Real Study Research Articles

Effectiveness of anti-IL5/5Rα biologics in severe asthma in real world studies: a systematic review and meta-analysis

BackgroundThree biologics targeting interleukin 5 (anti-IL5) or its receptor-α (anti-IL5Ra) are approved for patients with severe asthma.MethodsWe conducted a systematic search until May 1, 2023, to identify observational studies and non-randomised trials that assess the response to anti-IL5/5Rα of real-life patients with severe eosinophilic asthma in MEDLINE and EMBASE. We performed random-effects meta-analyses.ResultsWe identified 6,401 studies of which 92 with 9546 patients were analysed. Biologics use was associated with 62% reduction in severe exacerbations (risk ratio, RR, 0.38, 95%CI 0.29 to 0.50) and 54% reduction in hospitalisations (RR 0.46, 95%CI 0.35 to 0.61) at 12 months of treatment, compared to pre-treatment. Biologics improved asthma control [decrease in asthma control questionnaire (ACQ) by 1.11 points (95%CI −1.29 to −0.94) and increase in asthma control test (ACT) by 6.41 points (95%CI 5.66 to 7.16)], and increased the asthma quality of life questionnaire (AQLQ) by 1.08 points (95%CI 0.88 to 1.28) and forced expiratory volume in 1 s (FEV1) by 0.21 L (95% CI 0.15 to 0.27) at 12 months. There was a significant reduction in oral corticosteroids use by 51% (RR 0.49, 95%CI 0.42 to 0.56), with a mean dose reduction of 6.01 mg/d (95%CI −7.55 to −4.48) at 12 months of treatment. Similar findings were observed at 3–4, 6 and 24 months. Biomarker-related response to treatment was also noted.ConclusionsThis comprehensive meta-analysis summarises the significant clinical response to anti-IL5/5Rα biologics in real-life studies, providing important insights for clinical practice use of these agents.

Elexacaftor/tezacaftor/ivacaftor, a game-changer in cystic fibrosis: The Portuguese experience

BackgroundPhase 3 trials of elexacaftor/tezacaftor/ivacaftor (ELX/TEZ/IVA) combination treatment in people with cystic fibrosis (CF) with ≥1 F508del-CFTR allele showed profound short-term effects on lung function, weight, and pulmonary exacerbations (PEx). The authors conducted a 12-month study to add evidence on the real-world long-term effectiveness and safety of CFTR modulator therapy with ELX/TEZ/IVA in Portuguese CF adult population. MethodsAmbispective, multicentre, observational, real-life study involving all the Portuguese CF Reference Centres. Adult patients on treatment with ELX/TEZ/IVA combination outside clinical trials were included. Demographics, efficacy, and safety variables on the first 12 months of treatment were compared with the pre-treatment year. Results132 adult people with CF were included, of which 119 completed 12 months treatment (mean duration of treatment 21.5 months). Mean age was 31.7 ± 11.0 years, 53 % patients were homozygous for the F508del variant, baseline sweat chloride was 86.7 ± 25.9 mmol/L and pre-treatment percent-predicted FEV1 was 77.9 ± 19.7 %. At 1 year, mean absolute change from baseline in FEV1 was +0.46L (95 % CI: 0.37, 0.55; p < 0.001) and +13.9 percentage points (95 % CI: 11.5, 16.2; p < 0.001). PEx episodes decreased by 78 % (p < 0.001) and hospitalizations for PEx decreased by 91.4 % (p < 0.001). Body mass index (BMI) increased 1.2 kg/m2 (95 % CI: 0.9, 1.5; p < 0.001). Mean sweat chloride variation was −44.5 mmol/L (95 % CI: −49.8, −39.2; p < 0.001). No correlation was found between sweat chloride and lung function (r = −0.116, p = 0.335). There were no major safety concerns. Of note, headache was reported in 7.6 % and neuropsychiatric manifestations occurred in 12.6 % treated patients, being anxiety and depressive disorders the most common. ConclusionsELX/TEZ/IVA treatment in Portuguese adults with CF was associated with significant improvement in lung function, a drop in PEx and PEx-related hospitalizations and increase in BMI at 12 months and was well tolerated. These results add knowledge to our understanding of clinical benefits and tolerability of ELX/TEZ/IVA. Careful evaluation of adverse effects of ELX/TEZ/IVA therapy and its determinants, mainly concerning mental health, are a research priority.

