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BACKGROUND & AIMS: Biologic therapies in the context of inflammatory bowel disease and pregnancy lead to improved maternal and fetal outcomes. Placental transfer results in detectable drug concentrations in infants. Rotavirus infection results in diarrheal related hospitalizations; however, the live oral vaccine is not currently recommended in biologic exposed infants. The aim of this study was to assess the effect of maternal biologic therapies on the infant immune system and safety of live rotavirus vaccination in biologic-exposed infants. METHODS: Biologic-exposed infants underwent standardized clinical assessments, drug concentration, and immune function testing (complete blood count, differential, immunoglobulin levels, extended B-cell and T-cell subset enumeration, Recent Thymic Emigrants, regulatory T-cell numbers, mitogen stimulation assays, and review of T-cell Receptor Excision Circles in the newborn screen). Rotavirus vaccine-specific adverse effects following immunizations up to 42 days post the last dose of the vaccine series were recorded. RESULTS: There were 57 infants born to 52 mothers with inflammatory bowel disease exposed to infliximab (n = 21), adalimumab (n = 19), vedolizumab (n = 10), and ustekinumab (n = 7) in the third trimester for a median of 39 weeks (interquartile range, 38-39 weeks) at delivery. Immunologic assessments validated for age were normal in all infants despite median infliximab concentrations of 6.1 ug/mL (range, 0.4-28.8 ug/mL), adalimumab concentrations of 1.7 ug/mL (range, 0.7-7.9 ug/mL), ustekinumab concentrations of 0.6 ug/mL (range, 0-1.1), and undetectable for vedolizumab at 10.7 weeks (interquartile range, 9.4-12.4) of age. The live oral rotavirus vaccine series was provided to 50 infants with the first dose given at a median of 13 weeks of age. No adverse effects following immunization were reported. CONCLUSION: Immune function testing was normal, and administration of live rotavirus vaccination appeared low-risk in biologic-exposed infants irrespective of circulating drug levels.
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INTRODUCTION: Endoscopy plays a fundamental role in inflammatory bowel disease (IBD), and becomes essential in diagnosis, treatment monitoring, and detection and management of complications. MATERIALS AND METHODS: The Pan American Crohn's and Colitis Organization (PANCCO) and the Inter-American Society of Endoscopy (SIED) appointed 22 Latin American experts in IBD to develop a consensus study using the modified Delphi method, based on the best available evidence. A working group of 22 members from 9 countries identified 15 topics and formulated 98 statements, who participated in 2 rounds of voting. It was defined as agreement of ≥80% of experts for each statement. RESULTS: After the voting of all the statements, 8 statements were obtained that did not reach 80% consensus among the participants, so the questions were reconsidered in the Coordinating Committee of the consensus with the participation of the expert reviewers of these questions and 7 final statements were voted again by all the experts in a second round and 1 was eliminated with consensus. After two rounds of voting, the experts reached consensus with literature review with the best available evidence, the most important issues were developed with scientific evidence supporting each of the statements around the topic of endoscopy in IBD. CONCLUSIONS: Consensus statements were developed and based on the best available evidence about endoscopy in inflammatory bowel disease.
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Técnica Delphi , Enfermedades Inflamatorias del Intestino , Humanos , Enfermedades Inflamatorias del Intestino/diagnóstico , Endoscopía Gastrointestinal/normas , Enfermedad de Crohn/diagnóstico , América Latina , Sociedades Médicas , ConsensoRESUMEN
Tofacitinib, a potentially teratogenic nonselective Janus Kinase inhibitor was used as salvage therapy for ulcerative colitis during pregnancy with corticosteroids, maintenance ustekinumab, and rectal 5-ASA therapy. Corticosteroid-free remission ensued, resulting in term delivery without congenital malformations and avoidance of colectomy.
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Colitis Ulcerosa , Piperidinas , Complicaciones del Embarazo , Pirimidinas , Adulto , Femenino , Humanos , Embarazo , Colitis Ulcerosa/tratamiento farmacológico , Piperidinas/uso terapéutico , Complicaciones del Embarazo/tratamiento farmacológico , Pirimidinas/uso terapéutico , Inhibidores de las Cinasas Janus/uso terapéuticoRESUMEN
Background: Janus kinase (JAK) inhibitors are effective for the treatment of inflammatory bowel disease (IBD). However, this class of medications is not recommended during pregnancy or breastfeeding based on animal data suggesting teratogenesis and recent reports of transmammary transfer after maternal ingestion, raising concerns for immune system development in babies exposed to these drugs. Methods: We present the case of a patient with IBD treated with a JAK inhibitor who decided to continue the medication throughout her pregnancy and during breastfeeding. This is the first reported case of a detailed immunologic profile in a baby exposed to tofacitinib in utero and during lactation. Results: A 30-year-old female with ulcerative colitis with previous exposure to vedolizumab and infliximab achieved complete remission with tofacitinib therapy. The patient became pregnant after 5 months of JAK inhibitor therapy and decided to continue tofacitinib during pregnancy and while breastfeeding. The patient delivered a healthy offspring with no congenital malformations, a normal detailed immunologic profile, and subsequent safe provision of the live oral rotavirus vaccine. Conclusions: This case highlights the importance of individualized counseling for patients of childbearing age who are candidates for JAK inhibition. Those who are pregnant or breastfeeding with refractory disease may have limited medical therapeutic options. Ongoing effective therapy for IBD resulted in complete disease remission in the mother and favorable outcomes in the infant. Further, an in-depth infant immunological assessment can lead to specific vaccination recommendations in exposed infants.
