Comparative effectiveness and drug survival of biosimilar infliximab CPT-13 vs. reference infliximab in inflammatory bowel disease: A retrospective cohort study.

BACKGROUND: Studies have investigated the efficacy and safety of switching to the biosimilar infliximab (CT-P13) in patients with inflammatory bowel disease (IBD). However, there is limited research directly comparing the effectiveness, drug survival, and pharmacokinetic profiles of the reference infliximab (IFX) and CT-P13 in real clinical settings. OBJECTIVE: To compare the effectiveness and drug survival of CPT-13 and reference IFX at weeks 26 and 52, and to determine the pharmacokinetic profiles and safety profile in real-world settings. METHODS: A retrospective observational cohort analysis was conducted at a single center. The study compared the proportion of patients achieving clinical remission and experiencing poor clinical outcomes at weeks 26 and 52. The drug survival rate of CT-P13 and reference infliximab was also assessed during the follow-up period. RESULTS: A total of 153 patients were included in the study, 39.2% receiving CPT-13 and 60.8% reference IFX. At week 26, clinical remission rates were 66.7% (CPT-13: 74.4% vs. reference IFX: 62.3%, p=0.178), and at week 52, they were 64% (CPT-13: 85.4% vs. reference IFX: 63.0%, p=0.012). Subgroup analysis with therapeutic drug monitoring (TDM) found no significant differences at week 26 (CPT-13: 74.4% vs. reference IFX: 58.8%, p=0.235) or at week 52 (CPT-13: 85.4% vs. reference IFX: 68.8%, p=0.153). CONCLUSION: Our study demonstrates comparable efficacy, drug survival, pharmacokinetic profiles, and incidence of immunogenicity between both drugs in a real clinical setting. Further studies with greater statistical power are needed to validate these findings.

Impact of proactive therapeutic drug monitoring of infliximab during the induction phase in IBD patients. A Bayesian approach.

BACKGROUND AND OBJECTIVES: there is increasing evidence that proactive therapeutic drug monitoring in induction is useful to improve the control of inflammatory bowel disease (IBD), although it remains controversial. The primary objective of the study was to assess the short-term outcomes of proactive Bayesian therapeutic drug monitoring (TDM) during induction, to optimize infliximab (IFX) maintenance dose. METHODS: retrospective observational cohort of IBD patients > 18 years. They were divided into two cohorts, standard therapy group (ST-group), with clinically based dose adjustment, and monitoring group (iTDM-group), with pharmacokinetic parameters calculated by Bayesian prediction at week 6 and individualized dosage regimens thereafter. In patients with an infliximab trough level (ITL) at week 6 below the optimal therapeutic range, the dose adjustment was performed at the first maintenance dose. RESULTS: a total of 153 patients were included, 40 in the iTDM-group. Median ITL at week 6 during the induction period was 12.8 µg/ml (IRQ: 12.7) in this group. Only 16 patients (40.0 %) had ITL ≥ 15 µg/ml. Half of the patients (50.3 %) received intensified maintenance therapy during the study period (57.5 % iTDM vs 47.8 % ST, p = 0.291). The proportion of patients achieving primary response at week 14 was 51.8 %. When comparing the two groups, this proportion was higher in the iTDM group (74.3 % vs 44.2 %, p = 0.002). With regards to the variable "poor clinical outcomes" at week 26, this proportion was lower in the iTDM group (3.3 % iTDM vs 21.1 % ST, p = 0.024). CONCLUSIONS: proactive therapeutic drug monitoring using Bayesian approach is associated with higher primary response rates and fewer short-term complications.

Acute hepatocellular drug-induced liver injury probably caused by doxazosin.

Drug-induced liver injury (DILI) is a diagnostic challenge, due to the hepatotoxic potential of drugs, herbs and dietary supplements, the variety of pathological phenotypes and the absence of specific biomarkers.

Problems with a prophylactic non-expulsive pancreatic stent.

We appreciate the advice and comment of Drs. García Cano and Viñuelas about the best plastic stent for the prevention of post-endoscopic retrograde cholangiopancreatography (post-ERCP) pancreatitis. We are aware of the benefit of placing a plastic stent in cases where the pancreatic duct is incorrectly and accidentally canalized in an attempt to access the biliary tree, as shown in their original paper.

Spanish online survey on informed consent for the performance of paracentesis. Do we have it? Do we use it?

INTRODUCTION: informed consent is necessary for invasive procedures as a document that guarantees the ethical health relationship and patient safety. AIMS: to analyze whether we have and use informed consent documents for paracentesis in our hospitals and to obtain data on the technique. METHODS: a descriptive observational study was performed during December 2019, via a cross-sectional survey disseminated through social networks, aimed at specialists and residents of gastroenterology. RESULTS: two hundred and three anonymous surveys were included (55.2 % gastroenterologist and 44.8 % residents) from 74 hospitals in 34 Spanish provinces. Ninety respondents (44.3 %) stated that they had the document in their centers. Of these, 29 (32.2 %) always provided it, 31 (34.4 %) provided it sometimes and 21 (23.3 %) never. Seventy-two professionals (35.5 %) answered that they did not have it and 41 (20.5 %) selected "unknown". Of these, 77 (68.1 %) considered it was necessary to create this document, 31 (27.4 %) did not think it was necessary and five (4.4 %) did not answer. With regards to the technique, 173 (85.2 %) performed paracentesis under direct visualization and 30 (14.8 %) were eco-guided on most occasions. One hundred and nine (53.7 %) always applied local anesthetic, 80 (39.4 %) sometimes and 14 (6.9 %) did not. One hundred and sixty-seven respondents (82.3 %) considered it to be a simple technique versus 36 (17.7 %) who thought that it was of intermediate complexity. In terms of risk, 150 (73.5 %) considered it was low and 52 (25.6 %), medium. Ninety-nine (48.8 %) experienced minor complications and 37 (18.2 %) experienced major complications. CONCLUSIONS: paracentesis is a common technique in digestive services and could be associated with complications, even though it is considered to be simple and safe. Due to the important intra- and inter-hospital variability that this technique presents, we consider standardized training in this technique is necessary, as well as the creation, spread and use of informed consents.

Acute pancreatitis secondary to a plastic prophylactic pancreatic prosthesis.

Plastic pancreatic prosthesis are indicated in the prophylactic of post-ERCP pancreatitis. But paradoxically, these prosthesis can cause pancreatitis if they are not expelled in a short period of time.

Tear of the secondary gastric mucous membrane to the extraction of the biliary prosthesis.

The extraction of a biliary prosthesis can be done by various techniques. It is usually simple, but it can be difficult for granulation tissue to adhere to the bile duct or its migration. In our case, it was complicated by an iatrogenic injury from the exit of the instruments for extraction.

The gastro-gastric fistula as a complication of a gastric bypass.

The gastric-gastric fistula is an infrequent complication of bariatric surgery, but one you have to suspect it in cases of weight gain or sickness. For its diagnosis it is necessary to conduct an upper digestive endoscopy or other imaging techniques, such as a barium-based contrast examination or CT with water-soluble contrast.