Similar incidence of Coronavirus Disease 2019 (COVID-19) in patients with rheumatic diseases with and without hydroxychloroquine therapy
Macias et al., medRxiv, 10.1101/2020.05.16.20104141 (Preprint)
Macias et al., Similar incidence of Coronavirus Disease 2019 (COVID-19) in patients with rheumatic diseases with and without.., medRxiv, 10.1101/2020.05.16.20104141 (Preprint)
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.Although the 26% lower hospitalization is not statistically significant, it is consistent with the significant 16% lower hospitalization [6‑24%] from meta analysis of the 59 hospitalization results to date.
This study is excluded in the after exclusion results of meta
analysis:
not fully adjusting for the baseline risk differences within systemic autoimmune patients.
Abstract: medRxiv preprint doi: https://doi.org/10.1101/2020.05.16.20104141; this version posted May 20, 2020. The copyright holder for this preprint
(which was not certified by peer review) is the author/funder, who has granted medRxiv a license to display the preprint in perpetuity.
All rights reserved. No reuse allowed without permission.
1
Similar incidence of Coronavirus Disease 2019 (COVID-19) in
patients with rheumatic diseases with and without
hydroxychloroquine therapy
Authors:
Juan Macías, MD, PhD1; Paz González-Moreno, MD2; Esther Sánchez-García, MD,
PhD3; Ramón Morillo-Verdugo, PharmD4; Carmen Domínguez-Quesada, BSN2; Ana
Pinilla, RPH1; MªMar Macho, BSN1; MªVictoria Martínez, BSN1; Alejandro GonzálezSerna, PhD1; Anaïs Corma, MD1; Luis M. Real, PhD1; Juan A. Pineda, MD, PhD1
1
Infectious Diseases and Microbiology Unit, Hospital Universitario Virgen de Valme.
Seville. Spain
2
Rheumatology Unit, Hospital Universitario Virgen Macarena. Seville. Spain
3
Internal Medicine Service, Hospital Universitario Virgen de Valme. Seville. Spain
4
Pharmacy, Hospital Universitario Virgen de Valme. Seville. Spain
Corresponding author: Juan Macías. Infectious Diseases and Microbiology Unit,
Hospital Universitario Virgen de Valme. Avda Bellavista s/n. 41014-Seville. Spain.
Email: juan.macias.sanchez@gmail.com
NOTE: This preprint reports new research that has not been certified by peer review and should not be used to guide clinical practice.
medRxiv preprint doi: https://doi.org/10.1101/2020.05.16.20104141; this version posted May 20, 2020. The copyright holder for this preprint
(which was not certified by peer review) is the author/funder, who has granted medRxiv a license to display the preprint in perpetuity.
All rights reserved. No reuse allowed without permission.
2
Abstract
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.
medRxiv preprint doi:..
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