people who struggle with symptoms associated with long COVID and rheumatic autoimmune diseases.

Nicole Bundy, MD

Sabato discussed how research in the field will inform how to best utilize novel therapies for indolent systemic mastocytosis now that a disease-modifying therapy is available.

Optimizing ISM Treatment Beyond Approval, with Vito Sabato, MBBS

Mastocytosis is a rare disorder driven by 

 D816V mutations, with historically few options in the treatment landscape for patients. One subtype of mastocytosis, indolent systemic mastocytosis (ISM), only received approval of avapritinib (Ayvakit), a disease-modifying therapy, in 2023.

Research continues in the field to evaluate the long-term efficacy of avapritinib and to evaluate the best treatment strategies with the therapy. Vito Sabato, MBBS, Associate professor at University of Antwerp in Belgium, presented biomarker data in patients with ISM from a proteomic analysis of PIONEER (NCT03731260), a pivotal study of avapritinib, at the 2025 American Academy of Allergy, Asthma, and Immunology (AAAAI)/World Allergy Organization (WAO) Joint Congress, February 28-March 3, in San Diego, California.

® spoke with Sabato to learn more about the findings from the PIONEER analysis as well as a post-hoc analysis of the PROSPECTOR study that used more sensitive tests to identify 

 Sabato also shared his excitement about the recent progress in research in the ISM field, and the continuing trajectory of research. Lastly, he also noted that overestimating the risk of anaphylaxis in patients with ISM may increase their perceived disease burden, as recent research does report a low frequency of anaphylaxis.

“What’s happened in terms of clinical research in mast cells in the last 3, 5 years hasn't happened in the last 20 years. I mean, the progress that has been made in ISM is really high,” Sabato said. “There are a lot of studies also in mast cell associated disorders that are quite frequent when compared to mastocytosis. But you know, what we can learn from the non-mutated mast cells, maybe we can still apply to the mutated mast cells. So, we are quite excited about that. And of course, we are happy for our patients.”

Sabato's disclosures include Blueprint Medicines Corporation, Novartis, and Cogent.

FDA Approves AYVAKIT® (avapritinib) as the First and Only Treatment for Indolent Systemic Mastocytosis. News release. Blueprint Medicines. May 22, 2023. 

https://ir.blueprintmedicines.com/news-releases/news-release-details/fda-approves-ayvakitr-avapritinib-first-and-only-treatment

Sabato V, Panse J, George T, et al. Multiple Proteins Correlate With Tryptase Levels in Patients With Indolent Systemic Mastocytosis (ISM): Preliminary Results of Plasma Proteomic Analysis in PIONEER. Presented at: 2025 AAAAI/WAO Joint Congress, February 28-March 3. Abstract 518

Hartmann K, Livideanu CB, Alvarez-Twose I, et al. Identification of Clonal Mast Cell Disease in Patients With Anaphylaxis or Evidence of Systemic Mast Cell Activation: A Post Hoc Analysis From PROSPECTOR. Abstract 301

Vito Sabato, MBBS

This article was originally published on 


Reduced-dose CT is not only effective in imaging patients for kidney stones, but it also lowers the overall radiation exposure for individuals who might need repeated imaging. But, the protocols aren’t implemented as frequently as they should be, experts say.

Journal of the American College of Radiology

a team of investigators from Yale University School of Medicine pointed out that use of the protocol falls far below the “as low as reasonably achievable” goal. In their findings, they outlined the efficacy of the reduced-dose protocol and the impact greater utilization could have.

“Increased adoption of reduced-dose CT protocols will decrease the overall radiation burden associated with kidney stone CT, which often requires repeat imaging in relatively young patients,” said the team led by Christopher Moore, M.D., emergency medicine professor and emergency ultrasound section chief.

According to the National Kidney Foundation, more than a half million patients present to the emergency department each year with kidney stone symptoms – and the incidence has increased in the last 40 years. Between the late 1970s and 2014, the prevalence has risen from 3.8 percent to 10 percent, respectively. Most patients are young, average age of 30 for men and 35 for women, making the need to control dose even greater.

Of the patients impacted by kidney stones, 85 percent undergo CT imaging, Moore’s team said, and the average number of scans is between 1.4 and 1.7 per kidney stone occurrence, adding to their cumulative radiation exposure.

To increase use of the reduced-dose protocol, the team created an intervention – Dose Optimization for Stone Evaluation (DOSE) – that combined continuing education, consultation, and protocol recommendations. This is the first national study to examine the use of reduced-dose CT on kidney imaging, the team said, and they tested DOSE in 192 facilities, totaling 422,039 kidney stone CT scans between 2015 and 2019.

The team split the centers into a group that implemented DOSE and a group that did not, and they sub-divided the intervention group into those that had participated in the intervention (25 facilities) and those that had not (71 institutions). They, then, tracked the dose-length product (DLP) every year, beginning in 2015.

Based on their analysis, they found that the DLP fell by 16 percent between 2015 and 2017 in facilities that used the intervention. Overall, the average reduction throughout all years of the study was 14 percent.

In addition, their results showed that facilities began using reduced-dose CT protocols more frequently throughout the study timeframe. Facilities in the DOSE intervention saw a more significant bump in their percentages of these lower-dose scans -- they rose from 22 percent in 2015 to 36 percent in 2019.

These findings show implementing reduced-dose CT protocols is a feasible option for kidney stone imaging in the long-term, the team said. But, providers must be conscientious about using it on a wider scale.

“It is the shared responsibility of medical users of radiation dose or radiation dose-based imaging tests, such as CT, to ensure use of as low as reasonably achievable radiation doses,” the team said. “This is particularly true for an indication, such as kidney stone CT, in which there is unequivocal evidence that reduced-dose CT can be employed without adverse effects.”

New research suggests use of reduced-dose CT scans could be as effective and reduce the need for re-imaging. 

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