OP0286 CHARACTERISTICS ASSOCIATED WITH SEVERE COVID-19 OUTCOMES IN SYSTEMIC LUPUS ERYTHEMATOSUS (SLE): RESULTS FROM THE COVID-19 GLOBAL RHEUMATOLOGY ALLIANCE (COVID-19 GRA)
Manuel F. Ugarte‐GilG S AlarcónAndrea M. SeetZara IzadiC. Reategui SokolovaAnn E. ClarkeLeanna WiseGuillermo J. Pons‐EstelMaría José SantosSasha BernatskyL MathíasN. LimJeffrey A. SparksZachary S. WallaceKimme L HyrichAnja StrangfeldLaure GossecLoreto CarmonaElsa F MateusSaskia Lawson‐ToveyLaura TrupinStephanie RushGabriela SchmajukPatricia KatzLindsay JacobsohnSamar Al EmadiEmily GilbertAlí Duarte‐GarcíaMaria O. Valenzuela‐AlmadaTiffany HsuKristin M. D’SilvaNaomi Serling‐BoydPhilippe DieudéElena NikiphorouVanessa L. KronzerNamrata SinghBryan C. WallaceA.A. AkpabioRanjeny ThomasSuleman BhanaW. CostelloRebecca GraingerJonathan S. HausmannJean W. LiewEmily SirotichPaul SufkaPaul RobinsonPedro MachadoMilena GianfrancescoJinoos Yazdany
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Background: An increased risk of severe COVID-19 outcomes may be seen in patients with autoimmune diseases on moderate to high daily doses of glucocorticoids, as well as in those with comorbidities. However, specific information about COVID-19 outcomes in SLE is scarce. Objectives: To determine the characteristics associated with severe COVID-19 outcomes in a multi-national cross-sectional registry of COVID-19 patients with SLE. Methods: SLE adult patients from a physician-reported registry of the COVID-19 GRA were studied. Variables collected at COVID-19 diagnosis included age, sex, race/ethnicity, region, comorbidities, disease activity, time period of COVID-19 diagnosis, glucocorticoid (GC) dose, and immunomodulatory therapy. Immunomodulatory therapy was categorized as: antimalarials only, no SLE therapy, traditional immunosuppressive (IS) drug monotherapy, biologics/targeted synthetic IS drug monotherapy, and biologic and traditional IS drug combination therapy. We used an ordinal COVID-19 severity outcome defined as: not hospitalized/hospitalized without supplementary oxygen; hospitalized with non-invasive ventilation; hospitalized with mechanical ventilation/extracorporeal membrane oxygenation; and death. An ordinal logistic regression model was constructed to assess the association between demographic characteristics, comorbidities, medications, disease activity and COVID-19 severity. This assumed that the relationship between each pair of outcome groups is of the same direction and magnitude. Results: Of 1069 SLE patients included, 1047 (89.6%) were female, with a mean age of 44.5 (SD: 14.1) years. Patient outcomes included 815 (78.8%) not hospitalized/hospitalized without supplementary oxygen; 116 (11.2) hospitalized with non-invasive ventilation, 25 (2.4%) hospitalized with mechanical ventilation/extracorporeal membrane oxygenation and 78 (7.5%) died. In a multivariate model (n=804), increased age [OR=1.03 (1.01, 1.04)], male sex [OR =1.93 (1.21, 3.08)], COVID-19 diagnosis between June 2020 and January 2021 (OR =1.87 (1.17, 3.00)), no IS drug use [OR =2.29 (1.34, 3.91)], chronic renal disease [OR =2.34 (1.48, 3.70)], cardiovascular disease [OR =1.93 (1.34, 3.91)] and moderate/high disease activity [OR =2.24 (1.46, 3.43)] were associated with more severe COVID-19 outcomes. Compared with no use of GC, patients using GC had a higher odds of poor outcome: 0-5 mg/d, OR =1.98 (1.33, 2.96); 5-10 mg/d, OR =2.88 (1.27, 6.56); >10 mg/d, OR =2.01 (1.26, 3.21) (Table 1). Table 1. Characteristics associated