Publications by authors named "Leonardi C"

Background: The clinical utility of increasing to weekly adalimumab therapy in patients with psoriasis with inadequate response to every other week (eow) dosing is unknown.

Objectives: (i) To determine the effectiveness of escalating adalimumab dosage from 40 mg eow to 40 mg weekly in patients with < PASI 50 response following ≥ 24 weeks treatment. (ii) To identify retrospectively characteristics of patients likely to benefit from dose escalation using classification and regression tree analysis.

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Background: Type 17 helper T cells have been suggested to play a pathological role in psoriasis. They secrete several proinflammatory cytokines, including interleukin-17A (also known as interleukin-17). We evaluated the safety and efficacy of ixekizumab (LY2439821), a humanized anti-interleukin-17 monoclonal antibody, for psoriasis treatment.

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Background: In this phase 2, randomized, double-blind, placebo-controlled, dose-ranging study, we assessed the efficacy and safety of brodalumab (AMG 827), a human anti-interleukin-17-receptor monoclonal antibody, for the treatment of moderate-to-severe plaque psoriasis.

Methods: We randomly assigned patients with a score of 12 or higher on the psoriasis area-and-severity index (PASI, on which scores range from 0 to 72, with higher scores indicating more severe disease) and with 10% or more of their body-surface area affected by psoriasis to receive brodalumab (70 mg, 140 mg, or 210 mg at day 1 and weeks 1, 2, 4, 6, 8, and 10 or 280 mg monthly) or placebo. The primary end point was the percentage improvement from baseline in the PASI score at week 12.

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Biological aging alters the metabolism and volume of adipose tissue depots. Recent evidence suggests that circadian mechanisms play a role in promoting adipogenesis, obesity, and lipodystrophy. The current study compared cohorts of younger (5-9 months) and older (24-28 months) C57BL/6 mice as a function of biological age and circadian time.

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The entry of biosimilar forms of biopharmaceutical therapies for the treatment of psoriasis and other immune-mediated disorders has provoked considerable interest. Although dermatologists are accustomed to the use of a wide range of generic topical agents, recognition of key differences between original agent (ie, the name brand) and the generic or biosimilar agent is necessary to support optimal therapy management and patient care. In this review we have summarized the current state of the art related to the impending introduction of biosimilars into dermatology.

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A 2-year-old boy was referred for evaluation of a systolic heart murmur. Two-dimensional Doppler echocardiogram showed an abnormal flow through the interventricular septum, directed upward and toward the posterior wall of the main pulmonary artery. Left coronary angiogram showed a normal distribution of the anterior descending and circumflex arteries.

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Objective: To determine time spent on the working day in sleep, work, sedentary behaviors, and light-, moderate-, and vigorous-intensity behaviors by occupation intensity.

Methods: Data came from 30,758 working respondents to the 2003 to 2009 American Time Use Survey. Mean ± SEM time spent in work, sedentary behaviors, light-, moderate-, and vigorous-intensity activities, and sleep were computed by occupations classified as sedentary, light, moderate, and vigorous intensity.

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Background: Multiple trials demonstrate the tolerability and safety of etanercept. However, there are limited data on etanercept tolerability in large populations of patients with psoriasis or with extended therapy.

Objectives: We sought to determine whether there is an increased safety risk associated with higher etanercept doses or with extended exposure in patients with psoriasis.

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Background: Ustekinumab targets interleukin (IL)-12 and IL-23 in the treatment of moderate-to-severe psoriasis.

Objective: To evaluate overall pooled study data to assess the safety profile of ustekinumab through 3 years of treatment.

Methods: Cumulative safety data were pooled from studies in 3117 ustekinumab-treated patients.

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Context: Ustekinumab and briakinumab, monoclonal antibodies to the shared p40 subunit of interleukin (IL)-12 and IL-23, have shown efficacy in treating chronic plaque psoriasis (CPP). Preliminary reports of major adverse cardiovascular events (MACEs) in psoriasis patients receiving anti-IL-12/23 agents have prompted concern.

Objective: To evaluate a possible association between biologic therapies for CPP and MACEs via meta-analysis.

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Background: A favorable benefit-risk profile has been established for adalimumab, with up to 5 years of treatment in 13 clinical trials in patients with moderate to severe chronic plaque psoriasis.

Objective: The aim of this analysis was to assess the long-term safety of all adalimumab exposure in all psoriasis clinical trials.

Methods: A total of six sets of data were analyzed as follows: (i) all cumulative safety data from all exposure for all adalimumab-treated patients in the 13 clinical trials in moderate to severe psoriasis (All Adalimumab Treatment Population) through April 2007, November 2008, and November 2009, respectively; (ii) longitudinal data for 1403 patients treated with adalimumab 40 mg every other week (eow) dosing (Every Other Week Population) through June 2007 and April 2010; and (iii) data from placebo-controlled periods of clinical trials.

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Aim of this paper is to investigate the psychobiological reactions to experimentally induced negative emotional states in active marijuana-dependent smokers and whether changes in emotional reactivity were reversed by prolonged abstinence. Twenty-eight patients were randomly included into group A (fourteen active marijuana-dependent smokers) or group B (fourteen abstinent marijuana-dependent subjects). Emotional response evaluation of group B subjects was assessed after 6 months of abstinence.

