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Sociodemographic and clinical factors associated with poor COVID-19 outcomes in patients with rheumatic diseases: data from the SAR-COVID Registry

Isnardi et al., Clinical Rheumatology, doi:10.1007/s10067-022-06393-8, NCT04568421
Oct 2022  
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Mortality 34% Improvement Relative Risk Severe case 48% Hospitalization 17% HCQ for COVID-19  Isnardi et al.  Prophylaxis Is pre-exposure prophylaxis with HCQ beneficial for COVID-19? Retrospective 2,066 patients in Argentina (August 2020 - July 2021) Lower severe cases with HCQ (p=0.018) c19hcq.org Isnardi et al., Clinical Rheumatology, Oct 2022 FavorsHCQ Favorscontrol 0 0.5 1 1.5 2+
HCQ for COVID-19
1st treatment shown to reduce risk in March 2020, now with p < 0.00000000001 from 419 studies, recognized in 46 countries.
No treatment is 100% effective. Protocols combine treatments.
5,100+ studies for 109 treatments. c19hcq.org
Retrospective 1,915 rheumatic disease patients with COVID-19 in Argentina, showing lower mortality, severe oxygen requirement, and hospitalization with CQ/HCQ (antimalarial) use in unadjusted results, statistically significant only for severe oxygen requirement.
risk of death, 33.9% lower, RR 0.66, p = 0.23, treatment 11 of 361 (3.0%), control 72 of 1,554 (4.6%), NNT 63, odds ratio converted to relative risk.
risk of severe case, 48.0% lower, RR 0.52, p = 0.02, treatment 14 of 361 (3.9%), control 117 of 1,554 (7.5%), NNT 27, odds ratio converted to relative risk.
risk of hospitalization, 17.0% lower, RR 0.83, p = 0.09, treatment 83 of 512 (16.2%), control 429 of 1,554 (27.6%), NNT 8.8, odds ratio converted to relative risk.
Effect extraction follows pre-specified rules prioritizing more serious outcomes. Submit updates
Isnardi et al., 6 Oct 2022, retrospective, Argentina, peer-reviewed, mean age 51.4, 198 authors, study period 13 August, 2020 - 31 July, 2021, trial NCT04568421 (history).
This PaperHCQAll
Sociodemographic and clinical factors associated with poor COVID-19 outcomes in patients with rheumatic diseases: data from the SAR-COVID Registry
Carolina A Isnardi, Karen Roberts, Verónica Saurit, Ingrid Petkovic, Roberto M Báez, Rosana Quintana, Yohana Tissera, Sofía Ornella, Maria Eugenia D.Angelo Exeni, Cecilia N Pisoni, Vanessa V Castro Coello, Guillermo Berbotto, María J Haye Salinas, Edson Velozo, Álvaro A Reyes Torres, Romina Tanten, Marcos D Zelaya, Carla Gobbi, Carla G Alonso, María De Los Ángeles Severina, Florencia Vivero, Alba Paula, Adriana K Cogo, Gelsomina Alle, Mariana Pera, Romina E Nieto, Micaela Cosatti, Cecilia Asnal, Dora Pereira, Juan A Albiero, Verónica G Savio, Federico N Maldonado, María Julieta Gamba, Noelia F Germán, Andrea Baños, Josefina Gallino Yanzi, María Soledad Gálvez Elkin, Julieta S Morbiducci, María Victoria Martire, Hernán Maldonado Ficco, Maria Marcela Schmid, Jaime A Villafañe Torres, Maria De Los Ángeles Correa, María Alejandra Medina, María Alejandra Cusa, Julia Scafati, Santiago E Agüero, Nicolás M Lloves Schenone, Enrique R Soriano, Cesar Graf, Bernardo A Pons-Estel, Gimena Gomez, Margarita Landi, María Celina De La Vega, Guillermo J Pons-Estel, Veronica Saurit, Ingrid Petkovic, Roberto Miguel Baez, Guillermo J Pons-Estel, Yohana Tissera, Sofía Ornella, Ida Elena Exeni, Cecilia Pisoni, Vanessa Castro Coello, Guillermo Berbotto, Maria Jezabel Haye Salinas, Edson Velozo, Alvaro Andres Reyes Torres, Romina Tanten, Marcos David Zelaya, Carla Gobbi, Carla Gimena Alonso, Maria Severina, Florencia Vivero, Paula Alba, Karina Cogo, Gelsomina Alle, Mariana Pera, Romina Nieto, Micaela Cosatti, Cecilia Asnal, Dora Pereira, Juan Alejandro Albiero, Verónica Gabriela Savio, Federico Nicolas Maldonado, Maria Julieta Gamba, Noelia F Germán, Andrea Baños, Josefina Gallino Yanzi, Maria Soledad Gálvez Elkin, Julieta Silvana Morbiducci, María Victoria Martire, Hernan Maldonado Ficco, Maria Marcela Schmid, Jaime Villafane, Maria De Los Angeles Correa, María Alejandra Medina, María Alejandra Cusa, Julia Scafati, Santiago Eduardo Agüero, Nicolás Martín Lloves Schenone, Ivana Romina Rojas Tessel, Rodolfo Perez Alamino, Aixa