with more severe COVID-19 outcomes in SLE. (N=804) OR (95% CI ) Age, years 1.03 (1.01, 1.04) Sex, Male 1.93 (1.21, 3.08) Race/Ethnicity, Non-White vs White 1.47 (0.87, 2.50) Region Europe Ref. North America 0.67 (0.29, 1.54) South America 0.67 (0.29, 1.54) Other 1.93 (0.85, 4.39) Season, June 16th 2020-January 8th 2021 vs January-June 15th 2020 1.87 (1.17, 3.00) Glucocorticoids 0 mg/day Ref. 0-5 mg/day 1.98 (1.33, 2.96) 5-10 mg/day 2.88 (1.27, 6.56) =>10 mg/day 2.01 (1.26, 3.21) Medication Category Antimalarial only Ref. No IS drugs 2.29 (1.34, 3.91) Traditional IS drugs as monotherapy 1.17 (0.77, 1.77) b/ts IS drugs as monotherapy 1.00 (0.37, 2.71) Combination of traditional and b/ts IS 1.00 (0.55, 1.82) Comorbidity Burden Number of Comorbidities (excluding renal and cardiovascular disease) 1.39 (0.97, 1.99) Chronic renal disease 2.34 (1.48, 3.70) Cardiovascular disease 1.93 (1.34, 3.91) Disease Activity, Moderate/ high vs Remission/ low 2.24 (1.46, 3.43) IS: immunosuppressive. b/ts: biologics/targeted synthetics Conclusion: Increased age, male sex, glucocorticoid use, chronic renal disease, cardiovascular disease and moderate/high disease activity at time of COVID-19 diagnosis were associated with more severe COVID-19 outcomes in SLE. Potential limitations include possible selection bias (physician reporting), the cross-sectional nature of the data, and the assumptions underlying the outcomes modelling. Acknowledgements: The views expressed here are those of the authors and participating members of the COVID-19 Global Rheumatology Alliance and do not necessarily represent the views of the ACR, EULAR) the UK National Health Service, the National Institute for Health Research (NIHR), or the UK Department of Health, or any other organization. Disclosure of Interests: Manuel F. Ugarte-Gil Grant/research support from: Pfizer, Janssen, Graciela S Alarcon: None declared, Andrea Seet: None declared, Zara Izadi: None declared, Cristina Reategui Sokolova: None declared, Ann E Clarke Consultant of: AstraZeneca, BristolMyersSquibb, GlaxoSmithKline, Exagen Diagnostics, Leanna Wise: None declared, Guillermo Pons-Estel: None declared, Maria Jose Santos: None declared, Sasha Bernatsky: None declared, Lauren Mathias: None declared, Nathan Lim: None declared, Jeffrey Sparks Consultant of: Bristol-Myers Squibb, Gilead, Inova, Janssen, and Optum unrelated to this work., Grant/research support from: Amgen and Bristol-Myers Squibb, Zachary Wallace Consultant of: Viela Bio and MedPace, Grant/research support from: Bristol-Myers Squibb and Principia/Sanofi, Kimme Hyrich Speakers bureau: Abbvie, Grant/research support from: MS, UCB, and Pfizer, Anja Strangfeld Speakers bureau: AbbVie, MSD, Roche, BMS, Pfizer, Grant/research support from: AbbVie, BMS, Celltrion, Fresenius Kabi, Lilly, Mylan, Hexal, MSD, Pfizer, Roche, Samsung, Sanofi-Aventis, and UCB, Laure Gossec Consultant of: Abbvie, Biogen, Celgene, Janssen, Lilly, Novartis, Pfizer, Sanofi-Aventis, UCB, Grant/research support from: Lilly, Mylan, Pfizer, Loreto Carmona: None declared, Elsa Mateus Grant/research support from: Pfizer, Abbvie, Novartis, Janssen-Cilag, Lilly Portugal, Sanofi, Grünenthal S.A., MSD, Celgene, Medac, Pharmakern, GAfPA, Saskia Lawson-Tovey: None declared, Laura Trupin: None declared, Stephanie Rush: None declared, Gabriela Schmajuk: None declared, Patti Katz: None declared, Lindsay Jacobsohn: None declared, Samar Al Emadi: None declared, Emily Gilbert: None declared, Ali Duarte-Garcia: None