Scholarly Activity

INTRODUCTION: A cell harvesting device for preparing non-cultured autologous skin cell suspension (ASCS) at the point-of-care is FDA-approved for repigmentation of stable depigmented vitiligo lesions in patients 18 years and older. The pivotal RSVP trial showed ≥80% repigmentation at Week-24 in 36% of lesions treated with laser ablation, ASCS, and narrowband ultraviolet B phototherapy compared to 0% with phototherapy alone (p = 0.012). The objective of this analysis was to evaluate the potential economic impact of laser ablation plus ASCS with phototherapy versus phototherapy alone for repigmentation of stable vitiligo lesions from a US payer perspective.

METHODS: A 5-year decision-tree model was developed reflecting clinical pathways of adults with stable vitiligo lesions who had an inadequate response to prior topicals and phototherapy. Patients entering the model were treated with ASCS plus phototherapy or phototherapy alone and assessed for treatment response at Weeks-24 and 52 based on the RSVP trial's effectiveness endpoints. Durable response for Year-2 onwards was proxied by melanocyte-keratinocyte transplantation data. Model outcomes included per-patient total and incremental healthcare costs, treatment costs and total costs, cost per-patient per-month (PPPM), and cost per-patient per-year (PPPY). One-way sensitivity analyses assessed model result robustness.

RESULTS: The cumulative total per-patient cost for ASCS plus phototherapy increased from $28,177 to $92,779 between Year-1 and Year-5. Phototherapy alone increased from $21,146 to $101,518 over the same period. Compared to phototherapy alone, ASCS plus phototherapy incurred $7,030 more total per-patient cumulative costs in Year-1 and $8,738 less by Year-5 (-$146 PMPM; -$1,748 PPPY). Breakeven occurred between Years 2-3. Results were most sensitive to changes in ASCS response at Weeks-24 and 52 and healthcare costs.

CONCLUSION: Among adults with stable vitiligo with prior inadequate response to topicals or phototherapy, ASCS treatment may lead to lower all-cause direct medical costs over 5 years compared to phototherapy alone.

INTRODUCTION: Allergists and dermatologists often take different approaches to caring for pediatric patients with atopic dermatitis (AD).

METHODS: A retrospective chart review was performed on patients < 18 years old treated for AD within the University of Virginia health system from 2015 to 2020. Data were collected on patient and referring provider demographics as well as initial visit evaluation and management.

RESULTS: A total of 269 patients presented to allergy, 685 patients presented to dermatology, and 14 patients presented to a combined allergy-dermatology clinic as an initial visit with a primary diagnosis of AD. Both specialties were most often referred to by a generalist though dermatology received more specialty provider referrals. In addition, allergy ordered more diagnostic testing (IgE, allergens, complete blood count), while dermatology prescribed more medications (topical corticosteroids, topical calcineurin inhibitors, immunosuppressants). Patients seen in the combined dermatology-allergy clinic were more likely to receive diagnostic testing than patients seen in dermatology clinic and were more likely to be prescribed medications than patients seen in allergy clinic.

CONCLUSIONS: Our findings suggest allergists may focus more on identifying triggers of AD, while dermatologists largely focus on the prescription of therapies. Clinical care may be more comprehensive when allergists and dermatologists work synergistically.

PURPOSE: Vitiligo often affects quality of life and psychosocial well-being. This analysis of the population-based global Vitiligo and Life Impact Among International Communities (VALIANT) study sought to understand the impact of vitiligo on depression and depressive symptoms from the patient perspective.

MATERIALS AND METHODS: The cross-sectional survey collected information on patient demographics, clinical characteristics, mental health diagnoses, and depressive symptoms (assessed using the Patient Health Questionnaire-Depression screener [PHQ-9]) among recruited patients who reported a vitiligo diagnosis.

RESULTS: Of 3541 VALIANT respondents, 24.5% reported formal diagnosis of depression, and 55.0% reported moderate-to-severe symptoms of depression per the PHQ-9. Rates of formally diagnosed depression and moderate-to-severe depressive symptoms were significantly higher in younger patients, those with Fitzpatrick skin types IV-VI (i.e. darker skin), >5% affected body surface area, hand or face involvement, and those receiving mental healthcare versus their counterparts (all p <  0.0001). Interestingly, moderate-to-severe depressive symptoms were more common among patients with shorter disease duration (≤2 vs 3-9 and ≥ 10 years; p <  0.01), but there was no correlation between diagnosed depression and disease duration.

