Scholarly Activity

INTRODUCTION: Many patients with psoriasis remain on topical therapy despite meeting criteria for systemic therapy. Our objective was to estimate the effect of earlier initiation of apremilast on attaining body surface area (BSA) treatment targets in patients with psoriasis in a real-world setting.

METHODS: This retrospective cohort study conducted in the OM1 database analyzed patients with psoriasis and a BSA value between ≥ 1 and ≤ 10% (on index date) who had initiated apremilast or a topical treatment. Relative risks were used to compare achieved BSA targets across treatment groups. Confounding, selection bias, and missing data may have been present, but measures were taken to limit their impact.

RESULTS: Of 3589 apremilast initiators, 2073 (57.8%) initiated early (≤ 6 months after index date) and 1516 (42.2%) initiated late (> 6 months); separately, 9777 patients initiated their second or later topical treatment (topical users). Compared with early initiators, late initiators had higher BSA values at treatment initiation. Early apremilast initiators were more likely than topical users to achieve BSA ≤ 1% or ≥ 75% improvement in BSA (BSA-75) at 6 and 12 months after treatment initiation: for early apremilast initiators, the relative risks of achieving BSA ≤ 1% and BSA-75 compared with topical users were 1.54 (95% confidence interval [CI]: 1.27, 1.87) and 1.52 (95% CI: 1.21, 1.89), respectively, at 6 months, and 1.49 (95% CI: 1.23, 1.80) and 1.50 (95% CI: 1.22, 1.85), respectively, at 12 months.

CONCLUSIONS: Earlier initiation of apremilast, an oral systemic treatment, was associated with lower cumulative disease burden and increased likelihood of attaining BSA goals compared with topical users.

BACKGROUND: Data regarding short-term and long-term cosmesis and functional outcomes of excisional surgical wounds healed by secondary intention healing (SIH) are limited.

OBJECTIVE: To conduct a systematic review and assess the cosmetic and functional acceptability of SIH for acute excisional surgical wounds.

METHODS: Full-text articles queried from PubMed and Embase databases between January 1964 and April 2024 with cosmetic outcome data of human subjects with acute surgical wounds healed by SIH were included. Preferred Reporting Items for Systematic reviews and Meta-Analyses guidelines were followed.

RESULTS: A total of 1655 surgical wounds, of which 1518 (91.7%) healed by SIH, from 35 studies, were included in this review. The most frequent indication for SIH was a defect resulting from excision of nonmelanoma skin cancer (keratinocyte carcinoma), which was identified in 1439 (86%) of patients. Common sites for SIH included the nose (23.3%), periocular region (15.46%), and forehead (13.5%). The majority of wounds on the forehead, medial canthus, lower eyelid, nasal ala, cheeks, lips, postauricular area, and feet resulted in good to excellent cosmetic results, whereas those on the scalp, nasal dorsum, nasal tip, nasal sidewall, and chin yielded less acceptable cosmetic results. Given the baseline variability in cosmesis of primarily closed wounds in some anatomic locations, however, these data suggest the need for future prospective studies.

SUMMARY: SIH may produce an acceptable cosmetic and functional outcome for selected defects and may be of clinical benefit in the appropriate setting. This must be weighed against the potentially improved cosmesis and more rapid healing seen with primarily closed defects.

BACKGROUND: Monoclonal antibodies targeting interleukin-23 and interleukin-12 are efficacious in treating plaque psoriasis but must be delivered via intravenous or subcutaneous injection. Here, we aimed to evaluate the efficacy and safety of icotrokinra (JNJ-77242113), a targeted oral peptide that selectively binds the interleukin-23 receptor, compared with both placebo and deucravacitinib in adults with moderate-to-severe plaque psoriasis.