declared, Maria Valenzuela-Almada: None declared, Tiffany Hsu: None declared, Kristin D’Silva: None declared, Naomi Serling-Boyd: None declared, Philippe Dieudé Consultant of: Boerhinger Ingelheim, Bristol-Myers Squibb, Lilly, Sanofi, Pfizer, Chugai, Roche, Janssen unrelated to this work, Grant/research support from: Bristol-Myers Squibb, Chugaii, Pfizer, unrelated to this work, Elena Nikiphorou: None declared, Vanessa Kronzer: None declared, Namrata Singh: None declared, Beth Wallace: None declared, Akpabio Akpabio: None declared, Ranjeny Thomas: None declared, Suleman Bhana Consultant of: AbbVie, Horizon, Novartis, and Pfizer (all <$10,000) unrelated to this work, Wendy Costello: None declared, Rebecca Grainger Speakers bureau: Abbvie, Janssen, Novartis, Pfizer, Cornerstones, Jonathan Hausmann Consultant of: Novartis, Sobi, Biogen, all unrelated to this work (<$10,000), Jean Liew Grant/research support from: Pfizer outside the submitted work, Emily Sirotich Grant/research support from: Board Member of the Canadian Arthritis Patient Alliance, a patient run, volunteer based organization whose activities are largely supported by independent grants from pharmaceutical companies, Paul Sufka: None declared, Philip Robinson Speakers bureau: Abbvie, Eli Lilly, Janssen, Novartis, Pfizer and UCB (all < $10,000), Consultant of: Abbvie, Eli Lilly, Janssen, Novartis, Pfizer and UCB (all < $10,000), Pedro Machado Speakers bureau: Abbvie, BMS, Celgene, Eli Lilly, Janssen, MSD, Novartis, Pfizer, Roche and UCB, all unrelated to this study (all < $10,000)., Consultant of: Abbvie, BMS, Celgene, Eli Lilly, Janssen, MSD, Novartis, Pfizer, Roche and UCB, all unrelated to this study (all < $10,000), Milena Gianfrancesco: None declared, Jinoos Yazdany Consultant of: Eli Lilly and AstraZeneca unrelated to this projectKeywords:
Hydroxychloroquine
Background: Hydroxychloroquine is currently being tested as post-exposure prophylaxis against coronavirus disease 2019 (COVID-19) in several ongoing clinical trials. Objective: To compare the incidence of COVID-19 in Spanish patients with autoimmune rheumatic diseases treated with and without hydroxychloroquine. Methods: Retrospective electronic record review, from February 27th to April 16th, of patients with autoimmune inflammatory diseases followed at two academic tertiary care hospitals in Seville, Spain. The cumulative incidence of COVID-19, confirmed or suspected, was compared between patients with and without hydroxychloroquine as part of their treatment of autoimmune inflammatory diseases. Results: Among 722 included subjects, 290 (40%) were receiving hydroxychloroquine. During the seven-week study period, five (1.7% [95% CI: 0.5%-4.0%] cases of COVID-19 were registered among patients with hydroxychloroquine and five (1.2% [0.4%-2.7%]) (p=0.523) in without hydroxychloroquine. COVID-19 was confirmed by PCR in one (0.3%, 95% CI 0.008-1.9%) patient with hydroxychloroquine and two (0.5%, 95% CI 0.05%-1.6%) without hydroxychloroquine (p=1.0). One patient on hydroxychloroquine and two subjects without hydroxychloroquine were admitted to the hospital, none of them required to be transferred to the intensive care unit and no patient died during the episode. Conclusions: The incidence and severity of COVID-19 among patients with autoimmune rheumatic diseases with and without hydroxychloroquine was not significantly different. Hydroxychloroquine does not seem to be an appropriate therapy for post-exposure prophylaxis against COVID-19.
