Efficacy and safety of tildrakizumab for the treatment of moderate-to-severe plaque psoriasis of the scalp: A multicenter, randomized, double-blind, placebo-controlled, Phase 3b study.

BACKGROUND: Scalp psoriasis is common and difficult to treat. OBJECTIVE: To evaluate efficacy and safety of tildrakizumab for the treatment of scalp psoriasis. METHODS: In this Phase 3b, randomized, double-blind, placebo (PBO)-controlled study (NCT03897088), patients with moderate-to-severe plaque psoriasis affecting the scalp (Investigator Global Assessment modified [IGA mod] 2011 [scalp] ≥3, Psoriasis Scalp Severity Index [PSSI] ≥12, ≥30% scalp surface area affected) received tildrakizumab 100 mg or PBO at W0 and W4. The primary endpoint was IGA mod 2011 (scalp) score of "clear" or "almost clear" with ≥2-point reduction from baseline at W16 (IGA mod 2011 [scalp] response). Key secondary endpoints were PSSI 90 response at W12 and W16 and IGA mod 2011 (scalp) response at W12. Safety was assessed from adverse events. RESULTS: Of patients treated with tildrakizumab (n = 89) vs PBO (n = 82), 49.4% vs 7.3% achieved IGA mod 2011 (scalp) response at W16 (primary endpoint) and 46.1% vs 4.9% at W12; 60.7% vs 4.9% achieved PSSI 90 response at W16 and 48.3% vs 2.4% at W12 (all P < .00001). No serious treatment-related adverse events occurred. LIMITATIONS: Only short-term data are presented. CONCLUSION: Tildrakizumab was efficacious for the treatment of scalp psoriasis with no new safety signals.

Effect of Roflumilast Cream vs Vehicle Cream on Chronic Plaque Psoriasis: The DERMIS-1 and DERMIS-2 Randomized Clinical Trials.

Importance: Once-daily roflumilast cream, 0.3%, a potent phosphodiesterase 4 inhibitor, demonstrated efficacy and was well tolerated in a phase 2b trial of patients with psoriasis. Objective: To evaluate the efficacy of roflumilast cream, 0.3%, applied once daily for 8 weeks in 2 trials of patients with plaque psoriasis. Design, Setting, and Participants: Two phase 3, randomized, double-blind, controlled, multicenter trials (DERMIS-1 [trial 1; n = 439] and DERMIS-2 [trial 2; n = 442]) were conducted at 40 centers (trial 1) and 39 centers (trial 2) in the US and Canada between December 9, 2019, and November 16, 2020, and between December 9, 2019, and November 23, 2020, respectively. Patients aged 2 years or older with plaque psoriasis involving 2% to 20% of body surface area were enrolled. The dates of final follow-up were November 20, 2020, and November 23, 2020, for trial 1 and trial 2, respectively. Interventions: Patients were randomized 2:1 to receive roflumilast cream, 0.3% (trial 1: n = 286; trial 2: n = 290), or vehicle cream (trial 1: n = 153; trial 2: n = 152) once daily for 8 weeks. Main Outcomes and Measures: The primary efficacy end point was Investigator Global Assessment (IGA) success (clear or almost clear status plus ≥2-grade improvement from baseline [score range, 0-4]) at week 8, analyzed using a Cochran-Mantel-Haenszel test stratified by site, baseline IGA score, and intertriginous involvement. There were 9 secondary outcomes, including intertriginous IGA success, 75% reduction in Psoriasis Area and Severity Index (PASI) score, and Worst Itch Numeric Rating Scale score of 4 or higher at baseline achieving 4-point reduction (WI-NRS success) at week 8 (scale: 0 [no itch] to 10 [worst imaginable itch]; minimum clinically important difference, 4 points). Results: Among 881 participants (mean age, 47.5 years; 320 [36.3%] female), mean IGA scores in trial 1 were 2.9 [SD, 0.52] for roflumilast and 2.9 [SD, 0.45] for vehicle and in trial 2 were 2.9 [SD, 0.48] for roflumilast and 2.9 [SD, 0.47]) for vehicle. Statistically significantly greater percentages of roflumilast-treated patients than vehicle-treated patients had IGA success at week 8 (trial 1: 42.4% vs 6.1%; difference, 39.6% [95% CI, 32.3%-46.9%]; trial 2: 37.5% vs 6.9%; difference, 28.9% [95% CI, 20.8%-36.9%]; P < .001 for both). Of 9 secondary end points, statistically significant differences favoring roflumilast vs vehicle were observed for 8 in trial 1 and 9 in trial 2, including intertriginous IGA success (71.2% vs 13.8%; difference, 66.5% [95% CI, 47.1%-85.8%] and 68.1% vs 18.5%; difference, 51.6% [95% CI, 29.3%-73.8%]; P < .001 for both), 75% reduction in PASI score (41.6% vs 7.6%; difference, 36.1% [95% CI, 28.5%-43.8%] and 39.0% vs 5.3%; difference, 32.4% [95% CI, 24.9%-39.8%]; P < .001 for both), WI-NRS success (67.5% vs 26.8%; difference, 42.6% [95% CI, 31.3%-53.8%] and 69.4% vs 35.6%; difference, 30.2% [95% CI, 18.2%-42.2%]; P < .001 for both). The incidence of treatment-emergent adverse events was 25.2% with roflumilast vs 23.5% with vehicle in trial 1 and 25.9% with roflumilast vs 18.4% with vehicle in trial 2. The incidence of serious adverse events was 0.7% with roflumilast vs 0.7% with vehicle in trial 1 and 0% with roflumilast vs 0.7% with vehicle in trial 2. Conclusions and Relevance: Among patients with chronic plaque psoriasis, treatment with roflumilast cream, 0.3%, compared with vehicle cream resulted in better clinical status at 8 weeks. Further research is needed to assess efficacy compared with other active treatments and to assess longer-term efficacy and safety. Trial Registration: ClinicalTrials.gov Identifiers: NCT04211363, NCT04211389.

