Retrospective Cohort Study Comparing Infliximab-dyyb and Infliximab in Biologic Naïve Patients with Inflammatory Bowel Disease in the United States

Background Real-world assessments of biosimilars are needed to understand their effectiveness and safety in practice settings that may differ from those seen in clinical trials or healthcare systems in different countries. Objective To assess the effectiveness and safety of a biosimilar (infliximab-dyyb) and its reference product (infliximab) in patients with inflammatory bowel disease (IBD) in the United States (US). Methods We conducted a retrospective cohort study of biologic-naïve patients with IBD who started treatment with infliximab-dyyb or infliximab. The study included 3,206 patients identified through electronic health records in a US integrated healthcare delivery system. The effectiveness outcome was a composite of IBD-related surgery, IBD-related emergency room visit, and IBD-related hospitalization within 12 months of initiation. Safety outcomes included incidence of any or serious infection, cancer, acute liver dysfunction, and tuberculosis. We used a non-inferiority test with an upper-limit margin of 10% to analyze effectiveness. Doubly robust methods incorporating Cox proportional hazard regression with standardized inverse probability of treatment weighting were used to analyze both effectiveness and safety outcomes. Results The composite effectiveness outcome occurred in 107 of 870 patients (12.3%) in the infliximab-dyyb and 379 of 2,336 patients (16.2%) in the infliximab groups. Infliximab-dyyb was non-inferior (P < .01) and was not different (HR 0.81;CI 0.65-1.01;P = .06) to infliximab. Safety outcomes were not different between infliximab-dyyb and infliximab for any infections (HR 1.01;CI 0.86-1.17;P = .95), serious infections (HR 0.83;CI 0.54-1.26;P = .38), cancers (HR 0.83;CI 0.44-1.54;P = .55), and tuberculosis (HR 0.59;CI 0.10-3.55;P = .57). Conclusion Initiation of infliximab-dyyb was non-inferior to infliximab among biologic-naïve patients with IBD in an US integrated healthcare delivery system. Lay summary In this US-based, retrospective, multi-center, cohort study of 3,206 biologic-na�ve patients with IBD, treatment with the biosimilar infliximab-dyyb was non-inferior to reference product infliximab for the effectiveness composite of IBD-related surgery, IBD-related emergency room visit, and IBD-related hospitalization.

Long-Term Pulmonary Damage From SARS-CoV-2 in an Infant With Brief Unexplained Resolved Events: A Case Report

A brief unexplained resolved event (BRUE) is an event observed in a child under 1 year of age in which the observer witnesses a sudden, brief but resolved episode of change in skin color, lack of breathing, weakness or poor responsiveness. Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is the causative agent of coronavirus disease-2019 (COVID-19). We report the case of a previously healthy, full-term infant infected with SARS-CoV-2 when he was 8 months old. Previous to this event, both his grandfather and great-uncle had died of severe pneumonia and his mother had developed respiratory symptoms and fever. Over the following month he was seen five times in the emergency room and was hospitalized twice for recurrent BRUE. At the first hospital admission, after the second emergency room visit, he twice tested positive for COVID-19 after nasopharyngeal swab tests. During his second hospital admission, after the fifth emergency room visit, chest computed tomography revealed typical SARS-CoV-2 pneumonia. During a follow-up examination 6 months later, mild respiratory distress required administration of inhaled oxygen (0.5 L/min) and chest computed tomography disclosed a slight improvement in pulmonary involvement. The clinical manifestation of pulmonary complications from COVID-19 infection was unusual. This is the first report of an infant at high-risk for BRUE, which was the only manifestation of long-term lung involvement due to SARS-CoV-2 pneumonia.

