Early identification of golimumab-treated patients with higher likelihood of long-term retention.

Background: The early identification of patients' profiles most likely to respond to and maintain long-term therapy with a biological drug can have clinical and cost-effectiveness implications. Objectives: To evaluate the utility of an innovative approach for early identification of patient profiles associated with long-term persistence of golimumab, a tumour necrosis factor inhibitor, in patients with rheumatoid arthritis (RA), psoriatic arthritis (PsA), and axial spondyloarthritis (SpA) under real-world conditions. Design: Retrospective non-interventional database analysis. Methods: Kaplan-Meier curves of golimumab retention over 8 years from the BIOBADASER registry, overall and by indication, were analysed using a novel approach (a two-phase decay model) to identify the point at which the golimumab retention curve shifted from rapid (indicating high golimumab discontinuation rate) to slow decay (low discontinuation rate). Factors associated with golimumab retention at these time points were identified using Cox regression, and retention rates for different patient profiles were calculated. Results: 885 patients were included. The golimumab retention curve shifted from rapid to slow decay at month 10 for the overall population (retention rate: 73.4%), at month 24 for RA patients (retention: 45.0%), and at month 8 for SpA, including axial SpA and PsA (81.6%). Factors associated with golimumab discontinuation at these early points were, overall, similar to those previously identified at year 8 (RA diagnosis, golimumab as second- or third-line of biological therapy, disease activity over the median and treatment with corticosteroids at golimumab initiation, advanced age [in RA], and female gender [in SpA]). Conclusion: With this novel approach, the factors associated with long-term retention were identified in the initial period of rapid discontinuation of golimumab.

Social cognition and emotional rehabilitation in participants with schizofrenia.

Introduction: People with schizophrenia have deficits in social cognition, emotion and social perception, as well as attributional style. The purpose of this study was to evaluate the efficacy of a multicomponent social cognition training program, e-Motional Training® (ET), in people with schizophrenia and to compare its efficacy with people who did not receive it. Therefore, a single-blind RCT was conducted in participants with a diagnosis of schizophrenia. Methods: A randomized, single-blind, clinical trial was conducted with 50 stable outparticipants with schizophrenia (registry number CHUC_2019_109). All participants (control and intervention) were treated with pharmacotherapy, case management and were on Individual Placement and Support methodology for competitive employment. The intervention group was treated with ET, an online program designed for social cognition rehabilitation. Pre and post assessment was performed using different battery of tests. General mixed models with subject identification and repeated measures over time were used. Results: Different pre and post measurements were performed in the two groups. No significant differences were found in sociodemographic characteristics between the control and intervention groups. Improvements were obtained in the intervention group in the Ekman test (p = 0.009), mainly enhanced by the improvement shown in three emotions: fear, sadness and disgust (p = 0.041, p = 0.021 and p = 0.038 respectively). Conclusion: ET is a promising online training tool for social cognition deficits in schizophrenia, in particular, for the improvement of emotions.Clinical Trial Registration: https://beta.clinicaltrials.gov, NCT05866328.

Screening uptake of colonoscopy versus fecal immunochemical testing in first-degree relatives of patients with non-syndromic colorectal cancer: A multicenter, open-label, parallel-group, randomized trial (ParCoFit study).

