scholarly journals A Brazilian Cohort of Patients With Immuno-Mediated Chronic Inflammatory Diseases Infected by SARS-CoV-2 (ReumaCoV-Brasil Registry): Protocol for a Prospective, Observational Study

10.2196/24357 ◽  
2020 ◽  
Vol 9 (12) ◽  
pp. e24357
Author(s):  
Claudia Marques ◽  
Adriana Maria Kakehasi ◽  
Ana Paula Monteiro Gomides ◽  
Eduardo Dos Santos Paiva ◽  
Edgard Torres dos Reis Neto ◽  
...  

Background Patients with immune-mediated rheumatic diseases (IMRD) are at increased risk of infections, including significant morbidity and high mortality. Considering the potential for unfavorable outcomes of SARS-CoV-2 infection in patients with IMRD, several questions were raised regarding the impact of COVID-19 at the start of the pandemic. Objective This paper presents the protocol of a study that aims to prospectively evaluate patients with IMRD and a confirmed COVID-19 diagnosis (using criteria provided by the Brazilian Ministry of Health). Methods The study comprised a prospective, observational cohort (patients with IMRD and COVID-19) and a comparison group (patients with only IMRD), with a follow-up time of 6 months to evaluate differences in health outcomes. The primary outcomes will be changes in IMRD disease activity after SARS-CoV-2 infection at 4 time points: (1) at baseline, (2) within 4-6 weeks after infection, (3) at 3 months after the second assessment (±15 days), and (4) at 6 months (±15 days). The secondary outcomes will be the progression rate to moderate or severe forms of COVID-19, need for intensive care unit admission and mechanical ventilation, death, and therapeutic changes related to IMRD. Two outcomes—pulmonary and thromboembolic events in patients with both IMRD and SARS-CoV-2 infection—are of particular interest and will be monitored with close attention (clinical, laboratory, and function tests as well as imaging). Results Recruitment opened in May 2020, with 1300 participants recruited from 43 sites as of November 2020. Patient recruitment will conclude by the end of December 2020, with follow-up occurring until April 2021. Data analysis is scheduled to start after all inclusion data have been collected, with an aim to publish a peer-reviewed paper in December 2020. Conclusions We believe this study will provide clinically relevant data on the general impact of COVID-19 on patients with IMRD. Trial Registration Brazilian Registry of Clinical Trials RBR-33YTQC; http://www.ensaiosclinicos.gov.br/rg/RBR-33ytqc/ International Registered Report Identifier (IRRID) DERR1-10.2196/24357

Author(s):  
Claudia Marques ◽  
Adriana Maria Kakehasi ◽  
Ana Paula Monteiro Gomides ◽  
Eduardo Dos Santos Paiva ◽  
Edgard Torres dos Reis Neto ◽  
...  

BACKGROUND Patients with immune-mediated rheumatic diseases (IMRD) are at increased risk of infections, including significant morbidity and high mortality. Considering the potential for unfavorable outcomes of SARS-CoV-2 infection in patients with IMRD, several questions were raised regarding the impact of COVID-19 at the start of the pandemic. OBJECTIVE This paper presents the protocol of a study that aims to prospectively evaluate patients with IMRD and a confirmed COVID-19 diagnosis (using criteria provided by the Brazilian Ministry of Health). METHODS The study comprised a prospective, observational cohort (patients with IMRD and COVID-19) and a comparison group (patients with only IMRD), with a follow-up time of 6 months to evaluate differences in health outcomes. The primary outcomes will be changes in IMRD disease activity after SARS-CoV-2 infection at 4 time points: (1) at baseline, (2) within 4-6 weeks after infection, (3) at 3 months after the second assessment (±15 days), and (4) at 6 months (±15 days). The secondary outcomes will be the progression rate to moderate or severe forms of COVID-19, need for intensive care unit admission and mechanical ventilation, death, and therapeutic changes related to IMRD. Two outcomes—pulmonary and thromboembolic events in patients with both IMRD and SARS-CoV-2 infection—are of particular interest and will be monitored with close attention (clinical, laboratory, and function tests as well as imaging). RESULTS Recruitment opened in May 2020, with 1300 participants recruited from 43 sites as of November 2020. Patient recruitment will conclude by the end of December 2020, with follow-up occurring until April 2021. Data analysis is scheduled to start after all inclusion data have been collected, with an aim to publish a peer-reviewed paper in December 2020. CONCLUSIONS We believe this study will provide clinically relevant data on the general impact of COVID-19 on patients with IMRD. CLINICALTRIAL Brazilian Registry of Clinical Trials RBR-33YTQC; http://www.ensaiosclinicos.gov.br/rg/RBR-33ytqc/ INTERNATIONAL REGISTERED REPORT DERR1-10.2196/24357


2020 ◽  
Author(s):  
Claudia Diniz Lopes Marques ◽  
Adriana Maria Kakehasi ◽  
Ana Paula Monteiro Gomides ◽  
Danyelly Bruneska Gondim Martins ◽  
Eduardo dos Santos Paiva ◽  
...  

