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Competing Interests: Declaration of Conflicting InterestsThe author(s) declared the following potential conflicts of interest with respect to the research, authorship, and/or publication of this article: EYL has received speaker honorarium from Sanofi and AstraZeneca. IT: none. AWC: none. JB: none. RB is an advisory board member, consultant, speaker, and/or investigator for and receives honoraria and/or grant from AbbVie, Amgen, Arcutis, Asana BioSciences, Bellus Health, BioMimetix, Bluefin Biomedicine, Boehringer-Ingelheim, Boston, CARA Therapeutic, Clexio, Dermavant, Eli Lilly, Escient, Evidera, Fresh Tracks (Brickell), Galderma, GlaxoSmithKline, Incyte, Inmagene Bio, Janssen, LEO Pharma, Novartis, Opsidio, Pfizer, RAPT Therapeutic, Regeneron, Sanofi, Target RWE and Vyne Therapeutics. RB is also an employee and shareholder of Innovaderm Research. HC: none. ACM: none. MG has been an investigator, speaker, and/or advisor for: AbbVie, Amgen, Akros, Arcutis, Aristea, AnaptysBio, Apogee, Bausch Health, BMS, Boehringer Ingelheim, Celgene, Dermira, Dermavant, Eli Lilly, Galderma, GSK, Incyte, Janssen, Kyowa Kirin, LEO Pharma, MedImmune, Meiji, Merck, Moonlake, Nimbus, Novartis, Pfizer, Regeneron, Roche, Sanofi Genzyme, Sun Pharma, Tarsus, Takeda, UCB, Union and Ventyx. NH was on the advisory board/ round table honoraria for L’Oreal, Abbvie, Leo, Sun, Eucerin, Lilly, J&J, Arcutis, Sanofi, and Regeneron. HCHH has been an investigator for and/or speaker for and/or received honoraria from the following companies: Abbvie, Amgen, Arcutis, Bausch Health, Boehringer-Ingelheim, Bristol Meyers Squibb, Celgene, Cutanea, Dermira, Dermavant, DS Biopharma, Eli Lilly, Galderma, GSK, Incyte, Janssen, Leo Pharma, Medimmune, Merck, Mirimar, Novartis, Pfizer, Regeneron, Sanofi-Genzyme, Roche, and UCB. NJL: none. JALM: none. RM: none. KP received honoraria from AbbVie, Acelyrin, Akros, Amgen, Aralez Pharmaceuticals, Bausch Health/Valeant, Boehringer Ingelheim Celgene, Celltrion, Coherus, Dermavant, Dice Pharmaceuticals, Eli Lilly, Forbion, Galderma, Janssen, Kyowa Hakko Kirin, Leo, Meiji Seika Pharma, Merck (MSD), Mitsubishi Pharma, Novartis, Pfizer, Reistone, Sanofi-Aventis/Genzyme, Sandoz, Sun Pharma, Takeda, UCB, and vTv Therapeutics. KP received clinical research grants from AbbVie, Akros, Amgen, Anacor, Arcutis, Avillion, Bausch Health/Valeant, Boehringer Ingelheim, Bristol-Myers Squibb, Can-Fite Biopharma, Celgene, Coherus, CorEvitas, Dermavant, Dermira, Dow Pharma, Eli Lilly, Evelo, Galderma, Gilead, GSK, Incyte, Janssen, Kyowa Hakko Kirin, Leo, Merek (MSD), Novartis, Pfizer, Regeneron, Roche, Sanofi-Aventis/Genzyme, Sun Pharma, Takeda, and UCB. AMD has received compensation from the British Journal of Dermatology (reviewer and Section Editor), American Academy of Dermatology (guidelines writer), National Eczema Association (grant reviewer), Canadian Dermatology Today (manuscript writer), and Canadian Agency for Drugs and Technologies in Health (consultant). Dr Drucker has received research grants to his institution from the National Eczema Association, Eczema Society of Canada, Canadian Dermatology Foundation, Canadian Institutes for Health Research, US National Institutes of Health, and Physicians Services Incorporated Foundation.

