Patrick Campbell is the editorial director of HCPLive. Patrick has spent years spearheading coverage surrounding cardiometabolic health and rheumatic disease for MJH Life Sciences. Before joining MJH Life Sciences in 2019, he spent time as a beat reporter and/or multimedia specialist with the Pocono Record, Star News Group, and NJ Advance Media. He is the executive producer for multiple HCPLive podcasts, including Diabetes Dialogue, Don't Miss a Beat, Kidney Compass, Medical Ethics Unpacked, The Medical Sisterhood, and Skin of Color Savvy. 


Follow him on Twitter @RealPatCampbell or reach him via email at PCampbell@mjhlifesciences.com.

Linda Stein Gold, MD
Credit: Henry Ford Health

A post-hoc pooled analysis of 2 pivotal phase 3 trials evaluating tapinarof cream 1% (Vtama) in patients with moderate to severe 

 demonstrated statistically significant improvements in disease severity and itch beginning as early as week 1 of treatment, including in pediatric patients as young as 2 years of age. 

“The new findings from this analysis demonstrate significant improvements across key clinical endpoints, including reductions in disease severity and itch, as early as week 1,” said Linda Stein Gold, MD, director of Clinical Research and Division Head of Dermatology, Henry Ford Health System, in a press release from Organon. “Seeing these positive outcomes in many patients across the study, especially since 80% of the trial participants were children, highlights the potential of [tapinarof] cream to address common symptoms, such as itch, early in the treatment course and provides healthcare providers with an evidence-based option to help manage the disease.”

The data originated from ADORING 1 (NCT05014568) and ADORING 2 (NCT05032859), 2 randomized, vehicle-controlled, double-blind, 8-week phase 3 pivotal trials conducted as part of the ADORING clinical development program for tapinarof in atopic dermatitis. The pooled analysis presented at the 

2026 American Academy of Dermatology (AAD) Annual Meeting

 in Denver, Colorado, was a post-hoc sub-analysis of combined data from ADORING 1 and ADORING 2.¹

Adults and children aged 2 years and older (N=813) with moderate to severe atopic dermatitis were randomized to tapinarof cream 1% or vehicle applied once daily for 8 weeks. The primary and key secondary endpoints included the validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD), the Eczema Area and Severity Index 75 (EASI75), and the Peak Pruritus Numerical Rating Scale (PP-NRS).¹

According to study results, statistically significant improvements versus vehicle were observed across all 3 endpoints as early as week 1.¹

At week 1, a vIGA-AD response, which was defined as clear (score of 0) or almost clear (score of 1) with a ≥2-grade improvement from baseline, was achieved in 5.8% of tapinarof-treated patients versus 1.6% in the vehicle group (

=.0315). By week 8, the vIGA-AD response rate was 45.9% versus 15.9% (

EASI75 response at week 1 was achieved in 9.0% of tapinarof-treated patients versus 3.3% receiving vehicle (

.0164), increasing to 57.4% versus 22.1% at week 8 (

Meaningful itch improvement, defined as a ≥4-point reduction in PP-NRS score among patients with a baseline score of ≥4, was observed in 18.8% of tapinarof-treated patients at week 1 versus 11.3% in the vehicle group (

=.0128), and in 59.3% versus 33.5% at week 8 (

Additionally, the analysis reported that 96.9% of patients in the tapinarof arm achieved any measurable EASI improvement from baseline at week 8.¹

With regard to safety, the investigators reported that the treatment was well tolerated. Treatment-emergent adverse events occurring in ≥3% of any group included folliculitis, headache, upper respiratory tract infection, and nasopharyngitis. 

The full prescribing information for tapinarof in the atopic dermatitis indication lists upper respiratory tract infection, folliculitis, lower respiratory tract infection, headache, asthma, vomiting, ear infection, pain in extremity, and abdominal pain as the most common adverse reactions (incidence ≥1%).¹

Tapinarof is a first-in-class, non-steroidal, small-molecule aryl hydrocarbon receptor (AhR) agonist. 

According to the prescribing information, its mechanism involves modulation of the AhR pathway, which plays a role in skin barrier function and inflammatory signaling. It is formulated as a 1% topical cream applied once daily and carries  approvals from the US Food and Drug Administration for both plaque psoriasis in adults and atopic dermatitis in adults and pediatric patients aged 2 years and older.¹

The post-hoc, pooled, sub-analysis design warrants interpretive caution. Post-hoc analyses are hypothesis-generating rather than confirmatory, and while the underlying ADORING 1 and ADORING 2 trials were prospectively powered and conducted under controlled conditions, the combined subanalysis was not a pre-specified primary endpoint analysis. These findings should be viewed as supportive and contextualizing, rather than as new primary efficacy evidence.