Long-Term Outcome of Patients with Low-Risk Differentiated Thyroid Cancer Treated with Total Thyroidectomy Alone.

Differentiated thyroid carcinoma (DTC), mainly papillary (PTC), at low risk of recurrence is currently managed with active surveillance strategies or less aggressive surgeries. However, total thyroidectomy with 131I treatment is still performed both if these tumors are diagnosed before or occasionally after surgery. This real-life study aimed to evaluate the rate of biochemical, structural, and functional events in a large series of consecutive DTCs at low risk of recurrence treated by total thyroidectomy, but not with 131I, in a medium-long-term follow-up. We evaluated clinical-pathologic data of 383 consecutive patients (2006-2012) with unifocal DTC [T1a/b(s)] at low risk of recurrence, treated with total thyroidectomy but without lymph node dissection and 131I treatment after surgery. We evaluated if structural, biochemical, and functional events were detected during the follow-up. Females accounted for 75.7% of our study group, and the median age was 50 years. The median tumor dimension was 0.4 cm (range 0.1-1.2). Most of the patients had a unifocal T1a tumor (98.9%), and 73.6% had a classic variant of PTC. We divided the patients according to the absence (group A-n = 276) or presence (group B-n = 107) of interfering TgAb at first control after surgery. After a median follow-up of 10 years, no structural events were detected. Sixteen out of three hundred and eighty-three (4.2%) patients developed biochemical events: 12/276 (4.3%) in group A and 4/107 (3.7%) in group B. The median time elapsed from surgery to detecting a biochemical event was 14.5 and 77.5 months in groups A and B, respectively. No patients performed additional treatments and were followed up with an active surveillance strategy. This study confirmed that patients with DTC at low risk of recurrence showed an excellent outcome in a medium long-term follow-up since no structural events were diagnosed. Significant variations in Tg/TgAb were detected in a few cases, all managed with an active surveillance strategy without the need for other treatments. Therefore, a relaxed follow-up with neck ultrasound and Tg/TgAb measurement is enough to early identify those very unusual cases of recurrence.

Sustainable management of polyethylene terephthalate waste flow using a fuzzy frank weighted assessment model

The consequences for the ecosystem of polyethylene terephthalate (PET) waste are becoming increasingly significant and widespread. Companies managing PET waste strive to enhance sustainability in all areas. The development of systematic decision-making approaches and frameworks for PET waste management is strongly needed. This research aims to present a new methodological framework for the categorization of the most efficient PET waste management solutions. The introduced fuzzy Frank weighted sum product assessment (FWESPA) model enables rational and flexible reasoning by nonlinearly processing uncertain information. A nonlinear aggregation function is proposed for the fusion of fuzzy strategic options. It is advantageous in simulating the impact of strategic options on a final decision. An integral part of the introduced fuzzy FWESPA model is a reverse sorting algorithm. This innovative algorithm can improve the performance of traditional normalization techniques. Also, an improved fuzzy Frank ordinal priority approach linear model is formulated to define the significance of evaluation criteria. The comprehensive real-life study demonstrates the proposed decision-analytics-based approach. The results showed the following rankings of considered alternatives: “recycling” (ℤA2 = 0.8565) > “energy recovery” (ℤA1 = 0.7364) > “remanufacturing” (ℤA4 = 0.690) > “incineration” (ℤA3 = 0.6592). Based on the results presented, alternatives “recycling” (A2) and “energy recovery” (A1) represent dominant alternatives with a slight advantage of recycling. Research findings can be used when deciding the appropriate way to enhance PET waste handling. The findings also describe the benefits and limitations of each treatment option for PET waste, as well as highlight the crucial challenges.

