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In the USA, an interchangeability designation provides biosimilar sponsors with a pathway for achieving what is standard for small-molecule generics: pharmacy-level auto-substitution for an innovator. No other major health authority links interchangeability to automatic substitution, as all require the involvement of the prescriber or patient in a medication change. This editorial considers the clinical impact and practicality of auto-substitution. First, interchangeability is linked to non-medical switching (NMS), the practice of switching treatment in patients with stable disease for non-clinical reasons. NMS may generate negative sentiment in those unwilling or reluctant to switch, which can adversely impact treatment outcomes (i.e., nocebo effect). Indeed, in real-world studies of tumor necrosis factor inhibitors, discontinuation rates have been shown to be higher in patients switched to biosimilars for non-medical reasons than in historical cohorts maintained on innovators. Second, interchangeability may impede pharmacovigilance and traceability, as not all jurisdictions require innovators and biosimilars to have distinct biologic names. Third, an interchangeability designation from the US Food and Drug Administration only permits a biosimilar to be automatically substituted for its innovator, not other biosimilars (if available). Pharmacist education would be needed to avoid off-label, automatic substitution among biosimilars of a single innovator. Last, once granted, an interchangeability designation exists in perpetuity under current US federal law. However, the supply chains of innovators and biosimilars are maintained independently, with no requirement for reconfirmation of biosimilarity or interchangeability. We feel that additional guidance is needed for the auto-substitution of biosimilars and innovators to become a reality. [ABSTRACT FROM AUTHOR]

Introduction: Despite availability of advanced therapies (ATs) for ulcerative colitis (UC), many patients fail to respond to treatment. This study examined real-world clinical and humanistic outcomes associated with current treatments in patients with UC., Methods: This cross-sectional study used US data from the Adelphi Real World Disease Specific Programme for inflammatory bowel disease from before (2017-2018) and during the COVID-19 pandemic (2020-2021). Physicians (gastroenterologists) seeing > 5 patients/month reported patients' disease characteristics, current symptoms and treatments, and reasons for treatment choices for their next seven consecutive patients aged ≥ 18 years with moderately to severely active UC before current treatment. Patients were asked to complete the EQ-5D-5L health-related quality of life (HRQoL) measure. ATs included tumor necrosis factor inhibitors (TNFis), integrin receptor antagonists, interleukin-12/23 antagonists, and Janus kinase inhibitors. Patients were classified as AT-naïve or AT-experienced based on current treatment received for ≥ 8 weeks and further classified as responders or non-responders based on symptoms, disease flare status, and remission. Descriptive analyses are presented., Results: The 2017-2018 cohort included 92 physicians and 539 patients (208 [38.6%] AT-experienced). The 2020-2021 cohort included 73 physicians and 448 patients (349 [77.9%] AT-experienced). TNFis were the most common ATs. In 2017-2018, 195 (58.9%) AT-naïve and 113 (54.3%) AT-experienced patients were non-responders; in 2020-2021 this was 57 (57.6%) and 182 (52.1%). Efficacy and induction of remission were physicians' most common reasons for AT choice. Dislike of injections/infusions was the most common reason for eligible patients not receiving biologic therapy. Numerically, non-responders (both AT-naïve and AT-experienced) had more symptoms, overall pain and fatigue, and lower HRQoL scores than responders., Conclusions: Before (2017-2018) and during the pandemic (2020-2021), over half of patients with UC did not respond to AT. Non-responders carried a high burden of disease. Alternative therapies are urgently needed to treat UC., (© 2023. The Author(s).)

Background: We aimed to examine opioid use among adult patients with inflammatory bowel disease (IBD) in the United States and the impact of extended opioid use on emergency health care services and health care costs among patients., Methods: We conducted a retrospective cohort study using medical claims data from the Truven Health MarketScan research databases, consisting of patients across the United States with employer-based health insurance. Subjects with IBD were identified in 2009. The occurrence of an emergent encounter in 2010 and health care costs were assessed., Results: There were 76,171 subjects with 35,993 emergent encounters among the study population, for an overall rate of 0.47 per patient-year. However, these encounters were confined to 6.9% of patients overall. The median total charges per patient in 2010 were $5372. Extended opioid use in 2009 was associated with a higher odds of an emergent encounter in 2010 (odds ratio [OR], 1.82; 95% confidence interval [CI], 1.67-1.98), higher incidence rate of emergent encounters (incidence rate ratio, 2.07; 95% CI, 1.91-2.24), and higher odds of being in the top quartile of cost in 2010 (OR, 1.90; 95% CI, 1.79-2.02). Depression was a strong predictor of extended opioid use (OR, 2.64; 95% CI, 2.49-2.81; P < 0.001)., Conclusions: Extended opioid use among patients with IBD is an important predictor of emergent encounters and is associated with higher total health care costs. Psychosocial comorbidities are significant predictors of extended opioid use in patients with IBD., (© 2019 Crohn’s & Colitis Foundation. Published by Oxford University Press. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.)