CONCLUSIONS: These VALIANT study findings highlight that depression may be common but often undiagnosed among patients with vitiligo, reinforcing the importance of an improved and multifaceted approach to vitiligo management.

Purpose: Provide insights into the incidence, pre-sentation and management of follicular events and contact dermatitis in patients with plaque psoriasis or atopic dermatitis (AD) treated with tapinarof cream 1%.

Materials and methods: Key clinical trial publications for tapinarof were reviewed and augmented with the authors' opinions based on real-world clinical experience.

Results: In the PSOARING and ADORING trials, discontinuation rates due to follicular events and contact dermatitis were low and most patients did not require dose modifications or treatment interruptions. In our experience, which includes the use of tapinarof in combination with other agents, tapinarof is generally well tolerated and if events of folliculitis or contact dermatitis occur, patients can be advised to temporarily discontinue application on affected sites until the event resolves, continuing application to other affected areas and body regions. Education on the correct application of tapinarof is important in the management of psoriasis and AD.

Conclusions: Tapinarof is a novel topical treatment option for adults with plaque psoriasis and patients with AD, with no restrictions regarding application sites and duration of use. Follicular events and contact dermatitis associated with tapinarof treatment are generally mild and self-limiting and rarely interfere with therapy.

Clinicaltrials.gov numbers: NCT05014568, NCT05032859, NCT05142774, NCT03956355, NCT03983980, NCT04053387.

INTRODUCTION: Vitiligo is a chronic autoimmune disease characterized by destruction of pigment-producing melanocytes in the skin. This study explores the patient and treatment history of vitiligo and associated mental health burden in EU5 countries.

METHODS: The cross-sectional global Vitiligo and Life Impact Among International Communities (VALIANT) study recruited people with vitiligo via an online panel and surveyed them regarding clinical characteristics, vitiligo treatment, quality of life (QoL), and mental health.

RESULTS: A total of 1151 patients were surveyed in EU5 countries (France, n = 250; Germany, n = 250; Italy, n = 200; Spain, n = 200; UK, n = 251). Half of patients (50.3%) reported a family history of vitiligo, with highest rates in France (66.4%) and Germany (58.8%). Many patients experienced flares during periods of stress (65.1%) or itching before/during a flare (61.5%), with highest rates in Germany (78.4%/78.8%, respectively; P <  0.01 vs all). German patients used the greatest mean number of vitiligo treatments (6.5; P <  0.0001 vs all), and French patients reported the highest rates of current non-treatment (20.8%; P <  0.05 vs Germany). Half of patients (53.9%) reported frequently hiding their vitiligo lesions, with highest rates in Germany (60.4%) and France (58.4%; both P <  0.05 vs Italy/Spain). German and French patients also reported highest disease burden (P <  0.05 vs Italy/Spain/UK). Over half (58.3%) of patients reported diagnosed mental health conditions (anxiety [26.5%]; depression [23.4%]). Rates of moderate to severe depressive symptoms were highest in Germany (64.8%; P <  0.05 vs all).

CONCLUSION: Among EU5 countries, patients from Germany and France generally reported higher burden than those from Italy, Spain, or the UK, although the impact of vitiligo on these patients cannot be discounted. Patients reported flares during periods of stress and great impact of vitiligo on their QoL and mental health. There is continued need for improved management strategies for patients with vitiligo, including the reduction of QoL and mental health burden.

INTRODUCTION: The tralokinumab pre-filled pen was developed to improve patient convenience and deliver 300 mg tralokinumab (the recommended dose for most patients) with one injection. This study evaluated the efficacy, safety, and usability of the tralokinumab pre-filled pen autoinjector in patients with moderate-to-severe atopic dermatitis.

