A real-world, non-interventional, prospective study of the effectiveness and safety of apremilast in bio-naïve adults with moderate plaque psoriasis treated in the routine care in Greece - the 'APRAISAL' study.

BACKGROUND: Real-world data in patients with moderate psoriasis treated with apremilast is limited. OBJECTIVES: To evaluate the effectiveness and safety of apremilast in bio-naïve patients with moderate psoriasis in real-world clinical settings. METHODS: This was a 52-week multicenter, observational, prospective study of adult outpatients with moderate psoriasis {[10% < body surface area < 20% or 10 < psoriasis area severity index (PASI) < 20] and 10 < dermatology quality of life index (DLQI) < 20} initiated on apremilast ≤7 days before enrollment. Missing data were imputed using the last observation carried forward method. RESULTS: A total of 287 eligible patients (median age: 54.2 years; median psoriasis duration: 9.8 years) were consecutively enrolled. At baseline, the median DLQI and PASI scores were 12.0 and 11.8, respectively. The 52-week DLQI ≤ 5 and PASI75 response rates were 68.3% and 61.0%. At 52 weeks, 70.8% and 72.7% of the patients shifted from moderate/severe/very severe to clear/minimal scalp and palmoplantar psoriasis involvement, respectively; the pruritus severity state improved in 67.2%. The 52-week Kaplan-Meier estimated drug continuation rate was 85.3%. The adverse drug reaction rate was 19.9%. CONCLUSIONS: Apremilast is a safe and effective treatment for bio-naïve patients with moderate psoriasis and specific psoriasis manifestations.

Effectiveness and safety of apremilast in biologic-naïve patients with moderate psoriasis treated in routine clinical practice in Greece: the APRAISAL study.

BACKGROUND: Apremilast is an oral phosphodiesterase-4 inhibitor indicated for patients with moderate-to-severe chronic plaque psoriasis and active psoriatic arthritis. OBJECTIVES: To examine the effectiveness of apremilast on Dermatology Life Quality Index (DLQI), Psoriasis Area and Severity Index (PASI) and nail, scalp and palmoplantar involvement, when administered prior to biologics. METHODS: This 52-week real-world study included biologic-naive adults with moderate psoriasis (psoriasis-involved body surface area 10% to <20%, or PASI 10 to <20 and DLQI 10 to <20). Apremilast was initiated ≤7 days before enrolment. Data from the first 100 eligible patients who completed 24 weeks (W24) of observation (or were prematurely withdrawn) are presented in this interim analysis using the last-observation-carried-forward imputation method. RESULTS: Eligible patients (mean age: 49.9 years; 71.0% males; median disease duration: 8.0 years) were consecutively enrolled between April and October 2017, by 18 dermatology specialists practising in hospital outpatient settings in Greece. Baseline DLQI (median: 12.0) and PASI (median: 11.7) scores improved (P < 0.001) at all postbaseline timepoints (Weeks 6, 16 and 24; W24 median decreases: 9.0 and 9.4 points respectively). At W24, DLQI ≤5, DLQI 0 or 1, and PASI-75 response rates were 63.0%, 25.0% and 48.0% respectively. The Nail Psoriasis Severity Index score in patients with baseline nail involvement (n = 57) decreased at all postbaseline timepoints (P < 0.001; W24 median decrease: 20.0 points). At W24, 50.0% and 51.7% of patients with baseline scalp (n = 76) and palmoplantar (n = 29) involvement respectively achieved postbaseline Physician's Global Assessment (PGA) score of 0 or 1 if baseline score was ≥3, or 0 if baseline score was 1 or 2. The adverse drug reaction rate was 21.0% (serious: 2.0%). CONCLUSIONS: These interim results indicate that through 24 weeks, apremilast improved quality of life and reduced disease severity in biologic-naive patients with moderate plaque psoriasis, while demonstrating safety consistent with the known safety profile.

Multiple Nonfamilial Unilateral Trichoepitheliomas: Report of a Case-Mini Review of the Literature.

Trichoepitheliomas are benign skin tumors with follicular differentiation that present most commonly as solitary lesions. They can also present as multiple centrofacial papules due to several mutations in the CYLD gene. Multiple unilateral trichoepitheliomas in a linear or dermatomal distribution may rarely be seen. Herein, we report a case of multiple unilateral trichoepitheliomas on the face of a healthy 34-year-old woman of Caucasian origin.