Background: The Psoriasis Longitudinal Assessment and Registry (PSOLAR) is a global, prospective, longitudinal, disease-based registry. It serves as a post-marketing safety commitment with a focus on patients with moderate to severe plaque psoriasis who are candidates for systemic therapy., Objectives: To describe the baseline disease demographics and clinical characteristics of a Canadian subgroup of participants enrolled in PSOLAR., Methods: Baseline demographic/disease characteristics, medical histories, and previous psoriasis treatments for Canadian patients in PSOLAR were summarized using descriptive statistics., Results: There were 1896 patients analyzed in the Canadian subgroup at 37 clinical sites, accounting for 15.7% of the global PSOLAR population. Baseline disease and clinical characteristics were as expected for a moderate to severe psoriasis population and were generally similar to the global PSOLAR population. Two distinctions were noted in the Canadian subgroup versus those enrolled globally: a higher proportion of patients were overweight/obese (84.7% vs. 80.4%) and male (61.4% vs. 54.7%). In addition, the Canadian subgroup had numerically higher historical peak disease activity (PGA score 3.35 vs. 3.1) and longer disease duration (22.3 years vs. 17.5 years). Canadian PSOLAR patients reported a variety of comorbidities, including psoriatic arthritis (31.5%), hypertension (34.6%), hyperlipidemia (24.3%), mental illness (24.1%), and inflammatory bowel disease (1.6%)., Conclusion: The Canadian subgroup of PSOLAR patients was generally similar to those enrolled globally with respect to baseline disease demographics and clinical characteristics. Multiple comorbidities are noted in the Canadian subgroup, underscoring the need for a holistic approach to the treatment of psoriatic patients., Competing Interests: Declaration of Conflicting InterestsThe authors declared the following potential conflicts of interest with respect to the research, authorship, and/or publication of this article: MJG: Consultant, speaker and/or advisory boards for AbbVie, Akros Pharma, Amgen, Arcutis, Aslan, Aristea, AnaptysBio, Boehringer Ingelheim, BMS, Celgene, Dermira, Dermavant, Eli Lilly and Company, Galderma SA, GSK, Incyte, Janssen, Kyowa Kirin, Leo Pharma, MedImmune, Merck, Moonlake, Meiji, Nimbus, Novartis, Pfizer, Regeneron, Reistone, Roche, Sanofi Genzyme, and UCB; RB: Advisory Board Member, Consultant, Speaker and/or Investigator for and received honoraria and/or grants from, AbbVie, Alumis, Amgen, AnaptysBio, Bausch Health, Boston, BMS/Celgene, Dermavant, Eli Lilly, Janssen, LEO Pharma, Nimbus, Novartis, Pfizer, Regeneron, UCB, VentyxBio and Xencor. R Bissonnette is also an employee and shareholder of Innovaderm Research; SK: Consultant, speaker or advisory boards for AbbVie, Actelion Pharmaceuticals, Amgen, Boehringer Ingelheim, BMS, Celgene, Eli Lilly and Company, Galderma SA, GSK, Janssen, Leo Pharma, Merck, Novartis, Pfizer, Regeneron, Roche, Sanofi Genzyme, UCB, and Valeant Pharmaceutical; KAP: Receive honoraria and/ or clinical research grants as a consultant, speaker, scientific officer, steering committee member, and/or advisory board member for 3M, AbbVie, Akesis, Akros, Alza, Amgen, Astellas, Baxter, Boehringer Ingelheim, Celgene, Centocor, Cipher, Eli Lilly, Forward Pharma, Funxional Therapeutics, Galderma, Glaxo Smith Kline, Isotechnika, Janssen, Janssen Biotech, Kirin, Kyowa, Lypanosys, Merck-Serono, Merck Sharpe Dome, Mitsubishi Pharma, Novartis, Pfizer, Takeda, UCB, Vertex, and/ or Wyeth; LCG: Consultant, speaker, and received grants for clinical research from AbbVie, Amgen, Celgene, Eli Lilly, Janssen, Leo Pharma, Merck, Novartis, Pfizer, and Valeant; speaker and consultant for Aralez; consultant and received grants for clinical research from Bristol-Meyers Squibb, and received grants for clinical research from Boehringer Ingelheim and UCB. WPG: grants/research support from AbbVie, Amgen, Eli Lilly, Novartis, Pfizer; honoraria for ad boards/invited talks/consultation from AbbVie, Actelion, Amgen, Arylide, Bausch Health, Boehringer, Celgene, Cipher, Eli Lilly, Galderma, Janssen, LEO Pharma, Merck, Novartis, PeerVoice, Pfizer, Sanofi-Genzyme, Tribute, UCB, Valeant; and clinical trials (study fees) from AbbVie, Asana Biosciences, Astellas, Boerhinger-Ingleheim, Celgene, Corrona/National Psoriasis Foundation, Devonian, Eli Lilly, Galapagos, Galderma, Janssen, LEO Pharma, Novartis, Pfizer, Regeneron, UCB.>.; VH: Consultant, speaker or advisory boards for Abbvie, Eli Lilly, Janssen, and Novartis; NHS: Consultant for AbbVie, Bausch Medicine, Celgene, Janssen, Leo Pharma, Lilly, Novartis, Sanofi Genzyme; RV: Consultant, speaker and/or advisory boards for AbbVie, Actelion Pharmaceuticals, Amgen, Boehringer Ingelheim, BMS, Celgene, Dermira, Eli Lilly and Company, Galderma SA, GSK, Janssen, Leo Pharma, Merck, Novartis, Pfizer, Regeneron, Roche, Sanofi Genzyme, UCB, and Valeant Pharmaceutical; RG: clinical trials for AbbVie, Bausch Health, and Janssen and has received honoraria as consultant and/or speaker from AbbVie, Bausch Health, Eli Lilly, Janssen, Kyowa Kirin, Mallinckrodt, Novartis, Sun Pharma and Sanofi; VHP: Consultant, speaker and/or advisory boards for AbbVie, Actelion, Amgen, AnaptysBio, Aralez, Arcutis, Aspen, Bausch Health, Boehringer Ingelheim, Bristol Myers Squibb, Celgene, Cipher, Eli Lilly, Galderma, GlaxoSmithKline, Homeocan, Incyte, Janssen, LEO Pharma, L’Oreal, Medexus, Novartis, Pediapharm, Pfizer, Sanofi Genzyme, Sun Pharma, Tribute, UCB Pharma, and Valeant; investigator for AbbVie, Amgen, Arcutis, Arena, Asana, Bausch Health, Boehringer Ingelheim, Bristol Myers Squibb, Celgene, Concert, Dermavant, Dermira, Eli Lilly, Galderma, Incyte, Janssen, LEO Pharma, Nimbus Lakshmi, Novartis, Pfizer, Regeneron, Reistone, Sanofi Genzyme, UCB Pharma, and Valeant; received educational grants from AbbVie, Bausch Health, Celgene, Janssen, LEO Pharma, Novartis, Sanofi Genzyme, and Valeant; IT: Consultant, speaker or investigator for Abbvie, Amgen, Arcutis, Aristea, Bausch Health, BMS, Boehringer Ingelheim, Celgene, Eli Lilly, Galderma, Incyte, Janssen, Kiniksa, LeoPharma, Mallinckrodt, Novartis, Pfizer, Sanofi, SunPharma, UCB; WL, KP, SDS, NA and OL: Employee of either Janssen Research & Development or Janssen Inc. Canada; RA: Consultant, speaker or advisory boards for Abbvie, Amgen, Boehringer Ingelheim, Eli Lilly and Company, Galderma, Janssen, Leo Pharma, Novartis, Pfizer, Sandoz, Sanofi, Sun pharma, and UCB.