Impact analysis of SARS-CoV-2 vaccination in patients treated with monoclonal antibodies: A monocentric experience

BackgroundSince the discovery of SARS-CoV-2, no treatment has been able to completely eradicate the virus. The study aimed to evaluate the virological and clinical impact of the vaccination in SARS-CoV-2 infected patients treated with monoclonal antibodies (mAbs). MethodsThis single-centre, observational, retrospective, real-life study was performed on SARS-CoV-2 symptomatic outpatients and inpatients treated with mAbs from March 2021 to November 2022 includes 726 patients. Each patient received available mAbs (bamlanivimab-etesevimab or casirivimab-indevimab or sotrovimab or tixagevimab-cilgavimab) according to the circulating virus strains. Age, comorbidities, vaccination status, death rates, duration of virological clearance, average length of stay, risk factors, and hospitalization or ICU admission were recorded. ResultsOf 726 patients with complete data analyzed (median age 64), 516 outpatients and 210 inpatients were included. Vaccination status was known for all participants: 74.4 % and 51.7 % were vaccinated against SARS-CoV-2 among inpatients and outpatients, respectively. A shorter duration of virological clearance was observed in the vaccinated group, with a median of 16 days (IQR 15–17), compared to 19 days (IQR 18–21) in the unvaccinated group [HR 1.21; p < 0.032]. Multivariate analysis of virological clearance also showed statistical significance with tixagevimab cilgavimab 300 mg/300 mg (HR 2.73, p value < 0.001). No significant difference was found in worsening [OR 1,29; p = 0.57] and mortality [OR 0.65; p = 0.81] rates between vaccinated and unvaccinated patients treated with mAbs. ConclusionsKey findings include a shorter duration of virological clearance in vaccinated outpatients but no significant differences in worsening or mortality rates between vaccinated and unvaccinated patients treated with mAbs. The study suggests a potential synergistic role of mAbs in accelerating virological clearance in vaccinated patients with mild to moderate COVID-19, with differing effects in hospitalized patients. Therefore, it is essential to implement health surveillance in high-risk patients with comorbidities in order to identify early any variants that might otherwise escape neutralizing antibodies.

Long-Term Change in BMI for Children with Obesity Treated in Family-Centered Lifestyle Interventions

Introduction: Several evaluations of lifestyle interventions for childhood obesity exist; however, follow-up beyond 2 years is necessary to validate the effect. The aim of the present study was to investigate long-term weight development following children participating in one of two pragmatic family-centered lifestyle interventions treating childhood obesity. Methods: This real-life observational study included Danish children 4–17 years of age classified as having obesity. Data from 2010 to 2020, from two community-based family-centered lifestyle interventions (designated hereafter as the Aarhus- and the Randers-intervention) were merged with national registers and routine health check-ups, including height and weight. Adjusted mixed effect models were used to model changes in body mass index (BMI) z score. We performed exploratory analyses of the development in BMI z-score within stratified subgroups of children treated in the interventions before investigating potential effect modifications induced by sex, age, family structure, socioeconomic, or immigration status. Results: With a median follow-up of 2.8 years (interquartile range: 1.3; 4.8), 703 children participated in an intervention (445 the Aarhus-intervention; 258 the Randers-intervention) and 2,337 children were not invited to participate (no-intervention). Children in both interventions experienced a comparable reduction in BMI z-scores during the first 6 months compared to the no-intervention group (Aarhus-intervention: −0.12 SD/year and Randers-intervention: −0.25 SD/year). Only children in the Randers-intervention reduced their BMI z-score throughout follow-up (Aarhus-intervention vs. no-intervention: 0.01 SD/year; confidence interval [CI]: −0.01; 0.04; Randers-intervention vs. no-intervention: −0.05 SD/year; CI: −0.08; −0.02). In subgroup comparisons, combining the two interventions, family income below the median (−0.05 SD/year, CI: −0.02; −0.09), immigrant background (0.04 SD/year, CI: 0.00; 0.07), or receiving intervention less than 1 year (0.04 SD/year, CI: 0.00; 0.08) were associated with a yearly increase in BMI z score. In addition, effect modification analyses did not observe any interaction by sex, age, family structure, socioeconomic, or immigration. Conclusions: Although the more dynamic intervention with longer duration obtained and sustained a minor reduction in BMI z score, the clinical impact may only be modest and still not effective enough to induce a long-term beneficial development in BMI in children with obesity.

Beta-blockers and breastfeeding: a real-life prospective study.

