Prescribing of antivirals for COVID-19 in a South Australian local health network according to statewide guidelines.

Antiviral drugs were rapidly implemented into clinical practice for the treatment of high-risk patients with COVID-19, prompting the development of statewide guidelines. This South-Australian study reviewed guideline adherence, assessed prescribing patterns and highlighted the inappropriate management of relative drug-drug interactions and dosing for renal function. Additionally, it evaluated the impact of inappropriate antiviral drug use and suggested methods to improve quality use of medicines.

Nosocomial COVID-19 infection in the era of vaccination and antiviral therapy.

BACKGROUND AND AIMS: Coronavirus disease 2019 (COVID-19) vaccination and antiviral therapies have altered the course of the COVID-19 pandemic through mitigating severe illness and death. However, immunocompromised, elderly and multimorbid patients remain at risk of poor outcomes and are overrepresented in hospital populations. The aim of this study was to describe the characteristics and outcomes of patients with nosocomial COVID-19 infection. METHODS: This was a retrospective, observational study of patients who acquired COVID-19 after 7 days of hospital admission within the Southern Adelaide Local Health Network (SALHN) in South Australia between 1 June 2022 and 30 November 2022. Data were ascertained from the electronic medical record and the South Australian registry of births, deaths and marriages. RESULTS: Of 1084 COVID-19 inpatient cases managed in SALHN, 295 (27%) were nosocomial, with 215 included in the study. The median age of patients was 80 years (interquartile range [IQR], 68-88 years), the median Charlson Comorbidity Index score was 5 (IQR, 4-7) and 6% were immunocompromised. Most nosocomial COVID-19 infections were of mild severity (81%). The 30-day all-cause mortality rate following COVID-19 infection was 6%, and, in most cases, a cause of death other than COVID-19 was recorded on the death certificate. CONCLUSION: The majority of cases of nosocomial COVID-19 infection were mild, with a lower mortality rate than in earlier studies. This finding is likely attributable to immunity through vaccination and prior infection, early antiviral therapy and attenuated severity of the Omicron variant. The high proportion of nosocomial infections supports ongoing infection control measures.

Organizational Adaptive Capacity during a Large-Scale Surprise Event: A Case Study at an Academic Institution during the COVID-19 Pandemic.

OCCUPATIONAL APPLICATIONSThe COVID-19 pandemic caused large organizations and institutions to adapt their decision-making procedures and hierarchical structures to address pandemic-specific concerns. By examining a large public university, we found that effective adaptation occurred through restructuring the decision-making processes, coordinating decisions between departments, and effective monitoring of prior decisions. When considering the COVID-19 pandemic as a fundamental surprise event, our work identified strategies and decision-making that both maintained and increased adaptive capacity through the course of such an event. Through this case study, we highlight decisions that can be made by similar large organizations, to increase adaptive capacity when they are faced with similar surprise events.

Background In 2020, the COVID-19 pandemic caused significant disruptions for institutions of higher education around the world. In response to these disruptions, academic institutions adapted policies and standard operations to continue providing learning for students.Purpose We conducted a case study examining a large public university in the United States, wherein the COVID-19 pandemic had drastic effects on the university decision-making structure. We aimed to obtain insights into how a restructuring of this university's decision-making hierarchy in response to the pandemic ultimately increased adaptive capacity.Methods We used semi-structured interviews of 11 participants to identify key areas of organizational adaptation and qualitative content analysis of these interviews to identify key themes within the data.Results Identified themes pertained to adaptations at multiple levels of organizational scale, including decision-making hierarchical structure, general preparedness for a fundamental surprise event, allocation of resources during the pandemic, and monitoring of policy effectiveness.Conclusions Results from our case study identify how a large public university adapted to the COVID-19 pandemic as a fundamental surprise event. These findings offer guidance for similar organizations to actualize adaptive capacity across different levels of scale.

Stool donor screening within a Therapeutic Goods Administration compliant donor screening program for fecal microbiota transplantation.