A multicenter, prospective, observational study examining the impact of risk factors, such as BMI and waist circumference, on quality of life improvement and clinical response in moderate-to-severe plaque-type psoriasis patients treated with infliximab in routine care settings of Greece.

BACKGROUND: Obesity has been associated with moderate-to-severe plaque psoriasis severity and PASI 75 response attainment of biologic therapies, but findings are inconsistent. OBJECTIVE: This study aimed to examine the association of body mass index (BMI) and waist circumference (WC) on disease severity, to identify potential patient characteristics associated with response attainment and to assess the impact of infliximab on the patients' health-related quality of life (HRQoL) among infliximab-treated patients in the routine care setting of Greece. METHODS: This was a multicenter, prospective, observational study of adult moderate-to-severe plaque psoriasis patients who had initiated treatment with originator infliximab within 2 weeks prior to enrolment. Postenrolment visits occurred at 14 ± 4, 30 ± 4 and 54 ± 4 weeks following treatment onset. RESULTS: Between October 2012 and June 2014, 136 eligible patients (62.5% males) with a median age of 48.6 years, BMI of 29.6 kg/m2 and WC of 107.0 cm at enrolment were recruited by 21 dermatology hospital/private offices. All patients had received prior psoriasis treatment(s); 62.5% were biologic-naïve. Mean baseline psoriasis area severity index (PASI) and Dermatology Quality of Life Index (DLQI) scores were 23.4 ± 13.6 and 15.0 ± 8.3, respectively. A low correlation was observed between WC at enrolment and baseline PASI [ρ = 0.324 (P < 0.001)]. Over a median 48.4 weeks of infliximab exposure, 89.3% of the per protocol set achieved a PASI 75 response. At 14, 30 and 54 weeks, the PASI 75 attainment rate was 66.4%, 74.8% and 76.6%, respectively; the clinically meaningful DLQI improvement (≥5 point decrease) rate was 68.9%, 75.7% and 69.8%, respectively. BMI category and abdominal obesity at enrolment did not impact PASI 75 or DLQI improvement rate attainment. CONCLUSION: In the routine care of Greece, infliximab reduced disease activity and improved the quality of life of moderate-to-severe psoriasis patients through 1 year of treatment, independent of their BMI and WC.

Successful response in a case of severe pustular psoriasis after interleukin-1ß inhibition.

Generalized pustular psoriasis (GPP) is a severe type of psoriasis accompanied by systemic and often life-threatening manifestations. The efficacy of the interleukin (IL)-1 antagonist anakinra in cases of GPP underscores the role of IL-1 in disease pathogenesis. We present a case of a middle-aged man who developed an abrupt and severe form of GPP with severe eosinophilia and cholestatic hepatitis. The patient received salvage treatment with a combination of glucocorticoids, hydroxyurea and imatinib, while administration of the IL-1 inhibitor anakinra resulted in remission of hepatitis and a significant skin improvement. However, due to persistent hypersensitivity skin reactions, anakinra was withdrawn and replaced with the anti-IL-1ß antagonist canakinumab. As a result of canakinumab, the patient's skin completely cleared, while no systemic manifestations recurred. After 1 year of continuous canakinumab therapy, the patient remained virtually free of symptoms, while the drug was well tolerated.

Applicability of dermoscopy for evaluation of patients' response to nonablative therapies for the treatment of superficial basal cell carcinoma.

BACKGROUND: Applicability of dermoscopy in evaluation of outcome and monitoring of superficial basal cell carcinoma (sBCC) after nonablative therapies has not been sufficiently assessed. OBJECTIVES: Certain dermoscopic criteria, namely pigmented structures, ulceration and arborizing vessels, have been suggested to predict the presence of residual disease [residual disease-associated dermoscopic criteria (RDADC)]. We aimed to assess this hypothesis. PATIENTS AND METHODS: Lesions exhibiting RDADC 3 months after treatment were biopsied and in the case of histopathological confirmation were excised. Lesions characterized by white/red structureless areas, superficial fine telangiectasias, or lacking any dermoscopic criterion, were monitored for 12 months. RESULTS: At the 3-month evaluation, one or more of the RDADC were detected in 25/98 (25·5%) sBCCs, in which histology confirmed tumour persistence. In 45 (61·6%) of the 73 remaining lesions, dermoscopy showed white/red structureless areas and/or superficial fine telangiectasias. Twenty-eight lacked any dermoscopic criterion of sBCC. The two latter groups entered follow-up. In total, disease recurred in 13 (17·8%) of the 73 lesions. CONCLUSIONS: RDADC accurately predict residual disease. Absence of dermoscopic criteria of sBCC safely predicts complete histopathological clearance. Detection of white/red structureless areas and/or superficial fine telangiectasias warrants close monitoring to recognize early recurrence.