At Lille University Hospital, a pregnancy heart team including cardiologists, obstetricians, pediatricians, anesthetists, geneticists, and pharmacologists discusses about treatment compatibility taken during breastfeeding in pregnant women (or those wishing to be pregnant) with complex cardiovascular pathologies. Beta-blockers are among the drug most often used in these patients, and data are missing or suggest a risk to the breastfed child. The aim of this study was to evaluate the proportion of women treated with beta-blockers, identified during the multidisciplinary meeting, who breastfed and to monitor adverse effects (AEs) in newborns. A prospective descriptive study was conducted from 1 December 2017 to 1 December 2021. All pregnant patients followed up by the pregnancy heart team in Lille University Hospital, treated with beta-blockers and who gave birth, were contacted as part of the pharmacovigilance follow-up. The proportion of women treated with beta-blockers intending to breastfeed was 69.8%. Among the 53 women interviewed, 49% did not breastfeed, including 10 because of the theoretical incompatibility of their beta-blocker with breastfeeding. Among the 27 women who breastfed, 30% breastfed while treated with a theoretically incompatible beta-blocker; 56% was changed from their initial beta-blocker to allow safe breastfeeding. No serious AE was observed. To our knowledge, our study is the largest series of patients treated with beta-blockers during breastfeeding. Taking a treatment can be an obstacle to breastfeeding, but for the particular case of beta-blockers, even if the available data are few and sometimes worrying, the data from this study are reassuring.

Impact of biological therapies on laboratory outcomes and FEV1 in patients with severe eosinophilic asthma with chronic rhinosinusitis: a real-life study from Saudi Arabia.

From March to September 2022, a retrospective observational cohort study was undertaken at the severe asthma clinics of the Armed Forces Hospital-Southern Region (AFHSR) and King Khalid University Hospital, Abha, Saudi Arabia, to delineate the effects of 3 biological therapies (benralizumab, dupilumab, and omalizumab) in adults with SA and concomitant CRS in terms of FEV1 and laboratory parameters (serum IgE and eosinophilic counts). Eighty patients were enrolled, with a mean age of 46.68. There were 45 (56%) females and 35 (44%) males. There were significant improvements in FEV1 and laboratory parameters (serum IgE and eosinophilic counts) after 6 &12 months of biological therapies compared to pre-biological therapies (p<0.001, each). The response was different among different biological therapies. The improvements in FEV1, serum IgE, and eosinophilic counts were manifest with benralizumab and dupilumab but not with omalizumab. Results from the first study from two large Saudi Arabian tertiary centers for patients with severe asthma and chronic rhinosinusitis agree with and support those of worldwide real-life ones. One-year follow-up of patients with SA and CRS showed the effectiveness of benralizumab and dupilumab, but not omalizumab, regarding FEV1, serum IgE, and eosinophilic counts. Further prospective multicenter studies are warranted.

Mask side-effects are related to gender in long-term CPAP: results from the InterfaceVent real-life study

BackgroundOver the past three decades, our understanding of sleep apnea in women has advanced, revealing disparities in pathophysiology, diagnosis, and treatment compared to men. However, no real-life study to date has explored the relationship between mask-related side effects (MRSEs) and gender in the context of long-term CPAP.MethodsThe InterfaceVent-CPAP study is a prospective real-life cross-sectional study conducted in an apneic adult cohort undergoing at least 3 months of CPAP with unrestricted mask-access (34 different masks, no gender specific mask series). MRSE were assessed by the patient using visual analog scales (VAS). CPAP-non-adherence was defined as a mean CPAP-usage of less than 4 h per day. The primary objective of this ancillary study was to investigate the impact of gender on the prevalence of MRSEs reported by the patient. Secondary analyses assessed the impact of MRSEs on CPAP-usage and CPAP-non-adherence depending on the gender.ResultsA total of 1484 patients treated for a median duration of 4.4 years (IQ25–75: 2.0–9.7) were included in the cohort, with women accounting for 27.8%. The prevalence of patient-reported mask injury, defined as a VAS score ≥ 5 (p = 0.021), was higher in women than in men (9.6% versus 5.3%). For nasal pillow masks, the median MRSE VAS score for dry mouth was higher in women (p = 0.039). For oronasal masks, the median MRSE VAS score for runny nose was higher in men (p = 0.039). Multivariable regression analyses revealed that, for both women and men, dry mouth was independently and negatively associated with CPAP-usage, and positively associated with CPAP-non-adherence.ConclusionIn real-life patients treated with long-term CPAP, there are gender differences in patient reported MRSEs. In the context of personalized medicine, these results suggest that the design of future masks should consider these gender differences if masks specifically for women are developed. However, only dry mouth, a side effect not related to mask design, impacts CPAP-usage and non-adherence.Trial Registration: InterfaceVent is registered with ClinicalTrials.gov (NCT03013283).First registration date is 2016–12-23.

