Baseline Characteristics of Canadian Patients in the Psoriasis Longitudinal Assessment and Registry (PSOLAR).

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.

What causes hidradenitis suppurativa ?-15 years after.

The 14 authors of the first review article on hidradenitis suppurativa (HS) pathogenesis published 2008 in EXPERIMENTAL DERMATOLOGY cumulating from the 1st International Hidradenitis Suppurativa Research Symposium held March 30-April 2, 2006 in Dessau, Germany with 33 participants were prophetic when they wrote "Hopefully, this heralds a welcome new tradition: to get to the molecular heart of HS pathogenesis, which can only be achieved by a renaissance of solid basic HS research, as the key to developing more effective HS therapy." (Kurzen et al. What causes hidradenitis suppurativa? Exp Dermatol 2008;17:455). Fifteen years later, there is no doubt that the desired renaissance of solid basic HS research is progressing with rapid steps and that HS has developed deep roots among inflammatory diseases in Dermatology and beyond, recognized as "the only inflammatory skin disease than can be healed". This anniversary article of 43 research-performing authors from all around the globe in the official journal of the European Hidradenitis Suppurativa Foundation e.V. (EHSF e.V.) and the Hidradenitis Suppurativa Foundation, Inc (HSF USA) summarizes the evidence of the intense HS clinical and experimental research during the last 15 years in all aspects of the disease and provides information of the developments to come in the near future.

Weight Loss and Dietary Interventions for Hidradenitis Suppurativa: A Systematic Review.

Hidradenitis suppurativa (HS) is a common inflammatory disorder characterized by recurrent, painful, and malodorous abscesses and nodules predominantly in skin folds. HS is associated with substantial morbidity and poor quality of life. There are no curative therapies, and the only approved biologic drug has variable efficacy and requires high doses, making adjunct treatments crucial. An important risk factor for disease severity is obesity. Our primary objective was to conduct a systematic review examining weight loss and dietary interventions, in HS. Our secondary objective was to examine nutritional supplements in HS.A systematic literature search was conducted using Medline, EMBASE, and the Cochrane Database. We included all study types in adults (>18 years), with a minimum sample size of 5, examining the effects of any dietary or weight loss intervention on HS severity. Two authors screened n = 1279 articles of which 9 met inclusion criteria. All included studies were observational and all interventions were associated with various measures of decreased HS severity. Patient-controlled weight loss and bariatric surgery were associated with HS regression, though a subset of patients with significant increase in panniculi experienced exacerbations and required excision of excess skin. Diets demonstrating benefit eliminated dairy and brewer's yeast. Nutritional supplements including zinc gluconate, vitamin D, and riboflavin had a suppressive, rather than curative, effect on HS lesions in single studies. Overall, the reviewed interventions show promise as potential adjunct treatments in a HS management plan. Prospective randomized controlled trials should validate these findings.

An Investigation of Comorbid Disease and Health Service Utilization Among Patients With Moderate to Severe Psoriasis in Newfoundland and Labrador.

Psoriasis is an inflammatory skin condition affecting 2% to 3% of the population and is associated with several comorbidities, including cardiovascular disease, depression, inflammatory bowel disease, metabolic syndrome, mood disorder, psoriatic arthritis, and weight gain. Psoriasis is treated with a number of topical and systemic therapies, including biologic drugs that directly target proinflammatory cytokines. This cross-sectional retrospective study investigated comorbid conditions reported in the Newfoundland and Labrador psoriasis population, outcomes associated with therapeutic treatment, and use of health care resources. Of the psoriasis comorbidities investigated, psoriatic arthritis was significantly associated with the use of biologic therapy while a failure to respond to biologics was associated with a higher incidence of cardiovascular disease. Patients responsive to biologic treatment had fewer hospital stays than patients treated with other therapies. Our results suggest that biologic therapies have a cardioprotective effect and reduce the number of hospital visits in patients whose symptoms are responsive to treatment.

Comparison of Management Guidelines for Moderate-to-Severe Plaque Psoriasis: A Review of Phototherapy, Systemic Therapies, and Biologic Agents.