Background: Inflammatory bowel disease (IBD) has predominantly affected whites, particularly Ashkenazi Jews. Over the last 2 decades, IBD has "emerged" in minorities. Differences in natural history and disease characteristics have been suggested. The objective of this systematic review is to summarize these differences in studies from the United States., Methods: A structured search was performed within the Medline database through PubMed, EMBASE, and Cochrane databases. Published studies of genetics, pathogenesis, prevalence or incidence, disease location and behavior, extraintestinal manifestations, disparities and access to care in patients with IBD who are of African American, Asian, and Hispanic descent living in the United States were eligible., Results: A total of 47 studies were included for African Americans (n = 20,054), Hispanics (n = 10,762), and Asians (n = 2668). The incidence and prevalence of IBD is increasing among minorities. There is less of a genetic influence in the pathogenesis of IBD among African Americans; however, novel variants have been identified. There is a predilection for pancolonic ulcerative colitis among Hispanics and Asians. Crohn's disease-related hospitalizations are increasing in Asians, whereas African Americans are more likely to use the emergency department. No major differences are seen in disease location and behavior, upper gastrointestinal tract, and perianal involvement and extraintestinal manifestations among races and ethnic groups. Medication utilization seems to be similar. Differences in surgery are likely explained by health insurance status., Conclusions: Future prospective studies are needed to fully characterize disease characteristics and treatment response among minorities. With novel IBD therapies in the pipeline, enrollment in clinical trials should emphasize increased representation of all races and ethnic groups.

Because of the ongoing epidemics of obesity and diabetes, nonalcoholic steatohepatitis (NASH) may become a leading indication for liver transplantation. There are concerns about the posttransplant survival of patients with NASH because of associated cardiovascular and metabolic risk factors. We aimed to determine recent trends in the proportion of patients undergoing transplantation for NASH-related cirrhosis in the United States and to estimate their posttransplant survival. We used data provided by the United Network for Organ Sharing for first-time adult cadaveric liver transplants performed in the United States between January 1, 1997 and October 31, 2010 (n = 53,738). The proportion of liver transplants performed for NASH-related cirrhosis increased dramatically from 1.2% in 1997-2003 to 7.4% in 2010 when NASH was the fourth most common indication for transplantation. The posttransplant survival of patients with NASH (n = 1810) at 1 (87.6%), 3 (82.2%), and 5 years (76.7%) was superior to the survival of patients with hepatocellular carcinoma, hepatitis C virus, alcoholic liver disease, acute hepatic necrosis, hemochromatosis, or cryptogenic liver disease and was inferior to the survival of only 4 groups of patients (those with primary biliary cirrhosis, primary sclerosing cholangitis, autoimmune hepatitis, or hepatitis B virus). In conclusion, NASH-related cirrhosis is increasing rapidly as an indication for liver transplantation in the United States and is associated with excellent posttransplant survival., (Copyright © 2011 American Association for the Study of Liver Diseases.)

Unlabelled: Elevated serum uric acid (UA) levels strongly reflect and may even cause oxidative stress, insulin resistance, and metabolic syndrome, which are risk factors for the progression of liver disease. We sought to determine whether serum UA levels are associated with the development of cirrhosis or the presence of elevated serum liver enzymes. We used cohort data from the first National Health and Nutrition Examination Survey (NHANES I) to determine whether the baseline serum UA level was associated with the incidence of hospitalization or death due to cirrhosis among 5518 participants during a mean follow-up of 12.9 years (range = 4-21 years) after the exclusion of the first 4 years of follow-up. We also used cross-sectional data from NHANES 1988-1994 (n = 10,993) and NHANES 1999-2006 (n = 6186) to determine whether the serum UA level was associated with elevated serum alanine aminotransferase (ALT) or gamma-glutamyl transferase (GGT), two markers of hepatic necroinflammation. Compared to persons in the lower third of the distribution of serum UA (<4.8 mg/dL), those in the top third (>6 mg/dL) had a higher risk of cirrhosis-related hospitalization or death [adjusted hazard ratio (AHR) = 2.8, 95% confidence interval (CI) =1.3-5.7], whereas the risk was not substantially increased in persons within the middle third (serum UA level = 2.6-4.8 mg/dL, AHR = 1.3, 95% CI = 0.6-2.7). A higher serum UA level was associated with greater mean serum ALT and GGT levels and a greater probability of elevated serum ALT and GGT., Conclusion: The serum UA level is associated with the development of cirrhosis and the presence of elevated serum liver enzymes after adjustments for important causes and risk factors of chronic liver disease.