METHODS: The phase 3, randomised, double-blind, placebo-controlled and active-comparator-controlled ICONIC-ADVANCE 1 and ICONIC-ADVANCE 2 trials, which are being done at 149 sites across 13 countries and 114 sites across 11 countries, respectively, randomly assigned (2:1:2 and 4:1:4, respectively) adults with moderate-to-severe plaque psoriasis diagnosed for at least 26 weeks (body-surface-area involvement ≤10%, Psoriasis Area and Severity Index [PASI] ≤12, and Investigator's Global Assessment [IGA] ≤3) to once-daily oral icotrokinra 200 mg, placebo, or deucravacitinib 6 mg; participants randomly assigned to placebo or deucravacitinib transitioned to icotrokinra at week 16 or week 24, respectively. Coprimary endpoints were proportions of participants achieving IGA 0 or 1 (clear or almost clear skin) with at least a two-grade improvement and at least 90% improvement in PASI (PASI 90) at week 16 with icotrokinra versus placebo. These studies are registered with ClinicalTrials.gov, NCT06143878 (ADVANCE 1) and NCT06220604 (ADVANCE 2), and are ongoing.

FINDINGS: ICONIC-ADVANCE 1 enrolled participants from Jan 17, 2024, to May 24, 2024, and ICONIC-ADVANCE 2 enrolled participants from March 9, 2024, to June 13, 2024. Participants (ADVANCE 1: 774 of 988 patients screened; ADVANCE 2: 731 of 917 patients screened) were randomly assigned to icotrokinra (n=311 and 322), placebo (n=156 and 82), or deucravacitinib (n=307 and 327). All coprimary endpoints were met in both trials. Higher proportions of icotrokinra-treated versus placebo-treated participants achieved IGA 0 or 1 (ADVANCE 1: 213 [68%] of 311 vs 17 [11%] of 156, treatment difference 95% CI 58% [50-64]; ADVANCE 2: 227 [70%] of 322 vs seven [9%] of 82, 62% [53-69]; both p< 0·0001) and PASI 90 (ADVANCE 1: 171 [55%] of 311 vs six [4%] of 156, treatment difference 95% CI 51% [44-57]; ADVANCE 2: 184 [57%] of 322 vs one [1%] of 82, 56% [48-62]; both p< 0·0001) at week 16. Across studies, adverse event rates to week 16 were 303 (48%) of 632 and 136 (57%) of 237 with icotrokinra and placebo, respectively; the most common adverse events were nasopharyngitis (37 [6%] of 632 and 13 [5%] of 237) and upper respiratory tract infection (23 [4%] of 632 and eight [3%] of 237). To week 24, adverse event rates were lower than with icotrokinra (359 [57%] of 632) than deucravacitinib (411 [65%] of 634).

INTERPRETATION: Icotrokinra showed superior clinical response rates versus placebo and deucravacitinib in phase 3 moderate-to-severe plaque psoriasis trials, with similar adverse event rates to placebo. These findings suggest the potential of once-daily oral icotrokinra to provide robust efficacy and a favourable safety profile.

FUNDING: Johnson & Johnson.

BACKGROUND: Melasma, an acquired hyperpigmentation disorder, affects individuals of all ethnicities. Its multifactorial aetiology, high recurrence rates and psychosocial impact complicate management and necessitate comprehensive, evidence-based recommendations.

OBJECTIVES: The objective was to develop an international consensus on the diagnosis and management of melasma by synthesizing expert opinions and the latest scientific evidence.

METHODS: This consensus was developed using a modified Delphi approach. A core group of two senior dermatologists who were experts in pigmentary disorders guided the process, and a diverse panel of 38 dermatologists with a special interest in pigmentary disorders from 11 countries (Australia, Brazil, France, India, Italy, Mexico, Philippines, South Africa, South Korea, Taiwan and the USA) participated in three rounds of surveys and discussions, under the aegis of the Pigmentary Disorders Society (PDS). A literature search of articles published between 2014 and 2024 identified key studies that were graded using the Oxford levels of evidence (2009). Consensus statements were drafted, refined and finalized based on expert feedback. Responses were assessed using a 5-point Likert scale, with predefined thresholds for high (≥75%), moderate (55%-74%) and low (< 55%) agreement.

RESULTS: The consensus development process started with 34 statements, and at the end of the third round of the Delphi process, 21, 4 and 1 statement reached high, moderate and low consensus, respectively. Key recommendations highlighted photoprotection with broad-spectrum sunscreens as essential, regulated and supervised use of hydroquinone-based triple combination creams as the gold standard, and alternatives such as topical azelaic acid, kojic acid and oral tranexamic acid. Adjunctive procedural therapies, such as chemical peels and microneedling, were suggested to enhance topical efficacy, while lasers were reserved for refractory cases.