METHODS: This 16-week, open-label, single-arm phase 3 study enrolled patients ≥ 12 years with Investigator's Global Assessment (IGA) score ≥ 3 and Eczema Area and Severity Index (EASI) ≥ 12. Patients received tralokinumab 300 mg via self-administered pre-filled pen every 2 weeks for 16 weeks. The primary endpoints were IGA 0/1 and ≥ 75% improvement in EASI (EASI-75) at week 16. Safety was assessed as the number of adverse events from baseline to week 16.

RESULTS: At week 16, 28.7% (39/136) of patients achieved IGA 0/1 (28.6% [30/105] adults; 29.0% [9/31] adolescents) and 43.4% (59/136) of patients achieved EASI-75 (44.8% [47/105] adults; 38.7% [12/31] adolescents). The tralokinumab pre-filled pen was well tolerated, and the observed safety profile was comparable to the safety profile with the tralokinumab pre-filled syringe.

CONCLUSIONS: Tralokinumab formulated as a pre-filled pen was effective, well tolerated, and easy to use. The tralokinumab pre-filled pen may offer a more convenient method of tralokinumab administration with fewer injections per dose.

TRIAL REGISTRATION: ClinicalTrials.gov identifier, NCT05194540.

INTRODUCTION: Psoriasis body surface area (BSA) of 10% or more has been a major criterion for determining systemic therapy eligibility. However, patients with BSA <  10% and even ≤ 3% may have high disease burden and difficulties accessing biologics. To assess psoriasis burden among patients with BSA ≤ 10%, this study characterized patient-reported outcomes (PROs) across BSA categories among systemic treatment-naïve patients initiating biologic therapy.

METHODS: Patients from the CorEvitas Psoriasis Registry initiating biologics between April 2015 and September 2023 were categorized according to low (<  3%), medium (3-10%), or high (> 10%) BSA involvement. Measures assessed at initiation of biologic therapy included health-related quality of life, itch, pain, fatigue, psoriatic arthritis, psoriasis disease characteristics, and medical history. Overlap between BSA groups for each outcome was calculated via non-parametric Mann-Whitney statistic transformation (range 0.0-1.0; 0.5 indicates complete similarity [i.e., for a comparison between low and high BSA groups, overlap of 0.5 means there is 50% probability that a randomly selected patient with low BSA would have the same or greater PRO burden as one with high BSA]; 0 or 1 indicates complete dissimilarity) to determine whether each measure differed in randomly selected patients with low or medium versus high BSA.

RESULTS: Of 1640 patients who initiated biologics, 7.0% had low BSA, 46.9% had medium BSA, and 46.2% had high BSA involvement. PRO overlap statistics ranged from 0.52 to 0.59 and from 0.60 to 0.70 for randomly selected patients with high versus medium and low BSA, respectively, indicating patients with high and medium BSA are likely to have similar levels of disease burden, and patients with high BSA are slightly more likely to have higher disease burden than those with low BSA. Near complete overlap (range 0.44-0.58) was observed for psoriasis disease characteristics and medical history in the low versus high and medium BSA groups.

CONCLUSION: Observed overlap in PROs across BSA categories shows that patients with low BSA can experience similarly poor quality of life and high symptom burden to those with higher BSA. These findings support the appropriateness of considering biologic therapies for patients with low BSA and indicators of high disease burden.

TRIAL REGISTRATION: ClinicalTrials.gov: NCT02707341.

This case describes a woman with a decades-long history of misdiagnosed eczematous dermatitis ultimately identified as subcorneal pustular dermatosis (SPD), a rare neutrophilic dermatosis. Initially treated unsuccessfully for presumed atopic dermatitis and prurigo nodularis with various immunomodulatory agents, including dupilumab and Janus kinase (JAK) inhibitors, the correct diagnosis was made only after the appearance of characteristic flaccid pustules in intertriginous areas. Histopathological analysis confirmed SPD, and following intolerance to initial treatment with dapsone, the patient experienced a dramatic and sustained clinical improvement with infliximab. This case highlights the diagnostic challenges posed by atypical presentations of SPD and supports the use of tumour necrosis factor-alpha (TNFα) inhibitors as a highly effective treatment option.