Background and Aim: This study evaluates whether a stool donor program to supply fecal microbiota transplantation (FMT) product is feasible in the Australian regulatory environment. The primary outcome was capacity to supply FMT product. The secondary outcomes were donor eligibility, retention, and output. Methods: Prospective observational cohort study using data collected from the stool donor and FMT production records from BiomeBank, South Australia. Participants were people who engaged with BiomeBank's donor screening and FMT manufacturing process between 01 January 2021 and 31 December 2021. Results: In total 176 people registered interest in the program, 74 of 176 (42.0%) proceeded to written questionnaire, 14 of 176 (8.0%) underwent clinical assessment, and 8 of 176 (4.5%) enrolled in the program. Two people were ineligible based on laboratory tests: both had an extended spectrum beta-lactamase producing organism in stool and one also tested positive for hepatitis B core antibody. Two donors remained eligible from 2020, resulting in 10 enrolled donors in 2021; 5 of 10 (50%) male with a median age of 36.9 years (interquartile range, 30.3-42.7 years). All donors were ineligible to donate at some time point. There were 144 stool donations processed into 1480 50 mL FMT; 413 FMT were shipped to 33 Australian hospitals for treatment, 470 for clinical trials, and 89 were destroyed prior to release from quarantine. Conclusion: Recruitment into the program, retention, and maximizing the yield from a donation period was challenging. Despite this, BiomeBank was able to produce and supply FMT to Australian hospitals under the TGA-regulated Class 2 Biologicals framework.

Hospitalizations Among Children and Youth With Autism in the United States: Frequency, Characteristics, and Costs.

National estimates of hospitalization diagnoses and costs were determined using the 2016 HCUP Kids' Inpatient Database. Children and youth with autism were hospitalized over 45,000 times at over $560 million in costs and 260,000 inpatient days. The most frequent principal diagnoses for hospitalizations of children and youth with autism were epilepsy, mental health conditions, pneumonia, asthma, and gastrointestinal disorders, which resulted in almost $200 million in costs and 150,000 inpatient days. Mental health diagnoses accounted for 24.8% of hospitalizations, an estimated $82 million in costs, and approximately 94,000 inpatient days. Children and youth with autism were more likely hospitalized for epilepsy, mental health diagnoses, and gastrointestinal disorders, and less likely for pneumonia and asthma compared to other children and youth.

Surrogate "Level-Based" Lagrangian Relaxation for mixed-integer linear programming.

Mixed-Integer Linear Programming (MILP) plays an important role across a range of scientific disciplines and within areas of strategic importance to society. The MILP problems, however, suffer from combinatorial complexity. Because of integer decision variables, as the problem size increases, the number of possible solutions increases super-linearly thereby leading to a drastic increase in the computational effort. To efficiently solve MILP problems, a "price-based" decomposition and coordination approach is developed to exploit 1. the super-linear reduction of complexity upon the decomposition and 2. the geometric convergence potential inherent to Polyak's stepsizing formula for the fastest coordination possible to obtain near-optimal solutions in a computationally efficient manner. Unlike all previous methods to set stepsizes heuristically by adjusting hyperparameters, the key novel way to obtain stepsizes is purely decision-based: a novel "auxiliary" constraint satisfaction problem is solved, from which the appropriate stepsizes are inferred. Testing results for large-scale Generalized Assignment Problems demonstrate that for the majority of instances, certifiably optimal solutions are obtained. For stochastic job-shop scheduling as well as for pharmaceutical scheduling, computational results demonstrate the two orders of magnitude speedup as compared to Branch-and-Cut. The new method has a major impact on the efficient resolution of complex Mixed-Integer Programming problems arising within a variety of scientific fields.

Tolerability, gastric emptying patterns, and symptoms during the Nottingham Test Meal in 330 secondary care non-diabetic dyspeptic patients.

BACKGROUND: Scintigraphy is used for overall assessment of gastric emptying. Adherence to an international consensus protocol is recommended to ensure quality; however, this has not been widely adopted because preparation of the "egg-beater" meal is inconvenient in clinical practice. In this report, we audit the tolerability and the results of gastric emptying scintigraphy with the 400 ml Tc-99 m-labeled liquid nutrient Nottingham Test Meal (NTM). METHODS: Results from 330 consecutive adult, non-diabetic patients with dyspeptic symptoms referred for gastric scintigraphy were analyzed. Gastric half-emptying time (T50) and validated measurements of early- and late-phase gastric emptying were acquired. Postprandial sensations of fullness, bloating, heartburn, nausea, and epigastric pain were recorded using 100 mm visual analog scales (VAS) before and 0, 30, and 90 min after NTM ingestion. Results were compared with those previously obtained in healthy subjects. KEY RESULTS: Almost all (98%) of the patients were able to consume the 400 ml NTM. Considering early- and late-phase gastric emptying, frequently observed patterns included normal early- with slow late-phase (25%) and fast early- with slow late-phase emptying (27%). Abnormal score of fullness and/ or dyspeptic symptoms were observed in 88% of dyspeptic patients. Abnormal fullness at T0 (after completed drink ingestion) was associated with slow late phase of gastric emptying, especially in women. CONCLUSIONS: Gastric scintigraphy with the NTM is simple to perform and well tolerated. Whether the identified abnormal gastric emptying patterns could predict different treatment outcome in patients with functional dyspepsia is the subject of ongoing prospective studies.

