Bezlotoxumab is marketed for the prevention of recurrent Clostridioides difficile infection (rCDI). Its high cost could be determining its prescription to a different population than that represented in clinical trials. The objective of the study was to verify the effectiveness and safety of bezlotoxumab in preventing rCDI and to investigate factors related to bezlotoxumab failure in the real world. A retrospective, multicentre cohort study of patients treated with bezlotoxumab in Spain was conducted. We compared the characteristics of cohort patients with those of patients treated with bezlotoxumab in the pivotal MODIFY trials. We assessed recurrence rates 12 weeks after completion of treatment against C. difficile, and we analysed the factors associated with bezlotoxumab failure. Ninety-one patients were included in the study. The cohort presented with more risk factors for rCDI than the patients included in the MODIFY trials. Thirteen (14.2%) developed rCDI at 12 weeks of follow-up, and rCDI rates were numerically higher in patients with two or more previous episodes (25%) than in those who had fewer than two previous episodes of C. difficile infection (CDI) (10.4%); p = 0.09. There were no adverse effects attributable to bezlotoxumab. Despite being used in a more compromised population than that represented in clinical trials, we confirm the effectiveness of bezlotoxumab for the prevention of rCDI.

Background: Both fidaxomicin and bezlotoxumab (used in combination with an antibiotic against Clostridioides difficile) achieve reductions in recurrence rates of C. difficile infection (CDI). However, the two strategies have never been compared. Methods: Data from two retrospective cohorts of ‘real-life’ use of fidaxomicin and bezlotoxumab in combination with a standard anti-C. difficile antibiotic were used to compare the rates of recurrence of both strategies. Since the two cohorts were not identical, we used a propensity score analysis. Results: Three hundred and two patients were included: 244 in the fidaxomicin cohort and 78 in the bezlotoxumab cohort. A history of renal failure or immunosuppression was more frequent in patients receiving bezlotoxumab (39.7% and 66.7% versus 26.6% and 38.9%; P = 0.03 and P < 0.001, respectively), but the severity and number of previous CDI episodes were similar in both cohorts. We observed that 19.3% of the patients in the fidaxomicin cohort experienced recurrence, compared with 14.1% in the bezlotoxumab cohort (OR 1.45; 95% CI 0.71–2.96; P = 0.29) but the difference remained non-significant after propensity score matching using previously defined variables (OR 1.24; 95% CI 0.50–3.07; P = 0.64). Moreover, the multivariate analysis did not show differences depending on the drug used. Conclusions: We observed that fidaxomicin and bezlotoxumab are prescribed in similar clinical scenarios, although those treated with bezlotoxumab have greater comorbidity. The proportion of recurrences was numerically lower in those treated with bezlotoxumab, although the propensity analysis did not find significant differences between the two drugs.

Objectives This study aimed to explore the prevalence of potentially inappropriate medications (PIMs) in a cohort of older adults with advanced cancer referred to palliative care. Secondary objectives were to describe the categories of identified PIMs and assess risk factors associated with their presence in this population. Methods This retrospective, observational study evaluated patients with advanced cancer admitted to a tertiary university hospital in Madrid, Spain and referred to palliative care between 1 January 2020 and 30 June 2020. Demographic, clinical, and pharmacotherapeutic data were obtained from the electronic medical records and regional databases. PIMs were assessed using the Screening Tool of Older Persons Prescriptions in Frail adults (STOPPFrail) criteria, V1. Results Among 123 patients (median age 80 years (IQR 73.5–87), 64.2% male), 74% presented at least one PIM according to the STOPPFrail criteria. The most common categories of inappropriate medications were lipid-lowering therapies, proton pump inhibitors, calcium supplements, and oral antidiabetics. The number of chronic comedications was significantly associated with PIM presence. Conclusions Our study found a high prevalence of PIM among a cohort of older adults with advanced cancer and short life expectancy. This underlines the need for a comprehensive medication review to optimise pharmacotherapy in this population.

Objectives Evidence on the effectiveness of remdesivir when used in real-life clinical practice is controversial. This study aims to analyse its effectiveness and the factors associated with increased mortality in non-critically ill patients with COVID-19 pneumonia who require supplemental low-flow oxygen and received remdesivir. Methods A retrospective cohort study was conducted at Ramón y Cajal University Hospital (Madrid, Spain) which included all patients treated with remdesivir in our institution during the second pandemic breakout in Spain, from August to November 2020. Treatment with remdesivir was limited to non-critically ill patients with COVID-19 pneumonia requiring low-flow supplemental oxygen, with a treatment duration of 5 days. Results A total of 1757 patients were admitted with COVID-19 pneumonia during the study period, of which 281 non-critically ill patients were treated with remdesivir and included in the analysis. Mortality at 28 days after initiation of treatment was 17.1%. The median (IQR) time to recovery was 9 days (6–15). 104 (37.0%) patients had complications during hospitalisation, with renal failure being the most frequent (31 patients; 36.5%). After adjustment for confounding factors, high-flow oxygen therapy was associated with increased 28-day mortality (HR 2.77; 95% CI 1.39 to 5.53; p=0.004) and decreased 28-day clinical improvement (HR 0.54; 95% CI 0.35 to 0.85; p=0.008). A significant difference in survival and clinical improvement was identified between patients treated with high and low-flow oxygen. Conclusion The 28-day mortality rate in patients treated with remdesivir needing low-flow oxygen therapy was higher than that published in clinical trials. Age and increased oxygen therapy needed after the beginning of treatment were the main risk factors associated with mortality.

Objectives: To describe the impact of immune checkpoint inhibitors (ICPi) in infection control in people living with HIV (PLWHIV) and to explore their safety compared with a matched cohort of people living without HIV (PLWOHIV). Secondary, to report inclusion and exclusion criteria for PLWHIV in clinical trials (CT) with ICPi. Methods: Observational, retrospective, single-center study. PLWHIV initiating ICPi from January 2018 until June 2023 were included. Biomarkers of HIV infection control were collected at baseline and after ICPi initiation. Safety data were compared with a 1:2 matched cohort of PLWOHIV. CT with ICPi starting recruitment between January 2018 and December 2022 were analyzed. Results: Twenty-eight PLWHIV were included, most male (22; 78.6%), median age 57 years (IQI 55.0–60.0). Follow-up data on infection control were available in 19 (67.9%) patients. In 17 (89.5%) the viral load was <200 copies/ml throughout the complete follow-up, in 13 (68.4%) CD4 + remained above 200 cells/µl and in 13 (68.4%) the CD4/CD8 ratio persisted ≥0.4. In 11 (57.9%) all three conditions were met. Forty-eight PLWOHIV were identified for the matched cohort. Adverse events rates were similar between groups. A total of 126 CT with ICPi were identified: 91 (72.2%) explicitly excluded PLWHIV, 24 (19.0%) did not mention HIV infection, and 11 (8.7%) allowed their inclusion under certain conditions. Conclusions: ICPi in PLWHIV appeared to have a safety profile similar to that observed in PLWOHIV without evident negative effects on viral control. However, PLWHIV remain frequently excluded from ICPi CT.