Efficacy and safety of infliximab-biosimilar compared to other biological drugs in rheumatoid arthritis: a mixed treatment comparison.

OBJECTIVE: The aim of this meta-analysis was to compare the efficacy and safety of infliximab-biosimilar and other available biologicals for the treatment of rheumatoid arthritis (RA), namely abatacept, adalimumab, certolizumab pegol, etanercept, golimumab, infliximab, rituximab and tocilizumab. METHODS: A systematic literature review of MEDLINE database until August 2013 was carried out to identify relevant randomized controlled trials (RCTs). Bayesian mixed treatment comparison method was applied for the pairwise comparison of treatments. Improvement rates by the American College of Rheumatology criteria (ACR20 and ACR50) at week 24 were used as efficacy endpoints, and the occurrence of serious adverse events was considered to assess the safety of the biologicals. RESULTS: Thirty-six RCTs were included in the meta-analysis. All the biological agents proved to be superior to placebo. For ACR20 response, certolizumab pegol showed the highest odds ratio (OR) compared to placebo, OR 7.69 [95 % CI 3.69-14.26], followed by abatacept OR 3.7 [95 % CI 2.17-6.06], tocilizumab OR 3.69 [95 % CI 1.87-6.62] and infliximab-biosimilar OR 3.47 [95 % CI 0.85-9.7]. For ACR50 response, certolizumab pegol showed the highest OR compared to placebo OR 8.46 [3.74-16.82], followed by tocilizumab OR 5.57 [95 % CI 2.77-10.09], and infliximab-biosimilar OR 4.06 [95 % CI 1.01-11.54]. Regarding the occurrence of serious adverse events, the results show no statistically significant difference between infliximab-biosimilar and placebo, OR 1.87 [95 % CI 0.74-3.84]. No significant difference regarding efficacy and safety was found between infliximab-biosimilar and the other biological treatments. CONCLUSION: This is the first indirect meta-analysis in RA that compares the efficacy and safety of biosimilar-infliximab to the other biologicals indicated in RA. We found no significant difference between infliximab-biosimilar and other biological agents in terms of clinical efficacy and safety.

Establishment of a PCR and restriction enzyme assay for the detection of the hemochromatosis gene in normal subjects and diabetic patients

The purpose of this study was to establish a polymerase chain reaction (PCR)-restriction enzyme assay for detecting the hereditary hemochromatosis (HHC) mutation, C282Y, in gestational and gestational diabetic subjects in South Florida. DNA samples from 43 gestational subjects were amplified by PCR, digested with RsaI, and analyzed by electrophoresis. An allelic frequency of 2.33%, or 4.65% heterozygosity, was observed. The assay is successful and applicable to future studies on HHC and gestational diabetes. ^

Risk factors and associations for hepatitis C infection among Hispanic/Latino intravenous drug users in Miami-Dade County, Florida

Hepatitis C infection (HCV) continues to disproportionately affect Hispanics/Latinos in the United States. Hispanic/Latino intravenous drug users (IDUs), because of their risky injection and sexual behaviors, are prone to HCV infection and rapid transmission of the virus to others via several routes. With a prevalence rate of approximately 75% among IDUs, it is imperative that transmission of HCV be prevented in this population. This study aims to examine the associations between demographic, injection and sexual risk factors to HCV infection in a group Hispanic/Latino IDUs in Miami-Dade County, Florida. Preliminary unadjusted results in this sample reveal that age (OR=4.592, p=0.004), weekly injection (OR=5.171, p=0.000), daily injection frequency (OR=3.856, p=0.000) and use of a dirty needle (OR=2.320, p= 0.006) were all significantly associated with HCV infection. Being born outside the U.S. was significantly negatively associated with HCV infection (OR=0.349, p=0.004). Additionally, having two or more sex partners in the past three months (OR=0.472, p=0.014) was negatively associated with HCV infection. After adjusting for all other variables, older age (AOR=7.470, p=0.006), weekly injection (AOR=3.238, p=0.007) and daily injection frequency (AOR=2.625, p=0.010) were all significantly associated with HCV infection. Being born outside the U.S. (AOR=0.369, p=0.019) was a significant protective factor for HCV infection, along with having two or more sex partners in the past three months (AOR=0.481, p=0.037). When analyzing the significant variables in a backward regression model, having 2 or more sex partners in the past three months was not significant at the p