An updated study protocol for a real-life digital 12-month weight management program, the Healthy Weight Coaching

Obesity is an important health concern that poses many public health challenges. Evidence-based treatment modalities, capable of cost-effectively reaching large patient groups are needed. In this paper, we present the design and methods of the updated national, 12-month, digital weight management program, the Healthy Weight Coaching (HWC). The major updates, as compared to the previous version, are related to the theoretical background of the obesity management and updated BMI cut-offs. The HWC is available, based on physicians’ referrals, to adult Finnish citizens with BMI ≥30 kg/m2 or ≥27 kg/m2 with a comorbidity, who have a health-based need to lose weight. Rooted in the principles of behavioural therapy, the HWC focuses on teaching coping skills, guides to healthy self-reflection, and supports concrete lifestyle changes as part of healthy weight loss. The automated weekly training sessions, supplemented by 3-8 exercises, form the basis of the program. These sessions address topics such as diet, physical activity, stress management, and rest and recovery. Additionally, a personal coach is allocated to each patient to provide tailored support. At baseline, patients record their weight, height, and waist circumference, online, and complete questionnaires on lifestyle, diet, physical activity, sleep, psychological factors, and health. Thereafter weight recording is conducted at least every 4 weeks, while the questionnaires and measuring the weight circumference are repeated at 3, 6, 9, and 12 months. In addition, patients can make use of diaries and peer group chats for additional support. Data collected from the consenting patients will be used for research purposes with the weight change from baseline to 12 months as the main outcome in the real-life observational study. The study will provide invaluable insights into the application of digital modalities in the treatment of obesity.

Impact of primary dressings on healing of venous leg ulcers: a French cohort study from the healthcare insurance database.

Multicomponent bandages (MCBs) are recommended by the French Authority for Health (Haute Autorité de Santé) as first-line treatment for venous leg ulcers (VLUs). A first analysis of the data collected from the French administrative healthcare database (Système National des Données de Santé (SNDS)) on 25,255 patients with a VLU supported superiority of MCBs versus short stretch bandages when considering the healing outcomes and costs associated with closure of these wounds. The aim of this study was to assess how beneficial the primary dressing (technology lipido-colloid nano-oligosaccharide factor (TLC NOSF) or control dressing group (CDG)) could be, when used in combination with MCBs in the treatment of VLUs. Data from the SNDS were collected for patients meeting the following inclusion criteria: treatment for a VLU with MCBs and with the same dressing type (TLC-NOSF or CDG) during the whole treatment period. Healing outcomes were documented on the global cohorts and propensity score-matched cohorts. The mean healthcare cost and the ecological impact were calculated for those patients healed within the study period. In total, 12,507 patients met the criteria for treatment with both MCBs and TLC-NOSF dressings (n=1134) versus MCBs and CDG (n=11,373); with 1134 and 2268 patients per group following propensity score matching. Healing outcomes were favourable for the TLC-NOSF group in the global cohort and were enhanced in the propensity score-matched cohorts. At every point of the analysis, the adjusted healing rates were significantly higher in the TLC-NOSF group than in the CDG group (p<0.001). In the propensity score-matched cohorts (n=3402), the healing rate at three months was 52% in the TLC-NOSF group versus 37% in the CDG group (p<0.001). The median healing time was 87 days versus 125.5 days in the TLC-NOSF and CDG groups, respectively (p<0.0001). TLC-NOSF dressings significantly reduced the average treatment cost per healed ulcer (€2099) by 23.7% compared with dressings without TLC-NOSF (€2751) (p<0.001), as well as the resources used. This SNDS analysis confirms, in the largest real-life study performed in VLU management, the superiority of the TLC-NOSF dressings versus those not impregnated with the NOSF compound. Better clinical outcomes associated with cost savings and a positive ecological impact support the combination of MCBs and TLC-NOSF dressings and should be considered as an optimal standard of care for the global management of VLUs. These outcomes reinforce the current positions of the international guidelines on the use of NOSF impregnated dressings (UrgoStart range; Laboratoires Urgo, France) in this pathology.