Abstract Patients with immune-mediated rheumatic diseases (IMRD) are at increased risk of infections, including significant morbidity and high mortality. Considering the potential for unfavorable outcomes of SARS-CoV-2 infection in patients with IMRD, a huge number of questions were released regarding the impact of COVID-19 in the beginning of the pandemic. Seeking to better understand this complex interaction, this study was developed to evaluate prospectively patients with IMRD and a suspected or confirmed COVID-19 diagnosis, according to the Ministry of Health of Brazil’s definitions. The primary outcomes will be the IMRD disease activity changes after COVID-19, at four time points: (1) At baseline and prior 6 months; (2) The first rheumatic evaluation after known infection by SARS-CoV-2 (4-6 weeks); (3) 3 months after the inclusion (±15 days); (4) 6 months after inclusion (±15 days). The secondary outcomes will be the progression rate to severe forms of COVID-19, need for intensive care unit admission and mechanical ventilation, death and therapeutic changes related to the IMRD. Two outcomes are of particular interest considering the COVID-19 in IMRD patients, namely pulmonary and the thromboembolic events, and they will be monitored with more attention and details (clinical, lab, function tests and imaging). This protocol was approved by the Brazilian Committee of Ethics in Human Research (CONEP) on April 5th, 2020 (CAAE 30186820.2.1001.8807; Number: 3.933.204) and registered on the Brazilian Registry of Clinical Trials – REBEC (RBR-33YTQC) in June, 1st 2020. We believe this study will provide many clinically relevant data on the general impact of COVID-19 on IMRD patients.


2021 ◽  
Vol 14 ◽  
pp. 175628482110048
Author(s):  
Mohamed Attauabi ◽  
Mirabella Zhao ◽  
Flemming Bendtsen ◽  
Johan Burisch

Background: Patients with Crohn’s disease (CD) are at increased risk of co-occurring immune-mediated inflammatory diseases (IMIDs). As discrepancy exists regarding the phenotypic presentation of CD among patients with such co-occurring IMIDs, we aimed to conduct a systematic review with meta-analysis characterizing the phenotype of CD among this subgroup of patients. Methods: PubMed, Embase, and Scopus were searched from their earliest records to October 2019 for studies reporting the behavior and localization of CD according to the Vienna or Montreal Classifications and CD-related surgery in patients with co-occurring IMIDs. These studies were the subject of a random effect meta-analysis. Results: After reviewing 24,413 studies, we identified a total of 23 studies comprising 1572 and 35,043 CD patients with and without co-occurring IMIDs, respectively, that fulfilled our inclusion criteria. Overall, patients with co-occurring IMIDs were more likely to have upper gastrointestinal inflammation than were patients without co-occurring IMIDs [relative risk (RR) = 1.49 (95% confidence interval (CI) 1.09–2.04), p = 0.01, I2 = 7%]. In addition, presence of primary sclerosing cholangitis (PSC) was associated with a lower occurrence of ileal affection [RR = 0.44 (95% CI 0.24–0.81), p < 0.01, I2 = 32%], increased occurrence of colonic affection [RR = 1.78 (95% CI 1.33–2.38), p < 0.01, I2 = 32%] and an increased likelihood of non-stricturing and non-penetrating behavior [RR = 1.43 (95% CI 0.97–2.11), p = 0.07, I2 = 86%]. The latter reached significance when cumulating different IMIDs [RR = 1.30 (95% CI 1.09–1.55), p < 0.01, I2 = 88%]. CD patients with PSC also underwent fewer CD-related surgeries [RR = 0.55 (95% CI 0.34–0.88), p = 0.01, I2 = 0%], irrespective of CD location or behavior. Conclusion: This study emphasizes that CD patients with co-existing PSC are likely to have a unique inflammatory distribution primarily confined to the colon, while patients with IMIDs in general have higher likelihood of affection of upper gastrointestinal tract and a non-stricturing and non-penetrating behavior. As such a phenotype of CD is typically associated with a milder disease course; future studies are needed to confirm these results.


