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1.
Ann Saudi Med ; 42(3): 155-164, 2022.
Article in English | MEDLINE | ID: covidwho-1879589

ABSTRACT

BACKGROUND: Anti-cytokine treatments are used in the treatment of severe COVID-19. Other studies have shown statistical significance with TNF inhibitors but not with other biological/targeted synthetic disease-modifying anti-rheumatic drugs (b/tsDMARD). OBJECTIVES: Compare the rate of severe acute respiratory syndrome coronavirus-2 (SARS-COV-2) infection and the course and incidence of COVID-19 infection in patients who received b/tsDMARD with control patients. DESIGN: Analytical cross-sectional SETTINGS: Tertiary care hospital PATIENTS AND METHODS: All patients who applied to the rheumatology outpatient clinic between June 2020-March 2021 and received b/tsDMARD were included in the study. All patients with rheumatoid arthritis, psoriatic arthritis and spondyloarthritis who applied to the rheumatology outpatient clinic in the three months before March 2021 and did not receive b/tsDMARD were included as the control group. History of COVID-19 infection and treatments were recorded. Multivariate analysis was performed to assess factors associated with use of tumor necrosis factor (TNF) inhibitors and differences between specific biologic drugs. MAIN OUTCOME MEASURES: Rate of COVID-19 disease among patients using biological/targeted synthetic therapy and non-biological/targeted synthetic therapy. COVID-19 clinical outcomes (hospitalization, intensive care admission, mechanical ventilation and death). SAMPLE SIZE: 533 in total; 341 received b/tsDMARD, 212 in the control group that did not receive b/tsDMARD. RESULTS: One hundred patients (18%) had been infected with SARS-COV-2. The difference in SARS-COV-2 infection between b/tsDMARD and the control was statistically significant (13, 2% vs. 25, 9%, respectively) (P<.001). The hospital stays were longer in the controls (P<.001). Multinomial regression analysis revealed that COVID-19 negative patients were more likely to use tumor necrosis factor (TNF) inhibitors (OR: 2, 911; 95% CI: 1.727-4.908; P<.001) compared to COVID-19 positive participants. Multinomial logistic regression analysis indicated that hospitalized patients were more likely to use TNF inhibitors (OR: 11, 006; 95% CI: 3.447-35.138; P<.001) and there was no significant difference between b/tsDMARDs other than TNF inhibitors in frequency of hospitalization. CONCLUSIONS: Patients who were medicated with b/tsDMARD were less likely to be infected with COVID-19 and be hospitalized due to the infection. We have found that this effect was particularly dependent on the use of TNF inhibitors. LIMITATIONS: Conducted in a single center and unable to provide a homogeneous study population. CONFLICT OF INTEREST: None.


Subject(s)
Arthritis, Rheumatoid , COVID-19 , Arthritis, Rheumatoid/drug therapy , COVID-19/drug therapy , Cross-Sectional Studies , Humans , SARS-CoV-2 , Tumor Necrosis Factor Inhibitors/therapeutic use , Tumor Necrosis Factors/therapeutic use
3.
J Crohns Colitis ; 14(12): 1780-1784, 2020 Dec 02.
Article in English | MEDLINE | ID: covidwho-1672170

ABSTRACT

BACKGROUNDS AND AIMS: We aimed to evaluate the safety of Bacille Calmette-Guérin [BCG] vaccination in infants born to mothers receiving anti-tumour necrosis factor [anti-TNF] therapy for inflammatory bowel disease. METHODS: Adverse events of BCG vaccination were evaluated in 90 infants who were last exposed to anti-TNF agents at a median of gestational week 30. RESULTS: After receiving BCG vaccination at a median age of 6 months [range, 0.25-11 months], three infants [3.3%] showed injection site swelling, two of whom also showed axillar lymphadenopathy. The rates of adverse events were similar between infants who were last exposed to anti-TNF agents before the third trimester [n = 35] and those who were last exposed in the third trimester [n = 55] [2.9% vs 3.6%; p = 1.00]. All adverse events were spontaneously resolved and there were no serious adverse events such as active tuberculosis infection or death. CONCLUSIONS: BCG vaccination after 6 months of age is of low risk in infants exposed to anti-TNF agents in utero.