Topical calcineurin inhibitors (TCIs) were approved in the early 2000s for the treatment of atopic dermatitis (AD), and despite the recent introduction of newer topical and systemic therapies for AD, TCIs such as tacrolimus ointment (0.03% and 0.1%) and pimecrolimus cream (1%), remain recommended treatment options in contemporary management guidelines. The goal of this article is to review the evidence supporting the approved indications for TCIs in adults with AD, including short-term treatment of active disease and as intermittent or maintenance treatment for the prevention of flares. Other evidence reviewed in this article includes the treatment of specific body areas (such as the face and eyelids), combination or sequential use of TCIs with topical corticosteroids, and the comparative efficacy of the 2 commercially available TCIs. This review of the evidence confirms that TCIs remain an effective treatment option for the management of adult AD.

Background:: Patients with immune-mediated diseases on immunosuppressive therapies have more infectious episodes than healthy individuals, yet vaccination practices by physicians for this patient population remain suboptimal., Objectives:: To evaluate the safety and efficacy of vaccines in individuals exposed to immunosuppressive therapies and provide evidence-based clinical practice recommendations., Methods:: A literature search for vaccination safety and efficacy in patients on immunosuppressive therapies (2009-2017) was conducted. Results were assessed using the Grading of Recommendation, Assessment, Development, and Evaluation system., Results:: Several immunosuppressive therapies attenuate vaccine response. Thus, vaccines should be administered before treatment whenever feasible. Inactivated vaccines can be administered without treatment discontinuation. Similarly, evidence suggests that the live zoster vaccine is safe and effective while on select immunosuppressive therapy, although use of the subunit vaccine is preferred. Caution regarding other live vaccines is warranted. Drug pharmacokinetics, duration of vaccine-induced viremia, and immune response kinetics should be considered to determine appropriate timing of vaccination and treatment (re)initiation. Infants exposed to immunosuppressive therapies through breastmilk can usually be immunized according to local guidelines. Intrauterine exposure to immunosuppressive agents is not a contraindication for inactivated vaccines. Live attenuated vaccines scheduled for infants and children ⩾12 months of age, including measles, mumps, rubella, and varicella, can be safely administered as sufficient time has elapsed for drug clearance., Conclusions:: Immunosuppressive agents may attenuate vaccine responses, but protective benefit is generally maintained. While these recommendations are evidence based, they do not replace clinical judgment, and decisions regarding vaccination must carefully assess the risks, benefits, and circumstances of individual patients.