Author(s):  
Marie Muller ◽  
Ferdinando D’Amico ◽  
Stefanos Bonovas ◽  
Silvio Danese ◽  
Laurent Peyrin-Biroulet

Abstract Background and Aims The association between tumour necrosis factor inhibitors [TNFi] and malignancy in patients with inflammatory bowel disease [IBD] is not well understood. Our aim was to systematically evaluate the impact of TNFi use on risk of malignancy in IBD patients in daily clinical practice. Methods We searched Pubmed, Embase and Scopus until March 1, 2020 for observational cohort studies on adult IBD patients reporting malignancy occurrence and TNFi use. Results Twenty-eight studies [20 retrospective and eight prospective] were included, involving 298 717 IBD patients. Mean age at inclusion ranged from 28 to &gt;65 years. Mean follow-up varied from 7 to 80 months. Infliximab was the most frequently used TNFi [13/28 studies, 46.4%], followed by adalimumab [3/28, 10.7%], while both infliximab and adalimumab were evaluated in five studies [17.8%]. In total, 692 malignancies were diagnosed in IBD patients treated with TNFi, accounting for an overall occurrence of 1.0%. The most frequent malignancies were non-melanoma skin cancers [123/692, 17.8%], digestive malignancies [120/692, 17.3%] and haematological malignancies [106/692, 15.3%]. The association between TNFi and malignancy was evaluated in 11 studies [39.3%]: no significant association was found in ten studies, while an increased risk of lymphoma in patients exposed to TNFi was reported in one study. Conclusion TNFi treatment is not associated with an increased risk of malignancy in IBD patients in real-life settings. Further large studies are needed to assess the prognosis of patients exposed to TNFi and risk of recurrence or new cancers in subjects with personal malignancy history.


Author(s):  
Mohamed Attauabi ◽  
Mirabella Zhao ◽  
Flemming Bendtsen ◽  
Johan Burisch

Abstract Background and Aims Patients with inflammatory bowel diseases (IBDs) are at risk of developing a variety of other immune-mediated inflammatory diseases (IMIDs). The influence of co-occurring IMIDs on the disease course of IBD remains unknown. The aim of this study was therefore to conduct a systematic review and meta-analysis of the impact of IMIDs on phenotypic presentation and outcome in patients with IBD. Methods PubMed and Embase were searched from their earliest records through December 2018 and updated in October 2019 for studies reporting proportions or ratios of IBD-related disease outcomes in patients with and without co-occurring IMIDs. Meta-analyses were performed to estimate summary proportions and risks of the main outcomes. PRISMA guidelines were used, and study quality was assessed according to the Newcastle-Ottawa Scale. Results A total of 93 studies were identified, comprising 16,064 IBD patients with co-occurring IMIDs and 3,451,414 IBD patients without IMIDs. Patients with IBD and co-occurring IMIDs were at increased risk of having extensive colitis or pancolitis (risk ratio, 1.38; 95% Cl, 1.25–1.52; P &lt; 0.01, I2 = 86%) and receiving IBD-related surgeries (risk ratio, 1.17; 95% Cl, 1.01–1.36; P = 0.03; I2 = 85%) compared with patients without IMIDs. Co-occurrence of IMIDs other than primary sclerosing cholangitis in patients with IBD was associated with an increased risk of receiving immunomodulators (risk ratio, 1.15; 95% Cl, 1.06–1.24; P &lt; 0.01; I2 = 60%) and biologic therapies (risk ratio, 1.19; 95% Cl, 1.08–1.32; P &lt; 0.01; I2 = 53%). Conclusion This meta-analysis found that the presence of co-occurring IMIDs influences the disease course of IBD, including an increased risk of surgery and its phenotypical expression.