BACKGROUND: Colonoscopy screening is underused by first-degree relatives (FDRs) of patients with non-syndromic colorectal cancer (CRC) with screening completion rates below 50%. Studies conducted in FDR referred for screening suggest that fecal immunochemical testing (FIT) was not inferior to colonoscopy in terms of diagnostic yield and tumor staging, but screening uptake of FIT has not yet been tested in this population. In this study, we investigated whether the uptake of FIT screening is superior to the uptake of colonoscopy screening in the familial-risk population, with an equivalent effect on CRC detection. METHODS AND FINDINGS: This open-label, parallel-group, randomized trial was conducted in 12 Spanish centers between February 2016 and December 2021. Eligible individuals included asymptomatic FDR of index cases <60 years, siblings or ≥2 FDR with CRC. The primary outcome was to compare screening uptake between colonoscopy and FIT. The secondary outcome was to determine the efficacy of each strategy to detect advanced colorectal neoplasia (adenoma or serrated polyps ≥10 mm, polyps with tubulovillous architecture, high-grade dysplasia, and/or CRC). Screening-naïve FDR were randomized (1:1) to one-time colonoscopy versus annual FIT during 3 consecutive years followed by a work-up colonoscopy in the case of a positive test. Randomization was performed before signing the informed consent using computer-generated allocation algorithm based on stratified block randomization. Multivariable regression analysis was performed by intention-to-screen. On December 31, 2019, when 81% of the estimated sample size was reached, the trial was terminated prematurely after an interim analysis for futility. Study outcomes were further analyzed through 2-year follow-up. The main limitation of this study was the impossibility of collecting information on eligible individuals who declined to participate. A total of 1,790 FDR of 460 index cases were evaluated for inclusion, of whom 870 were assigned to undergo one-time colonoscopy (n = 431) or FIT (n = 439). Of them, 383 (44.0%) attended the appointment and signed the informed consent: 147/431 (34.1%) FDR received colonoscopy-based screening and 158/439 (35.9%) underwent FIT-based screening (odds ratio [OR] 1.08; 95% confidence intervals [CI] [0.82, 1.44], p = 0.564). The detection rate of advanced colorectal neoplasia was significantly higher in the colonoscopy group than in the FIT group (OR 3.64, 95% CI [1.55, 8.53], p = 0.003). Study outcomes did not change throughout follow-up. CONCLUSIONS: In this study, compared to colonoscopy, FIT screening did not improve screening uptake by individuals at high risk of CRC, resulting in less detection of advanced colorectal neoplasia. Further studies are needed to assess how screening uptake could be improved in this high-risk group, including by inclusion in population-based screening programs. TRIAL REGISTRATION: This trial was registered with ClinicalTrials.gov (NCT02567045).

Functional Status of Patients over 65 Years Old Intervened on for a Hip Fracture One Year after the Operation.

OBJECTIVES: Evaluation of the functional status one year after a hip fracture surgery and the influence of sarcopenia and other clinical factors at the time of admission. METHOD: Prospective observational study with 135 patients over 65 years of age. Functional status of basic (modified Katz) and instrumental activities (Lawton and Brody) and walking ability (Functional Ambulation Classification, FAC) was measured on admission, at discharge, and telephonically one year later. The risk or positive screening of sarcopenia (SARC-F) and cognitive status (Pfeiffer), as well as clinical variables, were evaluated. RESULTS: 72% of patients are women; 36% have a risk of sarcopenia (Sarc-F ≥ 4), and 43% have moderate-severe cognitive impairment (Pfeiffer ≥ 5). Walking capacity at one year was closer to the values at admission more often in women than in men (0.2 ± 1.3 points vs. 0.9 ± 1.6; p = 0.001), as well as in patients without risk of sarcopenia versus sarcopenic patients (0.3 ± 1.2 points vs. 0.7 ± 1.7; p = 0.001), although their evolution did not show significant differences (p = 0.183). Instrumental activities after one year have not been recovered (1.7 ± 2.5 points; p = 0.032), and patients at risk of sarcopenia showed worse values (1.7 ± 1.9 points vs. 3.7 ± 2.7; p < 0.001) and worse evolution (p = 0.012). The evolution of basic activities varied according to the risk of sarcopenia (0.6 ± 1.4 points vs. 1.4 ± 2.1; p = 0.008). CONCLUSIONS: Functional status at one year is related to the functional status at admission, the positive screening of sarcopenia, sex, and cognitive impairment of the patient. Knowing at the time of admission an estimate of the functional status at one year will help to reinforce the individual treatment of patients with a worse prognosis.

Eosinophil Subtypes in Adults with Asthma and Adults with Chronic Obstructive Pulmonary Disease.

