Gastrointestinal adverse drug reaction profile of etanercept: real world data from patients and healthcare professionals

2021 ◽  
pp. jrheum.201373
Author(s):  
Jette A. van Lint ◽  
Naomi T. Jessurun ◽  
Sander W. Tas ◽  
Bart J.F. van den Bemt ◽  
Michael T. Nurmohamed ◽  
...  

Objective We aimed to describe the nature and frequency of gastrointestinal adverse drug reactions (GI-ADRs) of etanercept (ETN) using patient-reported and healthcare professional (HCP)-registered data and compared this frequency with the GI-ADR frequency of the widely used TNFα-inhibitor adalimumab. Methods Reported GI-ADRs of ETN for rheumatic diseases were collected from the Dutch Biologic Monitor and DREAM registries. We described the clinical course of GI-ADRs and compared the frequency with adalimumab in both data sources using a Fisher’s exact test. Results Out of 416 patients using ETN for inflammatory rheumatic diseases in the Dutch Biologic Monitor, 25 patients (6%) reported 36 GI-ADRs. In the DREAM registries 11 GI-ADRs were registered for 9 patients (2.3%), out of 399 patients using ETN, with an incidence of 7.14 per 1000 patient years. Most GI-ADRs concerned diarrhoea, nausea and abdominal pain. GI-ADRs led to ETN discontinuation in one patient (4%) and dose adjustment in four (16%) in the Dutch Biologic Monitor. Eight GI-ADRs (73%) led to ETN discontinuation in the DREAM registries. The frequency of GI-ADRs of ETN did not significantly differ from GI-ADRs of adalimumab in both data sources (Dutch Biologic Monitor: ETN 8.7% vs. ADA 5.3%, p=0.07; DREAM: ETN 2.8% vs. ADA 4.7%, p=0.16). Conclusion Most GI-ADRs associated with ETN concerned gastrointestinal symptoms. These ADRs may lead to dose adjustment or ETN discontinuation. The frequency of ETN associated GI-ADRs was comparable to the frequency of adalimumab associated GI-ADRs. Knowledge about these previously unknown ADRs can facilitate early recognition and improve patient communication.

2020 ◽  
Vol 79 (Suppl 1) ◽  
pp. 1862.2-1862
Author(s):  
X. Baraliakos ◽  
I. Redeker ◽  
M. Zacharopoulou ◽  
S. Tsiami ◽  
K. Tsiaousi ◽  
...  

