Real-world outcomes of switching from adalimumab originator to adalimumab biosimilar in patients with inflammatory bowel disease: The ADA-SWITCH study.

BACKGROUND AND AIMS: Data on the outcomes after switching from adalimumab (ADA) originator to ADA biosimilar are limited. The aim was to compare the treatment persistence, clinical efficacy, and safety outcomes in inflammatory bowel disease patients who maintained ADA originator vs. those who switched to ADA biosimilar. METHODS: Patients receiving ADA originator who were in clinical remission at standard dose of ADA originator were included. Patients who maintained ADA originator formed the non-switch cohort (NSC), and those who switched to different ADA biosimilars constituted the switch cohort (SC). Clinical remission was defined as a Harvey-Bradshaw index ≤4 in Crohn's disease and a partial Mayo score ≤2 in ulcerative colitis. To control possible confounding effects on treatment discontinuation, an inverse probability treatment weighted proportional hazard Cox regression was performed. RESULTS: Five hundred and twenty-four patients were included: 211 in the SC and 313 in the NSC. The median follow-up was 13 months in the SC and 24 months in the NSC (p < 0.001). The incidence rate of ADA discontinuation was 8% and 7% per patient-year in the SC and in the NSC, respectively (p > 0.05). In the multivariate analysis, switching from ADA originator to ADA biosimilar was not associated with therapy discontinuation. The incidence rate of relapse was 8% per patient-year in the SC and 6% per patient-year in the NSC (p > 0.05). Six percent of the patients had adverse events in the SC vs. 5% in the NSC (p > 0.05). CONCLUSION: Switching to ADA biosimilar did not impair patients' outcomes in comparison with maintaining on the originator.

Immigrant IBD Patients in Spain Are Younger, Have More Extraintestinal Manifestations and Use More Biologics Than Native Patients.

BACKGROUND: Previous studies comparing immigrant ethnic groups and native patients with IBD have yielded clinical and phenotypic differences. To date, no study has focused on the immigrant IBD population in Spain. METHODS: Prospective, observational, multicenter study comparing cohorts of IBD patients from ENEIDA-registry who were born outside Spain with a cohort of native patients. RESULTS: We included 13,524 patients (1,864 immigrant and 11,660 native). The immigrants were younger (45 ± 12 vs. 54 ± 16 years, p < 0.001), had been diagnosed younger (31 ± 12 vs. 36 ± 15 years, p < 0.001), and had a shorter disease duration (14 ± 7 vs. 18 ± 8 years, p < 0.001) than native patients. Family history of IBD (9 vs. 14%, p < 0.001) and smoking (30 vs. 40%, p < 0.001) were more frequent among native patients. The most prevalent ethnic groups among immigrants were Caucasian (41.5%), followed by Latin American (30.8%), Arab (18.3%), and Asian (6.7%). Extraintestinal manifestations, mainly musculoskeletal affections, were more frequent in immigrants (19 vs. 11%, p < 0.001). Use of biologics, mainly anti-TNF, was greater in immigrants (36 vs. 29%, p < 0.001). The risk of having extraintestinal manifestations [OR: 2.23 (1.92-2.58, p < 0.001)] and using biologics [OR: 1.13 (1.0-1.26, p = 0.042)] was independently associated with immigrant status in the multivariate analyses. CONCLUSIONS: Compared with native-born patients, first-generation-immigrant IBD patients in Spain were younger at disease onset and showed an increased risk of having extraintestinal manifestations and using biologics. Our study suggests a featured phenotype of immigrant IBD patients in Spain, and constitutes a new landmark in the epidemiological characterization of immigrant IBD populations in Southern Europe.

Adherence to endoscopic surveillance for advanced lesions and colorectal cancer in inflammatory bowel disease: an AEG and GETECCU collaborative cohort study.