Rationale: There is a differential response to eosinophilic modulation between patients with asthma and those with chronic obstructive pulmonary disease (COPD). There is also evidence of different subtypes of eosinophils in murine models. However, no study has compared eosinophil subtypes in individuals with COPD and in those with asthma. Objectives: Study the differences in eosinophils subtypes based in the surface protein expression in COPD patients and asthmatic patients. Methods: We studied 10 stable subjects in each of four groups: subjects with COPD, subjects with asthma, smokers without COPD, and healthy volunteers. Subjects with COPD and those with asthma were matched by age, sex, and FEV1% predicted. The following variables were determined: anthropometrics, smoking, exacerbation history, medication use, lung function, and comorbidities. Using flow cytometry and confocal microscopy from blood samples, we determined differences in eosinophil surface proteins and classified them as 1) resident eosinophils (Siglec-8+CD62L+IL-3Rlo) or 2) inflammatory eosinophils (iEos; Siglec-8+CD62LloIL-3Rhi). IL-5 receptor was also determined. Findings were validated in 59 patients with COPD and in 17 patients with asthma. Measurements and Main Results: Patients with asthma had a higher proportion of iEos (25 ± 15%) compared with those with COPD (0.5 ± 1%), smokers without COPD (0.14 ± 0.24%), and healthy volunteers (0.67 ± 1.72%). In patients with asthma, the proportion of iEos was independent of total eosinophil number. iEos had more IL-5 receptors than resident eosinophils (777.02 ± 124.55 vs. 598.35 ± 318.69; P < 0.01). In patients with COPD, there was no relation between iEos number and inhaled corticosteroid use, disease severity, or exacerbations rate. The findings in patients with COPD and those with asthma were confirmed in validation cohorts. Conclusions: There are differences in the subtypes of circulating eosinophils between patients with asthma and those with COPD. This could have clinical implications in the interpretation of eosinophil significance and the approach to therapy in these patients.

Effects of COVID-19 vaccination on disease activity in patients with rheumatoid arthritis and psoriatic arthritis on targeted therapy in the COVIDSER study.

OBJECTIVE: To investigate the influence of COVID-19 vaccination on disease activity in rheumatoid arthritis (RA) and psoriatic arthritis (PsA) patients under targeted therapies. PATIENTS AND METHODS: 1765 vaccinated patients COVID-19, 1178 (66.7%) with RA and 587 (33.3%) with PsA from the COVID-19 registry in patients with rheumatic diseases (COVIDSER) project, were included. Demographics, disease characteristics, Disease Activity Score in 28 joints (DAS28) and targeted treatments were collected. DAS28-based flare rates and categorised disease activity distribution prevaccination and post vaccination were analysed by log-linear regression and contingency analyses, respectively. The influence of vaccination on DAS28 variation as a continuous measure was evaluated using a random coefficient model. RESULTS: The distribution of categorised disease activity and flare rates was not significantly modified by vaccination. Log-linear regression showed no significant changes in the rate of flares in the 6-month period after vaccination compared with the same period prior to vaccination in neither patients with RA nor patients with PsA. When DAS28 variations were analysed using random coefficient models, no significant variations in disease activity were detected after vaccination for both groups of patients. However, patients with RA treated with Janus kinase inhibitors (JAK-i) (1) and interleukin-6 inhibitor (IL-6-i) experienced a worsening of disease activity (1.436±0.531, p=0.007, and 1.201±0.550, p=0.029, respectively) in comparison with those treated with tumour necrosis factor inhibitor (TNF-i). Similarly, patients with PsA treated with interleukin-12/23 inhibitor (IL-12/23-i) showed a worsening of disease activity (4.476±1.906, p=0.019) compared with those treated with TNF-i. CONCLUSION: COVID-19 vaccination was not associated with increased rate of flares in patients with RA and PsA. However, a potential increase in disease activity in patients with RA treated with JAK-i and IL-6-i and in patients with PsA treated with IL-12/23-i warrants further investigation.

Abnormal Maternal Body Mass Index and Customized Fetal Weight Charts: Improving the Identification of Small for Gestational Age Fetuses and Newborns.

