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Impact of SARS-CoV-2 infection on patients with systemic lupus erythematosus in England prior to vaccination: a retrospective observational cohort study

Rabe et al., BMJ Open, doi:10.1136/bmjopen-2022-071072
Nov 2023  
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Case 29% Improvement Relative Risk HCQ for COVID-19  Rabe et al.  Prophylaxis Is pre-exposure prophylaxis with HCQ beneficial for COVID-19? Retrospective 6,145 patients in the United Kingdom (May - Oct 2020) Fewer cases with HCQ (not stat. sig., p=0.22) c19hcq.org Rabe et al., BMJ Open, November 2023 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 cohort of 6,145 SLE patients showing lower incidence of COVID-19 for patients receiving HCQ/CQ (antimalarials), without statistical significance. Groups were not matched and results may be influenced by factors such as disease severity. HCQ/antimalarials were used more in moderate/severe SLE patients, suggesting that the estimated protective effect will underestimate the real effect.
Although the 29% fewer cases is not statistically significant, it is consistent with the significant 29% fewer cases [21‑35%] from meta analysis of the 82 cases results to date.
risk of case, 28.6% lower, RR 0.71, p = 0.22, treatment 24 of 3,248 (0.7%), control 30 of 2,897 (1.0%), NNT 337.
Effect extraction follows pre-specified rules prioritizing more serious outcomes. Submit updates
Rabe et al., 22 Nov 2023, retrospective, United Kingdom, peer-reviewed, mean age 45.2, 7 authors, study period 1 May, 2020 - 31 October, 2020.
This PaperHCQAll
Impact of SARS-CoV-2 infection on patients with systemic lupus erythematosus in England prior to vaccination: a retrospective observational cohort study
Adrian Paul J Rabe, Wei Jie Loke, Rubana N Kalyani, Raj Tummala, Heide A Stirnadel-Farrant, John Were, Kevin L Winthrop
BMJ Open, doi:10.1136/bmjopen-2022-071072
Objectives Determine the prevaccination healthcare impact of COVID-19 in patients with systemic lupus erythematosus (SLE) in England. Design Retrospective cohort study of adult patients with SLE from 1 May to 31 October 2020. Setting Clinical Practice Research Datalink (CPRD) Aurum and Hospital Episode Statistics (HES) databases from general practitioners across England combining primary care and other health-related data. Participants Overall, 6145 adults with confirmed SLE diagnosis ≥1 year prior to 1 May 2020 were included. Most patients were women (91.0%), white (67.1%), and diagnosed with SLE at age <50 (70.8%). Patients were excluded if they had a COVID-19 diagnosis before 1 May 2020. Primary and secondary outcome measures Demographics and clinical characteristics were compared. COVID-19 severity was determined by patient care required and procedure/diagnosis codes. COVID-19 cumulative incidence, hospitalisation rates, lengths of stay and mortality rates were determined and stratified by SLE and COVID-19 severity. Results Of 6145 patients, 3927 had mild, 1288 moderate and 930 severe SLE at baseline. The majority of patients with moderate to severe SLE were on oral corticosteroids and antimalarial treatments. Overall, 54/6145 (0.88%) patients with SLE acquired and were diagnosed with COVID-19, with 45 classified as mild, 6 moderate and 3 severe COVID-19. Cumulative incidence was higher in patients with severe SLE (1.4%) compared with patients classified as mild (0.8%) or moderate (0.8%). Ten COVID-19-specific hospital admissions occurred (n=6 moderate; n=4 severe). Regardless of COVID-19 status, hospital admission rates and length of stay increased with SLE severity. Of 54 patients with SLE diagnosed with COVID-19, 1 (1.9%) COVID-19-related death was recorded in a patient with both severe SLE and severe COVID-19. Conclusions SLE severity did not appear to impact COVID-19 outcomes in this study. The COVID-19 pandemic is evolving and follow-up studies are needed to understand the relationship between COVID-19 and SLE. ⇒ This study provided unique insight into the outcomes of COVID-19 for patients with systemic lupus erythematosus (SLE) before the availability of COVID-19 vaccines. ⇒ Due to the nature of a database study, there were limitations in the data captured in the system. ⇒ The number of diagnosed COVID-19 cases was low in patients with SLE. ⇒ The information about secondary care prescriptions in this population was limited.
Ethics approval This study used data that existed in an anonymised, structured format that contained no personal patient information. The study protocol was reviewed and approved by CPRD's Independent Scientific Advisory Committee (application number 21_000327) on 9 March 2021. Linkage of datasets was performed using anonymised and pseudonymised patient identification codes and was undertaken by NHS Digital, following study protocol approval. The CPRD obtains research ethics approval annually for receiving and supplying patient data for public health research from the UK's Health Research Authority Research Ethics Committee; no additional ethics approval is required for observational studies in public health research using CPRD Aurum data. Provenance and peer review Not commissioned; externally peer reviewed. Data availability statement Data are available upon reasonable request. Data underlying the findings described in this article may be obtained in accordance with AstraZeneca's data sharing policy described at https://astrazenecagrouptrials. pharmacm.com/ST/Submission/Disclosure Supplemental material This content has been supplied by the author(s). It has not been vetted by BMJ Publishing Group Limited (BMJ) and may not have been peer-reviewed. Any opinions or recommendations discussed are solely those of the author(s) and are not endorsed by BMJ. BMJ disclaims all liability and responsibility arising from any reliance placed on the content. Where the content includes any..
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Most ' 'patients were women (91.0%), white (67.1%), and diagnosed with SLE at age &lt;50 (70.8%). ' 'Patients were excluded if they had a COVID-19 diagnosis before 1 May ' '2020.</jats:p></jats:sec><jats:sec><jats:title>Primary and secondary outcome ' 'measures</jats:title><jats:p>Demographics and clinical characteristics were compared. ' 'COVID-19 severity was determined by patient care required and procedure/diagnosis codes. ' 'COVID-19 cumulative incidence, hospitalisation rates, lengths of stay and mortality rates ' 'were determined and stratified by SLE and COVID-19 ' 'severity.</jats:p></jats:sec><jats:sec><jats:title>Results</jats:title><jats:p>Of 6145 ' 'patients, 3927 had mild, 1288 moderate and 930 severe SLE at baseline. The majority of ' 'patients with moderate to severe SLE were on oral corticosteroids and antimalarial ' 'treatments. 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