AB0884-HPR PERSONALISED TREATMENT GOALS IN PATIENTS WITH IMMUNE MEDIATED INFLAMMATORY DISEASE

2021 ◽  
Vol 80 (Suppl 1) ◽  
pp. 1465.1-1466
Author(s):  
S. Fadaei ◽  
H. Van Os-Medendorp ◽  
A. Sloeserwij ◽  
V. Sigurdsson ◽  
J. M. Van Laar ◽  
...  
Keyword(s):  
Inflammatory Diseases ◽  
Personalised Medicine ◽  
Clinical Information ◽  
Daily Functioning ◽  
Personal Goals ◽  
Treatment Goals ◽  
Emotional Wellbeing ◽  
Record System ◽  
Immune Mediated

Background:Immune mediated inflammatory diseases (IMIDs) often have a chronic character and large impact on daily life of patients. In order to provide patient-centred care, insight in personal goals is a key issue.Objectives:The aim of this study was to evaluate treatment goals of patients with IMIDs over time.Methods:Patients with IMIDs were invited to complete a self-designed questionnaire about lifestyle, personal treatment goals and perceived care at their first visit to our centre and one year after referral. Clinical information was collected through the electronic patient record system.Results:41 (30%) patients of the 137 invited, completed both questionnaires. Participants had a mean age of 45.6 years (SD 13.4), N=35 (83%) was female, mean disease duration was 12.7 years (SD 12.7). Patients were diagnosed with connective tissue disease (CTD, n=19; 45%), antiphospholipid syndrome (APS, n=10; 24%), inflammatory arthritis (n=7; 17%) and psoriasis (n=7; 17%). We identified six categories of treatment goals: disease related, daily functioning, lifestyle, emotional wellbeing. Figure 1 shows the reported treatment goals at baseline and follow-up. Most frequently mentioned were goals related to disease, lifestyle and daily functioning. At follow-up we observed a vast increase in reported goals related to psychological wellbeing (from 5% to 16%). At baseline patients with APS chose lifestyle-related goals more often than other patients (RR=3.2; p=0.015). At follow-up patients with CTDs reported disease related-goals less often than other patients (RR=0.4; p=0.002). Patients did not report significant progress in reaching their goals on a Likert scale of 1-10. However, in 90% at first visit and in 83% of patients at follow-up, patients reported that the provided care was addressing issues they personally prioritized.Conclusion:IMID patients’ most frequent treatment goals relate to disease activity, lifestyle and daily functioning. Patients frequently change their treatment goals during the first year of treatment. Better understanding of personal goals can help physicians providing targeted and personalised medicine.Figure 1.themes of treatment goals at baseline and follow-upAcknowledgements:The researchers would like to thank all patients participating in this study and acknowledge the UMC Utrecht research program Infection and Immunity for supporting this initiative.Disclosure of Interests:None declared

scholarly journals Prevalence of Hospital PCR Confirmed COVID-19 Cases in Patients with Chronic Inflammatory and Autoimmune Rheumatic Diseases

2020 ◽  
Author(s):  
José L. Pablos ◽  
Lydia Abasolo-Alcázar ◽  
José M. Álvaro-Gracia ◽  
Francisco J. Blanco ◽  
Ricardo Blanco ◽  
...  
Keyword(s):  
Rheumatic Diseases ◽  
Lupus Erythematosus ◽  
Inflammatory Diseases ◽  
Age Distribution ◽  
Reference Population ◽  
Disease Modifying Antirheumatic Drugs ◽  
Antirheumatic Drugs ◽  
Immune Mediated ◽  
Specific Factors

ABSTRACTBackgroundThe susceptibility of patients with rheumatic diseases, and the risks or benefits of immunosuppressive therapies for COVID-19 are unknown.MethodsWe performed a retrospective study with patients under follow-up in rheumatology departments from seven hospitals in Spain. We matched updated databases of rheumatology patients with SARS-CoV-2 positive PCR tests performed in the hospital to the same reference populations. Rates of PCR+ confirmed COVID-19 were compared among groups.ResultsPatients with chronic inflammatory diseases had 1.32-fold higher prevalence of hospital PCR+ COVID-19 than the reference population (0.76% vs 0.58%). Systemic autoimmune or immune mediated diseases (AI/IMID) patients showed a significant increase, whereas inflammatory arthritis (IA) or systemic lupus erythematosus (SLE) patients did not. COVID-19 cases in some but not all diagnostic groups had older ages than cases in the reference population. IA patients on targeted-synthetic or biological disease-modifying antirheumatic drugs (ts/bDMARD), but not those on conventional-synthetic (csDMARD), had a greater prevalence despite a similar age distribution.ConclusionPatients with AI/IMID show a variable risk of hospital diagnosed COVID-19. Interplay of aging, therapies, and disease specific factors seem to contribute. These data provide a basis to improve preventive recommendations to rheumatic patients and to analyze the specific factors involved in COVID-19 susceptibility.