Background:Early diagnosis and treatment are important for the management of inflammatory rheumatic diseases (RMD). However, the availability of rheumatologists is limited in most European countries and selection strategies lack sensitivity and/or specificity.Objectives:To evaluate a triage strategy that offers the possibility to see patients within 4 weeks for short term appointments in order to check the probability of an inflammatory RMD and the necessity to further evaluate the patients in due time.Methods:Physician’s and patient’s information who called our tertiary rheumatology department´s outpatient clinic for a date in the triage system were included in this analysis. The time to first appointment as assessed by a nurse (Step 1), the short evaluation by a rheumatologist in the triage (Step 2) and the patient´s complaints and the diagnoses after an extensive diagnostic evaluation (Step 3) were documented.Results:In a period of 9 months in 2018, a total of 982 patients presented. A total of 62 patients (6.3%) were considered urgent (appointment within 3 days), while 240 (24.4%) were appointed within 4 weeks at Step 2. Of the former 46 (19.2%), and of the latter 151 patients (62.9%) were diagnosed with inflammatory RMD at Step 3.In total, 334 patients (34.0%) were diagnosed with inflammatory RMD at Step 3, including 126 with RA (37.7%), 71 with axSpA/PsA (21.3%), 95 with connective tissue disease/vasculitis (28.4%) and 20 with gout (6.0%). The diagnosis suspected in Step 2 was confirmed in Step 3 in 77.9% of cases. In 217 patients, the diagnosis suspected in Step 2 was not confirmed in Step 3. Of them, 34 (15.7%) had unclear findings at Step 2 but an inflammatory RMD was found at Step 3, while 148 (68.2%) had a suspected inflammatory RMD at Step 2 but this was not confirmed at Step 3.The most frequent musculoskeletal complaint at the time point of referral was pain in small peripheral joints (hands and/or feet) in 858 patients (87.4%), in large peripheral joints (knees, shoulders and/or hips) in 780 patients (79.4%) and back pain in 682 patients (69.5%). Fever, night sweats and unclear weight loss was reported by 50 patients (5.1%), while 210 patients (24.5%) presented with findings suspicious of inflammatory RMD such as elevated CRP of unclear origin, and 43 patients (4.8%) because of a threat of organ damage such as unclear elevation of creatinine, as reported by the referring physician. In addition, 167 patients (17.0%) had received glucocorticoids prior to referral, 87 (52.1%) of which finally did not receive the diagnosis of inflammatory RMD at Step 3, while 737 patients (75.1%) were receiving NSAIDs prior to referral.Conclusion:In this prospective evaluation of a triage system where all patients were pre-screened by a nurse and were seen within 4 weeks by a rheumatologist, clinical differentiation could be performed timely due to a successfully structured triage system. The initially suspected diagnosis was finally confirmed in ≥75% of cases, while ≥1/3 of patients had a definite inflammatory RMD.This work was supported by an unrestricted Grant from AbbvieDisclosure of Interests:Xenofon Baraliakos Grant/research support from: Grant/research support from: AbbVie, BMS, Celgene, Chugai, Merck, Novartis, Pfizer, UCB and Werfen, Consultant of: AbbVie, BMS, Celgene, Chugai, Merck, Novartis, Pfizer, UCB and Werfen, Speakers bureau: AbbVie, BMS, Celgene, Chugai, Merck, Novartis, Pfizer, UCB and Werfen, Imke Redeker: None declared, Maria Zacharopoulou: None declared, Styliani Tsiami: None declared, Konstantia Tsiaousi: None declared, Doris Morzeck: None declared, Juergen Braun Grant/research support from: Abbvie (Abbott), Amgen, BMS, Boehringer, Celgene, Celltrion, Centocor, Chugai, Eli Lilly and Company, Medac, MSD (Schering Plough), Mundipharma, Novartis, Pfizer (Wyeth), Roche, Sanofi- Aventis, and UCB Pharma, Consultant of: Abbvie (Abbott), Amgen, BMS, Boehringer, Celgene, Celltrion, Centocor, Chugai, EBEWE Pharma, Eli Lilly and Company, Medac, MSD (Schering-Plough), Mundipharma, Novartis, Pfizer (Wyeth), Roche, Sanofi-Aventis, and UCB Pharma, Speakers bureau: Abbvie (Abbott), Amgen, BMS, Boehringer, Celgene, Celltrion, Centocor, Chugai, EBEWE Pharma, Eli Lilly and Company, Medac, MSD (Schering-Plough), Mundipharma, Novartis, Pfizer (Wyeth), Roche, Sanofi-Aventis, and UCB Pharma


2021 ◽  
Author(s):  
M Syafiq Ismail ◽  
Greg Murphy ◽  
Serhiy Semenov ◽  
Deirdre McNamara

Abstract Introduction:Colon Capsule Endoscopy (CCE) has proven efficacy in a variety of gastrointestinal diseases. Few studies have assessed patient-reported outcomes and preference between colonoscopy and CCE.Aims:To identify comfort scores and patient preferences between CCE and colonoscopy.Methods:Patients from our centre who had both a CCE and colonoscopy within a 12-month period were identified. We performed over-the-phone interviews focused on satisfaction, comfort, and overall preference with a 10-point Likert scale. Electronic records were reviewed; reported Modified-Gloucester-Comfort-Scale (GCS) score, sedation, bowel preparation and endoscopist grade were documented. Data was compared between procedures. A Fishers exact test was used to compare proportions and a Student t-test was used to compare means, a p < 0.05 was considered significant.Results:In all, 40 patients were identified, 57.5% (23/40) were female and the mean age was 48 years (24 – 78). All patients were referred for investigation of lower gastrointestinal symptoms as part of an ongoing study (1).There was a significance difference in mean comfort (9.2 vs 6.7, p<0.0001, 95% CI -3.51 to -1.44) but not satisfaction (8.3 vs 7.7, p=0.2, 95% CI -1.48 to 0.33) between CCE and colonoscopy. Main cause of dissatisfaction with CCE was bowel preparation and for colonoscopy was discomfort. Age and gender were not found to be variables. The correlation between GCS and patient reported values was weak (R = -0.28).Overall, 77.5% (31/40) of patients would prefer a CCE if they required further bowel investigation. Of these, 77.4% (24/31) preferred a CCE despite the potential need for follow-up colonoscopy.Conclusions:CCE has a high satisfaction rating (8.3 vs 7.7) and has a higher patient reported comfort rating (9.2 vs 6.7) than colonoscopy. Studies have confirmed CCE and colonoscopy have equivalent diagnostic yields. The majority of patients in our cohort prefer CCE to colonoscopy. CCE should be considered as an alternative to colonoscopy in selected individuals.


