Tapinarof 1% Cream Significantly Improves Patient Reported Outcomes, Including Family QoL, in Atopic Dermatitis

Tapinarof cream 1%, a nonsteroidal topical therapy for atopic dermatitis (AD), significantly improved patient reported outcomes (PROs) including quality of life (QoL), sleep, and family well being in adults and children aged 2 years and older, according to an analysis of data from the pivotal phase 3 ADORING 1 and ADORING 2 trials.¹

Eric L Simpson, MD, MCR

Courtesy OHSU

Improvements in these measures as well as in AD symptoms, eg, pruritis, were reported from the first week of study treatment through week 8, across all measures used and across age groups, researchers reported in the journal Dermatology and Therapy.¹

Individuals with AD report reduced QoL and also greater psychological distress than the general population.^2,3 In families with children who have AD, the detrimental effects extend to caregivers and the entire family unit, including through disturbed sleep, increased health care utilization, and missed work. 2,3 According to first author Eric L Simpson MD, MCR, Frances J. Storrs Medical Dermatology Professor at Oregon Health & Science University, and colleagues, there are few studies published that have evaluated the impact of nonsteroidal topical monotherapy on QoL and the family.¹

In the replicate ADORING 1 and 2 clinical trials, investigators randomly assigned 813 participants with moderate to severe AD to treatment with either tapinarof 1% cream or vehicle once daily for 8 weeks. Overall, 80% of participants were children, aged 12 to 17 years, according to the study. Simpson et al used the following instruments to assess PROs¹:

Quality of life:

• Dermatology Life Quality Index (DLQI) for those aged 16 years and older
• Children’s Dermatology Life Quality Index (CDLQI) for children aged 4 to 15 years
• Infants’ Dermatitis Quality of Life Index (IDQOL) for children aged 2 and 3 years.

Family impact:

• Dermatitis Family Impact Questionnaire (DFI) for those aged 15 years and younger, completed by a parent/caregiver and evaluates how having a child with AD may affect QoL and household sleep
• Patient Oriented Eczema Measure (POEM) monitors self-reported AD for participants aged 12 years and older and completed by parents/caregivers for children aged younger than age 12

Baseline patient-reported measures, including family impact, indicated a significant burden of AD on patients and family members, with a moderate to large effect on QoL, Simpson and team wrote. Participants/caregivers reported moderate to severe AD symptoms, as assessed by the POEM.

Findings

The research team reported rapid improvements in QOL, eczema severity, and family burden that were sustained throughout the study period.

DLQI. When compared with those receiving vehicle, patients aged 16 years or older achieved significant reductions in mean DLQI scores by week 2 (ADORING 1, -5.2 vs -3.3; P =.023; and ADORING 2, -4.5 vs -2.8; P =.004). These scores continued to improve through week 8 in both studies (ADORING 1, -6.2 vs -3.5; P =.003; and ADORING 2, -5.5 vs -3.5, P =.003).¹

CDLQI. According to parent/caregiver assessments, children aged 4 to 15 years showed similar gains in mean CDLQI scores vs vehicle at week 8 (ADORING 1, -5.2 vs -3.8; P =.004; and ADORING 2, -6.8 vs -4.1; P <.001), including sleep-related measures. Investigators made no meaningful interpretations for IDQOL, according to the study.¹

POEM. POEM scores also reflected significant reductions in eczema severity across all age groups and beginning at week 1. When compared with treatment with vehicle, treatment with tapinarof was associated with sustained improvement through week 8 in children younger than age 12 (ADORING 1, -11.4 vs -5.7; P <.0001; and ADORING 2, -10.8 vs -7.3; P =.0005) and also in those aged 12 years and older (ADORING 1, -9.4 vs -5.3; P <.0001; and ADORING 2, -10.6 vs -3.6; P <.0001).¹

DFI. As with the other PROs, improvement in DFI scores with tapinarof treatment were seen at the end of the first week of the study in ADORING 1 (-3.4 vs -1.6; P <.001) and the end of the second week in ADORING 2 (-4.0 vs -2.8; P =.05).¹

Mean sleep subdomain scores on both POEM and DFI were significantly improved by week 1 with the gains sustained through the end of the study, the authors reported.

Simpson et al acknowledge study limitations including the short follow-up period as well as the large proportion of participants with moderate disease severity, which could limit generalizing the findings across the spectrum of severity.

“Tapinarof cream 1% QD significantly improved AD symptoms and QoL, including sleep, compared with vehicle in patients with moderate to severe AD, irrespective of age,” the authors wrote in conclusion. The once-daily, non-steroidal cream rapidly improves AD symptoms and QoL in patients down to 2 years of age with AD, they wrote, “and has the potential to be used without restrictions on duration of use, extent of BSA treated, or sites of application.”¹

1. Simpson EL, Hebert AA, Browning J, et al. Tapinarof improved outcomes and sleep for patients and families in two phase 3 atopic dermatitis trials in adults and children. Dermatol Ther (Heidelb). Published online January 7, 2025. doi:10.1007/s13555-024-01318-6
2. Weidinger S, Novak N. Atopic dermatitis. Lancet. 2016;387(10023):1109–22. https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(15)00149-X/abstract
3. Carroll CL, Balkrishnan R, Feldman SR, Fleischer AB Jr, Manuel JC. The burden of atopic dermatitis: impact on the patient, family, and society. Pediatr Dermatol. 2005;22(3):192–9.