Subject(s)
BCG Vaccine/adverse effects , COVID-19/complications , Inflammatory Bowel Diseases/diagnosis , Pneumonia/etiology , Tumor Necrosis Factor Inhibitors/adverse effects , BCG Vaccine/therapeutic use , COVID-19/drug therapy , COVID-19/epidemiology , Female , Humans , Infant , Infant, Newborn , Inflammatory Bowel Diseases/epidemiology , Male , Pneumonia/epidemiology , Tumor Necrosis Factor Inhibitors/therapeutic use
4.
Mol Biol Rep ; 49(3): 2303-2309, 2022 Mar.
Article in English | MEDLINE | ID: covidwho-1648443

ABSTRACT

Global vaccination effort and better understanding of treatment strategies provided a ray of hope for improvement in COVID-19 pandemic, however, in many countries, the disease continues to collect its death toll. The major pathogenic mechanism behind severe cases associated with high mortality is the burst of pro-inflammatory cytokines TNF, IL-6, IFNγ and others, resulting in multiple organ failure. Although the exact contribution of each cytokine is not clear, we provide an evidence that the central mediator of cytokine storm and its devastating consequences may be TNF. This cytokine is known to be involved in activated blood clotting, lung damage, insulin resistance, heart failure, and other conditions. A number of currently available pharmaceutical agents such as monoclonal antibodies and soluble TNF receptors can effectively prevent TNF from binding to its receptor(s). Other drugs are known to block NFkB, the major signal transducer molecule used in TNF signaling, or to block kinases involved in downstream activation cascades. Some of these medicines have already been selected for clinical trials, but more work is needed. A simple, rapid, and inexpensive method of directly monitoring TNF levels may be a valuable tool for a timely selection of COVID-19 patients for anti-TNF therapy.


Subject(s)
COVID-19/drug therapy , Cytokine Release Syndrome/drug therapy , Pandemics , SARS-CoV-2 , Tumor Necrosis Factor Inhibitors/therapeutic use , Biomarkers , COVID-19/complications , COVID-19/metabolism , Cytokine Release Syndrome/etiology , Cytokine Release Syndrome/prevention & control , Drug Repositioning , Humans , Interleukin-6/metabolism , Multiple Organ Failure/etiology , Multiple Organ Failure/prevention & control , NF-kappa B/antagonists & inhibitors , NF-kappa B/metabolism , Patient Selection , Protein Kinase Inhibitors/pharmacology , Protein Kinase Inhibitors/therapeutic use , Signal Transduction/drug effects , Tumor Necrosis Factor Inhibitors/pharmacology , Tumor Necrosis Factor-alpha/antagonists & inhibitors , Tumor Necrosis Factor-alpha/physiology
5.
Clin Gastroenterol Hepatol ; 20(6): e1263-e1282, 2022 06.
Article in English | MEDLINE | ID: covidwho-1634596

