Real-world data on the effectiveness of brodalumab in patients with moderate-to severe plaque psoriasis in the Greek clinical setting (the BrIDGE study).

BACKGROUND: Despite that brodalumab's efficacy and safety have been assessed in randomized clinical trials, real-life data remain scarce. BrIDGE was an observational, prospective, single-cohort, multicentre study that recruited patients with moderate-to severe plaque psoriasis in Greece. OBJECTIVES: The primary objective was to assess the proportion of patients who achieved Psoriasis Area and Severity Index (PASI)100 after 24 weeks. Other endpoints included: the maintenance of PASI90/100 through to 104 weeks, the short-term response [PASI75/90/100 and static Physician's Global Assessment (sPGA) 0/1] to brodalumab at 12-16 weeks and time to complete clearance. Moreover, we explored the change in quality of life [Dermatology Life Quality Index (DLQI) 0/1] and adherence to brodalumab. METHODS: Two hundred patients who were initiating treatment with or switching to brodalumab, were recruited. Analyses were conducted using the as observed data and three imputation approaches were also applied for the missing data (last observation carried forward, 'worst case' and 'best case' scenario). Continuous variables were reported using summary statistics, whereas categorical variables were reported in frequency tables. RESULTS: Based on the 'as observed data', 42.0% of patients achieved PASI100 at Week 24 after 25.9 ± 3.5 weeks and 65% of patients attained PASI100 at Week 104. In total, 70.2%, 47.5% and 32.0% achieved PASI75/90/100, respectively, whereas 72.6% of patients achieved sPGA 0/1, at Weeks 12-16. With respect to sPGA status 82.8%, 89.2% and 92.5% of patients achieved sPGA 0/1 at Weeks 24, 52 and 104, respectively. The time to achieve PASI100 at Weeks 12-16 was 13.7 ± 1.3, 52.1 ± 3.4 weeks at Week 52 and 105.5 ± 4.8 weeks at Week 104. Mean DLQI and Psoriasis Symptom Inventory (PSI) scores decreased by 11.4 ± 7.0 and 15.4 ± 6.5 points from baseline to Week 104, respectively. Adherence to treatment was equal to 98.9%. CONCLUSIONS: Brodalumab confers rapid and durable responses, as well as improvements in the quality of life of moderate-to-severe psoriasis patients.

S2k guidelines on diagnosis and treatment of linear IgA dermatosis initiated by the European Academy of Dermatology and Venereology.

INTRODUCTION: Linear IgA dermatosis (LAD) is a rare subepidermal autoimmune bullous disease (AIBD) defined by predominant or exclusive immune deposits of immunoglobulin A at the basement membrane zone of skin or mucous membranes. This disorder is a rare, clinically and immunologically heterogeneous disease occurring both in children and in adults. The aim of this project is to present the main clinical features of LAD, to propose a diagnostic algorithm and provide management guidelines based primarily on experts' opinion because of the lack of large methodologically sound clinical studies. METHODS: These guidelines were initiated by the European Academy of Dermatology and Venereology (EADV) Task Force Autoimmune Bullous Diseases (AIBD). To achieve a broad consensus for these S2k consensus-based guidelines, a total of 29 experts from different countries, both European and non-European, including dermatologists, paediatric dermatologists and paediatricians were invited. All members of the guidelines committee agreed to develop consensus-based (S2k) guidelines. Prior to a first virtual consensus meeting, each of the invited authors elaborated a section of the present guidelines focusing on a selected topic, based on the relevant literature. All drafts were circulated among members of the writing group, and recommendations were discussed and voted during two hybrid consensus meetings. RESULTS: The guidelines summarizes evidence-based and expert opinion-based recommendations (S2 level) on the diagnosis and treatment of LAD. CONCLUSION: These guidelines will support dermatologists to improve their knowledge on the diagnosis and management of LAD.

Real-Life Data on the Management of Incompletely Excised Basal Cell Carcinoma.