BACKGROUND: Obesity and thinness are serious diseases, but cases with abnormal maternal weight have not been excluded from the calculations in the construction of customized fetal growth curves (CCs). METHOD: To determine if the new CCs, built excluding mothers with an abnormal weight, are better than standard CCs at identifying SGA. A total of 16,122 neonates were identified as SGA, LGA, or AGA, using the two models. Logistic regression and analysis of covariance were used to calculate the OR and CI for adverse outcomes by group. Gestational age was considered as a covariable. RESULTS: The SGA rates by the new CCs and by the standard CCs were 11.8% and 9.7%, respectively. The SGA rate only by the new CCs was 18% and the SGA rate only by the standard CCs was 0.01%. Compared to AGA by both models, SGA by the new CCs had increased rates of cesarean section, (OR 1.53 (95% CI 1.19, 1.96)), prematurity (OR 2.84 (95% CI 2.09, 3.85)), NICU admission (OR 5.41 (95% CI 3.47, 8.43), and adverse outcomes (OR 1.76 (95% CI 1.06, 2.60). The strength of these associations decreased with gestational age. CONCLUSION: The use of the new CCs allowed for a more accurate identification of SGA at risk of adverse perinatal outcomes as compared to the standard CCs.

The Influence of Follicular Fluid Metals on Assisted Reproduction Outcome.

Infertility has become more common, with an increased exposure to toxic compounds including heavy metals (HM). Follicular fluid (FF) surrounds the developing oocyte in the ovary and can be analysed to assess metal content. The levels of twenty-two metals were measured in the FF of ninety-three females in a reproduction unit, and their influence on assisted reproduction technique (ART), were examined. The metals were determined by optical emission spectrophotometry. Low values of copper, zinc, aluminium, and calcium favour polycystic ovary syndrome. The relationships between the number of oocytes and metals: iron (rs=0.303; p=0.003) and calcium (rs=-0.276; p=0.007) are significant, as well as between the number of mature oocytes with iron (rs=0.319; p=0.002), calcium (rs=-0.307; p=0.003) and sodium (rs=-0.215; p=0.039) and are near to significance in the case of aluminium (rs=-0.198; p=0.057). In the group with a fertilisation rate ≤ 75%, 36% of the women presented calcium >176.62 mg/kg compared to the group with a fertilisation rate ≥ 75% where this percentage was only 10% (p=0.011). An excess of iron and calcium reduces the good quality embryo rate, and an excess of potassium impairs the blastocyst rate. If potassium is above 237.18 mg/kg and calcium is below 147.32 mg/kg, these conditions favour embryo implantation. Pregnancy is influenced by high potassium and low copper levels. Controlling exposure to toxic elements is recommended for all couples with reduced fertility or receiving an ART.

The NDDG criteria versus the IADPSG or the ADA criteria for diagnosing early-onset gestational diabetes mellitus or abnormal glucose tolerance.

OBJECTIVE: To analyze the effects of substituting the National Diabetes Data Group (NDDG) criteria with the International Association of Diabetes and Pregnancy Study Groups (IADPSG) or American Diabetes Association (ADA) criteria for the diagnosis of early-onset gestational diabetes mellitus (Early-GDM) or first trimester abnormal glucose tolerance (1 t-AGT). METHODS: A retrospective cohort study was conducted of 3200 women: 400 with Early-GDM, 800 with GDM, and 2000 with Non-GDM, according to the NDDG criteria. Rates of women with missed and new Early-GDM according to the IADPSG or ADA criteria were calculated. Multivariate logistic regression analysis was used to compare perinatal outcomes between groups. RESULTS: Using the IADPSG criteria, 61.6% of women with Early-GDM according to the NDDG were undiagnosed (Missed-Early-GDM group), and 25.9% of women with GDM and 15.7% of women with Non-GDM were diagnosed with Early-GDM (New-Early-GDM groups). Perinatal outcomes were worse in Missed-Early-GDM than in Non-GDM and better in New-Early-GDM groups than in the Early-GDM group. According to the ADA recommendations, only 11.8% of women with Early-GDM according to the NDDG criteria were diagnosed. CONCLUSION: Replacing the NDDG recommendations for the diagnosis of Early-GDM with the IADPSG or ADA criteria would mean depriving a large number of women with AGT and higher risk of adverse perinatal outcomes from early treatment and treating others with lower risk.

Fasting Glucose for the Diagnosis of Gestational Diabetes Mellitus (GDM) during the COVID-19 Pandemic.