Switch from Infliximab to Infliximab-dyyb for Rheumatology Indications

Introduction Multiple expert panels at Kaiser Permanente approved infliximab-dyyb (Inflectra®), a biosimilar to the reference product infliximab (Remicade®), to be the preferred infliximab agent for therapeutic substitution from infliximab for adult patients with dermatologic, rheumatologic, and/or gastroenterologic diagnoses. The objective of this study was to assess the safety and effectiveness of infliximab-dyyb for Kaiser Permanente Northern California patients with psoriatic and rheumatoid arthritis who switched from infliximab to infliximab-dyyb. Methods This was an observational, data-only, non-inferiority study assessing adult patients with a rheumatologic condition of psoriatic arthritis (PsA) or rheumatoid arthritis (RA) who were switched from infliximab to infliximab-dyyb or used infliximab continuously in the Northern California region of Kaiser Permanente from May 2017 through May 2018. Both groups were followed for 12 months. The primary effectiveness outcome was disease worsening requiring acute care defined as emergency room visit or hospitalization related to the rheumatologic condition or orthopedic surgery intervention. Non-inferiority was set at an upper limit of 4%. Results A total of 70 individuals were identified as continuing infliximab and 727 individuals were switched to infliximab-dyyb. There were 2 patients (2.9%) in the infliximab group and 22 patients (3.0%) in the infliximab-dyyb group who experienced disease worsening requiring acute care (P = 0.03 for non-inferiority). Conclusion There was no increased risk of disease worsening requiring acute care in patients with RA or PsA who switched from infliximab to infliximab-dyyb when compared to patients who remained on infliximab in this population.

Comorbidities and Age Are Associated With Persistent COVID-19 PCR Positivity

ObjectivesThe impact of demographics and comorbidities on the duration of COVID-19 nasopharyngeal swab PCR positivity remains unclear. The objective of our analysis is to determine the impact of age, intensive care unit (ICU) admission, comorbidities, and ethnicity on the duration of COVID-19 PCR positivity among hospitalized patients in a large group of hospital.MethodWe studied 530 patients from a large hospital system and time to SARS-CoV-2 virus RNA PCR negativity at any-time during hospitalization or following discharge from the hospital was the primary endpoint. We included patients 18 years or older who tested positive for COVID-19 during an inpatient, outpatient, or emergency room visit between February 1, 2020, and April 14, 2020.ResultsOverall, 315 (59.4%) of our patient population continued to have a positive SARS-CoV-2 virus RNA PCR 4 weeks after the initial positive test. We found that age>70 years, chronic kidney disease, hypertension, hyperlipidemia, obesity, or coronary artery disease are associated with persistent PCR positivity for more than 4 weeks after initial diagnosis.ConclusionAge, and the presence of co-morbidities should be taken into consideration when interpreting a positive COVID PCR test.

Pelvic Inflammatory Disease (PID) Management in Corona Virus Disease 2019 (COVID-19) Era

Objective: This article aims to review pelvic inflammatory disease management during the coronavirus disease 2019 pandemic Method: We conducted a search for scientific articles through PubMed and Google Scholar, using the terminologies of “PID AND COVID-19”, “Pelvic Inflammatory Disease”; “Pelvic Inflammatory Disease AND COVID-19”, “PID Management AND COVID-19”, “Pelvic Inflammatory Disease Management AND COVID-19”, and “PID AND Pandemic” in English and Indonesian from 2019-2020. Result: There were a total of 25 scientific articles from PubMed and Google Scholar within 2019-2020 that were included as the source of this review Conclusion: There is no difference between the management of pelvic inflammatory disease during and before the pandemic. The mode of medical services and follow up tends to be conducted virtually. Technology-based services for pelvic inflammatory disease during the corona virus disease 2019 pandemic are promising and have been proven to be an effective method, therefore virtual-based pelvic inflammatory disease services may be safely applied. However, if there is any indication of emergency found during the telemedicine services, a face-to-face consultation or emergency room visit should be recommended. Key words : COVID-19, Pelvic Inflammatory Disease, SARS-CoV-2

Abstract 13534: Reduced Hospitalizations, Emergency Room Vists and Death Among Patients Seen Once in a Heart Failure Bridge Clinic (HFBC) Program

