34039 Maintenance of skin clearance in a long-term open-label study of fixed-combination halobetasol propionate and tazarotene lotion for psoriasis in participants with prior use of topical treatments

Background: Most patients with psoriasis are dissatisfied with their current treatment, primarily because of limited effectiveness. This post hoc subgroup analysis evaluated long-term efficacy and safety of fixed-combination halobetasol propionate (0.01%) and tazarotene (0.045%) lotion (HP/TAZ) in participants with use of topical corticosteroid (TCS; 137/550 [24.9%]) or other antipsoriatic topical medications (51/550 [9.3%]) before entry in an open-label study of HP/TAZ (NCT02462083). Methods: Participants in the open-label study received HP/TAZ once daily. At week 8, participants who achieved treatment success (investigator’s global assessment [IGA] score of 0 or 1) stopped treatment and were reevaluated monthly through 52 weeks; those who did not achieve treatment success continued HP/TAZ. Twenty-four continuous weeks of treatment were allowed if participants achieved ≥1-grade improvement in IGA from baseline at week 12, with monthly reevaluation. If at any point the condition intensified to IGA ≥2, HP/TAZ was resumed, otherwise, HP/TAZ was discontinued. Results: From weeks 8 to 52, similar treatment success rates were achieved by participants with prior use of TCS (range, 20.0%-40.0%) or other topicals (range, 21.1%-53.8%). Mean affected body surface area at baseline was 5.7% and 5.5%, respectively, and decreased to 3.8% and 2.4%, respectively, at week 52. Percentage of participants who maintained disease control for 29 to 85 days after HP/TAZ cessation was comparable. Rates of adverse events were similar between groups. Conclusions: Regardless of the type of previous topical therapy, participants with prior use of topical medications maintained skin clearance with HP/TAZ over 52 weeks

367 Googling acne: Analyzing ingredients and price of over the counter acne products

Introduction: Given the convenience of the over-the-counter (OTC) market, many individuals trial OTC products as a means to combat their acne. Within the OTC acne market, there is great heterogeneity in ingredients and price. Herein, we analyze the distribution of ingredients and price among OTC acne products in top Google searches, which the public may encounter when performing an online search. Methods: Google searches for key terms “acne”, “acne treatment”, “top acne treatment”, and “best acne regimen” were performed. Unique acne products for the first 100 websites for each term were collected. Summary statistics for median, range, mean, and standard deviation for price per topical therapy were analyzed. A factorial ANOVA was performed assessing effect of ingredient on price. Results: A total of 272 unique products were collected out of the 400 websites analyzed. The mean price per ounce of all products was $24.79 (standard deviation of$31.84) and median[range] was $10.40 [ Conclusion: Providers play an important role in educating and helping patients to navigate the OTC market. Based on efficacy and affordability, benzoyl peroxide and adapalene should remain the active ingredient of choice when turning to the OTC market. Given the heterogeneity of the OTC market, patients should carefully evaluate OTC products and be aware that not all products will have ingredients containing a grade A strength of recommendation and know that products with the same topical therapy can vary dramatically in price

Proactive Management with Cal/BD Foam in Patients with Plaque Psoriasis prolongs Time with improved health-related Quality of Life when compared with reactive Management