Background: During the COVID-19 pandemic, different non-validated tests were proposed to simplify the diagnosis of gestational diabetes (GDM). Aim: To analyse the effects of replacing the two-step approach for Early-GDM and GDM diagnosis, with a fasting plasma glucose test. Material and Methods: This is a cohort study consisting of 3200 pregnant women: 400 with Early-GDM, 800 with GDM and 2000 with Non-GDM diagnosed using the two-step approach. Using fasting plasma glucose for Early-GDM and GDM diagnosis, according to the recommendations of Spain, Australia, Italy and the UK during the pandemic, the rates of missed and new Early-GDM and GDM were calculated and perinatal outcomes were analysed. Results: Using fasting plasma glucose in the first trimester >100 mg/dL for Early-GDM diagnosis, the rates of post-COVID missed and new Early-GDM were 79.5% and 3.2%, respectively. Using fasting plasma glucose at 24−28 weeks <84 or >92, 95 or 100 mg/dL for GDM diagnosis, the rates of missed GDM were 50.4%, 78%, 82.6% and 92.4%, respectively, and 8.6%, 5.6% and 2.3% women with Non-GDM were diagnosed with new GDM. Conclusion: Fasting plasma glucose is not a good test for the diagnosis of GDM either in the first trimester or at 24−28 weeks.

Las personas con trastorno mental grave en un programa de alojamiento supervisado por un Equipo Comunitario Asertivo / People with severe mental disorders in a housing program supervised by an Assertive Community Team

El objetivo de este trabajo es evaluar la actitud y satisfacción de 182 pacientes con trastorno mental grave alojados en pisos y residencias supervisadas, sus redes sociales, las necesidades de atención y los cambios clínicos. Se recogieron datos sociodemográficos y clínicos. Se aplicaron los cuestionarios de Actitudes del Usuario (CAU), de Red Social (CURES) y la Escala ENAR-CPB de Valoración de los Niveles de Atención Residencial, con repetición a los dos años. El 86% refirieron mejoría en su vida, 77% en su enfermedad y 50% en sus relaciones sociales. Se observó una reducción significativa en las necesidades de atención a los dos años. Un 86% no tuvo ingresos hospitalarios, frente al 99% del año previo. En general, encontramos una buena aceptación de los alojamientos, con mejoría en las relaciones sociales, la estabilidad clínica y hospitalizaciones. Gracias al tratamiento asertivo comunitario, la mayoría consideraba que había habido una mejoría en su enfermedad y en sus vidas. (AU)

The aim of this work was to evaluate the attitude and satisfaction of 182 patients with severe mental disorder in supervised accommodation, their social networks, their care needs and clinical changes. Sociodemographic and clinical data were collected. The User Attitudes Questionnaire (CAU), the Social Network Questionnaire (CURES) and the Scale of Assessment of the Levels of Residential Attention for people with Severe Mental Disorder (ENAR-CPB) were administered with repetition at two years. 86% of them reported improvement in their life, 77% in their illness, and 50% in their social relationships. There was a significant reduction in care needs at two years. 86% of the participants did not have hospital admissions, compared to 99% the previous year. In general, we found a good acceptance of the accommodations, as well as an improvement in their social relationships, clinical stability, and hospitalizations. Thanks to the assertive community treatment, the majority considered that there was an improvement both in their disease and in their lives. (AU)

An effective algorithm to detect the possibility of being MSI phenotype in endometrial cancer given the BMI status and histological subtype: a statistical study.

PURPOSE: In endometrial cancer, the incidence of mutations in mismatch repair genes (MMR) is estimated at 17-30%. Patients with alterations at this level (MSI) are known to have different clinical and anatomopathological characteristics than those without this genetic alteration (MSS). In this study, we aim to identify the MSI phenotype in patients who underwent hysterectomy for endometrial cancer. We assessed the correlation of this phenotype with anatomoclinical parameters such as obesity and histological subtype. METHODS/PATIENTS: Clinical and anatomopathological data were collected from 147 patients diagnosed with endometrial cancer and an immunohistochemical study of MMR system proteins was performed. PMS2 and MSH6 proteins were evaluated as primary screening and subsequent evaluation of MLH1 and MSH6, respectively, if the former were negative. Statistical association between the anatomopathological data and the immunohistochemical result was analyzed. RESULTS AND CONCLUSIONS: 22.4% of our patients were MSI phenotype. We obtained statistically significant differences by multivariate analysis between endometrioid subtype and higher FIGO classification grade with MSI phenotype and obesity with MSS phenotype. Given these statistical results, we propose a function for predicting the probability of being MSI phenotype taking into account the histological subtype (endometrioid/non-endometrioid carcinoma) and FIGO grade as well as obesity. This prediction may be useful prior to hysterectomy, for genetic study of the MLH1 promoter and subsequent genetic counseling.