Genetic markers, birth characteristics, and childhood leukemia risk

The cause for childhood acute lymphoblastic leukemia (ALL) remains unknown, but male gender is a risk factor, and among ethnicities, Hispanics have the highest risk. In this dissertation, we explored correlations among genetic polymorphisms, birth characteristics, and the risk of childhood ALL in a multi-ethnic sample in 161 cases and 231 controls recruited contemporaneously (2007-2012) in Houston, TX. We first examined three lymphoma risk markers, since lymphoma and ALL both stem from lymphoid cells. Of these, rs2395185 showed a risk association in non-Hispanic White males (OR=2.8, P=0.02; P interaction=0.03 for gender), but not in Hispanics. We verified previously known risk associations to validate the case-control sample. Mutations of HFE (C282Y, H63D) were genotyped to test whether iron-regulatory gene (IRG) variants known to elevate iron levels increase childhood ALL risk. Being positive for either polymorphism yielded only a modestly elevated OR in males, which increased to 2.96 (P=0.01) in the presence of a particular transferrin receptor (TFRC) genotype for rs3817672 (Pinteraction=0.04). SNP rs3817672 itself showed an ethnicity-specific association (P interaction=0.02 for ethnicity). We then examined additional IRG SNPs (rs422982, rs855791, rs733655), which showed risk associations in males (ORs=1.52 to 2.60). A polygenic model based on the number of polymorphic alleles in five IRG SNPs revealed a linear increase in risk (OR=2.00 per incremental change; P=0.002). Having three or more alleles compared with none was associated with increased risk in males (OR=4.12; P=0.004). Significant risk associations with childhood ALL was found with birth length (OR=1.18 per inch, P=0.04), high birth weight (>4,000g) (OR=1.93, P=0.01), and with gestational age (OR=1.10 per week, P=0.04). We observed a negative correlation between HFE SNP rs9366637 and gestational age (P=0.005), again, stronger in males ( P=0.001) and interacting with TFRC (P interaction=0.05). Our results showed that (i) ALL risk markers do not show universal associations across ethnicities or between genders, (ii) IRG SNPs modify ALL risk presumably by their effects on iron levels, (iii) a negative correlation between an HFE SNP and gestational age exists, which implicates an iron-related mechanism. The results suggest that currently unregulated supplemental iron intake may have implications on childhood ALL development.

Relationship of Omega-3 Fatty Acids on C-Reactive Protein and Homocysteine in Haitian and African Americans with and without Type 2 Diabetes

Background: Omega-3 fatty acids (n-3) may be protective of cardiovascular risk factors for vulnerable populations. The purpose of this study was to assess the association between n-3 with, C-reactive protein (CRP), and homocysteine (HCY) in Black minorities with and without type 2 diabetes. Methods: A cross-sectional study was conducted with 406 participants: Haitian Americans (HA): n=238. African Americans (AA): n=172. Participants were recruited from a randomly generated mailing lists, local diabetes educators, community health practitioners and advertisements from 2008-2010. Sociodemographics and anthropometrics were collected and used to adjust analyses. All dietary variables were collected using the semi-quantitative food frequency questionnaire (FFQ) and used to quantify vitamin components. Blood was collected to measure CVD risk factors (blood lipids, HCY, and CRP). Results: African Americans had higher waist circumferences and C-reactive protein and consumed more calories as compared to Haitian Americans. Omega 3 fatty acid intake per calorie did not differ between these ethnicities, yet African Americans with low n-3 intake were three times more likely to have high C-reactive protein as compared to their counterparts [OR=3. 32 (1. 11, 9. 26) p=0.031]. Although homocysteine did not differ by ethnicity, African Americans with low omega 3 intake (<1 g/day) were four times as likely to have high homocysteine (>12 mg/L) as compared to their counterparts, adjusting for confounders [OR=4.63 (1.59, 12.0) p=0.004]. Consumption of n-3 by diabetes status was not associated with C-reactive protein or homocysteine levels. Conclusions: Consumption of n-3 may be protective of cardiovascular risk factors such as C-r

Diabetes Self Management: Are Cuban Americans Receiving Quality Health Care?

