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Introduction Psoriasis (Pso) is a common, immune-mediated, chronic-relapsing, inflammatory skin disease. While a great deal is known about Pso and its treatment, there remain several treatment scenarios unaddressed by clinical studies. To be effective, treatment for Pso must alter the activity of one or more immunological pathways important in the pathogenesis of the disease. While the benefit of blocking these pathways may be apparent, there remain uncertainties regarding safety, such as infections, malignancies, and the potential for off-target effects. Existing guidelines and treatment recommendations rely primarily on clinical trial or observational data, none of which adequately address specific clinical challenges. This document describes a methodological framework for generating practical and clinically relevant guidance for situations where direct evidence is rare or absent. Guidelines implementing this framework are currently ongoing. Methods We develop a knowledge synthesis approach to guideline development, utilizing clinical trial data where available, and a formalized inferential decision-making process that considers indirect data coupled with structured expert opinion and analysis. This approach is best suited for situations where direct, high-level evidence is lacking. Support for each resultant recommendation is expressed as a quantified assessment of confidence. Results The topics to be addressed by this set of guidelines are ranked by clinicians and patients as areas of concern, with an emphasis on topics where high-level evidence may have limited availability. Conclusion Through this novel approach, we will derive practical, informative recommendations using the best evidence available in combination with structured expert opinion to guide best practices in complex, real-world settings. Supplementary file2 (MP4 98653 kb) Supplementary Information The online version contains supplementary material available at 10.1007/s13555-021-00642-5., Plain Language Summary Clinical guidelines aim to assist doctors in managing their patients’ medical conditions. A limitation of current guidelines is that they are frequently based on randomized clinical research trials—often considered the gold standard in medical research. Clinical trials are designed to estimate the safety and effectiveness of treatment. Outside of clinical trials, doctors encounter a range of patient cases excluded from clinical trials. Our group aims to create guidelines for those clinical scenarios not adequately addressed by clinical trials. Examples include patients excluded from clinical trials, the elderly, patients with human immunodeficiency virus (HIV), and pregnant or breastfeeding women. When clinical trial data is limited, doctors must make decisions nonetheless. In certain clinical situations they are left to their own resources to consult with experts, review the data, and make inferences based on the limited data available. Instead of concluding that there is no data, the topic of interest can be broken down into components that are answerable by different types of research studies. This inference-based approach uses expert opinion and indirect evidence to support an inference-based position on topics where direct clinical data is sparse or insufficient to answer the question. This approach can be used as a complement to clinical trial data informing disease management guidelines. Supplementary Information The online version contains supplementary material available at 10.1007/s13555-021-00642-5.

Atopic dermatitis is a common skin disorder for which there remains an unmet need for topical pharmacotherapies that are safe and effective. This phase 2 study assessed the efficacy and safety of 3 dosages of PUR 0110 (Thykamine; Devonian Health Group Inc.) cream (0.05%, 0.1%, and 0.25%) compared to vehicle for treatment of adults with mild to moderate atopic dermatitis. The primary efficacy endpoint was the proportion of patients with an Investigatorrsquo;s Global Assessment (IGA) of clear/almost clear and with a decrease from baseline score of at least 2 grades at day 29. Key secondary efficacy endpoints included change from baseline to day 29 in IGA, percent body surface area (%BSA) affected, Eczema Area and Severity Index (EASI) score, pruritus, and quality of life. Safety outcomes included the incidence of local and systemic adverse events. The primary efficacy endpoint was met with PUR 0110 cream 0.10% compared to vehicle (30.8% vs 6.7%, respectively, P=.014). Most secondary endpoints also favored PUR 0110 cream 0.10% vs vehicle, including change from baseline to day 29 in IGA score, %BSA affected, pruritus, and patient-reported quality of life. Adverse events occurred at a similar rate in all treatment groups; most were mild to moderate in intensity and were infrequently associated with study withdrawal. PUR 0110 cream 0.10% demonstrated rapid improvement in signs and symptoms of atopic dermatitis. This observation, along with its favorable safety and tolerability profile, could make it a useful therapeutic option for the treatment of atopic dermatitis. J Drugs Dermatol. 2022;21(10):1091-1097. doi:10.36849/JDD.6729.

Introduction An estimated 2–4% of Western populations are thought to have psoriasis, with a regional incidence ranging from 0.09% to 11.43%. Variance in estimates is a result of differences in study populations, methodology, regional differences, and definitions of disease. Reliable prevalence estimates of plaque psoriasis are challenging to establish. Further, the distribution of psoriasis severity in the population is unknown. This study aims to establish the utility of expert elicitation (EE) as a method for estimating unknown parameters in dermatology by (1) estimating the prevalence of psoriasis in the adult population, and (2) estimating previously unknown disease severity distribution. Methods An expert panel of 11 Canadian dermatologists with demonstrated expertise in psoriasis was formed. A proof-of-concept EE exercise estimated psoriasis prevalence in the general population in Canada, followed by estimation of psoriasis disease severity distribution by body surface area (BSA). Expert estimates were consolidated using Bayesian methods to statistically model the data and represent uncertainty. Results The median prevalence of psoriasis in the adult population using the Bayesian estimate was 3.0% (95% credibility interval, 2.7–3.3%), compared with the estimated mean prevalence of 3.4% (95% confidence interval, 2.2–4.9%). By EE, the estimated cumulative distribution of disease severity assessed by BSA suggests that approximately 50% of patients have a BSA of 50%. Conclusion The EE approach resulted in prevalence estimates that had a narrow distribution and were consistent with published literature, supporting its value in dermatology as a complementary method to help guide decision-making in areas where evidence is scarce or uncertain. Supplementary Information The online version contains supplementary material available at 10.1007/s13555-021-00518-8., Plain Language Summary Psoriasis is a common skin disease that affects 2–4% of the population. Prevalence estimates vary depending on factors such as study type and population studied. The distribution of disease severity (what proportion of patients have mild, moderate, or severe psoriasis) is not known. In this study, 11 dermatologists with expertise in psoriasis used an approach called expert elicitation to make educated guesses about prevalence and disease severity distribution in the real world. Using a statistical approach called Bayesian estimation, experts can represent the level of certainty in what they know and do not know and make inferences or assumptions about a population. Bayesian estimates are not based on the amount of data; rather, each datum contributes to a statistically meaningful result. The median prevalence of psoriasis in the adult population using the Bayesian estimate was 3.0%, which is in the expected range based on prior literature and supports the use of this expert elicitation method. This study provides the first expert estimate of disease severity distribution in the population assessed by body surface area affected by psoriasis. Approximately 50% of psoriasis patients have mild disease (