Arterial Hypertension in Morbid Obesity after Bariatric Surgery: Five Years of Follow-Up, a Before-And-After Study.

BACKGROUND: Arterial hypertension (HTN) is common among morbidly obese patients undergoing bariatric surgery. The aim of this study is to analyse the prevalence and evolution of HTN and weight loss in patients suffering from morbid obesity before and after bariatric surgery, during a follow-up period of five years. METHODS: A before-and-after study was carried out on severely obese patients undergoing Laparoscopic Roux-En-Y Gastric Bypass (LRYGB). Criteria for HTN diagnosis were current treatment with antihypertensive agents and/or systolic blood pressure (SBP) > 140 mmHg and/or diastolic (DBP) > 90 mmHg. HTN remission was defined as normalisation of blood pressure (BP) maintained after discontinuation of medical treatment, and HTN recurrence was considered when HTN diagnostic criteria reappeared after remission. Weight loss during the study period was evaluated for each patient, calculating excess weight loss percentage (% EWL) and BMI loss percentage (% BMIL) with reference to the baseline value. RESULTS: A total of 273 patients were included in the study. HTN was present in 48.2%; 29.4% of hypertensive patients showed HTN remission two years after the surgical procedure, 30.3% of them had relapsed at five years. CONCLUSION: LRYGB in obese patients is associated with a remission of HTN, and no weight loss differences were observed between the group of patients showing HTN remission at two years and the group who did not. However, differences were observed after the second follow-up year, with an increased weight loss in the remission group, which could indicate that sustained weight loss favours the control of HTN.

Role of targeted therapies in rheumatic patients on COVID-19 outcomes: results from the COVIDSER study.

OBJECTIVES: To analyse the effect of targeted therapies, either biological (b) disease-modifying antirheumatic drugs (DMARDs), targeted synthetic (ts) DMARDs and other factors (demographics, comorbidities or COVID-19 symptoms) on the risk of COVID-19 related hospitalisation in patients with inflammatory rheumatic diseases. METHODS: The COVIDSER study is an observational cohort including 7782 patients with inflammatory rheumatic diseases. Multivariable logistic regression was used to estimate ORs and 95% CIs of hospitalisation. Antirheumatic medication taken immediately prior to infection, demographic characteristics, rheumatic disease diagnosis, comorbidities and COVID-19 symptoms were analysed. RESULTS: A total of 426 cases of symptomatic COVID-19 from 1 March 2020 to 13 April 2021 were included in the analyses: 106 (24.9%) were hospitalised and 19 (4.4%) died. In multivariate-adjusted models, bDMARDs and tsDMARDs in combination were not associated with hospitalisation compared with conventional synthetic DMARDs (OR 0.55, 95% CI 0.24 to 1.25 of b/tsDMARDs, p=0.15). Tumour necrosis factor inhibitors (TNF-i) were associated with a reduced likelihood of hospitalisation (OR 0.32, 95% CI 0.12 to 0.82, p=0.018), whereas rituximab showed a tendency to an increased risk of hospitalisation (OR 4.85, 95% CI 0.86 to 27.2). Glucocorticoid use was not associated with hospitalisation (OR 1.69, 95% CI 0.81 to 3.55). A mix of sociodemographic factors, comorbidities and COVID-19 symptoms contribute to patients' hospitalisation. CONCLUSIONS: The use of targeted therapies as a group is not associated with COVID-19 severity, except for rituximab, which shows a trend towards an increased risk of hospitalisation, while TNF-i was associated with decreased odds of hospitalisation in patients with rheumatic disease. Other factors like age, male gender, comorbidities and COVID-19 symptoms do play a role.

Maternal Thinness and Obesity and Customized Fetal Weight Charts.