The Prevalence of Salmonella and Campylobacter on Broiler Meat at Different Stages of Commercial Poultry Processing.

In poultry processing, Salmonella and Campylobacter contaminations are major food safety concerns. Peracetic acid (PAA) is an antimicrobial commonly used in commercial poultry processing to reduce pathogen prevalence so as to meet the USDA-FSIS performance standards. The objective of this study was to determine the prevalence of Salmonella and Campylobacter on broiler meat in various steps of commercial poultry processing in plants that use PAA. Post-pick, pre-chill, post-chill, and drumstick chicken samples were collected from three processing plants and mechanically deboned meat (MDM) was collected from two of the three plants. Each plant was sampled thrice, and 10 samples were collected from each processing step during each visit. Among the 420 samples, 79 were contaminated with Salmonella and 155 were contaminated with Campylobacter. Salmonella and Campylobacter contamination on the post-pick samples averaged 32.2%. Significant reductions in Salmonella and Campylobacter were observed in pre-chill to post-chill samples, where the prevalence was reduced from 34% and 64.4% to nondetectable limits and 1.1%, respectively (p < 0.001). Salmonella and Campylobacter remained undetectable on the drumstick samples in all three processing plants. However, the prevalence of Salmonella and Campylobacter on MDM was similar to the post-pick prevalence, which suggests substantial cross-contamination from post-chill to MDM.

Spoilage Bacteria Counts on Broiler Meat at Different Stages of Commercial Poultry Processing Plants That Use Peracetic Acid.

In poultry processing, spoilage microbes are persistent microorganisms, which affect the quality of broiler meat. Peracetic acid (PAA) is the most common antimicrobial used by commercial processing plants, which can reduce the prevalence of these microbes. The goal of this study was to determine the concentrations of aerobic bacteria, coliforms, lactic acid bacteria, and Pseudomonas on broiler meat in processing plants that use peracetic acid in various concentrations as the primary antimicrobial. Samples were collected from three processing plants at five processing steps: post-pick (defeathering), pre-chill, post-chill, mechanically deboned meat (MDM), and drumsticks. Samples were rinsed in buffered peptone water for bacteria isolation. Over six log CFU/sample of aerobic plate counts (APC), lactic acid bacteria, and coliforms were detected on post-pick samples. All spoilage bacteria were reduced to nondetectable levels on post-chill samples (p < 0.001). However, the presence of all bacteria on mechanically deboned meat (MDM) samples indicated varying degrees of cross contamination from post-chill and MDM samples. These results suggest PAA effectively reduces spoilage microbes in chilling applications irrespective of differences in PAA concentrations. However, due to the levels of spoilage microbes detected in MDM, it may be worth investigating the potential interventions for this stage of processing.

Drug shortages in low- and middle-income countries: Colombia as a case study.

BACKGROUND: Drug shortages are a global problem. Analyzing shortages worldwide is important to identify possible relationships between drug shortages across countries, determine strategies that reduce drug shortages, and reduce the inequality in access to medicines between countries. In contrast to well-documented shortages in high-income countries, there are few studies that consider low- and middle-income economies. We evaluate drug shortages in one middle-income country, Colombia. METHODS: We collected data from INVIMA, the institution responsible for managing medicine shortage alerts in Colombia. We classified the data using the Anatomical Therapeutic Chemical (ATC) classification system and analyzed them using descriptive statistics. We considered a study period from 2015 to 2021 (vital medicines) and from 2010 to 2020 (non-vital medicines). RESULTS: In total, 173 unique ATC codes were in shortage. These included antidotes, alimentary tract and metabolism products, anesthetics, cardiac stimulants and antithrombotic agents. The major causes were manufacturing problems and few suppliers. Drug shortages substantially increased from 2020 to May 2021 due to the COVID-19 pandemic. Among resolved shortages, the average duration was 1.6 years with a standard deviation of 1.9 years. The longest, naloxone tablets, were in shortage for almost 10 years. CONCLUSIONS: Drug shortages are a persistent problem in Colombia. Government institutions have made progress in implementing systems and procedures to report them. However, the approaches implemented need to be maintained and refined. This study lays the groundwork for the analysis of drug shortages in other LMICs. We highlight the necessity of addressing drug shortages in their global context and reducing the inequality in access to medicines between countries.

