Remission Duration and Long-Term Outcomes in Patients with Moderate-to-Severe Psoriasis Treated by Biologics or Tofacitinib in Controlled Clinical Trials: A 15-Year Single-Center Experience Abstract Introduction Relapse is common after treatment discontinuation for patients with moderate-to-severe psoriasis. The objective of this study was to understand the remission duration and long-term outcomes in psoriasis patients after biologic withdrawal. Methods We retrospectively included the follow-up data of 184 patients with moderate-to-severe psoriasis after the end of 11 biologic or tofacitinib trials conducted between 2004 and 2016. Results Among the 232 treatment courses, 95 achieved (psoriasis area and severity index) PASI 75 at the end of the studies. At 6 months after treatment discontinuation, the systemic treatment-free rates of our patients who entered the PRESTA, PRISTINE, PEARL, ERASURE, CLEAR, the global tofacitinib study, and the IXORA-P study were 66.7%, 66.7%, 75.0%, 16.7%, 22.2%, 33.3%, and 29.2%, respectively. Pooled data showed a serious adverse event incidence rate of 1.5/100 person-years. The proportions of systemic treatment-free episodes were 16.8%, 7.4%, 4.3%, 3.2%, and 3.2% at 1, 2, 3, 4, and 5 years, respectively. Biologics were reinitiated in 41.9%, 66.7%, 77.1%, 83.5%, and 86.1% at 1, 2, 3, 4, and 5 years, respectively. Multivariate generalized estimating equation (GEE) regression analysis demonstrated that predictors for a longer relapse-free duration were baseline PASI, PASI improvement, biologic naivety, and early biologic intervention. Patients who received early biologic intervention, who achieved PASI 90, and who were biologic naive showed significantly higher relapse-free rate by Kaplan–Meier analysis with log rank test. Conclusions Systemic treatment was required in 86.1% of patients within 12 months after biologic withdrawal and biologics were reinitiated in 77.1% of patients after 3 years. However, early biologic administration within 2 years after diagnosis demonstrated a lower risk of relapse in patients with moderate-to-severe psoriasis.

Factors Influencing Sleep Difficulty and Sleep Quantity in the Citizen Pscientist Psoriatic Cohort Abstract Introduction Sleep is essential for overall health and well-being, yet more than one-third of adults report inadequate sleep. The prevalence is higher among people with psoriasis, with up to 85.4% of the psoriatic population reporting sleep disruption. Poor sleep among psoriasis patients is particularly concerning because psoriasis is independently associated with many of the same comorbidities as sleep dysfunction, including cardiovascular disease, obesity, and depression. Given the high prevalence and serious consequences of disordered sleep in psoriasis, it is vital to understand the nature of sleep disturbance in this population. This study was designed to help meet this need by using survey data from Citizen Pscientist, an online patient portal developed by the National Psoriasis Foundation. Methods Our analysis included 3118 participants who identified as having a diagnosis by a physician of psoriasis alone or psoriasis with psoriatic arthritis. Demographic information, psoriasis severity and duration, sleep apnea status, smoking and alcohol consumption, itch timing, and sleep characteristics were included. Two separate multivariate logistic regression models in STATA were used to determine whether the presence of psoriatic arthritis, age, gender, body mass index, comorbid sleep apnea, psoriasis severity, timing of worst itch, smoking status, or high-risk alcohol consumption were associated with sleep difficulty or low sleep quantity, defined by the American Academy of Sleep Medicine as less than 7 h of sleep per night on average. Results Results from the multivariate logistic regressions found that sleep difficulty was associated with psoriatic arthritis (OR 2.15, 95% CI [1.79–2.58]), female gender (2.03 [1.67–2.46]), obese body mass index (BMI ≥ 30) (1.25 [1.00–1.56]), sleep apnea (1.41 [1.07–1.86]), psoriasis severity of moderate (1.59 [1.30–1.94]) or severe (2.40 [1.87–3.08]), and smoking (1.60 [1.26–2.02]). Low sleep quantity was associated with obese BMI (1.62 [1.29–2.03]), sleep apnea (1.30 [1.01–1.68]), psoriasis severity of moderate (1.41 [1.16–1.72]) or severe (1.40 [1.11–1.76]), and smoking (1.62 [1.31–2.00]). Sleep difficulty and low sleep quantity were not associated with age, alcohol consumption, or timing of worst itch. Conclusion These results are potentially meaningful in several aspects. We identify an important distinction between sleep difficulty and sleep quantity in psoriatic disease, whereby having psoriatic arthritis and being female are each associated with sleep difficulty despite no association with low sleep quantity. Furthermore, there is conflicting evidence from prior studies as to whether psoriasis severity is associated with sleep difficulty, but this well-powered, large study revealed a strong, graded relationship between psoriasis severity and both sleep difficulty and low sleep quantity. Overall, our results show that both sleep difficulty and low sleep quantity were associated with multiple factors in this analysis of a large psoriatic cohort. These findings suggest that dermatologists may gather clinically useful information by screening psoriatic patients for trouble sleeping and low sleep quantity to identify potential comorbidities and to more effectively guide disease management.