Background The effects of systemic therapy on mortality risk among patients with psoriasis are not fully understood. Objective To evaluate the impact of systemic treatment on mortality risk in patients enrolled in the Psoriasis Longitudinal Assessment and Registry. Methods Nested case-control analyses were performed to estimate mortality risk. Cases were defined as patients who died while participating in the Psoriasis Longitudinal Assessment and Registry. Cases were matched (1:4) with controls by age, race, sex, and geographic region. Evaluated treatments included methotrexate, ustekinumab, and tumor necrosis factor α inhibitors. Exposure was defined as at least 1 dose of treatment within 3 months before death and was stratified by duration of therapy. Results Among 12,090 patients, 341 deaths occurred, matched to 1364 controls. Biologic treatment within the preceding 3 months was protective against mortality versus no exposure: odds ratio (OR) for exposure of less than 1 year, 0.08 (95% confidence interval [CI], 0.03-0.23); OR for exposure of 1 year or longer, 0.09 (95% CI, 0.06-0.13). Methotrexate was protective against mortality only with exposure for 1 year or longer (OR, 0.08; 95% CI, 0.02-0.28). Limitations Observational studies are subject to unmeasured confounding. Conclusions Biologic therapy was associated with reduced mortality risk in patients with moderate to severe psoriasis, regardless of treatment duration; methotrexate reduced risk only with exposure for 1 year or longer.

Background Certolizumab pegol (CZP) is an Fc-free, PEGylated anti-tumour necrosis factor biologic. Objectives To report the 3-year efficacy of CZP in plaque psoriasis, pooled from the CIMPASI-1 (NCT02326298) and CIMPASI-2 (NCT02326272) phase III trials. Methods Adults with moderate-to-severe psoriasis for ≥ 6 months were randomized 2 : 2 : 1 to CZP 200 mg, CZP 400 mg or placebo, every 2 weeks (Q2W) for up to 48 weeks. Patients entering the open-label period (weeks 48-144) from double-blinded CZP initially received CZP 200 mg Q2W. Patients not achieving ≥ 50% improvement in Psoriasis Area and Severity Index (PASI 50) at week 16 entered an open-label CZP 400 mg Q2W escape arm (weeks 16-144). Dose adjustments based on PASI response were permitted during open-label treatment. Outcomes included PASI 75, PASI 90 and Physician's Global Assessment (PGA) 0/1 responder rates, based on a logistic regression model (missing data imputed using Markov Chain Monte Carlo methodology). Results In total, 186 patients were randomized to CZP 200 mg Q2W and 175 to CZP 400 mg Q2W. At week 48, PASI 75/90 was achieved by 72·7%/51·3% of patients randomized to CZP 200 mg and 84·4%/62·7% randomized to CZP 400 mg. Patients entering the open-label period at week 48, from blinded treatment, received CZP 200 mg Q2W. At week 144, PASI 75/90 was achieved by 70·6%/48·7% patients randomized to CZP 200 mg and 72·9%/42·7% randomized to CZP 400 mg. At week 16, 72 placebo-randomized patients entered the CZP 400 mg Q2W escape arm; 75.7%/58.5% achieved PASI 75/90 at week 144. Conclusions Both CZP 200 mg and 400 mg Q2W demonstrated sustained, durable efficacy, with numerically higher responses for some outcomes with 400 mg Q2W.

Summary Background Patients with plaque psoriasis treated with biologic therapies need more efficacious, safe and convenient treatments to improve quality of life. Risankizumab and secukinumab inhibit interleukin‐23 and interleukin‐17A, respectively, and are effective in adult patients with moderate‐to‐severe plaque psoriasis but have different dosing regimens. Objectives To compare directly the efficacy and safety of risankizumab vs. secukinumab over 52 weeks. Methods IMMerge was an international, phase III, multicentre, open‐label, efficacy–assessor‐blinded, active‐comparator study, in which adult patients with chronic, moderate‐to‐severe plaque psoriasis were randomized in a 1 : 1 ratio to treatment with risankizumab 150 mg or secukinumab 300 mg. Primary efficacy endpoints were the proportions of patients achieving ≥ 90% improvement from baseline in Psoriasis Area and Severity Index (PASI 90) at week 16 (noninferiority comparison with margin of 12%) and week 52 (superiority comparison). Results In total 327 patients from nine countries were treated with risankizumab (n = 164) or secukinumab (n = 163). Risankizumab was noninferior to secukinumab in the proportion of patients achieving PASI 90 at week 16 [73·8% vs. 65·6%; difference of 8·2%, 96·25% confidence interval (CI)−2·2 to 18·6; within the 12% noninferiority margin] and superior to secukinumab at week 52 (86·6% vs. 57·1%; difference of 29·8%, 95% CI 20·8–38·8; P < 0·001), thus meeting both primary endpoints. All secondary endpoints (PASI 100, static Physician's Global Assessment 0 or 1, and PASI 75) at week 52 demonstrated superiority for risankizumab vs. secukinumab (P < 0·001). No new safety concerns were identified. Conclusions At week 52, risankizumab demonstrated superior efficacy and similar safety with less frequent dosing compared with secukinumab., What is already known about this topic? The need remains for treatments with sustained efficacy and a more convenient dosing schedule in moderate‐to‐severe psoriasis.Risankizumab and secukinumab are indicated for the treatment of adults with moderate‐to‐severe plaque psoriasis and target interleukin‐23 and interleukin‐17, respectively.To date, risankizumab and secukinumab have not been directly compared. What does this study add? IMMerge directly compared the safety and efficacy of risankizumab and secukinumab in patients with moderate‐to‐severe plaque psoriasis using ≥ 90% improvement in Psoriasis Area and Severity Index at weeks 16 (noninferiority) and 52 (superiority) as primary endpoints.In terms of efficacy risankizumab was noninferior to secukinumab at week 16 and superior to secukinumab at week 52 of treatment based on primary endpoint analyses. The two medications had a similar safety profile. Linked Comment: Schmitt-Egenolf. Br J Dermatol 2021; 184: 3–4. Plain language summary available online

Background In Québec, targeted biologic therapies for moderate to severe plaque psoriasis are restricted to patients who have not responded to phototherapy or conventional systemic treatment, primarily due to high drug costs. Apremilast, an oral treatment for plaque psoriasis, was added to the Québec provincial health insurance plan (Régie de l’assurance maladie du Québec; RAMQ) formulary in 2015, making this the only province in Canada with public drug plan reimbursement for apremilast. Objectives The aim of this study is to describe patients’ characteristics, treatment patterns, healthcare resource utilization (HCRU), and associated costs and to measure real-world budget impact of using apremilast before biologics in plaque psoriasis. Methods This study was performed using RAMQ drug claims and medical services data. Patients diagnosed with psoriasis between January 2015 and December 2017 were identified. Medical services and prescription claims were categorized as all-cause and psoriasis-related. Using RAMQ database estimates, a 3-year budget impact analysis was developed comparing treatment cost with and without the addition of apremilast to the formulary. Results In all, 540 patients were identified (apremilast: n = 92; biologics: n = 448). Comorbidity burden and treatment persistence and adherence were comparable between apremilast and biologic users. The year following the index date, all-cause HCRU was lower for apremilast versus biologic users (CAN$19 763 vs CAN$28 025; P < .01), mainly driven by drug cost. Using apremilast before biologics resulted in an estimated RAMQ net savings of CAN$49 290 (2015), CAN$746 856 (2016), and CAN$1 216 512 (2017), and a total savings of CAN$2 012 658 since apremilast’s addition to the formulary. Conclusion Adding apremilast to the drug formulary of other Canadian provinces could result in significant healthcare savings.

