Tapinarof Improved Outcomes and Sleep for Patients and Families in Two Phase 3 Atopic Dermatitis Trials in Adults and Children
Abstract Introduction Tapinarof is a topical aryl hydrocarbon receptor (AhR) agonist in development for the treatment of atopic dermatitis (AD). In two phase 3 trials (ADORING 1 and 2), tapinarof cream 1% once daily (QD) demonstrated significant efficacy and was well tolerated in patients down to ag...
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Adis, Springer Healthcare
2025-01-01
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| Series: | Dermatology and Therapy |
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| Online Access: | https://doi.org/10.1007/s13555-024-01318-6 |
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| author | Eric L. Simpson Adelaide A. Hebert John Browning Rocco T. Serrao Howard Sofen Philip M. Brown Stephen C. Piscitelli David S. Rubenstein Anna M. Tallman |
| author_facet | Eric L. Simpson Adelaide A. Hebert John Browning Rocco T. Serrao Howard Sofen Philip M. Brown Stephen C. Piscitelli David S. Rubenstein Anna M. Tallman |
| author_sort | Eric L. Simpson |
| collection | DOAJ |
| description | Abstract Introduction Tapinarof is a topical aryl hydrocarbon receptor (AhR) agonist in development for the treatment of atopic dermatitis (AD). In two phase 3 trials (ADORING 1 and 2), tapinarof cream 1% once daily (QD) demonstrated significant efficacy and was well tolerated in patients down to age 2 years with AD. Here, we evaluate patient-reported outcomes (PROs), including family impact, with tapinarof in ADORING 1 and 2. Methods In ADORING 1 and 2, 813 patients were randomized to tapinarof or vehicle QD for 8 weeks. PROs were assessed using the Dermatology Life Quality Index (DLQI), Children’s Dermatology Life Quality Index (CDLQI), Infants’ Dermatitis Quality of Life Index (IDQOL), Dermatitis Family Impact Questionnaire (DFI), and Patient Oriented Eczema Measure (POEM). Results Mean baseline DLQI, CDLQI, IDQOL, and DFI scores indicated that the impact on families and patients’ quality of life (QoL) of AD was moderate to very large. Mean POEM scores indicated moderate to severe AD symptoms at baseline. Tapinarof improved QoL versus vehicle across all endpoints at week 8: DLQI, − 6.2 vs − 3.5 (P = 0.0031) and − 5.5 vs − 3.5 (P = 0.0028); DFI, − 5.6 vs − 2.9 (P < 0.0001) and − 5.6 vs − 3.8 (P = 0.0037), in ADORING 1 and 2, respectively. Similar improvements in CDLQI and IDQOL were reported with tapinarof versus vehicle. Tapinarof also significantly improved CDLQI, DFI, and POEM sleep subdomain scores versus vehicle. POEM scores also improved with tapinarof versus vehicle: ≥ 12 years, − 9.4 vs − 5.3 and − 10.6 vs − 3.6 (both P < 0.0001); < 12 years, − 11.4 vs − 5.7 (P < 0.0001), and − 10.8 vs − 7.3 (P = 0.0005). Conclusions Tapinarof significantly improved QoL across PROs, including sleep and family impact, regardless of age, from week 1 (the earliest evaluation) through week 8. Tapinarof is a once-daily, non-steroidal cream that rapidly improves AD symptoms, sleep, and QoL in patients down to age 2 years with AD. Trial Registration Clinical Trials.gov identifier: NCT05014568; NCT05032859. |
| format | Article |
| id | doaj-art-410237f66d144e7dbafa2d8e7ea881d9 |
| institution | Kabale University |
| issn | 2193-8210 2190-9172 |
| language | English |
| publishDate | 2025-01-01 |
| publisher | Adis, Springer Healthcare |
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| series | Dermatology and Therapy |