BACKGROUND: The histopathologic presence of basal cell carcinoma (BCC) cells at one or more margins of the specimen after surgical excision is considered suggestive of incomplete tumor clearance. The management of incompletely excised BCC might vary in different clinical scenarios from re-excision to application of other treatments or even watchful waiting. OBJECTIVE: The aims of the study were to report the real-life management of incompletely excised BCC in a tertiary referral center and compare the recurrence rates according to the selected management modality. METHODS: A retrospective study was conducted at a tertiary Dermatology Center in Northern Greece. Our electronic database was scanned over a 5-year period to retrieve all BCCs with available histopathologic assay reporting at least one involved margin (lateral or deep). The included patients were divided into 3 groups according to the selected management after incomplete excision: group 1 included those who underwent immediate re-excision (n = 26), group 2 those who were followed up without any additional therapy (n = 40), and group 3 those who were treated with adjuvant/complementary non-surgical treatment (n = 18). Finally, we recorded the presence or absence of residual tumor in the new histopathologic report of those tumors that were selected to be re-excised (group 1). The primary outcome was the appearance of clinical tumor recurrence. RESULTS: Of 1,689 BCCs recorded in our database, 84 met the inclusion criteria and were included in the analysis. Re-excision had been selected in 26 of 84 patients (group 1), watchful waiting in 40 (group 2), and non-surgical treatments in 18 (group 3). The histopathologic reports of the 26 tumors of group 1 that were re-excised revealed residual tumor in 14 (53.8%) cases. Overall, a clinical recurrence occurred in 14 of 84 patients (16.7%) after a mean follow-up of 17 months. The median time to recurrence was 14 months. Of 40 patients without any treatment, recurrence developed in 10 (25%), while only 2 of 18 patients treated with non-surgical treatments recurred (11.1%). CONCLUSIONS: Our study suggests that positive histopathologic margins after BCC excision result in a clinical recurrence only in a proportion of patients. This percentage is higher when no further treatment is applied and lower when the area is re-excised or treated with imiquimod alone or combined with cryotherapy.

Sub-population analysis of patients with plaque psoriasis treated with calcipotriol/betamethasone aerosol foam; effectiveness and patient satisfaction, according to baseline disease severity and prior psoriasis treatment experience, in a Greek population.

Fixed combination calcipotriol/betamethasone (Cal/BD) aerosol foam has been shown to be effective in psoriasis treatment in clinical trials, but real-world evidence is currently sparse. The real-world CELSUS study in Greece found that Cal/BD aerosol foam treatment was effective and associated with satisfaction in psoriasis patients. Patients from the CELSUS study (N = 400) were stratified by baseline disease severity according to physician's global assessment (PGA) score (mild vs. moderate vs. severe) and by previous psoriasis treatment (naïve vs. treatment-experienced). Proportions of patients achieving treatment success (clear/almost clear [PGA 0/1]) after 4 weeks' treatment with Cal/BD aerosol foam were reported for each subgroup. Psoriasis area and severity index (PASI) and patient-reported itch, itch-related sleep loss, scaling, dry skin, and erythema numerical rating scores were reported by subgroup. At baseline, 216 (54%) patients were systemic-or-topical psoriasis treatment-naïve and 184 (46%) were treatment experienced. By disease severity, there were 135 versus 89 patients with mild, 69 versus 83 with moderate and 12 versus 12 with severe disease in the treatment-naïve versus treatment-experienced groups, respectively. In the treatment-naïve group, treatment success was achieved by 72.6%, 56.5%, and 66.7% of patients with mild, moderate, and severe disease, respectively, while the proportions in the treatment-experienced group were 60.7%, 42.2%, and 25%, respectively. Reduction from baseline in psoriasis symptoms was observed in all patient groups. The greatest reductions were observed in treatment-naïve patients with severe disease. Clinically relevant benefits were observed with Cal/BD aerosol foam in psoriasis patients, regardless of prior treatment-experience and disease severity at baseline.

Real world experience of brodalumab treatment in patients with moderate-to-severe plaque psoriasis in the Greek population: Results from an interim analysis of the BrIDGE study.