Antihistamines in Psoriasis.

Psoriasis is polygenic, interleukin (IL)-17 and IL-23 driven chronic relapsing inflammatory multisystem disease caused by a complex interplay of endogenous and environmental factors. The most common and distressing symptom in psoriasis is itch, adding significantly to the burden of disease. Although histamine has historically not been considered a key itch mediator in psoriasis, there is some evidence from the literature that antihistamines may be effective to reduce itch in psoriasis. This review focuses on the role of antihistamines in the management of itch in psoriasis. The literature search included peer-reviewed articles published in English language (clinical trials or scientific reviews). Studies were identified by searching electronic databases (MEDLINE and PubMed) until January 2021 and by reference lists of respective articles. J Drugs Dermatol. 2021;20(8):844-847. doi:10.36849/JDD.5966.

Interleukin 23p19 inhibitors in chronic plaque psoriasis with focus on mirikizumab: A narrative review.

Psoriasis, a T-cell mediated chronic dermatosis, has a complex etiopathogenesis. There has been extensive research into the aberrant immune response, which leads to the formation of clinical lesions, and the need for developing better and safer drugs has been unrelenting. The past two decades of research has opened up new areas of the immune pathway that can be targeted in order to control the disease. Therefore, we have seen the emergence of biologics which either target T-cell receptors or inhibit Tumor Necrosis Factor-alpha (TNF-α) or inhibit interleukins (IL) like IL-12, IL-17, IL-17 receptor, and more recently IL-23. Drugs specifically targeting the p19 subunit of IL-23 have shown promising results in the management of chronic plaque psoriasis. This has given way to the development of a new class of biologics, that is, the IL-23p19 inhibitors that have a better safety profile as compared to its predecessors. In this review, we shall scrutinize the role of IL-23 and Th17 cell signaling in the evolution of the psoriatic lesions and summarize the clinical experience with IL-23p19 inhibitors especially mirikizumab in the treatment of chronic plaque psoriasis.

Increased Trend of Cosmetic Procedures in Patients With Psoriasis Who Attain 75% or Greater Improvement.