Background:: Atopic dermatitis (AD) is a chronic, relapsing, and remitting inflammatory skin disease with complex pathophysiology, primarily driven by type 2 inflammation. Existing guidelines often do not reflect all current therapeutic options and guidance on the practical management of patients with AD is lacking., Objectives:: To develop practical, up-to-date guidance on the assessment and management of adult patients with AD., Methods:: An expert panel of 17 Canadian experts, including 16 dermatologists and 1 allergist, with extensive clinical experience managing moderate-to-severe AD reviewed the available literature from the past 5 years using a defined list of key search terms. This literature, along with clinical expertise and opinion, was used to draft concise, clinically relevant reviews of the current literature. Based on these reviews, experts developed and voted on recommendations and statements to reflect the practical management of adult patients with AD as a guide for health care providers in Canada and across the globe, using a prespecified agreement cutoff of 75%., Results:: Eleven consensus statements were approved by the expert panel and reflected 4 key domains: pathophysiology, assessment, comorbidities, and treatment., Conclusions:: These statements aim to provide a framework for the assessment and management of adult patients with AD and to guide health care providers in practically relevant aspects of patient management.

Clinicians rely on clinical measures to define the severity of atopic dermatitis and assess outcomes of therapy. These measures can be objective (ie, physician assessments of disease severity) or subjective (ie, patient-reported symptoms and quality of life outcomes). In this review, the most commonly used tools for assessing atopic dermatitis severity in adult patients are presented and compared. These include Eczema Area and Severity Index (EASI); SCORing Atopic Dermatitis (SCORAD); Physician Global Assessment (PGA); body surface area (BSA); Atopic Dermatitis Severity Index (ADSI); Six Area, Six Sign Atopic Dermatitis (SASSAD); Patient Oriented Eczema Measure (POEM); Dermatology Life Quality Index (DLQI); and pruritus Numerical Rating Scale (NRS). Available severity strata for the tools are summarized, although the use of severity strata in clinical practice is not recommended. Since both objective and subjective assessments of disease severity are important to assess, consideration of clinical characteristics such as disease recurrence or persistence, as well as location of the affected areas, should be considered in the overall judgement of disease severity and consideration of therapy choice.

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.

Background: Smoking has been associated with psoriasis prevalence and severity., Objective: To evaluate prevalence of smoking in patients with psoriasis and to examine the relationship between smoking and psoriasis severity., Methods: MEDLINE, EMBASE, and Cochrane databases (1960-2012) and conference proceedings (2010-2012) were systematically searched using keywords relevant to psoriasis and smoking. Controlled studies addressing psoriasis and smoking status were included. A meta-analysis for the relative risk of smoking in psoriasis patients was performed., Results: Meta-analysis identified a significant association between smoking and psoriasis with a relative risk of 1.88 (95% CI, 1.66-2.13) for smoking in patients with psoriasis versus patients without psoriasis. Eight articles of 11 with data on smoking and psoriasis severity suggested that severity increases with smoking status., Conclusions: This literature review is in favor of a positive association between the prevalence of smoking and psoriasis as well as an association between smoking and severity of psoriasis., (© The Author(s) 2015.)

Background: Studies have shown that psoriatic patients are at increased risk for myocardial infarction (MI) and stroke. There is a lack of data on MI risk in Canadian psoriatic patients., Objective: To compare MI risk in Canadian psoriatic patients to that in control patients., Methods: This was a retrospective cohort study using Quebec's health insurance database (2005-2010) comparing MI risk in psoriatic patients to that in matched controls. Severe psoriasis was defined as any diagnosed psoriatic patient who used phototherapy or oral or injectable psoriasis treatments. Adjustments were made for several MI risk factors., Results: There were 31,421 patients in the psoriasis population, of which 5,159 had severe psoriasis. The unadjusted MI incidence rate per 1,000 person-years was 4.88 (95% confidence interval [95% CI] 4.50-5.20), 5.58 (95% CI 5.10-6.10), and 5.32 (95% CI 4.40-6.40) for the control and mild and severe psoriasis groups, respectively. After adjustments, the hazard ratio of MI was significantly higher for psoriatic patients than for controls (1.17; 95% CI 1.04-1.31). The hazard ratio was also significantly higher than for controls in the mild psoriasis group (1.18; 95% CI 1.05-1.33) but not in the severe psoriasis group (1.16; 95% CI 0.94-1.42)., Conclusion: The relative MI risk is higher for Canadian psoriatic patients than for controls.