| spelling | doaj-art-410237f66d144e7dbafa2d8e7ea881d92025-02-02T12:09:39ZengAdis, Springer HealthcareDermatology and Therapy2193-82102190-91722025-01-0115111112410.1007/s13555-024-01318-6Tapinarof Improved Outcomes and Sleep for Patients and Families in Two Phase 3 Atopic Dermatitis Trials in Adults and ChildrenEric L. Simpson0Adelaide A. Hebert1John Browning2Rocco T. Serrao3Howard Sofen4Philip M. Brown5Stephen C. Piscitelli6David S. Rubenstein7Anna M. Tallman8Oregon Health and Science UniversityUTHealth McGovern School of Medicine and Children’s Memorial Hermann HospitalUT Health San AntonioDermatologists of Southwest OhioDavid Geffen School of Medicine at UCLADermavant Sciences, Inc.Dermavant Sciences, Inc.Dermavant Sciences, Inc.Dermavant Sciences, Inc.Abstract Introduction Tapinarof is a topical aryl hydrocarbon receptor (AhR) agonist in development for the treatment of atopic dermatitis (AD). In two phase 3 trials (ADORING 1 and 2), tapinarof cream 1% once daily (QD) demonstrated significant efficacy and was well tolerated in patients down to age 2 years with AD. Here, we evaluate patient-reported outcomes (PROs), including family impact, with tapinarof in ADORING 1 and 2. Methods In ADORING 1 and 2, 813 patients were randomized to tapinarof or vehicle QD for 8 weeks. PROs were assessed using the Dermatology Life Quality Index (DLQI), Children’s Dermatology Life Quality Index (CDLQI), Infants’ Dermatitis Quality of Life Index (IDQOL), Dermatitis Family Impact Questionnaire (DFI), and Patient Oriented Eczema Measure (POEM). Results Mean baseline DLQI, CDLQI, IDQOL, and DFI scores indicated that the impact on families and patients’ quality of life (QoL) of AD was moderate to very large. Mean POEM scores indicated moderate to severe AD symptoms at baseline. Tapinarof improved QoL versus vehicle across all endpoints at week 8: DLQI, − 6.2 vs − 3.5 (P = 0.0031) and − 5.5 vs − 3.5 (P = 0.0028); DFI, − 5.6 vs − 2.9 (P < 0.0001) and − 5.6 vs − 3.8 (P = 0.0037), in ADORING 1 and 2, respectively. Similar improvements in CDLQI and IDQOL were reported with tapinarof versus vehicle. Tapinarof also significantly improved CDLQI, DFI, and POEM sleep subdomain scores versus vehicle. POEM scores also improved with tapinarof versus vehicle: ≥ 12 years, − 9.4 vs − 5.3 and − 10.6 vs − 3.6 (both P < 0.0001); < 12 years, − 11.4 vs − 5.7 (P < 0.0001), and − 10.8 vs − 7.3 (P = 0.0005). Conclusions Tapinarof significantly improved QoL across PROs, including sleep and family impact, regardless of age, from week 1 (the earliest evaluation) through week 8. Tapinarof is a once-daily, non-steroidal cream that rapidly improves AD symptoms, sleep, and QoL in patients down to age 2 years with AD. Trial Registration Clinical Trials.gov identifier: NCT05014568; NCT05032859.https://doi.org/10.1007/s13555-024-01318-6Atopic dermatitisFamily impactPatient-reported outcomesQuality of lifeSleep improvementTapinarof cream 1% once daily |
| spellingShingle | Eric L. Simpson Adelaide A. Hebert John Browning Rocco T. Serrao Howard Sofen Philip M. Brown Stephen C. Piscitelli David S. Rubenstein Anna M. Tallman Tapinarof Improved Outcomes and Sleep for Patients and Families in Two Phase 3 Atopic Dermatitis Trials in Adults and Children Dermatology and Therapy Atopic dermatitis Family impact Patient-reported outcomes Quality of life Sleep improvement Tapinarof cream 1% once daily |
| title | Tapinarof Improved Outcomes and Sleep for Patients and Families in Two Phase 3 Atopic Dermatitis Trials in Adults and Children |
| title_full | Tapinarof Improved Outcomes and Sleep for Patients and Families in Two Phase 3 Atopic Dermatitis Trials in Adults and Children |
| title_fullStr | Tapinarof Improved Outcomes and Sleep for Patients and Families in Two Phase 3 Atopic Dermatitis Trials in Adults and Children |
| title_full_unstemmed | Tapinarof Improved Outcomes and Sleep for Patients and Families in Two Phase 3 Atopic Dermatitis Trials in Adults and Children |
| title_short | Tapinarof Improved Outcomes and Sleep for Patients and Families in Two Phase 3 Atopic Dermatitis Trials in Adults and Children |
| title_sort | tapinarof improved outcomes and sleep for patients and families in two phase 3 atopic dermatitis trials in adults and children |
| topic | Atopic dermatitis Family impact Patient-reported outcomes Quality of life Sleep improvement Tapinarof cream 1% once daily |
| url | https://doi.org/10.1007/s13555-024-01318-6 |
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