ABSTRACT

BACKGROUND & AIMS: Studies have shown decreased response to coronavirus disease 2019 (COVID-19) vaccinations in some populations. In addition, it is possible that vaccine-triggered immune activation could trigger immune dysregulation and thus exacerbate inflammatory bowel diseases (IBD). In this population-based study we used the epi-Israeli IBD Research Nucleus validated cohort to explore the effectiveness of COVID-19 vaccination in IBD and to assess its effect on disease outcomes. METHODS: We included all IBD patients insured in 2 of the 4 Israeli health maintenance organizations, covering 35% of the population. Patients receiving 2 Pfizer-BioNTech BNT162b2 vaccine doses between December 2020 and June 2021 were individually matched to non-IBD controls. To assess IBD outcomes, we matched vaccinated to unvaccinated IBD patients, and response was analyzed per medical treatment. RESULTS: In total, 12,109 IBD patients received 2 vaccine doses, of whom 4946 were matched to non-IBD controls (mean age, 51 ± 16 years; median follow-up, 22 weeks; interquartile range, 4-24). Fifteen patients in each group (0.3%) developed COVID-19 after vaccination (odds ratio, 1; 95% confidence interval, 0.49-2.05; P = 1.0). Patients on tumor necrosis factor (TNF) inhibitors and/or corticosteroids did not have a higher incidence of infection. To explore IBD outcomes, 707 vaccinated IBD patients were compared with unvaccinated IBD patients by stringent matching (median follow-up, 14 weeks; interquartile range, 2.3-20.4). The risk of exacerbation was 29% in the vaccinated patients compared with 26% in unvaccinated patients (P = .3). CONCLUSIONS: COVID-19 vaccine effectiveness in IBD patients is comparable with that in non-IBD controls and is not influenced by treatment with TNF inhibitors or corticosteroids. The IBD exacerbation rate did not differ between vaccinated and unvaccinated patients.


Subject(s)
COVID-19 , Inflammatory Bowel Diseases , Adult , Aged , /therapeutic use , COVID-19/prevention & control , Chronic Disease , Disease Progression , Humans , Inflammatory Bowel Diseases/complications , Inflammatory Bowel Diseases/drug therapy , Middle Aged , SARS-CoV-2 , Tumor Necrosis Factor Inhibitors/therapeutic use
6.
Am J Gastroenterol ; 117(3): 462-469, 2022 03 01.
Article in English | MEDLINE | ID: covidwho-1625333

ABSTRACT

INTRODUCTION: Although an additional coronavirus disease 2019 vaccine dose for immunocompromised persons has been recommended in some countries, further data to guide vaccination strategies for patients with inflammatory bowel disease (IBD) are urgently needed. We sought to identify factors affecting initial humoral immune response to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) vaccines among patients with IBD. METHODS: In this prospective cohort of SARS-CoV-2 immunized patients with IBD, we evaluated associations between participant age, sex, vaccine type, medication use, and the presence of a detectable antireceptor binding domain antibody and quantitative antibody level. RESULTS: In total, 1,909 participants were included (1,123, 692, and 94 received BNT162b2, mRNA-1273, and Ad26.COV2.S, respectively) of whom 96% achieved a positive antibody response. On multivariable analysis, factors associated with lack of antibody response were older age (P = 0.043), BNT162b2 vs mRNA-1273 (odds ratio [OR] 2.1, 95% confidence interval [CI] 1.0-3.9), and combination therapy with anti-TNF and 6MP, azathioprine, or methotrexate (OR 4.2, 95% CI 2.4-7.3). The use of 5-aminosalicylate or sulfasalazine (OR 0.3, 95% CI 0.1-0.8) and ustekinumab (OR 0.2, 95% CI 0.05-0.8) was associated with decreased odds of lacking antibody response. DISCUSSION: Most patients with IBD mount an initial response to SARS-CoV-2 vaccination; however, older patients and those treated with anti-TNF and immunomodulator have blunted responses and may benefit the most from an additional vaccine dose. Patients treated with other classes of immunosuppressive medications have more robust initial immune responses to vaccination. These data should inform key decisions about patient selection for additional coronavirus disease 2019 vaccine doses in patients with IBD.