Background Plaque psoriasis (PsO) is a chronic inflammatory disease that often presents at peak reproductive age in women of child-bearing potential (WOCBP). With the emergence of biologic therapies to treat PsO, guidance on disease management in WOCBP is needed to inform treatment decisions before, during, and after pregnancy. Objectives To develop a practical, up-to-date consensus document, based on available evidence and expert opinion where evidence was lacking, in order to guide both Canadian and international clinicians treating PsO in WOCBP. Methods A panel of 9 Canadian dermatologists with extensive clinical experience managing PsO reviewed the relevant literature from the past 25 years in 3 key domains: overview of PsO in WOCBP and clinical considerations, treatment considerations, and postpartum considerations. The structured literature search focused on WOCBP treated with TNF-alpha inhibitors (adalimumab, certolizumab, etanercept, golimumab, infliximab), IL-23 inhibitors (guselkumab, risankizumab, tildrakizumab), IL-12/23 inhibitors (ustekinumab), and IL-17 inhibitors (brodalumab, ixekizumab, secukinumab). This literature review, along with clinical expertise and opinion, was used to develop concise and clinically relevant consensus statements to guide practical management of PsO in WOCBP. Experts voted on the statements using a modified Delphi process and prespecified agreement cut-off of 75%. Results and implications After review, discussion, and voting on 19 draft consensus statements at an in-person meeting and remotely, 12 consensus statements were approved by the expert panel. The statements presented here will guide healthcare providers in practical disease management using biologic therapies for the treatment of PsO in WOCBP.

Background: Nemolizumab targets the IL-31 receptor a subunit involved in atopic dermatitis (AD) pathogenesis. Objective: We sought to evaluate a new dosing strategy of nemolizumab in patients with AD. Methods: We performed a 24-week, randomized, double-blind, multicenter study of nemolizumab (10, 30, and 90 mg) subcutaneous injections every 4 weeks versus placebo, with topical corticosteroids in adults with moderate-to-severe AD, severe pruritus, and inadequate control with topical treatment (n 5 226). The Eczema Area and Severity Index (EASI), the peak pruritus (PP) numeric rating scale (NRS), and the Investigator’s Global Assessment (IGA) were assessed. Standard safety assessments were performed. Results: Nemolizumab improved EASI, IGA, and/or NRS-itch scores, with the 30-mg dose being most effective. Nemolizumab (30 mg) reduced EASI scores versus placebo at week 24 (268.8% vs 252.1%, P 5 .016); significant differences were observed by week 8 (P _4-point decrease) were greater for 30 mg of nemolizumab versus placebo at week 16 (P

Background Patients with psoriatic arthritis (PsA) have increased risk of adverse events, including serious infections (SI), compared with psoriasis patients. Methods Patients eligible for, or receiving conventional systemic and biologic agents for psoriasis were followed prospectively using PSOLAR. Cohorts included: ustekinumab, tumor necrosis factor (TNF) inhibitors; infliximab; etanercept; adalimumab; non-biologic/methotrexate (MTX) (reference group); and non-biologic/non-MTX. Multivariate analyses using Cox hazard regression were used to identify factors associated with time to first SI. Rates of SI in PSOLAR psoriasis patients with self-reported PsA and possible risks with biologic therapy were evaluated. Results PSOLAR enrolled 4315 psoriasis patients with self-reported PsA. The overall population (N = 2401) included patients (n): 628 ustekinumab; 1413 TNF inhibitors; 258 infliximab; 481 etanercept; 674 adalimumab; 54 other biologics, 98 non-biologic/MTX; 208 non-biologic/non-MTX. Overall, 138 SI were reported with incidence rates per 100 patient-years as follows: a) ustekinumab: 1.00; b) TNF inhibitors: 2.22; c) infliximab: 2.12; d) etanercept: 2.58; e) adalimumab: 1.99; f) non-biologic/MTX: 3.01; g) and non-biologic/non-MTX: 2.31. Age, time-dependent disease activity Physician’s Global Assessment (PGA) of 4, 5, history of infection, and diabetes were associated with increased risk for SI (p Conclusions PSOLAR psoriasis patients with self-reported PsA in the TNF inhibitors, infliximab, adalimumab, etanercept, and MTX cohorts had numerically higher SI rates than the ustekinumab cohort, although not statistically significant. Age, PGA 4, 5, history of infection, and diabetes were associated with an increased risk for SI, irrespective of biologic exposure. Trial registration NCT00508547; Registered July 30, 2007.

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Psoriasis is a chronic and debilitating inflammatory immune-mediated skin disorder. Several cytokines including interleukin (IL)-23 were demonstrated to play a central role in the pathogenesis of this disease. Treatment options for psoriasis range from topical to systemic modalities, depending on the extent, anatomical locations involved and functional impairment level. Targeting cytokines or their cognate receptors that are involved in disease pathogenesis such as IL-12/23 (i.e., targeting the IL-12p40 subunit shared by these cytokines), IL-17A, IL-17F, IL-17RA, and TNF-α using biologic agents emerged in recent years as a highly effective therapeutic option for patients with moderate-to-severe disease. This review provides an overview of the important role of IL-23 signaling in the pathogenesis of psoriasis. We describe in detail the available IL-23 inhibitors for chronic plaque psoriasis. The efficacy, pharmacokinetic properties, and the safety profile of one of the most recent IL-23 biologic agents (tildrakizumab) are evaluated and reviewed in depth.

Off-label prescribing is a common practice in dermatology, particularly when uncommon dermatologic diseases have limited or no approved treatment options. Topical calcineurin inhibitors are approved for the treatment of eczema, and their anti-inflammatory, immunomodulatory, and steroid-sparing effects make them an attractive therapeutic option for a wide variety of other dermatologic diseases. This review summarizes and qualifies the available evidence supporting the clinical effectiveness of tacrolimus ointment and pimecrolimus cream in non-eczema indications. There is high-quality evidence supporting the effectiveness of topical calcineurin inhibitors in multiple dermatological disorders including vitiligo; psoriasis of the face, folds, and genitals; seborrheic dermatitis; chronic hand dermatitis; contact dermatitis; oral lichen planus; lichen sclerosus; morphea; and cutaneous lupus erythematosus. Lower-quality evidence suggests they may be considered as an option in many other cutaneous disorders.