Lucia Mercé, Maria De La Vega, Verónica Bellomio, Leandro Carlevaris, Jonatan Marcos Mareco, Rosa María Figueroa, Maria Alicia Lazaro, Mercedes García, Maria Isabel Quaglia, Luciana González Lucero, Lorena Takashima, Marina Laura Werner, Fabian Risueño, Natalia Lili Cucchiaro, Ana Bertoli, Gisela Pendon, Gustavo Fabián Rodriguez Gil, Pablo Finucci Curi, Laura Raiti, Andrea Belen Gomez Vara, Luciana Casalla, Eugenia Picco, Leila Mariana Muñoz, Maria Elena Calvo, Diana Marcela Castrillón, Catalina Gómez, Mercedes Cecilia Córdoba, Camila Rosario Reyes Gómez, Brian Manases Roldán, Cristina Amitrano, Carla Matellan, Sidney Soares De Souza, Florencia Rodriguez, Carolina Aeschlimann, Vicente Juarez, César Graf, Marianela Eliana Mauri, Cecilia Romeo, Elisa Novatti, Maria Natalia Tamborenea, Raúl Paniego, Malena Viola, Vanesa Cosentino, Sandra Petruzzeli, Zaida Noemi Bedran, Sebastián Moyano, Tatiana Barbich, Silvana Conti, Carla Maldini, Maria Daniela Alonso, María Victoria Borgia, Ana Carolina Ledesma, Maria Luz Martin, Boris Kisluk, Susana Isabel Pineda, Natalia Agustina Herscovich, Leticia Ibañez Zurlo, Elda Rossella Tralice, Dora Lia Vasquez, Natalia Morales, Mónica Patricia Díaz, Hernan Ariel Molina Merino, Rosana Gallo, Jessica Luciana Tomas, Anibal Alba, Graciela Gómez, Gisela Subils, Adriana Testi, Gisele Verna, Maria Eugenia Bedoya, Victor Yohena, Debora Guaglionone, Jonathan Eliseo Rebak, Maria Mercedes Croce, Carolina Dieguez, Mara Guinsburg, Santiago Catalán Pellet, Pablo Maid, Sabrina Porta, Norberto Javier Quagliato, Sabrina Solange De La Vega Fernandez, Emilio Buschiazzo, José Luis Velasco Zamora, María Silvina Pérez Rodríguez, Federico Martin Paniego, Maria Lourdes Mamani Ortega, Graciela Vanesa Betancur, Rosa Serrano, Maria Sol Castaños Menescardi, Cinthya Retamozo, Cecilia Goizueta, Ana Quinteros, Fernanda Abadie, Ignacio Carrillo, Fernanda Guzzanti
Clinical Rheumatology, doi:10.1007/s10067-022-06393-8
Background/objective This study aims to describe the course and to identify poor prognostic factors of SARS-CoV-2 infection in patients with rheumatic diseases. Methods Patients ≥ 18 years of age, with a rheumatic disease, who had confirmed SARS-CoV-2 infection were consecutively included by major rheumatology centers from Argentina, in the national, observational SAR-COVID registry between August 13, 2020 and July 31, 2021. Hospitalization, oxygen requirement, and death were considered poor COVID-19 outcomes. Results A total of 1915 patients were included. The most frequent rheumatic diseases were rheumatoid arthritis (42%) and systemic lupus erythematosus (16%). Comorbidities were reported in half of them (48%). Symptoms were reported by 95% of the patients, 28% were hospitalized, 8% were admitted to the intensive care unit (ICU), and 4% died due to COVID-19. During hospitalization, 9% required non-invasive mechanical ventilation (NIMV) or high flow oxygen devices and 17% invasive mechanical ventilation (IMV). In multivariate analysis models, using poor COVID-19 outcomes as dependent variables, older age, male gender, higher disease activity, treatment with glucocorticoids or rituximab, and the presence of at least one comorbidity and a greater number of them were associated with worse prognosis. In addition, patients with public health insurance and Mestizos were more likely to require hospitalization. Conclusions In addition to the known poor prognostic factors, in this cohort of patients with rheumatic diseases, high disease activity, and treatment with glucocorticoids and rituximab were associated with worse COVID-19 outcomes. Furthermore, patients with public health insurance and Mestizos were 44% and 39% more likely to be hospitalized, respectively. Study registration This study has been registered in ClinicalTrials.gov under the number NCT04568421. Key Points • High disease activity, and treatment with glucocorticoids and rituximab were associated with poor COVID-19 outcome in patients with rheumatic diseases. • Some socioeconomic factors related to social inequality, including non-Caucasian ethnicity and public health insurance, were associated with hospitalization due to COVID-19.