Subject(s)
COVID-19/prevention & control , Immunity, Humoral/physiology , Inflammatory Bowel Diseases/immunology , Adult , Age Factors , Cohort Studies , Female , Humans , Immunologic Factors/therapeutic use , Inflammatory Bowel Diseases/drug therapy , Male , Middle Aged , Odds Ratio , Risk Factors , Sex Factors , Tumor Necrosis Factor Inhibitors/therapeutic use
9.
Aging (Albany NY) ; 13(21): 23895-23912, 2021 11 01.
Article in English | MEDLINE | ID: covidwho-1498164

ABSTRACT

The coronavirus disease 2019 (COVID-19) is presently the most pressing public health concern worldwide. Cytokine storm is an important factor leading to death of patients with COVID-19. This study aims to characterize serum cytokines of patients with severe or critical COVID-19. Clinical records were obtained from 149 patients who were tested at the Sino-French New City Branch of Tongji Hospital from 30 January to 30 March 2020. Data regarding the clinical features of the patients was collected and analyzed. Among the 149, 45 (30.2%) of them had severe conditions and 104 (69.8%) of that presented critical symptoms. In the meantime, 80 (53.7%) of that 149 died during hospitalization. Of all, male patients accounted for 94 (69.1%). Compared with patients in severe COVID-19, those who in critical COVID-19 had significantly higher levels of tumor necrosis factor-α (TNF-α), interleukin-6 (IL-6), IL-8, and IL-10. Moreover, the passed-away patients had considerably higher levels of TNF-α, IL-6, IL-8, and IL-10 than those survived from it. Regression analysis revealed that serum TNF-α level was an independent risk factor for the death of patient with severe conditions. Among the proinflammatory cytokines (IL-1ß, TNF-α, IL-8, and IL-6) analyzed herein, TNF-α was seen as a risk factor for the death of patients with severe or critical COVID-19. This study suggests that anti-TNF-α treatment allows patients with severe or critical COVID-19 pneumonia to recover.


Subject(s)
COVID-19 , Critical Illness , Interleukins/blood , Pneumonia, Viral , Tumor Necrosis Factor-alpha/blood , COVID-19/diagnosis , COVID-19/immunology , COVID-19/mortality , COVID-19/therapy , China/epidemiology , Critical Illness/mortality , Critical Illness/therapy , Female , Hospital Mortality , Humans , Immunologic Tests/methods , Male , Middle Aged , Mortality , Pneumonia, Viral/diagnostic imaging , Pneumonia, Viral/etiology , Predictive Value of Tests , Risk Factors , SARS-CoV-2 , Severity of Illness Index , Tomography, X-Ray Computed/methods , Tumor Necrosis Factor Inhibitors/therapeutic use
10.
JAMA Netw Open ; 4(10): e2129639, 2021 10 01.
Article in English | MEDLINE | ID: covidwho-1473778

