Adalimumab Persistence and Its Biosimilar in Inflammatory Bowel Disease: A Real-World Study.

Adalimumab biosimilar experience is still recent. Interchangeability differences could reduce persistence times. Our goal was to compare biosimilar persistence differences with a reference. A retrospective observational study was performed in three groups divided according to the adalimumab received. The primary outcome measure was persistence, represented with Kaplan-Meier analysis, and we secondarily evaluated security, efficacy, and biomarkers. We obtained approval from the regional ethical committee, and the study was conducted following the Helsinki Declaration as revised in 2013. Data from 104 patients were collected: 50 received the biosimilar, 29 received the reference, and 25 switched from the original to the biosimilar. After a follow-up of 12 months, the biosimilar's persistence was higher, without differences in mild adverse events per group. In contrast, there were differences in severe events, with the switched group's frequency being higher. Biomarkers were reduced at similar proportions in all groups, and 43% had a clinical response at week 20 without differences. Adalimumab biosimilars are a valuable option for IBD based on clinical equivalence that are less expensive than the original drug. Their use does not have a detrimental influence on disease, although there are a few nuances in terms of interchangeability. These results support increasing confidence in using biosimilars, thus promoting the better sustainability of health systems.

A Gastroenterologist' clinical experience in COVID 19 and in-hospital mortality and length of stay analysis.

OBJECTIVES: COVID19 pandemic has forced physicians from different specialties to assist cases overload. Our aim is to assess gastroenterologist's assistance in COVID-19 by assessing mortality, ICU admission, and length of stay, and seek for risk factors for in-hospital mortality and longer hospital stay. METHODS: A total of 41 COVID-19 patients assisted by gastroenterologist (GI cohort) and 137 assisted by pulmonologist, internal medicine practitioners, and infectious disease specialists (COVID expert cohort) during October-November 2020 were prospectively collected. Clinical, demographic, imaging, and laboratory markers were collected and compared between both cohorts. Bivariate analysis and logistic regression were performed to search for risk factors of mortality and longer hospital stays. RESULTS: A total of 27 patients died (15.1%), 11 were admitted to ICU (6.1%). There were no differences between cohorts in mortality (14.6% vs 15.4%;p = 0.90), ICU admission (12.1% vs 4%;p = 0.13), and length of stay (6.67 ± 4 vs 7.15 ± 4.5 days; p = 0.58). PaO2/FiO2 on admission (OR 0.991;CI95% 0.984-0.998) and age > 70 (OR 17.54;CI95% 3.93-78.22) were independently related to mortality. Age > 70, history of malignancy, diabetes, and cardiovascular disease were related to longer hospital stays (p < 0.001, p = 0.03, p = 0.04, p = 0.02 respectively). CONCLUSIONS: COVID-19 assistance was similar between gastroenterologist and COVID experts when assessing mortality, ICU admission, and length of stay. Age>70 and decreased PaO2/FiO2 on admission were independent risk factors of mortality. Age and several comorbidities were related to longer hospital stay.

Keriorrhea (waxy diarrhea), a new sign to bear in mind.

Due to the increasing intake of raw fish, the appearance of keriorrhea in our environment has become more and more frequent. We present three clinical cases in order to aknowledge this sign and avoid unnecesary diagnostic tests.

Infectious etiology of diarrheas studied in a third-level hospital during a five-year period.

INTRODUCTION AND OBJECTIVE: Infectious diarrheas are highly frequent and responsible for a major consumption of resources. This study identified the main diarrhea-causing microorganisms in a health area of Granada (Spain) and determined changes in the epidemiologic pattern over a five-year period. MATERIAL AND METHOD: A retrospective study was conducted based on results obtained in the Microbiology Laboratory of Hospital Universitario Virgen de las Nieves (Granada, Spain). RESULTS: Out of the 25,113 stool microbiological and/or parasitological studies ordered, 2,292 microorganisms were identified in 2,152 samples from 1,892 patients. There was a predominance of bacterial diarrheas (50.1 %), mainly caused by Campylobacter spp. (22.2 %), whose frequency increased significantly during the last two years, and by Salmonella spp. (16.4 %), whose frequency remained stable during the whole study period. We highlight the high frequency of Rotavirus (33.5 %), although a significant decrease was observed during the last two years. Salmonella spp. was more frequently detected during the summer and autumn, Campylobacter spp. during the spring, and Rotavirus during the winter. Viral processes were predominant (53.3 %) in pediatric patients, mainly Rotavirus in under 2-yr-olds, whereas bacterial processes predominated in older children and adults. Diarrhea began at community level in 84.2 % of patients, requiring hospitalization in 25.8 % of cases, and diarrhea was nosocomial in the remaining 15.8 %. CONCLUSIONS: During the study period, there was a significant increase in the frequency of diarrhea caused by Campylobacter spp., a significant reduction in the frequency of diarrhea due to Rotavirus, and no change in the frequency of diarrhea due to Salmonella spp., all of which showing a marked seasonal distribution.

Wireless capsule endoscopy: perspectives beyond gastrointestinal bleeding.

Wireless capsule endoscopy (CE) is a technology developed for the endoscopic exploration of the small bowel. The first capsule model was approved by the Food and Drug Administration in 2001, and its first and essential indication was occult gastrointestinal (GI) bleeding. Over subsequent years, this technology has been refined to provide superior resolution, increased battery life, and capabilities to view different parts of the GI tract. Indeed, cases for which CE proved useful have increased significantly over the last few years, with new indications for the small bowel and technical improvements that have expanded its use to other parts of the GI tract, including the esophagus and colon. The main challenges in the development of CE are new devices with the ability to provide therapy, air inflation for a better vision of the small bowel, biopsy sampling systems attached to the capsule and the possibility to guide and move the capsule with an external motion control. In this article we review the current and new indications of CE, and the evolving technological changes shaping this technology, which has a promising potential in the coming future of gastroenterology.