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 ◽  
...  
Keyword(s):  
Clinical Laboratory ◽  
Inflammatory Diseases ◽  
Progression Rate ◽  
Immune Mediated ◽  
Increased Risk ◽  
Observational Cohort ◽  
And Function ◽  
The Impact ◽  
Brazilian Cohort

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

Safety of Recombinant Zoster Vaccine: a Retrospective Study of 622 Rheumatology Patients

Rheumatology ◽  
2021 ◽  
Author(s):  
Tiphaine Lenfant ◽  
Yuxuan Jin ◽  
Elizabeth Kirchner ◽  
Rula A Hajj-Ali ◽  
Leonard H Calabrese ◽  
...  
Keyword(s):  
Inflammatory Diseases ◽  
Cox Model ◽  
Patient Portal ◽  
Single Center ◽  
Zoster Vaccine ◽  
Treatment Change ◽  
Immune Mediated ◽  
Recombinant Zoster Vaccine ◽  
Insight Into

Abstract Objectives To provide insight into the safety of Recombinant Zoster Vaccine (RZV) in patients with Immune-Mediated Inflammatory Diseases (IMID). Methods Patients who received RZV in a single center Rheumatology Department were retrospectively included. An IMID flare was defined as a) a documentation of flare in the office notes or patient portal communication or b) new prednisone prescription, in the 12 weeks after each dose. Results Six-hundred twenty-two patients were included (67% female, median age 67 years), 8.5% of them experienced AEs and HZ incidence was 0.6% after median follow-up of 36 weeks. Of 359 IMID patients: 88 had RA (25%), 50 vasculitis (14%), 29 PMR (8%). At vaccination, 35% were on glucocorticoids (GC). Fifty-nine patients (16%) experienced a flare, 18 flares occurred in temporal relation to a treatment change (31%). RA patients had the highest flare rate (n = 21, 24%), 25% of patients who flared required adjustment of immunosuppression. In a multivariate analysis, use of GC at time of vaccination was associated with flare after vaccination (OR 2.31 [1.3-4.1], p = 0.004). A time-to-flare survival analysis (Cox-model) showed that GC was a significant predictor of IMID flare after first RZV dose (HR 2.4 [1.3-4.5], p = 0.0039) and that a flare after the first dose was associated with flaring after the second RZV dose (HR 3.9 [1.7-9], p = 0.0015). Conclusion RZV administration in patients with IMIDs was generally well-tolerated, though mild flares were not uncommon in the first 12 weeks after vaccination. These data may provide useful information for patient education when considering RZV administration.

Design and implementation of a mobile app for the pharmacotherapeutic follow-up of patients diagnosed with immune-mediated inflammatory diseases: eMidCare (Preprint)

2022 ◽  
Author(s):  
Rosa Romero-Jimenez ◽  
Vicente Escudero-Vilaplana ◽  
Esther Chamorro-de-Vega ◽  
Arantza Ais-Larisgoitia ◽  
Maria Elena Lobato Matilla ◽  
...  
Keyword(s):  
Adverse Events ◽  
Healthcare Professionals ◽  
Biological Therapy ◽  
Inflammatory Diseases ◽  
Injection Site Reaction ◽  
Mobile App ◽  
Biological Therapies ◽  
Patient Profile ◽  
Immune Mediated

