Bezlotoxumab during the first episode of Clostridioides difficile infection in patients at high risk of recurrence.

PURPOSE: To describe a cohort with a high risk of recurrence who received bezlotoxumab during the first episode of Clostridioides difficile infection (CDI) and to compare this cohort with patients with similar characteristics who did not receive the monoclonal antibody. METHODS: A prospective and multicentre study of patients with a high risk of recurrence (expected recurrence rate>35%) who were treated with bezlotoxumab during their first episode of CDI was conducted. A propensity score-matched model 1:2 was used to compare both cohorts that were weighed according to basal characteristics (hospital-acquisition, creatinine value, and fidaxomicin as a CDI treatment). RESULTS: Sixty patients (mean age:72 years) were prospectively treated with bezlotoxumab plus anti-Clostridioides antibiotic therapy. Vancomycin (48 patients) and fidaxomicin (12 patients) were prescribed for CDI treatment, and bezlotoxumab was administered at a mean of 4.2 (SD:2.1) days from the beginning of therapy. Recurrence occurred in nine out of 54 (16.7%) evaluable patients at 8 weeks. Forty bezlotoxumab-treated patients were matched with 69 non-bezlotoxumab-treated patients. Recurrence rates at 12 weeks were 15.0% (6/40) in bezlotoxumab-treated patients vs. 23.2% (16/69) in non-bezlotoxumab-treated patients (OR:0.58 [0.20-1.65]). No adverse effects were observed related to bezlotoxumab infusion. Only one of 9 patients with previous heart failure developed heart failure. CONCLUSION: We observed that patients treated with bezlotoxumab in a real-world setting during a first episode of CDI having high risk of recurrence, presented low rate of recurrence. However, a significant difference in recurrence could not be proved in comparison to the controls. We did not detect any other safety concerns.

Improving Recognition of Fracture Risk in People with Human Immunodeficiency Virus: Performance and Model Contribution of Two Common Risk Assessment Tools.

Current guidelines recommend screening people with HIV (PWH) for bone disease using predictive tools developed for the general population, although data on PWH are scarce. In this study, we assessed the performance of FRAX and QFracture scoring systems to predict the occurrence of fragility fractures in a prospective cohort of 17,671 adults with human immunodeficiency virus (HIV) included in the HIV/AIDS research network (CoRIS) in Spain. The survival estimates of fragility fractures during follow-up were calculated and FRAX and QFracture scores were computed at cohort inclusion. For both tools, discriminatory measures and the observed-to-expected (O/E) ratios were assessed. During a follow-up time of 42,411.55 person-years, 113 fragility fractures were recorded. Areas under the curve were 0.66 [95% confidence interval (95% CI) 0.61-0.71] for FRAX and 0.67 (95% CI 0.62-0.73) for QFracture for major osteoporotic fractures, and 0.72 (95% CI 0.57-0.88) and 0.81 (95% CI 0.68-0.95) for hip fracture, respectively. The O/E was 1.67 for FRAX and 5.49 for QFracture for major osteoporotic fractures, and 11.23 for FRAX and 4.87 for QFracture for hip fractures. Moreover, O/E raised as the risk increased for both tools and in almost all age groups. When using the recommended assessment thresholds, <6% and 10% of major osteoporotic and hip fractures would have been identified, respectively. In conclusion, FRAX and QFracture displayed acceptable discrimination, although both tools significantly underestimated the risk of fragility fractures in PWH. The recommended assessment thresholds may not be appropriate for this population as they were unable to identify individuals with fragility fractures during follow-up.