Objective: This study (MATCH) was designed to assess the clinical utility of a machine-learning based tool (Mind.Px) that predicts patient response to the most common biologic drug classes used in the management of psoriasis patients. Methods: The MATCH study was designed to assess Mind.Px utility in physician decision making and patient outcomes. Psoriasis patients who were biologic naïve or those who were approaching a change due to non-response were enrolled into the study (N=112). At baseline, a dermal biomarker patch was applied to lesional skin and Mind.Px test results were provided to physicians prior to biologic selection. The choice of biologic for each patient was recorded and in the case of physician non-concordance with Mind.Px test results, a questionnaire completed to determine the reason for non-concordance. Patients were evaluated at weeks 4, 8, 12, and 16 after baseline using PASI, PGA, and BSA. Statistical analysis between groups was performed using Fisher’s exact test. Results: Physician prescribing behavior was measured with and without the inclusion of Mind.Px test results in the decision-making process. This data set was compared to a previously obtained data set in which dermal biomarker patches were applied at baseline, but Mind.Px results were not provided to physicians at any point during treatment (N=180). Statistical analysis of concordance between the Mind.Px-informed and Mind.Px-uninformed groups within the MATCH study (84.4% vs 53.8%, respectively) showed that when given access to Mind.Px results, physician behavior was significantly altered (p = 0.0022). Furthermore, analysis of those patients who have completed the study showed improved clinical outcomes in those patients whose physicians were provided Mind.Px test results. Specifically, this cohort reached PASI75 sooner than those who were not provided test results (p = 0.004). Conclusion: These results provide an interim measurement of the clinical utility of Mind.Px by demonstrating that physicians will utilize this test in psoriasis biologic decision making and by doing so, this leads to improved patient outcomes. These improved patient outcomes can also potentially translate into tremendous cost savings for healthcare systems. Mind.Px can effectively minimize the trial-and-error approach to psoriasis treatment, and provide physicians, patients, and payers with a powerful tool for improving psoriasis patient management.

BACKGROUND:The efficacy and safety of once-daily roflumilast foam 0.3%, a potent phosphodiesterase 4 inhibitor, has been demonstrated in patients with seborrheic dermatitis (SD). OBJECTIVES:To evaluate long-term effects of roflumilast foam 0.3% in patients with SD. METHODS:A phase II, open-label trial (no. NCT04445987) was conducted in patients (aged ≥ 12 years) with SD who completed a prior roflumilast foam trial or were naïve to roflumilast and vehicle. Patients applied roflumilast foam 0.3% once daily to all affected areas, including the scalp, face, trunk, and intertriginous areas, for 24 or 52 weeks (during the course of the trial, the protocol was amended to extend the duration of treatment from 24 weeks to 52 weeks). The primary endpoints were occurrence of treatment-emergent adverse events (AEs); local tolerability and efficacy (via Investigator Global Assessment [IGA]) were also assessed. RESULTS:Overall, 400 patients participated, among whom 62 were enrolled for 52 weeks. AE rates were low, and ≤ 1.1% reported stinging sensation at the application site at each visit. Durable improvement in signs and symptoms of SD was observed at weeks 24 and 52, with 76.0% and 80.4% of patients, respectively, achieving an IGA of clear or almost clear. CONCLUSIONS:Roflumilast foam 0.3% was well tolerated and improved and/or maintained improvements in signs and symptoms of SD for up to 52 weeks. CLINICALTRIALS: GOV LISTING:NCT04445987.

