The safety profile of biologic agents in comparison with non-biologic systemic agents, and topical compounds in the management of psoriasis-A 30-month prospective, observational cohort study.

BACKGROUND: Although biologic agents (BAs) are very effective, solid data proving they are safer than other therapies in psoriasis are still lacking. METHODS: A total of 289 psoriatic patients were followed for 30 months; of which number 118 were treated with topical agents alone, 112 received BAs, and the remaining 59 patients were on non-biologic systemic agents (NBSAs). The rates of adverse events in these groups were recorded and statistically analysed. RESULTS: Patients treated with BAs had higher rates of adverse events (P = .017), including overall infections (P = .003), respiratory infections (P < .001), renal, urinary (P < .001), musculoskeletal, connective tissue (P < .001, and P = .021) and oral cavity-related (P = .046) disorders. Except for the incidence of infections, all the above adverse events occurred more often in our study than in clinical trials. The occurrence of serious adverse events was P = .066, with the incidence of serious infections being P = .164. Unlike patients on topical therapy and NBSAs, patients treated with BAs were forced to discontinue their therapies (P = .001). The Psoriasis Area Severity Index (PASI) and body surface area (BSA) scores were the lowest among patients on BAs. CONCLUSION: While BAs were the most effective therapies, they were associated with higher rates of treatment discontinuation and adverse events in comparison with other forms of therapy.

The Safety Profiles of Adalimumab, Infliximab, Etanercept, Secukinumab and Ustekinumab in Psoriasis - A 30-month Observational Cohort Prospective Study of Adverse Events in Biologic Therapy.

BACKGROUND: Although biologic agents are very effective, long-term comparative studies demonstrating their safety relative to one another are still lacking. METHODS: A total of 124 patients with psoriasis were followed up for 30 months; 74 received anti-TNF-alpha inhibitors (adalimumab, etanercept, infliximab), 33 were on ustekinumab, and 17 were treated with secukinumab. The rates of adverse events in these groups were recorded and statistically analyzed. RESULTS: Infliximab-treated patients showed a high occurrence of asymptomatic, but increased liver enzymes, fatigue, and respiratory as well as dermatologic infections. Adalimumab-treated patients were more often affected by musculoskeletal disorders and infections of all types. Patients treated with secukinumab presented with higher rates of cardiovascular disorders as well as respiratory and dermatologic infections. The group receiving etanercept was more often diagnosed with musculoskeletal and reproductive disorders, specifically menstrual disorders. The rates of therapy discontinuation and serious adverse events did not reach statistically significant values. CONCLUSION: A higher incidence of adverse events was observed among adalimumab-, and infliximab-treated patients, with ustekinumab found to have the safest profile. Our results demonstrate that a personalized approach, including evaluation of a patient's risk profile, is necessary before commencing a biologic. Further research is warranted to confirm the findings of our study.

Epidemiology of moderate-to-severe psoriasis: a comparison between psoriasis patients treated with biological agents, conventional systemic drugs and topical agents.

INTRODUCTION: Understanding how different comorbidities and epidemiological factors are related to psoriasis severity can help us estimating patients' clinical outcome. AIM: Establish possible prognostic factors of severe psoriasis. METHODS: Three groups of patients were included: 118 were on topical therapy, 83 used conventional systemic drugs, and 112 were treated with biological agents. Based on the fact that patients on topical therapy have a lower grade of disease severity than patients treated systemically, we compared a variety of comorbidities and epidemiological parameters between the three groups. RESULTS: Patients treated more aggressively have an increased risk of cardiovascular disease (p = .044), suffer more from depression (p = .020), hyperuricemia (p = .031) and nonspecific noninfectious liver disease (p = .005). Male gender (p < .001), increased height (p < .001), early age of disease onset (p < .001), viral upper respiratory infections (p = .049) and periods of hormonal changes (p = .045) are associated with these therapies. CONCLUSION: Psoriasis severity is directly related to an increased risk of cardiovascular disease, depression, hyperuricemia and nonspecific noninfectious liver disease. Male gender, increased height, early age of disease onset, viral upper respiratory infections and periods of hormonal changes seem to be prognostic of higher degrees of psoriasis severity. We are pioneering the use of increased height and puberty, menopause/andropause as independent prognostic factors of psoriasis severity.

Neurotoxic side effects of acyclovir: two case reports.

Acyclovir is an antiviral drug frequently used in clinical practice. It is indicated for the treatment of infections caused by herpes simplex virus and varicella zoster virus. The drug has a good safety profile; however, severe side effects may rarely occur during therapy. These include renal failure as a major risk factor for neurotoxic side effects potentially developing within 24-48 hours of therapy initiation. The paper presents the cases of two patients developing neurotoxic side effects while treated for herpes zoster. The aim of the authors is to highlight the potential for developing neurotoxic side effects in high-risk groups such as the elderly, patients with impaired renal function or multiple comorbidities on polypharmacy, or those using nephrotoxic drugs. Acyclovir use could lead to renal impairment and an increase in its plasma and CNS concentrations with severe neuropsychiatric side effects. The neurotoxic side effects are reversible after therapy withdrawal. Thus, in patients developing mental impairment or showing other neurological symptoms during acyclovir therapy, the patient should be promptly assessed for potential drug neurotoxicity, their therapy should be discontinued and drug elimination with forced diuresis or hemodialysis considered. Early recognition of acyclovir neurotoxic side effects can significantly improve a patient's prognosis.

