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Although several randomized clinical trials have confirmed that there is no difference in efficacy between etanercept and its biosimilar versions in the treatment of rheumatoid arthritis (RA), limited real-world evidence is available. We conducted a cohort study to compare the effectiveness and treatment persistence between the reference etanercept (ETN) and the biosimilar GP2015 in RA patients in a real-life setting. Adults with a diagnosis of RA who initiated treatment with ETN or GP2015, between January 2007 and December 2019, were included. The follow-up period was 52 weeks. The primary outcome was the mean of change in the DAS28-CRP values and the adjusted mean difference from baseline to 52 weeks between ETN and GP2015. Other effectiveness endpoints assessed were the rate of patients who achieved remission or low disease activity (LDA) at week 52, who showed a reduction of DAS28-CRP value greater than or equal to 1.2 from baseline to week 52 and rate of good responder patients (those meeting both effectiveness measures) at week 52. Treatment effectiveness over time (baseline, 26 and 52 weeks) was compared between the ETN and GP2015 groups using mixed effects models. Treatment persistence (probability of maintaining the same treatment over time) was also evaluated and shown using Kaplan–Meier survival curves. A total of 115 RA patients were included (ETN, n = 90; GP2015, n = 25). No differences were observed in the primary outcome: DAS28-CRP score decreased from baseline to week 52 [5.1 to 2.7 (mean of change -2.37) in ETN group and 5.0 to 2.2 (mean of change -2.84) in GP2015 group, p-value = 0.372] and the adjusted mean difference was −0.37 (−1.03 to 0.29). No differences were also observed in the other effectiveness endpoints assessed among patients treated with ETN or GP2015: rate of patients who achieved remission (54.1% vs. 66.7%, p-value = 0.303) and LDA (71.6% vs. 80.9%, p-value = 0.391) at week 52, reduction of DAS28-CRP value greater than or equal to 1.2 from baseline to week 52 (75.6% vs. 80.9%, p-value = 0.613) and rate of good responder patients (58.1% vs. 76.1%, p-value = 0.202). Drug survival was 82% and 80% for ETN and GP2015, respectively (log-rank p-value = 0.804). Etanercept and its biosimilar GP2015 show similar effectiveness and treatment persistence in RA patients in a real-life setting.

Enterococcus faecium es tracta d’un microorganisme comensal amb capacitat per a provocar infeccions com la bacterièmia. La incidència de bacterièmia per aquest microorganisme s’ha incrementat durant els darrers anys, presentant una elevada mortalitat. No obstant, malgrat aquestes dades no existeix evidència suficient que avali l’elecció del tractament més apropiat. L’objectiu principal d’aquesta tesi, elaborada per compendi de publicacions, consisteix a estudiar l’efectivitat i la seguretat dels diferents tractaments antibiòtics disponibles (vancomicina, linezolid i daptomicina) en el tractament de la bacterièmia per E. faecium sensible a la vancomicina. En el primer treball es va observar que el linezolid podria ser una alternativa efectiva i segura a la vancomicina en el tractament d’aquesta entitat. En el segon treball, la daptomicina va presentar un major risc de fracàs terapèutic en comparació amb la vancomicina, per la qual cosa hauria de ser utilitzat amb precaució i un estricte monitoratge. Finalment, són necessaris assajos clínics que confirmin l’observat en aquests estudis observacionals. Fins a disposar d’aquesta evidència, linezolid podria considerar-se una alternativa a vancomicina, mentre que la daptomicina hauria de ser utilitzada com a fàrmac de segona línia. Enterococcus faecium se trata de un microorganismo comensal con capacidad para provocar infecciones como bacteriemia. La incidencia en la bacteriemia por este microorganismo se ha incrementado durante los últimos años, presentando una elevada mortalidad. Sin embargo, a pesar de estos datos no existe evidencia suficiente que avale la elección del tratamiento más apropiado. El objetivo principal de esta tesis, elaborada por compendio de publicaciones, consiste en estudiar la efectividad y seguridad de los diferentes tratamientos antibióticos disponibles (vancomicina, linezolid y daptomicina) en el tratamiento de la bacteriemia por E. faecium sensible a la vancomicina. En el primer trabajo se observó que linezolid podría ser una alternativa efectiva y segura a vancomicina en el tratamiento de esta entidad. En el segundo trabajo daptomicina presentó un mayor riesgo de fracaso terapéutico en comparación con vancomicina, por lo que debería ser utilizado con precaución y una estricta monitorización. Finalmente, son necesarios ensayos clínicos que confirmen lo observado en estos estudios observacionales. Hasta disponer de esa evidencia, linezolid podría considerarse una alternativa a vancomicina, mientras que daptomicina debería ser utilizado como fármaco de segunda línea. Enterococcus faecium is a commensal microorganism with the ability to cause infections as bacteraemia. The incidence in the bacteraemia of this microorganism has increased in recent years, showing a high mortality. Despite these data, there is a lack of evidence to support the choice of the most appropriate treatment. The main objective of this thesis, presented as a compendium of publications, is to study the effectiveness and safety of the different antibiotic treatments (vancomycin, linezolid and daptomycin) in the treatment of the bacteraemia caused by vancomycin susceptible E. faecium. In the first study, linezolid appeared as an effective and safe alternative to vancomycin. In the second, daptomycin presented a higher risk of therapeutic failure compared to vancomycin, so it should be used with caution and strict monitoring. Finally, randomised clinical trials are necessary to confirm what has been observed in these observational studies. Until this evidence is available, linezolid could be considered an alternative to vancomycin, while daptomycin should be used as a second-line therapy. Universitat Autònoma de Barcelona. Programa de Doctorat en Medicina