Background: Current therapeutic options for extensive alopecia areata (AA) often lead to disappointing results., Objective: To study the efficacy and safety of adalimumab in patients with severe AA., Methods: This was a prospective, open-label, single-center, pilot study. Three subjects of the planned 10 were enrolled and received two weekly subcutaneous (SC) loading doses of adalimumab 80 mg followed by 40 mg SC every week for 6 months. Patients were evaluated for efficacy and safety on a monthly basis., Results: Enrolment in this trial was stopped following publication of studies showing no improvement in patients with AA treated with tumor necrosis factor α antagonists. One patient had a favorable response to adalimumab, whereas the two other patients had no benefit from the therapy. Adalimumab was well tolerated by patients with AA., Conclusion: Adalimumab was well tolerated in patients with AA but did not induce clinically significant hair regrowth.

Background: Little is known about the interaction between dermatologists and their patients in facilitating treatment decisions for psoriasis., Purpose: Our objective was to determine dermatologists' perceptions of the needs of psoriasis patients in treatment decisions., Methods: Dermatologists were invited to complete an 18-item online survey on the treatment of psoriasis, including questions on decision-making roles, factors they considered important to patients in treatment decisions, and patients' needs for decision support., Results: Seventy dermatologists completed the survey (15% response rate). The highest rated factors in decision making were access to physicians for discussion (86%) and information about the risks and benefits (80%); the latter was more frequently reported by those ≥ 50 years (p  =  .021). Treatment-specific factors of greatest importance were side-effect profile (87%) and cost (80%). Potential hindrances were patient misconceptions about disease, inadequate patient education materials, patient indecision, and inadequate physician time., Conclusion: Although dermatologists consider accessibility to dermatologists and information on treatment risk and benefits to be important in treatment decision making, they report time with patients and educational materials to be inadequate., Limitations: The small sample size may limit the generalizability of our findings.

Background: Hand dermatitis (HD) is one of the most common skin conditions; however, it is not a homogeneous disease entity. The severity of HD may range from very mild cases to severe chronic forms, which may result in prolonged disability and, occasionally, refractory HD. Chronic hand dermatitis (CHD) is associated with a high health- economic burden and significant loss of quality of life., Objective: Although numerous treatment options are available, the management of CHD is often difficult and unsatisfactory. There is a paucity of well-designed, randomized, controlled clinical trials in support of the efficacy of established treatment modalities., Conclusion: These guidelines cover the epidemiology, burden, quality of life, etiology, diagnosis, classification, and prevention of HD and provide guidance on management using an approach that is as evidence based as possible.

Background: Informed shared decision making is a mutual process engaging both doctor and patient and informed by best medical evidence and patient values and preferences., Objective: Our aim was to identify the needs of psoriasis patients in decisions on selecting treatment., Methods: Psoriasis subjects participated in an online survey on decisional role, postdecisional conflict, and treatment awareness., Results: Of 2,622 people invited to participate, 248 completed surveys. Their most recent treatment decision was either made by subjects alone (42%) or physicians alone (28%) or was shared (29%). Subjects perceived that their doctors lacked time to stay abreast of treatments, to provide counseling, and to access appropriate treatments. Deficiencies most frequently identified were information on options, clarification of values, access to physicians, and decision-making skills. Those with a body surface area (BSA) ≥ 3% more frequently indicated that having the skill or ability to make treatment decisions was important., Limitations: The limitations of this study include sampling, recall, and reporting bias. Percent BSA was not verified., Conclusions: The multiple deficiencies in support of psoriasis patients in treatment decisions may preclude informed shared decision making.

Background: Alefacept has been demonstrated in clinical trials to be an effective, safe, and well-tolerated treatment strategy when used alone or in combination with other antipsoriatic therapies in patients with chronic plaque psoriasis., Objective: AWARE (Amevive Wisdom Acquired from Real-World Evidence) is a multicenter, observational, Canadian phase IV registry evaluating the efficacy and safety of alefacept, alone or in combination with other antipsoriatic therapies, in patients with psoriasis., Methods: Patients with chronic plaque psoriasis were treated with at least one course of alefacept followed by an off-treatment period, typically lasting 12 or more weeks. Prospective follow-up was at least 60 weeks, depending on when patients presented for retreatment. Safety data collected throughout the study included the incidence of serious adverse events (SAEs), dosing suspensions, and withdrawals owing to adverse events., Results: Twelve SAEs were reported in psoriasis patients treated with at least one course of alefacept, with only one considered to be possibly related to the study drug. Approximately one-quarter of patients missed at least one dose of alefacept during the course of the study. A total of 291 doses of alefacept were missed, representing almost 4% of the total doses administered in this group of patients. Low CD4(+) count was the most frequent reason for missed doses; however, no patient had persistently low CD4(+) counts requiring permanent discontinuation of alefacept treatment. Seven patients in the AWARE registry discontinued treatment with alefacept, with the most common reason being patient request., Conclusion: The AWARE study supports the safety of alefacept used alone or in combination with other antipsoriatic therapies, in a broad population of real-world chronic plaque psoriasis patients in Canada.

