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Vermeire S, Rubin DT, Peyrin-Biroulet L, Dubinsky MC, Regueiro M, Irving PM, Goetsch M, Lazin K, Gu G, Wu J, Modesto I, McDonnell A, Guo X, Green J, Dalam AB, Yarur AJ. Cardiovascular events observed among patients in the etrasimod clinical programme: an integrated safety analysis of patients with moderately to severely active ulcerative colitis. BMJ Open Gastroenterol 2025; 12:e001516. [PMID: 39778975 PMCID: PMC11748931 DOI: 10.1136/bmjgast-2024-001516] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 07/02/2024] [Accepted: 11/15/2024] [Indexed: 01/11/2025] Open
Abstract
OBJECTIVE Etrasimod is an oral, once-daily, selective sphingosine 1-phosphate (S1P)1,4,5 receptor modulator for the treatment of moderately to severely active ulcerative colitis (UC). S1P1 receptor expression on cardiac cells is involved in cardiac conduction. We report cardiovascular treatment-emergent adverse events (TEAEs) associated with S1P receptor modulators and other cardiovascular events in the etrasimod UC clinical programme. METHODS Patients were analysed in the Placebo-controlled UC cohort and All UC cohort. Incidence rates (IRs, per 100 patient-years) of cardiovascular-related TEAEs associated with S1P receptor modulators, including bradycardia/atrioventricular (AV) block and hypertension, and other cardiovascular events, including coronary artery disease (CAD) and cerebrovascular disease (CVD), were analysed. RESULTS In patients receiving etrasimod, cardiovascular-related TEAEs were infrequent (≤2.6% per AE). In the Placebo-controlled UC cohort, IRs (95% CIs) for cardiovascular-related TEAEs were higher for patients receiving etrasimod (n=577) vs placebo (n=314), respectively, for bradycardia/sinus bradycardia, 3.85 (1.58 to 6.13) vs 0 and AV block, 1.40 (0.03 to 2.76) vs 0; and numerically higher for hypertension, 5.31 (2.62 to 7.99) vs 3.40 (0.07 to 6.72). Most bradycardia/AV block events were reported on day 1. All bradycardia and hypertension TEAEs were non-serious. One serious second-degree AV block type 1 TEAE occurred in the etrasimod group; no events of second-degree AV block type 2 or higher were reported. One event each of CAD and CVD occurred in two patients receiving etrasimod. CONCLUSIONS In the etrasimod UC clinical programme, IRs of cardiovascular-related TEAEs and other cardiovascular events were low. Most cardiovascular-related TEAEs were non-serious. TRIAL REGISTRATION NUMBERS NCT02447302; NCT03945188; NCT03996369; NCT02536404; NCT03950232; NCT04176588.
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Affiliation(s)
- Séverine Vermeire
- Department of Gastroenterology and Hepatology, University Hospitals Leuven, Leuven, Belgium
| | - David T Rubin
- Inflammatory Bowel Disease Center, University of Chicago Medicine, Chicago, Illinois, USA
| | - Laurent Peyrin-Biroulet
- Department of Gastroenterology, Nancy University Hospital, F-54500 Vandœuvre-lès-Nancy, France
- INSERM, NGERE, University of Lorraine, F-54000 Nancy, France
- INFINY Institute, Nancy University Hospital, F-54500 Vandœuvre-lès-Nancy, France
- FHU-CURE, Nancy University Hospital, F-54500 Vandœuvre-lès-Nancy, France
- Groupe Hospitalier privé Ambroise Paré - Hartmann, Paris IBD Center, 92200 Neuilly sur Seine, France
- Division of Gastroenterology and Hepatology, McGill University Health Centre, Montreal, Quebec, Canada
| | - Marla C Dubinsky
- Susan and Leonard Feinstein IBD Center, Icahn School of Medicine at Mount Sinai, New York, New York, USA
| | - Miguel Regueiro
- Department of Gastroenterology, Hepatology, and Nutrition, Cleveland Clinic, Cleveland, Ohio, USA
| | | | | | | | - Guibao Gu
- Pfizer Inc, La Jolla, California, USA
| | - Joseph Wu
- Pfizer Inc, Cambridge, Massachusetts, USA
| | | | | | - Xiang Guo
- Pfizer Inc, Collegeville, Pennsylvania, USA
| | | | | | - Andres J Yarur