Background Few clinical trials have evaluated long‐term treatment of nail psoriasis with biologics. Objective Safety and efficacy of adalimumab [ADA; Humira AbbVie Inc, North Chicago, IL, USA)] long‐term treatment (52 weeks) was evaluated in a phase‐3, randomized trial in patients with moderate‐to‐severe plaque psoriasis and concomitant moderate‐to‐severe fingernail psoriasis. Results from the first 26 weeks (Period A) have been reported. Methods Patients receiving 40 mg ADA every other week or placebo in Period A, continued with or switched to 40 mg ADA every‐other‐week treatment in the subsequent 26‐week open‐label extension (OLE) period. Main efficacy evaluations were ≥75% improvement in total‐fingernail modified Nail Psoriasis Severity Index (mNAPSI 75) and achievement of Physician's Global Assessment for Fingernail Psoriasis of clear or minimal disease (PGA‐F 0/1) with a ≥2‐grade improvement from baseline, across the trial for patients who continued ADA from Period A through the OLE (Continuous‐ADA Population). Safety was evaluated during the OLE and for patients receiving ADA at any time during the study (All‐ADA Population). Results Of the 217 patients initially randomized in Period A, 188 (86.6%; 94 in each treatment group) entered the OLE after completion of or early escape from Period A. For the Continuous‐ADA Population (N = 109), endpoint achievement rates improved from OLE entry (Week 26) to Week 52, including total‐fingernail mNAPSI 75 (47.4–54.5%); PGA‐F 0/1 (51.1–55.6%) and total‐fingernail mNAPSI = 0 (6.6–17.9%). Serious adverse event and serious infection rates for the All‐ADA Population (N = 203) were 6.9% and 3.4%, respectively. Conclusions In this population of psoriasis patients with concomitant, moderate‐to‐severe nail psoriasis, long‐term efficacy and improvement in signs and symptoms of nail disease were demonstrated after every‐other‐week ADA treatment, including incremental improvements in rate of total clearance of nail disease. No new safety risks were identified for patients receiving at least one ADA dose across 52 weeks., Linked Commentary: D. Rigopoulos. J Eur Acad Dermatol Venereol 2019; 33: 2014–2015. https://doi.org/10.1111/jdv.15988.

Hidradenitis suppurativa is a severe and debilitating dermatologic disease. Clinical management is challenging and consists of both medical and surgical approaches, which must often be combined for best outcomes. Therapeutic approaches have evolved rapidly in the last decade and include the use of topical therapies, systemic antibiotics, hormonal therapies, and a wide range of immunomodulating medications. An evidence-based guideline is presented to support health care practitioners as they select optimal medical management strategies and is reviewed in this second part of the management guidelines. A therapeutic algorithm informed by the evidence available at the time of the review is provided.

A phase 2, double-blind, placebo-controlled trial evaluated apremilast efficacy, safety, and pharmacodynamics in adults with moderate to severe atopic dermatitis. Patients were randomly assigned to receive placebo, apremilast 30 mg twice daily (APR30), or apremilast 40 mg twice daily (APR40) for 12 weeks. During weeks 12-24, all patients received APR30 or APR40. A biopsy substudy evaluated atopic dermatitis-related biomarkers. Among 185 randomly assigned intent-to-treat patients at week 12, a dose-response relationship was observed; APR40 (n = 63), but not APR30 (n = 58), led to statistically significant improvements (vs. placebo, n = 64) in Eczema Area and Severity Index (mean [standard deviation] percent change from baseline = -31.6% [44.6] vs. -11.0% [71.2], P 0.04; primary endpoint). mRNA expression of T helper type 17/T helper type 22-related markers (IL-17A, IL-22, and S100A7/A8; P0.05) showed the highest reductions with APR40, with minimal changes in other immune axes. Safety with APR30 was largely consistent with apremilast's known profile (common adverse events: nausea, diarrhea, headache, and nasopharyngitis). With APR40, adverse events were more frequent, and cellulitis occurred (n = 6). An independent safety monitoring committee discontinued the APR40 dosage. APR40 showed modest efficacy and decreased atopic dermatitis-related biomarkers in moderate to severe atopic dermatitis patients. Adverse events, including cellulitis, were more frequent with APR40, which was discontinued during the trial. Clinical Trial Registration Number: NCT02087943 (clinicaltrials.gov).

This document is a concise, current, and practical guide for dermatologists and other health care providers managing adult patients with moderate-to-severe atopic dermatitis (AD). The recommendations made here are based on a consensus of specialists with extensive experience managing patients with AD. Topics reviewed in this publication include AD pathophysiology, assessment, comorbidities, and treatment options.

The objectives of therapy for atopic dermatitis (AD) are to reduce skin inflammation and pruritus, restore skin barrier function, and improve quality of life (QoL). Treatments can be classified as moisturizing and basic care, topical therapy, phototherapy, and systemic therapy. In this review, we summarize the treatments for AD and recommendations for their use.

Summary Background Tralokinumab, a fully human monoclonal antibody, specifically neutralizes interleukin‐13, a key cytokine driving peripheral inflammation in atopic dermatitis (AD). In phase II studies, tralokinumab combined with topical corticosteroids provided early and sustained improvements in AD signs and symptoms. Objectives To evaluate the efficacy and safety of tralokinumab monotherapy in adults with moderate‐to‐severe AD who had an inadequate response to topical treatments. Methods In two 52‐week, randomized, double‐blind, placebo‐controlled, phase III trials, ECZTRA 1 and ECZTRA 2, adults with moderate‐to‐severe AD were randomized (3 : 1) to subcutaneous tralokinumab 300 mg every 2 weeks (Q2W) or placebo. Primary endpoints were Investigator’s Global Assessment (IGA) score of 0 or 1 at week 16 and ≥ 75% improvement in Eczema Area and Severity Index (EASI 75) at week 16. Patients achieving an IGA score of 0 or 1 and/or EASI 75 with tralokinumab at week 16 were rerandomized to tralokinumab Q2W or every 4 weeks or placebo, for 36 weeks. The trials were registered with ClinicalTrials.gov: NCT03131648 and NCT03160885. Results At week 16, more patients who received tralokinumab vs. placebo achieved an IGA score of 0 or 1: 15·8% vs. 7·1% in ECZTRA 1 [difference 8·6%, 95% confidence interval (CI) 4·1–13·1; P = 0·002] and 22·2% vs. 10·9% in ECZTRA 2 (11·1%, 95% CI 5·8–16·4; P, What is already known about this topic? Atopic dermatitis (AD) is a chronic interleukin (IL)‐13‐mediated disease.There is a need for safe and effective long‐term treatment options for AD.Tralokinumab is a fully human monoclonal antibody that binds specifically to IL‐13 with high affinity, thereby preventing receptor interaction and subsequent downstream signalling.Tralokinumab combined with topical corticosteroids showed early and sustained efficacy and safety in a 12‐week, phase IIb trial in moderate‐to‐severe AD. What does this study add? These are the first pivotal phase III trials demonstrating that by specifically targeting IL‐13 alone, patients can achieve significant improvements in AD signs and symptoms and quality of life, and maintain these improvements over time without the requirement for topical corticosteroids.These trials provide evidence that tralokinumab offers a long‐term, well‐tolerated treatment option for patients with moderate‐to‐severe AD. Linked Comment: Morra and Drucker. Br J Dermatol 2021; 184:386–387. Plain language summary available online