Several limitations should be noted. As stated above, this was a post-hoc pooled analysis, and its findings are exploratory rather than confirmatory in nature. Additionally, the 8-week treatment duration of the ADORING 1 and ADORING 2 trials limits conclusions about long-term efficacy maintenance; the ongoing ADORING 3 open-label extension (48 weeks) may provide more durable data, though it lacks a vehicle control arm. 

“In treating atopic dermatitis, our goal as healthcare providers is to find therapies that deliver fast and clinically meaningful skin clearance and itch reduction, and a favorable safety profile,” Stein Gold remarked. 

Organon. Organon Debuts New Analysis of VTAMA® (tapinarof) cream, 1%, Phase 3 Pooled Data Demonstrating Early and Consistent Skin Clearance and Itch Improvement in Atopic Dermatitis Patients Down to 2 Years of Age. Business Wire. Published March 27, 2026. Accessed March 27, 2026. 

https://www.businesswire.com/news/home/20260327556082/en/Organon-Debuts-New-Analysis-of-VTAMA-tapinarof-cream-1-Phase-3-Pooled-Data-Demonstrating-Early-and-Consistent-Skin-Clearance-and-Itch-Improvement-in-Atopic-Dermatitis-Patients-Down-to-2-Years-of-Age

Silverberg JI, Eichenfield LF, Stein Gold L, Arjona Ferreira JC, Bissonnette R. Efficacy and safety of tapinarof cream 1% once daily monotherapy in adults and children with atopic dermatitis: pooled results from ADORING 1 and 2. Presented at: American Academy of Dermatology Annual Meeting; March 27-31, 2026; Denver, Colorado.

https://www.organon.com/product/usa/pi_circulars/v/VTAMA/vtama_pi_ppi_combo.pdf

Articles

A post-hoc analysis of phase 3 trials found tapinarof cream 1%  produced skin clearance and itch relief as early as week 1 in patients aged 2 years and older.

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Atopic Dermatitis

Atopic Dermatitis condition center page, audiences can find a variety of coverage mediums for medical news and updates, including articles, video interviews, podcasts, and breaking news on dermatitis research, treatment, and drug development.

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Tapinarof Cream Clears Skin, Eases Itch Within 1 Week in Kids as Young as 2 Years

Shared decision-making around initiating targeted therapy, key safety considerations for avapritinib, and core efficacy and safety findings from the 6‑month randomized phase of the PIONEER trial.

Targeted Therapy in ISM: Shared Decision-making, Safety, and Early PIONEER Data

Initiation of targeted therapy in indolent systemic mastocytosis (ISM) requires nuanced shared decision-making that incorporates symptom burden, prior treatment history, comorbidities, and patient preferences. The first step is to optimize conventional mediator-directed therapy; only when patients remain significantly symptomatic despite well-structured regimens should a tyrosine kinase inhibitor be considered. Because avapritinib does not eradicate the disease clone but substantially lowers mast cell burden and improves symptoms, it is generally anticipated to be a chronic therapy. Patients should therefore be counseled regarding the likelihood of long-term use and the potential for symptom and lesion recurrence upon discontinuation.

Safety is a critical component of these discussions. Avapritinib carries a contraindication in patients with severe thrombocytopenia (platelet count <50 × 10^9/L) owing to a risk of intracranial hemorrhage observed in earlier, higher-dose studies in advanced systemic mastocytosis. Notably, such events were not seen in the indolent population treated at lower doses in ISM trials, where baseline platelet counts are, by definition, within normal limits. Cognitive adverse events, including memory and concentration difficulties, were likewise reported at higher doses in advanced disease but have not emerged as a significant signal in ISM at the approved dose. These historical data nonetheless inform risk–benefit conversations and underscore the importance of individualized monitoring strategies.

The phase 2 PIONEER study, reported in a randomized, placebo-controlled design over 24 weeks, established the efficacy and safety of avapritinib 25 mg once daily in patients with ISM. Participants receiving avapritinib experienced significant reductions in validated symptom scores—the primary endpoint—as well as meaningful decreases in mast cell–related biomarkers, including serum tryptase, bone marrow mast cell burden, and KIT D816V allele fraction. In this video segment, Akin reviews these findings and highlights how the PIONEER trial’s short‑term results laid the foundation for longer-term extension studies that further characterize the durability of benefit and safety profile of avapritinib in chronic ISM management.