Appendix List of SAR-COVID investigators Author contribution All authors listed in this manuscript made substantial contributions to the acquisition, analysis, or interpretation of data and were involved in drafting or revising this article critically for important intellectual content. All authors approved the final version to be published. A list of all the SAR-COVID registry sub-investigators is included in the Appendix. Funding The authors disclosed receipt of the following financial support for the research, authorship, and/or publication of this article: SAR-COVID, as a strategic registry from the Argentine Society of Rheumatology, has received unrestricted research grants to carry out this project from Pfizer, AbbVie, and Elea Phoenix. In addition, two grants from the International League of Associations of Rheumatology have been obtained. Data availability All data and materials generated and analyzed during the current study belong to the SAR-COVID registry and the Argentine Society of Rheumatology. They are available from the corresponding author on reasonable request. The authors declare that all relevant data is included in the article and its supplementary information files. More information about the registry is available in https:// www. unisar. reuma tolog ia. org. ar/ regis tros_ sarco vid. php. Declarations Ethics approval This study is being conducted in accordance with Good Clinical Practice (GCP) guidelines, the International Conference on..
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ACR Open Rheumatol 3:333–340', 'journal-title': 'ACR Open Rheumatol'}, { 'key': '6393_CR26', 'doi-asserted-by': 'publisher', 'first-page': '2179', 'DOI': '10.1002/art.41800', 'volume': '73', 'author': 'BR England', 'year': '2021', 'unstructured': 'England BR, Roul P, Yang Y et al (2021) Risk of COVID-19 in rheumatoid ' 'arthritis: a national Veterans Affairs matched cohort study in at-risk ' 'individuals. Arthritis Rheumatol 73:2179–2188', 'journal-title': 'Arthritis Rheumatol'}, { 'key': '6393_CR27', 'unstructured': 'Ministerio de salud de Argentina. (2021) Reporte de situación COVID-19. ' 'IOP Publishing Ministerio de salud de Argentina ' 'https://www.argentina.gob.ar/coronavirus/informes-diarios/reportes/julio2021. ' 'Accessed 24 April 2022.'}, { 'key': '6393_CR28', 'doi-asserted-by': 'publisher', 'first-page': 'e24357', 'DOI': '10.2196/24357', 'volume': '9', 'author': 'C Marques', 'year': '2020', 'unstructured': 'Marques C, Kakehasi AM, Gomides APM et al (2020) 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. JMIR Res Protoc 9:e24357', 'journal-title': 'JMIR Res Protoc'}, { 'key': '6393_CR29', 'doi-asserted-by': 'publisher', 'first-page': 'e001461', 'DOI': '10.1136/rmdopen-2020-001461', 'volume': '7', 'author': 'CDL Marques', 'year': '2021', 'unstructured': 'Marques CDL, Kakehasi AM, Pinheiro MM et al (2021) High levels of ' 'immunosuppression are related to unfavorable outcomes in hospitalized ' 'patients with rheumatic diseases and COVID-19: first results of ReumaCoV ' 'Brasil registry. RMD Open 7:e001461', 'journal-title': 'RMD Open'}, { 'key': '6393_CR30', 'doi-asserted-by': 'crossref', 'unstructured': 'Ugarte-Gil MF, Marques CDL, Alpizar-Rodriguez D, et al. (2020) ' 'Characteristics associated with Covid-19 in patients with rheumatic ' 'disease in Latin America: data from the Covid-19 Global Rheumatology ' 'Alliance physician-reported registry. IOP Global Rheumatology by PANLAR ' 'web. https://www.globalrheumpanlar.org/node/254. Accessed 31 August ' '2022.', 'DOI': '10.46856/grp.10.e003'}, { 'key': '6393_CR31', 'doi-asserted-by': 'crossref', 'unstructured': 'Landewé RBM, Kroon FPB, Alunno A, et al. (2022) EULAR recommendations ' 'for the management and vaccination of people with rheumatic and ' 'musculoskeletal diseases in the context of SARS-CoV-2: the November 2021 ' 'update. Ann Rheum Dis. annrheumdis-2021–222006.', 'DOI': '10.1136/annrheumdis-2021-222006'}, { 'key': '6393_CR32', 'unstructured': 'ACR COVID-19 Vaccine Clinical Guidance Task Force. (2022) COVID-19 ' 'Vaccine Clinical Guidance Summary for Patients with Rheumatic and ' 'Musculoskeletal Diseases. Version 5. Revised February 2, 2022. IOP ' 'American College of Rheumatology web. ' 'https://www.rheumatology.org/Portals/0/Files/COVID-19-Vaccine-Clinical-Guidance-Rheumatic-Diseases-Summary.pdf. ' 'Accessed 31 August 2022.'