Volume 85 - 2022 - Fasc.4 - Original articles
Evaluation of the safety and effectiveness after switch from adalimumab originator to biosimilar SB5 in patients with inflammatory bowel disease in a real-life setting
Background and study aims: Prospective data are lacking on evolution of trough levels, effectiveness, acceptance rate and patient satisfaction after switch from the adalimumab originator to a biosimilar in patients with inflammatory bowel disease.
Patients and methods: Patients in clinical remission or stable response and treated with adalimumab originator in 2 Belgian centers were offered to participate in this phase IV, prospective trial in which patients were switched to adalimumab biosimilar SB5. The primary outcome was the description of adalimumab trough levels over time. Secondary outcomes were secondary loss of response, disease activity, patient satisfaction score and drug persistence over 12 months.
Results: The study included 110 patients. Mean baseline adalimumab trough level was 9.21 μg/ml. Concentration remained within the therapeutic range over time. No changes were observed in disease activity scores nor in biochemical parameters over time. The acceptance rate of switch was 84.6%. By month 12, 74.5% was still treated with SB5. The most frequent reason for discontinuation was occurrence of adverse events. 50% of these adverse events were injection site pain. The local discomfort was only significant the first 30 minutes after injection. Satisfaction with the decision to switch to SB5 was high and remained stable over time.
Conclusions: After being well informed the great majority of patients treated with the adalimumab originator is willing to switch to biosimilar SB5. In our study, there was a persistence rate of 75% over one year. The trough levels remained within the therapeutic range and no change in disease activity was seen over time. (Acta gastroenterol. belg., 2022, 85, 557-564).
Changes in bone turnover markers in adolescents with gastroesophageal reflux disease treated with lansoprazole
Background: Proton pump inhibitors (PPIs) have been suggested to lead to bone resorption, while the effects of PPIs on the bone mineral metabolism in children has received only limited attention in literature to date. The present study investigates whether lansoprazole alters bone turnover markers in adolescents with gastroesophageal reflux disease (GERD).
Patients and methods: Included in the study were adolescents aged 16–18 with GERD and a healthy volunteers group. The GERD patient group was treated with lansoprazole 30 mg once daily for eight weeks. The serum calcium, phosphorus, magnesium, alkaline phosphatase (ALP), parathormone (PTH), 25 (OH) vitamin D, osteocalcin and urinary calcium, creatinine, deoxypyridinoline (DPD), collagen type-1 crosslinked C-telopeptide (CTX) and collagen type-1 crosslinked N-telopeptide (NTX) of both groups were studied before and after the end of the treatment.
Results: A comparison of the 30 patients with GERD and the 30 volunteers revealed no significant difference in the serum calcium, phosphorus, magnesium, ALP, urinary calcium/creatinine ratio, 25 (OH) vitamin D and PTH levels measured before and after the lansoprazole treatment, while the osteocalcin, DPD, CTX and NTX values were found to be higher after treatment when compared to those at pre- treatment.
Conclusions: The results of this study reveal that eight weeks of treatment with 30 mg lansoprazole daily increased the bone turnover markers of CTX, NTX, DPD and osteocalcin in adolescents aged 16-18. (Acta gastroenterol. belg., 2022, 85, 565-571).
Cytoreductive surgery and hyperthermic intraperitoneal chemotherapy for peritoneal carcinomatosis from colorectal cancer: a 13 years-retrospective monocentric study
Background and study aim: Over the last 20 years, cytoreductive surgery (CRS) combined with hyperthermic intraperitoneal chemotherapy (HIPEC) has progressively become a therapeutic option for peritoneal carcinomatosis thanks to its favourable oncologic results. The aim of this study is to analyse the overall survival and recurrence-free survival, after complete CRS and closed abdomen technique HIPEC for peritoneal carcinomatosis from colorectal cancer.
Patients and methods: This retrospective study collected the data from all patients who underwent a CRS with HIPEC for colorectal cancer at “Cliniques universitaires Saint Luc” from October 2007 to December 2020. Ninety-nine patients were included.