Concu dans une approche de gestion, cet ouvrage repertorie et documente toutes les etapes du cycle de vie d’un projet de developpement international ou d’action humanitaire. Ce guide propose une demarche rigoureuse qui permet a la fois d’integrer une vision complete et actuelle des concepts, methodes et outils d’application en matiere de gestion de projets et d’aborder de facon simultanee le developpement international et l’action humanitaire. L’accent a volontairement ete mis sur les competences et les roles des personnes qui proposent des projets, les gerent, en assurent le suivi ou en font l’evaluation. Cet ouvrage est une source d’enrichissement pour la formation et pour la pratique professionnelle des personnes qui veulent s’engager dans l’action humanitaire et le developpement international.

Coronavirus disease 2019 (COVID‐19) is caused by SARS‐CoV‐2, a novel RNA virus that was declared a global pandemic on 11 March 2020. The efficiency of infection with SARS‐CoV‐2 is reflected by its rapid global spread. The SARS‐CoV‐2 pandemic has implications for patients with inflammatory skin diseases on systemic immunotherapy who may be at increased risk of infection or more severe infection. This position paper is a focused examination of current evidence considering the mechanisms of action of immunotherapeutic drugs in relation to immune response to SARS‐CoV‐2. We aim to provide practical guidance for dermatologists managing patients with inflammatory skin conditions on systemic therapies during the current pandemic and beyond. Considering the limited and rapidly evolving evidence, mechanisms of action of therapies, and current knowledge of SARS‐CoV‐2 infection, we propose that systemic immunotherapy can be continued, with special considerations for at risk patients or those presenting with symptoms.

It is unclear whether primary efficacy outcomes in plaque psoriasis clinical trials represent residual disease during treatment.To evaluate supplementing dichotomous efficacy with residual disease activity.This post hoc analysis used pooled, patient-level data after tildrakizumab 100 mg (Median baseline Psoriasis Area and Severity Index (PASI) was 17.9 for patients receiving tildrakizumab 100 mg. At Week 12, median PASI was 2.9, whereas dichotomous PASI 90 response rate was 36.9%, and absolute PASI5.0,3.0, and1.0 were 64.0%, 50.8%, and 23.3%, respectively. At Week 28, median PASI was 1.7, whereas PASI 90 response rate was 51.9%, and absolute PASI5.0,3.0, and1.0 were 75.3%, 62.8%, and 38.0%, respectively. Dermatology Life Quality Index and PASI scores were correlated through Week 28 (Disease activity was more reliably estimated by PASI scores than percentage PASI improvement; this may partially explain efficacy disparities between clinical trials and practice. These results suggest supplementing dichotomous PASI improvement with PASI scores and consideration of patient treatment goals could facilitate clinical decisions.

Ixekizumab was efficacious in treating moderate-to-severe genital psoriasis over 12 weeks. We evaluated the long-term efficacy and safety of ixekizumab for up to 52 weeks. Patients were randomized to 80 mg ixekizumab every 2 weeks or to placebo through Week 12, then received 80 mg open-label ixekizumab every 4 weeks through Week 52. In patients initially randomized to ixekizumab, clear or almost clear genital skin was achieved for 73% of patients at Week 12 and 75% at Week 52. Persistent improvements were also observed for overall psoriasis, genital itch, and the impact of genital psoriasis on the frequency of sexual activity. The safety profile was consistent with studies of ixekizumab in patients with moderate-to-severe plaque psoriasis. Ixekizumab provided rapid and persistent improvements in the signs and symptoms of genital psoriasis for up to 52 weeks of treatment.

Background Risankizumab is a humanised IgG1 monoclonal antibody that binds to the p19 subunit of interleukin-23, inhibiting this key cytokine and its role in psoriatic inflammation. We aimed to assess the efficacy and safety of risankizumab compared with placebo or ustekinumab in patients with moderate-to-severe chronic plaque psoriasis. Methods UltIMMa-1 and UltIMMa-2 were replicate phase 3, randomised, double-blind, placebo-controlled and active comparator-controlled trials done at 139 sites in Australia, Austria, Belgium, Canada, Czech Republic, France, Germany, Japan, Mexico, Poland, Portugal, South Korea, Spain, and the USA. Eligible patients were 18 years or older, with moderate-to-severe chronic plaque psoriasis. In each study, patients were stratified by weight and previous exposure to tumour necrosis factor inhibitor and randomly assigned (3:1:1) by use of interactive response technology to receive 150 mg risankizumab, 45 mg or 90 mg ustekinumab (weight-based per label), or placebo. Following the 16-week double-blind treatment period (part A), patients initially assigned to placebo switched to 150 mg risankizumab at week 16; other patients continued their originally randomised treatment (part B, double-blind, weeks 16-52). Study drug was administered subcutaneously at weeks 0 and 4 during part A and at weeks 16, 28, and 40 during part B. Co-primary endpoints were proportions of patients achieving a 90% improvement in the Psoriasis Area Severity Index (PASI 90) and a static Physician's Global Assessment (sPGA) score of 0 or 1 at week 16 (non-responder imputation). All efficacy analyses were done in the intention-to-treat population. These trials are registered with ClinicalTrials.gov, numbers NCT02684370 (UltIMMa-1) and NCT02684357 (UltIMMa-2), and have been completed. Findings Between Feb 24, 2016, and Aug 31, 2016, 506 patients in UltIMMa-1 were randomly assigned to receive 150 mg risankizumab (n= 304), 45 mg or 90 mg ustekinumab (n= 100), or placebo (n= 102). Between March 1, 2016, and Aug 30, 2016, 491 patients in UltIMMa-2 were randomly assigned to receive 150 mg risankizumab (n= 294), 45 mg or 90 mg ustekinumab (n= 99), or placebo (n= 98). Co-primary endpoints were met for both studies. At week 16 of UltIMMa-1, PASI 90 was achieved by 229 (75.3%) patients receiving risankizumab versus five (4.9%) receiving placebo (placebo-adjusted difference 70.3% [95% CI 64.0-76.7]) and 42 (42.0%) receiving ustekinumab (ustekinumab-adjusted difference 33.5% [22.7-44.3]; p

