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Background and study aims: Advanced liver disease frequently culminates in hepatic encephalopathy (HE), which can be classified as covert or overt HE, with subtle or clinically obvious changes respectively. 30-40% of patients with cirrhosis develop overt HE, which negatively affects the patients’ quality of life. Next to lactulose, rifaximin-a has been prescribed as a second line therapy to treat and reduce the risk of recurrence of overt HE. In this study, we aimed to evaluate the effect of rifaximin-a therapy, both on the number of occurring infections and on the evolution in hospital admissions of patients with overt HE. Patients and methods: A total of 66 cirrhotic patients, treated for at least 6 months with rifaximin-a at AZ Maria Middelares, between October 1st 2014 and January 1st 2020, were included in the study analysis. Medical records of all patients were evaluated over a period of 6 months prior and after initiation of rifaximin-a therapy. Results: Data analysis revealed that the included cirrhotic patients were severely ill, with a mean model for end-stage liver disease (MELD) score of 21, and a median Child Pugh score of 11. Among these patients, rifaximin-a treatment significantly downgraded the total number of infections, with a main effect on respiratory infections. Furthermore, rifaximin-a therapy led to a significant decrease in HE-related, as well as in other liver-related hospital admissions. Conclusions: This study confirms the potential value of rifaximin-a in reducing the number of developing infections and hospital admissions in a severely ill cirrhotic patient population.

Background SB5 is approved as a biosimilar of the adalimumab originator. However, data on patient acceptance of switch from originator to biosimilar, patient satisfaction, adverse events and nocebo effects are lacking, especially in the inflammatory bowel disease (IBD) population. We sought to elucidate these issues in a real-life switch IBD population. Methods IBD patients, in clinical remission or stable response, treated with adalimumab originator in 2 Belgian centers were offered to participate in this phase IV, interventional trial. Switch was voluntary and was offered after being informed about biosimilars. Satisfaction with the switch and local discomfort after injection (within and after 30 minutes) was semi-quantitatively (visual analogue scales (VAS)) assessed at baseline and 8 weeks, 6 months and 12 months after switch. Reasons for non-switch, discontinuation and adverse events were documented. Results An acceptance of switch rate of 79.3% was observed. Fifteen patients reported 22 reasons for refusal; the most common were fear for a flare (n = 8), ease to stay on the originator (n = 4) and absence of trust in biosimilars (n = 3). No patient-related demographic factors associated with refusal of switch could be defined. By month 12, 28 patients discontinued SB5 for several reasons; the most frequent being high anti-adalimumab antibodies at baseline (n = 5), secondary loss of response (n = 3), injection site pain (ISP) (n = 8) and other adverse events (n = 10) not causally related to SB5. At month 12 after switch, 74.5% of the study population was still treated with SB5 (table 1). The median VAS for local discomfort up to 30 minutes after injection of the originator was 1/10 and increased significantly to values between 2 and 3/10 at the different time points on SB5 (p < 0.001 for all) (table 2). However, the median VAS for local discomfort after 30 minutes was between 0 and 1/10 at all time points, which was not significantly different compared to the originator. Nevertheless, satisfaction with the decision to switch was high and remained stable over the different time points with a median VAS between 7 and 8/10, which was not significantly different compared to baseline. Conclusion After being well informed, the great majority of patients treated with adalimumab originator is willing to switch to biosimilar SB5. The rate of satisfaction under treatment with SB5 is high and remains stable over time. The most important reasons for discontinuation were adverse events, which could be mostly attributed to the nocebo effect and to ISP. Of note, patients in general report a higher, temporary, local discomfort within 30 minutes after injection with SB5.

BACKGROUND Hepatocellular carcinoma (HCC) is one of the leading causes of cancer-related death worldwide. The landscape of the systemic treatment for advanced HCC is changing quickly, and recently, the standard of care became either atezolizumab plus bevacizumab or tremelimumab plus durvalumab in the single tremelimumab regular interval durvalumab regimen. Nivolumab monotherapy has proven to be effective sometimes for advanced HCC and could be a valuable treatment option for patients outside current treatment indications and reimbursement criteria for the standard of care. This is a particular population of interest. AIM To evaluate the real-world effectiveness of nivolumab monotherapy in patients with advanced HCC who are not eligible for other treatment. METHODS We conducted a retrospective, multicentric study including 29 patients with advanced HCC from 3 Belgian tertiary hospitals. All patients had had prior chemotherapy or were intolerant or ineligible for treatments. All study subjects received nivolumab 3 mg/kg in monotherapy, administered once every two weeks intravenously. Treatment continued until disease progression, severe adverse events or death. Data were retrieved from patients’ medical records. The outcome parameters such as radiological response according to response evaluation criteria in solid tumors (RECIST) criteria, the biological response through the evolution of the alpha-fetoprotein (AFP) level, and clinical response considering both the Child–Pugh (CP) score and the World Health Organization (WHO) performance status (PS) were reported. A safety profile was also reported. Statistical analysis was performed using the SPSS Statistics 27 statistical software package. RESULTS The radiological overall response rate (defined as complete or partial response according to the immune RECIST and modified RECIST criteria) to nivolumab monotherapy was 24.1%. The biological overall response rate (defined as a decrease of ≥ 25% in AFP blood level) was 20.7%. Radiological and biological responses were significantly associated both with each other ( P < 0.001) and with overall survival ( P < 0.005 for radiological response and P < 0.001 for biological response). Overall survival was 14.5 mo (+/- 2.1), and progression-free survival was 10.9 mo (+/- 2.3). After 4 mo of treatment, 78.3% of patients remained clinically stable or even showed improvement in WHO PS. Grade 3 adverse events occurred in 17.2% of patients, none had grade 4 adverse events, and no patients ceased nivolumab due to adverse events. CONCLUSION Nivolumab monotherapy is a good treatment choice in frail patients with HCC who are ineligible for the standard of care or other validated systemic treatments.