CONCLUSION: These recommendations aim to improve the outcomes of melasma patients globally by integrating expert opinion and evidence-based strategies. Future research should focus on evaluating emerging therapies and optimizing long-term maintenance strategies.

Bone marrow-derived multipotent hematopoietic progenitors seed the thymus and generate early thymic progenitors (ETPs). However, the factors governing ETP formation remain poorly defined. Using single-cell RNA sequencing (scRNA-seq) and single-cell assay for transposase-accessible chromatin with sequencing (scATAC-seq), we dissected the heterogeneity of transcriptomic and chromatin accessibility landscapes in murine ETPs. Whereas Tcf1(-) ETPs exhibited higher proliferative capacity, Tcf1(+) ETPs appeared to be immediate, more robust precursors to T lineage-specified early thymocytes. Prethymic ablation of Tcf1 and its homolog Lef1 severely impaired ETP formation in vivo. Whereas ablating Tcf1 alone had limited impact, loss of both Tcf1 and Lef1 impaired transcriptional activation of Notch1 and Notch pathway effector molecules, including Hes1 and Hhex, accompanied by aberrantly induced B cell and myeloid gene programs. Acute deletion of both factors compromised Notch pathway, glycolysis, and T cell gene programs in emergent ETPs ex vivo. Thus, Tcf1 and Lef1 act upstream of the Notch pathway, functioning as prethymic initiators of ETP fate and intrathymic gatekeepers of ETP identity and T lineage potential.

Introduction: In the ADORING 1 and 2 Phase 3 trials, tapinarof cream 1% (VTAMA®, Dermavant Sciences, Inc.) once daily (QD) demonstrated significant efficacy and was well tolerated in patients down to age 2 years with atopic dermatitis (AD). We present efficacy, safety, and tolerability outcomes from ADORING 3. Methods: Eligible patients from ADORING 1, ADORING 2, from a four-week maximal usage pharmacokinetics trial, and tapinarof-naive patients with mild AD, or moderate or severe AD, that did not meet inclusion criteria for ADORING 1 or 2, received tapinarof cream 1% QD for up to 48 weeks. Efficacy endpoints included achievement of complete disease clearance (Validated Investigator Global Assessment for Atopic Dermatitis™ [vIGA-AD™] score=0 [clear]), and clear or almost clear skin (vIGA-AD™=0 or 1). Safety and tolerability were assessed. Patients entering with vIGAAD™ ≥ 1 were treated with tapinarof until complete clearance (vIGA-AD™=0). Those entering with or achieving complete clearance discontinued tapinarof and were assessed for maintenance of clear or almost clear skin off-treatment (duration of treatment-free interval). Patients whose AD returned to mild (vIGA-AD™ ≥ 2) were re-treated until complete clearance was achieved. Results: In total, 728 patients enrolled; 83.0 percent were pediatric (2–17 years). Overall, 51.9 percent (378/728) achieved complete disease clearance, and 81.6 percent achieved clear or almost clear skin at least once in the trial. Mean duration of first treatment-free interval was 79.8 consecutive days (standard deviation: 81.4 days). No tachyphylaxis on either continuous or intermittent therapy was observed for up to 48 weeks. Most frequent adverse events were folliculitis (12.1%), nasopharyngitis (6.9%), and upper respiratory tract infection (6.9%). Follicular events and contact dermatitis were mostly mild or moderate and associated with low discontinuations (1.0% and 0.4%, respectively). Tapinarof was well tolerated locally, even when applied on sensitive skin. Conclusion: Tapinarof cream monotherapy demonstrated a high rate of complete disease clearance in patients down to age 2 years with AD. After discontinuing tapinarof, patients maintained clear or almost clear skin for 79.8 consecutive days. Tapinarof was well tolerated over 48 weeks.