Results: The median follow-up was 34 months. Post-operative mortality and Clavien-Dindo grade III/IV morbidity rates were 2.0% and 28.3%. The overall 2-year and 5-year survival rates were 80.1% and 54.4%. Using the multivariate analysis, age at surgery, liver metastases and PCI score >13 showed a statistically significant negative impact on overall survival. The 2-year and 5-year recurrence-free survival rates were 33.9% and 22%. Using the multivariate analysis, it was found that liver metastases, the extent of carcinomatosis with PCI>7 have a statistically significant negative impact on recurrence-free survival.
Conclusions: Despite a high recurrence rate, CRS followed by HIPEC to treat peritoneal carcinomatosis from colorectal origin offer encouraging oncologic results with a satisfying survival rate. When PCI>13, CRS and HIPEC does not seem to offer any survival benefit and to efficiently limit recurrence, our data are in favor of a maximum PCI of 7. (Acta gastroenterol. belg., 2022, 85, 573-579).
Pre-Endoscopy real-time PCR testing for SARS-CoV2 does not reduce health care workers infection and is associated with a higher reduction of endoscopic activity in an outpatient setting
Objective: The role of pre-procedure SARS-CoV2 testing in digestive endoscopy is still debated. AGA guidelines recommend against pre-procedure testing considering low prevalence of SARS- CoV2 infection in the general population and low incidence of infection among endoscopy units Health Care Workers (HCWs). However, no studies have compared pre-procedure testing associated to symptom screening vs. symptom screening alone in reducing the risk of infection for HCWs. Main aim of the present study is to compare the risk of infection for HCWs in different Endoscopy Units adopting different pre-endoscopy screening and operating in two nearby hospital of the same region in Northern Italy in pre-vaccination period. For outpatients in the Endoscopy Unit of Trento (Unit 1) only pre-procedure symptom screening was performed, while in the Endoscopy Unit of Bolzano (Unit 2) pre-procedure symptom screening and negative pre-procedure real-time PCR were requested. Secondary aims were to assess the impact of pre-procedure real-time PCR testing on endoscopic activity and diagnostic delay.
Design: Retrospective data collection on a prospectively maintained database was performed, including outpatient endoscopy procedures performed between June 1st 2020 and February 28th 2021 in Unit 1 and Unit 2.
Results: No differences in terms of infection rate in HCWs have been identified in Unit 1 and Unit 2 (9.0 vs. 19.3% P=0.2) over a nine-month period. Moreover, in the unit performing pre- procedure real-time PCR before endoscopy a significantly higher reduction in endoscopic activity has been recorded (61.9% vs. 53.4%; P<0.01). In patients with positive real-time PCR, endoscopy was performed with a mean delay of 61.7 days (range 9-294) and 22.5% of them were lost at follow-up and did not undergo any endoscopic procedure in the following 12 months.
Conclusions: This study supports the AGA recommendation suggesting that pre-endoscopy real-time PCR is an expensive and time-consuming procedure without proven benefits in an outpatient setting. (Acta gastroenterol. belg., 2022, 85, 581-585).
Comparison of the side effects of antivirals in chronic hepatitis B patients: a single-center experience
Background and study aim: Entecavir (ETV), Tenofovir Disoproxil Fumarate (TDF), and Tenofovir Alafenamide (TAF) have been approved for treating Chronic Hepatitis B (CHB) and recommended due to their high safety profile and high resistance barriers. This study aimed to evaluate the kidney functions, bone, and metabolic parameters in CHB patients receiving ETV, TDF, and TAF treatment.
Patients and methods: In this retrospective cohort study, a total of 469 CHB patients who were treated with TDF (n = 256), ETV (n = 184), or TAF (n = 129) for at least six months between March 2012 and March 2022, were enrolled.