2021 ◽  
Vol 80 (Suppl 1) ◽  
pp. 871.2-871
Author(s):  
F. Araujo ◽  
N. Gonçalves ◽  
A. F. Mourão

Background:The outcomes of the infection by the SARS-CoV-2 in patients with immune-mediated inflammatory diseases were largely unknown during the early days of the COVID-19 pandemic. It was hypothesized that these patients were at higher risk of morbidity and mortality due to their inherent immune dysfunction and immunosuppressive therapy. Several rheumatology societies issued recommendations urging patients not to stop their anti-rheumatic treatments.Objectives:To assess treatment compliance of patients with rheumatoid arthritis (RA) during the first wave of the SARS-CoV-2/COVID-19 pandemic in Portugal.Methods:The web-based survey COVIDRA (COVID in RA) was developed to assess the impact of the first wave mandatory confinement in patients with RA focusing on 5 domains: RA symptoms, attitudes towards medication, employment status, physical exercise and mental health. The questionnaire was sent to RA patients through e-mail and social media of the Portuguese Society of Rheumatology and two patient associations; and it was filled locally at two rheumatology centers in Lisbon. Recruitment took place during June and July 2020. Descriptive statistics were generated by the survey software and were afterwards transported and evaluated using appropriate biostatistics software.Results:We obtained 441 valid questionnaires. Most respondents were female (88.4%), caucasian (93.6%), with a mean age of 58 (+/-13) years. The majority (57.6%) had longstanding disease (>10 years) and were treated with csDMARDs (63.2%) and/or bDMARDs/tsDMARDS (23,7%). Only 14% (N=61) discontinued or reduced the dosage or frequency of their RA treatment. Most of these changes were previously planned by the attending physician (27.9%). Only 11 patients (18%) discontinued their immunosuppressive medication out of fear of becoming infected with SARS-CoV-2 (corresponding to 2.5% of total responders). Another 11 patients did so because they had no prescription, couldn’t go to the community/hospital pharmacy or couldn’t afford the medication. Although these numbers preclude any statistical analysis, when compared to patients who persisted on their treatment, those discontinuing due to fear of contagion were younger (56.4 vs 58.5 years), all female (100 vs 86.8%), with long-lasting disease (≥ 11 years) (90.9% vs 57.5%), more frequently treated with bDMARDs (36.4 vs 23.1%) and presenting more symptoms of depression (54.5 vs 49.7%).Conclusion:Most RA patients complied with their treatment during the first wave of the SARS-CoV-2 pandemic in Portugal. Only a minority changed their immunosuppressive treatment due to fear of SARS-CoV-2 infection. Very similar rates of immunosuppressive discontinuation due to fear of contagion were reported by other authors (such as Schmeiser et al, Pineda-sic et al and Fragoulis et al).Disclosure of Interests:Filipe Araujo Speakers bureau: Pfizer, Biogen, Novartis, Menarini, Consultant of: MSD, Nuno Gonçalves: None declared, Ana Filipa Mourão: None declared.


2021 ◽  
Vol 11 (1) ◽  
Author(s):  
Diana Prieto-Peña ◽  
Sara Remuzgo-Martínez ◽  
Fernanda Genre ◽  
Verónica Pulito-Cueto ◽  
Belén Atienza-Mateo ◽  
...  

AbstractCytokines signalling pathway genes are crucial factors of the genetic network underlying the pathogenesis of Immunoglobulin-A vasculitis (IgAV), an inflammatory vascular condition. An influence of the interleukin (IL)33- IL1 receptor like (IL1RL)1 signalling pathway on the increased risk of several immune-mediated diseases has been described. Accordingly, we assessed whether the IL33-IL1RL1 pathway represents a novel genetic risk factor for IgAV. Three tag polymorphisms within IL33 (rs3939286, rs7025417 and rs7044343) and three within IL1RL1 (rs2310173, rs13015714 and rs2058660), that also were previously associated with several inflammatory diseases, were genotyped in 380 Caucasian IgAV patients and 845 matched healthy controls. No genotypes or alleles differences were observed between IgAV patients and controls when IL33 and IL1RL1 variants were analysed independently. Likewise, no statistically significant differences were found in IL33 or IL1RL1 genotype and allele frequencies when IgAV patients were stratified according to the age at disease onset or to the presence/absence of gastrointestinal (GI) or renal manifestations. Similar results were disclosed when IL33 and IL1RL1 haplotypes were compared between IgAV patients and controls and between IgAV patients stratified according to the clinical characteristics mentioned above. Our results suggest that the IL33-IL1RL1 signalling pathway does not contribute to the genetic network underlying IgAV.


Open Heart ◽  
2021 ◽  
Vol 8 (1) ◽  
pp. e001425
Author(s):  
Marc Meller Søndergaard ◽  
Johannes Riis ◽  
Karoline Willum Bodker ◽  
Steen Møller Hansen ◽  
Jesper Nielsen ◽  
...  