Introduction: Multidisciplinary clinics established in the care of heart failure patients are particularly impactful after hospital discharge. Clinical pharmacist integration with HFBC allows focused attention to optimizing guideline directed medical therapies (GDMT). The clinical impact of pharmacist inclusive HFBC requires further evaluation. Hypothesis: Patients with a HFBC encounter within 30 days after index heart failure hospitalization have reduced recurrent hospitalization, emergency room visits and mortality. Methods: All patients with left ventricular ejection fraction (LVEF) less than 40% obtained within 90 days prior to hospital discharge from Mission Memorial Hospital between 8/2018 and 7/2019 were screened. Patients included in the HFBC arm had a clinic encounter within 30 days of hospital discharge and the remainder of patients comprised the control arm. Electronic and manual chart abstraction was used to assess and follow patients. Baseline characteristics were compared for differences using descriptive statistics. HFBC included clinical assessment, detailed heart failure education, medication reconciliation and adjustment with an emphasis on optimization of GDMT. Patients were followed for 90 day for the primary endpoints of hospitalization, emergency room visit and death Results: A total of 1,463 patients (HFBC 307, Control 1156) comprised our final cohort. After accounting for baseline variables associated with endpoints the cumulative rates of hospitalization, emergency room visit or death still favor HFBC compared with controls at 90 days (HFBC 26% vs Control 32%, p=0.03). The 30 and 90 day frequencies of individual endpoints are represented in figure 1. Conclusions: Clinical pharmacist integrated HFBC program allows for focused medication review and optimization is associated with 19% risk reduction in hospitalization, emergency room visit and death at 90 days.

Association between mental health comorbidity and health outcomes in type 2 diabetes mellitus patients

Type 2 diabetes mellitus (T2D) is often accompanied by chronic diseases, including mental health problems. We aimed at studying mental health comorbidity prevalence in T2D patients and its association with T2D outcomes through a retrospective, observational study of individuals of the EpiChron Cohort (Aragón, Spain) with prevalent T2D in 2011 (n = 63,365). Participants were categorized as having or not mental health comorbidity (i.e., depression, anxiety, schizophrenia, and/or substance use disorder). We performed logistic regression models, controlled for age, sex and comorbidities, to analyse the likelihood of 4-year mortality, 1-year all-cause hospitalization, T2D-hospitalization, and emergency room visit. Mental health comorbidity was observed in 19% of patients. Depression was the most frequent condition, especially in women (20.7% vs. 7.57%). Mortality risk was higher in patients with mental health comorbidity (odds ratio 1.24; 95% confidence interval 1.16–1.31), especially in those with substance use disorder (2.18; 1.84–2.57) and schizophrenia (1.82; 1.50–2.21). Mental health comorbidity also increased the likelihood of all-cause hospitalization (1.16; 1.10–1.23), T2D-hospitalization (1.51; 1.18–1.93) and emergency room visit (1.26; 1.21–1.32). These results suggest that T2D healthcare management should include specific strategies for the early detection and treatment of mental health problems to reduce its impact on health outcomes.

Predictors of Psychiatric Outpatient Adherence after an Emergency Room Visit for a Suicide Attempt

Objective This study aimed to investigate the potential correlation between baseline characteristics of individuals visiting an emergency room for a suicide attempt and subsequent psychiatric outpatient treatment adherence.Methods Medical records of 525 subjects, who visited an emergency room at a university-affiliated hospital for a suicide attempt between January 2017 and December 2018 were retrospectively reviewed. Potential associations between baseline characteristics and psychiatric outpatient visitation were statistically analyzed.Results 107 out of 525 individuals (20.4%) who attempted suicide visited an outpatient clinic after the initial emergency room visit. Several factors (e.g., sober during suicide attempt, college degree, practicing religion, psychiatric treatment history) were significantly related to better psychiatric outpatient follow-up.Conclusion Several demographic and clinical factors predicted outpatient adherence following a suicide attempt. Therefore, additional attention should be given to suicide attempters who are at the risk of non-adherence by practitioners in the emergency room.