Objectives: To quantify treatment priorities and unmet need among adults and adolescents with vitiligo in the United States (US). Methods: An adaptive self-explicated preference-elicitation survey was administered to adults (age ≥18 years) and adolescents (age 12-17 years) with non-segmental vitiligo. The preference-elicitation included 26 attributes related to treatment efficacy, safety, and mode of administration. Relative importance (RI) of each attribute was estimated using latent class analysis (LCA). Satisfaction with the 10 most important attributes for each patient was elicited using rating scales. RI and satisfaction were combined to estimate unmet need using a modified outcome-driven innovation approach which defines unmet need as high RI combined with low satisfaction. Results: The sample comprised adults (N=321) and adolescents (N-201) who received vitiligo care from 83 sites across the US. They had a mean (SD) age of 26 (9.1) and 14 (1.6) years, respectively. More than 50% of participants self-identified as non-White; 50% were female. Fitzpatrick skin types were 23.9% Type I-II (pale white, fair), 43.6% III-IV (darker white, light brown), and 32.4% V-VI (brown, black). LCA identified three preference segments: Efficacy (N=182,34.9%), most important attributes were amount of repigmentation on the entire body (RI=5.16) and reducing the emotional burden of vitiligo (RI=5.00); Mode of Administration (MOA) (N=159,30.5%), most important attributes were having an oral (RI=4.80), systemic (RI=5.03) treatment; Safety (N=181,34.7%), most important attributes were avoiding cardiovascular events (RI=4.53), cancer (RI=4.38), or shingles (RI=4.42). Among the full sample, the greatest areas of unmet need were reducing the emotional burden of vitiligo and having access to an oral systemic (rather than topical) treatment. Conclusions: Treatment preferences among people with vitiligo are heterogeneous. In addition to repigmentation, reducing the emotional burden of vitiligo is a key treatment goal for patients. An effective oral systemic treatment could help address unmet need in this patient population.

Background: Acne-induced post-inflammatory hyperpigmentation (PIH) is a common, long-lasting sequela of acne with a significant psychosocial impact. To assess its impact on sufferers, interviews were conducted in a phase IV study of trifarotene treatment of acne and PIH. Methods: Cross-sectional blinded qualitative interviews as a sub-study of a 6-month phase IV randomized controlled study of patients (n=123) with acne and moderate-to-marked PIH treated with trifarotene or vehicle. Semi-structured interviews conducted by trained interviewers with patients (n=30, 18-34 y). Results: Patients had a mean age of 24.8 years, 73.3% had Fitzpatrick skin types IV-VI, and 40% (12/30) were treated with trifarotene. More than half (60%) rated their PIH severity at ≥7 at study entry, and 57% said PIH disturbed their daily life at a level of 7 (0=no disturbance to 10=worst disturbance). Improvement in PIH was reported by 100% of the trifarotene group vs 83% in the vehicle group and those in the trifarotene group had a greater reduction in self-reported PIH severity (-5.5 vs -3.5 vehicle). Patients reported lack of treatment success with prior treatments but noticeable improvements in uniformity of skin color during this study: “my skin got brighter, lighter, the dark spots have faded,” and “at first it was very, very noticeable … it just faded.” Other patients reported increased self-confidence and reduced reliance on makeup and lengthy cover-up daily routines. AEs were more common with vehicle vs trifarotene (30.2% vs 16.7%). Conclusions: Patients described noticeable and meaningful changes in the appearance of PIH and daily life impacts.

Background: Trifarotene belongs to a new generation of topical retinoids for acne. Data indicate multiple mechanisms through which trifarotene may interrupt acne pathogenesis and improve acne-related scarring and pigmentation. Acne sequelae impact patients’ lives and frequently outlast the causative acne lesion. Thus, treatment addressing both acne lesions and sequelae is likely to improve long-term outcomes. Methods: Two vehicle-controlled, 24-week phase 4 studies evaluated trifarotene treatment (with appropriate skin care regimen) and 1) atrophic acne scarring and 2) acne-related hyperpigmentation. The scarring study (Study 1) utilized a split-face design (N = 121) while the pigmentation study (Study 2) randomized patients 1:1 to active or vehicle arms (N = 123). Results: In study 1, trifarotene treatment resulted in significant improvement in scar counts, with differences from vehicle apparent as early as week 2 (W2) and progressively improving through W24. There was also a significant difference between trifarotene and vehicle in scar global assessment (SGA) success from W12 through W24. Study 2 enrolled a diverse population of patients with a range of skin tones. In study 2, trifarotene treatment accelerated pigment reduction at week 12 vs vehicle. Active and vehicle were similar at week 24. Although not a defined study endpoint, reduction in macular erythema was also observed. Trifarotene was well tolerated in both studies, with tolerability scores higher than vehicle but mild in severity. Conclusions: Management of atrophic acne scarring and hyperpigmentation is an important consideration in acne therapy. Trifarotene achieved rapid improvements in these acne sequelae along with efficacious acne control.