Pilot Double-Blind Randomised Controlled Trial: Effects of Jejunal Nutrition on Postprandial Distress in Diabetic Gastropathy (J4G Trial).

Nausea, vomiting and abdominal pain in diabetic patients are often attributed to diabetic gastropathy (DG). Post-pyloric ("jejunal") enteral nutrition (JN) may improve nutrition and glycaemia in difficult cases. The acute effects of JN on postprandial symptoms and gastric function in DG patients has not been studied. DG patients with moderate to severe symptoms (gastroparesis cardinal symptom index (GCSI) > 27), diabetic controls without symptoms (DC; GCSI < 14) and healthy controls (HV) were entered into a randomized, double blind controlled trial. JN with liquid nutrient (2 kcal/min) or water was infused for 60 min prior to ingestion of a standardized mixed solid/liquid test meal. Outcomes included postprandial symptoms and effects on gastrointestinal (GI)−peptide hormones and gastric emptying (GE) assessed by magnetic resonance imaging (MRI). Nine DG, nine DC and twelve HV were recruited. DG patients reported more symptoms after meals than other groups (p < 0.05). Post-prandial symptoms were reduced after JN in DG patients (p < 0.01). GE was more rapid after JN in DG and DC patients (p < 0.05). JN induced a GI−peptide response in all subjects; however, this was less pronounced in diabetic groups. JN has beneficial effects on DG patients' symptoms after a meal. The mechanism is not primarily mediated by effects on GE, but appears to involve other aspects of GI function, including visceral sensitivity.

Utilization of EHR to Improve Support Person Engagement in Health Care for Patients With Chronic Conditions.

Innovations in electronic health record (EHR) systems invite new patient and family engagement methods and create opportunities to reduce healthcare disparities. However, many patients and their identified support persons (ie, proxies) are unsure how to interface with the technology. This phenomenological qualitative study served as a pilot study to investigate the patient, proxy, and provider lived experiences utilizing patient-facing EHR portals. Individual interviews and focus groups were utilized to collect qualitative data from 21 patient, proxy, and healthcare provider participants across 3 time points. Colaizzi's phenomenological data analysis method was utilized to interpret the data. Four themes emerged highlighting critical benefits and obstacles for patients and support persons interfacing with a patient portal: (a) agency, (b) connection, (c) support, and (d) technology literacy. Results help highlight strategies and dispel myths essential to advancing patient and family engagement using EHR patient portal systems. The study's outcomes reflect recommendations for onboarding proxies and improving patient/family engagement and family-centered care models.

ASH Research Collaborative: a real-world data infrastructure to support real-world evidence development and learning healthcare systems in hematology.

The ASH Research Collaborative is a nonprofit organization established through the American Society of Hematology's commitment to patients with hematologic conditions and the science that informs clinical care and future therapies. The ASH Research Collaborative houses 2 major initiatives: (1) the Data Hub and (2) the Clinical Trials Network (CTN). The Data Hub is a program for hematologic diseases in which networks of clinical care delivery sites are developed in specific disease areas, with individual patient data contributed through electronic health record (EHR) integration, direct data entry through electronic data capture, and external data sources. Disease-specific data models are constructed so that data can be assembled into analytic datasets and used to enhance clinical care through dashboards and other mechanisms. Initial models have been built in multiple myeloma (MM) and sickle cell disease (SCD) using the Observational Medical Outcomes Partnership (OMOP) Common Data Model (CDM) and Fast Healthcare Interoperability Resources (FHIR) standards. The Data Hub also provides a framework for development of disease-specific learning communities (LC) and testing of health care delivery strategies. The ASH Research Collaborative SCD CTN is a clinical trials accelerator that creates efficiencies in the execution of multicenter clinical trials and has been initially developed for SCD. Both components are operational, with the Data Hub actively aggregating source data and the SCD CTN reviewing study candidates. This manuscript describes processes involved in developing core features of the ASH Research Collaborative to inform the stakeholder community in preparation for expansion to additional disease areas.