2021 ◽  
Vol 22 (2) ◽  
pp. 488
Author(s):  
Young-Su Yi

Inflammation, an innate immune response that prevents cellular damage caused by pathogens, consists of two successive mechanisms, namely priming and triggering. While priming is an inflammation-preparation step, triggering is an inflammation-activation step, and the central feature of triggering is the activation of inflammasomes and intracellular inflammatory protein complexes. Flavonoids are natural phenolic compounds predominantly present in plants, fruits, and vegetables and are known to possess strong anti-inflammatory activities. The anti-inflammatory activity of flavonoids has long been demonstrated, with the main focus on the priming mechanisms, while increasing numbers of recent studies have redirected the research focus on the triggering step, and studies have reported that flavonoids inhibit inflammatory responses and diseases by targeting inflammasome activation. Rheumatic diseases are systemic inflammatory and autoimmune diseases that primarily affect joints and connective tissues, and they are associated with numerous deleterious effects. Here, we discuss the emerging literature on the ameliorative role of flavonoids targeting inflammasome activation in inflammatory rheumatic diseases.


2021 ◽  
Vol 80 (Suppl 1) ◽  
pp. 914-914
Author(s):  
A. Boteanu ◽  
A. García Fernández ◽  
N. De la Torre ◽  
M. Pavia Pascual ◽  
O. Sanchez Pernaute ◽  
...  

Background:Patients with inflammatory rheumatic diseases (IRD) infected with SARS-CoV-2 may be at risk to develop a severe course of COVID-19 due to the immune dysregulation or the influence of immunomodulating drugs on the course of the infection. For a better understanding of SARS-CoV-2 infections in patients with IRD and due to the high incidence of COVID-19 in Madrid from the beginning of this pandemic infection in Spain, the Society of Rheumatology from Madrid (SORCOM) established a registry (REUMA-COVID SORCOM) shortly after the beginning of the pandemic in Spain.Objectives:To determine factors associated with severity of infection with SARS-CoV-2 in patients with inflammatory rheumatic diseases in MadridMethods:The REUMA-COVID SORCOM registry is a multicenter, retrospective, observational cohort study conducted in Madrid, a SORCOM initiative. All rheumatology departments from Madrid were invited to participate. The study includes patients with IRD presenting with a confirmed or highly suspected diagnosis of COVID-19 between March 1, 2020, and November 10, 2020. We consider severe infection death or need of hospitalization. Inclusion criteria was having an IRD and at least 1 of the following 4 criteria: (1) a biologically confirmed COVID-19 diagnosis based on a positive result of a SARS-CoV-2 polymerase chain reaction (PCR) test on a nasopharyngeal swab; (2) Detection of IgM or IgG anti SARS-CoV2 in a symptomatic or asymptomatic patients (3)typical thoracic computed tomography (CT) abnormalities (ground-glass opacities) in epidemic areas; (4) COVID19–typical symptoms in an epidemic zone of COVID-19.Results:As of November 10, 2020, 417 patients with IRD were included in the REUMA-COVID SORCOM registry. 5 patients were discharged for incomplete data. Of 412 patients (mean age 57 years, 87.4% Caucasian race, 66.3% female) 174 need hospitalization (42.2%) and 33 patients died (18.4% mortality in hospitalized patients). 82.3% had comorbidities. 234 (56.8%) patients were classified as inflammatory arthropathy, 133 (32.3%) had connective tissue diseases (CTD). 41.1% of the patients had a large history of IRD (> 10 years). 10.4% of patients had previously pulmonary involvement. The study includes 143 patients taking Methotrexate, 89 patients taking anti-TNFα therapy and 27 Rituximab. In the univariant analysis, no differences were seen in the severity of COVID-19 infection in patients taking methotrexate. 63% of the all patients taking Rituximab included in the registry need hospitalization and 22% of them died. Hypertension, COPD or cardiovascular disease was associated with hospitalization.Independent factors associated with COVID-19 hospitalization in the multivariate analysis was: age (>62 years), male sex, IMC >30, previous cardiovascular comorbidities and the IRD disease duration (> 10 years). Independent factors associated with COVID-19 related death was: age (> 62 years), having a CTD diagnose, pulmonary involvement before infection and chronical GC treatment.Conclusion:Patients with IRD represent a population of particular interest in the pandemic context because the baseline immunological alteration and the treated with immunosuppressants agents they receive, comorbidities and the well-known risk of severe infection. Older age, male sex, cardiovascular comorbidities were factors associated with high risk of hospitalization in IRD patients. CTD diseases, previously pulmonary involvement and chronical GC treatment with more than 10mg/day were associated with high risk of death. Neither anti TNF-α treatment nor Methotrexate were risk factor for hospitalization or death COVID-19 related in IRD patients.Disclosure of Interests:None declared


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