OBJECTIVE: The aim of the study was to determine if customized fetal growth charts developed excluding obese and underweight mothers (CC(18.5-25)) are better than customized curves (CC) at identifying pregnancies at risk of perinatal morbidity. MATERIAL AND METHODS: Data from 20,331 infants were used to construct CC and from 11,604 for CC(18.5-25), after excluding the cases with abnormal maternal BMI. The 2 models were applied to 27,507 newborns and the perinatal outcomes were compared between large for gestational age (LGA) or small for gestational age (SGA) according to each model. Logistic regression was used to calculate the OR of outcomes by the group, with gestational age (GA) as covariable. The confidence intervals of pH were calculated by analysis of covariance. RESULTS: The rate of cesarean and cephalopelvic disproportion (CPD) were higher in LGAonly by CC(18.5-25) than in LGAonly by CC. In SGAonly by CC(18.5-25), neonatal intensive care unit (NICU) and perinatal mortality rates were higher than in SGAonly by CC. Adverse outcomes rate was higher in LGAonly by CC(18.5-25) than in LGAonly by CC (21.6%; OR = 1.61, [1.34-193]) vs. (13.5%; OR = 0.84, [0.66-1.07]), and in SGA only by CC(18.5-25) than in SGAonly by CC (9.6%; OR = 1.62, [1.25-2.10] vs. 6.3%; OR = 1.18, [0.85-1.66]). CONCLUSION: The use of CC(18.5-25) allows a more accurate identification of LGA and SGA infants at risk of perinatal morbidity than conventional CC. This benefit increase and decrease, respectively, with GA.

Changes in the use patterns of bDMARDs in patients with rheumatic diseases over the past 13 years.

The better understanding of the safety of biologic DMARDs (bDMARDs), as well as the emergence of new bDMARDs against different therapeutic targets and biosimilars have likely influenced the use patterns of these compounds over time. The aim of this study is to assess changes in demographic characteristics, disease activity and treatment patterns in patients with rheumatoid arthritis (RA), psoriatic arthritis (PsA), or ankylosing spondylitis (AS) who started a first- or second-line biologic between 2007 and mid-2020. Patients diagnosed with RA, PsA or AS included in the BIOBADASER registry from January 2007 to July 2020 were included. According to the start date of a first- or second-line biologic therapy, patients were stratified into four time periods: 2007-2009; 2010-2013; 2014-2017; 2018-2020 and analyzed cross-sectionally in each period. Demographic and clinical variables, as well as the type of biologic used, were assessed. Generalized linear models were applied to study the evolution of the variables of interest over time periods, the diagnosis, and the interactions between them. A total of 4543 patients initiated a first biologic during the entire time frame of the study. Over the four time periods, disease evolution at the time of biologic initiation (p < 0.001), disease activity (p < 0.001), retention rate (p < 0.001) and the use of tumor necrosis factor inhibitors as a first-line treatment (p < 0.001) showed a significant tendency to decrease. Conversely, comorbidities, as assessed by the Charlson index (p < 0.001), and the percentage of patients using bDMARDs in monotherapy (p < 0.001), and corticosteroids (p < 0.001) tended to increase over time. Over the entire period of the study's analysis, 3289 patients started a second biologic. The following trends were observed: decreased DAS28 at switching (p < 0.001), lower retention rates (p = 0.004), and incremental changes to the therapeutic target between the first and second biologic (p < 0.001). From 2007 until now rheumatic patients who started a biologic were older, exhibited less clinical activity, presented more comorbidities, and switched to a different biologic more frequently and earlier.

Baseline Levels of Vitamin D in a Healthy Population from a Region with High Solar Irradiation.