Objectives: We investigated the relationship among factors predicting inadequate glucose control among 182 Cuban-American adults (Females=110, Males=72) with type 2 diabetes mellitus (CAA). Study Design: Cross-sectional study of CAA from a randomized mailing list in two counties of South Florida Methods: Fasted blood parameters and anthropometric measures were collected during the study. BMI was calculated (kg/ m2). Characteristics and diabetes care of CAA were self-reported Participants were screened by trained interviewers for heritage and diabetes status (inclusion criteria: self-reported having type 2 diabetes; age  35 years, male and female; not pregnant or lactating; no thyroid disorders; no major psychiatric disorders). Participants signed informed consent form. Statistical analyses used SPSS and included descriptive statistic, multiple logistic and ordinal logistic regression models, where all CI 95%. Results: Eighty-eight percent of CAA had BMI of ≥ 25 kg/ m2. Only 54% reported having a diet prescribed/told to schedule meals. We found CAA told to schedule meals were 3.62 more likely to plan meals (1.81, 7.26), p<0.001) and given a prescribed diet, controlling for age, corresponded with following a meal plan OR 4.43 (2.52, 7.79, p<0.001). The overall relationship for HbA1c < 8.5 to following a meal plan was OR 9.34 (2.84, 30.7. p<0.001). Conclusions: The advantage of having a medical professional prescribe a diet seems to be an important environmental support factor in this sample’s diabetes care, since obesity rates are well above the national average. Nearly half CAA are not given dietary guidance, yet our results indicate CAA may improve glycemic control by receiving dietary instructions.

The new DGFI-TUM realization of the ITRS: DTRF2014 (data)

The DTRF2014 is a realization of the the fundamental Earth-fixed coordinate system, the International Terrestrial Reference System (ITRS). It has been computed by the Deutsches Geodätisches Forschungsinstitut der Technischen Universität München (DGFI-TUM). The DTRF2014 consists of station positions and velocities of 1712 globally distributed geodetic observing stations of the observation techniques VLBI, SLR, GNSS and DORIS. Additionally, for the first time, non-tidal atmospheric and hydrological loading is considered in the solution. The DTRF2014 was released in August 2016 and incorporates observation data of the four techniques up 2014. The observation data were processed and submitted by the corresponding technique services: IGS (International GNSS Service, http://igscb.jpl.nasa.gov) IVS (International VLBI Service, http://ivscc.gsfc.nasa.gov) ILRS (International Laser Ranging Service, http://ilrs.gsfc.nasa.gov) IDS (International DORIS Service, http://ids-doris.org). The DTRF2014 is an independent ITRS realization. It is computed on the basis of the same input data as the realizations JTRF2014 (JPL, Pasadena) and ITRF2014 (IGN, Paris). The three realizations of the ITRS differ conceptually. While DTRF2014 and ITRF2014 are based on station positions at a reference epoch and velocities, the JTRF2014 is based on time series of station positions. DTRF2014 and ITRF2014 result from different combination strategies: The ITRF2014 is based on the combination of solutions, the DTRF2014 is computed by the combination of normal equations. The DTRF2014 comprises 3D coordinates and coordinate changes of 1347 GNSS-, 113 VLBI-, 99 SLR- and 153 DORIS-stations. The reference epoch is 1.1.2005, 0h UTC. The Earth Orientation Parameters (EOP) - that means the coordinates of the terrestrial and the celestial pole, UT1-UTC and the Length of Day (LOD) - were simultaneously estimated with the station coordinates. The EOP time series cover the period from 1979.7 to 2015.0. The station names are the official IERS identifiers: CDP numbers or 4-character IDs and DOMES numbers (http://itrf.ensg.ign.fr/doc_ITRF/iers_sta_list.txt). The DTRF2014 solution is available in one comprehensive SINEX file and four technique-specific SINEX files, see below. A detailed description of the solution is given on the website of DGFI-TUM (http://www.dgfi.tum.de/en/science-data-products/dtrf2014/). More information can be made available by request.

Fatores determinantes da near miss materna em uma unidade de terapia intensiva obstétrica: avaliação das competências profissionais da área médica

Objective: Evaluate the determinants of morbidity and mortality in an obstetric intensive care unit and professional medical skills of students/residents at a university hospital. Methods: observational cross - sectional with 492 pregnant/pue rperal women and 261 students/residents. Patients were admitted to the obstetric intensive care unit during a year, being informed about the proposals of the study and a questionnaire was applied. The analysis was performed using Microsoft Excel 2013 and G raphPad6. Chi - square tests were used to evaluate risk factors and student t test evaluates resident/students' skills concerning the cognitive test and the Mini - Cex. Results: the main risk factors to near miss were: non - white race (OR = 2.527; RR = 2.342) ; marital status(married women) (OR = 7.968; RR = 7.113) , schooling (primary) (OR = 3.177 ; RR = 2.829) , from country town (OR = 4.643 ; RR = 4.087), low income (OR = 7014 ; RR = 5.554) , gestational hypertensive disorders (OR = 16.35 ; RR = 13.27) , re alization of pre - natal (OR = 5.023 ; RR = 4.254) and C - section before labor(OR = 39.21 ; RR = 31.25). In cognitive/Mini - cex analysis were noted significant difference in the performance of students on the subject (3.75 ± 0.93, 4.03 ± 0.94 and 4.88 ± 0.35). We still observed the best performance of residents, when compared to graduation students (p < 0.01). Conclusions: the prevalence of near miss was associated with socioeconomic/clinics factors and care issues, revealing the importance of interventions to improve these indicators. In addition, we suggest a better curriculum insertion of this subject in the medical Course disciplines due the importance to avoid the near miss through of adequacy of medical education.