}], 'container-title': 'Clinical Rheumatology', 'original-title': [], 'language': 'en', 'link': [ { 'URL': 'https://link.springer.com/content/pdf/10.1007/s10067-022-06393-8.pdf', 'content-type': 'application/pdf', 'content-version': 'vor', 'intended-application': 'text-mining'}, { 'URL': 'https://link.springer.com/article/10.1007/s10067-022-06393-8/fulltext.html', 'content-type': 'text/html', 'content-version': 'vor', 'intended-application': 'text-mining'}, { 'URL': 'https://link.springer.com/content/pdf/10.1007/s10067-022-06393-8.pdf', 'content-type': 'application/pdf', 'content-version': 'vor', 'intended-application': 'similarity-checking'}], 'deposited': { 'date-parts': [[2022, 10, 6]], 'date-time': '2022-10-06T09:06:20Z', 'timestamp': 1665047180000}, 'score': 1, 'resource': {'primary': {'URL': 'https://link.springer.com/10.1007/s10067-022-06393-8'}}, 'subtitle': [], 'short-title': [], 'issued': {'date-parts': [[2022, 10, 6]]}, 'references-count': 32, 'alternative-id': ['6393'], 'URL': 'http://dx.doi.org/10.1007/s10067-022-06393-8', 'relation': {}, 'ISSN': ['0770-3198', '1434-9949'], 'subject': ['General Medicine', 'Rheumatology'], 'container-title-short': 'Clin Rheumatol', 'published': {'date-parts': [[2022, 10, 6]]}, 'assertion': [ { 'value': '15 June 2022', 'order': 1, 'name': 'received', 'label': 'Received', 'group': {'name': 'ArticleHistory', 'label': 'Article History'}}, { 'value': '22 September 2022', 'order': 2, 'name': 'revised', 'label': 'Revised', 'group': {'name': 'ArticleHistory', 'label': 'Article History'}}, { 'value': '23 September 2022', 'order': 3, 'name': 'accepted', 'label': 'Accepted', 'group': {'name': 'ArticleHistory', 'label': 'Article History'}}, { 'value': '6 October 2022', 'order': 4, 'name': 'first_online', 'label': 'First Online', 'group': {'name': 'ArticleHistory', 'label': 'Article History'}}, {'order': 1, 'name': 'Ethics', 'group': {'name': 'EthicsHeading', 'label': 'Declarations'}}, { 'value': 'This study is being conducted in accordance with Good Clinical Practice (GCP) ' 'guidelines, the International Conference on Harmonization (ICH), the ethical ' 'principles established in the Declaration of Helsinki, the law 3301/09, and ' 'local guidelines. Personal identification data was kept anonymous. An ' 'independent ethics committee approved the protocol and the informed consent ' 'form (Comité de Ética Dr Claude Bernard – SARCOVID.20200526.16.PI, June 8, ' '2020).', 'order': 2, 'name': 'Ethics', 'group': {'name': 'EthicsHeading', 'label': 'Ethics approval'}}, { 'value': 'All patients signed the corresponding informed consent form to participate in ' 'this registry.', 'order': 3, 'name': 'Ethics', 'group': {'name': 'EthicsHeading', 'label': 'Consent to participate'}}, { 'value': 'Individuals provided consent for the publication of their data.', 'order': 4, 'name': 'Ethics', 'group': {'name': 'EthicsHeading', 'label': 'Consent for publication'}}, { 'value': 'The authors declared the following potential conflicts of interest with respect ' 'to the research, authorship, and/or publication of this article: SAR-COVID is a ' 'multi-sponsor registry, where Pfizer, Abbvie, and Elea Phoenix provided ' 'unrestricted grants. None of them participated or influenced the development of ' 'the project, data collection, analysis, interpretation, or writing of the ' 'report. They do not have access to the information collected in the database.', 'order': 5, 'name': 'Ethics', 'group': {'name': 'EthicsHeading', 'label': 'Conflict of interest'}}, { 'value': 'This content has been made available to all.', 'name': 'free', 'label': 'Free to read'}]}
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