Background: Alefacept was the first biologic therapy approved by Health Canada for the treatment of moderate to severe chronic plaque psoriasis and is used either alone or as part of combination therapy., Objective: AWARE (Amevive Wisdom Acquired from Real-World Evidence) is a multicenter, observational phase IV Canadian study of psoriasis patients treated with alefacept. This study's main goals were to develop a shared, real-time, national clinical database to support best practice and optimize the care of patients receiving alefacept and to gain an understanding of how alefacept is used in Canadian clinical practice. Baseline patient demographic data are described herein., Methods: Patients with chronic plaque psoriasis were enrolled from 37 clinics across Canada. Subjects received at least one course of alefacept treatment followed by a period of at least 12 weeks off treatment and were prospectively followed for at least 60 weeks. Baseline assessments included patient demographics, relevant medical history, psoriasis and treatment history, reasons for initiating alefacept, enrolling physician's initial alefacept treatment plan and strategy, percent body surface area (BSA) involvement with psoriasis, and physician's baseline assessment of disease control. Subsequent assessments at each follow-up visit included the patient's response and the physician's assessment., Results: A total of 426 adult patients with predominantly chronic plaque psoriasis, with or without other types of psoriasis, were enrolled into the AWARE registry. Patients generally had moderate to severe psoriasis, with more than half (55.8%) having little or no disease control at baseline as assessed by their clinician, and 77% had > 10% BSA involvement with psoriasis. All patients in the AWARE patient population were receiving one or more treatments for psoriasis prior to or at the time of enrolment, and the majority continued to receive concomitant treatments at the time of study enrolment., Conclusion: The AWARE registry enrolled a broad group of real-world patients with chronic plaque psoriasis treated with alefacept in clinical practices across Canada.

Background: Alefacept has demonstrated efficacy in clinical trials of patients with chronic plaque psoriasis, either as monotherapy or combined with other treatment modalities such as phototherapy., Objective: AWARE (Amevive Wisdom Acquired from Real-World Evidence) is a multicenter, observational, phase IV Canadian registry of psoriasis patients treated with alefacept., Methods: Patients with chronic plaque psoriasis were treated with at least one course of alefacept, either alone or added on to their existing antipsoriatic treatment regimen. Each course of alefacept was followed by a period of at least 12 weeks off treatment. Efficacy outcomes included physicians' and patients' assessments of response at week 18, as well as change in percent body surface area (BSA) involvement with psoriasis. The time to retreatment was assessed in patients receiving a second course of alefacept during at least 60 weeks of prospective follow-up., Results: The majority of patients received alefacept in combination with other antipsoriatic therapies. Physicians' and patients' assessments of response at 18 weeks showed that 42% and 41% of patients, respectively, had a "cleared to marked response" and a further 42% had a "moderate to some response." Among those patients whose psoriasis was moderately controlled or not controlled at baseline, 49 to 51% and 33 to 36%, respectively, improved to "cleared to marked response" at 18 weeks. A substantial shift in percent BSA involvement with psoriasis was observed at 18 weeks, with 55% of patients having a BSA involvement of < 10% at week 18 compared to only 20% having this level of BSA involvement at baseline. The mean time to retreatment among the 60% of patients who received a second course of alefacept was 19.3 weeks (range 2-47 weeks)., Conclusion: A single course of alefacept therapy improved outcomes in this broad population of real-world chronic plaque psoriasis patients., Study Limitations: The limitations of this study include its nonrandomized, noncontrolled, noncomparative design, which allowed multiple different treatment approaches across all patients. The rating scales used in this study have not been previously validated, and ranges were assigned to baseline control and response data that are not specifically defined. Clinicians did not receive specific training in using these scales; therefore, interrater variability could not be assessed.