Introduction: In the phase 3b/4 PSORIATYK SCALP trial, deucravacitinib achieved superiority vs placebo for the primary and all key secondary endpoints at Week 16 in patients with moderate to severe scalp psoriasis. Patient-reported outcomes (PROs) provide additional information on treatment efficacy by capturing patients’ experiences and impact on their quality of life (QoL). This analysis evaluated the association between PROs and clinician-reported outcomes (CROs) in patients treated with deucravacitinib vs placebo. Methods: This ad hoc analysis evaluated the associations between PROs (scalp-specific itch, pain, and flaking numeric rating scale [NRS], Scalpdex, and Dermatology Life Quality Index [DLQI]) and CROs (scalp-specific Physician Global Assessment [ss-PGA] and Psoriasis Scalp Severity Index [PSSI]) using Spearman’s correlation coefficients for absolute scores at baseline and Week 16. Descriptive analyses of PRO changes from baseline and response rates by CRO response groups were also calculated for deucravacitinib-treated patients. Results: Baseline severity, scalp-specific symptoms, and QoL were similar between treatment groups, yet correlations were weak between PRO and CRO absolute values. At Week 16, correlations between PROs and CROs were stronger in deucravacitinib-treated patients vs placebo. The strongest correlations in deucravacitinib-treated patients were for itch and flaking NRS and Scalpdex symptoms (≥0.6; P<0.0001). QoL was moderately correlated with CROs (<0.6; P<0.0001) in deucravacitinib-treated patients. At Week 16, clinically meaningful improvements in scalp-specific itch, pain, and flaking and DLQI were reported by 76.2%, 89.5%, 88.4%, and 82.6% of patients who achieved ss-PGA 0/1 and by 72.7%, 66.7%, 91.7%, and 83.3% of those achieving PSSI 90, respectively. A 20-point reduction in Scalpdex total score was also reported by 75.6% and 66.7% of deucravacitinib-treated patients who achieved ss-PGA 0/1 and PSSI 90, respectively. Conclusion: In deucravacitinib-treated patients, there was a strong correlation between patient-reported scalp symptoms and scalp-specific CROs, confirming the treatment benefit from the patient perspective. Moderate QoL/scalp-specific CRO correlations indicate that PROs provide complementary information about treatment benefits.

INTRODUCTION:Roflumilast cream 0.3% contains a selective, highly potent phosphodiesterase 4 inhibitor approved to treat plaque psoriasis. The Psoriasis Area and Severity Index (PASI)-High Discrimination (PASI-HD) is more precise than PASI when psoriasis involves < 10% of the area of an anatomic region. Clinical trials of roflumilast utilized PASI and its modified version, PASI-HD, to assess disease improvement. The objective of this analysis was to demonstrate the effect of topical roflumilast in patients with psoriasis and to compare PASI-HD with PASI. METHODS:DERMIS-1 and DERMIS-2 were phase III, 8-week, randomized, vehicle-controlled trials of once-daily roflumilast cream 0.3% in patients aged ≥ 2 years with psoriasis involving 2-20% body surface area. PASI and PASI-HD were clinical endpoint measures. RESULTS:At week 8, statistically significantly more roflumilast- than vehicle-treated patients achieved ≥ 75% reduction in PASI (40.3% vs 6.5%; P < 0.0001) and PASI-HD (59.9% vs 17.9%; P < 0.0001). Evaluations using PASI-HD resulted in larger effect sizes compared with PASI at higher levels of response. CONCLUSIONS:Roflumilast-treated patients experienced greater improvements in disease severity than vehicle-treated patients. The PASI-HD can more accurately assess disease changes compared with PASI. TRIAL REGISTRATION:ClinicalTrials.gov Identifiers: DERMIS-1, NCT04211363; DERMIS-2, NCT04211389.

The efficacy and safety of once-daily roflumilast foam 0.3

A 27-week analysis of this phase 3 study demonstrated the interchangeability of the adalimumab biosimilar CT-P17 and reference adalimumab. The current 52-week analysis reports secondary data from the open-label extension period (OLE) of the study. In this randomized, double-blind, active-controlled phase 3 study, adults with moderate-to-severe chronic plaque psoriasis received (via prefilled syringe) 80 mg subcutaneous reference adalimumab on day 1, then 40 mg 1 week later, and every other week (EOW) until week 11. At week 13, patients were randomized (1:1) to continue reference adalimumab (“continuous” group) or undergo repeated switching between CT-P17 and reference adalimumab (“switching” group) until week 25. Thereafter, patients entered an OLE and received 40 mg CT-P17 EOW from week 27 to 49, with an end-of-study visit at week 52. Here we present findings from the OLE. Pharmacokinetics (PK), efficacy (including mean percent improvement from baseline in Psoriasis Area Severity Index [PASI] score), safety, and immunogenicity were evaluated. Post hoc subgroup analyses were also conducted. Of 327 patients who initiated the OLE, 152 and 160 patients from the switching group and continuous group, respectively, completed the study. Mean serum concentrations were similar between groups throughout the OLE. Efficacy improvements observed up to week 27 were maintained during the OLE and were comparable between groups. At week 52, overall mean (standard deviation [SD]) improvement from baseline in PASI score was 90.34

