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: A low-dose modified formulation of minocycline hydrochloride, DFD-29, is under evaluation for treating papulopustular rosacea (PPR).

OBJECTIVE: To determine the efficacy and safety of DFD-29, 40 mg, compared with doxycycline, 40 mg, and placebo for treating PPR.

DESIGN, SETTING, AND PARTICIPANTS: This study included data from 2 double-blind, placebo-controlled, phase 3 randomized clinical trials (MVOR-1 and MVOR-2) conducted between March 2022 and May 2023 at 61 centers in the US and Germany. Healthy adults 18 years and older with moderate to severe PPR were included.

INTERVENTIONS: Participants were randomized 3:3:2 to oral DFD-29 (minocycline hydrochloride capsules), 40 mg; doxycycline, 40 mg; or placebo once daily for 16 weeks.

MAIN OUTCOMES AND MEASURES: The coprimary efficacy outcomes were (1) proportion of participants with Investigator's Global Assessment (IGA) treatment success with DFD-29 vs placebo and (2) total inflammatory lesion count reductions with DFD-29 vs placebo. Secondary outcomes included comparisons between DFD-29 and doxycycline in coprimary outcomes and between DFD-29 and placebo in erythema reduction.

RESULTS: Of 653 participants enrolled, 323 were randomized in MVOR-1 (247 [76.5%] women; mean [SD] age, 47.2 [13.7] years) and 330 were randomized in MVOR-2 (249 [75.5%] women; mean [SD] age, 51.6 [14.0] years). DFD-29 demonstrated superior efficacy in IGA success rates compared with placebo (MVOR-1: treatment difference [TD], 32.9%; 95% CI, 19.6-46.2; P <  .001; MVOR-2: TD, 34.1%; 95% CI, 21.3-46.8; P <  .001) and compared with doxycycline (MVOR-1: TD, 18.0%; 95% CI, 5.0-31.1; P = .01; MVOR-2: TD, 28.3%; 95% CI, 17.4-39.3; P <  .001). DFD-29 also showed superior efficacy in least-squares mean reductions in total inflammatory lesions vs placebo (MVOR-1: TD, -9.2; 95% CI, -11.5 to -6.9; P <  .001; MVOR-2: TD, -6.8; 95% CI, -8.9 to -4.8; P <  .001) and doxycycline (MVOR-1: TD, -4.7; 95% CI, -6.7 to -2.8; P <  .001; MVOR-2: TD, -3.5; 95% CI, -5.4 to -1.6; P <  .001). Adverse events with DFD-29, doxycycline, and placebo were reported in 32 of 121 (26.4%), 25 of 116 (21.6%), and 27 of 76 (35.5%), respectively, in MVOR-1 and 51 of 122 (41.8%), 40 of 121 (33.1%), and 30 of 82 (36.6%), respectively, in MVOR-2. The most common adverse events with DFD-29, doxycycline, and placebo were nasopharyngitis, reported in 4 of 121 (3.3%), 2 of 116 (1.7%), and 3 of 76 (3.9%), respectively, in MVOR-1 and 13 of 122 (10.7%), 10 of 121 (8.3%), and 13 of 82 (15.9%), respectively, in MVOR-2, and COVID-19, reported in 4 of 121 (3.3%), 3 of 116 (2.6%), and 4 of 76 (5.3%) in MVOR-1 and 7 of 122 (5.7%), 8 of 121 (6.6%), and 5 of 82 (6.1%) in MVOR-2.

CONCLUSIONS AND RELEVANCE: In this study, DFD-29 was superior in efficacy to both doxycycline and placebo and demonstrated a favorable risk-benefit profile in the treatment of PPR.

TRIAL REGISTRATION: ClinicalTrials.gov Identifiers: NCT05296629 and NCT05343455.

BACKGROUND: Abrocitinib has a manageable long-term safety profile for patients with moderate-to-severe atopic dermatitis. Identifying populations at higher risk of adverse events will help optimize dose selection.

OBJECTIVE: To evaluate abrocitinib long-term safety by age.