Performance of new low-cost handheld NIR spectrometers for nondestructive analysis of umbu (Spondias tuberosa Arruda) quality.

The objective of this study was to evaluate the analytical performance of two new low-cost handheld NIR spectrometers for the determination of umbu fruit (Spondias tuberosa Arruda) quality. A third handheld spectrometer, representing a proven good performance for fruit quality analysis, was used as reference instrument. Multivariate calibration models were built using Partial Least Squares regression to determine dry matter (DM), soluble solids (SS), flesh firmness (FF) and skin color (SC). No significant statistical difference was found among the analytical performances of all three spectrometers. The average of the relative root mean square error of prediction (RMSEPr) obtained with the three spectrometers were 5.2 ± 0.9% for DM, 8.4 ± 1.5% for SS, 27.6 ± 2.0% for FF and 8.0 ± 0.6% for SC. According to these results, the new low-cost handheld NIR spectrometers can be used to monitor umbu fruit quality during ripening with suitable accuracy.

Comparing the analytical performances of Micro-NIR and FT-NIR spectrometers in the evaluation of acerola fruit quality, using PLS and SVM regression algorithms.

The main goal of this study was to investigate the analytical performances of a state-of-the-art device, one of the smallest dispersion NIR spectrometers on the market (MicroNIR 1700), making a critical comparison with a benchtop FT-NIR spectrometer in the evaluation of the prediction accuracy. In particular, the aim of this study was to estimate in a non-destructive manner, titratable acidity and ascorbic acid content in acerola fruit during ripening, in a view of direct applicability in field of this new miniaturised handheld device. Acerola (Malpighia emarginata DC.) is a super-fruit characterised by a considerable amount of ascorbic acid, ranging from 1.0% to 4.5%. However, during ripening, acerola colour changes and the fruit may lose as much as half of its ascorbic acid content. Because the variability of chemical parameters followed a non-strictly linear profile, two different regression algorithms were compared: PLS and SVM. Regression models obtained with Micro-NIR spectra give better results using SVM algorithm, for both ascorbic acid and titratable acidity estimation. FT-NIR data give comparable results using both SVM and PLS algorithms, with lower errors for SVM regression. The prediction ability of the two instruments was statistically compared using the Passing-Bablok regression algorithm; the outcomes are critically discussed together with the regression models, showing the suitability of the portable Micro-NIR for in field monitoring of chemical parameters of interest in acerola fruits.

Rapid and non-destructive determination of quality parameters in the 'Tommy Atkins' mango using a novel handheld near infrared spectrometer.

The objective of this study was to evaluate the potential of a new handheld ultra-compact near infrared (NIR) spectrometer, based on the linear-variable filter (LVF) technology for rapid and non-destructive quality control analysis of the 'Tommy Atkins' mango. Multivariate calibration models were built using the Partial Least Squares (PLS) regression method to determine soluble solids (SS), dry matter (DM), titratable acidity (TA) and pulp firmness (PF). Different spectral pre-processing techniques were tested. Coefficient of determination and root mean square errors of prediction (RMSEP) values were, respectively: 0.92 and 0.55°Brix for SS, 0.67 and 0.51% for DM, 0.50 and 0.17% citric acid for TA, 0.72 and 12.2N for PF. The predictive models allowed monitoring physico-chemical changes in each fruit during ripening. The results show the feasibility of using the new NIR handheld spectrometer to determine quality parameters in the 'Tommy Atkins' mango.

Queiloplastia por técnica de Fisher: relato de caso / Fisher's cheiloplasty: case report

As fissuras labiopalatinas são as anomalias craniofaciais mais comuns, com uma prevalência mundial de 1 paciente para cada 1000 nascimentos, e de 1 para cada 650 nascidos no Brasil. O presente artigo relata um caso de um paciente com fissura labial unilateral completa, operado pela técnica de Fisher aos 10 meses, detalhando o método cirúrgico. Diversas técnicas de queiloplastias são descritas na literatura, com variáveis resultados estéticos e funcionais. No referido caso a técnica mostrou uma excelente qualidade de cicatriz, permitindo o trabalho fonoaudiológico para melhorar a motricidade oral... (AU)

As cleft lip and palate are the most common craniofacial anomalies, with a worldwide prevalence of 1 patient per 1000 births and 1 per 650 born in Brazil. This article reports a case of a patient with complete unilateral cleft lip, operated by Fisher's technique at 10 months, detailing the surgical method. Several cheiloplasty techniques are described in the literature, with several aesthetic and functional results. In this case, the technique showed an excellent quality of healing, allowing speech therapy to improve oral motor skills... (AU)