Dermoscopy of early stage mycosis fungoides.

BACKGROUND: Early stage mycosis fungoides (MF) is difficult to be clinically differentiated from chronic dermatitis (CD) in a high proportion of patients. Dermoscopy is a rapid, cheep, non-invasive and widely used method for the evaluation of skin tumours and, recently, of inflammatory skin diseases, as well. OBJECTIVE: To describe the dermoscopic pattern of early stage MF and compare it with the dermoscopic features observed in CD. METHODS: This was a retrospective study. Dermoscopic images of lesions that were clinically equivocal between MF and CD were evaluated for the presence of predefined morphologic criteria. Diagnosis had been histopathologically and immunohistochemically confirmed in all cases. Sensitivity, specificity, positive predictive value, and negative predictive value were calculated for predefined dermoscopic criteria in relation to the diagnosis of mycosis fungoides. RESULTS: A total of 67 dermoscopic images were selected for dermoscopic evaluation. Mycosis fungoides lesions exhibited a characteristic dermoscopic pattern consisting of fine short linear vessels (sensitivity 93.7%, specificity 97.1%) and orange-yellowish patchy areas (sensitivity 90.6%, specificity 99.7%). A characteristic vascular structure resembling spermatozoa was also found to be highly specific for the diagnosis of mycosis fungoides. CD was typified by a different dermoscopic pattern, usually consisting of dotted vessels. CONCLUSIONS: These observations provide a first indication that early stage MF exhibits a characteristic dermoscopic pattern which is different from CD. Prospective studies with long term follow-up are needed to determine the value of these dermoscopic criteria in the differentiation between the two entities in the daily routine.

Dermoscopy of discoid lupus erythematosus.

BACKGROUND: Dermoscopy is useful in evaluating skin tumours, but its applicability also extends into the field of inflammatory skin disorders. Discoid lupus erythematosus (DLE) represents the most common subtype of cutaneous lupus erythematosus. While dermoscopy and videodermoscopy have been shown to aid the differentiation of scalp DLE from other causes of scarring alopecia, limited data exist concerning dermoscopic criteria of DLE in other locations, such as the face, trunk and extremities. OBJECTIVE: To describe the dermoscopic criteria observed in a series of patients with DLE located on areas other than the scalp, and to correlate them to the underlying histopathological alterations. METHODS: DLE lesions located on the face, trunk and extremities were dermoscopically and histopathologically examined. Selection of the dermoscopic variables included in the evaluation process was based on data in the available literature on DLE of the scalp and on our preliminary observations. Analysis of data was done with SPSS analysis software. RESULTS: Fifty-five lesions from 37 patients with DLE were included in the study. Perifollicular whitish halo, follicular keratotic plugs and telangiectasias were the most common dermoscopic criteria. Statistical analysis revealed excellent correlation between dermoscopic and histopathological findings. Notably, a time-related alteration of dermoscopic features was observed. CONCLUSIONS: The present study provides new insights into the dermoscopic variability of DLE located on the face, trunk and extremities.

Accuracy of dermoscopic criteria for the diagnosis of psoriasis, dermatitis, lichen planus and pityriasis rosea.