Background: The relationship between the clearance of psoriasis and improved quality of life together with an increased uptake of cosmetic procedures has not been reported to date. Objective: A survey was conducted at a single dermatology center to determine if there was an increased trend in cosmetic procedures in patients with moderate to severe psoriasis who attained 75% or greater reduction of the body surface area (BSA) with biologic agents and oral systemic therapies, and if this was related to an improvement in quality of life following psoriasis clearance. Study Design: In this case series, 138 patients with a history of moderate to severe psoriasis who attained 75% or greater body surface area (BSA) reduction with biologic agents or oral systemic therapies and had undergone at least one cosmetic procedure in the past 2 years were surveyed. Patient characteristics were collected including age, sex, percent BSA at initiation of therapy, the class of biologic or oral systemic therapies, and the different types of cosmetic procedures. Patients were asked to answer a 5-question survey on quality of life improvement, satisfaction with treatment, and correlation with the cosmetic procedure they had undergone, Patients also completed the Dermatology Quality of Life Index (DLQI) questionnaire in the survey. Results: The majority of patients who had undergone a cosmetic procedure after achieving 75% BSA stated that their psoriasis had previously prevented them from undergoing a cosmetic procedure. Regardless of therapy, all patients felt their quality of life had improved as a result of their treatment, and 91% of patients stated this was the impetus to undergo a cosmetic procedure. The mean DLQI score prior to therapy was 14.3 and 71% of patients reported a DLQI score of 0/1 after their psoriasis improved. Conclusion: There was a correlation between improvement in quality of life in patients who had achieved at least a 75% reduction in BSA with either a biologic agent, oral agent, or both, and the uptake of cosmetic procedures. J Drugs Dermatol. 2020;19(8): doi:10.36849/JDD.2020.5104R1.

Comparison of the Safety and Efficacy of Tumor Necrosis Factor Inhibitors and Interleukin-17 Inhibitors in Patients With Psoriasis

Psoriasis (PsO) is a common, systemic, chronic inflammatory disease characterized by key clinical symptoms, including itching, pain, and scaling, and is associated with substantial physical, psychosocial, and economic health burdens. Currently, there is no cure for PsO; however, the introduction of biologic therapies has revolutionized the clinical management of patients with PsO by expanding treatment options to include multiple therapies with different mechanisms of action targeting cytokines, including tumor necrosis factor inhibitors (TNFis), interleukin (IL)-17A inhibitors, an IL-12/23 inhibitor, and IL-23 inhibitors. TNFis are historically considered the first-line biologic treatment and the first-generation biologics; however, increased understanding of TNF-α and IL-17 synergistic functions have recently led to evidence that specifically targeting IL-17 may be more likely to improve disease activity than a more general, nonspecific therapy target, such as TNF-α. This review highlights currently available evidence and demonstrates the differences between TNFis and IL-17A inhibitors in patients with PsO with regard to efficacy and safety.

Efficacy of a Once-Daily Fixed Combination Halobetasol (0.01%) and Tazarotene (0.045%) Lotion in the Treatment of Localized Moderate-to-Severe Plaque Psoriasis

Recently, clinical data on 8 weeks' once-daily treatment of localized moderate-to-severe psoriasis with a novel fixed combination halobetasol propionate 0.01%/tazarotene 0.045% (HP/TAZ) lotion were published.1,2 HP/TAZ lotion was significantly more effective than individual active ingredients or vehicle, based on improvements in Investigator's Global Assessment (IGA), body surface area (BSA) involvement, and signs and symptoms of psoriasis (erythema, plaque elevation, and scaling) at the target lesion as well as a synergistic benefit over individual active ingredients, and good tolerability.

Successful Treatment of Refractory Plaque-Type Psoriasis and Psoriatic Arthritis With Guselkumab and Adalimumab Combination Therapy: A Case Report

Copy: A number of biologics have been approved for use in plaque-type psoriasis. They act by either blocking the action of a specific type of cell or protein in the immune system. Case presentation: Herein, we report a case of a 46-year-old woman with a 12-year history of severe plaque psoriasis and psoriatic arthritis who was treated successfully with guselkumab and adalimumab after failure of prior topical corticosteroids, cyclosporine and narrow-band ultraviolet B (NBUVB) phototherapy. Conclusion: There is limited data supporting the combination of biological agents in the management of psoriasis and psoriatic arthritis. This is the first case report of plaque psoriasis with arthritis, successfully treated with guselkumab and adalimumab combination therapy, without concurrent use of other systemic agents during the treatment. However, further studies need to be carried out to evaluate the efficacy and safety of this biologic combination therapy. J Drugs Dermatol. 2019;18(4):394-396.