- Inflammatory Bowel Disease Center and Division of Gastroenterology and Hepatology, Cedars-Sinai Medical Center, Los Angeles, California, USA
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2
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Simão Raimundo D, Cordeiro AI, Parente Freixo J, Valente Pinto M, Neves C, Farela Neves J. Case Report: Patient with deficiency of ADA2 presenting leukocytoclastic vasculitis and pericarditis during infliximab treatment. Front Pediatr 2023; 11:1200401. [PMID: 37388286 PMCID: PMC10303984 DOI: 10.3389/fped.2023.1200401] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 04/04/2023] [Accepted: 05/15/2023] [Indexed: 07/01/2023] Open
Abstract
Deficiency of adenosine deaminase 2 (DADA2), first reported in 2014, is a disease with great phenotypic variability, which has been increasingly reported. Therapeutic response depends on the phenotype. We present a case of an adolescent with recurrent fever, oral aphthous ulcers, and lymphadenopathy from 8 to 12 years of age and subsequently presented with symptomatic neutropenia. After the diagnosis of DADA2, therapy with infliximab was started, but after the second dose, she developed leukocytoclastic vasculitis and showed symptoms of myopericarditis. Infliximab was switched to etanercept, with no relapses. Despite the safety of tumor necrosis factor alpha inhibitors (TNFi), paradoxical adverse effects have been increasingly reported. The differential diagnosis between disease new-onset manifestations of DADA2 and side effects of TNFi can be challenging and warrants further clarification.
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Affiliation(s)
- Diana Simão Raimundo
- Pediatrics Department, Hospital do Divino Espírito Santo, Ponta Delgada, Portugal
| | - Ana Isabel Cordeiro
- Primary Immunodeficiencies Unit, Hospital Dona Estefânia, Centro Hospitalar Universitário de Lisboa Central, Lisboa, Portugal
| | - João Parente Freixo
- Centro de Genética Preditiva e Preventiva, Instituto de Biologia Molecular e Celular, Instituto de Investigação e Inovação em Saúde, Porto, Portugal
| | - Marta Valente Pinto
- Primary Immunodeficiencies Unit, Hospital Dona Estefânia, Centro Hospitalar Universitário de Lisboa Central, Lisboa, Portugal
- Egas Moniz Center for Interdisciplinary Research (CiiEM); Egas Moniz School of Health & Science, Caparica, Almada, Portugal
| | - Conceição Neves
- Primary Immunodeficiencies Unit, Hospital Dona Estefânia, Centro Hospitalar Universitário de Lisboa Central, Lisboa, Portugal
| | - João Farela Neves
- Primary Immunodeficiencies Unit, Hospital Dona Estefânia, Centro Hospitalar Universitário de Lisboa Central, Lisboa, Portugal
- NOVA Medical School, Faculdade de Ciências Médicas, NMS, FCM, Universidade NOVA de Lisboa, Lisboa, Portugal
- CHRC, NOVA Medical School, Faculdade de Ciências Médicas, NMS, FCM, Universidade NOVA de Lisboa, Lisboa, Portugal
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3
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Li H, Xing H, Hu C, Sun BY, Wang S, Li WY, Qu B. Hemorrhagic pericardial effusion following treatment with infliximab: A case report and literature review. World J Clin Cases 2021; 9:7593-7599. [PMID: 34616831 PMCID: PMC8464448 DOI: 10.12998/wjcc.v9.i25.7593] [Citation(s) in RCA: 3] [Impact Index Per Article: 0.8] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 05/06/2021] [Revised: 06/16/2021] [Accepted: 07/02/2021] [Indexed: 02/06/2023] Open
Abstract
BACKGROUND Infliximab (IFX) is an anti-tumor necrosis factor alpha (TNF-α) agent that is widely used for the management of a variety of autoimmune and inflammatory diseases, including Crohn's disease (CD). As a result of its increasing administration, new complications have emerged. Hemorrhagic pericardial effusion, secondary to IFX therapy, is a rare but life-threatening complication.