Hintergrund: Die Phase-III-Studie PSO-LONG (NCT02899962) zeigte, dass ein proaktives Management (PM) mit Cal/BD-Schaum (Calcipotriol 0,005 %/Betamethason Dipropionat 0,064 %) gegenüber einem reaktiven (RM) über bis zu 52 Wochen bei Erwachsenen mit Psoriasis zu einer überlegenen Wirksamkeit führt. [1] Der von Patienten angegebene DLQI [2] bewertet deren Wahrnehmung der Psoriasis hinsichtlich der gesundheitsbezogenen Lebensqualität (HRQoL). Diese Post-hoc-Analyse von PSO-LONG untersucht, ob das initiale DLQI-Ansprechen nach Cal/BD-Schaumbehandlung in der Open-Label-Phase besser durch anschließendes PM oder RM gehalten werden konnte. Ziele: 1) Hervorheben, dass eine 1x tgl. offene Behandlung mit Cal/BD-Schaum über 4 Wo. die HRQoL von Plaque-Psoriasis-Patienten verbessert 2) Zeigen, dass ein PM mit Cal/BD-Schaum über bis zu 52 Wo. die anfängliche HRQoL-Response, die nach einer 4-wöch. offenen Cal/BD-Schaum-Behandlung erreicht wurde, im Vergleich zum RM bei Plaque-Psoriasis-Patienten signifikant verlängert Methoden: PSO-LONG beinhaltete eine initiale 4-wöchige Open-Label-Phase (OLP) (1x tgl. Cal/BD-Schaum) und eine 52-wöchige doppelblinde Erhaltungsphase (EP), in der Patienten randomisiert zweimal wöchentlich Cal/BD- oder Vehikel-Schaum (PM bzw. RM) anwendeten. Bei Rezidiven (Physician’s Global Assessment [PGA] ≥2) wurde über 4 Wo. 1x tgl. Cal/BD-Schaum gegeben. Der Anteil der Patienten mit einem DLQI = 0/1 nach der OLP wurde während der EP weiter beobachtet, um festzustellen, wie lange anfänglich erzielte Ergebnisse anhielten. Pro Gruppe wurden Kaplan-Meier-Kurven und Hazard Ratios (HR) für die Zeit mit Ansprechen ausgewertet. Ergebnisse: Die Analyse umfasste 521 Patienten mit überwiegend PGA-moderater Psoriasis (85,2 %). Während der OLP erreichten 49 % der Patienten einen DLQI = 0/1. Während der EP war das RM versus PM mit fast doppelt so hohem Risiko assoziiert, den DLQI = 0/1 zu verlieren (HR: 1,92; p\u3c0,001), und die mediane Zeit bis zum Ansprechverlust war fast 3,5x kürzer (57 bzw. 197 Tage). Fazit: Bei einer Untergruppe von Patienten, die nach initialer Behandlung mit Cal/BD-Sprühschaum ein DLQI = 0/1 HRQoL-Ansprechen erreichten, verlängerte das anschließende PM mit Cal/BD-Schaum die Zeit mit DLQI-Ansprechen signifikant gegenüber RM

Tapinarof in the treatment of psoriasis: A review of the unique mechanism of action of a novel therapeutic AhR modulating agent (TAMA)

Tapinarof, a novel, first-in-class small-molecule topical therapeutic aryl hydrocarbon receptor (AhR) modulating agent (TAMA), is in clinical development for the treatment of psoriasis and atopic dermatitis. The efficacy of tapinarof in psoriasis is attributed to its specific binding and activation of AhR, a ligand-dependent transcription factor, leading to the downregulation of pro-inflammatory cytokines, including interleukin-17, and regulation of skin barrier protein expression to promote skin barrier normalization. AhR signaling regulates gene expression in immune cells and skin cells, and has critical roles in the regulation of skin homeostasis. Tapinarof-mediated AhR signaling underlies the mechanistic basis for the significant efficacy and acceptable tolerability observed in early phase clinical trials of tapinarof cream in the treatment of psoriasis

Impact of crisaborole in patients with mild-to-moderate atopic dermatitis who received prior treatment