Safety and Efficacy of a Fixed Combination Halobetasol and Tazarotene Lotion in the Treatment of Moderate-to-Severe Plaque Psoriasis: A Pooled Analysis of Two Phase 3 Studies.

BACKGROUND: Topical corticosteroids (TCS) are the mainstay of psoriasis treatment. Safety concerns may limit use. Combination with tazarotene may optimize efficacy and minimize safety and tolerability concerns. OBJECTIVE: Investigate safety and efficacy of halobetasol propionate 0.01%/tazarotene 0.045% (HP/TAZ) lotion in moderate-to-severe plaque psoriasis. METHODS: Two multicenter, randomized, double-blind, vehicle-controlled phase 3 studies (N=418). Subjects randomized (2:1) to HP/TAZ lotion or vehicle once-daily for 8 weeks, 4-week follow-up. Primary efficacy assessment: treatment success (at least a 2-grade improvement from baseline in IGA score and 'clear' or 'almost clear'). Safety and treatment emergent AEs evaluated throughout. RESULTS: HP/TAZ lotion demonstrated statistically significant superiority over vehicle as early as week 2 (P equals 0.002). By week 8, 40.6% of subjects were treatment successes compared with 9.9% on vehicle (P less than 0.001). A third of subjects remained treatment successes post-treatment. HP/TAZ lotion was also superior in reducing psoriasis signs and symptoms, and Body Surface Area (BSA) involvement. Most frequently reported treatment related AEs were contact dermatitis (6.3%), application site pain (2.6%), and pruritus (2.2%). LIMITATIONS: No data were collected beyond the 4-week follow-up. CONCLUSIONS: HP/TAZ lotion provides synergistic efficacy that is both rapid and sustained, with good tolerability and safety over 8 weeks use. J Drugs Dermatol. 2018;17(8):855-861.

From the Medical Board of the National Psoriasis Foundation: Treatment targets for plaque psoriasis.

BACKGROUND: An urgent need exists in the United States to establish treatment goals in psoriasis. OBJECTIVE: We aim to establish defined treatment targets toward which clinicians and patients with psoriasis can strive to inform treatment decisions, reduce disease burden, and improve outcomes in practice. METHODS: The National Psoriasis Foundation conducted a consensus-building study among psoriasis experts using the Delphi method. The process consisted of: (1) literature review, (2) pre-Delphi question selection and input from general dermatologists and patients, and (3) 4 Delphi rounds. RESULTS: A total of 25 psoriasis experts participated in the Delphi process. The most preferred instrument was body surface area (BSA). The most preferred time for evaluating patient response after starting new therapies was at 3 months. The acceptable response at 3 months postinitiation was either BSA 3% or less or BSA improvement 75% or more from baseline. The target response at 3 months postinitiation was BSA 1% or less. During the maintenance period, evaluation every 6 months was most preferred. The target response at every 6 months maintenance evaluation is BSA 1% or less. LIMITATIONS: Although BSA is feasible in practice, it does not encompass health-related quality of life, costs, and risks of side effects. CONCLUSION: With defined treatment targets, clinicians and patients can regularly evaluate treatment responses and perform benefit-risk assessments of therapeutic options individualized to the patient.

Systematic review of efficacy of anti-tumor necrosis factor (TNF) therapy in patients with psoriasis previously treated with a different anti-TNF agent.

BACKGROUND: Tumor necrosis factor (TNF) antagonists have improved outcomes for patients with psoriasis, but some patients are unresponsive to treatment (primary failure) or lose an initially effective response (secondary failure). OBJECTIVE: We sought to systematically investigate the efficacy and safety of a second TNF antagonist after failure of a first TNF antagonist. METHODS: Published primary studies evaluating the efficacy of switching TNF antagonists after failure were systematically extracted. RESULTS: Fifteen studies were included. Although response rates to a second TNF antagonist were lower than for a first, a substantial proportion of patients in every study achieved treatment success. Week-24 response rates for a second antagonist were 30% to 74% for a 75% improvement in Psoriasis Area and Severity Index score and 20% to 70% for achieving a Physician Global Assessment score of 0/1; mean improvements in Dermatology Life Quality Index ranged from -3.5 to -13. In general, patients who experienced secondary failure achieved better responses than patients with primary failure. Adverse event incidences ranged from 20% to 71%, without unexpected adverse events; 0% to 11% of patients experienced serious adverse events. LIMITATIONS: There was no common definition of treatment failure across these studies of varied design. CONCLUSIONS: Some patients benefit from switching to a second TNF antagonist after failure of a first TNF antagonist, with improved quality of life.