CASE SUMMARY A 27-year-old man was diagnosed with CD (Montreal A2L3B1) 6 years prior. After failing to respond to mesalazine and methylprednisolone, he took the first dose of IFX 300 mg based on his weight (60 kg, dose 5 mg/kg) on December 3, 2018. He responded well to this therapy. However, on January 21, 2019, 1 wk after the third injection, he suddenly developed dyspnea, fever, and worsening weakness and was admitted to our hospital. On admission, computed tomography scan of the chest revealed a large pericardial effusion and a small right-side pleural effusion. An echocardiogram showed a large pericardial effusion and normal left ventricular function. Then successful ultrasound-guided pericardiocentesis was performed and 600 mL hemorrhagic fluid was drained. There was no evidence of infection and the concentrations of TNF-α, IFX, and anti-IFX antibody were 7.09 pg/mL (reference range < 8.1 pg/mL), < 0.4 μg/mL (> 1.0 μg/mL), and 373 ng/mL (< 30 ng/mL), respectively. As the IFX instruction manual for injection does mention pericardial effusion as a rare adverse reaction (≥ 1/10000, < 1/1000), so we discontinued the IFX. Monitoring of the patient’s echocardiogram for 2 mo without IFX therapy showed no recurrence of hemorrhagic pericardial effusion. Follow-up visits and examinations every 3 to 6 mo until April 2021 showed no recurrence of CD or pericardial effusion.
CONCLUSION This is a case of hemorrhagic pericardial effusion following treatment with IFX. It is a rare but life-threatening complication of IFX. Early recognition helps prevent the occurrence of hemorrhagic pericardial effusion and minimize the impact on the natural evolution of the disease.
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Affiliation(s)
- Hui Li
- Department of Gastroenterology, The 2nd Affiliated Hospital of Harbin Medical University, Harbin 150086, Heilongjiang Province, China
| | - Hui Xing
- Department of Gastroenterology, The 2nd Affiliated Hospital of Harbin Medical University, Harbin 150086, Heilongjiang Province, China
| | - Chen Hu
- Department of Gastroenterology, The 2nd Affiliated Hospital of Harbin Medical University, Harbin 150086, Heilongjiang Province, China
| | - Bai-Yang Sun
- Department of Gastroenterology, The 2nd Affiliated Hospital of Harbin Medical University, Harbin 150086, Heilongjiang Province, China
| | - Shuang Wang
- Department of Gastroenterology, The 2nd Affiliated Hospital of Harbin Medical University, Harbin 150086, Heilongjiang Province, China
| | - Wan-Ying Li
- Department of Gastroenterology, The 2nd Affiliated Hospital of Harbin Medical University, Harbin 150086, Heilongjiang Province, China
| | - Bo Qu
- Department of Gastroenterology, The 2nd Affiliated Hospital of Harbin Medical University, Harbin 150086, Heilongjiang Province, China
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Thiriveedi M, Steuber TD, Hasan M, Baggett A. Infliximab-Induced Lupus Causing Pericarditis: a Case Report and Review of the Literature. J Gen Intern Med 2021; 36:2134-2138. [PMID: 33855671 PMCID: PMC8298630 DOI: 10.1007/s11606-021-06781-x] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 10/05/2020] [Accepted: 03/30/2021] [Indexed: 10/21/2022]
Affiliation(s)
- Mrudula Thiriveedi
- UAB School of Medicine Huntsville Regional Medical Campus, Huntsville, AL, USA
| | - Taylor D Steuber
- Auburn University Harrison School of Pharmacy, Huntsville, AL, USA.
| | - Mohamed Hasan
- UAB School of Medicine Huntsville Regional Medical Campus, Huntsville, AL, USA
| | - Alan Baggett
- UAB School of Medicine Huntsville Regional Medical Campus, Huntsville, AL, USA
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5
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Patel RS, Rohit Reddy S, Llukmani A, Hashim A, Haddad DR, Patel DS, Ahmad F, Gordon DK. Cardiovascular Manifestations in Inflammatory Bowel Disease: A Systematic Review of the Pathogenesis and Management of Pericarditis. Cureus 2021; 13:e14010. [PMID: 33884251 PMCID: PMC8054944 DOI: 10.7759/cureus.14010] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/29/2022] Open
Abstract
Inflammatory bowel disease (IBD) is a chronic condition of the bowel that can be further categorized into ulcerative colitis and Crohn’s disease. Rarely, this condition can be associated with pericarditis, which can be an extraintestinal manifestation of the disease or drug-induced. This review aims to determine the pathogenesis and management of pericarditis in IBD. In this review, the goal is to elucidate the pathogenesis of pericarditis in IBD and determine if pericarditis is an extraintestinal manifestation of IBD or a complication of current drug therapy used to manage IBD. Additionally, this review intends to explain the first-line management of pericarditis in IBD and explore the role of biologicals in attenuating pericarditis. An electronic search was conducted to identify relevant reports of pericarditis in IBD, and a quality assessment was conducted to identify high-quality articles according to the inclusion criteria. Full-text articles from inception to November 2020 were included, while non-English articles, gray literature, and animal studies were excluded. The majority of studies suggest that pericarditis arises as a complication of drug therapy by 5-aminosalicylic acid derivatives such as sulfasalazine, mesalamine, and balsalazide, and it occurs due to IgE-mediated allergic reactions, direct cardiac toxicity, cell-mediated hypersensitivity reactions, and humoral antibody response to therapy. Drug cessation or the initiation of a corticosteroid regimen seems to be the most effective means of managing pericarditis in IBD due to drug therapy or an extraintestinal manifestation.
