Tapinarof Cream Shows Early, Consistent Improvement in Sleep for Patients With Atopic Dermatitis

Findings from the phase 3 ADORING 1 (NCT05014568) and ADORING 2 (NCT05032859) clinical trials demonstrate that tapinarof cream, 1% (Vtama; Organon), resulted in early and consistent improvements in the Patient-Oriented Eczema Measure (POEM) sleep subdomain for pediatric patients as young as 2 years with moderate to severe atopic dermatitis (AD) and in the Dermatitis Family Impact (DFI) sleep subdomain for family members of patients aged 2 to 15 years.^1-3

“Sleep disturbance is a significant problem for children with AD and their families, and one that I always take time to address in my clinic,” analysis author Mark Boguniewicz, MD, professor at the Department of Pediatrics, Division of Pediatric Allergy and Clinical Immunology at National Jewish Health and the University of Colorado School of Medicine, said at the 2026 American Academy of Allergy, Asthma & Immunology (AAAAI) Annual Meeting. “When a child with AD struggles through the night, parents and caregivers are often awake as well, sharing in the fatigue and emotional stress associated with ongoing sleep disturbance.”³

Assessing Tapinarof in Pediatric AD

Tapinarof cream, 1% is an aryl hydrocarbon receptor agonist indicated for the topical treatment of plaque psoriasis in adults and AD in adults and patients 2 years and older.⁴ It was evaluated in the phase 3 AD clinical development program, ADORING, which consisted of 2 trials: phase 3 ADORING 1 and ADORING 2, which were 8 weeks in duration, as well as ADORING 3 (NCT05142774), a 48-week, open-label, long-term extension trial.^1,5

ADORING 1 and ADORING 2 enrolled a cumulative 813 adults and children 2 years and older with moderate to severe AD. Patients were randomly assigned to receive tapinarof cream or vehicle once daily for 8 weeks. The findings presented at the AAAAI 2026 Annual Meeting are from a subanalysis of pooled data from 654 children aged 2 to 17 years who were enrolled in ADORING 1 and ADORING 2. Clinically relevant improvements in sleep subdomains of patient-reported outcomes, as measured by POEM and DFI scores, were seen across all age groups, including pediatric patients as young as 2 years with moderate to severe AD and family members of patients aged 2 to 15 years.³

Key Findings From the Subanalysis

The subanalysis demonstrated that the mean POEM sleep subdomain scores significantly improved as early as week 1 when patients received tapinarof cream, including children aged 2 to 6 and 12 to 17 years. Improvements in children aged 7 to 11 years were observed by week 4.³

Mean changes in POEM sleep scores with tapinarof cream compared with vehicle at week 8 were clinically significant across age groups: –1.9 compared with –0.9 for children aged 2 to 6 years (P < .0001); –1.5 compared with –1.0 for children aged 7 to 11 years (P = .0029); and –1.2 compared with –0.6 for children aged 12 to 17 years (P < .0001). Additionally, mean DFI sleep subdomain scores improved significantly as early as week 1 with tapinarof cream compared with vehicle in patients aged 12 to 15 years and as early as week 2 for those aged 2 to 6 and 7 to 11 years.³

Clinically significant improvements in DFI sleep subdomain scores continued through week 8 with tapinarof cream compared with vehicle. These improvements were –1.1 compared with –0.6 for children aged 2 to 6 years (P = .0002); –0.6 compared with -0.4 for children aged 7 to 11 years (P = .0049); and –0.4 compared with –0.2 for children aged 12 to 15 years (P = .0283).³

Conclusions

The investigators noted that the most frequently reported treatment-emergent adverse events (AEs) reported during the trials were consistent with the prescribing information, with the most common being folliculitis, headache, and nasopharyngitis.³ Other common AEs reported across AD clinical trials were upper respiratory tract infection, lower respiratory tract infection, asthma, vomiting, ear infection, pain in extremity, and abdominal pain.⁴

“These findings demonstrate early and sustained improvements in sleep-related measures, including for those as young as 2 years of age,” said Juan Camilo Arjona Ferreira, MD, head of research and development and chief medical officer at Organon. “Sleep disturbance is an important and measurable aspect of pediatric AD, and these positive results reinforce our commitment to advancing therapies that address meaningful treatment outcomes across chronic skin conditions. We are encouraged by these findings and look forward to continuing to disseminate data that are clinically relevant for patients, caregivers, and prescribers.”³

REFERENCES

1. Tapinarof for the treatment of atopic dermatitis in children and adults. ClinicalTrials.gov. Updated September 4, 2025. Accessed February 27, 2026. https://clinicaltrials.gov/study/NCT05014568

2. Tapinarof for the treatment of atopic dermatitis in children and adults (DMVT-505-3102). ClinicalTrials.gov. Updated September 2, 2025. Accessed February 27, 2026. https://clinicaltrials.gov/study/NCT05032859

3. New analysis of Organon’s VTAMA (tapinarof) cream, 1%, phase 3 data showed early and consistent improvement in patient-reported sleep subdomains in pediatric patients down to 2 years of age with atopic dermatitis. News release. Organon. February 27, 2026. Accessed February 27, 2026. https://www.organon.com/news/new-analysis-of-organons-vtama-tapinarof-cream-1-phase-3-data-showed-early-and-consistent-improvement-in-patient-reported-sleep-subdomains-in-pediatric-patients-down-to-2-years-of-a/

4. Vtama (tapinarof) cream 1%. Accessed February 27, 2026. https://vtama.com/

5. Long term extension study of tapinarof cream, 1% for subjects with atopic dermatitis. ClinicalTrials.gov. Updated August 13, 2025. Accessed February 27, 2026. https://clinicaltrials.gov/study/NCT05142774