Introduction: Acne vulgaris is a common dermatologic condition and a leading dermatologic diagnosis in Black and Hispanic patients. Topical clindamycin phosphate 1.2%/adapalene 0.15%/benzoyl peroxide 3.1% (CAB) gel is the only fixed-dose, triple-combination formulation approved for the treatment of acne. In three published clinical studies of participants with moderate-to-severe acne, CAB gel demonstrated superior efficacy to vehicle and component dyads, with good safety/tolerability. The objective of these analyses was to determine the efficacy, safety, and tolerability of CAB in Hispanic participants of these studies. Methods: In one Phase 2 (NCT03170388) and two Phase 3 (NCT04214652, NCT04214639) randomized, double-blind, 12-week studies, participants aged nine years or older with moderate-to-severe acne were randomized to once-daily CAB or vehicle gel. Endpoints included percentage of participants achieving treatment success (≥2-grade reduction from baseline in Evaluator's Global Severity Score [EGSS] and clear/almost clear skin) and least-squares mean percent change from baseline in inflammatory/noninflammatory lesion counts at Week 12. Treatment-emergent adverse events (TEAEs) and cutaneous safety and tolerability were also assessed. Pooled data across all three studies were analyzed for participants who self-identified as Hispanic/Latino (herein referred to as Hispanic; n=90 CAB; n=57 vehicle gel). Results: At Week 12, over half of Hispanic participants achieved treatment success with CAB versus less than one-quarter with vehicle gel (56.2% vs. 18.4%; p<0.001). CAB treatment provided more than 75-percent reductions in inflammatory/noninflammatory lesion counts at Week 12 vs 56.4 percent and 45.0 percent, respectively, with vehicle (p<0.001, both). TEAE rates with CAB in the Hispanic population were similar to those in the overall study populations (27% vs. 24.6–36.2%). Most TEAEs were of mild-to-moderate severity, and discontinuations due to AEs were low (<4%). Mean cutaneous safety and tolerability scores (0=none to 3=severe) with CAB at all visits were less than one (mild), similar to the overall study populations. Hyperpigmentation scores decreased from baseline (0.6) to Week 12 (0.3) following CAB treatment. Conclusion: In Hispanic participants with moderate-to-severe acne treated with CAB, over half achieved treatment success and acne lesion reductions were reduced by more than 75 percent by Week 12, without any additional safety signals. These results, combined with those of previous post-hoc analyses in Black study participants, demonstrate that CAB is an efficacious, safe, and tolerable acne treatment for patients of different racial and ethnic groups.

Introduction: Treatments with fast and substantial acne clearance are highly desirable. While a three-pronged approach can increase treatment efficacy versus monotherapy or dual-combination therapy, it is unknown if triple-combination provides more rapid improvement. CAB gel—clindamycin phosphate (clin) 1.2%/adapalene 0.15%/benzoyl peroxide (BPO) 3.1%—is the first fixed-dose, triple-combination acne topical. Since rapid/substantial acne improvements and fewer side effects can increase adherence, the efficacy and safety of CAB in the first four weeks of treatment was evaluated. Methods: In a Phase 2 (N=741; NCT03170388) and two Phase 3 (N=183; N=180; NCT04214639; NCT04214652), double-blind, 12-week studies, participants aged nine years or older with moderate-to-severe acne were randomized to once-daily CAB or vehicle gel; the Phase 2 study included three additional dyad arms: BPO/adapalene; clin/BPO; and clin/adapalene. Efficacy assessments included least-squares mean percent change from baseline in inflammatory and noninflammatory lesions. Cutaneous safety/tolerability assessments were graded from 0=none to 3=severe. Post-hoc analyses included percentages of participants with one-third and one-half acne lesion reductions. Results: At Week 4, CAB led to approximately 55 percent reductions from baseline in inflammatory acne lesions in the ph2 and pooled ph3 studies, significantly greater than vehicle (~40%) and its three dyads (ph2 range: 44.2-47.6%; p<0.05, all). The percentages of participants with one-third and one-half reductions of inflammatory lesions were significantly greater with CAB than vehicle and dyads (p<0.05, all). Similar trends were observed for noninflammatory lesions, though reductions were less pronounced. As expected for retinoids, transient increases from baseline to Week 2 in scaling, erythema, itching, burning, and stinging were observed for CAB, BPO/adapalene, and clin/adapalene, with mean scores ≤ 0.6 (1=mild); no trends in dyspigmentation were observed. Mean scores for all cutaneous assessments were highest for BPO/adapalene, indicating that adding a third product in the fixed-dose CAB gel formulation did not worsen tolerability. Conclusion: Acne lesion reductions were significantly greater with clin 1.2%/adapalene 0.15%/BPO 3.1% gel versus its dyads and vehicle gel as early as Week 4. More rapid efficacy with this first fixed-dose triple-combination acne product—coupled with its optimized formulation, once-daily dosing, and tolerability—might positively impact treatment adherence.