Age, job characteristics and coronary health

Background: Workplace demographics are changing in many European countries with a higher proportion of older workers in employment. Research has shown that there is an association between job strain and cardiovascular disease, but this relationship is unclear for the older worker. Aims: To investigate the association between job strain and a coronary event comparing younger and older male workers. Methods: Cases with a first-time coronary event were recruited from four coronary/intensive care units (1999-2001). Matched controls were recruited from the case's general practitioner surgery. Physical measurements were taken and self-administered questionnaires completed with questions on job characteristics, job demands and control. Unconditional logistic regression was carried out adjusting for classical cardiovascular risk factors. Results: There were 227 cases and 277 matched controls. Age stratified analyses showed a clear difference between younger (= 50 years) workers with regard to the exposure of job strain (job demands and control) and the association between these factors and cardiovascular disease. Older workers who had a coronary event were four times as likely to have high job strain [OR = 4.09 (1.29-13.02)] and more likely to report low job control [ OR = 0.83 (0.72-0.95)]. Conclusions: Job control emerged as a potential protective factor for heart disease and this evidence was stronger in the older male worker. Nevertheless, they were significantly more likely to have job strain. These results suggest that older workers may be more susceptible to job strain.

Soil temperature along a plant diversity gradient in the Jena Experiment (Main Experiment, 2013)

Soil temperature (in °C) was determined using a frequency domain sensor probe (WET-2 Sensor, Delta-T Devices, Cambridge, United Kingdom) on 1st August 2013. The device was inserted from the top 6 cm deep (length of the prongs) into the soil. The average of three measurements on the same day was calculated. All data where measured in the main experiment plots of a large grassland biodiversity experiment (the Jena Experiment; see further details below). In the main experiment, 82 grassland plots of 20 x 20 m were established from a pool of 60 species belonging to four functional groups (grasses, legumes, tall and small herbs). In May 2002, varying numbers of plant species from this species pool were sown in the plots to create a gradient of plant species richness (1, 2, 4, 8, 16 and 60 species) and functional richness (1, 2, 3, or 4 functional groups). Plots were maintained by bi-annual weeding and mowing.

Soil porosity along a plant diversity gradient in the Jena Experiment (Main Experiment, 2013)

Soil porosity is the fraction of total volume occupied by pores or voids measured at matric potential 0. To measure soil porosity, soil samples were taken from each plot using sample rings with an internal diameter of 57 mm and height of 40.5 mm (inner volume of Vs=100 cm3). The samples were placed on a sand bed box with water level set to allow saturation of the samples with water. After 48 h the samples were weighed (ms), oven dried at 105 °C and weighed again to determine the dry weight (md). We calculated soil porosity (n [%]) using the density of water (?w=1 g cm?3), n=100 ? (mw-md) / (?w?Vs). To account for the spatial variation of soil properties, three replicates were taken per plot, approximately 2, 3 and 4 weeks after the flood that occurred at the field site during June 2013. Data are the average soil porosity values per plot. All data where measured in the main experiment plots of a large grassland biodiversity experiment (the Jena Experiment; see further details below). In the main experiment, 82 grassland plots of 20 x 20 m were established from a pool of 60 species belonging to four functional groups (grasses, legumes, tall and small herbs). In May 2002, varying numbers of plant species from this species pool were sown in the plots to create a gradient of plant species richness (1, 2, 4, 8, 16 and 60 species) and functional richness (1, 2, 3, or 4 functional groups). Plots were maintained by bi-annual weeding and mowing.