Background: Acne is highly visible andone of the most common skin diseases. Healthcare professionals should have a reliable first-line approach that is efficacious and suited for a broad range of patient skin types, ages, and demographics. Methods: Including the Phase 3 program, trifarotene has been studied in thousands of acne subjects in clinical trials. Most recently two vehicle-controlled, 24-week phase 4 studies evaluated trifarotene treatment of acne and 1) atrophic acne scarring (4-1) and 2) acne-related hyperpigmentation (4-2). The scarring study 4-1) utilized a split-face design (N = 121) while the pigmentation study (Phase4-2) randomized subjects 1:1 to active or vehicle arms (N = 123). Results: The studies were international, with men and women in the studies ranging from 9 to 58 years of age. The phase 3 studies were majority White, but included substantial diversity, including 74 Black/African-American and 195 Latino subjects treated with trifarotene. In 4-2 <50% of subjects were White. Additionally, 30.6% of subjects in 4-1 and 61.7% of subjects in 4-2 had type IV-VI skin. Approximately 35% of subjects in 4-1 and 2 identified as Hispanic/Latino. In Study 2, 18.2% of subjects in the trifarotene group were Asian. In all studies, trifarotene was significantly superior to vehicle in improving acne. In 4-1, trifarotene rapidly improved atrophic acne scars and in 4-2 trifarotene reduced hyperpigmentation. In all studies, trifarotene had a positive risk/benefit ratio. Conclusions: Across a broad range of subject types, trifarotene had good efficacy for improving acne, atrophic scars, and hyperpigmentation, and safety.

Background: Atopic dermatitis (AD), a highly pruritic inflammatory skin disease, typically begins in childhood and affects up to 23% of children globally. Ruxolitinib cream was effective and well tolerated in adults/adolescents (TRuE-AD1/TRuE-AD2 [NCT03745638/NCT03745651]) and children 2–<12 years old (y/o; TRuE-AD3 [NCT04921969]). Here, efficacy by baseline clinical characteristics in children 2–<12 y/o enrolled in TRuE-AD3 is reported. Methods: Patients 2–<12 y/o with AD for ≥3 months, Investigator’s Global Assessment (IGA) score of 2/3, and 3%–20% affected body surface area (BSA) were randomized (2:2:1) to apply twice-daily ruxolitinib cream (0.75%/1.5%) or vehicle for 8 weeks. Results: Patients 2–<12 y/o (N=330) had a median (range) age of 6 (2–11) years; AD duration, 4.8 (0.3–11.3) years; mean (SD) affected BSA was 10.5% (5.40%). At Week 8, 49/134 (36.6%) children applying 0.75% ruxolitinib cream and 74/131 (56.5%) applying 1.5% ruxolitinib cream vs 7/65 (10.8%) applying vehicle achieved IGA treatment success (IGA-TS; score 0/1 with ≥2-grade improvement from baseline); 69/134 (51.5%) and 88/131 (67.2%) vs 10/65 (15.4%) achieved ≥75% improvement in Eczema Area and Severity Index (EASI75), respectively. IGA-TS was observed regardless of baseline AD severity measure. For IGA-TS: IGA score of 2 and 3, 32.3%/48.4% vs 0% and 37.9%/59.0% vs 14.3%, respectively; EASI score ≤7 and >7, 41.7%/58.8% vs 17.2% and 30.6%/55.0% vs 5.6%. Ruxolitinib cream was well tolerated; no serious treatment-emergent adverse events were reported. Conclusions: Ruxolitinib cream is a well-tolerated and effective treatment for AD in children 2–<12 y/o, independent of baseline clinical characteristics.