Brodalumab's clinical efficacy and favorable safety profile have been demonstrated during controlled clinical trials, but real-world data remain scarce. BrIDGE, an ongoing 104 week, observational, prospective, multicenter study conducted in Greece, enrolled moderate-to-severe plaque psoriasis patients, with body surface area (BSA) > 10 or psoriasis area severity index score (PASI) > 10 and dermatology life quality index (DLQI) > 10, based on European consensus, initiating brodalumab treatment as per routine clinical practice. This interim analysis includes evaluations 12-16 weeks following treatment initiation. Key efficacy endpoints included proportion of patients achieving static Physician's Global Assessment (sPGA) score of "clear/almost clear" (0/1) and a reduction ≥75%, 90%, 100% from baseline in PASI (PASI75, PASI90, and PASI100) at weeks 12-16. Other endpoints included time to achieve PASI100, changes in self-reported DLQI and psoriasis symptom inventory (PSI) at weeks 12-16. From 200 patients (mean age 51.4 years, 70% male, mean disease duration 13.8 years) enrolled, 72.8% achieved sPGA of 0/1, whereas 70.2%, 47.5%, and 32.0% achieved corresponding PASI75, PASI90, and PASI100 responses following 12-16 weeks of brodalumab treatment, according to the "as-observed" analysis. The mean time to achieve PASI100 was 13.7 ± 1.2 weeks for the 32% who achieved PASI100. Concurrent decreases in mean DLQI and PSI were observed. Furthermore, 90% adherence to brodalumab was noted and nine adverse events were reported. Brodalumab confers substantial clinical improvements short-term as reflected by high levels of skin clearance in moderate-to-severe plaque psoriasis patients within 12-16 weeks of treatment under everyday clinical conditions, followed by improvements in symptoms and quality of life and a favorable safety profile.

Dermoscopic Predictors of Benignity and Malignancy in Equivocal Lesions Predominated by Blue Color.

BACKGROUND: Blue color in dermoscopy can be seen in a wide range of benign and malignant lesions, melanocytic or not. Some blue-colored dermoscopic criteria have been associated with specific tumors, such as blue-white veil with melanoma and homogeneous blue with blue nevi. However, when blue color occupies a large part of the lesion's surface, the dermoscopic assessment might be particularly challenging. OBJECTIVE: To identify dermoscopic predictors associated with benignity and malignancy in tumors characterized by a predominant dermoscopic presence of blue color. METHODS: We retrospectively screened our institutional database for tumors exhibiting blue color in at least 50% of their surface with available histopathologic diagnosis. Lesions with blue color covering less than 50% of their extent and lesions not histopathologically assessed were excluded. The dermoscopic images were evaluated for the presence of predefined criteria, including the characteristics of the blue color, coexisting colors, and the vascular structures. RESULTS: Of 91 included tumors, 53 were benign (35 blue nevi, 10 angiomas, and 8 seborrheic keratoses) and 38 malignant (12 melanomas and 26 basal cell carcinomas). Our analysis revealed 3 potent dermoscopic predictors of benignity: extension of blue color in more than 75% of the surface, diffuse distribution of blue color, and absence of vessels, posing a 2.3-fold, 5.6-fold, and 6.7-fold increased probability of benignity, respectively. In contrast, asymmetric distribution of blue color, blue clods, coexistence of gray color and linear vessels were significantly predictive of malignancy, posing a 8.9-fold, 2.8-fold, 13.5-fold, and 10.4-fold increased probability, respectively. CONCLUSION: In predominantly blue tumors, the probability of malignancy is high when blue color is seen in clods or is asymmetrically distributed and when gray color or linear vessels coexist. In contrast, a diffuse distribution of blue color, its expansion in more than 75% of the surface, and the absence of vessels are highly suggestive of a benign tumor.

Extensive acquired macular hyperpigmentation in a teenager.

A teenage girl with phototype IV skin presented with extensive gradually progressing asymptomatic macular hyperpigmentation not responding to topical steroids for several months. Histopathology showed foci of increased numbers of melanophages and melanin in the dermis. Click here for the corresponding questions to this CME article.

Hidradenitis suppurativa-related expenditure, a call for awareness: systematic review of literature.

