Pressure ulcers after prone positioning in patients undergoing extracorporeal membrane oxygenation: A cross-sectional study.

BACKGROUND: The combination of prone positioning and extracorporeal membrane oxygenation (ECMO) in patients with acute respiratory distress syndrome (ARDS) is recognized as safe but its use has been limited due to potential complications. AIM: To report the prevalence of pressure ulcers and other complications due to prone positioning in adult patients receiving veno-venous ECMO. STUDY DESIGN: This cross-sectional study was conducted in a tertiary level intensive care unit (ICU) in Milan (Italy), between January 2015 and December 2019. The study population was critically ill adult patients undergoing veno-venous ECMO. Statistical association between pressure ulcers and the type of body positioning (prone versus supine) was explored fitting a logistic model. RESULTS: In the study period, 114 patients were treated with veno-venous ECMO and 62 (54.4%) patients were placed prone for a total of 130 prone position cycles. ECMO cannulation was performed via femoro-femoral configuration in the majority of patients (82.4%, 94/114). Pressure ulcers developed in 57.0% of patients (95%CI: 44.0%-72.6%), most often arising on the face and the chin (37.1%, 23/62), particularly in those placed prone. The main reason of prone positioning interruption was the decrease of ECMO blood flow (8.1%, 5/62). The fitted model showed no association between body position during ECMO and occurrence of pressure ulcers (OR 1.3, 95%CI: 0.5-3.6, p = .532). CONCLUSIONS: Facial pressure ulcers were the most frequent complications of prone positioning. Nurses should plan and implement evidence-based care to prevent such pressure injuries in patients undergoing ECMO. RELEVANCE TO CLINICAL PRACTICE: The combination of prone positioning and ECMO shows few life-threating complications. This manoeuvre during ECMO is feasible and safe when performed by experienced ICU staff.

SPOSAB ABP 501: A Sicilian Prospective Observational Study of Patients with Inflammatory Bowel Disease Treated with Adalimumab Biosimilar ABP 501.

BACKGROUND AND AIM: There are few clinical data on Adalimumab (ADA) biosimilars in inflammatory bowel disease. We aimed to perform a multicenter, observational, prospective study on safety and effectiveness of ADA biosimilar ABP 501 in patients with inflammatory bowel disease. METHODS: All consecutive patients from the cohort of the Sicilian Network for Inflammatory Bowel Disease treated with ADA biosimilar ABP 501 from February 2019 to February 2020 were enrolled. Patients were divided into three groups: group A, naïve to ADA and naïve to anti-tumor necrosis factors; group B, naïve to ADA and previously exposed to anti-tumor necrosis factors; and group C: switched from ADA originator to ABP 501. RESULTS: A total of 559 patients (median age 39 years; Crohn's disease 88.0%, ulcerative colitis 12.0%) were included, with a follow-up time of 403.4 patient-years. Thirty-six serious adverse events occurred in 36 patients (6.4%; incidence rate [IR]: 8.9 per 100 person-years [PY]). The IR of serious adverse events was higher among patients in group A compared with group C (17.4 vs 4.8 per 100 PY; IR ratio = 3.61; P < 0.001) and among patients in group B compared with group C (16.4 vs 4.8 per 100 PY; IR ratio = 3.42; P = 0.041). Among ADA-naïve patients (group A + B), 188 (85.8%) had a clinical response after 12 weeks, including 165 (75.3%) who achieved steroid-free remission. Higher treatment persistence estimates were reported for patients in group C compared with groups A and B (log-rank P < 0.001). CONCLUSIONS: Safety and effectiveness of ABP 501 seem to be overall similar to those reported for ADA originator. Switching from originator to ABP 501 was safe and effective.

Complications of prone positioning in patients with COVID-19: A cross-sectional study.

OBJECTIVE: To determine the prevalence of complications in patients with COVID-19 undergone prone positioning, focusing on the development of prone-related pressure ulcers. METHODS: Cross-sectional study conducted in the hub COVID-19 centre in Milan (Italy), between March and June 2020. All patients with COVID-19 admitted to intensive care unit on invasive mechanical ventilation and treated with prone positioning were included. Association between prone-related pressure ulcers and selected variables was explored by the means of logistic regression. RESULTS: A total of 219 proning cycles were performed on 63 patients, aged 57.6 (10.8) and predominantly obese males (66.7%). The main complications recorded were: prone-related pressure ulcers (30.2%), bleeding (25.4%) and medical device displacement (12.7%), even if no unplanned extubation was recorded. The majority of patients (17.5%) experienced bleeding of upper airways. Only 15 prone positioning cycles (6.8%) were interrupted, requiring staff to roll the patient back in the supine position. The likelihood of pressure ulcers development was independently associated with the duration of prone positioning, once adjusting for age, hypoxemic level, and nutritional status (OR 1.9, 95%CI 1.04-3.6). CONCLUSION: The use of prone positioning in patients with COVID-19 was a safe and feasible treatment, also in obese patients, who might deserve more surveillance and active prevention by intensive care unit staff.

The SPOSIB SB2 Sicilian Cohort: Safety and Effectiveness of Infliximab Biosimilar SB2 in Inflammatory Bowel Diseases, Including Multiple Switches.

BACKGROUND: No data on the recently introduced infliximab (IFX) biosimilar SB2 in inflammatory bowel disease (IBD) are available. METHODS: The Sicilian Prospective Observational Study of Patients With IBD Treated With Infliximab Biosimilar SB2 is a multicenter, observational, prospective study performed among the cohort of the Sicilian Network for Inflammatory Bowel Disease. All consecutive IBD patients starting the IFX biosimilar SB2 from its introduction in Sicily (March 2018) to September 2019 (18 months) were enrolled. RESULTS: Two hundred seventy-six patients (Crohn disease: 49.3%, ulcerative colitis: 50.7%) were included: 127 (46.0%) were naïve to IFX and naïve to anti-tumor necrosis factor medications (anti-TNFs), 65 (23.5%) were naïve to IFX and previously exposed to anti-TNFs, 17 (6.2%) were switched from an IFX originator to SB2, 43 (15.6%) were switched from the biosimilar CT-P13 to SB2, and 24 (8.7%) were multiply switched (from IFX originator to CT-P13 to SB2). The cumulative number of infusions of SB2 was 1798, and the total follow-up time was 182.7 patient-years. Sixty-seven serious adverse events occurred in 57 patients (20.7%; incidence rate: 36.7 per 100 patient-year), and 31 of these events caused the withdrawal of the drug. The effectiveness after 8 weeks of treatment was evaluated in patients naïve to IFX (n = 192): 110 patients (57.3%) had steroid-free remission, while 56 patients had no response (29.2%). At the end of follow-up, 72 patients (26.1%) interrupted the treatment, without significant differences in treatment persistency estimations between the five groups (log-rank P = 0.15). CONCLUSIONS: The safety and effectiveness of SB2 seem to be overall similar to those reported for the IFX originator and CT-P13.