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Affiliation(s)
- Ravi S Patel
- Internal Medicine, California Institute of Behavioral Neurosciences & Psychology, Fairfield, USA
| | - Sai Rohit Reddy
- Internal Medicine, California Institute of Behavioral Neurosciences & Psychology, Fairfield, USA
| | - Adiona Llukmani
- Internal Medicine, California Institute of Behavioral Neurosciences & Psychology, Fairfield, USA
| | - Ayat Hashim
- Behavioral Neurosciences and Psychology, California Institute of Behavioral Neurosciences & Psychology, Fairfield, USA
| | - Dana R Haddad
- Plastic and Reconstructive Surgery, California Institute of Behavioral Neurosciences & Psychology, Fairfield, USA
| | - Dutt S Patel
- Internal Medicine, California Institute of Behavioral Neurosciences & Psychology, Fairfield, USA
| | - Farrukh Ahmad
- Emergency Department, California Institute of Behavioral Neurosciences & Psychology, Fairfield, USA
| | - Domonick K Gordon
- Internal Medicine, California Institute of Behavioral Neurosciences & Psychology, Fairfield, USA
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Zhang Q, Yue QY. Tumor necrosis factor inhibitor-induced pleuropericarditis: A retrospective evaluation using data from VigiBase. Int Immunopharmacol 2020; 89:107049. [PMID: 33045578 DOI: 10.1016/j.intimp.2020.107049] [Citation(s) in RCA: 3] [Impact Index Per Article: 0.6] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 07/03/2020] [Revised: 08/18/2020] [Accepted: 09/23/2020] [Indexed: 12/23/2022]
Abstract
OBJECTIVE The aim of this study was to assess the causality of anti-TNFα agents-associated pleuropericarditis in VigiBase with a focus on its diverse types. METHODS All variables contained in the pleuropericarditis reports were reviewed. Well-documented reports, vigiGrade completeness score ≥ 0.80 or with an informative narrative, were analyzed and with a focus on the clinical features of the cases. Bradford-Hill criteria were used in the case series assessment of causality. RESULTS From 1968 up to 18 December 2019, there were 94 unique cases from 18 countries reporting pleuropericarditis with anti-TNFα agents as a suspected or interacting medicine. Among the 94 reports, 42 were identified as well-documented and further assessed for clinical features. Of the 42 cases, 39 were serious, including three fatal and seven life-threatening. In 35 cases, an anti-TNFα agent was the only suspected drug. Positive de- and re-challenge were reported in 95% and 17% of the 42 cases, respectively. The times to onset (TTO) varied greatly among individual cases, ranging from one month to 75 months (mean = 24 months). The most commonly involved anti-TNFα agents were adalimumab, infliximab and etanercept; and the mostly reported pleuropericarditis types were classified as autoimmune-related with (n = 17) or without (n = 15) co-reported drug-induced lupus (DIL), or infection-related (n = 8). While adalimumab was the most reported in the infection-related cases (7/8), infliximab was the most frequent in the autoimmune-related cases, in particular co-reported with DIL (9/17). There were four cases where the reaction occurred one to two months after the anti-TNFα agents (infliximab and adalimumab) were stopped. Based on the review of the case series using Bradford-Hill criteria the anti-TNFα agents associated pleuropericarditis are considered as a class effect. CONCLUSIONS To clinically recognize and manage these potentially life-threatening serious cardiopulmonary complications, health care professionals should be aware of this possible risk. Meanwhile, attention should be paid to the clinical features of pleuropericarditis cases, since they may cause diagnostic and therapeutic difficulties. Considering the long elimination time, clinicians need to be reminded to remain vigilant for the adverse reactions even after discontinuing anti-TNFα therapy.
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Affiliation(s)
- Qingxia Zhang
- Department of Pharmacy, Xuan Wu Hospital, Capital Medical University, Beijing, PR China
| | - Qun-Ying Yue
- Uppsala Monitoring Centre, Box 1051, Uppsala 75140, Sweden.