INTRODUCTION:: Many international guidelines for management of psoriasis exist and most have variations in grading evidence quality, strength of recommendations, and dosing. The objective of our review is to compare international guidelines published in the United Kingdom, Canada, Europe, and the United States for the management of moderate-to-severe plaque psoriasis. METHODS:: We conducted a literature review on systemic therapies and phototherapy for moderate-to-severe plaque psoriasis in adult patients. The British, Canadian, European, and American guidelines served as the key comparators in our review. To identify relevant supporting clinical trials not referenced in the guidelines, we conducted literature searches in PubMed and EMBASE. Two authors independently extracted data on indications, dosing, efficacy, evidence grade, and strength of clinical recommendation for each therapy. RESULTS:: Monoclonal antibodies directed toward tumour necrosis factor and interleukin (IL)-12/23 received the strongest recommendations for treatment of moderate-to-severe plaque psoriasis, supported by robust, high-quality randomized controlled trials (RCTs). Newer agents such as IL-17 and IL-23 inhibitors are not referenced in most guidelines. There are fewer RCTs for conventional therapies and few head-to-head comparisons with biologics, making it difficult to draw direct comparisons. Among older agents, methotrexate is most strongly recommended for long-term maintenance and cyclosporine is recommended for short-term control of flares. CONCLUSION:: Physicians should individualize psoriasis-management strategies based on medication tolerance, efficacy, safety, patient comorbidities, availability of the medication, and patient preference.

Biologic Therapy Utilization in Patients With Moderate to Severe Psoriasis and Psoriatic Arthritis: An Observational Summary of Biologic Therapy Use in a Clinical Setting.

Plaque psoriasis affects approximately 2% to 3% of the global population, with psoriatic arthritis observed in approximately 20% to 30% of these individuals. Upon advances in research pathophysiology and treatment over the past decade, biologic therapies have been used more to treat moderate to severe psoriasis. In Canada, reimbursement bodies have defined prior authorization criteria to determine patient eligibility for funding of biologic treatments in moderate to severe plaque psoriasis. Generally, patients will have been treated with conventional therapies such as topical steroids, phototherapy, or systemic treatments such as methotrexate and cyclosporine before starting a biologic therapy. In difficult cases or severe flares in otherwise controlled disease, practitioners may augment the regimen with one or more conventional treatments. The objective of this observational report was to identify treatment pathways for psoriasis and psoriatic arthritis patients in Canada by examining initial biologic treatment and subsequent treatment optimization patterns for informed reimbursement discussions and decisions. A retrospective chart review was conducted at Newlab Clinical Research using medical records of patients who received at least 1 of 4 biologic agents approved at that time of the survey in Canada for the treatment of plaque psoriasis (adalimumab, etanercept, infliximab, ustekinumab). The study population consisted of patients who had moderate to severe plaque psoriasis, diagnosed by a dermatologist, for at least 6 months before the study index date and who attended Newlab Clinical Research between 2008 and 2013. All current and previous agents prescribed for the treatment of psoriasis were captured. A total of 248 patients with psoriasis treated with biologics were identified, of whom 27 (10.9%) were also diagnosed with psoriatic arthritis. Prior to initiating treatment with a biologic, most patients (72.1%) were treated with (or contraindicated to) methotrexate/cyclosporine. Treatment was supplemented with topical agents (70.6%) and/or followed by a course of ultraviolet light phototherapy (51.6%). Only 2.4% of patients were treated with a biologic first. Of 248 patients treated with biologics, almost half (47.6%) needed add-on therapy, whereas 16.5% of patients had an increase in dose or dosing interval. Furthermore, 14.1% of patients added a topical agent, 10.5% a topical steroid, or 6.5% a course of phototherapy while continuing biologic therapies. Finally, 30.4% of patients switched to another biologic treatment. Adalimumab was the most common agent used as a second-line agent (37.2%), and patients who started on adalimumab mainly switched to ustekinumab as a second-line agent (73.9%). Infliximab was the agent least often used as second-line therapy.

Psoriasis Patients Treated With Biologics and Methotrexate Have a Reduced Rate of Myocardial Infarction: A Collaborative Analysis Using International Cohorts.