Validation of the Lyon classification for GORD diagnosis: acid exposure time assessed by prolonged wireless pH monitoring in healthy controls and patients with erosive oesophagitis.

OBJECTIVE: Acid exposure time (AET) from ambulatory pH studies and reflux oesophagitis are independent measurements used by the Lyon classification to diagnose GORD. This study aimed to validate AET reference ranges and diagnostic thresholds by analysis of 96-hour wireless pH studies from healthy, asymptomatic controls (HCs) and patients with and without oesophagitis. DESIGN: HC and consecutive patients referred for wireless pH studies (off acid suppressants for >7 days) underwent 96-hour pH studies at two tertiary referral centres. Erosive oesophagitis was categorised by the Los Angeles (LA) classification. Linear regression and receiver operating curve (ROC) analysis were performed to define optimal diagnostic cut-offs. RESULTS: Prolonged, 96-hour pH studies were completed in 39 HCs (age 28 (18-53) years, 72% female) and 944 patients (age 46 (16-85) years, 65% female), of whom 136 (14.5%) had reflux oesophagitis. Median AET in HC was 1.3% (upper 95th percentile 4.6%) for any study day and 2.6% (upper 95th percentile 6.9%) for the worst day (24-hour period) during the study. ROC analysis for average AET differentiated HC from patients with moderate-to-severe oesophagitis (LA BCD; sensitivity 87%, specificity 95%, positive predictive value (PPV) 59%, negative predictive value 99% for a cut-off AET of 4.3%; area under the receiver operating curve 0.95). Specificity was higher, but PPV was substantially lower for severe oesophagitis (LA CD). 'Worst-day' analysis provided similar results; however, day-to-day variability was high. CONCLUSION: Diagnostic thresholds for average AET were identified that accurately discriminate between HCs and patients with erosive oesophagitis. The findings provide conditional support for diagnostic criteria for GORD proposed by the Lyon Consensus.

Detectable Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) in Human Breast Milk of a Mildly Symptomatic Patient With Coronavirus Disease 2019 (COVID-19).

SARS-CoV-2 is a novel coronavirus and causative pathogen to the pandemic illness COVID-19. Although RNA has been detected in various clinical samples, no reports to date have documented SARS-CoV-2 in human milk. This case report describes an actively breastfeeding patient with COVID-19 infection with detectable viral RNA in human milk.

Outcomes of patients with hematologic malignancies and COVID-19: a report from the ASH Research Collaborative Data Hub.

Coronavirus disease 2019 (COVID-19) is an illness resulting from severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) that emerged in late 2019. Patients with cancer, and especially those with hematologic malignancies, may be at especially high risk of adverse outcomes, including mortality resulting from COVID-19 infection. The ASH Research Collaborative COVID-19 Registry for Hematology was developed to study features and outcomes of COVID-19 infection in patients with underlying blood disorders, such as hematologic malignancies. At the time of this report, data from 250 patients with blood cancers from 74 sites around the world had been entered into the registry. The most commonly represented malignancies were acute leukemia (33%), non-Hodgkin lymphoma (27%), and myeloma or amyloidosis (16%). Patients presented with a myriad of symptoms, most frequently fever (73%), cough (67%), dyspnea (50%), and fatigue (40%). Use of COVID-19-directed therapies, such as hydroxychloroquine (n = 76) or azithromycin (n = 59), was common. Overall mortality was 28%. Patients with a physician-estimated prognosis from the underlying hematologic malignancy of <12 months at the time of COVID-19 diagnosis and those with relapsed/refractory disease experienced a higher proportion of moderate/severe COVID-19 disease and death. In some instances, death occurred after a decision was made to forgo intensive care unit admission in favor of a palliative approach. Taken together, these data support the emerging consensus that patients with hematologic malignancies experience significant morbidity and mortality resulting from COVID-19 infection. Batch submissions from sites with high incidence of COVID-19 infection are planned to support future analyses.

Physician and patient perceptions of fecal microbiota transplant for recurrent or refractory Clostridioides difficile in the first 6 years of a central stool bank.