Introduction: Deucravacitinib, an oral, selective, allosteric tyrosine kinase 2 inhibitor, is approved in multiple countries for treatment of adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy. Deucravacitinib was efficacious versus placebo and apremilast and was well tolerated in the global, 52-week, Phase 3 POETYK PSO-1 (NCT03624127) and POETYK PSO-2 (NCT03611751) parent trials. At Week 52, patients could enroll in the ongoing POETYK long-term extension (LTE) (NCT04036435) trial and receive open-label deucravacitinib. Changes in blood laboratory parameters known to be associated with Janus kinase (JAK) 1,2,3 inhibitors were evaluated through four years of deucravacitinib treatment. Methods: Changes from baseline in lipid (cholesterol, triglycerides), chemistry (alanine aminotransferase [ALT], aspartate aminotransferase [AST], creatinine, creatine phosphokinase [CPK]), and hematology (hemoglobin, lymphocytes, neutrophils, platelets) parameters in the blood known to be affected by JAK1,2,3 inhibitors in clinical trials were evaluated through Week 208 (4 years; data cutoff, November 1, 2023). Treatment discontinuations due to laboratory abnormalities were assessed. Results: A total of 1,519 patients received at least one deucravacitinib dose (total exposure, 4392.8 person-years); 1,203 (79.2%) had at least 52 weeks and 542 (35.7%) had at least 208 weeks of continuous deucravacitinib exposure (median, 185 weeks). No trends or clinically meaningful mean changes from baseline were observed in any of the above laboratory parameters. In total, three patients discontinued treatment due to increased CPK, and one patient each discontinued due to lymphopenia, abnormal hepatic function, increased ALT, and increased AST. Discontinuations due to triglyceride elevations were not observed. Conclusion: In PSO-1/PSO-2/LTE, no trends or clinically meaningful mean changes from baseline were observed in lipid, chemistry, or hematology parameters, in contrast to signature changes (eg, increased cholesterol, creatinine, serum transaminases, CPK, cytopenias) observed with JAK1,2,3 inhibitors. Discontinuations due to laboratory abnormalities noted above were rare (n=7 events) through four years of deucravacitinib treatment. Results suggest deucravacitinib treatment does not warrant routine laboratory testing for all patients, in contrast with the requirements for JAK1,2,3 inhibitors, reflecting its selectivity for TYK2.

Introduction: ADapt (NCT05369403), an open-label, Phase 3b, 24-week study, evaluated the efficacy and safety of lebrikizumab (LEB) in patients with moderate-to-severe atopic dermatitis (AD) previously treated with dupilumab (DUPI). Patients must have discontinued DUPI due to inadequate response (non-response, partial response, or loss of response), intolerance or an adverse event (AE), or other reasons. Methods: Four or more weeks after discontinuing DUPI, patients received a 500mg LEB loading dose at baseline and at Week 2 followed by 250mg every two weeks through Week 16 (Q2W). At Week 16, responders (IGA 0 or 1 with ≥ 2-point improvement [IGA0,1] or EASI75 [primary endpoint]) received LEB 250mg once every four weeks (Q4W); other patients continued with 250mg Q2W. Q2W and Q4W data were pooled and analyzed as-observed and with nonresponder/multiple imputation (NRI/MI). Results: Among 86 enrolled patients, 56 percent discontinued DUPI due to inadequate response, 16 percent due to intolerance/AEs to DUPI, and 28 percent for other reasons. For all patients, at Weeks 16 and 24, respectively, proportions of patients achieving: 1) EASI75: 57.4 percent and 60.0 percent, as-observed; 50.7 percent and 52.8 percent NRI/MI; 2) IGA0,1: 38.7 percent and 38.2 percent, as-observed; 35.6 percent and 36.8 percent, NRI/MI; 3) Face-IGA 0: 42 percent and 49 percent, as-observed; 4) Pruritus NRS ≥ 4-point improvement 53.2 percent and 61.5 percent as-observed; 48.8 percent and 47.9 percent NRI/MI; and 5) DLQI ≥ 4-point improvement 83.0 percent and 83.0 percent as-observed. The safety profile was consistent with other LEB Phase 3 trials. Four patients who discontinued DUPI due to conjunctivitis did not report conjunctivitis with LEB. Additionally, 3.5 percent of patients reported treatment-emergent conjunctivitis. Conclusion: In DUPI-experienced patients, treatment of moderate-to-severe AD with LEB resulted in meaningful improvements in skin clearance, itch, and quality of life.