Data regarding hidradenitis suppurativa (HS)-related expenditure is limited and non-homogeneous, but HS does incur significant expenses. We performed a systematic review of literature reports documenting financial data regarding any healthcare domain or other expenditure incurred by HS and/or HS impact on work, income and personal economic growth (indirect costs). Three electronic databases were searched (MEDLINE, ScienceDirect, and the Cochrane Library - last search date: September 14th , 2021). All costs were adjusted for inflation (2022) and converted into US dollars. Twenty-three papers were included (18 cost-of-illness studies, 4 observational studies and 1 case series), drawing economic data from 77,287 HS patients. The total mean cost incurred by HS per patient per year ranged from $ 258 to $ 8,078. This number increased in case of surgical intervention, disease progression, antibiotic failure and certain comorbid diseases. The costliest healthcare sector was inpatient care, followed by outpatient and emergency care. Significant differences were observed between the USA and the rest of studied countries. Hospitalization was likelier, lengthier, and costlier for HS compared to psoriasis patients, whereas the less costly outpatient care appeared to be reduced among HS patients. Preventing disease progression by optimizing early diagnosis and dermatology outpatient care could decrease HS-related expenditure.

Hidradenitis-suppurativa-bedingte Kosten, ein Plädoyer für Aufmerksamkeit: eine systematische Literaturübersicht.

Die Daten zu Hidradenitis suppurativa (HS)-bedingten Kosten sind begrenzt und inhomogen. Sie sind jedoch erheblich. Wir führten eine systematische Sichtung der Literaturberichte durch, in denen finanzielle Daten über jeden Gesundheitsbereich oder andere Ausgaben dokumentiert wurden, die durch HS und/oder HS-bedingte Auswirkungen auf Beschäftigung, Einkommen und persönliches wirtschaftliche Entwicklung entstanden sind (indirekte Kosten). Dafür wurden drei elektronische Datenbanken durchsucht (MEDLINE, ScienceDirect und die Cochrane Library -letzte Suche: 14. September 2021). Alle Kosten wurden inflationsbereinigt (2022) und in US-Dollar umgerechnet. Es wurden 23 Artikel eingeschlossen (18 Krankheitskostenstudien, 4 Beobachtungsstudien und 1 Fallserie), in denen ökonomische Daten von 77.287 HS-Patienten erfasst wurden. Die durch HS entstandenen durchschnittlichen jährlichen Kosten pro Patient reichten von 258 $ bis 8.078 $. Diese Zahl erhöhte sich bei chirurgischen Eingriffen, Krankheitsprogression, Antibiotika-Versagen und bestimmten Begleitkrankheiten. Der kostspieligste Faktor war die stationäre Versorgung, gefolgt von ambulanter und Notfallversorgung. Signifikante Unterschiede wurden zwischen den USA und den übrigen untersuchten Ländern beobachtet. Im Vergleich zu Psoriasis-Patienten waren Krankenhausaufenthalte bei HS wahrscheinlicher, länger und kostspieliger, während die weniger kostspielige ambulante Versorgung bei HS-Patienten verringert war. Das Vermeiden der Krankheitsprogression durch frühzeitige Diagnose und Optimierung der ambulanten dermatologischen Versorgung könnte HS-bedinge Ausgaben reduzieren.

Accuracy of dermoscopic criteria for the differential diagnosis between irritated seborrheic keratosis and squamous cell carcinoma.

BACKGROUND: Even with the addition of dermoscopy, a significant morphologic overlap exists between irritated seborrheic keratosis (ISK) and squamous cell carcinoma (SCC). OBJECTIVE: The aim of this study was to investigate the dermoscopic criteria that could serve as potent predictors for the differential diagnosis between ISK and SCC. METHODS: Dermoscopic images of histopathologically diagnosed ISKs and SCCs were evaluated by 3 independent investigators for the presence of predefined criteria. RESULTS: A total of 104 SCCs and 61 ISKs were included. The main dermoscopic predictors of SCC were dotted vessels (odds ratio [OR], 10.4), branched linear vessels (OR, 5.30), white structureless areas (OR, 6.78), white circles surrounding follicles (OR, 23.45), a diffuse irregular (OR, 2.55) or peripheral (OR, 2.8) vessel arrangement, and a central scale arrangement (OR, 3.35). Dermoscopic predictors of ISK were hairpin vessels (OR, 0.38), a diffuse regular vessel arrangement (OR, 0.39 and OR, 0.36), and white halos surrounding vessels covering more than 10% of the lesion (OR, 0.29 and OR, 0.12). LIMITATIONS: First, the retrospective design of the study; second, the differential diagnosis included in the study was restricted to ISK and SCC. CONCLUSIONS: We confirmed the significant morphologic overlap between ISK and SCC, but we also identified potent predictors for the differential diagnosis between these 2 entities.