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We read the article by McGill and Ambrose on lupus in young people with interest.1 They reiterate that patients should receive retinal screening after 5 years of exposure to hydroxychloroquine.1 It is estimated that there may be up to 161 000 users of hydroxychloroquine in the UK. The prevalence of hydroxychloroquine retinopathy is around 7.5% after …
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To study maternal and fetal outcome of pregnancy in patients with lupus who were exposed to hydroxychloroquine (HCQ).The case records of women (n = 33) exposed to HCQ during their pregnancies (n = 36) and of 53 control patients from a single lupus pregnancy centre were reviewed to determine lupus activity, obstetric experience, and infant outcome.HCQ was not apparently teratogenic. Lupus activity and obstetric outcome in the two groups were similar.HCQ continuation is probably safe during pregnancy in patients with lupus, but there is no obvious advantage in commencing treatment.
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Hydroxychloroquine (HCQ) is a valuable and possibly underused agent in treating mild lupus. Whether this drug should be discontinued in pregnancy is still controversial. We studied the full obstetric histories of 33 women with lupus who had taken HCQ at some point during pregnancy. HCQ was not, apparently, teratogenic and we believe that continuation of this drug is probably safe in lupus pregnancies.
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Objective
To study the relation between blood concentration of hydroxychloroquine and the clinical efficacy of hydroxychloroquine sulfate in a series of patients with cutaneous lupus erythematosus (CLE).Design
Prospective multicenter study. A staff dermatologist blinded to blood hydroxychloroquine concentrations performed a standardized review of medical records and assessment of hydroxychloroquine efficacy in the following 3 categories: complete remission, partial remission (clearing of >50% of skin lesions), or treatment failure. Whole-blood samples were collected for measurement of blood hydroxychloroquine concentration.Setting
Fourteen French university hospitals.Patients
Three hundred consecutive patients with subacute or chronic CLE who had been treated with hydroxychloroquine for at least 3 months.Main Outcome Measures
The statistical significance of correlation between blood hydroxychloroquine concentration and efficacy of hydroxychloroquine and the statistical associations in univariate and multivariate analyses of complete remission with several variables.Results
The study included 300 patients with discoid lupus erythematosus (n = 160), subacute CLE (n = 86), lupus erythematosus tumidus (n = 52), chilblain lupus (n = 26), and lupus panniculitis (n = 16); 38 of these patients had 2 or more associated forms. Median blood hydroxychloroquine concentration was significantly higher in patients with complete remission (910 [range, <50 to 3057] ng/mL) compared with partial remission (692 [<50 to 2843] ng/mL) and treatment failure (569 [<50 to 2242] ng/mL) (P = .007). In the multivariate analysis, complete remission was associated with higher blood hydroxychloroquine concentrations (P = .005) and the absence of discoid lesions (P = .004). Thirty patients (10.0%) had very low blood hydroxychloroquine concentrations (<200 ng/mL) and may be considered nonadherent to the treatment regimen.Conclusion
Monitoring hydroxychloroquine blood concentrations might improve the management of refractory CLE.Hydroxychloroquine
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SARS-CoV-2 is a novel virus that has infected millions of people across the world. Given the compelling need to develop a therapeutic strategy, hydroxychloroquine has been advocated as an effective drug for the infection. However, multiple clinical trials conducted using hydroxychloroquine have yielded contrasting results. An electronic search using the primary databases from WHO, PubMed and Google Scholar was performed that yielded 21 studies eligible for inclusion. Among a total of 1,350 patients who received hydroxychloroquine, 689 (51.04%) were females. The most commonly reported comorbidities include hypertension (15.18%), diabetes mellitus (8.44%) and pulmonary disease (8.96%). Of the hydroxychloroquine-treated patients, 70% were virologically cured compared to 12.5% of the control group ( p = 0.001). A good clinical outcome with virological cure was reported in 973 patients (91%) within 10 days out of 1,061 hydroxychloroquine-treated patients. A total of 29 (65%) renal transplant recipients achieved complete recovery following hydroxychloroquine administration. A total of 37 (2.7%) patients reported QT prolongation. Hydroxychloroquine was found to reduce mortality in healthy, SARS-Cov-2 positive patients and improve clinical recovery in renal transplant recipients. However, a definitive conclusion regarding its effect on viral clearance can only be reached by conducting more clinical trials involving bigger and diverse samples.