New insights to occult gastrointestinal bleeding: From pathophysiology to therapeutics.

Obscure gastrointestinal bleeding is still a clinical challenge for gastroenterologists. The recent development of novel technologies for the diagnosis and treatment of different bleeding causes has allowed a better management of patients, but it also determines the need of a deeper comprehension of pathophysiology and the analysis of local expertise in order to develop a rational management algorithm. Obscure gastrointestinal bleeding can be divided in occult, when a positive occult blood fecal test is the main manifestation, and overt, when external sings of bleeding are visible. In this paper we are going to focus on overt gastrointestinal bleeding, describing the physiopathology of the most usual causes, analyzing the diagnostic procedures available, from the most classical to the novel ones, and establishing a standard algorithm which can be adapted depending on the local expertise or availability. Finally, we will review the main therapeutic options for this complex and not so uncommon clinical problem.

Thiopurines related malignancies in inflammatory bowel disease: local experience in Granada, Spain.

AIM: To investigate the incidence of neoplasms in inflammatory bowel disease (IBD) patients and the potential causative role of thiopurines. METHODS: We performed an observational descriptive study comparing the incidence of malignancies in IBD patients treated with thiopurines and patients not treated with these drugs. We included 812 patients which were divided in two groups depending on whether they have received thiopurines or not. We have studied basal characteristics of both groups (age when the disease was diagnosed, sex, type of IBD, etc.) and treatments received (Azathioprine, mercaptopurine, infliximab, adalimumab or other immunomodulators), as well as neoplasms incidence. Univariate analysis was performed with the student t test, χ(2) test or Wilcoxon exact test as appropriate. A logistic regression analysis was performed as multivariate analysis. Statistical significance was establish at P values of less than 0.05, and 95%CI were used for the odds ratios. RESULTS: Among 812 patients included, 429 (52.83%) have received thiopurines: 79.5% azathioprine, 14% mercaptopurine and 6.5% both drugs. 44.76% of patients treated with thiopurines and 46, 48% of patients who did not receive this treatment were women (P > 0.05). The proportion of ulcerative colitis patients treated with thiopurines was 30.3% compare to 66. 67% of patients not treated (P < 0.001). Mean azathioprine dose was 123.79 ± 36.5 mg/d (range: 50-250 mg/d), mean usage time was 72.16 ± 55.7 mo (range: 1-300 mo) and the accumulated dose along this time was 274.32 ± 233.5 g (1.5-1350 g). With respect to mercaptopurine, mean dose was 74.7 ± 23.9 mg/d (range: 25-150 mg/d), mean usage time of 23.37 ± 27.6 mo (range: 1-118 mo), and the accumulated dose along this time was 52.2 ± 63.5 g (range: 1.5-243 g). Thiopurine S-methyltransferase activity was tested in 66% of patients treated with thiopurines, among which 98.2% had an intermediate or high activity. Among the patients treated with thiopurines, 27.27% (112 patients) and 11.66% (50 patients) received treatment with Infliximab and Adalimumab respectively, but only 1.83% (7 patients) and 0.78% (3 patients) received these drugs in the group of patients who did not received thiopurines (P < 0.001 and P < 0.001 respectively). Finally, 6.8% (29 patients) among those treated with thiopurines have received other immunosuppressants (Methotrexate, Tacrolimus, Cyclosporin), compare to 1% (4 patients) of patients not treated with thiopurines (P < 0.001). Among patients treated with thiopurines, 3.97% developed a malignancy, and among those not treated neoplasms presented in 8.1% (P = 0.013). The most frequent neoplasms were colorectal ones (12 cases in patients not treated with thiopurines but none in treated, P < 0.001) followed by non-melanoma skin cancer (8 patients in treated with thiopurines and 6 in not treated, P > 0.05). CONCLUSION: In our experience, thiopurine therapy did not increase malignancies development in IBD patients, and was an effective and safe treatment for these diseases.

Gastroenterologist-guided sedation with propofol for endoscopic ultrasonography in average-risk and high-risk patients: a prospective series.

OBJECTIVE: Only a few reports have addressed non-anesthesiologist-administered propofol for endoscopic ultrasonography (EUS), but none specifically in high-risk patients. Our aim was to study the application of a propofol sedation protocol for EUS in average-risk and high-risk patients. METHODS: This was a prospective observational study including 446 patients referred for EUS. We analyzed the induction time, procedure duration, recovery times, and patients' comfort and safety. Sedation was administered by a trained nurse, under the guidance of the endoscopist. We continuously monitored vital signs as well as patient cooperation and tolerance. Complications, patient, and endoscopist satisfaction were analyzed. RESULTS: No major complications occurred. The rate of minor complications was 9%, the most frequent being hypoxemia (8%). One hundred and thirty-eight high-risk patients were included [American Society of Anesthesiologists (ASA) III-IV]. Average-risk patients received higher propofol doses (202.9 ± 84.8 vs. 164.8 ± 84.3; P=0.003). No differences were found in the rate of complications or procedure-related variables. Overall patient and endoscopist satisfaction was excellent. The logistic regression model identified propofol doses (P=0.02) as a risk factor and ASA-I classification (P=0.03) as a protective factor for the appearance of complications. CONCLUSION: Non-anesthesiologist-administered propofol for upper EUS in high-risk and average-risk patients is safe and could be routinely offered to high-risk and elderly patients.