Background The Psoriasis Symptom Inventory (PSI) is a patient-reported outcome measure designed to assess psoriasis signs and symptoms. Objectives The aim was to assess the usefulness of the PSI in enhancing patient care in the clinical setting. Methods Eight dermatology clinics in six countries enrolled adults representing the full spectrum of psoriasis severity who regularly received care at the clinic. Patients were administered the eight-item PSI (score range 0–32; higher scores indicate greater severity) while waiting for the physician; the physician conducted a static physician global assessment (sPGA) and estimated psoriasis-affected body surface area (BSA) at the same visit. Physicians completed a brief questionnaire after each patient visit, and were interviewed about the PSI after all patients were seen. Results The clinics enrolled 278 patients; mean [standard deviation (SD)] psoriasis-affected BSA was 7.6% (11.4). Based on BSA, 47.8% had mild psoriasis, 29.1% had moderate psoriasis, and 23.0% had severe psoriasis. Based on sPGA, 18.7% were clear/almost clear, 67.3% were mild/moderate, and 14.0% were severe/very severe. The mean (SD) PSI total score was 12.2 (8.3). Physicians spent a mean (SD) 4.9 (4.8) min discussing PSI findings with their patients (range 0–20 min). Key benefits of PSI discussions included the following: new information regarding symptom location and severity for physicians; prompting of quality-of-life discussions; better understanding of patient treatment priorities; change in treatment regimens to target specific symptoms or areas; and improvement of patient–physician relationship. Conclusions The PSI was useful for treated and untreated patients to enhance patient–physician communication, and influenced treatment decisions. Electronic supplementary material The online version of this article (10.1007/s40257-019-00458-2) contains supplementary material, which is available to authorized users.

Introduction Demographic and disease characteristics may impact response to psoriasis therapies. The objective of this study is to explore the safety and efficacy profile of secukinumab in North American (NA) versus non-NA patients with moderate to severe psoriasis. Methods Data were pooled from four phase 3 studies of secukinumab. Secukinumab (300 and 150 mg) was administered at baseline, weeks 1, 2, and 3, then every 4 weeks from week 4 to 48. Results Peak efficacy was observed at week 16 in NA and non-NA patients with secukinumab 300 mg and secukinumab 150 mg, and disease clearance was maintained to week 52. At week 52 with secukinumab 300 mg, Psoriasis Area and Severity Index (PASI) 90/100 response was achieved by 62.9%/37.9% of NA patients, respectively, and 70.2%/42.0% of non-NA patients, respectively. At week 52 with secukinumab 150 mg, PASI 90/100 response was achieved by 30.9%/17.5% of NA patients, respectively, and 53.9%/26.9% of non-NA patients, respectively. Response to secukinumab was rapid, and 50% reduction in mean PASI was achieved in both groups after 2.9 weeks with secukinumab 300 mg and 3.7 weeks with secukinumab 150 mg. Conclusion Despite differences in baseline characteristics, the efficacy and safety of secukinumab were similar among NA and non-NA patients. Funding Novartis Pharma AG. Plain Language Summary Plain language summary available for this article.

Background: Atopic dermatitis (AD) is a common and chronic inflammatory skin disease. Approximately 10% of adults with AD do not respond adequately to topical therapies and require phototherapy and/or systemic therapy. Objective: To provide a patient-focused approach to the identification and management of adults with AD who require systemic treatment. Methods: A working group of clinicians experienced in managing AD was convened to review and discuss current evidence on the identification and clinical management of adults with moderate to severe AD. Results: We propose a set of simple and practical clinical criteria for selecting candidates for systemic treatment of AD based on their response to first-line topical therapy and 4 clinical measures that are easily incorporated into routine practice. We also suggest a framework for evaluating systemic treatments according to attributes that are important from both a clinician’s and a patient’s perspective. An algorithm was developed proposing a pathway for treatment of moderate to severe AD in adults. Conclusion: Adults with moderate to severe AD that does not respond adequately to topical therapies currently have few safe and effective treatment options. A clinical algorithm could help guide treatment decisions.

Item does not contain fulltext BACKGROUND: Psoriasis symptoms may decrease quality of life for patients. Skin-related personal relationship difficulties in psoriasis patients are common, under-reported and poorly understood. OBJECTIVE: To assess the effect of ixekizumab (IXE) treatment on skin-related personal relationship difficulties in patients with moderate-to-severe psoriasis. METHODS: Pooled data (N = 2570) on skin-related relationship problems were obtained from two large phase 3 trials (UNCOVER-2 and UNCOVER-3) in patients with moderate-to-severe plaque psoriasis randomized to subcutaneous placebo (PBO, N = 361), etanercept (ETN; 50 mg twice weekly, N = 740), or 80 mg IXE as one injection every 4 (IXEQ4W, N = 733) or 2 weeks (IXEQ2W, N = 736) for 12 weeks, following a 160-mg initial dose. The Dermatology Life Quality Index (DLQI) Personal Relationships Domain (PRD) (Items 8 and 9) was used to assess how much the skin caused any personal relationship difficulties at weeks 0, 2, 4 and 12. Improvement was compared for IXE vs PBO and ETN using logistic models. Factors associated with improvement were assessed using multiple linear regressions. DLQI Item 9, assessing sexual difficulties, was also analysed separately. RESULTS: PRD scores (mean +/- standard deviation) at baseline were similar across all treatment groups (PBO: 1.8 +/- 1.9; ETN: 1.7 +/- 1.8; IXEQ4W: 1.6 +/- 1.8; IXEQ2W: 1.7 +/- 1.8). Treatment with IXE rapidly and significantly improved the mean PRD score compared to PBO and ETN (P < 0.001 at all time points). Baseline PRD score was the strongest negative predictor of improvement. IXE enabled significantly more patients with moderate-to-severe plaque psoriasis to reduce their skin-related sexual difficulties at Week 12 compared to PBO (P < 0.001) or ETN (P < 0.001). CONCLUSION: Ixekizumab improves patient-reported skin-related PRD difficulties in patients with moderate-to-severe psoriasis.