Genetic Hair Disorders: A Review Abstract Hair loss in early childhood represents a broad differential diagnosis which can be a diagnostic and therapeutic challenge for a physician. It is important to consider the diagnosis of a genetic hair disorder. Genetic hair disorders are a large group of inherited disorders, many of which are rare. Genetic hair abnormalities in children can be an isolated phenomenon or part of genetic syndromes. Hair changes may be a significant finding or even the initial presentation of a syndrome giving a clue to the diagnosis, such as Netherton syndrome and trichothiodystrophy. Detailed history including family history and physical examination of hair and other ectodermal structures such as nails, sweat glands, and sebaceous glands with the use of dermoscopic devices and biopsy all provide important clues to establish the correct diagnosis. Understanding the pathophysiology of genetic hair defects will allow for better comprehension of their treatment and prognosis. For example, in patients with an isolated hair defect, the main problem is aesthetic. In contrast, when the hair defect is associated with a syndrome, the prognosis will depend mainly on the associated condition. Treatment of many genetic hair disorders is focused on treating the primary cause and minimizing trauma to the hair.

Economic Impact of Etanercept in Patients with Psoriasis and Psoriatic Arthritis in Spain: A Systematic Review Abstract Introduction Etanercept (ETN), a highly effective biological agent for the treatment of psoriasis (PSO) and psoriatic arthritis (PsA), is widely used in Spain. However, evidence of its economic impact is limited, indicating the need for a systematic review of the economic assessments conducted on the use of ETN in the treatment of both PSO and PsA in Spain. Methods A systematic review was carried out in PubMed, Embase, Cochrane Library, Health Technology Assessment reports and not indexed sources up to November 2018. The inclusion criteria were economic evaluations (total and partial) and dose optimization studies published in English or Spanish on the use of ETN to treat PSO and PsA for ETN in Spain. Results A total of 402 publications were identified, of which 32 were selected for inclusion in the review; of these 32 publications, 81.3% analyzed PSO (14 full economic evaluations, 5 partial economic evaluations and 7 dose optimization studies) and 18.8% analyzed PsA (1 economic analysis and 5 dose optimization studies). The perspective of the Spanish National Health Service (NHS) was used in 90.0% (n = 18) of the full and partial economic evaluations. The time horizons ranged from 12 weeks to 2 years. Reductions in the Psoriasis Area and Severity Index (PASI) of 50, 75 and 90% (PASI 50, 75 and 90, respectively) were most commonly used as efficacy outcomes in the complete evaluations. The economic impact of ETN ranged from €9110–14,337/PASI 75 at 12 weeks (50 mg/week) to €82,279/PASI 90 at 2 years, depending on the health outcome, time horizon and ETN dose used. Only one study determined the cost of using ETN for the treatment of PSO (€29,430–52,367/QALY for dose 2 × 25 mg/week or 50 mg/week, respectively). Only one partial economic evaluation on PSA was identified (NHS perspective), resulting in an ETN annual cost of €8585/patient-year. Conclusion Consistent evidence on the economic impact of ETN for the treatment of PSO and PSA in Spain is lacking, mainly due to the highly heterogeneous methodology used and the broad range of outcomes found in the economic evaluations published to date. Funding Pfizer S.L.U.