BACKGROUND:Botulinum neurotoxins in aesthetic medicine require reconstitution before administration, which may be inconvenient and present errors among injectors. OBJECTIVES:The aim of this study was to evaluate the efficacy and safety of ready-to-use nivobotulinumtoxinA liquid formulation for the treatment of glabellar lines (GL) with or without treatment of lateral canthal lines (LCL). METHODS:Two multicenter, phase 3, double-blind, randomized trials enrolled participants with moderate-to-severe GL (Study 001) or moderate-to-severe GL + LCL (Study 005). Participants received double-blind nivobotulinumtoxinA (20 U) or placebo (Period 1) then ≤2 open-label nivobotulinumtoxinA GL treatments (Period 2) in Study 001 or double-blind nivobotulinumtoxinA 20 U (GL), nivobotulinumtoxinA 44 U (GL + LCL), or placebo (Period 1) then ≤2 double-blind injections of the same treatment (Period 2) in Study 005. The composite primary endpoint was the proportion of participants achieving a ≥2-grade improvement on a facial wrinkle scale at maximum frown on investigator and participant assessment; coprimary endpoints were investigator- and participant-assessed FWS "none or mild" ratings. RESULTS:At Day 30, significantly higher responder rates were observed for the composite primary endpoint with GL treatment alone (Study 001, 46.1%; Study 005, 45.1%) and GL + LCL (Study 005, 41.3%) vs placebo (0%; all P < .001). Responder rates of "none or mild" by investigator and participant assessment, respectively, were significantly higher for GL treatment alone (Study 001, 77.2% and 65.0%; Study 005, 74.3% and 68.8%) and GL + LCL (Study 005, 74.0% and 61.2%) vs placebo (all P < .001). Adverse events were similar between treatment groups and placebo. CONCLUSIONS:Liquid nivobotulinumtoxinA was effective and well tolerated for treating moderate-to-severe GL alone or with LCL. LEVEL OF EVIDENCE: 1 (THERAPEUTIC):

Up to 20% of patients with stage I-II cutaneous melanoma (CM) will develop distant metastases (DMs), with the most frequent DM sites being the liver, lungs, bone, and brain. Although patients who develop DM have poor prognosis, trials of new immunotherapies in patients with DM have reported 5-year survival rates as high as 50%. Critically, early detection of DM, when tumor burden is lower, tends to lead to better treatment responses. Thus, it is important to identify patients at the highest risk of developing DM so clinicians can recommend risk-appropriate surveillance and treatment plans. We previously assessed the ability of the 31-gene expression profile (31-GEP) to predict CNS metastases, and here we expand our analysis to assess 31-GEP risk prediction for DMs to the lung, liver, and bone. We conducted a retrospective analysis of patients with stage I-II CM clinically tested with the 31-GEP from 2013-2017 (n=1, 661). Differences in DM rates between groups were assessed with Chi-squared test. Survival estimates (DM-free survival, DMFS) were estimated using Kaplan-Meier and compared using the log-rank test. (*, p<0.05; **, p<0.001). Among patients with stage I-II CM, a total of 90 DMs developed in 67 (4.0%) patients to the liver (n=48), lung (n=22), and/or bone (n=20). A higher percentage of patients with Class 2B than Class 1A developed DM to the liver (7.4% vs. 1.2%, **), lung (4.5% vs. 0.6%, **), and bone (3.0% vs. 0.8%, *). A 31-GEP Class 2B result was associated with significantly lower 5-year DMFS than Class 1B/2A or Class 1A for liver (91.7%, 92.2%, vs. 98.9%, **), lung (95.0%, 97.6%, vs. 99.4%, **), and bone (96.4%, 98.0%, vs. 99.2%, *). Of those with DM, the median time to develop DM (Class 1A, 1B/2A, vs. 2B) was 2.43, 2.22, vs. 2.27 years for liver; 1.74, 3.20, vs. 1.10 years for lung; and 3.2, 2.05, vs. 1.30 years for bone. Among patients with stage I-II CM, a greater percentage of those with a Class 2B 31-GEP developed DM at all studied sites, and 5-year DMFS was significantly lower for those with a Class 2B result. Thus, including 31-GEP testing with AJCC staging can allow clinicians to identify patients at higher risk of DM and recommend risk-appropriate surveillance modalities and frequency for early detection and treatment of DM. Merve Hasanov, Elshad Hasanov, David Pariser, Sonia Morgan-Linnell, Samuel Dierks, Brian Martin, Abel Jarell. The 31-gene expression profile identifies patients at risk of developing early distant metastases and can guide risk-appropriate surveillance strategies [abstract]. In: Proceedings of the American Association for Cancer Research Annual Meeting 2025; Part 1 (Regular Abstracts); 2025 Apr 25-30; Chicago, IL. Philadelphia (PA): AACR; Cancer Res 2025;85(8_Suppl_1):Abstract nr 3344.