METHODS: Data (cutoff: September 25, 2021) from JADE clinical trials were pooled in a consistent-dose cohort (patients who received the same abrocitinib dose throughout exposure) or a variable-dose cohort (patients who received abrocitinib 200 mg [12 wk], were randomly assigned later to receive abrocitinib 200 mg, 100 mg, or placebo [up to 40 wk], and assigned to receive abrocitinib 200 mg or 100 mg in the long-term study). Data were stratified post hoc by age at baseline (12 to < 18 y; 18 to < 40 y, 40 to < 65 y, and ≥65 y). Incidence rates of treatment-emergent adverse events (TEAEs) of special interest were assessed.

RESULTS: Analysis included 3,802 patients (exposure: 5,214 patient-years). The incidence rates for serious adverse events, TEAEs leading to study discontinuation, serious infections, herpes zoster, thrombocytopenia, lymphopenia, nonmelanoma skin cancer, malignancies (excluding nonmelanoma skin cancer), major cardiovascular events, and venous thromboembolism were numerically higher in patients aged 65 years or older than in younger patients. Overall, adolescents had the lowest rates for TEAEs of special interest.

CONCLUSIONS: Abrocitinib has a manageable long-term safety profile. TEAEs of special interest were lower in adolescents and higher in the 65-years-old or older age group. Risk of specific TEAEs was numerically higher in patients aged 65 years or older treated with abrocitinib 200 mg and underscores the importance of dose selection in older patients.

INTRODUCTION: Deucravacitinib, an oral, selective, allosteric tyrosine kinase 2 inhibitor, is approved in the USA and other countries for treatment of adults with moderate to severe plaque psoriasis who are candidates for systemic therapy. In POETYK PSO-1 and PSO-2, deucravacitinib was superior to placebo and apremilast and well tolerated in patients with plaque psoriasis. Patients who completed PSO-1/PSO-2 could enroll in the POETYK long-term extension (LTE) trial. This analysis evaluates the effects of deucravacitinib on laboratory parameters.

METHODS: POETYK PSO-1 and PSO-2 were 52-week, phase 3, double-blinded trials that randomized patients 1:2:1 to placebo, deucravacitinib 6 mg once daily, or apremilast 30 mg twice daily. At week 52, eligible patients enrolled in POETYK LTE and received open-label deucravacitinib. Mean changes from baseline in laboratory parameters, laboratory adverse events (AEs), and laboratory AEs resulting in discontinuation were evaluated over 3 years.

RESULTS: A total of 1519 patients received one or more doses of deucravacitinib across trials. Total exposure over 3 years was 3294.3 person-years. No clinically relevant mean changes were observed in laboratory parameters. Grade ≥ 3 laboratory AEs were infrequent during the 1-year period, with incidence rates remaining stable in patients treated with deucravacitinib through 3 years. Most laboratory AEs remained at the same grade; shifts to higher grades were infrequent, with most increases being to grade ≤ 2. Discontinuations due to laboratory AEs were rare.

CONCLUSIONS: Deucravacitinib did not result in clinically meaningful changes in laboratory parameters over 3 years, including changes seen with Janus kinase (JAK) 1,2,3 inhibitors. Grade ≥ 3 laboratory AEs and discontinuations were rare.

TRIAL REGISTRATION: ClinicalTrials.gov identifier, POETYK PSO-1 (NCT03624127), POETYK PSO-2 (NCT03611751), POETYK LTE (NCT04036435).

INTRODUCTION: The mental health burden associated with vitiligo can significantly impact patients' quality-of-life. Although successful for repigmentation of stable vitiligo, adoption of surgical melanocyte transplantation remains limited due to time and skilled-expertise requirements. A cell harvesting device prepares autologous skin cell suspension (ASCS) at point of care, simplifying the process.

OBJECTIVE: To confirm early and favorable repigmentation response and evaluate health-related quality-of-life changes following ASCS treatment of stable vitiligo.

METHODS: In this large (N = 107), prospective, multicenter study, vitiligo lesions were laser-ablated and received ASCS treatment followed by at-home phototherapy.

RESULTS: All Fitzpatrick skin types and major vitiligo subtypes were represented. Excellent repigmentation response (≥80%) was observed by week 4. By week-24, all lesions demonstrated improvement; 67% achieved >50% repigmentation, 42% achieved ≥80% repigmentation, and 8% achieved complete repigmentation. Vitiligo Noticeability Scale response was attained by 27.7% of lesions; 72.3% of patients reported treatment satisfaction. Significant improvement from baseline in Vitiligo Quality-of-Life Instrument (P < .05) was observed at week-24.

LIMITATIONS: No control.