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7
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Das BB, Dodson M, Guzman A. Recurrent pericarditis in an adolescent with Crohn's colitis. Ann Pediatr Cardiol 2020; 13:256-259. [PMID: 32863666 PMCID: PMC7437634 DOI: 10.4103/apc.apc_16_20] [Citation(s) in RCA: 2] [Impact Index Per Article: 0.4] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 01/31/2020] [Revised: 04/17/2020] [Accepted: 04/24/2020] [Indexed: 12/16/2022] Open
Abstract
Extraintestinal manifestations are common complications of inflammatory bowel disease (IBD), whereas the recurrent pericarditis during remission of Crohn's disease is rarely reported. Chest pain developed in a 13-year-old adolescent male who had a history of Crohn's colitis since 9 years of age and was in remission for 4 years after treatment with infliximab, adalimumab, and vedolizumab. Physicians should be aware of the pericardial involvement in patients with a history of IBD. The literature on pericardial involvement in Crohn's disease is reviewed with emphasis on the management of recurrent pericardial effusion in the pediatric age group.
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Affiliation(s)
- Bibhuti B Das
- Division of Pediatric Cardiology, Texas Children's Hospital, Austin Specialty Care, Austin, Texas, USA
| | - Morgan Dodson
- Division of Pediatric Cardiology, Texas Children's Hospital, Austin Specialty Care, Austin, Texas, USA
| | - Angel Guzman
- Division of Pediatric Cardiology, Texas Children's Hospital, Austin Specialty Care, Austin, Texas, USA
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8
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Qazi T, Christian KE, Farraye FA, Cross RK. Pericardial Manifestations in Inflammatory Bowel Disease: A Report of Two Cases. CROHNS & COLITIS 360 2019. [DOI: 10.1093/crocol/otz028] [Citation(s) in RCA: 5] [Impact Index Per Article: 0.8] [Reference Citation Analysis] [Abstract] [Track Full Text] [Subscribe] [Scholar Register] [Indexed: 11/14/2022]
Abstract
Abstract
Pericardial involvement in the setting of inflammatory bowel disease can occur not only as an adverse event related to medical therapy but also as an extraintestinal manifestation of the disease itself. In the following case series, we describe 2 cases of pericarditis in patients diagnosed with Crohn disease. Our first case reviews the clinical presentation of acute pericarditis as an adverse event associated with anti-tumor necrosis factor therapy. In contrast, our second patient is a case of acute pericarditis as a precursor of the clinical recurrence of Crohn disease following operative resection. Pericardial disease should be considered in the differential diagnosis of acute and subacute presentations of chest discomfort and shortness of breath in patients with inflammatory bowel disease.
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Affiliation(s)
- T Qazi
- Center for Digestive Disorders, Boston University/Boston Medical Center, Boston, MA
| | - K E Christian
- Division of Gastroenterology and Hepatology, University of Maryland School of Medicine, Baltimore, MD
| | - F A Farraye
- Inflammatory Bowel Disease Center, Division of Gastroenterology and Hepatology, Mayo Clinic, Jacksonville, FL
| | - R K Cross
- Center for Digestive Disorders, Boston University/Boston Medical Center, Boston, MA
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9
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Mitchell NE, Harrison N, Junga Z, Singla M. Heart Under Attack: Cardiac Manifestations of Inflammatory Bowel Disease. Inflamm Bowel Dis 2018; 24:2322-2326. [PMID: 29788235 DOI: 10.1093/ibd/izy157] [Citation(s) in RCA: 21] [Impact Index Per Article: 3.0] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 01/03/2018] [Indexed: 12/12/2022]
Abstract
There is a well-established association between chronic inflammation and an elevated risk of heart disease among patients with systemic autoimmune conditions. This review aims to summarize existing literature on the relationship between inflammatory bowel disease and ischemic heart disease, heart failure, arrhythmia, and pericarditis, with particular attention to approaches to management and treatment.