Hidradenitis Suppurativa (HS) is a chronic inflammatory disease characterized by painful nodules and sinus tunnels which significantly impacts quality of life. Diagnosis of HS is difficult and often delayed due to the lack of diagnostic tests, relying on clinical observation and patient history. The average diagnostic delay is between 7-10 years. The literature lacks substantial evidence on the impact of insurance status, family history, and comorbidities on diagnostic delays. Our study evaluated these and other previously studied factors' association with HS diagnostic delay at Henry Ford Hospital in Detroit. Data including age of HS onset, age of HS diagnosis, first degree family history, comorbidities and tobacco use history was extracted from the new patient intake forms at the HS specialty clinic from (January 2020 – March 2024) with demographics from chart reviews. Data from 228 records were analyzed. Diagnostic delay was defined as diagnosis over one year post-onset. A generalized additive model with non-linear regression was used to assess the association between each variable and average diagnostic delay. 228 records were reviewed, out of which 196 complete records were included in the analysis. Increased age (p=0.0329) and positive family history (p=0.0135) were associated with longer diagnostic delays after adjusting for confounders. Tobacco use revealed the longest delay (eight years). Sex was not significantly associated with diagnostic delay. Final analyses will include results for covariates including insurance status, comorbidities and average delay in years. This study will offer key insights into factors contributing to HS diagnostic delay.

Background: Optical Polarization Imaging (OPI) exhibits potential for indirectly determining basal cell carcinoma (BCC) margins via detection of peri-lesional dermal collagen disruption. Although the capability of OPI in BCC margin assessment prior to Mohs surgery was recently published, challenges remain in image acquisition and analysis leading to discrepancies between OPI and histopathology findings. This pilot study was to identify key aspects for optimal OPI image acquisition and analyses. Methods: OPI images were collected from 27 BCC lesions enrolled in an IRB approved study. Images were reviewed for quality and comparisons were made between OPI and histopathology, after the first Mohs layer, to identify limitations and areas of improvement to increase consistency. Results: The following were identified to improve image quality: avoidance of bubbles within the gel by applying gentle pressure, selecting relatively flat areas as curvature was resulting in pressure gradient, application of uniform pressure, and using appropriate exposure time. To improve image analysis, the following were identified: utilization of skin marker with color transparent in the blue channel, avoidance of, or adjustment to image processing algorithm to account for excessive vascularization, photodamage, or hair in the field of view. Conclusion: OPI remains a promising modality for indirect detection of BCC margin and could potentially be added to other direct tumor imaging modalities for increased specificity. OPI is a user-friendly, non invasive and time efficient imaging technique; however, further refinement of image acquisition and analysis methods, incorporating the respective criteria above in future studies are warranted to optimize its capabilities.