BACKGROUND AND AIMS: Patients with colonic inflammatory bowel disease (IBD) have a high risk of colorectal cancer (CRC). Current guidelines recommend endoscopic surveillance, yet epidemiological studies show poor compliance. The aims of our study were to analyse adherence to endoscopic surveillance, its impact on advanced colorectal lesions, and risk factors of non-adherence. METHODS: A retrospective multicentre study of IBD patients with criteria for CRC surveillance, diagnosed between 2005 and 2008 and followed up to 2020, was performed. Following European guidelines, patients were stratified into risk groups and adherence was considered when surveillance was performed according to the recommendations (±1 year). Cox-proportional regression analyses were used to compare the risk of lesions. p-values below 0.05 were considered significant. RESULTS: A total of 1031 patients (732 ulcerative colitis, 259 Crohn's disease and 40 indeterminate colitis; mean age of 36 ± 15 years) were recruited from 25 Spanish centres. Endoscopic screening was performed in 86% of cases. Adherence to guidelines was 27% (95% confidence interval, CI = 24-29). Advanced lesions and CRC were detected in 38 (4%) and 7 (0.7%) patients respectively. Adherence was associated with increased detection of advanced lesions (HR = 3.59; 95% CI = 1.3-10.1; p = 0.016). Risk of delay or non-performance of endoscopic follow-up was higher as risk groups increased (OR = 3.524; 95% CI = 2.462-5.044; p < 0.001 and OR = 4.291; 95%CI = 2.409-7.644; p < 0.001 for intermediate- and high- vs low-risk groups). CONCLUSIONS: Adherence to endoscopic surveillance allows earlier detection of advanced lesions but is low. Groups at higher risk of CRC are associated with lower adherence.

Specific cardiac disorders in 402 consecutive patients with ischaemic cardioembolic stroke.

BACKGROUND: To determine the cardiological substrate in acute stroke patients presenting with a cardioembolic stroke subtype. METHODS: Data of 402 consecutive patients with cardioembolic stroke (cerebral infarction, n=347; transient ischaemic attack, n=55) were collected from a prospective hospital-based stroke registry in which data on 2000 stroke patients over a 10-year period were included. In all patients, specific cardiac disorders were identified by physical examination and results of electrocardiography and transthoracic echocardiography. Holter monitoring and more sensitive techniques of cardiac imaging were used in selected cases. RESULTS: Cardioembolic cerebral ischaemia accounted for 20% of all acute strokes (25% of ischaemic cerebrovascular events). Cardiac sources of embolism included the following: (a) structural cardiac disorders associated with arrhythmia (n=232), the most frequent being left ventricular hypertrophic hypertensive disease (n=120) and rheumatic mitral valve disease (n=49); (b) structural cardiac disease with sustained sinus rhythm (n=81), the most frequent being systolic left ventricular dysfunction of both ischaemic (n=35) or non-ischaemic (n=24) aetiology; and (c) isolated atrial dysrhythmia (atrial fibrillation, n=88 and atrial flutter, n=1). CONCLUSIONS: Hypertrophic hypertensive cardiac disease complicated with atrial fibrillation was the most frequent cardiac source of emboli in cardioembolic stroke. Other important cardiac sources were isolated atrial fibrillation, rheumatic mitral valve disease, and systolic left ventricular dysfunction of ischaemic and non-ischaemic cause. The incidence of traditional emboligenous-prone cardiac disorders, such as mitral valve prolapse and mitral annular calcification was low.

[Valvular heart disease associated with benfluorex]. / Valvulopatía cardíaca asociada al uso de benfluorex.

We report the first case of valvular heart disease due to benfluorex. A 50-year-old woman who had been taking the anorectic agent benfluorex intermittently for one year developed severe fibrosis and regurgitation of the mitral, aortic and tricuspid valves. Clinical, echocardiographic and histopathological findings were analogous to those reported with fenfluramine and dexfenfluramine. The similarity between the histopathological lesion documented in patients treated with the appetite suppressants fenfluramine, dexfenfluramine and benfluorex and the valvular lesions reported in valve disease associated with ergot alkaloid use and carcinoid heart disease suggest a common pathophysiological mechanism and a central role for serotonin in the development of the disease.

Valvulopatía cardíaca asociada al uso de benfluorex / Valvular heart disease associated with benfluorex

Presentamos un caso asociado al tratamiento con benfluorex, con fibrosis tetravalvular subaguda que inducía intensa regurgitación mitral, aórtica y tricuspídea, además de moderada insuficiencia pulmonar. Las características clínicas, ecocardiográficas e histológicas del cuadro son análogas a las descritas con fenfluramina y dexfenfluramina, por lo que debería añadirse el benfluorex a la lista de fármacos anorexígenos que pueden inducir valvulopatía. La similitud entre la histopatología valvular hallada en los pacientes tratados con estos tres tipos de anorexígenos serotoninérgicos y la asociada al consumo de alcaloides ergotamínicos y a la cardiopatía carcinoide hacen pensar en la existencia de un mecanismo fisiopatológico común y un papel central de la serotonina como mediador de la lesión valvular. (AU)