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Affiliation(s)
- Natalie E Mitchell
- Department of Internal Medicine, Walter Reed National Military Medical Center, Bethesda, Maryland
| | - Nicole Harrison
- Gastroenterology Service , Walter Reed National Military Medical Center, Bethesda, Maryland
| | - Zachary Junga
- Gastroenterology Service , Walter Reed National Military Medical Center, Bethesda, Maryland
| | - Manish Singla
- Gastroenterology Service, Walter Reed National Military Medical Center, Bethesda, Maryland.,Department of Internal Medicine, Walter Reed National Military Medical Center, Bethesda, Maryland
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10
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Dipasquale V, Gramaglia SMC, Catena MA, Romano C. Pericarditis during infliximab therapy in paediatric ulcerative colitis. J Clin Pharm Ther 2017. [PMID: 28646522 DOI: 10.1111/jcpt.12586] [Citation(s) in RCA: 11] [Impact Index Per Article: 1.4] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 12/18/2022]
Abstract
WHAT IS KNOWN AND STUDY OBJECTIVE Infliximab is a widely used drug for treating inflammatory bowel disease (IBD). This drug is known to rarely cause pericarditis in adult populations. CASE SUMMARY This report details the case of a 14-year-old boy with ulcerative colitis who developed pericarditis after a second infliximab infusion. After discontinuation of therapy, the patient's symptoms were resolved. WHAT IS NEW AND CONCLUSION To our knowledge, this is the first reported paediatric case of pericarditis as a possible complication of infliximab therapy in IBD. Among infliximab-related delayed adverse reactions, cardiac complications should be monitored in the paediatric population.
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Affiliation(s)
- V Dipasquale
- Unit of Pediatrics, Department of Human Pathology in Adulthood and Childhood "G. Barresi", University of Messina, Messina, Italy
| | - S M C Gramaglia
- Unit of Pediatrics, Department of Human Pathology in Adulthood and Childhood "G. Barresi", University of Messina, Messina, Italy
| | - M A Catena
- Unit of Pediatrics, Department of Human Pathology in Adulthood and Childhood "G. Barresi", University of Messina, Messina, Italy
| | - C Romano
- Unit of Pediatrics, Department of Human Pathology in Adulthood and Childhood "G. Barresi", University of Messina, Messina, Italy
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11
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Hemorrhagic Pericardial Effusion with Tamponade: A Rare Adverse Effect of Infliximab-Case Report and Literature Review. Case Rep Rheumatol 2016; 2016:2576496. [PMID: 27822400 PMCID: PMC5086384 DOI: 10.1155/2016/2576496] [Citation(s) in RCA: 7] [Impact Index Per Article: 0.8] [Reference Citation Analysis] [Abstract] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 07/14/2016] [Accepted: 09/28/2016] [Indexed: 02/07/2023] Open
Abstract
Introduction. Antitumor necrosis factor (TNF) alpha agents are commonly used biologic therapies for a wide variety of rheumatic and inflammatory diseases. Here, we present a case of hemorrhagic pericarditis as a consequence of infliximab and review the literature on pericardial complications stemming from this drug class. Methods. For the literature review, search terms using versions of antitumor necrosis factor alpha AND pericardial effusion OR pericarditis OR pleuropericarditis OR cardiac tamponade were used. Results. Pericarditis is a rare but serious complication of anti-TNF based therapy, and hemorrhagic fluid is even more rare, with only one additional case reported. It is likely that this complication was secondary to a robust immune response to very high titer anti-infliximab antibodies. Providers should be aware that this complication can occur and that abnormal elevations in procalcitonin may accompany this unusual finding.
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12
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Feuerstein JD, Cheifetz AS. Miscellaneous adverse events with biologic agents (excludes infection and malignancy). Gastroenterol Clin North Am 2014; 43:543-63. [PMID: 25110258 DOI: 10.1016/j.gtc.2014.05.002] [Citation(s) in RCA: 32] [Impact Index Per Article: 2.9] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 02/21/2023]
Abstract
Anti-tumor necrosis factor-α (anti-TNF) agents are frequently used in the treatment of inflammatory bowel disease (IBD). Currently, there are 4 anti-TNF therapies that are Food and Drug Administration-approved for moderate to severe IBD: infliximab, adalimumab, golimumab, and certolizumab pegol. For most noninfectious, nonmalignant adverse events, cessation of anti-TNF therapy typically leads to improvement or resolution of drug-induced complications. In this article, the current knowledge regarding the noninfectious and nonmalignant toxicities associated with anti-TNF agents is summarized.
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Affiliation(s)
- Joseph D Feuerstein
- Division of Gastroenterology, Department of Medicine, Center for Inflammatory Bowel Diseases, Beth Israel Deaconess Medical Center, Harvard Medical School, 330 Brookline Avenue, Rabb 425, Boston, MA 02215, USA
| | - Adam S Cheifetz
- Division of Gastroenterology, Department of Medicine, Center for Inflammatory Bowel Diseases, Beth Israel Deaconess Medical Center, Harvard Medical School, 330 Brookline Avenue, Rabb 425, Boston, MA 02215, USA.