Second primary melanomas in a cohort of 977 melanoma patients within the first 5 years of monitoring.

BACKGROUND: In retrospective studies, a second primary melanoma (SPM) develops in 2%-20% of melanoma patients. Scarce evidence exists on the usefulness of total-body photography (TBP) and digital dermatoscopic documentation (DDD) for detecting SPMs. OBJECTIVE: The primary aim was to quantify the risk and investigate the time of occurrence of SPMs. Secondary aims were to identify risk factors for SPM and to assess the usefulness of TBP and DDD for SPM detection. METHODS: This prospective cohort included patients with recently diagnosed melanoma that underwent sequential clinical and dermatoscopic examinations for up to 5 years. Life table analysis and Kaplan-Meier survival analysis were performed. Multivariate Cox models were constructed to identify factors affecting the outcome. RESULTS: An SPM developed in 46 of 977 (4.7%) patients. Life table analysis revealed a 5-year cumulative risk of 8.0% for SPM. High nevus count, fair phototype, and occupational sun exposure were potent predictors of SPM. Of all new melanomas, 17.3% were diagnosed by clinical and dermatoscopic examination, 48.1% by TBP, and 34.6% by DDD. LIMITATIONS: All patients followed the same protocol and diagnostic bias associated with sequential dermatoscopic imaging. CONCLUSION: In this cohort, melanoma patients were at 8% risk of an SPM developing within 5 years. TBP and DDD significantly contributed to the early detection of SPM.

Diagnosis and management of pemphigus: Recommendations of an international panel of experts.

BACKGROUND: Several European countries recently developed international diagnostic and management guidelines for pemphigus, which have been instrumental in the standardization of pemphigus management. OBJECTIVE: We now present results from a subsequent Delphi consensus to broaden the generalizability of the recommendations. METHODS: A preliminary survey, based on the European Dermatology Forum and the European Academy of Dermatology and Venereology guidelines, was sent to a panel of international experts to determine the level of consensus. The results were discussed at the International Bullous Diseases Consensus Group in March 2016 during the annual American Academy of Dermatology conference. Following the meeting, a second survey was sent to more experts to achieve greater international consensus. RESULTS: The 39 experts participated in the first round of the Delphi survey, and 54 experts from 21 countries completed the second round. The number of statements in the survey was reduced from 175 topics in Delphi I to 24 topics in Delphi II on the basis of Delphi results and meeting discussion. LIMITATIONS: Each recommendation represents the majority opinion and therefore may not reflect all possible treatment options available. CONCLUSIONS: We present here the recommendations resulting from this Delphi process. This international consensus includes intravenous CD20 inhibitors as a first-line therapy option for moderate-to-severe pemphigus.

Dermoscopy in the diagnosis and management of basal cell carcinoma.

The dermoscopic findings of basal cell carcinoma (BCC) were first described more than a decade ago and the list of BCC-related criteria has been several times updated and enriched. Today, the dermatoscope is considered the key tool for the diagnosis of BCC, since it allows its early detection and enables its discrimination from other pigmented and nonpigmented skin tumors. The dermoscopic pattern of BCC results from several combinations of well-known BCC criteria, depending on several factors, including histopathologic subtype, location, gender, age and pigmentary trait. In addition, recent evidence highlighted that dermoscopy is also useful in the management of BCC, since it provides information on the tumor subtype, the presence of pigmentation or ulceration and the response to nonablative treatments.