AimLeft bundle branch block (LBBB) is associated with an increased risk of heart failure (HF). We assessed the impact of common ECG parameters on this association using large-scale data.Methods and resultsUsing ECGs recorded in a large primary care population from 2001 to 2011, we identified HF-naive patients with a first-time LBBB ECG. We obtained information on sex, age, emigration, medication, diseases and death from Danish registries. We investigated the association between the PR interval, QRS duration, and heart rate and the risk of HF over a 2-year follow-up period using Cox regression analysis.Of 2471 included patients with LBBB, 464 (18.8%) developed HF during follow-up. A significant interaction was found between QRS duration and heart rate (p<0.01), and the analyses were stratified on these parameters. Using a QRS duration <150 ms and a heart rate <70 beats per minute (bpm) as the reference, all groups were statistically significantly associated with the development of HF. Patients with a QRS duration ≥150 ms and heart rate ≥70 bpm had the highest risk of developing HF (HR 3.17 (95% CI 2.41 to 4.18, p<0.001). There was no association between the PR interval and HF after adjustment.ConclusionProlonged QRS duration and higher heart rate were associated with increased risk of HF among primary care patients with LBBB, while no association was observed with PR interval. Patients with LBBB with both a prolonged QRS duration (≥150 ms) and higher heart rate (≥70 bpm) have the highest risk of developing HF.


2014 ◽  
Vol 2014 ◽  
pp. 1-5 ◽  
Author(s):  
Michał Waszczykowski ◽  
Michał Polguj ◽  
Jarosław Fabiś

The aim of this study was to evaluate the impact of arthroscopic capsular release in patients with primary frozen shoulder on muscular strength of nonaffected and treated shoulder after at least two-year follow-up after the surgery. The assessment included twenty-seven patients, who underwent arthroscopic capsular release due to persistent limitation of range of passive and active motion, shoulder pain, and limited function of upper limb despite 6-month conservative treatment. All the patients underwent arthroscopic superior, anteroinferior, and posterior capsular release. After at least two-year follow-up, measurement of muscular strength of abductors, flexors, and external and internal rotators of the operated and nonaffected shoulder, as well as determination of range of motion (ROM) and function (ASES) in the operated and nonaffected shoulder, was performed. Measurement of muscular strength in the patient group did not reveal statistically significant differences between operated and nonaffected shoulder. The arthroscopic capsular release does not have significant impact on the decrease in the muscular strength of the operated shoulder.


2019 ◽  
Author(s):  
Charlotte Abrahamsen ◽  
Birgitte Nørgaard ◽  
Eva Draborg ◽  
Morten Frost Nielsen

Abstract Background: While orthogeriatric care to patients with hip fractures is established, the impact of similar intervention in patients with fragility fractures in general is lacking. Therefore, we aimed to assess the impact of an orthogeriatric intervention on postoperative complications and readmissions among patients admitted due to and surgically treated for fragility fractures. Methods: A prospective observational cohort study with a retrospective control was designed. A new orthogeriatric unit for acute patients of sixty-five years or older with fragility fractures in terms of hip, vertebral or appendicular fractures was opened on March 1, 2014. Patients were excluded if the fracture was cancer-related or caused by high-energy trauma, if the patient was operated on at another hospital, treated conservatively with no operation, or had been readmitted within the last month due to fracture-related complications. Results: We included 591 patients; 170 in the historical cohort and 421 in the orthogeriatric cohort. No significant differences were found between the two cohorts with regard to the proportion of participants experiencing complications (24.5% versus 28.3%, p = 0.36) or readmission within 30 days after discharge (14.1% vs 12.1%, p = 0.5). With both cohorts collapsed and adjusting for age, gender and CCI, the odds of having postoperative complications as a hip fracture patient was 4.45, compared to patients with an appendicular fracture (p < 0.001). Furthermore, patients with complications during admission were at a higher risk of readmission within 30 days than were patients without complications (22.3% vs 9.5%; p < 0.001). Conclusions: In older patients admitted with fragility fractures, our model of orthogeriatric care showed no significant differences regarding postoperative complications or readmissions compared to the traditional care. However, we found significantly higher odds of having postoperative complications among patients admitted with a hip fracture compared to other fragility fractures. Additionally, our study reveals an increased risk of being readmitted within 30 days for patients with postoperative complications.


Sign in / Sign up

Export Citation Format

Share Document