Background Biological agents targeting IL-17 are very effective for clearing moderate to severe psoriasis. There is limited information regarding the frequency and pattern of psoriasis relapse upon treatment cessation. Objective To investigate the pattern of psoriasis recurrence in patients who were treated with brodalumab following Amgen's decision to stop the clinical program in June 2015. Materials and Methods Between June 2015 and March 2016, we constructed a retrospective multicenter cohort study including patients who were treated with brodalumab in Amgen's protocols after the abrupt interruption of the drug development program. The relapse was defined as the request of patient to initiate a new treatment after brodalumab withdrawal. Results Seventy seven patients were followed up. At the time brodalumab treatment was stopped, 67 (87%) patients had reached PASI 90. After brodalumab discontinuation, all 77 patients relapsed after a follow up of 9 months. The median time to relapse was 46 days (range 7 to 224 days). Concerning the type of relapse, 73 patients presented with plaque psoriasis, one patient presented with erythrodermic psoriasis and 3 patients experienced pustular psoriasis. In 7 patients who had no previous history of psoriatic arthritis (PsA), the relapse of psoriasis was associated with inflammatory joint pain suggestive of PsA. At week 36, eight patients who had a limited relapse were controlled with topical treatment, 43 patients received a biological agent, two patients were included in a clinical trial with an investigational drug and 15 patients were treated with conventional systemic agents. Conclusion Abrupt cessation of brodalumab is associated with a rapid relapse of psoriasis with some patients experiencing a rebound. It seems not advisable to stop treatment with IL-17 receptor antagonists abruptly even in patients who experience complete clearance of psoriasis. This article is protected by copyright. All rights reserved.

Background: Treat-to-target therapy approaches are established for chronic diseases such as diabetes, hypertension, and more recently rheumatoid arthritis, resulting in improved patient outcomes. These approaches do not use patient reported outcomes (PRO) as targets of therapy. Chronic spontaneous urticaria (CSU), also called chronic idiopathic urticaria (CIU), is defined as recurrent urticaria of known and unknown cause, lasting more than 6 weeks. Treatment of CSU can be challenging. However, with the advent of proven therapies and validated instruments for measuring disease activity, the concept of treat-to-target (T2T) can be successfully applied to CSU. Herein, we propose a potential PRO therapeutic target and suggest a T2T approach for the management of patients with CSU. Methods: Principles and recommendations for a treat-to-target approach in CSU (T2T/CSU) were developed by a Canadian task force, consisting of dermatologists, immunologists, and allergists. The task force formulated recommendations for therapeutic targets in CSU on the basis of a systematic literature review and expert opinion. Results: The key features of these T2T/CSU recommendations are the use of a PRO as the principal target, with symptom control as measured by Urticaria Activity Score 7 (UAS7 ≤ 6), targeting symptom remission (UAS7 = 0). Conclusion: Treatment targets such as UAS7 ≤ 6 and UAS7 = 0 provide a benchmark for success in the care of patients with CSU, and will permit the evaluation of a PRO-based T2T approach in the care of these patients and the effect of this approach on improved patient care as seen in other chronic diseases.

Background: Hidradenitis suppurativa (HS) is a painful, debilitating, and poorly understood condition, which is suboptimally diagnosed, managed, and treated. Evidence supporting various treatment modalities is sparse. Objectives: To incorporate scientific evidence and expert opinions to develop useful guidance for the evaluation and management of patients with HS. Methods: An expert panel of Canadian dermatologists and surgeons developed statements and recommendations based on available evidence and clinical experience. The statements and recommendations were subjected to analysis and refinement by the panel, and voting was conducted using a modified Delphi technique with a prespecified cutoff agreement of 75%. Results: Ten specific statements and recommendations were accepted by the expert panel. These were grouped into 4 domains: diagnosis and assessment, treatment and management, comorbidities and a multidisciplinary approach, and education. Conclusions: These statements and recommendations will serve to increase awareness of HS and provide a framework for decisions involving diagnosis and management. Evidence suggests that antibacterial and anti–tumour necrosis factor therapies are effective in the treatment of HS. This is supported by the clinical experience of the authors. Further clinical research and the establishment of multidisciplinary management teams will continue to advance management of HS in Canada.

Background Olumacostat glasaretil (OG) inhibits acetyl-coenzyme A carboxylase, the enzyme responsible for the first, rate-limiting step in de novo fatty acid synthesis. OG inhibited in vitro human sebocyte lipid production and reduced in vivo sebaceous gland size in hamster ears. Objectives Safety and efficacy of OG 7.5% gel were evaluated in patients with moderate to severe facial acne vulgaris. Methods Patients were randomized (1:1) to twice-daily application of OG or vehicle for 12 weeks. Efficacy was measured through changes in lesion counts and improvement in acne severity scores. Results A total of 108 patients received OG (n = 53) or vehicle (n = 55); these groups had mean baseline counts of 29.7 and 28.6 inflammatory and 40.9 and 38.8 noninflammatory lesions, respectively. At week 12, OG treatment showed greater reductions from baseline in inflammatory lesions (−63.9% vs −45.9%; P = .0006) and noninflammatory lesions (−48.1% vs −28.8%; P = .0025), and more patients with greater than or equal to 2-grade improvement in investigator global assessment score (24.5% vs 7.3%; P = .0070) than vehicle. Application-site adverse events (typically mild or moderate intensity) were more common with OG. Limitations Larger trials are needed to optimize OG dosing and confirm the current results. Conclusion OG was well tolerated and showed evidence of efficacy, suggesting further development is warranted.

BACKGROUND\ud Dupilumab, a human monoclonal antibody against interleukin-4 receptor alpha, inhibits\ud signaling of interleukin-4 and interleukin-13, type 2 cytokines that may be important\ud drivers of atopic or allergic diseases such as atopic dermatitis.\ud METHODS\ud In two randomized, placebo-controlled, phase 3 trials of identical design (SOLO 1\ud and SOLO 2), we enrolled adults with moderate-to-severe atopic dermatitis whose\ud disease was inadequately controlled by topical treatment. Patients were randomly\ud assigned in a 1:1:1 ratio to receive, for 16 weeks, subcutaneous dupilumab (300 mg)\ud or placebo weekly or the same dose of dupilumab every other week alternating\ud with placebo. The primary outcome was the proportion of patients who had both\ud a score of 0 or 1 (clear or almost clear) on the Investigator’s Global Assessment\ud and a reduction of 2 points or more in that score from baseline at week 16.\ud RESULTS\ud We enrolled 671 patients in SOLO 1 and 708 in SOLO 2. In SOLO 1, the primary\ud outcome occurred in 85 patients (38%) who received dupilumab every other week and\ud in 83 (37%) who received dupilumab weekly, as compared with 23 (10%) who received\ud placebo (P

Background Apremilast, an oral phosphodiesterase 4 inhibitor, has an acceptable safety profile and is effective for treatment of plaque psoriasis and psoriatic arthritis. Objectives To evaluate the impact of apremilast on health-related quality of life (HRQOL), general functioning and mental health using patient-reported outcome (PRO) assessments among patients with moderate to severe plaque psoriasis in the ESTEEM 1 and 2 trials. Methods A total of 1255 patients were randomized (2 : 1) to apremilast 30 mg BID or placebo for 16 weeks; all received apremilast through Week 32. PRO assessments included the Dermatology Life Quality Index (DLQI), 36-Item Short-Form Health Survey version 2 mental/physical component summary scores (SF-36v2 MCS/PCS), Patient Health Questionnaire-8 (PHQ-8), EuroQol-5D (EQ-5D) and Work Limitations Questionnaire-25 (WLQ-25). Post hoc analyses examined relationships between Psoriasis Area and Severity Index (PASI) scores and PHQ-8 in the apremilast-treated population at Week 16. Results Treatment with apremilast improved all HRQOL PROs at Week 16 (vs. placebo), except the SF-36v2 PCS, and improvements were sustained through Week 32. Mean DLQI and SF-36v2 MCS improvements exceeded minimal clinically important differences. Changes at Week 16 in PHQ-8 and PASI were weakly correlated, and only 35.8% of patients who achieved a ≥75% reduction from baseline in PASI score (PASI-75) with apremilast treatment also achieved PHQ-8 scores of 0–4. Conclusions Apremilast led to improvements in HRQOL PROs vs. placebo in patients with moderate to severe plaque psoriasis.