Videos

Video Series

Addressing Access Barriers in Colorectal Cancer Screening

In this episode, ‘Addressing Access Barriers in Colorectal Cancer Screening,’ the panelists explore common patient concerns about the cost of colonoscopy following a positive colorectal cancer screening test. The speakers clarify that stool-based screening tests and subsequent diagnostic colonoscopy are generally covered by insurance, including procedures involving polyp removal and surveillance. They emphasize that financial worries, along with time off work and logistical challenges, can significantly reduce adherence. The discussion also highlights the growing role of health systems in addressing social drivers of health, such as transportation assistance and patient navigation services. Ultimately, the faculty underscore the importance of proactively addressing cost and access concerns to improve screening completion rates and reduce colorectal cancer disparities.

The next episode in this series, ‘Coordinating Care After Abnormal Colorectal Cancer Results,’ focuses on the importance of timely follow-up after a positive stool test, ideally within six months, closing the referral loop to gastroenterology, avoiding inappropriate stool testing in symptomatic patients, and ensuring that noticeable symptoms prompt direct diagnostic evaluation rather than screening.

Positive stool test? Learn why follow-up colonoscopy is often covered and how clinics tackle cost, time-off, and transport barriers.

Role of patient-reported outcomes in trials and practice, criteria for escalation beyond supportive care, and the paradigm shift introduced by selective KIT D816V inhibition, including avapritinib.

When Supportive Care Is Not Enough: Patient-Reported Outcomes and Escalation to Targeted Therapy

Symptom assessment tools play distinct but complementary roles in the clinical trial and routine practice settings for indolent systemic mastocytosis (ISM). In drug development, rigorously validated PRO instruments serve as primary endpoints, linking targeted biologic effects to patient-experienced benefit. For example, in pivotal trials of KIT D816V–selective inhibitors, sponsors developed disease-specific symptom scores incorporating multiple items rated on numerical scales and administered at each visit to quantify change over time. Similar frameworks have been applied in parallel ISM programs, enabling comparison of treatment arms and supporting regulatory decisions on the basis of clinically meaningful symptom improvement.

In everyday practice, formal PROs are less commonly used, but their value is increasingly recognized alongside tools such as the Mastocytosis Control Test. These instruments complement laboratory and histologic markers—serum tryptase levels, bone marrow mast cell burden, and KIT D816V allele fraction—by providing standardized insight into domains that may not correlate directly with mast cell burden. Importantly, eligibility criteria for clinical trials of targeted therapies have helped crystallize a practical definition of “treatment-refractory” ISM: patients receiving 2 or more optimized anti–mast cell mediator regimens (eg, H1 and H2 antihistamines, leukotriene antagonists, cromolyn sodium, omalizumab, or corticosteroids) who nonetheless exhibit persistently high symptom scores.

The emergence of selective KIT D816V inhibition has altered treatment paradigms for both indolent and advanced systemic mastocytosis. Avapritinib, the first such agent approved by the US Food and Drug Administration (FDA) for ISM, directly reduces the clone of KIT-mutated mast cells, distinguishing it from earlier multikinase inhibitors that primarily targeted wild-type KIT and had limited applicability in D816V-positive disease. In this segment of the video series, Akin explains how avapritinib’s demonstration of robust symptom reduction and biomarker improvement in clinical trials has validated KIT D816V as a driver mutation in ISM and opened a new therapeutic avenue for patients whose disease remains inadequately controlled with supportive care alone.

 Individualizing When to Stop Colorectal Cancer Screening 

This episode, titled ‘Individualizing When to Stop Colorectal Cancer Screening,’ examines the nuanced decision-making involved in determining when to discontinue colorectal cancer screening. While guidelines generally recommend screening from ages 45 to 75, faculty emphasize the importance of individualizing decisions based on overall health, life expectancy, and patient preferences. The discussion highlights that screening may remain appropriate for robust older adults, while it may not benefit patients with limited life expectancy due to advanced comorbid conditions. Speakers underscore the importance of framing conversations around overall health priorities rather than age alone, using shared decision-making to guide recommendations. Ultimately, the segment reinforces that stopping screening is not a rigid cutoff but a thoughtful, patient-centered clinical judgment.

In the next episode, ‘Addressing Access Barriers in Colorectal Cancer Screening,’ panelists will continue their discussion on colorectal cancer screening and address financial concerns related to follow-up colonoscopy after a positive screening test, emphasizing that most costs are covered by insurance and that removing financial misconceptions can improve adherence. The discussion also highlights the broader impact of social determinants of health, such as transportation, time off work, and childcare, and the role of patient navigation in improving screening completion rates.

See how FIT cutoffs change accuracy, why Cologuard raises sensitivity

Individualizing When to Stop Colorectal Cancer Screening

Xiao Xiao, PhD, from the Behavioral and Cognitive Neuroscience Center at Fudan University.

Study shows microglia-driven hippocampal remodeling may connect chronic pain to depression, highlighting the importance of timing for behavioral interventions.