Introduction: Deucravacitinib, an oral, selective, allosteric tyrosine kinase 2 (TYK2) inhibitor, is approved in multiple countries for treatment of adults with moderate to severe plaque psoriasis who are candidates for systemic therapy. In the phase 3b/4, PSORIATYK SCALP (NCT05478499) trial, deucravacitinib was superior to placebo at Week 16 in patients with moderate to severe scalp psoriasis, including those with more limited overall psoriasis.1 This analysis reports efficacy in overall body psoriasis by baseline total body surface area (BSA) involvement. Methods: Outcomes at Week 16, analyzed by BSA involvement of 3%-10% or >10%, included static Physician Global Assessment score of 0 (clear) or 1 (almost clear) with a ≥2-point reduction from baseline (sPGA 0/1) and adjusted mean change from baseline in PASI. Nonresponder imputation (binary outcomes) and modified baseline observation carried forward (continuous outcomes) were used for patients who had missing data. Analyses are post hoc; P values are nominal. Results: Baseline BSA-defined subgroups were 3%-10% (n=70 vs n=38) and >10% (n=33 vs n=13) for deucravacitinib vs placebo, respectively. Week 16 sPGA 0/1 response rates were comparable in 3%-10% and >10% BSA subgroups, with higher proportions among patients treated with deucravacitinib versus placebo (42.9% vs 5.3% and 57.6% vs 0%, respectively; P<0.001 for both). Similarly, decreases in adjusted mean PASI were greater with deucravacitinib than with both 3%-10% (−3.7 vs −1.0, respectively) and >10% (−13.2 vs −2.2) BSA subgroups (P<0.0001 for both). Conclusion: Deucravacitinib was efficacious in improving psoriasis in patients with a wide range of total BSA involvement.

Per-protocol response criteria can have limited ability to inform patient–healthcare provider dialogue as individual patient experiences may vary in the same responder population. This analysis aimed to assess individual patient trajectories of response to lebrikizumab using data from the ADvocate monotherapy trials. This analysis included patients with moderate-to-severe atopic dermatitis treated with 250-mg lebrikizumab every 2 weeks from the pooled ADvocate1 and ADvocate2 trials (modified intention-to-treat populations) during the induction period (weeks 0-16). A machine learning growth mixture model (GMM) was used to cluster patients by longitudinal trajectory of percent change in the Eczema Area and Severity Index (EASI). Proportions and rates of patients achieving EASI thresholds were evaluated. The GMM clustered patient response trajectories (N=564) into 2 groups. Cluster 1 (EASI responders) comprised 85% of patients (n=477), and on average achieved an EASI50 response at week 4 and with a continued response trajectory beyond EASI75. Cluster 2 (EASI nonresponders) comprised 15% of patients (n=87), with a mean EASI reduction of 24% at week 16. A GMM on Cluster 1 identified 3 subclusters (Clusters 1A/1B/1C), which varied by depth of and time to response and represented 38%, 32%, and 15% of patients, respectively. Patients in Clusters 1A, 1B, and 1C achieved mean EASI reductions of 93%, 84%, and 67%, respectively, at week 16. All clusters, including nonresponders in Cluster 2, had notable improvements in itch and quality of life. This analysis identified distinct EASI response patterns to lebrikizumab, which may help guide patient and healthcare provider expectations.

Background: Despite the growing minority population in the United States, there is no standardized method for incorporating skin color and its characteristics into clinical practice or research1. Skin classification aids in risk stratification, disease severity assessments, and monitoring adverse events, but most existing systems are limited (1). This study aims to identify components for an inclusive tool to diagnose and assess the severity of inflammatory and infectious conditions, evaluate disease course and treatment response, and classify participant categories in clinical research. Methods: A Delphi technique was utilized to transform expert opinion into group consensus through three survey rounds, meetings, and individual voting. A 66-item questionnaire scored with a 5-point Likert scale and 3 open-ended questions was distributed to a panel of SOCS dermatologists to gather opinions on skin type/color classification and assessment tools. Consensus for tool inclusion was defined as ≥80% agreement. Results: Twenty-two SOCS experts were invited to participate. Of these, twenty-one completed all three rounds and reached consensus on 21 statements. Critical consensus (≥70-79% agreement) was achieved for 7 statements, while 17 statements were excluded due to <70% agreement. 7 statements were selected for review based on panel members selecting “I don’t know/needs to be reviewed.” 100% consensus was reached on the need to validate the scale. Conclusions: Reliable tools for assessing dermatologic conditions in all skin types are essential. This study confirms that current classification tools are inadequate, and experts strongly agree on the need for a validated, inclusive tool for both clinical practice and research.