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Latin America (LATAM) is a large region comprising 47 countries and territories. Each one carries a different cultural and historical background, diverse political systems, and a particular approach to healthcare management. There is a lack of high-quality data on the epidemiology of inflammatory bowel diseases (IBD) in this region, including broad and detailed information about the penetration of biological and advanced therapies as treatment strategies. From an IBD perspective, patients experience, in general, fragmentations and inequities in the healthcare systems, with different and usually delayed access to qualified health services. This review explores the barriers to accessing IBD care throughout LATAM. The authors compiled data from multiple sources, such as studies focusing on epidemiology, biological penetration, and surgical rates. In addition, overall access to IBD treatments was assessed through a questionnaire distributed to physicians in LATAM via email and direct messaging to capture local perspectives.
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INTRODUCTION: We determined adverse events after 4 doses of severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) vaccine in those with inflammatory bowel disease (IBD), associations between antibodies and injection site reactions (ISR), and risk of IBD flare. METHODS: Individuals with IBD were interviewed for adverse events to SARS-CoV-2 vaccine. Multivariable linear regression assessed the association between antibody titers and ISR. RESULTS: Severe adverse events occurred in 0.03%. ISR were significantly associated with antibody levels after the fourth dose (geometric mean ratio = 2.56; 95% confidence interval 1.18-5.57). No cases of IBD flare occurred. DISCUSSION: SARS-CoV-2 vaccines are safe for those with IBD. ISR after the fourth dose may indicate increased antibodies.
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Vacunas contra la COVID-19 , COVID-19 , Enfermedades Inflamatorias del Intestino , Humanos , Anticuerpos Antivirales , COVID-19/epidemiología , COVID-19/prevención & control , Vacunas contra la COVID-19/efectos adversos , Reacción en el Punto de Inyección , SARS-CoV-2 , VacunaciónRESUMEN
With further knowledge of the pathogenesis of inflammatory bowel disease, small oral molecules have become available, including the Janus kinase (JAK) inhibitors. Upadacitinib (UPA) is a selective JAK1 inhibitor and has become the newest drug in this class, with recent approval for the management of moderate-to-severe ulcerative colitis. The large phase III program (including the U-ACHIEVE and U-ACCOMPLISH parallel induction trials and the U-ACHIEVE Maintenance trial) demonstrated superiority over placebo, for all primary and secondary endpoints including key clinical, endoscopic, and histological outcomes utilizing 45 mg orally (po) once daily (OD) during induction and either 30 mg or 15 mg po OD in maintenance. From a safety perspective, UPA has proven to be a safe and well-tolerated medication across immune-mediated diseases with manageable adverse risks such as an increase in herpes zoster. Proper discussion and patient profiling are essential when positioning UPA, considering efficacy and potential risks associated with this highly effective medication.
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Inteligencia Artificial , Endoscopía Gastrointestinal , Colonoscopía , Endoscopía , HumanosRESUMEN
BACKGROUND: The occurrence of false-positive alerts is an important outcome measure in computer-aided colon polyp detection (CADe) studies. However, there is no consensus definition of a false positive in clinical trials evaluating CADe in colonoscopy. We aimed to study the diagnostic performance of CADe based on different threshold definitions for false-positive alerts. METHODS: A previously validated CADe system was applied to screening/surveillance colonoscopy videos. Different thresholds for false-positive alerts were defined based on the time an alert box was continuously traced by the system. Primary outcomes were false-positive results and specificity using different threshold definitions of false positive. RESULTS: 62 colonoscopies were analyzed. CADe specificity and accuracy were 93.2â% and 97.8â%, respectively, for a threshold definition of ≥â0.5 seconds, 98.6â% and 99.5â% for a threshold definition of ≥â1 second, and 99.8â% and 99.9â% for a threshold definition of ≥â2 seconds. CONCLUSION: Our analysis demonstrated how different threshold definitions of false positive can impact the reported diagnostic performance of CADe for colon polyp detection.
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Benchmarking , Pólipos del Colon , Pólipos del Colon/diagnóstico por imagen , Colonoscopía , Computadores , Humanos , Tamizaje MasivoRESUMEN
BACKGROUND: Colonoscopy is the gold standard for polyp detection, but polyps may be missed. Artificial intelligence (AI) technologies may assist in polyp detection. To date, most studies for polyp detection have validated algorithms in ideal endoscopic conditions. AIM: To evaluate the performance of a deep-learning algorithm for polyp detection in a real-world setting of routine colonoscopy with variable bowel preparation quality. METHODS: We performed a prospective, single-center study of 50 consecutive patients referred for colonoscopy. Procedural videos were analyzed by a validated deep-learning AI polyp detection software that labeled suspected polyps. Videos were then re-read by 5 experienced endoscopists to categorize all possible polyps identified by the endoscopist and/or AI, and to measure Boston Bowel Preparation Scale. RESULTS: In total, 55 polyps were detected and removed by the endoscopist. The AI system identified 401 possible polyps. A total of 100 (24.9%) were categorized as "definite polyps;" 53/100 were identified and removed by the endoscopist. A total of 63 (15.6%) were categorized as "possible polyps" and were not removed by the endoscopist. In total, 238/401 were categorized as false positives. Two polyps identified by the endoscopist were missed by AI (false negatives). The sensitivity of AI for polyp detection was 98.8%, the positive predictive value was 40.6%. The polyp detection rate for the endoscopist was 62% versus 82% for the AI system. Mean segmental Boston Bowel Preparation Scale were similar (2.64, 2.59, P=0.47) for true and false positives, respectively. CONCLUSIONS: A deep-learning algorithm can function effectively to detect polyps in a prospectively collected series of colonoscopies, even in the setting of variable preparation quality.