Introduction: High frequency ultrasound (HFU) has been shown to be useful for Hidradenitis Suppurativa (HS) evaluation along with physical examination.1 Sonographic features of HS include dermal thickening, widening of hair follicles, anechoic or hypoechoic fluid deposits and fistulous tracts.2,3 Pre-surgical margin mapping with HFU, prior to CO2 laser surgery – an effective treatment for HS, may reduce recurrence rates; however, there is little existing literature on margin mapping methodology.4 Methods: This work describes methodology for HFU margin mapping of HS lesions prior to CO2 laser surgery. Results: Unlike traditional US imaging, skin imaging requires utilization of transducers with high frequency (15 MHz and above). A 1-2 mm gel bed is required for better visualization of changes in superficial features.5 For margin mapping, dermal thickening was found to be the most relevant HFU feature of HS. Skin marker was used to mark the border at the transition point between normal and thickened dermis every 1-2 cm around the HS lesion to demarcate the area of excision. Isolated lesions within 2-3 cm on the surrounding skin were evaluated for the presence of any sinus tracts connecting them to the main lesion as that would impact the area to be excised. Conclusion: Change in dermal thickening was the most pertinent HFU feature of HS when performing preoperative margin mapping. Future studies are needed to evaluate if preoperative margin mapping of HS lesions with HFU correlates with lower recurrence rates.

Introduction: Hidradenitis suppurativa (HS), a chronic, systemic inflammatory skin disease characterized by deep, painful, and difficult-to-treat lesions, often requires rescue interventions alongside conventional treatment.[1] Here, we investigate the impact of bimekizumab (BKZ), a monoclonal IgG1 antibody that inhibits interleukin (IL)-17F and IL-17A, on the need for concomitant rescue interventions in patients with moderate to severe HS. Methods: We report pooled, post hoc analysis from the initial treatment period (Weeks 0–16) of the BE HEARD I&II trials.[2,3] Adult patients with moderate to severe HS were randomized to BKZ (320mg every 2 weeks [Q2W] or Q4W) or placebo (PBO). The incidence of concomitant rescue interventions for HS, including medical (antibiotics, analgesics) and procedural (incision/drainage, intralesional triamcinolone injection), and time to first procedural intervention, are reported. Results: Overall, 1,014 patients were randomized to BKZ (n=868) or PBO (n=146) across BE HEARD I&II. In BKZ-treated and PBO-treated patients, 4.1% (n=36) and 8.9% (n=13) received ≥1 rescue analgesic; 4.0% (n=35) and 5.5% (n=8), received ≥1 rescue systemic antibiotic. Incidence of ≥1 incision/drainage intervention was 2.1% (n=18) in BKZ-treated and 3.4% (n=5) in PBO-treated patients; 1.6% BKZ-treated (n=14) and 3.4% PBO-treated (n=5) received ≥1 intralesional triamcinolone injection. Time to first procedural intervention was 65.3±36.2 (mean days±standard deviation) in BKZ-treated and 30.4±17.0 in PBO-treated patients. Conclusions: Over 16 weeks, the incidence of concomitant interventions for HS was low in BKZ-treated patients; low levels of rescue analgesic use in BKZ-treated patients may indicate reduced pain burden. Time to first procedure was numerically longer for BKZ- versus PBO-treated patients.