From the Medical Board of the National Psoriasis Foundation: Perioperative management of systemic immunomodulatory agents in patients with psoriasis and psoriatic arthritis.

Treatment with systemic immunomodulatory agents is indicated for patients with moderate to severe plaque psoriasis and psoriatic arthritis. In these patients, surgery may confer an increased risk of infectious or surgical complications. We conducted a literature review to examine studies addressing the use of methotrexate, cyclosporine, and targeted immunomodulatory agents (tumor necrosis factor-alfa inhibitors, interleukin [IL]-12/23 inhibitors, IL-17 inhibitors) in patients undergoing surgery. We examined 46 total studies; the majority were retrospective studies in patients with rheumatoid arthritis and inflammatory bowel disease. One study in patients with psoriasis and psoriatic arthritis reviewed 77 procedures and did not find an elevated risk of postoperative complications with tumor necrosis factor-alfa and IL-12/23 inhibitors even with major surgeries. Based on level III evidence, infliximab, adalimumab, etanercept, methotrexate, and cyclosporine can be safely continued through low-risk operations in patients with psoriasis and psoriatic arthritis. For moderate- and high-risk surgeries, a case-by-case approach should be taken based on the patient's individual risk factors and comorbidities.

Absence of Koebnerization Following Ablative and Nonablative Laser Therapy in Patients With Plaque Psoriasis.

BACKGROUND: The adverse effects of laser procedures performed in patients with psoriasis have not been reported to date. OBJECTIVE: The authors report the incidence of koebnerization in patients with psoriasis who underwent laser treatment with different devices over the past 12 years. MATERIALS AND METHODS: The medical records of 38 patients with psoriasis treated with laser therapy were reviewed. Patient characteristics, including duration and severity of psoriasis, baseline psoriasis treatment, laser modality and settings, facial areas treated, and number of sessions, were collected. The primary outcome of interest was incidence of koebnerization. RESULTS: None of the 38 patients with psoriasis treated with laser therapy experienced subsequent koebnerization. Seven patients were on oral systemic medications, 14 were on biologic agents, and 3 were on combination therapy. None of the patients experienced skin infections, delayed healing, or scarring, irrespective of their psoriasis therapy. CONCLUSION: Koebnerization did not occur on the face, neck, or scalp of patients with psoriasis who underwent laser therapy, irrespective of psoriasis severity or types of psoriasis medications they were receiving. Although these results are encouraging, the risk of koebnerization should be discussed with patients with psoriasis who wish to undergo laser procedures.

IL-4 and IL-13 Inhibition in Atopic Dermatitis.

Atopic dermatitis (AD) is a chronic, prevalent, multi-factorial condition that affects infants, children, and adults. Beyond topical therapy, a variety of systemic agents such as steroids, methotrexate, cyclosporine, azathioprine, mycophenoloic acid, and other agents are utilized to treat moderate to severe AD. However, these agents are associated with potential long term adverse events and organ toxicity. There is an unmet need for a safer, long-term systemic agent to adequately control moderate to severe AD. The role of the Th2 cytokines, IL-4 and IL-13, in AD has led to the development of biologic agents to treat AD. The aim of this article is to review the role of IL-4 and IL-13 in the pathogenesis of AD and discuss some of the clinical trial data that target and inhibit IL-4 and IL-13 in positively altering the course and outcome of AD.

J Drugs Dermatol. 2016;15(8):925-929.

Managing Patients With Psoriasis in the Busy Clinic: Practical Tips for Health Care Practitioners.