ABSTRACT

Importance: Although tumor necrosis factor (TNF) inhibitors are widely prescribed globally because of their ability to ameliorate shared immune pathways across immune-mediated inflammatory diseases (IMIDs), the impact of COVID-19 among individuals with IMIDs who are receiving TNF inhibitors remains insufficiently understood. Objective: To examine the association between the receipt of TNF inhibitor monotherapy and the risk of COVID-19-associated hospitalization or death compared with other commonly prescribed immunomodulatory treatment regimens among adult patients with IMIDs. Design, Setting, and Participants: This cohort study was a pooled analysis of data from 3 international COVID-19 registries comprising individuals with rheumatic diseases, inflammatory bowel disease, and psoriasis from March 12, 2020, to February 1, 2021. Clinicians directly reported COVID-19 outcomes as well as demographic and clinical characteristics of individuals with IMIDs and confirmed or suspected COVID-19 using online data entry portals. Adults (age ≥18 years) with a diagnosis of inflammatory arthritis, inflammatory bowel disease, or psoriasis were included. Exposures: Treatment exposure categories included TNF inhibitor monotherapy (reference treatment), TNF inhibitors in combination with methotrexate therapy, TNF inhibitors in combination with azathioprine/6-mercaptopurine therapy, methotrexate monotherapy, azathioprine/6-mercaptopurine monotherapy, and Janus kinase (Jak) inhibitor monotherapy. Main Outcomes and Measures: The main outcome was COVID-19-associated hospitalization or death. Registry-level analyses and a pooled analysis of data across the 3 registries were conducted using multilevel multivariable logistic regression models, adjusting for demographic and clinical characteristics and accounting for country, calendar month, and registry-level correlations. Results: A total of 6077 patients from 74 countries were included in the analyses; of those, 3215 individuals (52.9%) were from Europe, 3563 individuals (58.6%) were female, and the mean (SD) age was 48.8 (16.5) years. The most common IMID diagnoses were rheumatoid arthritis (2146 patients [35.3%]) and Crohn disease (1537 patients [25.3%]). A total of 1297 patients (21.3%) were hospitalized, and 189 patients (3.1%) died. In the pooled analysis, compared with patients who received TNF inhibitor monotherapy, higher odds of hospitalization or death were observed among those who received a TNF inhibitor in combination with azathioprine/6-mercaptopurine therapy (odds ratio [OR], 1.74; 95% CI, 1.17-2.58; P = .006), azathioprine/6-mercaptopurine monotherapy (OR, 1.84; 95% CI, 1.30-2.61; P = .001), methotrexate monotherapy (OR, 2.00; 95% CI, 1.57-2.56; P < .001), and Jak inhibitor monotherapy (OR, 1.82; 95% CI, 1.21-2.73; P = .004) but not among those who received a TNF inhibitor in combination with methotrexate therapy (OR, 1.18; 95% CI, 0.85-1.63; P = .33). Similar findings were obtained in analyses that accounted for potential reporting bias and sensitivity analyses that excluded patients with a COVID-19 diagnosis based on symptoms alone. Conclusions and Relevance: In this cohort study, TNF inhibitor monotherapy was associated with a lower risk of adverse COVID-19 outcomes compared with other commonly prescribed immunomodulatory treatment regimens among individuals with IMIDs.


Subject(s)
Arthritis, Rheumatoid/drug therapy , COVID-19/mortality , Inflammatory Bowel Diseases/drug therapy , Psoriasis/drug therapy , Tumor Necrosis Factor Inhibitors/therapeutic use , Adult , Arthritis, Rheumatoid/epidemiology , Comorbidity , Drug Therapy, Combination/adverse effects , Female , Hospitalization/statistics & numerical data , Humans , Inflammatory Bowel Diseases/epidemiology , Male , Middle Aged , Pandemics , Psoriasis/epidemiology , Registries , Retrospective Studies , SARS-CoV-2
11.
RMD Open ; 7(3)2021 10.
Article in English | MEDLINE | ID: covidwho-1476787

ABSTRACT

INTRODUCTION: Several risk factors for severe COVID-19 specific for patients with inflammatory rheumatic and musculoskeletal diseases (RMDs) have been identified so far. Evidence regarding the influence of different RMD treatments on outcomes of SARS-CoV-2 infection is still poor. METHODS: Data from the German COVID-19-RMD registry collected between 30 March 2020 and 9 April 2021 were analysed. Ordinal outcome of COVID-19 severity was defined: (1) not hospitalised, (2) hospitalised/not invasively ventilated and (3) invasively ventilated/deceased. Independent associations between demographic and disease features and outcome of COVID-19 were estimated by multivariable ordinal logistic regression using proportional odds model. RESULTS: 2274 patients were included. 83 (3.6%) patients died. Age, male sex, cardiovascular disease, hypertension, chronic lung diseases and chronic kidney disease were independently associated with worse outcome of SARS-CoV-2 infection. Compared with rheumatoid arthritis, patients with psoriatic arthritis showed a better outcome. Disease activity and glucocorticoids were associated with worse outcome. Compared with methotrexate (MTX), TNF inhibitors (TNFi) showed a significant association with better outcome of SARS-CoV-2 infection (OR 0.6, 95% CI0.4 to 0.9). Immunosuppressants (mycophenolate mofetil, azathioprine, cyclophosphamide and ciclosporin) (OR 2.2, 95% CI 1.3 to 3.9), Janus kinase inhibitor (JAKi) (OR 1.8, 95% CI 1.1 to 2.7) and rituximab (OR 5.4, 95% CI 3.3 to 8.8) were independently associated with worse outcome. CONCLUSION: General risk factors for severity of COVID-19 play a similar role in patients with RMDs as in the normal population. Influence of disease activity on COVID-19 outcome is of great importance as patients with high disease activity-even without glucocorticoids-have a worse outcome. Patients on TNFi show a better outcome of SARS-CoV-2 infection than patients on MTX. Immunosuppressants, rituximab and JAKi are associated with more severe course.


