The new data demonstrate that VTAMA cream provided early and consistent response for children aged 2-17 with atopic dermatitis (AD), with or without atopic comorbidities such as asthma, allergic rhinitis and food allergies.
“As many children with atopic dermatitis may also be living with potential comorbidities such as allergies and asthma that may add to their disease burden,1 it’s important to understand the effects of approved treatments on this population,” said Dr. Luz Fonacier, Professor of Medicine, Section Head of Allergy and Training Program Director, NYU Grossman Long Island School of Medicine. “These reassuring data show tapinarof cream provided early relief, including on bothersome symptoms such as itch, for children as young as 2 years of age with and without comorbidities.”
In the ADORING 1 and ADORING 2 pivotal trials, adults and children (≥2 years; N=813) with moderate to severe AD were randomized to VTAMA cream or vehicle once daily for 8 weeks. The results presented at ACAAI 2025 are from a sub-analysis of the 654 children in the trials aged 2-17, with and without comorbidities associated with AD. The data highlight improvements in clinically relevant patient-reported outcomes, Validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD™) response, and Eczema Area and Severity Index (EASI) scores in children aged 2-17 years, regardless of comorbidities.
Notable findings include:
- Early improvements in skin clearance were observed, with significant differences in vIGA-AD response rates as early as week 1 and maintained through week 8 in children with or without atopic comorbidities (with comorbidities: 42.3% with VTAMA cream vs. 11.8% with vehicle, p<0.0001; without comorbidities: 49.5% vs. 14.8%, respectively, p<0.0001).
- Improvement in eczema severity, as measured by EASI scores, was observed as early as week 2 and sustained through week 8 (with comorbidities: 54.5% with VTAMA cream vs. 21.8% with vehicle, p<0.0001; without comorbidities: 63.1% vs. 20.4%, respectively, p<0.0001).
- Improvements in patient-reported outcomes, including sleep, as measured by total mean Patient-Oriented Eczema Measure (POEM) and mean POEM sleep scores (based on a single question within the POEM and analyzed separately from the total POEM score), were noted as early as week 1 and maintained through week 8 (total POEM with comorbidities: 6.9 with VTAMA cream vs. 12.0 with vehicle, p<0.0001; total POEM without comorbidities: 6.7 vs. 11.9, respectively, p<0.0001; POEM sleep with comorbidities: 0.9 with VTAMA cream vs. 1.4 with vehicle, p=0.0003; POEM sleep without comorbidities: 0.6 vs. 1.4, respectively, p<0.0001).
- Clinically meaningful improvements in itch (a ≥4-point Peak Pruritus- Numeric Rating Scale [PP-NRS] response) were observed at week 2, based on responder analysis, with continued improvement through week 8 (with comorbidities: 55.6% with VTAMA cream vs. 36.3% with vehicle, p=0.0043; without comorbidities: 63.3% vs. 29.2%, respectively, p<0.0001).
Consistent with the prescribing information, the most frequently reported treatment-emergent adverse events in the sub-analysis of children aged 2-17 in the ADORING 1 and ADORING 2 trials were folliculitis (7.8%), upper respiratory tract infection (4.6%) and headache (3.7%).
“We are proud to announce data from this new sub-analysis demonstrating early and consistent skin clearance with VTAMA cream, as well as other clinically meaningful improvements in key atopic dermatitis measures in children 2 years and older, regardless of comorbidity status,” said Rafael Chaves Cardona, MD, Head of U.S. Medical Affairs and Outcomes Research, Organon. “This study represents the largest pediatric data set to date for VTAMA, and when added to the wealth of data from the pivotal trials, as well as the ADORING 3 open-label, long-term extension trial, these findings support Organon’s commitment to offering treatment options with a favorable safety and efficacy profile for children 2 years and older.”
In December 2024, the U.S. Food and Drug Administration (FDA) approved VTAMA cream for the topical treatment of AD in adults and pediatric patients 2 years of age and older. VTAMA cream was also approved by the FDA in May 2022, for the topical treatment of plaque psoriasis in adults.2
About the Phase 3 Program for VTAMA cream in Atopic Dermatitis
ADORING was the Phase 3 AD clinical development program for VTAMA cream, consisting of two 8-week pivotal trials, ADORING 1 (NCT05014568) and ADORING 2 (NCT05032859), as well as ADORING 3 (NCT05142774), a 48-week, open-label, long-term extension trial.2
INDICATIONS: VTAMA® (tapinarof) cream, 1% is an aryl hydrocarbon receptor (AhR) agonist indicated for:
- the topical treatment of plaque psoriasis in adults
- the topical treatment of atopic dermatitis in adults and pediatric patients 2 years of age and older
SELECTED SAFETY INFORMATION
Adverse Events: In plaque psoriasis, the most common adverse reactions (incidence ≥1%) were: folliculitis, nasopharyngitis, contact dermatitis, headache, pruritus, and influenza.
Adverse Events: In atopic dermatitis, the most common adverse reactions (incidence ≥1%) were: upper respiratory tract infection, folliculitis, lower respiratory tract infection, headache, asthma, vomiting, ear infection, pain in extremity, and abdominal pain.
About Atopic Dermatitis (AD)
AD, commonly referred to as eczema, is one of the most prevalent inflammatory skin diseases, affecting an estimated 26 million people in the U.S. alone and up to 10% of adults worldwide.3,4 AD occurs most frequently in children, affecting up to 20% worldwide, including nearly 10 million children in the US.4,5, The disease results in itchy, red, swollen, and cracked skin, often on the folds of the arms, back of the knees, hands, face, and neck.3, Itching is an especially bothersome symptom for those with AD, and tends to worsen at night.4 Around 90% of children with eczema also have another related condition such as allergies or asthma, according to international survey data.1
About Organon
Organon (NYSE: OGN) is a global healthcare company with a mission to deliver impactful medicines and solutions for a healthier every day. With a portfolio of over 70 products across Women’s Health and General Medicines, which includes biosimilars, Organon focuses on addressing health needs that uniquely, disproportionately, or differently affect women, while expanding access to essential treatments in over 140 markets.
For more information please visit, www.organon.com