Results: No significant difference was observed between three groups regarding ALT normalization, HBV DNA suppression, and HBs Ag seroconversion (p = 0.15, p = 0.26, p = 0.72). After the treatment, there was a significant decrease in GFR values in the TDF, ETV, and TAF groups (p<0.01, p = 0.01, p = 0.01, respectively). No significant improvement was observed in the GFR values after TAF treatment in 77 patients who had switched from TDF to TAF (p = 0.51). Moreover, no significant decrease in bone mineral densities was observed in the TDF, ETV, and TAF groups (p = 0.24, p = 0.41, p = 0.95, respectively). There was no significant difference between the three groups in metabolic parameters (serum glucose, lipid profile, calcium and phosphorus levels, etc.) when the data were adjusted for underlying comorbidities.
Conclusions: ETV, TDF, and TAF are comparably safe and effective antiviral agents against CHB. (Acta gastroenterol. belg., 2022, 85, 587-592).
Efficacy and predictive factors of glucocorticoid therapy for patients with hepatitis B virus-related acute-on-chronic liver failure
Background and study aims: Glucocorticoid (GC) treatment for liver failure is controversial. This study sought to evaluate the efficacy and predictive factors of glucocorticoid therapy for hepatitis B virus-related acute-on-chronic liver failure (HBV- ACLF).
Patients and methods: A total of 302 patients with HBV- ACLF were enrolled and categorized by treatment modality (GC vs. Control). Baseline characteristics, liver function, disease complications, and mortality were recorded. Univariate and multivariate analysis were used to identify predictive factors for HBV-ACLF-related mortality.
Results: GC therapy significantly improved the 30- and 60-day mortality of HBV-ACLF patients (4.64% vs. 11.92%, P=0.022 and 16.56% vs. 25.83%, P=0.049 for the Control and GC groups, respectively) and GC was an independent prognostic factor for 30-day mortality (OR = 0.177, 95% CI 0.051-0.616, P = 0.007). However, enhanced survival was not associated with improved liver function. There were no significant differences in the incidence of complications (i.e., ascites, bacterial infection, encephalopathy, hepatorenal syndrome, and gastrointestinal bleeding) between the GC and Control groups (P >0.05), except that fungal infection occurred with higher frequency in the GC group (P = 0.037). A significant improvement in the 30-day survival associated with GC therapy was observed among patients <40 years of age, a Model for End-stage Liver Disease (MELD) score of 25-35 or a CLIF- Consortium ACLF (CLIF-C ACLF) grade 0-1 (all P <0.05).
Conclusions: GC therapy improved the short-term (30- and 60- day) mortality of patients with HBV-ACLF. This treatment may be of particular benefit to patients who are <40 years of age, have a MELD score of 25-35, or have a CLIF-C ACLF grade of 0-1. (Acta gastroenterol. belg., 2022, 85, 593-600).
Prognosis and incidence of immunological and oncological complications after direct-acting antiviral therapy for chronic hepatitis C
Background and study aims: The long-term comprehensive prognosis of chronic hepatitis C after direct-acting antiviral (DAA) therapy is unclear. This study aimed to investigate the prognosis and incidence of immunological and oncological complications after DAA therapy.
Patients and methods: The study included a total of 1461 patients who received DAA therapy in our university hospital and affiliated hospitals between September 3, 2014 and September 30, 2018.
Results: The incidence rates of total malignancies in overall or female patients after DAA therapy were significantly greater than expected in the corresponding general population. The same was true for lung malignancies. Predictive risk factors associated with the occurrence and recurrence of hepatic malignancies after DAA therapy in patients with sustained virological response were cirrhosis and insulin use, protein induced by vitamin K absence or antagonist-II level, and albumin-bilirubin score, respectively. Eight (0.5%) patients were diagnosed with autoimmune diseases after starting DAA therapy. Importantly, the attending physician considered a possible causal relationship between DAA therapy and these autoimmune diseases in five cases (four rheumatoid arthritis and one membranoproliferative glomerulonephritis). The 5-year overall survival rate was 91.6%. The most frequent primary cause of death was malignancy in 41 (60.2%) patients, including 25 with hepatic malignancies. Lung and colorectal cancers were the next most common.
Conclusions: Given that the incidence of total and lung cancers might increase and DAA-related autoimmune diseases might emerge after DAA therapy, we should be alert for the development of these diseases as well as hepatic malignancies. (Acta gastroenterol. belg., 2022, 85, 601-609).