Psoriasis is a chronic inflammatory skin condition characterised by the formation of red scaly plaques on the skin. It is an autoimmune disease cause by the dysregulation of cytokines controlling the inflammatory pathways, a mechanism likely contributing to various comorbidities observed in patients with psoriasis. Cardiovascular disease is one comorbidity observed more frequently in the psoriasis patient population. Biologic treatments specifically target the dysregulation of cytokines in the inflammation pathway and have shown to be an effective treatment for moderate to severe psoriasis where other systemic treatments have failed. More recently, biologics have been shown to reduce the incidence of myocardial infarction in patients with psoriasis compared to patients treated with topical agents. In the present study, 4 international psoriasis patient cohorts are combined and analyzed to examine the effect that biologic or methotrexate treatment has on reducing the incidence of myocardial infarction. Both methotrexate and biologic treatments were found to lower the incidence of myocardial infarction in moderate to severe psoriasis patient populations.

Do Biologics Protect Patients With Psoriasis From Myocardial Infarction? A Retrospective Cohort.

BACKGROUND: Psoriasis is a chronic immune-mediated inflammatory disorder that affects approximately 2% to 3% of the population, which translates to 17 million in North America and Europe and approximately 170 million people worldwide. Although psoriasis can occur at any age, most cases develop before age 40 years. Some larger studies have noted bimodal age at onset with the first peak occurring at approximately age 30 years and the second peak at around 55 to 60 years, but most patients have a younger age of onset (15-30 years). Psoriasis is associated with multiple comorbidities, decreased quality of life, and decreased longevity of life. Two recent systematic reviews and a meta-analysis concluded that psoriasis patients are at increased risk of major adverse cardiovascular events. Multiple studies confirm that many of the comorbidities found in patients with psoriasis are also important risk factors for cardiovascular disease, stroke, diabetes mellitus, hypertension, hyperlipidemia, obesity, and metabolic syndrome. METHODS: We conducted a retrospective cohort study using charts from a dermatology clinic combined with an administrative database of patients with moderate to severe psoriasis in Newfoundland and Labrador, Canada. We examined the role of clinical predictors (age of onset of psoriasis, age, sex, biologic use) in predicting incident myocardial infarction (MI). RESULTS: Logistic regression revealed that age of onset (odds ratio [OR], 8.85; P = .005), advancing age (OR, 1.07; P < .0001), and being male (OR, 3.64; P = .018) were significant risk factors for the development of MI. Neither biologic therapy nor duration of biologic therapy were statistically significant risk factors for the development of MI. Our study found that in patients with psoriasis treated with biologics, there was a nonsignificant trend in reduced MI by 78% (relative risk, 0.18; 95% confidence interval, 0.24-1.34; P = .056). CONCLUSION: Our study demonstrated a trend toward decreased MI in patients with moderate to severe psoriasis on biologics. Patients with an early age of onset of psoriasis (<25 years) were nearly 9 times more likely to have an MI. Clinicians should consider appropriate cardiovascular risk reduction strategies in patients with psoriasis.

Psoriasis and Smoking: A Systematic Literature Review and Meta-Analysis With Qualitative Analysis of Effect of Smoking on Psoriasis Severity.

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.

Quality of life in patients with immune-mediated inflammatory diseases.

There is no doubt that patients with immune-mediated inflammatory diseases (IMID) have a significantly impaired quality of life (QOL). Pain and disability often leave these patients helpless and frustrated. The recognition that addressing physical and psychological functioning plays a significant role in an overall treatment approach led to the inclusion of QOL measures as secondary outcomes in clinical trials with IMID patients. To that end, both generic and disease-specific instruments have been utilized. Measurement of health-related QOL (HRQOL) and patient-reported outcomes (PRO) in a controlled manner allows for better understanding of the correlation between different aspects of disease activity and QOL. In addition, the effects of different therapeutic options on HRQOL-related outcomes can be further evaluated. This 3-part section describes key QOL-related complaints of patients with IMID affecting joints, skin, or gut. An overview of the strengths and weaknesses of various commonly used HRQOL instruments is provided. Finally, the influence of anti-tumor necrosis factor-α agents on HRQOL outcomes, as assessed in recent clinical trials, is highlighted.