Subject(s)
COVID-19 , Janus Kinase Inhibitors , Rituximab , Tumor Necrosis Factor Inhibitors , COVID-19/drug therapy , Humans , Janus Kinase Inhibitors/therapeutic use , Rituximab/therapeutic use , Tumor Necrosis Factor Inhibitors/therapeutic use
12.
J Crohns Colitis ; 16(3): 389-397, 2022 Mar 14.
Article in English | MEDLINE | ID: covidwho-1393233

ABSTRACT

BACKGROUND AND AIMS: Infliximab attenuates serological responses to SARS-CoV-2 infection. Whether this is a class effect, or if anti-tumour necrosis factor [anti-TNF] level influences serological responses, remains unknown. METHODS: Seroprevalence and the magnitude of SARS-CoV-2 nucleocapsid antibody responses were measured in surplus serum from 11 422 (53.3% [6084] male; median age 36.8 years) patients with immune-mediated inflammatory diseases, stored at six therapeutic drug monitoring laboratories between January 29 and September 30, 2020. Data were linked to nationally held SARS-CoV-2 PCR results to July 11, 2021. RESULTS: Rates of PCR-confirmed SARS-CoV-2 infection were similar across treatment groups. Seroprevalence rates were lower in infliximab- and adalimumab- than vedolizumab-treated patients (infliximab: 3.0% [178/5893], adalimumab: 3.0% [152/5074], vedolizumab: 6.7% [25/375], p = 0.003). The magnitude of SARS-CoV-2 reactivity was similar in infliximab- vs adalimumab-treated patients (median 4.30 cut-off index [COI] [1.94-9.96] vs 5.02 [2.18-18.70], p = 0.164), but higher in vedolizumab-treated patients (median 21.60 COI [4.39-68.10, p < 0.004). Compared to patients with detectable infliximab and adalimumab drug levels, patients with undetectable drug levels [<0.8 mg/L] were more likely to be seropositive for SARS-CoV-2 antibodies. One-third of patients who had PCR testing prior to antibody testing failed to seroconvert, all were treated with anti-TNF. Subsequent positive PCR-confirmed SARS-CoV-2 was seen in 7.9% [12/152] of patients after a median time of 183.5 days [129.8-235.3], without differences between drugs. CONCLUSION: Anti-TNF treatment is associated with lower SARS-CoV-2 nucleocapsid seroprevalence and antibody reactivity when compared to vedolizumab-treated patients. Higher seropositivity rates in patients with undetectable anti-TNF levels support a causal relationship, although confounding factors, such as combination therapy with a immunomodulator, may have influenced the results.


Subject(s)
Biological Products , COVID-19 , Inflammatory Bowel Diseases , Adalimumab , Adult , Antibody Formation , Biological Products/therapeutic use , Drug Monitoring , Humans , Inflammatory Bowel Diseases/drug therapy , Infliximab , Male , SARS-CoV-2 , Seroepidemiologic Studies , Tumor Necrosis Factor Inhibitors/therapeutic use
16.
Front Immunol ; 12: 677957, 2021.
Article in English | MEDLINE | ID: covidwho-1337637