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There have been controversies on the prophylactic effect of hydroxychloroquine against severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2). We describe a patient, 60-year old Korean woman, with coronavirus disease 2019 (COVID-19) who had been taking hydroxychloroquine for 6 months. Her serum and saliva concentrations of hydroxychloroquine were 280 μg/L and 4,890 μg/L, respectively. The present case raises concerns on hydroxychloroquine's role as a prophylactic agent for COVID-19.
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Background Hydroxychloroquine is not efficacious as post-exposure prophylaxis against coronavirus disease 2019 (COVID-19). It is not known whether as pre-exposure prophylaxis it may prevent COVID-19. Objective To compare the incidence of COVID-19 in Spanish patients with autoimmune rheumatic diseases treated with and without hydroxychloroquine. Patients and methods Retrospective electronic record review, from February 27 th to June 21 st , 2020, of patients with autoimmune inflammatory diseases followed at two academic tertiary care hospitals in Seville, Spain. The cumulative incidence of confirmed COVID-19, by PCR or serology, was compared between patients with and without hydroxychloroquine as part of their treatment of autoimmune inflammatory diseases. Results Among 722 included patients, 290 (40%) were receiving hydroxychloroquine. During the seventeen-week study period, 10 (3.4% [95% CI: 1.7%-6.7%] cases of COVID-19 were registered among patients with hydroxychloroquine and 13 (3.0% [1.6%-5.1%]) (p = 0.565) in those without hydroxychloroquine. COVID-19 was diagnosed by PCR in four (1.4%, 95% CI 0.38%-3.5%) subject with hydroxychloroquine and six (1.4%, 95% CI 0.5%-3.0%) without hydroxychloroquine (p = 0.697). Three patients on hydroxychloroquine and four patients without hydroxychloroquine were admitted to the hospital, none of them required to be transferred to the intensive care unit and no patient died during the episode. Conclusions The incidence and severity of COVID-19 among patients with autoimmune rheumatic diseases with and without hydroxychloroquine was not significantly different.
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Abstract INTRODUCTION: The effectiveness of hydroxychloroquine in SARS-CoV-2 prophylaxis and treatment is still controversial. In this study, our aim is to investigate the potential effects of hydroxychloroquine therapy on patients with diagnosed with rheumatoid arthritis and a confirmed SARS-CoV-2 infection.METHOD: We included patients who were followed up with a diagnosis of rheumatoid arthritis and whose SARS-CoV-2 infection was confirmed. The patients were divided into two groups as those who previously used hydroxychloroquine and those who did not, and were compared in terms of clinical and laboratory data.RESULTS: Our study included 17 patients with adequate data (2 males, 15 females). The mean age of the patients was 57.2 ± 11.6 years. 7 (41.2%) patients were receiving hydroxychloroquine regularly for the last 6 months. When the effect of hydroxychloroquine on clinical and laboratory parameters of patients was examined, there was no significant difference between the groups of patients using and not using hydroxychloroquine. The patients using and not using hydroxychloroquine were compared for the presence of typical SARS-CoV-2 infection findings on computed tomography images, admission to the hospital and intensive care. No significant differences were observed between these two groups.CONCLUSIONS: Many studies on the effectiveness of hydroxychloroquine use in SARS-CoV-2 infection are still ongoing. Due to its importance in rheumatology practice, it is very important to clarify the position of hydroxychloroquine in SARS-CoV-2 therapy. Our findings suggest that having previously used hydroxychloroquine does not have any negative or positive effect on the infection.
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