Background: Evidence from clinical trials supports the use of alefacept for the treatment of patients with chronic plaque psoriasis, either as monotherapy or combined with other treatment modalities., Objective: AWARE (Amevive Wisdom Acquired from Real-World Evidence) is a multicenter, observational, phase IV Canadian registry of psoriasis patients treated with alefacept., Methods: Patients with chronic plaque psoriasis were treated with at least one course of alefacept treatment followed by a period of at least 12 weeks off-treatment. The use of combination therapy with alefacept in a real-world population of psoriasis patients is presented here, including the types of psoriasis therapies received by patients at the time of enrolment, reasons for initiating alefacept, and discontinuation or dosage reduction of concomitant therapy., Results: The majority of patients were receiving other antipsoriatic therapies at the time of enrolment into the AWARE study, most commonly topical therapy, systemic agents, or phototherapy. Most patients were receiving monotherapy prior to the initiation of alefacept. There was little change in the use of topical therapies with alefacept at 24 weeks, whereas a substantial proportion of patients were able to reduce or discontinue concomitant systemic therapies and/or phototherapy. The use of combination therapy regimens was relatively consistent across the country and by age groups, although younger patients were prescribed systemic agents more often than older patients., Conclusion: Alefacept is commonly added to other antipsoriatic therapies in a broad population of real-world chronic plaque psoriasis patients in Canada and may allow for dosage reduction or discontinuation of concomitant systemic agents or phototherapy.

For many years, the mainstays of psoriasis therapy were conventional oral immunosuppressants (eg, cyclosporine and methotrexate) and retinoids. Recently, six biologic agents were approved for the treatment of psoriasis in Canada and the United States: alefacept, efalizumab, etanercept, infliximab, adalimumab, and ustekinumab. Biologic agents exert their therapeutic effect in psoriasis through inhibition of various pathways. Although these treatments are new to the management of psoriasis, many have been used in other disease states, such as rheumatoid arthritis, psoriatic arthritis, and Crohn's disease. Long-term safety data are available from the treatment of these diseases. Both conventional and biologic treatments are effective in the treatment of psoriasis, but they are associated with serious adverse events, ranging from organ toxicity to serious infections, birth defects, and malignancies. This article reviews the safety profiles of both classes of treatments.

Background: Genital psoriasis is difficult to treat and has a significant psychological impact on affected patients., Objective: To study the safety and efficacy of topical tacrolimus ointment in male patients with genital psoriasis., Methods: This was an open-label study in 12 male patients with genital psoriasis. Patients received topical tacrolimus 0.1% ointment twice daily for 8 weeks followed by a 4-week observational period. Efficacy was assessed by a modification of the Psoriasis Area and Severity Index (PASI) scale adapted for genital psoriasis (male genital PASI). Severity was also evaluated individually for the glans, shaft of the penis, and scrotum., Results: Male genital PASI decreased from a mean score of 15.8 at baseline to 1.2 at week 8 (p < .001). Psoriasis severity also improved significantly for the glans, shaft of the penis, and scrotum evaluated individually. Tacrolimus 0.1% ointment was very well tolerated, with only mild pruritus or burning sensation of limited duration reported., Conclusions: Topical tacrolimus ointment appears very efficacious and well tolerated in male patients with genital psoriasis.

Background: Local skin reactions are common during imiquimod treatment of actinic keratosis (AK). Cyclical application of imiquimod may improve tolerability while maintaining efficacy., Objective: To assess the tolerability of imiquimod and clearance rate of AK lesions after imiquimod application., Methods: Imiquimod 5% cream was administered three times per week for 4 weeks followed by 4 weeks of rest (cycle 1) to AK lesions on the head. If AK lesions remained visible at the end of cycle 1, a second treatment cycle was instituted., Results: Fifty percent (30 of 60) of patients experienced complete clearance of AK lesions, and 75% (30 of 40) of patients experienced partial clearance of AK lesions after imiquimod treatment at the end of cycle 2. Moreover, 77% of patients who achieved complete clearance had no visible AK lesions 12 weeks post-treatment. Imiquimod was well tolerated., Conclusion: Imiquimod cycle therapy may be a safe and effective treatment option for AK lesions.

Background: XP-828L, a protein extract obtained from sweet whey, has demonstrated potential benefit for the treatment of mild to moderate psoriasis in an open-label study., Objective: To study in a randomized, double-blind, placebo-controlled study the safety and efficacy of XP-828L in the treatment of mild to moderate psoriasis., Design: XP-828L 5 g/d (group A, n = 42) or placebo (group B, n = 42) was given orally for 56 days followed by XP-828L 5 g/d in group A and by XP-828L 10 g/d in group B for an additional 56 days., Results: Patients receiving XP-828L 5 g/d for 56 days had an improved Physician's Global Assessment (PGA) score compared with patients under placebo (p < .05). Considering the data of group A only, the PGA score improved from day 1 to day 56 (p < .01); the Psoriasis Area and Severity Index score improved as well, but to a lesser extent (p < .05)., Conclusion: Oral administration of 5 g/d XP-828L compared with a placebo significantly improved the PGA score of patients with mild to moderate psoriasis.