Investigating the therapeutic potential of a probiotic in a clinical population with chronic hand dermatitis.

BACKGROUND: Hand dermatitis or hand eczema (HD) is one of the most common dermatologic conditions. Lesions, scaling, pruritus and pain are chronic and relapsing. Improved HD has been reported with the probiotic composed of Lactobacillus acidophilus CL1285, Lactobacillus casei LBC80R and Lactobacillus rhamnosus CLR2 (Bio-K+). PURPOSE: Investigation of the therapeutic potential of this probiotic as the sole systemic treatment for adults with nonacute HD. SUBJECTS AND METHODS: A single-center study documented clinical ratings and patient-reported outcomes in adults with chronic HD. The probiotic was taken orally for 12 weeks, adjunctive to standard topical treatments and preventative measures. RESULTS: Most of the 30 subjects with mild to severe HD were compliant with the probiotic. Around 22 of the 30 subjects were able to complete the study, and of these subjects, an improvement was noted in 19. One required systemic therapy, and one subject was not able to tolerate the probiotic and therefore discontinued the study. 23% of the subjects achieved clear or almost clear hands by the end of 12 weeks. Pruritus, which was a common complaint at baseline, was improved with 59% of symptomatic patients within 2 weeks. CONCLUSION: It is feasible and safe to administer Bio-K+ for HD. Clinicians saw an improvement in most subjects' hands, and cases of significant improvement in dermatitis were documented. Pruritus was the most rapidly relieved symptom, as reported by patients.

Treating Psoriasis and Psoriatic Arthritis: Position Paper on Applying the Treat-to-target Concept to Canadian Daily Practice.

OBJECTIVE: To develop preliminary treat-to-target (T2T) recommendations for psoriasis and psoriatic arthritis (PsA) for Canadian daily practice. METHODS: A task force composed of expert Canadian dermatologists and rheumatologists performed a needs assessment among Canadian clinicians treating these diseases as well as an extensive literature search on the outcome measures used in clinical trials and practice. RESULTS: Based on results from the needs assessment and literature search, the task force established 5 overarching principles and developed 8 preliminary T2T recommendations. CONCLUSION: The proposed recommendations should improve management of psoriasis and PsA in Canadian daily practice. However, these recommendations must be further validated in a real-world observational study to ensure that their use leads to better longterm outcomes.

Medical Treatments of Hidradenitis Suppurativa: More Options, Less Evidence.

Hidradenitis suppurativa is a common debilitating skin disease that has been neglected by science. The disease is getting more and more attention, reflected by the rising number of scientific publications. There is a clear need for effective treatment. We are still at the beginning of improving care for these patients as demonstrated by the low levels of evidence for the medical treatments. Many of these therapies showed promising results, but are still waiting to be validated in randomized, controlled trials. Much more research is needed to strengthen the Level of Evidence for these therapies and thus improve patient care.

The Relationship of Obesity With the Severity of Psoriasis: A Systematic Review.

BACKGROUND: Psoriasis is a chronic inflammatory disease associated with obesity. The increased production of adipocytokines in central adiposity contributes to the systemic inflammation of obesity and perhaps to psoriasis. OBJECTIVE: The objective of this systematic review is to determine the association of obesity with psoriasis severity. METHODS: We searched PubMed, EMBASE, and Cochrane Database for English-language papers involving human subjects for all years. We extracted data on age, sex, body mass index (BMI), proportion obese, and psoriasis severity index score (PASI). RESULTS: We identified 254 articles in our search and included 9. The sample size was 134 823 psoriasis patients. Seven of the 9 studies found a statistically significant association of increased psoriasis severity with higher BMI. CONCLUSION: Increased severity of psoriasis appears to be associated with increased BMI. Most studies were cross-sectional or case-control, making it difficult to determine temporality. Dermatologists should consider recording BMI for psoriasis patients and offering them lifestyle counseling.

Long-term Management of Moderate to Severe Plaque Psoriasis Patients With Etanercept: A Case Series.

