Efficacy of an adjuvant Lactobacillus rhamnosus formula in improving skin lesions as assessed by PASI in patients with plaque psoriasis from a university-affiliated, tertiary-referral hospital in São Paulo (Brazil): a parallel, double-blind, randomized clinical trial.

Psoriasis is an inflammatory disease of the skin, characterized by erythematous plaques. It is rather common, affecting 2-4% of the population in western countries. Psoriasis' etiology encompasses both genetic and environmental factors. Evidence suggests that the latter reflect the importance of changes in the microbiome for developing the disease. Thus, it is hypothesized that gut microbiome manipulation may arise as a way of treating psoriasis. However, few trials assessed the use of probiotics in psoriasis, although promising results were detected in small studies. Our objective was to assess the efficacy of adjuvant probiotics (Lactobacillus rhamnosus) in treating plaque psoriasis patients. This was a randomized, parallel, placebo-controlled, double-blind trial with two arms: experimental (n = 50) and control (n = 53). Inclusion of subjects and data gathering lasted from November 2020 to August 2021. Subjects were consecutive plaque psoriasis patients under regular follow-up in the Dermatology unit of a university-affiliated, tertiary-referral hospital in São Paulo (Brazil). Eligibility criteria included being over 18 years old, having plaque psoriasis and not having other skin diseases, neoplasms nor systemic inflammatory diseases. Subjects received standard-of-care plus probiotics (Lactobacillus rhamnosus formula). Controls received standard-of-care plus placebo. Primary outcome was skin lesion improvement as assessed by psoriasis area of severity index (PASI) at six months. Secondary outcome was quality-of-life as assessed by dermatology life quality index (DLQI) at six months. Regarding within-group analyses, changes in both PASI and DLQI were non-significant for the experimental group (mean PASI decreased by 1.58, p = 0.105, and mean DLQI increased by 0.05, p = 0.873) and significant for controls (mean PASI decreased by 1.90, p = 0.019, and mean DLQI decreased by 3.33, p = 0.031). Between-group analyses returned non-significant results (p = 0.620). Our findings do not support the hypothesis that gut microbiome modulation via ingestion of Lactobacillus rhamnosus produces clinical improvement in psoriasis patients. Further research is encouraged.Trial registration: Retrospectively registered at the Brazilian Clinical Trials Registry (RBR-8js7t83) on 08/02/2022.

Humanistic and Economic Impact of Moderate to Severe Plaque Psoriasis in Brazil.

INTRODUCTION: Psoriasis is an immune-mediated, chronic, inflammatory disease, which has a substantial humanistic and economic burden. This study aimed to assess the impact of this disease on health-related quality of life (HRQoL), work productivity, and direct and indirect costs from a societal perspective among Brazilian patients. METHODS: This is a cross-sectional, observational, multicenter study, enrolling patients with moderate to severe plaque psoriasis according to physician evaluation. Data collection was performed from December 2015 to November 2016 through face-to-face interviews using a structured questionnaire and five standardized patient-reported outcomes instruments. Direct costs were estimated by multiplying the amount of resources used (12-month recall period) by the corresponding unit cost. Indirect costs were grouped in two time horizons: annual costs (income reduction and absenteeism) and lifetime costs (demission and early retirement). RESULTS: A total of 188 patients with moderate to severe plaque psoriasis were included, with mean age of 48.0 (SD 13.1). "Anxiety and depression" and "pain and discomfort" were the most impaired dimensions, according to the EuroQol Five-Dimension-Three-Level (EQ-5D-3L). The highest effect was found for "symptoms and feelings" [mean (SD) 2.4 (1.7)] Dermatology Life Quality Index (DLQI) subscale. Psoriatic arthritis (PsA) presence and biologic-naïve status were associated with worse HRQoL. Presenteeism was more frequent than absenteeism, according to the Work Productivity and Activity Impairment questionnaire-General Health (WPAI-GH) [17.4% vs. 6.3%], while physical demands and time management were the most affected Work Limitations Questionnaire (WLQ) subscales [means (SD) 23.5 (28.5) and 17.7 (24.9), respectively]. The estimated annual cost per patient was USD 4034. Direct medical costs accounted for 87.7% of this estimate, direct non-medical costs for 2.4%, and indirect costs for 9.9%. CONCLUSIONS: Results evidenced that moderate to severe plaque psoriasis imposes substantial costs to society. Our data showed that this disease negatively affects both work productivity and HRQoL of Brazilian patients. Subgroups with PsA and biologic-naïve patients presented lower HRQoL, showing the impact of this comorbidity and the relevance of biologics in psoriasis treatment. FUNDING: Novartis Biociências S.A.

Assessment of psoriasis severity in Brazilian patients with chronic plaque psoriasis attending outpatient clinics: a multicenter, population-based cross-sectional study (APPISOT).

PURPOSE: Data on chronic plaque psoriasis severity and its potential clinical and lifestyle implications in the Brazilian population are limited. The primary aim of this study was to assess the clinical severity of plaque psoriasis in Brazil. Further objectives included evaluating potential associations between disease severity and demographic, lifestyle, and clinical characteristics, health-related quality of life (HRQOL), and work productivity. MATERIALS AND METHODS: This observational (non-interventional) cross-sectional study was conducted in 26 dermatologic clinics across 11 Brazilian states. Psoriasis severity was assessed using investigator judgment and Finlay's Rule of Tens: a Psoriasis Area and Severity Index (PASI) score >10, a Body Surface Area (BSA) > 10%, or a Dermatology Life Quality Index (DLQI) score >10. RESULTS: Among 1125 patients, 205 (18.2%) had moderate-to-severe disease. On multiple regression analyses, psoriasis severity was significantly (directly) associated with the presence of physical inactivity and comorbid pain, anxiety, and depression; and significantly (inversely) associated with HRQOL and work productivity. LIMITATIONS: Cross-sectional studies cannot assess temporal trends, and observational studies cannot conclusively determine causality or exclude biases and confounding due to unmeasured variables. CONCLUSIONS: Among Brazilian patients with moderate-to-severe psoriasis, disease severity had far-reaching adverse impacts on lifestyle, comorbidities, HRQOL, and work productivity.

Contact dermatitis in adolescents.

BACKGROUND: Adolescents between the ages of 10 and 19 are exposed to a series of substances capable of causing contact dermatitis. OBJECTIVES: (1) To study the frequency and characteristics of allergic contact dermatitis in adolescents, (2) to characterize the group being studied, and (3) to verify the main sensitizing substances among this age group. METHODS: From 1996 to 2001, 1,027 patients with a suspicion of contact dermatitis were analyzed, and patients between 10 and 19 years of age were selected. These patients were submitted to contact tests. RESULTS: Among the 102 adolescents, 93 (91%) were female and 9 (9%) were male. The face was the area most affected by dermatosis. The contact tests were positive in 64 patients (56%), whereas in 45 (44%) they were negative. The main location of the contact dermatitis was the face (36%). The substances with higher frequencies of sensitization were nickel sulfate in 33 (31%) patients and tosylamide-formaldehyde resin in 13 (12%) patients. CONCLUSION: Contact dermatitis in adolescents was more frequent in white girls and on the face. The substances with greater frequency of sensitization were nickel sulfate and tosylamide-formaldehyde resin. These two substances are related to adolescent habits and behavior.