This study aimed to demonstrate the interchangeability of biosimilar CT-P17 and European Union reference adalimumab (EU-adalimumab) in a repeated-switch scenario. In this ongoing, randomized, double-blind, active-controlled, phase 3 study, adults with moderate-to-severe plaque psoriasis received 80 mg EU-adalimumab on day 1, then 40 mg 1 week later and every other week until week 11. At week 13, patients were randomized (1:1, via an interactive web response system) to continue EU-adalimumab (“continuous” group) or undergo repeated switches between CT-P17 and EU-adalimumab (“switching” group). Dosing was via subcutaneous administration. The primary endpoints were area under the concentration–time curve and maximum serum concentration between weeks 25 and 27 (AUCtau,W25–27 and Cmax,W25–27, respectively). Secondary endpoints comprised additional pharmacokinetic (PK) parameters, efficacy, safety, and immunogenicity. Week 27 findings are presented. The first patient provided signed informed consent on November 7, 2022. Week 27 visits were completed by August 14, 2023. Of 367 patients enrolled, 346 were randomized (switching group, n = 172; continuous group, n = 174). The ratios of least squares means between groups and associated 90

BACKGROUND:Surgical procedures remain the gold standard for treating basal cell carcinoma (BCC), although commonly associated with cosmetic defects. The demand for noninvasive alternatives remains high. OBJECTIVE:To determine efficacy and safety of red light photodynamic therapy (PDT) with 10% 5-aminolevulinic acid (ALA) gel vs vehicle for treatment of superficial BCC. METHODS:This randomized, double-blind, vehicle-controlled, pivotal phase III study was conducted at 21 centers in the US. Eligible participants had ≥1 naïve superficial BCC and received 1-2 PDT cycles (2 PDTs each cycle) followed by clinical and histological assessment 12 weeks after start of the last PDT cycle. RESULTS:Of 187 randomized participants, 145 received PDT with 10% ALA gel and 42 with vehicle. Histological clearance was 75.9% with 10% ALA gel vs 19.0% with vehicle (P < .0001). Clinical clearance was 83.4% with 10% ALA gel vs 21.4% with vehicle (P < .0001). A total of 88.1% of participants treated with 10% ALA gel rated the esthetic outcome as very good or good. No previously unknown adverse events occurred. LIMITATIONS:Few participants with lesions on face/scalp; to date, a 60-month follow-up is still ongoing. CONCLUSION:10% ALA gel showed significantly higher clearance rates than vehicle with unproblematic safety and positive esthetic outcome.

The Atopic Dermatitis Control Tool (ADCT) assesses six concepts regarding patient-perceived control of atopic dermatitis (AD) in adults and adolescents with AD. This study aimed to develop two modified ADCT versions, one for children with AD aged 8–11 years and another for caregivers of children with AD aged 6 months to 11 years. Following the US Food and Drug Administration patient-reported outcomes guidance, the ADCT was modified to produce draft Child and Caregiver ADCT versions, maintaining the original six concepts. The instruments were refined and finalized through an iterative process using input from children with AD and caregivers of children with AD via qualitative interviews. Inclusion criteria were clinician diagnosis of AD, prescription treatment use in the past 3 months, and itching/scratching or rash in the past month. Interviews consisted of concept elicitation to identify perceptions of AD control and cognitive debriefing to test and refine the ADCT items. In total, 19 children (mean age 9.2 years, 74