ABSTRACT

Patients with inflammatory bowel disease, psoriasis or other rheumatic diseases treated with corticosteroids, immunomodulators and biologics might face additional risk during COVID-19 epidemic due to their immunocompromised status. However, there was still no unanimous opinion on the use of these therapy during COVID-19 epidemic. Current studies suggested that systemic corticosteroids might increase the risk of hospitalization, as well as risks of ventilation, ICU, and death among patients with immune-mediated inflammatory diseases. Anti-TNF agent was associated with lower rate of hospitalization, as well as lower risks of ventilation, ICU, and death. No significant changes in rates of hospitalization, ventilation, ICU and mortality were observed in patients treated with immunomodulators or biologics apart from anti-TNF agents. The underlying mechanism of these results might be related to pathway of antiviral immune response and cytokine storm induced by SARS-COV-2 infection. Decision on the use of corticosteroids, immunomodulators and biologics should be made after weighing the benefits and potential risks based on individual patients.


Subject(s)
Adrenal Cortex Hormones/therapeutic use , Biological Products/therapeutic use , COVID-19/drug therapy , Cytokine Release Syndrome/drug therapy , Immunosuppressive Agents/therapeutic use , Inflammatory Bowel Diseases/drug therapy , Psoriasis/drug therapy , Rheumatic Diseases/drug therapy , SARS-CoV-2/physiology , Tumor Necrosis Factor Inhibitors/therapeutic use , COVID-19/mortality , Cytokine Release Syndrome/mortality , Hospitalization , Humans , Immunity , Inflammatory Bowel Diseases/mortality , Psoriasis/mortality , Rheumatic Diseases/mortality , Risk , Survival Analysis
17.
J Rheumatol ; 48(7): 1098-1102, 2021 07.
Article in English | MEDLINE | ID: covidwho-1211934

ABSTRACT

OBJECTIVE: To describe the cohort of patients with inflammatory rheumatic diseases (IRD) hospitalized due to SARS-CoV-2 infection in the Ramón y Cajal Hospital, and to determine the increased risk of severe coronavirus disease 2019 (COVID-19) in patients with no IRD. METHODS: This is a retrospective single-center observational study of patients with IRD actively monitored in the Department of Rheumatology who were hospitalized due to COVID-19. RESULTS: Forty-one (1.8%) out of 2315 patients admitted due to severe SARS-CoV-2 pneumonia suffered from an IRD. The admission OR for patients with IRD was 1.91 against the general population, and it was considerably higher in patients with Sjögren syndrome, vasculitis, and systemic lupus erythematosus. Twenty-seven patients were receiving treatment for IRD with corticosteroids, 23 with conventional DMARDs, 12 with biologics (7 rituximab [RTX], 4 anti-tumor necrosis factor [anti-TNF], and 1 abatacept), and 1 with Janus kinase inhibitors. Ten deaths were registered among patients with IRD. A higher hospitalization rate and a higher number of deaths were observed in patients treated with RTX (OR 12.9) but not in patients treated with anti-TNF (OR 0.9). CONCLUSION: Patients with IRD, especially autoimmune diseases and patients treated with RTX, may be at higher risk of severe pneumonia due to SARS-CoV-2 compared to the general population. More studies are needed to analyze this association further in order to help manage these patients during the pandemic.


Subject(s)
COVID-19 , Rheumatic Diseases , COVID-19/diagnosis , Humans , Retrospective Studies , Rheumatic Diseases/complications , Rheumatic Diseases/drug therapy , Risk Factors , Tumor Necrosis Factor Inhibitors/therapeutic use
18.
Diabetes ; 70(5): 1021-1028, 2021 05.
Article in English | MEDLINE | ID: covidwho-1105971