The use of vitamin D (VitD) supplements has become widespread in the last decade due not only to the dissociation between the blood levels recommended as "optimal" and those shown by the healthy population but also to its presumed beneficial effects on multiple disorders. This work evaluated the levels of 25-hydroxyvitamin D (25(OH)D) in a healthy population of European origin living in a region with high solar irradiation. In serum samples from a population-based study conducted in the Canary Islands, levels of 25(OH)D were analyzed. In 876 individuals who had no history of kidney or malabsorption disorders and, who had not been treated with calcium and/or VitD supplementation, the median 25(OH)D level was 26.3 (5th; 95th percentile, 14.3; 45.8) ng/mL. Notably, 65.4% of the population had 25(OH)D blood levels below 30 ng/mL, 23.4% below 20 ng/mL and 6.4% below 15 ng/mL. Based on the lack of evidence supporting causality between 25(OH)D levels below what is recommended as optimal (≥20 ng/mL, or even ≥30 ng/mL) and major skeletal and non-skeletal diseases, and in light of the distribution of the concentration of this vitamin in healthy adults living under optimal conditions of solar irradiation, it seems reasonable to consider 25(OH)D levels below 20 ng/mL and close to 15 ng/mL as adequate for the general population.

Natural Course of the Diffusing Capacity of the Lungs for Carbon Monoxide in COPD: Importance of Sex.

BACKGROUND: The value of the single-breath diffusing capacity of the lungs for carbon monoxide (Dlco) relates to outcomes for patients with COPD. However, little is known about the natural course of Dlco over time, intersubject variability, and factors that may influence Dlco progression. RESEARCH QUESTION: What is the natural course of Dlco in patients with COPD over time, and which other factors, including sex differences, could influence this progression? STUDY DESIGN AND METHODS: We phenotyped 602 smokers (women, 33%), of whom 506 (84%) had COPD and 96 (16%) had no airflow limitation. Lung function, including Dlco, was monitored annually over 5 years. A random coefficients model was used to evaluate Dlco changes over time. RESULTS: The mean (± SE) yearly decline in Dlco % in patients with COPD was 1.34% ± 0.015%/y. This was steeper compared with non-COPD control subjects (0.04% ± 0.032%/y; P = .004). Sixteen percent of the patients with COPD, vs 4.3% of the control subjects, had a statistically significant Dlco % slope annual decline (4.14%/y). At baseline, women with COPD had lower Dlco values (11.37% ± 2.27%; P < .001) in spite of a higher FEV1 % than men. Compared with men, women with COPD had a steeper Dlco annual decline of 0.89% ± 0.42%/y (P = .039). INTERPRETATION: Patients with COPD have an accelerated decline in Dlco compared with smokers without the disease. However, the decline is slow, and a testing interval of 3 to 4 years may be clinically informative. The lower and more rapid decline in Dlco values in women, compared with men, suggests a differential impact of sex in gas exchange function. TRIAL REGISTRY: ClinicalTrials.gov; No.: NCT01122758; URL: www.clinicaltrials.gov.

Association of Gender, Diagnosis, and Obesity With Retention Rate of Secukinumab in Spondyloarthropathies: Results Form a Multicenter Real-World Study.

Background: Secukinumab has been shown effective for psoriatic arthritis (PsA) and axial spondylarthritis (AxSpA) in randomized trials. The aim of this study was to analyze baseline patient and disease characteristics associated with a better retention rate of secukinumab under real-world conditions. Patients and Methods: Real-life, prospective multicenter observational study involving 138 patients, 61 PsA and 77 AxSpA, who were analyzed at baseline, 6, 12 months and subsequently every year after starting secukinumab regardless of the line of treatment. Demographics and disease characteristics, measures of activity, secukinumab use, and adverse events were collected. Drug survival was analyzed using Kaplan-Meier curves and factors associated with discontinuation were evaluated using Cox regression. The machine-learning J48 decision tree classifier was also applied. Results: During the 1st year of treatment, 75% of patients persisted with secukinumab, but accrued 71% (n = 32) in total losses (n = 45). The backward stepwise (Wald) method selected diagnosis, obesity, and gender as relevant variables, the latter when analyzing the interactions. At 1 year of follow-up, the Cox model showed the best retention rate in the groups of AxSpa women (95%, 95% CI 93-97%) and PsA men (89%, 95% CI 84-93%), with the worst retention in PsA women (66%, 95% CI 54-79%). The J48 predicted secukinumab retention with an accuracy of 77.2%. No unexpected safety issues were observed. Conclusions: Secukinumab shows the best retention rate at 1 year of treatment in AxSpA women and in PsA men, independently of factors such as the time of disease evolution, the line of treatment or the initial dose of the drug.