Psoriasis is a common inflammatory disease with significant comorbidities, whose management can be challenging given the variety of treatment options. It is critical for nurse practitioners, physician assistants, general practitioners, and dermatology trainees to have useful information about the treatment and monitoring of patients with psoriasis. Although certain aspects of care apply to all patients, each therapeutic agent has its own nuances in terms of assessments, dosing, and monitoring. The most appropriate treatment is based not only on disease severity but also on comorbid conditions and concomitant medications. These practitioners are vital in facilitating patient care by thorough understanding of systemic agents, selection criteria, dosing, and recommended monitoring. This article provides high-yield practical pearls on managing patients with moderate to severe psoriasis. It includes case-based discussions illustrating considerations for special populations, such as pregnant women, children, and patients with comorbidities (eg, human immunodeficiency virus infection, hepatitis C, hepatitis B, and history of malignancy).

OBSERVE-5: observational postmarketing safety surveillance registry of etanercept for the treatment of psoriasis final 5-year results.

BACKGROUND: OBSERVE-5 was a 5-year Food and Drug Administration-mandated surveillance registry of patients with psoriasis. OBJECTIVE: We sought to assess long-term etanercept safety and effectiveness. METHODS: Patients with moderate to severe psoriasis enrolled; a single baseline dose of etanercept was required. Key outcome measures included serious adverse events, serious infectious events, events of medical interest, psoriasis-affected body surface area, physician global assessment score, and Dermatology Life Quality Index score. Safety outcomes were assessed relative to data from the MarketScan database. RESULTS: For 2510 patients, 5-year cumulative incidence was 22.2% (95% confidence interval [CI] 20.3%-24.2%) for serious adverse events; 6.5% (95% CI 5.4%-7.7%) for serious infectious events; 3.2% (95% CI 2.3%-4.1%) for malignancies excluding nonmelanoma skin cancer; 3.6% (95% CI 2.7%-4.5%) for nonmelanoma skin cancer; 2.8% (95% CI 2.0%-3.6%) for coronary artery disease; 0.7% (95% CI 0.3%-1.2%) for psoriasis worsening; 0.2% (95% CI 0.0%-0.4%) for central nervous system demyelinating disorder; 0.1% (95% CI 0.0%-0.3%) for lymphoma and for tuberculosis; and 0.1% (95% CI 0.0%-0.2%) for opportunistic infection and for lupus; 55 fatal events were reported. Rates of malignancies, lymphomas, nonmelanoma skin cancer, and hospitalization-associated infections were not higher than expected relative to administrative claims data. The percentage of patients rated as clear/almost clear was 12% at baseline, which increased to 51% at month 6 and remained relatively stable throughout 5 years. LIMITATIONS: No internal comparator group was included; rare events may not have been detected. CONCLUSION: No new safety signals were observed with long-term, real-world etanercept use.

Next-generation biologics in the management of plaque psoriasis: a literature review of IL-17 inhibition.

Advances in the understanding of the pathogenesis of psoriasis have led to the development of biologic agents that target T cells and cytokines that play a specific role in the underlying inflammation associated with psoriasis (eg, tumor necrosis factor-α inhibitors, interleukin [IL]-12/23 inhibitors). In this review, evidence for the central role of IL-17 in the pathophysiology of psoriasis is presented, along with available clinical trial data on the selective IL-17 inhibitors in development. Three biologic agents that target IL-17 are currently in clinical development: secukinumab, ixekizumab, and brodalumab. Clinical studies to date suggest a favorable safety profile and the potential for better efficacy over the previous generation of agents, with Psoriasis Area Severity Index 75 response rates of up to 80% or greater. Fully published results of phase III studies of these agents are eagerly awaited.

OBSERVE-5 interim analysis: an observational postmarketing safety registry of etanercept for the treatment of psoriasis.

BACKGROUND: Etanercept is approved for the treatment of chronic moderate to severe plaque psoriasis in adults. OBJECTIVE: We sought to evaluate the long-term safety of etanercept in a real-world clinical setting. Assessment of etanercept efficacy was a secondary objective. METHODS: OBSERVE-5 is a 5-year observational safety registry initiated in May 2006 at multiple sites in the United States and Canada. Data collection includes the number of serious adverse events, serious infectious events, and prespecified events of medical interest. Efficacy data include body surface area assessments, physician and patient global assessments of psoriasis, and the Dermatology Life Quality Index. This interim analysis presents data from the first 3 years of the follow-up period. RESULTS: A total of 2511 patients were enrolled. Of 1890 patients continuing in the registry after 3 years, 113 were inactive for 1 to 2 years, and 115 were inactive for longer than 2 years. The 3-year incidence proportions of serious adverse events and serious infectious events based on Kaplan-Meier methodology were 0.14 and 0.04, respectively. The observed numbers of patients experiencing lymphoma, serious infectious events requiring hospitalization, nonmelanoma skin cancer, and malignancies excluding nonmelanoma skin cancer were not higher than the expected number of cases estimated from a large US administrative health claims database. LIMITATIONS: The registry lacks a control group, and the study is too small to measure the frequency of rare events. CONCLUSION: Etanercept demonstrated good tolerability in patients with plaque psoriasis in the clinical setting in this interim analysis. No new or unexpected safety concerns were observed.