Psychiatry

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Microglial Remodeling Links Chronic Pain to Depression, With Xiao Xiao, PhD

FDA News

Type 2 Diabetes

Endocrinology

The HCPLive endocrinology page is a comprehensive resource for clinical news and insights on endocrine system conditions. This page consists of interviews, articles, podcasts, and videos on the research, treatment and development of therapies for diabetes, hormonal disease, and more.

FDA Approves Insulin Icodec (Awiqli) as First Once-Weekly Basal Insulin for Type 2 Diabetes

Janiene Luke, MD, is a clinical professor and residency program director
at the department of dermatology for Loma Linda University Medical Center.

Janiene Luke, MD, co-chair of the Skin of Color Society (SOCS) Scientific Symposium, speaks about complex cases in dermatology and other topics covered at the meeting.

Addressing Complex Cases in Dermatology at SOCS Scientific Symposium, With Janiene Luke, MD

Barbara Gillespie, MD, is Chief Medical and Strategy Officer of the International Society of Glomerular Disease and Adjunct Professor at the University of North Carolina.

Experts discuss major advances in glomerular disease research and care, including molecular technologies, biomarker discovery, APOL1-mediated kidney disease, and evolving clinical trial design and endpoints.

Strategic Alliance Partnership

Nephrology

The HCPLive nephrology page is a resource for medical news and expert insights on kidney disease. This page features expert-led coverage, articles, videos and research on the therapies and development of treatments in nephrology, and more.

IgA Nephropathy

The HCPLive Berger disease page is a resource for medical news and expert insights on IgA nephropathy. This page features expert-led coverage, articles, videos and research on the therapies and development of treatments in Berger disease, and more.

Chronic Kidney Disease

From APOL1 to Biomarkers, Glomerular Disease Research Is Redefining Kidney Care, With Tobias Huber, MD, Barbara Gillespie, MD

Temitayo Ogunleye, MD, is a professor of Clinical Dermatology at the University of Pennsylvania. She also serves as associate director of Community Engagement and Academic Excellence in the Department of Dermatology and associate director of the Pre-Residency Fellowship in Skin of Color Program.

Temitayo Ogunleye, MD, co-chair of the Skin of Color Society Scientific Symposium, speaks with HCPLive about the meeting's guiding theme and topics.

Cross Collaboration and Key Topics at SOCS Scientific Symposium, With Temitayo Ogunleye, MD

Virginia Nuckols, PhD, is a postdoctoral fellow in the Department of Kinesiology and Applied Physiology at the University of Delaware.

Nuckols discusses her recent study highlighting a correlation between pregnancy complications, increased psychosocial stress, and cardiovascular disease risk.

Cardiology

Cardiology condition center page is a comprehensive resource for clinical news and insights on cardiovascular and cardiometabolic diseases. This page consists of interviews, articles, podcasts, and videos on the research, treatment and development of therapies for heart disease and cardiovascular events, as well as associated diabetes, renal failure, and more...

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Increased Stress Due to Pregnancy Complications Raises Cardiovascular Risk, With Virginia Nuckols, PhD

Sofia Holmqvist-Jämsén, PhD, from the University of Helsinki

Population study links respiratory allergies to hoarseness, throat clearing, and vocal fatigue, with greater symptom burden in women and unified airway implications.

Allergy

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Respiratory Allergies Linked to Vocal Symptoms, With Holmqvist-Jämsén, PhD

Christopher Kramer, MD, FACC, is the current president of the American College of Cardiology.

Kramer, the president of the American College of Cardiology, discusses the organization’s recent movement to adapt rapidly growing AI technology to clinical care.

Artificial Intelligence in Cardiology: The ACC’s Implementation Pipeline, With Christopher Kramer, MD, FACC

Akl Fahed, MD, MPH, Interventional Cardiologist at Massachusetts General Hospital and Instructor in Medicine at Harvard Medical School.

Fahed explains how a multi-ancestry metabolic poly genetic risk score from over 8.5 million individuals points to the utility of global collaboration in genetic research. 


Obesity Management

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Multi-Ancestry Genetic Risk Score Shows Value of Global Collaboration in Metabolic Disease, With Akl Fahed, MD, MPH

New research identifies dietary epitopes driving oral tolerance, offering insight into Treg responses, early exposure, and future food allergy therapies.

Latest News

Tapinarof Cream Clears Skin, Eases Itch Within 1 Week in Kids as Young as 2 Years

Targeted Therapy in ISM: Shared Decision-making, Safety, and Early PIONEER Data

Addressing Access Barriers in Colorectal Cancer Screening

When Supportive Care Is Not Enough: Patient-Reported Outcomes and Escalation to Targeted Therapy

Individualizing When to Stop Colorectal Cancer Screening