Very small retrospective study of rheumatic disease patients, sample size is too small for statistical significance (HCQ 0.5-4.0%, no-HCQ 0.4-2.7%). Confirmed cases were 1 HCQ and 2 no-HCQ, confirmed+likely cases were 1 HCQ and 3 no-HCQ. 1 HCQ and 2 no-HCQ patients were admitted to hospital. We do not think a conclusion can be drawn based on these sample sizes.
There are very significant differences between the groups, for example 30% of the HCQ group have SLE vs. 2.5% of the no-HCQ group. SLE patients have a 5.7 times relative risk of pneumonia according to
ncbi.nlm.nih.gov, whereas the relative risk with glucocorticoids and TNF-α inhibitors is significantly lower
academic.oup.com. Two more recent studies with rheumatic disease/autoimmune condition patients provide higher confidence.
This study is excluded in the after exclusion results of meta
analysis:
not fully adjusting for the baseline risk differences within systemic autoimmune patients.
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risk of hospitalization, 25.5% lower, RR 0.74, p = 1.00, treatment 1 of 290 (0.3%), control 2 of 432 (0.5%), NNT 846.
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risk of case, 49.0% higher, RR 1.49, p = 0.53, treatment 5 of 290 (1.7%), control 5 of 432 (1.2%).
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Effect extraction follows pre-specified rules prioritizing more serious outcomes. Submit updates
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Macias et al., 16 May 2020, retrospective, database analysis, Spain, preprint, 12 authors.
Similar incidence of Coronavirus Disease 2019 (COVID-19) in patients with rheumatic diseases with and without hydroxychloroquine therapy
Juan Macias, Paz Gonzalez-Moreno, Esther Sanchez-Garcia, Ramon Morillo-Verdugo, Carmen Dominguez-Quesada, RPH Ana Pinilla, Mamar Macho, Mavictoria Martinez, Alejandro Gonzalez-Serna, Anais Corma, PhD Luis Miguel Real, MD, PhD Juan Antonio Pineda
doi:10.1101/2020.05.16.20104141
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 27 th to April 16 th , 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.
References
Chowdhury, Rathod, Gernsheimer, A Rapid Systematic Review of Clinical Trials Utilizing Chloroquine and Hydroxychloroquine as a Treatment for COVID-19, Acad Emerg Med,
doi:10.1111/acem.14005Gautret, Lagier, Parola, Hoang, Meddeb et al., Clinical and microbiological effect of a combination of hydroxychloroquine and azithromycin in 80 COVID-19 patients with at least a six-day follow up: A pilot observational study, Travel Med Infect Dis,
doi:10.1016/j.tmaid.2020.101663Haberman, Chen, Castillo, Adhikari, Hundesman, Covid-19 in immune-mediated inflammatory diseases -Case series from New York, New Engl J Med,
doi:10.1056/NEJMc2009567Lai, Wang, Wang, Hsueh, Ko et al., Global epidemiology of coronavirus disease 2019: disease incidence, daily cumulative index, mortality, and their association with country healthcare resources and economic status, Int J Antimicrob Agents
Yao, Ye, Zhang, Cui, Huang et al., Vitro Antiviral Activity and Projection of Optimized Dosing Design of Hydroxychloroquine for the Treatment of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2), Clin Infect Dis,
doi:10.1093/cid/ciaa237