Therapeutic application of machine learning in psoriasis: A Prisma systematic review.

Dermatology, being a predominantly visual-based diagnostic field, has found itself to be at the epitome of artificial intelligence (AI)-based advances. Machine learning (ML), a subset of AI, goes a step further by recognizing patterns from data and teaches machines to automatically learn tasks. Although artificial intelligence in dermatology is mostly developed in melanoma and skin cancer diagnosis, advances in AI and ML have gone far ahead and found its application in ulcer assessment, psoriasis, atopic dermatitis, onychomycosis, etc. This article is focused on the application of ML in the therapeutic aspect of psoriasis.

Efficacy of Roflumilast Foam, 0.3%, in Patients With Seborrheic Dermatitis: A Double-blind, Vehicle-Controlled Phase 2a Randomized Clinical Trial.

Importance: Current topical treatment options for seborrheic dermatitis are limited by efficacy and/or safety. Objective: To assess safety and efficacy of roflumilast foam, 0.3%, in adult patients with seborrheic dermatitis affecting the scalp, face, and/or trunk. Design, Setting, and Participants: This multicenter (24 sites in the US and Canada) phase 2a, parallel group, double-blind, vehicle-controlled clinical trial was conducted between November 12, 2019, and August 21, 2020. Participants were adult (aged ≥18 years) patients with a clinical diagnosis of seborrheic dermatitis for a 3-month or longer duration and Investigator Global Assessment (IGA) score of 3 or greater (at least moderate), affecting 20% or less body surface area, including scalp, face, trunk, and/or intertriginous areas. Data analysis was performed from September to October 2020. Interventions: Once-daily roflumilast foam, 0.3% (n = 154), or vehicle foam (n = 72) for 8 weeks. Main Outcomes and Measures: The main outcome was IGA success, defined as achievement of IGA score of clear or almost clear plus 2-grade improvement from baseline, at week 8. Secondary outcomes included IGA success at weeks 2 and 4; achievement of erythema score of 0 or 1 plus 2-grade improvement from baseline at weeks 2, 4, and 8; achievement of scaling score of 0 or 1 plus 2-grade improvement from baseline at weeks 2, 4, and 8; change in Worst Itch Numeric Rating Scale (WI-NRS) score from baseline; and WI-NRS success, defined as achievement of 4-point or greater WI-NRS score improvement in patients with baseline WI-NRS score of 4 or greater. Safety and tolerability were also assessed. Results: A total of 226 patients (mean [SD] age, 44.9 [16.8] years; 116 men, 110 women) were randomized to roflumilast foam (n = 154) or vehicle foam (n = 72). At week 8, 104 (73.8%) roflumilast-treated patients achieved IGA success compared with 27 (40.9%) in the vehicle group (P < .001). Roflumilast-treated patients had statistically significantly higher rates of IGA success vs vehicle at week 2, the first time point assessed. Mean (SD) reductions (improvements) on the WI-NRS at week 8 were 59.3% (52.5%) vs 36.6% (42.2%) in the roflumilast and vehicle groups, respectively (P < .001). Roflumilast was well tolerated, with the rate of adverse events similar to that of the vehicle foam. Conclusions and Relevance: The results from this phase 2a randomized clinical trial of once-daily roflumilast foam, 0.3%, demonstrated favorable efficacy, safety, and local tolerability in the treatment of erythema, scaling, and itch caused by seborrheic dermatitis, supporting further investigation as a nonsteroidal topical treatment. Trial Registration: ClinicalTrials.gov Identifier: NCT04091646.