P200 INCIDENCE OF LENVATINIB INDUCED ARTERIAL HYPERTENSION IN THYROID CARCINOMA: A RETROSPECTIVE ANALYSIS OF A SERIES OF CASES

Background and Objective: Advanced thyroid cancer leads to worse overall survival and a higher risk of locoregional recurrence. Tyrosine kinase inhibitors have emerged as a management alternative in these conditions. However, serious adverse effects such as high blood pressure are common in clinical trials and real-life studies. The objective of this study was to evaluate the incidence of arterial hypertension in patients undergoing treatment for advanced thyroid cancer with the tyrosine kinase inhibitors lenvatinib Methods This is a retrospective cohort study of patients with advanced thyroid cancer being managed with Lenvatinib, a tyrosine kinase inhibitor. The incidence of arterial hypertension after the start of treatment was evaluated. Results Among the subjects included in the study (n=26), the mean age was 64.6 ±11.8; 57.7% were women and hypertension occurred in 88.5% (23/26), being CTCAE grade ≥ 3 in 43.5% (10/23). In 12 of 23 it occurred due to exacerbation of pre-existing hypertension and in 10 of 23 it corresponded to de novo hypertension induced by the drug. A patient presented grade 4 hypertension due to posterior reversible encephalopathy syndrome. 6 patients died during follow-up, all developed hypertension during treatment with Lenvatinib. Conclusions: High blood pressure is a common and early adverse effect in the management of advanced thyroid cancer with Lenvatinib. Management strategies to improve drug tolerability may improve disease outcomes, treatment adherence and patient-related outcomes.

52808 Guselkumab improves perceived stigmatization in moderate-to-severe psoriasis patients, including obese patients and patients with short disease duration: Results from the real-life G-EPOSS study until Week 76

52808 Guselkumab improves perceived stigmatization in moderate-to-severe psoriasis patients, including obese patients and patients with short disease duration: Results from the real-life G-EPOSS study until Week 76

Attainment of EULAR/ERA-EDTA targets of therapy with current immunosuppressive regimens and adjustments in treatment: a multicentre, real-life observational study

ObjectiveTo estimate real-life European Alliance of Associations for Rheumatology (EULAR)/European Renal Association (ERA)-European Dialysis and Transplantation Association (EDTA) response rates and predictors for no response in patients with lupus nephritis...

Održiva sveobuhvatna obnova zgrada: studija slučaja iz Švicarske

Renovation is a pivotal element in realising sustainability objectives in the construction industry, as established by the EU Commission. By analysing a real-life case study in Switzerland, this study provides insights into strategies and measures crucial not only for attaining an energy-efficient building state but also for achieving broader sustainability goals encompassing social and economic aspects. In addition, a general decision-making framework for residential building renovations is provided. The presented case study may serve as a role model for the successful sustainable renovation of other similar residential buildings and stimulate further research that facilitates effective holistic sustainable renovation.

52321 Assessment of Patient-Reported Outcomes at 48 months of treatment with Dupilumab for severe atopic dermatitis: a real-life single-centre study on 200 patients

52321 Assessment of Patient-Reported Outcomes at 48 months of treatment with Dupilumab for severe atopic dermatitis: a real-life single-centre study on 200 patients

52880 Guselkumab improves sexual health in patients with moderate-to-severe psoriasis, including patients across different age and weight groups: Results from the real-life G-EPOSS study until Week 76.

52880 Guselkumab improves sexual health in patients with moderate-to-severe psoriasis, including patients across different age and weight groups: Results from the real-life G-EPOSS study until Week 76.

Real-world experience with long-term albumin in patients with cirrhosis and ascites