BACKGROUND: Currently, etanercept (ETN) safety and efficacy in patients with moderate to severe plaque psoriasis (PsO) has been reported up to 5 years. OBJECTIVE: To present a case series of PsO patients receiving continuous ETN therapy for 7 or more years. METHODS: Physicians collected data retrospectively from 52 patient charts from 5 centres across Canada. RESULTS: Patients in this case series had PsO an average of 31.5 years. Nearly half of patients also had psoriatic arthritis (24/52). All patients demonstrated sustained improvement in Psoriasis Area and Severity Index (PASI) and percentage of affected body surface area (BSA) following ETN treatment. Of the 52 patients, 33 have been receiving ETN for 10 years or more. CONCLUSION: The clinical experience described in this case series report suggests maintenance of ETN efficacy in PsO patients who receive therapy for 7 years or more and indicates that patients can be successfully managed with long-term ETN therapy.

The Relationship Between Dermatologist- and Patient-Reported Acne Severity Measures and Treatment Recommendations.

BACKGROUND: Acne treatment recommendations for individual patients may be derived from multiple factors including dermatologist- and patient-reported constructs. OBJECTIVES: To evaluate the effects of dermatologist- and patient-reported measures on acne treatment recommendations by dermatologists. METHODS: An observational cross-sectional survey of acne patients was conducted with patient-reported quality of life and dermatologist-reported measures of primary and secondary (scar) acne severity using 3 assessment approaches: maximal regional grade, total grade, and facial grade. RESULTS: The most highly associated factors with acne treatment recommendations were patient emotions, maximal regional acne severity, and total acne scar grade. Better acne-specific quality of life was negatively related to acne treatment recommendation intensity, while all 3 grading approaches were positively related to acne treatment recommendations. CONCLUSIONS: For dermatologists, overall acne severity is most highly associated with maximal regional acne grade, total scar grade, and patient's emotional response to acne.

Effective treatment of chronic hand dermatitis with 36 continuous months of alitretinoin administration: report of three cases.

BACKGROUND: Moderate to severe chronic hand dermatitis (CHD) is not well controlled by current medical strategies; however, recent studies have shown significant improvement in patients treated with up to 6 months of oral alitretinoin (9-cis-retinoic acid). The results of longer-term continuous treatment are lacking. OBJECTIVE: To evaluate the long-term safety and efficacy of alitretinoin for the treatment of CHD. METHODS: The Physician's Global Assessment (PGA) and Modified Total Lesion Symptom Score (MTLSS) were used to assess CHD improvement in three patients treated with alitretinoin (10-30 mg/d). Patients had routine bloodwork and were monitored for adverse events. RESULTS: Significant improvement in MTLSS scores (≈ 76%) was seen at 2 months (p < .002) and maintained for the 3-year treatment period with occasional dosage adjustments. No significant adverse events developed that necessitated treatment withdrawal. CONCLUSION: Alitretinoin was well tolerated in the treatment of these three CHD patients who were carefully monitored over this prolonged treatment period.

Long-term prognosis and comorbidities associated with psoriasis in the Newfoundland and Labrador founder population.

BACKGROUND: Psoriasis is a common chronic immune-mediated inflammatory disorder of the skin with several associated comorbidities. OBJECTIVE: To assess the prevalence of comorbidities in a cohort of psoriasis patients within the Canadian province of Newfoundland and Labrador (NL). METHODS: This cross-sectional observational study investigated hospital-coded comorbidities associated with psoriasis in comparison to the general NL hospitalized population. RESULTS: Patients died significantly younger than the general population, with patients having an earlier disease onset (≤ 25 years) dying at a younger age than those with a later onset (> 25 years; 59.3 vs 71.2; p  =  .001). Patients were hospitalized more frequently for several system disorders than the general population, and a potential association was observed between prognostic factors such as age at onset, disease severity, and HLA-Cw6 genotype and certain comorbid conditions. CONCLUSION: This study supports an association between psoriasis and other conditions, such as circulatory and endocrine diseases.

The AWARE study: methodology and baseline characteristics.

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.