Evaluation of a Handheld Dermatoscope in Clinical Diagnosis of Primary Cicatricial Alopecias Abstract Introduction Clinical diagnosis of primary cicatricial alopecias presents difficulties. Studies regarding their trichoscopic features are scarce and mostly not comprehensive. The aim of this study is to evaluate the potential benefit of a handheld dermatoscope in clinical diagnosis of primary cicatricial alopecias. Methods In all, 69 patients with primary cicatricial alopecias were included in this prospective study. Preliminary diagnoses were established clinically, and confirmed by scalp biopsy in all cases. Trichoscopic examination was performed using a polarized-light handheld dermatoscope with tenfold magnification. The images were taken using a digital camera with threefold optical zoom. Results The following findings were significantly more common, or noted only, in particular types of primary cicatricial alopecias: “target” pattern blue-grey dots, perifollicular scaling, perifollicular cast in lichen planopilaris (n = 27); short vellus hairs, tufted hairs, crust formation, yellowish tubular scaling, pustule, red dots in folliculitis decalvans (n = 17); large keratotic yellow dots in discoid lupus erythematosus (n = 7); yellow dots, yellow dots with “three-dimensional” structure, black dots in dissecting cellulitis of the scalp (n = 6). Absence of vellus hairs was observed in patients with lichen planopilaris, frontal fibrosing alopecia, and discoid lupus erythematosus without a significant difference between the groups. Short vellus hairs were detected in all types, including frontal fibrosing alopecia (n = 7). Conclusion We suggest that a polarized-light handheld dermatoscope is useful for revealing several typical trichoscopic features of primary cicatricial alopecias that guide clinical diagnosis. As a novel observation, our data indicate that absence of vellus hairs is not an identifying feature for frontal fibrosing alopecia.

Atrophic Dermatofibroma: A Comprehensive Literature Review Abstract Introduction An atrophic dermatofibroma is a benign fibrohistiocytic neoplasm. It typically presents as an asymptomatic patch with a depressed central area. Methods The PubMed database was used to search the following words: atrophic, dermatofibroma, elastic and fibers. The relevant papers and their references generated by the search were reviewed. Images of the clinical and pathological features of two patients with an atrophic dermatofibroma are presented. In addition, a comprehensive review of the characteristics of this unique dermatofibroma is provided. Results An atrophic dermatofibroma has been reported in 102 patients: 53 women, 11 men and 38 individuals whose gender was not provided. It typically appeared as an asymptomatic solitary patch with a central umbilication—most commonly on the shoulder or lower extremity or back—of women aged 48 years or older. Dermoscopy typically showed white scar-like patches; a patchy pigment network was also noted in some lesions. The pathology of an atrophic dermatofibroma has the same features that can be observed in a common fibrous dermatofibroma; there is acanthosis, basal layer hyperpigmentation, and induction of basal cell carcinoma-like features, hair follicle formation or sebaceous hyperplasia in the epidermis and a proliferation of spindle-shaped fibroblasts in the dermis. However, atrophic dermatofibromas also demonstrate depression of the central surface and thinning of the dermis; in many cases, the dermal atrophy is at least 50%. Elastic fibers are either decreased or absent. Similar to non-atrophic dermatofibromas, the immunoperoxidase profile of atrophic dermatofibromas is factor XIIIa-positive and cluster of differentiation 34 (CD34)-negative. The pathogenesis of atrophic dermatofibromas remains to be established. Conclusion An atrophic dermatofibroma is an uncommon benign variant of a dermatofibroma. The diagnosis can be suspected based on clinical features and dermatoscopic findings. A biopsy of the lesion will confirm the diagnosis. Periodic evaluation of the lesion site is a reasonable approach to the management of the residual tumor.