Background and AimsLong-term albumin (LTA) is currently standard of care for patients with decompensated cirrhosis in many Italian hepatological centres. This real-life study aimed to describe patient, logistical and treatment-related characteristics in daily clinical practice and to identify predictors of response. MethodsMulticentre, retrospective, observational study in patients with cirrhosis and ascites receiving LTA between 01/2016 and 02/2022 and followed until death, TIPS, transplantation or 02/2023. Results312 patients, the majority with alcohol-related cirrhosis, were included. At baseline, median Child-Pugh was 8, MELD 15, and MELD-Na 18. Ascites was grade 2 in 55% of patients, grade 3 in 35% and refractory in 27%, while 47% had paracentesis in the previous 6 months. Median LTA was 10 months with a median dose of 40 g/week.Ascites resolved to grade 0-1 in 34% of patients within the first 3 months and 56% at the end of treatment. Predictors of ascites resolution were age (p=0.007), baseline grade of ascites (p=0.007), no paracentesis in the previous 6 months (p=0.001), etiological treatment in the past 12 months or during LTA (p=0.005), weekly albumin dose (p=0.014) and serum albumin concentration of 40 g/L after one month of treatment (p=0.017). Of the 83 patients with refractory ascites at inclusion, 26% had grade 0/1 ascites at the last observation. No severe albumin-related side-effects were reported and only 1% discontinued due to logistic reasons. ConclusionsLTA is feasible as an outpatient treatment for the management of ascites. In the current study, more than half of patients receiving LTA on top of diuretics resolved their ascites, including some with refractory ascites. Predictors of response to LTA provide useful information for tailoring treatment. IMPACT AND IMPLICATIONSThe ANSWER randomized clinical trial has shown that long-term albumin treatment (LTA) is an effective approach for the management of patients with cirrhosis and ascites. This observational study provides novel information on target patients, modalities and length of treatment, predictors of ascites resolution, stopping criteria, and clinical trajectories of patients on treatment.LTA is a feasible option in the daily clinical practice for the management of ascites when given on top of diuretics. Rather than an alternative therapy, LTA should be integrated with the other treatments options already available for patients with difficult-to-treat ascites. The predictive factors of response identified in the present study can help physicians to individualize LTA and optimize the decision-making process.

Registry of Percutaneous Closure of Patent Foramen Ovale in the Secondary Prevention of Stroke.

The foramen ovale remains patent in about 25% of the adult population. In adult life, thrombi form in the venous circulation and can cross the interatrial septum and trigger an ischemic stroke - called paradoxical embolism. The treatment can be performed through percutaneous closure of the patent foramen ovale (PFO), but still rarely performed in Brazil because it is not available in the public health care. To evaluate the reproducibility of clinical trial results in real-life studies due to the low number of records published about the topic. This study is a retrospective cohort study including 121 patients who underwent percutaneous PFO closure for secondary prophylaxis of ischemic stroke between January 2012 and June 2022. We observed a mean age of 50.3 years and most females . Severe interatrial shunt was observed in 82.6% and the presence of atrial septal aneurysm in 84.2%. After 6 months of the procedure, no patient still had a residual shunt. There were no serious bleeding or vascular complications. Recurrence of a new cerebrovascular event occurred in 1.6% of patients. We observed a low recurrence of new ischemic neurological events and lack major complications related to the procedure.

Predictors of Drug Retention and Survival Rate of bDMARDs in Rheumatoid Arthritis: A Four-Year Real-Life Tunisian Experience.

This study aims to investigate the efficacy and tolerance of biologic disease-modifying anti-rheumatic drug (bDMARDs) in the current management of rheumatoid arthritis (RA) by identifying the retention time and survival rate of bDMARDs. We conducted a retrospective cohort study including Tunisian patients initiating bDMARD treatment between 2016 and 2018 whose data were collected from the National Health Insurance Fund (NHIF). The NHIF is the national office which organises and centralises patients under bDMARDs from all over the country. Retention and survival rate of bDMARDs at 48 months were analysed using Kaplan-Meier survival curves and compared using the log-rank test. Survival factor analysis was performed using Cox regression. Three hundred seventy-four patients, aged 55.5±12.5years [20-90], (87.2%women), were included. The mean duration of RA was 11.7±6.7 years [2-41]. The mean disease activity score (DAS)28 at initiation of the first bDMARD was 6.01±0.89 [5.37-6.5]. This first bDMARD induced low disease activity (LDA) in 55% of cases. Remission was observed in 28% of patients. The highest LDA and remission rates were observed with Tocilizumab (70.8% and 33.3% of cases, respectively). LDA and remission were achieved within a mean of 45 weeks [26-88] and 72 weeks [31-117] respectively. The 48-month first-line survival rate was 55.9%. Retention time was 41.7 months, 95%CI [39.47-43.91]. Presence of rheumatoid factors, co-prescription of methotrexate, and good initial therapeutic response were factors influencing better survival of bDMARDs (p<0.01). Glucocorticoid use predicted poorer survival (p<10-3). The first bDMARD was interrupted in 39% of cases. Ineffectiveness was the most common cause of treatment cessation (52.7%). This real-life study of the Tunisian population allowed us to establish the factors that can influence the survival and retention rates of bDMARDs.