CONCLUSIONS: The cell harvesting device provides a simplified, more accessible technique for melanocyte transplantation. ASCS is highly effective for repigmentation of stable vitiligo lesions, with positive patient-reported outcomes and improvement in quality-of-life, as demonstrated in this large, diverse population.

INTRODUCTION: Clindamycin phosphate 1.2%/adapalene 0.15%/benzoyl peroxide 3.1% (CAB) gel is the only fixed-dose, triple-combination approved for acne. In phase 2 and 3 studies, CAB demonstrated superior efficacy to vehicle and component dyads. This post hoc analysis examined efficacy/tolerability of CAB in 147 self-identified Hispanic/Latino participants (referred to as Hispanic).

METHODS: Data were pooled from one phase 2 (NCT03170388) and two phase 3 (NCT04214652, NCT04214639) double-blind, 12-week studies. Eligible participants aged ≥9 years with moderate to severe acne were randomized to once-daily CAB or vehicle. Endpoints included ≥2-grade reduction from baseline in Evaluator's Global Severity Score with clear/almost clear skin (treatment success) and inflammatory/noninflammatory lesion counts. Treatment-emergent adverse events (TEAEs) were assessed.

RESULTS: At week 12, 56.2% of CAB-treated participants achieved treatment success vs 18.4% with vehicle (p <  0.001). Reductions in inflammatory/noninflammatory lesions were 77.1%/76.2% with CAB vs 56.4%/45.0% with vehicle, respectively (p <  0.001, all). CAB TEAE rates were similar to overall study populations (27.0% vs 24.6%-36.2%). Baseline hyperpigmentation scores decreased from 0.6 to 0.3 (1 = mild) at week 12 with CAB. CAB gel was efficacious, safe, and well tolerated in Hispanic participants. Limitations include lack of Fitzpatrick skin phototype and short study duration.

CONCLUSIONS: This study provides support for acne treatment with CAB in ethnically diverse populations.

OBJECTIVE: To evaluate the awareness of and attitudes toward various aspects of sun-exposure risks and protection methods among Canadians.

METHODS: An online survey conducted from September 28 to October 18, 2021, included 17,001 participants aged 18 years and above from 17 countries across 5 continents; the data presented are those of the Canadian population (n = 1,000). The survey focused on demographics, sun-exposure habits, comprehension of risks, and knowledge of photoprotection. The results were analyzed using descriptive statistics to identify prevalent trends and discrepancies in sun-protective behaviours among Canadians.

RESULTS: The majority of Canadian respondents (93%) acknowledged the health risks associated with sun exposure. While 81% of Canadians reported using some form of sun protection, only 10% systematically implemented all recommended protective measures, highlighting a gap in knowledge translation. Misconceptions regarding the safety of tanned skin and the effectiveness of sunscreens were widespread, particularly in younger demographics and in individuals with darker skin. Knowledge and preventive behaviours were markedly better among individuals who regularly consult dermatologists.

CONCLUSIONS: This study highlights general awareness of sun-protective behaviours but a lack of universal and comprehensive implementation among Canadians. Given the knowledge gaps in younger demographics and darker skin phototypes, targeted educational initiatives are essential to correct prevalent misconceptions about sun exposure and tanned skin. Dermatologists and other health care professionals can play a pivotal role in education and primary prevention strategies for skin cancer and other sun-related comorbidities.

BACKGROUND: Ostomates suffer from multiple comorbidities and social stigma, which can be especially debilitating in young patients. TikTok has become a popular platform for this population to establish a community and gain resources. This study aims to characterize intestinal ostomy videos on TikTok.

METHODS: The top 50 videos for search terms "ileostomy," "colostomy," "ostomy," and "stoma" were queried on TikTok. Information was compiled regarding the videos' creators, content type, overall sentiment, and viewer engagement.

RESULTS: A total of 113 videos amongst 38 creators garnered 52,021,700 likes and 370,983 comments. Most videos focused on education (45.5%) and personal stories (22.7%). Creators were predominantly young females (82.0%), with minimal input from healthcare professionals (3% of videos). Sixty-nine (61%) of videos had responses with further questions.

CONCLUSIONS: Our study reveals a gap between interest and availability of professional educational material regarding intestinal ostomies. Addressing this deficiency may improve patient acceptance, bystander understanding, and its negative stigma.

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.