Novel Non-Steroidal Facial Cream Demonstrates Antifungal and Anti-Inflammatory Properties in Ex Vivo Model for Seborrheic Dermatitis Abstract Introduction Seborrheic dermatitis (SEBD) is a chronic, recurrent skin disorder that typically occurs as an inflammatory response to fungi of the genus Malassezia. The development of an ex vivo model that mimics the fungal proliferation and skin inflammation of SEBD would play an important role in screening formulations for their efficacy in treating SEBD. Methods An ex vivo model for SEBD using human skin explants that had been mechanically manipulated to facilitate colonization of Malassezia furfur was developed. This model was used to evaluate the efficacy of a novel non-steroidal facial cream (NSFC) in inhibiting M. furfur proliferation and reducing inflammatory cytokine levels. Results This model reproduced some of the key pathological features of SEBD, including M. furfur proliferation and inflammatory cytokine production. Topical application of NSFC facial cream reduced M. furfur counts by 92% (p < 0.05) and levels of interleukin 8 (IL-8) and tumor necrosis factor alpha (TNF-α) by 82% and 40%, respectively (p < 0.05, both). Conclusion The proposed ex vivo model for SEBD could be a useful tool to evaluate topical antifungal treatments. The novel NSFC tested in this study reduced M. furfur proliferation and inflammatory cytokine levels following topical application and may be helpful in the management of SEBD. Funding ISDIN.

New Methodology to Evaluate Sunscreens Under Outdoor Conditions: A Double-Blind, Randomized Intra-Individual Clinical Study of a Water-Based Broad-Spectrum SPF50+ Versus SPF15 (P3) and SPF50+ Abstract Introduction This study explored a new method to test sunscreens in outdoor conditions (very high to extreme ultraviolet [UV] radiation) approximating real-life solar exposure while maintaining scientific standards and acceptable conditions, and assessed the efficacy of a water-based sun-protection factor (SPF) 50+ versus a reference SPF15 and two comparator SPF50+ products. Methods Thirty-five subjects underwent testing in summertime Mauritius. In each subject, five test areas were marked on the back. One area was left unprotected, and four sunscreens were applied to the others: investigational product (IP), SPF15 (ISO 24444:2010 reference standard P3), and two marketed SPF50+ controls. Subjects spent 1–2 h (depending on skin type) in the sun. After 24 h, erythema was assessed by clinical scoring (0–5) and colorimetry (a*, L*, and ITA). Secondary endpoints were correlation between clinical and colorimetry assessment, product tolerability, and total UV radiation received. Results All subjects were exposed to a very high UV index (≥ 8) and 30/35 were exposed to an extreme UV index (≥ 11). The IP showed statistically significant differences in clinical erythema scoring compared with unprotected skin and SPF15, but not with SPF50+ controls. On colorimetry, differences in a* (redness) and L* (lightness) reached statistical significance for the IP vs SPF15 but not vs SPF50+ controls. Clinical and instrumental erythema assessment correlated strongly (Spearman’s rho 0.663). No tolerability issues were reported. Conclusion This exploratory study confirmed the ability of this outdoor model to discriminate sunscreens with different SPF using clinical evaluation as an objective measure. The water-based sunscreen maintained its efficacy in outdoor conditions of very high to extreme UV radiation: it was superior to SPF15 and comparable to SPF50+ controls in preventing erythema. The method used represents an option for sunscreen efficacy comparison outside of the laboratory. Funding Isdin.