Our objective was to analyze in vitro the persistence of severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) in the packaging material of the drugs dispensed to hospital wards. Additionally, to evaluate if the protection with a double plastic bag prevents the contamination of the medication dispensed to an intensive care unit (ICU). On the first part, different materials containing different drugs within an ICU were sampled to confirm the lack of contamination by SARS-CoV-2. The confirmation of the virus was performed using real time reverse transcription polymerase chain reaction. As a control group, in the microbiology laboratory we inoculated the virus into the different surfaces containing the same drugs included in the first part. Samples were obtained with a sterile swab at 3, 6, 8, 10, 14, 21, and 30 days after inoculation and analyzed through real time reverse transcription polymerase chain reaction. None of the studied materials containing the drugs within an ICU was contaminated by SARS-CoV-2. In the second part, SARS-CoV-2 was found in all surfaces for up to 30 days. The use of double-bag unit-dose system to deliver medication in a pandemic seems effective to prevent the potential transmission of SARS-CoV-2. A striking SARS-CoV-2 RNA stability of up to 30 days was found in the surfaces containing the drugs.

COVID-19; Consumo de antimicrobianos; Dosis diarias definidas COVID-19; Consum d'antimicrobians; Dosis diàries definides COVID-19; Antimicrobial consumption; Defined daily doses Background: Antimicrobials have been widely used during the COVID-19 pandemic. This study aimed to analyze the impact of the COVID-19 pandemic on the antimicrobial consumption of 66 hospitals in Catalonia. Methods: Adult antibacterial and antimycotic consumption was calculated as defined daily doses (DDD)/100 bed-days and DDD/100 discharges. Firstly, overall and ICU consumption in 2019 and 2020 were compared. Secondly, observed ICU 2020 consumptions were compared with non-COVID-19 2020 estimated consumptions (based on the trend from 2008–2019). Results: Overall, antibacterial consumption increased by 2.31% and 4.15% DDD/100 bed-days and DDD/100 discharges, respectively. Azithromycin (105.4% and 109.08% DDD/100 bed-days and DDD/100 discharges, respectively) and ceftriaxone (25.72% and 27.97% DDD/100 bed-days and DDD/100 discharges, respectively) mainly accounted for this finding. Likewise, antifungal consumption increased by 10.25% DDD/100 bed-days and 12.22% DDD/100 discharges, mainly due to echinocandins or amphotericin B. ICU antibacterial and antimycotic consumption decreased by 1.28% and 4.35% DDD/100 bed-days, respectively. On the contrary, antibacterial and antifungal use, expressed in DDD/100 discharges, increased by 23.42% and 19.58%. Azithromycin (275.09%), ceftriaxone (55.11%), cefepime (106.35%), vancomycin (29.81%), linezolid (31.28%), amphotericin B (87.98%), and voriconazole (96.17%) use changed the most. Observed consumption of amphotericin B, azithromycin, caspofungin, ceftriaxone, vancomycin, and voriconazole were higher than estimated values. Conclusions: The consumption indicators for most antimicrobials deviated from the expected trend pattern. A worrisome increase in antibacterial and antifungal consumption was observed in ICUs in Catalonia. The present study was carried out as part of our routine work. The VINCat program is supported by public funding from the Catalan Health Service, Department of Health, Generalitat de Catalunya.

Background: High rates of amoxicillin-clavulanate (AMC) resistance among Enterobacterales isolated from urinary tract infections (UTIs) were observed in our area. The aim of this study was to identify risk factors associated with AMC resistance in patients with community-onset UTI in emergency departments (EDs). Methods: A retrospective study was performed of all ED patients with positive urine cultures for Escherichia coli or Klebsiella pneumoniae in a Spanish tertiary-care hospital. Results: 330 urine cultures in all were included: 261 (79.1%) for E. coli and 69 (20.90%) for K. pneumonia. Rates of AMC resistance were 14.94% and 34.78%, respectively. UTI was clinically confirmed in 212 (64.24%) cases. Previous antimicrobial exposure was independently associated with AMC resistance development in E. coli and K. pneumoniae urinary isolates (OR = 2.94, 95% CI = 1.55–5.58). Analyses of infected patients revealed that previous exposure to fluoroquinolones (OR = 3.33, 95% CI = 1.10–10.12, p = 0.034) and to AMC (OR = 5.68, 95% CI = 1.97–16.44, p = 0.001) was significantly associated with isolation of AMC-resistant strains. Conclusions: Prior antibiotic exposure, particularly to AMC or fluoroquinolones, was the only independent risk factor associated with development of AMC resistance in E. coli and K. pneumoniae urinary isolates from patients attending the ED.