Introduction Le traitement par ixekizumab (IXE) a montre son efficacite a 12 semaines chez des patients atteints de psoriasis genital (GenPso) modere a severe. L’efficacite et la tolerance d’IXE a 52 semaines dans le GenPso sont rapportees dans cette etude. Materiel et methodes Durant les 12 premieres semaines de traitement en aveugle, les patients avec un GenPso modere a severe avaient ete randomises en 1 : 1, soit sous 80 mg d’IXE toutes les 2 semaines (Q2W, n = 75) soit sous placebo (PBO, n = 74). La premiere dose d’IXE etait de 160 mg. Puis, durant la periode en ouvert a long terme (PLT), de la semaine 12 a la semaine 52, les patients ont recu 80 mg d’IXE toutes les 4 semaines (Q4W), avec possibilite aux semaines 24, 28 ou 40 de passer a une dose bimensuelle d’IXE jusqu’a la semaine 52. Les criteres evalues etaient le pourcentage de patients avec un score sPGA de la zone genitale de 0 ou 1 (sPGA-G 0/1), un sPGA global de 0/1, des ameliorations ≥ 3 et ≥ 4 points du prurit genital (Genital Itch NRS) pour les patients avec un score ≥ 3 ou ≥ 4 a l’etat initial, et un score de 0 ou 1 pour l’item 2 du Sexual Frequency Questionnaire GenPso pour les patients avec un score a l’etat initial ≥ 2. Les resultats d’efficacite presentes ne prennent en compte que les patients randomises dans le groupe IXE (IXE Q2W/IXE Q4W) et dans le groupe PBO (PBO/IXE Q4W) ayant recu la dose recommandee IXE Q4W pendant la periode en ouvert a long terme. La methode NRI a ete utilisee. La tolerance a ete evaluee pour tous les patients ayant recu au moins une dose d’IXE (n = 140). Resultats Sur 149 patients randomises, 139 (93,3 %) ont participe a la PLT et 126 (84,6 %) ont termine l’etude a la semaine 52. Groupe IXE Q2W/IXE Q4W : maintien du sPGA-G 0/1 avec 73,3 % a S12, et 74,7 % a S52. A S52, maintien du sPGA global 0/1 avec 72,0 %, et reduction du Genital Itch NRS (≥ 3 : 72,6 % ; ≥ 4 : 73,2 %) et de l’item 2 SFQ GenPs 0/1 (75,7 %). Groupe PBO/IXE Q4W (n = 65) : 75,4 % ont atteint le sPGA-G 0/1 a la semaine 24 et maintien jusqu’a S52 (78,5 %). A S52, maintien pour le sPGA global 0/1 (73,8 %), le Genital Itch NRS (≥ 3 : 68,6 % ; ≥ 4 : 75,0 %) et l’item 2 SFQ GenPs 0/1 (77,1 %). Des evenements indesirables (EI) sont apparus sous traitement chez 107 (76,4 %) patients, 99 (70,7 %) de gravite legere a moderee, 8 (5,7 %) EI graves (EIG), 41 (29,3 %) imputes au traitement et 3 (2,1 %) ayant entraine l’interruption du traitement. Aucun deces n’est rapporte. Conclusion L’ixekizumab a permis des ameliorations cliniques durables dans le GenPso modere a severe sur 52 semaines. Le profil de securite etait conforme a celui observe lors des etudes precedentes sur le psoriasis.

Trial design We report results from a phase IIa study of efficacy and safety of PF-06700841, an oral TYK2/Jak1 inhibitor, in patients with moderate-to-severe plaque psoriasis ( NCT02969018 ). Methods Patients were randomized to PF-06700841 30 mg once daily (QD), 60 mg QD, or placebo (4-week induction), followed by 10 mg QD, 30 mg QD, 100 mg once weekly, or placebo (8-week maintenance). The primary endpoint was week 12 change from baseline in PASI score. Secondary endpoints were the proportion of patients achieving 75% and 90% reduction from baseline PASI at week 12. Results In total, 212 patients in 35 sites were treated; mean (SD) baseline PASI score was 20.8 (7.68). Decreases in PASI at week 12 were statistically significant compared with placebo in five treatment groups. The greatest change from baseline (least squares mean change –17.3 [95% confidence interval, –20.0 to –14.6]) was observed in the 30-mg QD continuous treatment group. Overall, 136 patients experienced treatment-emergent adverse events, including six serious adverse events in five patients and 13 discontinuations in treatment groups because of adverse events. No herpes zoster cases or major adverse cardiac events including thromboembolic events occurred. Conclusions PF-06700841 was generally effective and well tolerated in patients with moderate-to-severe plaque psoriasis.

Background: Despite the complexity of psoriasis treatment using biologic therapy, there does not exist a standardized synoptic reporting form for the initiation of this population. The purpose of this study was to use a modified Delphi approach to develop a standard checklist for the standardized documentation of patients receiving systemic biologic therapy for psoriasis. Methods: A modified Delphi survey was conducted over 3 rounds (February 2017 through January 2018). An expert panel generated a 51-item checklist that was proposed to participants. Items were rated on an anchored 1-7 Likert scale. Consensus was defined apriori as ≥ 70% agreement by respondents. Results: A total of 58, 17, and 18 dermatologists participated in 3 consecutive Delphi rounds, respectively. Only half of the dermatologists surveyed reported using a checklist for the management of psoriasis. The final checklist comprised 19, 5, 6, and 9 items pertaining to patient history; physical exam and history of systemic therapy; vaccinations; and lab investigations and bloodwork, respectively. Conclusions: Given the increasing availability and complexity of biologic agents for psoriasis treatment, there is a need to promote standardized documentation for this population. The Checklist for the Systemic Treatment of Psoriasis presents 38 items that should be considered when initiating patients with psoriasis on biologic therapy.

not available.