Simpson Eric L, Hebert Adelaide A, Browning John, Serrao Rocco T, Sofen Howard, Brown Philip M, Piscitelli Stephen C, Rubenstein David S, Tallman Anna M
Oregon Health and Science University, 3181 S.W. Sam Jackson Park Road, Portland, OR, 97239-3098, USA.
UTHealth McGovern School of Medicine and Children's Memorial Hermann Hospital, Houston, TX, USA.
Dermatol Ther (Heidelb). 2025 Jan;15(1):111-124. doi: 10.1007/s13555-024-01318-6. Epub 2025 Jan 7.
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.
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).
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).
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.
Clinical Trials.gov identifier: NCT05014568; NCT05032859.
他扎罗芬是一种正在研发的局部芳烃受体（AhR）激动剂，用于治疗特应性皮炎（AD）。在两项3期试验（ADORING 1和2）中，1%的他扎罗芬乳膏每日一次（QD）显示出显著疗效，且2岁及以上的AD患者耐受性良好。在此，我们在ADORING 1和2中评估了患者报告的结局（PROs），包括对家庭的影响，使用他扎罗芬治疗。
在ADORING 1和2中，813名患者被随机分配至他扎罗芬组或赋形剂组，每日一次，持续8周。使用皮肤病生活质量指数（DLQI）、儿童皮肤病生活质量指数（CDLQI）、婴儿皮炎生活质量指数（IDQOL）、皮炎家庭影响问卷（DFI）和患者导向性湿疹评估（POEM）对PROs进行评估。
平均基线DLQI、CDLQI、IDQOL和DFI评分表明，AD对家庭和患者生活质量（QoL）的影响为中度至非常大。平均POEM评分表明基线时AD症状为中度至重度。在第8周时，他扎罗芬在所有终点均改善了QoL，与赋形剂相比：DLQI，-6.2对-3.5（P = 0.0031）和-5.5对-3.5（P = 0.0028）；DFI，-5.6对-2.9（P < 0.0001）和-5.6对-3.8（P = 0.0037），分别在ADORING 1和2中。与赋形剂相比，他扎罗芬在CDLQI和IDQOL方面也有类似改善。与赋形剂相比，他扎罗芬还显著改善了CDLQI、DFI和POEM睡眠子域评分。与赋形剂相比，他扎罗芬的POEM评分也有所改善：≥12岁，-9.4对-5.3和-10.6对-3.6（均P < 0.0001）；<12岁，-11.4对-5.7（P < 0.0001），和-10.8对-7.3（P = 0.0005）。
从第1周（最早评估）到第8周，无论年龄大小，他扎罗芬均显著改善了包括睡眠和家庭影响在内的PROs方面的QoL。他扎罗芬是一种每日一次的非甾体乳膏，可迅速改善2岁及以上AD患者的AD症状、睡眠和QoL。
ClinicalTrials.gov标识符：NCT05014568；NCT05032859。