BACKGROUND: Dermoscopy is useful in evaluating skin tumours, but its applicability extends also to the field of inflammatory skin disorders. Plaque psoriasis (PP), dermatitis, lichen planus (LP) and pityriasis rosea (PR) are common inflammatory skin diseases, but little is currently known about their dermoscopic features. OBJECTIVES: To determine and compare the dermoscopic patterns associated with PP, dermatitis, LP and PR and to assess the validity of certain dermoscopic criteria in the diagnosis of PP. METHODS: Patients with PP, dermatitis, LP and PR were prospectively enrolled. The single most recently developed lesion was examined dermoscopically and histopathologically. Variables included vascular morphology, vascular arrangement, background colour, scale colour, scale distribution and presence of Wickham striae. Univariate and adjusted odds ratios were calculated. Discriminant functions were used to plot receiver-operator characteristic curves. RESULTS: Eighty-three patients with PP and 86 patients with either dermatitis, LP or PR were included in the study. Dotted vessels in a regular arrangement over a light red background and white scales were highly predictive for the diagnosis of PP, whereas dermatitis more commonly showed yellow scales and dotted vessels in a patchy arrangement. PR was characterized by yellowish background, dotted vessels and peripheral scales; whitish lines (Wickham striae) were seen exclusively in LP. CONCLUSIONS: PP, LP, PR and dermatitis show specific dermoscopic patterns that may aid their clinical diagnosis. Certain combinations of dermoscopic features can reliably predict the diagnosis of PP.

Skin cancer: preventive photodynamic therapy in patients with face and scalp cancerization. A randomized placebo-controlled study.

Background Patients with a previous medical history of nonmelanoma skin cancers (NMSCs) often develop multiple or recurrent malignant lesions around the site of the primary tumour. This finding led to the field cancerization theory, which suggests that the entire epithelial surface of the regional skin has an increased risk for the development of malignant lesions. Management of field change is challenging, taking into account the high impact of NMSCs on public health and healthcare costs. Objectives We sought to investigate whether field-photodynamic therapy (PDT) of extreme photodamaged skin would prevent new NMSCs, in comparison with a control area receiving placebo-PDT, in patients with clinical and histological signs of field cancerization. Methods Forty-five patients, previously diagnosed as having NMSCs of the face or scalp, with actinic keratoses symmetrically distributed over the same regions, were randomized for field treatment with 20% aminolaevulinic acid (ALA)-PDT on one side and placebo-PDT on the other. During the next 12-month period of follow up, patients were clinically evaluated for new NMSCs. Results A significant delay in the mean time of appearance and a reduction in the total number of new lesions were observed in the field-PDT protocol, when compared with the control. Conclusions The results obtained showed that field therapy with ALA-PDT confers a significant preventive potential against the formation of new NMSCs in patients with field changes.

Impetigo herpetiformis: menstrual exacerbations for 7 years postpartum.

Impetigo herpetiformis (IH) is a rare pustular dermatosis that shares striking clinical and histological similarities to generalized pustular psoriasis. The case of a 26-year-old primigravida with IH progressing in the 30th week of her pregnancy is presented. The peculiarity of our presentation relies on the reappearance of the disease postpartum. Monthly exacerbations during menstruation lasted for 7 years. Some probable clues regarding the pathogenesis of IH are suggested.

Imiquimod 5% cream: a new treatment for Bowen's disease.

Bowen's disease (BD) is a squamous cell carcinoma in situ. Recent studies suggest that human papilloma virus plays an important role in the development of BD. We investigated whether imiquimod 5%, a topical immune response modifier, is an effective treatment for BD in five immunocompetent patients. The lesions were one genital and four extragenital. The frequency of application varied from three times weekly up to twice daily, and treatment duration ranged from 8-24 weeks. Four patients achieved clinical and histological cure. The patient with the genital lesion gained an important reduction in size and infiltration, which enabled surgical removal of the remaining lesion with good functional and cosmetic result. Our results suggest that topical imiquimod 5% is an effective treatment for BD through its viral and antitumor effects.

Pyogenic granulomas following topical application of tretinoin.

Topical tretinoin is used in the treatment of acne and other dermatoses. The most common side-effects are itching, dryness and reddening of the skin. We report an additional cutaneous reaction, which occurred in patients using topical tretinoin. Pyogenic granulomas developed in two patients with acne and in one with dermatofibroma following application of tretinoin. The granulomas grew on the lesions after 2-3 weeks of therapy initiation. All patients were men and the granulomas developed in their trunk. The lesions resolved when topical tretinoin was ceased. Although the number of patients reported is too small to estimate the true incidence of this reaction, it is likely that dermatologists will encounter similar reactions in patients treated with topical tretinoin for acne or other reasons.