Roflumilast is a nonsteroidal, highly potent phosphodiesterase 4 inhibitor developed as once-daily cream and foam formulations being studied in patients for long-term treatment of atopic dermatitis and seborrheic dermatitis (SD). Roflumilast cream 0.3% is approved as a once-daily, nonsteroidal cream for patients with chronic plaque psoriasis, including sensitive areas such as intertriginous, face, and genital areas. Efficacy and safety of once-daily roflumilast foam 0.3% in patients ≥9 years old with at least moderate SD from this phase 3 randomized controlled trial (NCT04973228) were reported previously. Roflumilast foam 0.3% (n=304) demonstrated statistically significant improvements in efficacy compared with vehicle (n=153) with low rates of adverse events, which were similar between treatment groups. Here we report the patient-reported outcomes: Worst Itch Numeric Rating Scale (WI-NRS), Scalpdex, and Dermatology Life Quality Index (DLQI)/Children’s DLQI (CDLQI), and local tolerability. Among patients with baseline WI-NRS score ≥2, more roflumilast-treated than vehicle-treated achieved WI-NRS score 0/1 at Week 8 (70.7% vs. 52.9%; P=0.0085), with improvements in itch compared to vehicle as early as 48 hours after first treatment (mean percent change from baseline [CfB]: -27.87% vs. -13.11%; nominal P=0.0024). Roflumilast-treated patients reported greater improvements in least squares (LS) mean CfB DLQI score (-3.8 vs. -2.7; nominal P<0.001), while those with scalp involvement, had greater improvements in LS mean CfB Scalpdex score (-23.21 vs. -15.42; nominal P<0.001) at Week 8. Local tolerability and safety were favorable. Treatment with once-daily roflumilast foam 0.3% reduced pruritus and improved quality of life with favorable tolerability. Sponsored by Arcutis Biotherapeutics, Inc.

Tapinarof cream 1% once daily (QD) demonstrated significant efficacy versus vehicle and was well-tolerated in adults and children down to 2 years of age with moderate to severe atopic dermatitis (AD) in two pivotal phase 3 trials (ADORING 1 and 2). Here, we present baseline characteristics and outcomes from the prespecified interim analysis of ADORING 3, the long-term extension trial assessing safety and efficacy of up to 48-weeks’ open-label tapinarof. 728 patients enrolled in ADORING 3, representing a large, diverse AD population comprising a high proportion (91%) of eligible patients from the pivotal ADORING trials, 28 patients from a 4-week maximal usage pharmacokinetic trial, and an additional 76 tapinarof-naive patients aged 2-17 years with various disease severities (mild; or moderate or worse with body surface area [BSA] ≥40%), who were ineligible for preceding trials. The majority of patients in ADORING 3 were pediatric; 26.6% were aged 2-6 years; 27.1% 7-11 years; 29.3% 12-17 years; and 17.0% were adults. Overall, 46.6% were male, 52.6% White, 11.1% Asian, 30.1% Black/African American, and 4.4% other race categories. Patients with AD present different phenotypes and treatment responses. A high proportion of primarily pediatric patients elected to rollover from previous trials, and the diverse population enrolled in ADORING 3 is representative across the broad spectrum of disease severity, BSA affected (up to 95%), and demographics. No new safety signals were reported with long-term treatment in this interim analysis. The full analysis in 2024 will report further safety and efficacy data with tapinarof cream 1% QD.

Introduction: New topical treatments were recently FDA approved for patients with plaque psoriasis. This study was designed to assess the effect of education on knowledge, competence, and confidence regarding new topical psoriasis treatments. Methods: Dermatologists (n= 76) participated in an online CME activity that featured video with synchronized slides. A repeated-pair design with pre/post-assessment including 3 multiple choice questions that assessed knowledge or competence and one confidence assessment question assess effectiveness, with each participant serving as his/her own control. A McNemar’s test was conducted to assess question level statistical significance (P <.05). The activity launched 3/10/23 and data were collected approximately 60 days post-launch. Data are presented as %improved (%pre/%post) correct responses. Results are presented by learning theme. New Topical Psoriasis Treatments: • 11% improved (58%/54%; P = NS) change in knowledge regarding calcipotriene/ betamethasone data • 34% increase in confidence in identifying patients who would benefit from new topical psoriasis treatments Psoriasis in Sensitive Areas: • 18% (49%/63%) increase in knowledge about the suitability of roflumilast in difficult to treat areas Psoriasis in Patients with Skin of Color: • 18% improved (53%/67%) competence in counseling patients with diverse skin tones on pigmentary changes associated with healing psoriasis. Discussion: Online CME resulted in improved knowledge, competence, and confidence among dermatologists regarding new topical psoriasis treatments. Baseline and post-education results suggest that there are remaining gaps regarding new topical treatments, managing psoriasis in difficult areas, and in treating psoriasis in patients with diverse skin tones.