ABSTRACT

Research-based immunotherapy trials seeking to prevent or reverse a number of autoimmune diseases, including type 1 diabetes, have seen near universal suspension due to the coronavirus disease 2019 (COVID-19) pandemic, caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Diabetes and hyperglycemia are now appreciated as significant risk factors for COVID-19 morbidity and mortality; however, the vast majority of studies have reported on adults. Recent data in children and adolescents with type 1 diabetes suggest no increased risk of COVID-19. Even with immense appreciation for COVID-19 morbidity and mortality, we believe compelling arguments exist to carefully and thoughtfully resume certain type 1 diabetes phase 2-3 immunotherapy trials. In this Perspective, we consider the experience of trials that never halted or have resumed in the oncology and rheumatology fields, and advocate for staged type 1 diabetes immunotherapy trial resumption. With this, we present recommendations to achieve equipoise and mitigate risks for SARS-CoV-2 infection in the weeks surrounding infusion. Given the fact that the COVID-19 pandemic is expected to persist for some time, it is in the best interest of our patients that we find ways to safely move our field forward.


Subject(s)
COVID-19/prevention & control , Diabetes Mellitus, Type 1/drug therapy , Immunosuppressive Agents/therapeutic use , Antibodies, Monoclonal/therapeutic use , Antibodies, Monoclonal, Humanized/therapeutic use , COVID-19/epidemiology , COVID-19/mortality , Clinical Trials, Phase II as Topic , Clinical Trials, Phase III as Topic , Disease Progression , Humans , Immunotherapy , Inflammatory Bowel Diseases/drug therapy , Leukemia/drug therapy , Risk Assessment , SARS-CoV-2 , Tumor Necrosis Factor Inhibitors/therapeutic use
19.
Arthritis Rheumatol ; 72(8): 1241-1251, 2020 08.
Article in English | MEDLINE | ID: covidwho-602110

ABSTRACT

OBJECTIVE: To provide guidance to rheumatology providers on the management of adult rheumatic disease in the context of the coronavirus disease 2019 (COVID-19) pandemic. METHODS: A task force, including 10 rheumatologists and 4 infectious disease specialists from North America, was convened. Clinical questions were collated, and an evidence report was rapidly generated and disseminated. Questions and drafted statements were reviewed and assessed using a modified Delphi process. This included 2 rounds of asynchronous anonymous voting by e-mail and 3 webinars with the entire panel. Task force members voted on agreement with draft statements using a 1-9-point numerical scoring system, and consensus was determined to be low, moderate, or high based on the dispersion of votes. For approval, median votes were required to meet predefined levels of agreement (median values of 7-9, 4-6, and 1-3 defined as agreement, uncertainty, or disagreement, respectively) with either moderate or high levels of consensus. RESULTS: The task force approved 77 initial guidance statements: 36 with moderate and 41 with high consensus. These were combined, resulting in 25 final guidance statements. CONCLUSION: These guidance statements are provided to promote optimal care during the current pandemic. However, given the low level of available evidence and the rapidly evolving literature, this guidance is presented as a "living document," and future updates are anticipated.


Subject(s)
Antirheumatic Agents/therapeutic use , Coronavirus Infections/epidemiology , Glucocorticoids/therapeutic use , Immunosuppressive Agents/therapeutic use , Pneumonia, Viral/epidemiology , Rheumatic Diseases/drug therapy , Adult , Advisory Committees , Angiotensin Receptor Antagonists/therapeutic use , Angiotensin-Converting Enzyme Inhibitors/therapeutic use , Anti-Inflammatory Agents, Non-Steroidal/therapeutic use , Betacoronavirus , COVID-19 , Coronavirus Infections/complications , Coronavirus Infections/prevention & control , Delivery of Health Care , Delphi Technique , Deprescriptions , Humans , Hydroxychloroquine/therapeutic use , Infection Control , Janus Kinase Inhibitors/therapeutic use , Pandemics/prevention & control , Pneumonia, Viral/complications , Pneumonia, Viral/prevention & control , Rheumatic Diseases/complications , Rheumatology , SARS-CoV-2 , Tumor Necrosis Factor Inhibitors/therapeutic use
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