BACKGROUND Pharmacotherapeutic management of immune-mediated inflammatory diseases (IMID) has become more complex due to the development of new treatments, such as biological therapies. Mobile health, especially apps, can provide IMID patients with greater autonomy and facilitate communication with healthcare professionals. OBJECTIVE Our objective was to design and implement an app for remote monitoring and communication with IMID patients. We also assessed the usability of and satisfaction with the app. METHODS A multidisciplinary group comprising pharmacists, dermatologists, rheumatologists, gastroenterologists, and nurses was created to design and develop an app for IMID patients in a tertiary hospital. The app functionalities were identified through a focus group with IMID patients and through an observational, cross-sectional, descriptive study of all available apps for IMID patients at App Store and Play Store platforms. Once the app was designed and developed, we started offering the app to all IMID patients who initiated a new biological therapy. We performed an observational, longitudinal study of patients followed using the app to assess the tool's impact on safety, communication, satisfaction, and usability. The inclusion period was from December 2020 to August 2021. The inclusion criteria were age ≥ 18 years, diagnosis of an IMID, and ownership of a Smartphone. Patients with language barriers were excluded. RESULTS We designed an app (eMidCare®) with the following modules: My Medication, My Questionnaires, Adverse Events, Useful Information, Messages, and Patient Profile. A total of 86 patients were installed with the app (the median age was 48.3 [18.1-79.4] years and 62.4 were female). The median (range) follow-up time for app use was 123 (5-270) days. In the My Medication module, 100% of patients registered their biological therapy and 25.9% also used this module to record each dose of medication administered. A total of 82 adverse events (AEs) were registered. Thirty-two percent of the patients registered at least 1 AE. The most frequent AEs were fatigue, injection site reaction, headache, and nausea. Fifty-two percent of patients used the Messages module to communicate with healthcare professionals. The most frequent messages concerned doubts about managing AEs (26.2%) and drug interactions (18.9%). The satisfaction survey yielded a median (range) score of 9.1 (7-10) out of 10. The app sections that patients browsed for the longest time were Messages (21.9%), Start screen (20.9%), My questionnaires (20.4%), My medication (8.8%), and Adverse events (7.1%). CONCLUSIONS We developed an app, eMidCare®, which reminds patients to take their medication, enables them to record AEs, and helps them communicate with healthcare professionals. Approximately one-third of the patients registered the administration of the biological therapies and registered at least 1 AE. The most used and most satisfactory functionality was communication with health professionals. Patient satisfaction and retention were very high.

scholarly journals Risk of venous thromboembolism in immune-mediated inflammatory diseases: a UK matched cohort study

RMD Open ◽  
2020 ◽  
Vol 6 (3) ◽  
pp. e001392
Author(s):  
James Galloway ◽  
Kevin Barrett ◽  
Peter Irving ◽  
Kaivan Khavandi ◽  
Monica Nijher ◽  
...  
Keyword(s):  
Risk Factors ◽  
Ulcerative Colitis ◽  
Venous Thromboembolism ◽  
Proportional Hazards ◽  
Inflammatory Diseases ◽  
Clinical Information ◽  
Cox Proportional Hazards ◽  
Smoking History ◽  
Immune Mediated ◽  
Increased Risk

ObjectivesTo describe the risk of venous thromboembolism (VTE), and risk factors for VTE, in people with immune-mediated inflammatory diseases (IMID) (ulcerative colitis, Crohn’s disease (CD), rheumatoid arthritis (RA) and psoriatic arthritis (PsA)), compared with a matched control population.MethodsA total of 53 378 people with an IMID were identified over 1999–2019 in the UK Royal College of General Practitioners (RCGP) Research and Surveillance Centre (RSC) primary care database and were matched to 213 512 people without an IMID. The association between the presence of any IMID, and each IMID separately, and risk of VTE was estimated using unadjusted and multivariable-adjusted Cox proportional hazards models. The prevalence of VTE risk factors, and associations between VTE risk factors and risk of VTE, were estimated in people with and without an IMID.ResultsPeople with an IMID were at increased risk of VTE (adjusted HR [aHR] 1.46, 95% CI 1.36,1.56), compared with matched controls. When assessing individual diseases, risk was increased for CD (aHR 1.74, 95% CI 1.45 to 2.08), ulcerative colitis (aHR 1.27, 95% CI 1.10 to 1.45) and RA (aHR 1.54, 95% CI 1.40 to 1.70) but there was no evidence of an association for PsA (aHR 1.21, 95% CI 0.96 to 1.52). In people with an IMID, independent risk factors for VTE included male sex, overweight/obese body mass index, current smoking, history of fracture, and, across study follow-up, abnormal platelet count.ConclusionsVTE risk is increased in people with IMIDs. Routinely available clinical information may be helpful to identify individuals with an IMID at increased future risk of VTE.Observational study registration numberClinicaltrials.gov (NCT03835780).

scholarly journals Prevalence of hospital PCR-confirmed COVID-19 cases in patients with chronic inflammatory and autoimmune rheumatic diseases