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13
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Wang HL, Ghanem KG, Wang P, Yang S, Li TS. Listeriosis at a tertiary care hospital in beijing, china: high prevalence of nonclustered healthcare-associated cases among adult patients. Clin Infect Dis 2012; 56:666-76. [PMID: 23175565 PMCID: PMC3563391 DOI: 10.1093/cid/cis943] [Citation(s) in RCA: 27] [Impact Index Per Article: 2.1] [Reference Citation Analysis] [Abstract] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 12/20/2022] Open
Abstract
Thirty-eight cases of listeriosis over a 12-year period from inpatients at a tertiary care hospital in China were reviewed. We found a high prevalence of healthcare-associated cases that did not cluster in time and space. Background. Listeriosis is an emerging infectious disease associated with high mortality. There are few published reports from East Asia and developing countries. Our goal was to describe the clinical characteristics and outcomes of patients diagnosed with Listeria monocytogenes at a tertiary care hospital in Beijing, China. Methods. Peking Union Medical College Hospital (PUMCH), an 1800-bed hospital, consists of 2 campuses that house different medical departments. We retrospectively reviewed all culture-proven cases of listeriosis occurring at PUMCH between 1999 and 2011. Point estimates and 95% confidence intervals are presented. Results. There were 38 patients with listeriosis: 5 neonatal, 8 maternal, and 25 nonmaternal. The median age of the adult nonmaternal patients was 47 (range, 18–79) years with a female predominance (72%). Forty percent (n = 10) had an underlying rheumatic disease. Forty-four percent of cases (n = 11) were healthcare-associated infections occurring a median of 20 (range, 3–44) days after hospital admission. Only 2 of the 11 healthcare-associated cases clustered in space and time. One healthcare-associated case occurred in a patient receiving KHI-272 therapy, an oral, irreversible dual EGFR/HER2 inhibitor. The neonatal and maternal listeriosis cases were similar to those reported in the literature. Conclusions. Nonclustered healthcare-associated cases of L. monocytogenes occurred at a large tertiary care hospital in Beijing, China. The source of these infections is unclear. Although rare, in the setting of immunosuppression, Listeria should be considered in the differential diagnosis of healthcare-associated infections, even in the absence of a point-source outbreak.
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Affiliation(s)
- Huan-Ling Wang
- Department of Infectious Diseases, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences, Beijing, People's Republic of China
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Nakamura Y, Izumi C, Nakagawa Y, Hatta K. A case of effusive-constrictive pericarditis accompanying rheumatoid arthritis: The possibility of adverse effect of TNF-inhibitor therapy. J Cardiol Cases 2012; 7:e8-e10. [PMID: 30533107 DOI: 10.1016/j.jccase.2012.08.007] [Citation(s) in RCA: 7] [Impact Index Per Article: 0.5] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 05/08/2012] [Revised: 07/26/2012] [Accepted: 08/28/2012] [Indexed: 12/27/2022] Open
Abstract
A 68-year-old female, suffering from rheumatoid arthritis, was admitted to our institution for right heart failure with massive pericardial effusion. Her pericardial effusion had increased after starting infliximab, tumor necrosis factor (TNF)-inhibitor therapy, despite improvement in arthralgia. Hemodynamic findings demonstrated effusive-constrictive pericarditis. Because association between exacerbation of pericarditis and infliximab was highly suspected through her clinical course, its administration was stopped. We should pay much attention to pericardial effusion and symptoms of right heart failure after starting TNF-inhibitor therapy in patients with rheumatoid arthritis. <Learning objective: TNF-inhibitor therapy has become a treatment option for rheumatoid arthritis, however, it may cause exacerbation of extra articular manifestations such as pericarditis. We encountered a patient with rheumatoid arthritis who developed effusive-constrictive pericarditis while on TNF-inhibitor therapy. We should pay much attention to pericardial effusion and symptoms of right heart failure after starting TNF-inhibitor therapy in patients with rheumatoid arthritis.>.