BACKGROUND AND AIM: Fecal microbiota transplantation (FMT) is a highly effective therapy for recurrent or refractory Clostridioides difficile infection (rCDI). Despite inclusion in society guidelines, the uptake of FMT therapy has been variable. Physician and patient attitudes may be a barrier to evidence-based uptake of therapies; however, data assessing attitudes regarding FMT for rCDI are limited. METHODS: The South Australian FMT for CDI database prospectively recorded patient outcomes of FMT for CDI from August 2013 to January 2019. A total of 93 consecutive patients who underwent FMT for rCDI in South Australia were invited to participate in a 20-question survey regarding the patient experience of FMT. All gastroenterologists and infectious disease physicians practicing in South Australia were invited to participate in an online survey comprised of 22 questions that addressed referral experience, indications for referral, perceived risks, and regulation and funding. RESULTS: Fifty-four patients (54/93, 58%) returned the survey, of whom 52 (96%) would recommend FMT to others, and 51 (94%) were satisfied with treatment outcome. Fifty physicians returned the online survey (50/100, 50%), of whom 23 (46%) were concerned about disease transmission risk, and 15 (30%) believed that the risk of FMT would outweigh the benefit. Infectious diseases physicians and advanced trainees had significantly greater concern regarding the potential alteration of the microbiome than gastroenterology physicians and advanced trainees (8/17 (47%) vs 6/33 (18%); P = 0.047). CONCLUSION: Despite high levels of patient-reported satisfaction following FMT, physician-reported reservations exist and may present a barrier to uptake of this therapy.

Copper and zinc generated by the Aquascape IonGen pond clarifier system can be detrimental to koi (Cyprinus carpio) health.

BACKGROUND: Copper is frequently used as an algicide, and copper ion generators such as the Aquascape IonGen claim to be safe for use in systems containing fish. In 2012, a die-off of koi (Cyprinus carpio) in a pond in Raleigh, North Carolina, occurred after the IonGen was added to the system. METHODS: Physical and postmortem examinations suggested that heavy metal toxicity was the likely cause of morbidity and mortality. This was supported by a heavy metal screening of the owners' pond. Additional experiments were performed to determine if the IonGen produced toxic levels of copper and zinc. RESULTS: The tank containing the IonGen had higher concentrations of copper and zinc, and copper levels exceeded those associated with toxicity in both hard and soft water. CONCLUSION: The results of this study indicate that ion generators might not be safe for fish, and copper should only be used as an algicide if concentrations are closely monitored.

Experiences of using vedolizumab in the treatment of inflammatory bowel disease in the East Midlands UK - a retrospective observational study.

PURPOSE: Clinical trials have demonstrated efficacy of vedolizumab in ulcerative colitis (UC) and Crohn's disease (CD). Further real-world data is needed to inform clinical practice. The primary outcome was to assess corticosteroid-free and clinical remission after vedolizumab initiation. Secondary outcomes included effect on disease activity scores, biochemical markers, concomitant drug use, endoscopic remission, surgical intervention, hospital admissions and adverse events. MATERIALS AND METHODS: A multi-centre retrospective observational study was conducted with patients initiated on vedolizumab across seven UK hospitals 1/11/14-30/11/16. Clinical disease activity was assessed using the partial Mayo Scores (pMS) and Harvey Bradshaw Index (HBI). Clinical remission was defined as HBI ≤4 or pMS <2 with a combined stool frequency and rectal bleeding sub score of ≤1. Clinical response was defined as ≥2-point decrease from baseline in pMS and ≥3-point decrease from baseline in HBI. RESULTS: One hundred ninety-two patients were included in the final analysis. 45% of UC and 10% of CD patients were anti-TNF naive. Over the observation period corticosteroid-free remission rates for UC and CD were 46% and 45%, while clinical remission rates were 52% and 44%, respectively. Time to corticosteroid free remission for UC and CD was 17.6 [IQR: 8.7-29.6] and 14.1 [QR: 6.0-21.7] weeks, respectively. Time to clinical response for UC was 9.4 [IQR: 5.7-15.4] and CD was 9.5 [IQR: 6.1-18.2] weeks. There was a substantial decrease in the concomitant use of immunomodulators and a similar decrease in concomitant corticosteroid use over the study period. CONCLUSIONS: Results in this predominately anti-TNF experienced population mirror other published real-world data, demonstrating good clinical effectiveness and a comparable safety profile.