2020 ◽  
Vol 79 (9) ◽  
pp. 1170-1173 ◽  
Author(s):  
Jose L Pablos ◽  
Lydia Abasolo ◽  
Jose M Alvaro-Gracia ◽  
Francisco J Blanco ◽  
Ricardo Blanco ◽  
...  
Keyword(s):  
Rheumatic Diseases ◽  
Lupus Erythematosus ◽  
Inflammatory Diseases ◽  
Age Distribution ◽  
Reference Population ◽  
Disease Modifying Antirheumatic Drugs ◽  
Immune Mediated ◽  
Synthetic Dmards ◽  
Specific Factors

BackgroundThe susceptibility of patients with rheumatic diseases and the risks or benefits of immunosuppressive therapies for COVID-19 are unknown.MethodsWe performed a retrospective study with patients under follow-up in rheumatology departments from seven hospitals in Spain. We matched updated databases of rheumatology patients with severe acute respiratory syndrome coronavirus 2-positive PCR tests performed in the hospital to the same reference populations. Rates of PCR+ confirmed COVID-19 were compared among groups.ResultsPatients with chronic inflammatory diseases had 1.32-fold higher prevalence of hospital PCR+ COVID-19 than the reference population (0.76% vs 0.58%). Patients with systemic autoimmune or immune-mediated disease (AI/IMID) showed a significant increase, whereas patients with inflammatory arthritis (IA) or systemic lupus erythematosus did not. COVID-19 cases in some but not all diagnostic groups had older ages than cases in the reference population. Patients with IA on targeted-synthetic or biological disease-modifying antirheumatic drugs (DMARDs), but not those on conventional-synthetic DMARDs, had a greater prevalence despite a similar age distribution.ConclusionPatients with AI/IMID show a variable risk of hospital-diagnosed COVID-19. Interplay of ageing, therapies and disease-specific factors seem to contribute. These data provide a basis to improve preventive recommendations to rheumatic patients and to analyse the specific factors involved in COVID-19 susceptibility.

scholarly journals Short-term absolute B-cell counts monitoring in systemic sclerosis patients treated with rituximab

2020 ◽  
Vol 58 (4) ◽  
pp. 395-400
Author(s):  
L. P. Ananieva ◽  
L. A. Garzanova ◽  
O. V. Desinova ◽  
O. A. Koneva ◽  
M. N. Starovoytova ◽  
...  
Keyword(s):  
B Cell ◽  
Peripheral Blood ◽  
Inflammatory Diseases ◽  
Inverse Correlation ◽  
Peripheral Circulation ◽  
Cell Counts ◽  
Immune Mediated ◽  
Group 2 ◽  
One Year

Objective. To evaluate B-cell counts in circulation of SS patients prior to initiation and one year after completion of RTM therapy.Subjects and methods. The study included 71 patients. Median follow up was 13,2±2,0 months (11-18 Mo.). Average cumulative RTM dose during the follow up period was 1,43±0,60 g, with 48 patients receiving < 2 g RTM (Group 1, mean dose 1,1±0,1 g) and 23 patients receiving ≥ 2 g RTM (Group 2, mean dose 2,2±0,6 g). CD19+ lymphocyte counts in peripheral blood were determined using flow cytometry in PSS patients and 20 healthy volunteers matched by sex and age. In SS patients B-cell counts were obtained before initiating RTM, within first month after first administration, then after 6 months and at the end of this study.Results. Baseline absolute and proportional В-lymphocyte counts in peripheral blood was almost similar in SS patients and healthy subjects. Highest counts were observed in SS patients with <3 years disease duration, showing inverse correlation between baseline absolute (R – 0,36, р=0,003) and proportional (R – 0,48, р=0,001) B cell counts and duration of the disease. Complete B-cell depletion from peripheral circulation was documented one month after RTM administration. It persisted in 79% 6 months later, although initiation of B- cell repopulation was documented in some patients. In one year after RTM initiation В-cell counts were significantly lower than at baseline. Complete or partial depletion was still there in the majority of patients with normal counts achieved only in 10% of SS patients. Inverse correlation was found between absolute B-cell count and cumulative RTM dose (R=-0,237, p=0,048).Conclusion. Higher RTM doses resulted in more pronounced В-lymphocytes depletion and more evident improvement of lung function. Current state of practice requires further research to identify most optimal regimens in the context of personalized therapy for SS and other immune-mediated inflammatory diseases. 

scholarly journals Fecal calprotectin as a predictor of gastrointestinal immune-related adverse events (CF-19): A prospective study.