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Affiliation(s)
- Yoshiaki Nakamura
- Department of Cardiology, Tenri Hospital, 200 Mishima-cho, Tenri City, Nara 632-8552, Japan
| | - Chisato Izumi
- Department of Cardiology, Tenri Hospital, 200 Mishima-cho, Tenri City, Nara 632-8552, Japan
| | - Yoshihisa Nakagawa
- Department of Cardiology, Tenri Hospital, 200 Mishima-cho, Tenri City, Nara 632-8552, Japan
| | - Kazuhiro Hatta
- Department of Cardiology, Tenri Hospital, 200 Mishima-cho, Tenri City, Nara 632-8552, Japan
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Devasahayam J, Pillai U, Lacasse A. A rare case of pericarditis, complication of infliximab treatment for Crohn's disease. J Crohns Colitis 2012; 6:730-1. [PMID: 22465046 DOI: 10.1016/j.crohns.2012.02.016] [Citation(s) in RCA: 17] [Impact Index Per Article: 1.3] [Reference Citation Analysis] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 02/23/2012] [Accepted: 02/23/2012] [Indexed: 02/06/2023]
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Taylor GK, Elliott L, Sosin MD, Soo SS. Complication of etanercept treatment for rheumatoid arthritis--purulent pericarditis caused by a commensal organism. BMJ Case Rep 2012; 2012:bcr.01.2012.5644. [PMID: 22605835 DOI: 10.1136/bcr.01.2012.5644] [Citation(s) in RCA: 6] [Impact Index Per Article: 0.5] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 12/11/2022] Open
Abstract
The patient presented with increasing fatigue and dyspnoea. The patient had medical history of rheumatoid arthritis for which she had been taking methotrexate for the past 15 years and etanercept for the past 6 years. Initial diagnosis was cardiac failure but further investigation by echocardiogram revealed a large pericardial effusion. Empirical piperacillin-tazobactam was started due to moderately raised inflammatory markers. Four hundred millilitre of frank pus was aspirated from the pericardial sac and antimicrobial treatment was changed to meropenem. Gram positive cocci were seen in the initial Gram stain, but conventional cultures remained negative. However, 16S ribosomal RNA gene sequencing of the pus sample detected the presence of Parvimonas micra genome. Reaccumulation of the effusion required further drainage where again P micra was detected by 16S ribosomal RNA gene sequencing. Two weeks of meropenem was completed followed by treatment with benzylpenicillin and metronidazole.
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Affiliation(s)
- Gemma K Taylor
- Microbiology Department, Nottingham University Hospitals NHS Trust, Nottingham, UK
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Silva LCR, Ortigosa LCM, Benard G. Anti-TNF-α agents in the treatment of immune-mediated inflammatory diseases: mechanisms of action and pitfalls. Immunotherapy 2010; 2:817-33. [DOI: 10.2217/imt.10.67] [Citation(s) in RCA: 160] [Impact Index Per Article: 10.7] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 02/07/2023] Open
Abstract
TNF-α is a potent inducer of the inflammatory response, a key regulator of innate immunity and plays an important role in the regulation of Th1 immune responses against intracellular bacteria and certain viral infections. However, dysregulated TNF can also contribute to numerous pathological situations. These include immune-mediated inflammatory diseases (IMIDs) including rheumatoid arthritis, Crohn’s disease, psoriatic arthritis, ankylosing spondylitis, ulcerative colitis and severe chronic plaque psoriasis. Animal and human studies concerning the role of TNF-α in IMIDs have led to the development of a therapy based on TNF blockage. This article focuses first on the potential mechanisms by which the three currently licensed agents, adalimumab, etarnecept and infliximab, decrease the inflammatory activity of patients with different IMIDs. Second, it focuses on the risks, precautions and complications of the use of TNF-α inhibitors in these patients.
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Affiliation(s)
- Léia CR Silva
- Laboratory of Dermatology & Immunodeficiencies, Dermatology Division, Clinics Hospital, São Paulo, Brazil
| | - Luciena CM Ortigosa
- Laboratory of Dermatology & Immunodeficiencies, Dermatology Division, Clinics Hospital, São Paulo, Brazil
| | - Gil Benard
- Laboratory of Medical Mycology, Tropical Medicine Institute, University of São Paulo Medical School, São Paulo, Brazil: R Dr Eneas de Carvalho Aguiar 470, Instituto de Medicina Tropical (IMT), Cerqueira Cesar, São Paulo, SP, 05403 903, Brazil
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Current awareness: Pharmacoepidemiology and drug safety. Pharmacoepidemiol Drug Saf 2008. [DOI: 10.1002/pds.1490] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/10/2022]
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