A Real-World, Non-interventional Indian Study Evaluating Intensive Plant-Based Butter Moisturizing Cream in Psoriasis Abstract Introduction Psoriasis is estimated to affect 0.44–2.8% of the Indian population. Moisturizers are a key adjuvant psoriasis treatment strategy, but data regarding their effectiveness, safety and compliance pattern in an Indian context are lacking. Hence, this real-world study on an intensive plant-based butter moisturizing cream (Venusia ® Max) was conducted among Indian patients with psoriasis. Methods This was an observational, patient-reported outcomes (PRO) study in patients with psoriasis aged 18–75 years who were prescribed the cream in routine clinical practice, as per clinician’s discretion, over 4 weeks. The primary outcome measure was improvement from baseline in quality of life assessed using the Dermatology Quality of Life Index (DLQI) at 4 weeks of the study period. The secondary outcome measures were improvement in dryness using the Dry Skin/Ichthyosis Area and Severity Index (DASI) score at 4 weeks, safety and compliance. The DLQI and DASI scores were recorded by the clinicians at baseline and after 2 (optional) and 4 weeks of starting the cream. Safety was assessed throughout the study. Results The study included 400 patients from 9 outpatient dermatology centers across India. Of 400 patients, 384 completed the study. A significant reduction in both the mean DLQI score (66.7%; p < 0.001) and mean DASI score (84.6%; p < 0.001) was observed at week 4 after starting the cream vs. baseline in the overall population. Overall, the cream showed a good safety and compliance profile during the study period. There were no serious adverse events or deaths. Conclusions The evidence from the PRO study suggests that use of the intensive plant-based butter moisturizing cream in a real-world scenario has a noticeable impact on improving the quality of life and reducing the skin dryness associated with psoriasis over 4 weeks. The moisturizing cream may serve as a valuable adjuvant treatment option for the management of psoriasis. Trial Registration Number CTRI/2017/03/008023. Funding Dr. Reddy’s Laboratories Ltd.

ERAPSO: Revealing the High Burden of Obesity in German Psoriasis Patients Abstract Introduction Plaque psoriasis is a chronic, systemic-inflammatory disease characterized by skin erythema, plaques and scaling, and is associated with different comorbidities like psoriatic arthritis, obesity, and cardiometabolic diseases. Obesity aggravates cardiovascular risk in psoriasis patients and can negatively affect psoriasis disease severity with proinflammatory adipocytokine production by adipocytes and infiltrated immune cells. Methods An online survey on nutrition and physical activity in psoriasis participants (ERAPSO) collected cross-sectional data about eating behavior, physical activity, and prevalence of obesity and metabolic syndrome components from 9940 psoriasis participants in Germany. Results ERAPSO revealed a high burden of obesity in German psoriasis participants with 66.9% overweight or obese (body mass index [BMI] ≥ 25 kg/m2), compared to approximately 50% of the German general population. Affected body surface area (BSA), cardiovascular risk factors, and cardiovascular event frequency increased with increasing BMI. Severe psoriasis was more frequent in overweight participants and impaired engagement in weight loss diets and physical activity. Most German psoriasis participants (90.2%) with BMI ≥ 25 kg/m2 perceived themselves as overweight. A minority (21.2%) were currently exercising with the aim of losing weight, and 12.6% were currently on a weight loss diet. In overweight participants, just 13.3% stated that their physicians and/or health insurance offered specific weight loss programs. Conclusion ERAPSO revealed inadequate medical care of obese psoriasis participants with insufficient support for weight loss through diet or increased physical activity. Although psoriasis participants showed an intact self-perception of obesity, they seemed to lack intrinsic motivation to lose weight, highlighting the need for external support in losing weight via tailored programs. Since psoriasis severity correlates with impairment in diets and sports, treating psoriasis adequately may allow participants to follow weight loss programs more successfully. Funding Novartis Pharma GmbH, Nuremberg, DE.