Topical treatments can provide relief with minimal adverse events (AEs) in patients with atopic dermatitis (AD). Crisaborole ointment 2% is a nonsteroidal phosphodiesterase inhibitor for the treatment of mild-to-moderate AD. The objective was to assess the efficacy and safety of crisaborole ointment in patients with AD who had received prior treatments of corticosteroids [topical corticosteroids (TCS) or systemic corticosteroids)], topical calcineurin inhibitors (TCI) or no prior treatments (treatment-naive). This was a post-hoc analysis of two identically designed, vehicle-controlled, randomized, double-blind, phase III studies of patients aged ≥2 years (ClinicalTrials.gov NCT02118766 and NCT02118792). Patients were assigned crisaborole or vehicle (2: 1) twice daily for 28 days and had a baseline Investigator’s Static Global Assessment (ISGA) score of mild (2) or moderate (3). Patients were divided into three subgroups: treatment-experienced patients who had received prior treatments of corticosteroids (systemic or dermatologic) or TCI; treatment-experienced patients who had received prior treatment with TCS or TCI; and treatment-naive patients who received no prior treatments within 90 days to screening. The primary endpoint was success in ISGA, defined as an ISGA score at day 29 of clear (0) or almost clear (1) with a ≥ 2-grade improvement from baseline. Additional endpoints included a Severity of Pruritus Scale (SPS) at week 4 (weekly average) of none (0) or mild (1) with a ≥ 1-grade improvement from baseline; changes in the Atopic Dermatitis Severity Index (ADSI), Dermatology Life Quality Index (DLQI), Children’s Dermatology Life Quality Index (CDLQI) and Dermatitis Family Impact Questionnaire (DFI) results were also assessed at day 29. AEs, including treatment-emergent AEs and serious AEs, were analysed. A significantly higher proportion of crisaborole-treated patients than vehicle-treated patients achieved success in ISGA in all subgroups [corticosteroids or TCI: 27.9% vs. 15.9% (P = 0.001); TCS or TCI: 27.4% vs. 14.7% (P = 0.001); treatment-naive: 35.0% vs. 26.8% (P = 0.017)]. SPS score 0/1 with a ≥ 1-grade improvement was also achieved by a significantly higher proportion of crisaborole-treated patients than vehicle-treated patients in all subgroups [corticosteroids or TCI: 35.1% vs. 14.9% (P \u3c 0.001); TCS or TCI: 34.5% vs. 13.5% (P \u3c 0.001); treatment-naive: 36.3% vs. 26.0% (P = 0.01)]. Changes in the least squares mean for ADSI, DLQI, CDLQI and DFI results were also significant for crisaborole- vs. vehicle-treated patients in all subgroups except for DLQI, DFI and ADSI (not examined) results for the treatment naive subgroup. Treatment-related AEs were infrequent and mild to moderate in severity. Crisaborole demonstrated a favourable efficacy and safety profile in both treatment-naive and treatment-experienced patients with AD

34794 Long-term safety and disease control of ruxolitinib cream among Black or African American patients with atopic dermatitis: Pooled results from 2 phase 3 studies

Atopic dermatitis (AD) is an inflammatory skin disease with a prevalence in the United States of approximately 20%/5%–10% in Black or African American children/adults. In 2 phase 3 studies (TRuE-AD1/TRuE-AD2), 1249 patients (≥12 years old, Investigator’s Global Assessment [IGA] score 2/3, 3%–20% affected body surface area [BSA]) were randomized (2:2:1) to twice-daily 0.75% ruxolitinib (Janus kinase [JAK] 1/JAK2 inhibitor) cream, 1.5% ruxolitinib cream, or vehicle for an 8-week, double-blind vehicle-controlled period, followed by a double-blind long-term safety period (LTS; as-needed treatment; assessments every 4 weeks) up to Week 52. Patients initially randomized to ruxolitinib remained on their regimen during the LTS; patients initially on vehicle were rerandomized to either ruxolitinib strength. During the LTS, patients treated areas with active AD only, stopped treatment 3 days after lesion clearance, and restarted treatment at recurrence. Among self-identifying Black or African American patients in the 0.75%/1.5% ruxolitinib groups for the full study in this pooled analysis (n = 91/n = 97), 53.8%/61.9% achieved clear/almost clear skin (IGA 0/1) at Week 8. From Week 12–52, 55.2%–73.3%/59.3%–78.7% of patients (range) achieved IGA 0/1. Mean affected BSA was 8.6%/8.3% at baseline, 3.8%/3.6% at Week 8, and 1.7%–3.3%/1.3%–2.5% (range of mean values) through Week 52. Over 52 weeks, treatment-emergent adverse events were reported in 59.3%/56.7% of patients; treatment-related adverse events were reported in 4.4%/6.2%. Incidence of application site reactions was low. In summary, the majority of Black or African American patients achieved clear/almost clear skin using ruxolitinib cream monotherapy, which was well tolerated