Background: Approximately 2% of people worldwide have psoriasis, with as many as 1 million people with psoriasis in Canada alone.1,2 The severity of psoriasis ranges from mild to severe. It can lead to substantial morbidity and psychological stress and have a profound negative impact on patient quality of life.3,4 Although available therapies reduce therapies reduce the extent and severity of the disease and improve quality of life,3 reports have indicated a patient preference for more aggressive therapy and a dissatisfaction with the effectiveness of current treatment options.5, Objective: A Canadian Expert Panel, comprising Canadian dermatologists, convened in Toronto on 27 February 2004 to reach a consensus on unmet needs of patients treated with current therapies and how to include the pending biologic agents in and improve the current treatment algorithm for moderate-to-severe psoriasis. Current treatment recommendations suggest a stepwise strategy starting with topical agents followed by phototherapy and then systemic agents.3,6,7 The Panel evaluated the appropriate positioning of the biologic agents, once approved by Health Canada, for the treatment of moderate-to-severe psoriasis., Methods: The Panel reviewed available evidence and quality of these data on current therapies and from randomized, controlled clinical trials.8-14 Subsequently, consensus was achieved by small-group workshops followed by plenary discussion., Results: The Panel determined that biologic agents are an important addition to therapies currently available for moderate-to-severe psoriasis and proposed an alternative treatment algorithm to the current step wise paradigm., Conclusion: The Panel recommended a new treatment algorithm for moderate-to-severe psoriasis whereby all appropriate treatment options, including biologic agents, are considered together and patients' specific characteristics and needs are taken into account when selecting the most appropriate treatment option.

Background: The use of photodynamic therapy (PDT) with topical aminolevulinic acid (ALA) on large skin surfaces has recently been reported for patients with multiple actinic keratoses., Objective: The current study compared the ability of topical and systemic ALA-PDT as well as topical ALA-PDT with blue light to delay the appearance of UV-induced skin cancer using the hairless mouse as a model., Methods: Groups of hairless mice were exposed daily to UV radiation and weekly to ALA-PDT. Tumor-free survival was compared for mice exposed to UV and treated weekly with ALA-PDT and mice exposed only to UV radiation., Results: Weekly topical or systemic ALA-PDT was able to delay the induction of skin tumors. A significant difference in tumor-free survival was also observed for both actinic keratoses and invasive squamous cell carcinoma in mice treated weekly with topical ALA-PDT performed with blue light. This was observed even when weekly ALA-PDT was started after 8 weeks of UV exposure., Conclusion: Large-surface topical ALA-PDT with blue light can delay the appearance of UV-induced actinic keratoses and squamous cell carcinoma in hairless mice.

Background: Preliminary studies have suggested that photodynamic therapy (PDT) with 5-aminolevulinic acid (ALA) can improve psoriasis and mycosis fungoides, two diseases where normal or malignant T cells play a central role., Objectives: To determine if ALA-PDT induces apoptosis and caspase activation in Jurkat cells, a malignant T-cell line., Methods: Jurkat cells were incubated with ALA in the presence of [14C]-thymidine followed by red light exposure. DNA fragmentation was measured 24 hours later with a DNA elution assay. The influence on DNA fragmentation of ALA concentration, time between ALA addition and light exposure, as well as light fluence were studied. The occurrence of oligonucleosome-sized DNA fragmentation was also studied with DNA electrophoresis. Caspase-3-like activity was monitored by measuring Ac-DEVD-AMC hydrolysis., Results: DNA fragmentation as high as 88% was observed 24 hours after ALA-PDT. The percentage of DNA fragmentation increased with increasing doses of ALA, red light fluence, as well as longer incubation time with ALA. DNA fragmentation was observed as early as 3 hours after ALA-PDT. The presence of apoptosis after ALA-PDT was confirmed by DNA electrophoresis. An increase in caspase-3-like activities was detected following ALA-PDT., Conclusion: ALA-PDT induces apoptosis and caspase-3-like activation in Jurkat cells.

Background: Solar urticaria is a photodermatosis that can be very disabling for patients who are highly sensitive to light and can also be very resistant to therapy., Objective: To correlate the results of serial phototesting in a patient with severe and refractory solar urticaria before and after treatment with plasma exchange., Methods: Plasma exchange was performed five times over a period of 10 days. Phototesting to ultraviolet A (UVA) irradiation and visible light was performed with fluorescent ultraviolet tubes and an incandescent lamp., Results: The urticaria that developed after very low light doses during baseline phototesting could not be provoked following plasma exchange. The patient is now almost symptom-free, with only occasional and transient hives more than 21 months after her last plasma exchange., Conclusions: Plasma exchange is a therapeutic modality to consider in highly light-sensitive patients when other treatments have failed.

A simple technique for the localization of foreign bodies using a spring hook wire under computed tomographic (CT) guidance is described. The advantages of CT in detecting foreign bodies of near water density and in planning a surgical approach which avoids important anatomical structures are emphasized.