Soil temperature along a plant diversity gradient in the Jena Experiment (Main Experiment, 2006)

Soil temperature (in °C) was determined using a PT100 resistance thermometer that was inserted 5 cm into the ground. Soil temperature was recorded every hour of the day during July 2006. The average of five monthly measurements of soil temperature was calculated. All data where measured in the main experiment plots of a large grassland biodiversity experiment (the Jena Experiment; see further details below). In the main experiment, 82 grassland plots of 20 x 20 m were established from a pool of 60 species belonging to four functional groups (grasses, legumes, tall and small herbs). In May 2002, varying numbers of plant species from this species pool were sown in the plots to create a gradient of plant species richness (1, 2, 4, 8, 16 and 60 species) and functional richness (1, 2, 3, or 4 functional groups). Plots were maintained by bi-annual weeding and mowing.

Ant abundance and occurrence along the plant diversity gradient in the Jena Experiment (Main Experiment, year 2006)

This data set contains measurements of ant abundance (number of individuals observed at the baits) and ant occurrence (binary data) measured in the Main Experiment plots of a large grassland biodiversity experiment (the Jena Experiment; see further details below). Ants were sampled in 80 plots of the Main Experiment using baited traps in July 2006. In each plot two petri dishes were set on the ground, one received ~10g of Tuna the other ~10g of sugar (Sucrose). After 30min the occurrence (presence = 1 / absence = 0) and abundance (number) of ants at the two baits was recorded. Given is, per plot, the sum of ants attracted to the two different baits. In the Main Experiment, 82 grassland plots of 20 x 20 m were established from a pool of 60 species belonging to four functional groups (grasses, legumes, tall and small herbs). In May 2002, varying numbers of plant species from this species pool were sown in the plots to create a gradient of plant species richness (1, 2, 4, 8, 16 and 60 species) and functional richness (1, 2, 3, or 4 functional groups). Plots were maintained by bi-annual weeding and mowing.

Ant abundance and occurrence along the plant diversity gradient in the Jena Experiment (Main Experiment, year 2013)

This data set contains measurements of ant abundance (number of individuals attracted to baits) and ant occurrence (binary data) measured in the Main Experiment plots of a large grassland biodiversity experiment (the Jena Experiment; see further details below). In the Main Experiment, 82 grassland plots of 20 x 20 m were established from a pool of 60 species belonging to four functional groups (grasses, legumes, tall and small herbs). In May 2002, varying numbers of plant species from this species pool were sown in the plots to create a gradient of plant species richness (1, 2, 4, 8, 16 and 60 species) and functional richness (1, 2, 3, or 4 functional groups). Plots were maintained by bi-annual weeding and mowing. Ants where sampled in 80 plots of the Main Experiment using baited traps end of July/ beginning of August 2013. Sampling took place 36 days after the end of a major flooding of the field site that lasted for several weeks (see DOI flood descriptor). In each plot two petri dishes were set on the ground, one received ~10g of Tuna the other ~10g of Honey. After 30min the occurrence (presence = 1 / absence = 0) and abundance (number) of ants at the two baits was recorded. Given is, per plot, the sum of ants attracted to the two different baits.

Duration of a flood along a plant diversity gradient in the Jena Experiment (Main Experiment, June 2013)

The Jena Biodiversity Experiment is located on a Central European mesophilic floodplain on the banks of the Saale River (see further details below). In the main experiment, 82 grassland plots of 20 x 20 m were established from a pool of 60 species belonging to four functional groups (grasses, legumes, tall and small herbs). In May 2002, varying numbers of plant species from this species pool were sown in the plots to create a gradient of plant species richness (1, 2, 4, 8, 16 and 60 species) and functional richness (1, 2, 3, or 4 functional groups). Plots were maintained by bi-annual weeding and mowing. In June 2013, a natural 200-year flood event occurred at the field site. Rainfall in May 2013 in Jena was ~150mm, constituting >25% of annual precipitation at the site that year. Overall the flood affected the entire Elbe River Basin and much of Europe and was one of the largest natural flooding events in the past two centuries. The flood lasted for a total of 24 days at the site (30 May-24 June) and led to anaerobic soil conditions. Due to small topographical differences among the plots in the experiment (<1m), there was variation in the duration of flooding and the proportion of each plot that was flooded. This variation was well-distributed across the diversity gradient. To assess the importance of flood severity, the proportion of each plot that was flooded was estimated by eye (using five classes: 0 completely dry, 0.25 up to a quarter under water, 0.5 half, 0.75 up to three quarters under water, and 1 more than three quarters under water up to completely submerged). These values, for each of the 24 days that the flood lasted, were summed up to calculate a flooding index. The resulting flooding index is given for each plot of the Main Experiment.