F1000Research ◽  
2021 ◽  
Vol 10 ◽  
pp. 534
Author(s):  
Ana Cardeña Gutiérrez ◽  
Xabier Mielgo Rubio ◽  
Manuel Ruiz Muñoz ◽  
Ruth Martinez Cabañes ◽  
Diana Moreno Muñoz ◽  
...  
Keyword(s):  
Prospective Study ◽  
Roc Curve ◽  
Inflammatory Diseases ◽  
Fecal Calprotectin ◽  
Predictive Values ◽  
Immune Mediated ◽  
Contradictory Evidence ◽  
Sensitivity Specificity ◽  
A Prospective Study

Background: Colitis is a frequent immune-related toxicity, without any biomarker that may predict its onset. It is endoscopically similar to intestinal inflammatory diseases, where fecal calprotectin (FC) is used as a biomarker to early-detect a relapse. We found contradictory evidence about FC and immunotherapy and no prospective study was already published.   Methods: We present an analytical, observational and prospective study of one year’s duration. We analyzed FC basal, and then prior to each cycle until the sixth, ending with quarterly follow-up. For evaluating the predictive value of FC we estimated the area under the ROC curve for basal absolute values and for each cycle, and calculated its relative percentage change with respect to basal. We also planned to estimate sensitivity, specificity and predictive values indexes for different cut-off points. Because of lack of recruitment we did a preliminary analysis at the end of the initially estimated period before suggesting its prolongation.   Results: 24 patients (19 male) were included in the study. This included n=15 diagnosed with lung cancer, head and neck, renal, bladder and colorectal cancer (n=2, each), and melanoma (n=1). They were treated with Anti PD-1/PDL-1 mono therapy (n=18), combo with chemo (n=2), or combo with anti-CTLA4 (n=2). Three patients had G1 colitis and two, >=G2, all treated with anti-PD1 and before 6th cycle, as described on literature. ROC curve presents AUC 0,559 (CI95%:0,32-0,798) and RR for colitis taking FC value is 1,001 for each 10 units (p=0,493).   Conclusion: Even though we must take into account the limitations of the study we cannot conclude that FC could be used as a predictor for detecting immune-mediated colitis.

scholarly journals Machine Learning Techniques for Personalised Medicine Approaches in Immune-Mediated Chronic Inflammatory Diseases: Applications and Challenges

2021 ◽  
Vol 12 ◽  
Author(s):  
Junjie Peng ◽  
Elizabeth C. Jury ◽  
Pierre Dönnes ◽  
Coziana Ciurtin
Keyword(s):  
Machine Learning ◽  
Clinical Research ◽  
Inflammatory Diseases ◽  
Target Identification ◽  
Personalised Medicine ◽  
Drug Repurposing ◽  
Machine Learning Techniques ◽  
Chronic Inflammatory Diseases ◽  
Complex Disorders ◽  
Immune Mediated

In the past decade, the emergence of machine learning (ML) applications has led to significant advances towards implementation of personalised medicine approaches for improved health care, due to the exceptional performance of ML models when utilising complex big data. The immune-mediated chronic inflammatory diseases are a group of complex disorders associated with dysregulated immune responses resulting in inflammation affecting various organs and systems. The heterogeneous nature of these diseases poses great challenges for tailored disease management and addressing unmet patient needs. Applying novel ML techniques to the clinical study of chronic inflammatory diseases shows promising results and great potential for precision medicine applications in clinical research and practice. In this review, we highlight the clinical applications of various ML techniques for prediction, diagnosis and prognosis of autoimmune rheumatic diseases, inflammatory bowel disease, autoimmune chronic kidney disease, and multiple sclerosis, as well as ML applications for patient stratification and treatment selection. We highlight the use of ML in drug development, including target identification, validation and drug repurposing, as well as challenges related to data interpretation and validation, and ethical concerns related to the use of artificial intelligence in clinical research.

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 (Preprint)

2020 ◽  
Author(s):  
Claudia Marques ◽  
Adriana Maria Kakehasi ◽  
Ana Paula Monteiro Gomides ◽  
Eduardo Dos Santos Paiva ◽  
Edgard Torres dos Reis Neto ◽  
...  
Keyword(s):  
Clinical Laboratory ◽  
Inflammatory Diseases ◽  
Progression Rate ◽  
Immune Mediated ◽  
Increased Risk ◽  
Observational Cohort ◽  
And Function ◽  
The Impact ◽  
Brazilian Cohort

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

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