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Objective: Laboratory studies of adult walking behavior have consistently found that a cadence of 100 steps/min is a reasonable threshold for moderate intensity. The purpose of this study was to determine cadence patterns in free-living adults, and in particular, time spent at increasing cadence increments including 100 steps/min and beyond.

Method: 3744 adults ≥20 years provided at least one valid day (minimally 10/24 h of wear) of minute-by-minute accelerometer-determined step data during the 2005-2006 U.

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Aim: The physiochemical properties, controlled release characteristics, stability and cellular uptake of chitosan (Chi)/poly(D,L-lactide-co-glycolide) (PGLA) and PLGA particles with entrapped α-tocopherol were investigated to understand the behavior of these nanoparticles in the GI tract.

Materials & Methods: Chi/PLGA and PLGA particles stabilized by lecithin were synthesized and fully characterized for oral gastrointestinal delivery via transmission electron microscopy, dynamic light scattering, high-performance liquid chromatography and fluorescence microscopy.

Results: Particle stability was pH- and system-dependent.

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This study correlated assessment tools for evaluating the severity of skin, nail, and joint symptoms in patients with psoriasis (Pso) and psoriatic arthritis (PsA). Adults with plaque Pso (with or without PsA) were enrolled from four U.S.

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Aims: Itraconazole and coumarin-6 loaded polylactic-co-glycolic acid-nanoparticles (PLGA-ITZ- and PLGA-C6-NPs) were synthesized and tested for fungal cell uptake and antifungal ability based on particle size.

Materials & Methods: PLGA-ITZ- and PLGA-C6-NPs were synthesized using an oil-in-water emulsion evaporation method. Fungal cell uptake and antifungal activity of the polymeric NPs was tested on Aspergillus flavus.

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Background: The anti-interleukin-12/23p40 monoclonal antibody briakinumab has been shown in a phase II study to be effective psoriasis treatment.

Objectives: The aim of the current study was to assess the efficacy, safety and tolerability of briakinumab compared with etanercept and placebo in patients with moderate to severe chronic plaque psoriasis.

Methods: In this phase III, 12-week study (M10-114, NCT00691964), 347 patients were randomized in a 2 : 2 : 1 ratio to receive 200 mg briakinumab at weeks 0 and 4 followed by 100 mg briakinumab at week 8 (n = 138); 50 mg of etanercept twice weekly 3-4 days apart at weeks 0-11 (n = 141); or placebo injections matching active treatment (n = 68).

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Psoriasis is a common, chronic, inflammatory, multisystem disease with predominantly skin and joint manifestations affecting approximately 2% of the population. In the first 5 parts of the American Academy of Dermatology Psoriasis Guidelines of Care, we have presented evidence supporting the use of topical treatments, phototherapy, traditional systemic agents, and biological therapies for patients with psoriasis and psoriatic arthritis. In this sixth and final section of the Psoriasis Guidelines of Care, we will present cases to illustrate how to practically use these guidelines in specific clinical scenarios.

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Unlabelled: Physical activity (PA) guidelines are typically communicated in terms of duration, frequency and intensity, e.g., 30 min/day of moderate-to-vigorous physical activity (MVPA) on at least 5 days/week.

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Cervical malignancies are a rare but well-known cause of syncope. Gestural automatisms during syncope have only rarely been reported. We describe a patient presenting with bimanual automatisms during syncopal episodes caused by parapharyngeal carcinoma involving the right laterocervical region.

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The global spread of hepatitis B virus (HBV) and hepatitis C virus (HCV), their high chronicity rates and their progression to cirrhosis and hepatocellular carcinoma, are major public health problems. Research and intervention programmes for special population groups are needed in order to assess their infection risk and set up suitable prevention and control strategies. Aim of this paper is to give health care professionals information on HBV and HCV infections amongst migrants, drug users and prison inmates.

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Objective: To determine the efficacy, safety, and sustainability of response to adalimumab therapy for moderate to severe chronic plaque psoriasis involving hands and/or feet.

Design: Sixteen-week, randomized, double-blind, placebo-controlled evaluation of adalimumab therapy for moderate to severe chronic plaque psoriasis involving the hands and/or feet with a 12-week open-label extension (Randomized Controlled Evaluation of Adalimumab in Treatment of Chronic Plaque Psoriasis of the Hands and Feet [REACH]).

Setting: Multicenter outpatient study in the United States and Canada.

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Epidemiological and clinical data show frequent associations between adverse childhood experiences (ACEs) and substance abuse susceptibility particularly in adolescents. A large body of evidences suggests that the possible dysregulation of neuroendocrine responses as well as neurotransmitters function induced by childhood traumatic experiences and emotional neglect could constitute one of the essential biological changes implementing substance abuse vulnerability. Moreover, genotype variables and its environment interactions have been associated with an increased risk for early onset substance abuse.

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Background: As few data are available on irradiation of the draining nodes after conservative surgery (CS), this study was designed to identify patients with T1-T2 breast cancer and one to three positive axillary nodes who needed regional radiotherapy (RT).

Patients And Methods: Five hundred seventy-five patients were treated between 1988 and 2001 with CS and RT to the breast. All but three received adjuvant chemotherapy and/or hormone therapy.

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