BACKGROUND One-third of US adults are bothered by excessive sweating, approximately 5% are diagnosed with hyperhidrosis. A topical patch using targeted alkali thermolysis (TAT) was developed for treatment of this condition. OBJECTIVE This study was intended to assess the efficacy and safety of the TAT-Patch for axillary sweat reduction. MATERIALS AND METHODS A randomized, multicenter, double-blind, sham-controlled, pivotal trial enrolled 120 subjects to a bilateral axillary treatment with a TAT patch (63 subjects) or sham patch (57 subjects). RESULTS The primary end point was achieved; 64% of TAT-treated versus 44% of sham-treated subjects (p = .0332) improved from Hyperhidrosis Disease Severity Scale (HDSS) 3/4 to HDDS 1/2 at 4 weeks. Targeted alkali thermolysis treatment also showed a statistically significant improvement over sham treatment for all secondary end points, including gravimetric sweat production and subject-reported quality-of-life (QoL) assessments. The duration of effect is approximately 3 months, determined by the time to return to baseline HDSS. Mild-to-moderate treatment-site adverse events (AEs) were reported in 22% of TAT patch subjects. No serious or severe AEs were reported. CONCLUSION HDSS, GSP, and QoL findings confirm clinically meaningful sweat reduction and a significant improvement in quality of life following a single TAT patch treatment. This device has potential to offer a new, noninvasive treatment option that is well tolerated with minimal downtime.

Introduction Pour améliorer la prise en charge du psoriasis, les patients (pts) et leur clinicien peuvent conjointement décider de changer de biothérapie en cas de réponse insuffisante. Une résolution rapide de la peau après passage au bimékizumab (BKZ) a déjà été rapportée chez des pts ayant une réponse inadéquate à l’adalimumab (ADA), au sécukinumab (SEC) ou à l’ustékinumab (UST) et maintenue jusqu’à 80 semaines (S). Ici, nous visons à évaluer le maintien des réponses cliniques et de qualité de vie après passage au BKZ jusqu’à 4ans de trt dans 2 phases 3/3b BE RADIANT et BE BRIGHT. Matériel et méthodes Les pts de BE BRIGHT ont été randomisés en amont par ADA jusqu’à S24, puis BKZ toutes les 4S (T4S) jusqu’à S56 (BE SURE), ou UST jusqu’à S52 (BE VIVID), et sont ensuite entrés dans l’extension ouverte (OLE) BE BRIGHT où ils ont reçu BKZ T4S ou T8S. Les pts de BE RADIANT ont reçu du SEC jusqu’à S48, puis BKZ T4S ou T8S dans l’OLE. Tous les pts ont reçu BKZ T8S dans les OLE S16/48 (BE RADIANT/BE BRIGHT).Une amélioration≥90 % par rapport à l’inclusion des réponses PASI90, PASI100 et DLQI 0/1 est rapportée par semaine après passage au BKZ, jusqu’à 4ans de trt global, regroupés par réponse PASI90 lors du passage au BKZ. Les pts qui ont arrêté le trt pour un manque d’efficacité ou d’effets indésirables ont été considérés comme des non-répondeurs (NR). L’imputation multiple a été utilisée pour toutes les autres données manquantes (mNRI). Les données relatives aux cas observés (CO) sont également rapportées. Résultats Parmi les pts provenant des bras ADA, SEC et UST qui sont entrés dans l’OLE, 54/129 (41,9 %) ADA, 58/314 (18,5 %) SEC et 44/132 (33,3 %) UST et n’ayant pas atteint le PASI90 au moment du passage au BKZ (à S24, 48, 52, respectivement) (CO). 29,6 %, 53,5 % et 50,0 % des pts NR PASI90 avaient un DLQI 0/1 (mNRI) respectivement.Chez les pts NR PASI90, des réponses rapides et maintenues ont été observées après le passage au BKZ. Les pts venant du bras ADA, après 176S de BKZ, 92,2 %, 74,4 % et 81,0 % ont respectivement atteint le PASI90, le PASI100 et le DLQI 0/1 (mNRI). Les pts venant du bras SEC, après 96S de BKZ, 71,7 %, 39,8 % et 64,5 % ont atteint respectivement le PASI90, le PASI100 et le DLQI 0/1. Après le passage de l’UST, 82, %, 58,8 % et 76,6 % ont atteint respectivement le PASI90, le PASI100 et le DLQI 0/1 après 144S de BKZ.Le passage des répondeurs PASI90 de l’ADA, SEC et UST au BKZ a permis de maintenir les réponses PASI90, PASI100 et DLQI 0/1 après 4ans de trt. Discussion La plupart des pts NR PASI90 d’ADA, SEC ou UST ont atteint un PASI100 ou un DLQI 0/1 à long terme après le passage au BKZ. Les répondeurs ADA, SEC ou UST PASI90 ont maintenu des réponses à long terme après le passage au BKZ. Conclusion Le passage des pts NR PASI90 ADA, SEC ou UST au BKZ a permis à la plupart des patients d’atteindre rapidement et de maintenir un PASI90, pendant une durée de trt allant jusqu’à 4ans.