Baseline use of hydroxychloroquine in systemic lupus erythematosus does not preclude SARS-CoV-2 infection and severe COVID-19
Konig et al.,
Baseline use of hydroxychloroquine in systemic lupus erythematosus does not preclude SARS-CoV-2 infection and..,
Annals of the Rheumatic Diseases, doi:10.1136/annrheumdis-2020-217690
Analysis of 80 SLE patients diagnosed with COVID-19, showing the frequency of hospitalisation did not differ between individuals using an antimalarial versus non-users (55% (16/29) vs 57% (29/51), p=ns. Authors suggest that the dosage used may be too low to reach therapeutic levels.
This study is excluded in the after exclusion results of meta
analysis:
not fully adjusting for the baseline risk differences within systemic autoimmune patients.
risk of hospitalization, 3.0% lower, RR 0.97, p = 0.88, treatment 16 of 29 (55.2%), control 29 of 51 (56.9%), NNT 59.
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Effect extraction follows pre-specified rules prioritizing more serious outcomes. Submit updates
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Konig et al., 7 May 2020, retrospective, database analysis, multiple countries, peer-reviewed, 11 authors.
Abstract: Letters
Baseline use of hydroxychloroquine in systemic
lupus erythematosus does not preclude SARS-
CoV-2 infection and severe COVID-19
The use of hydroxychloroquine (HCQ) in the prophylaxis
and treatment of coronavirus disease 2019 (COVID-19) has
received significant attention by politicians and media figures.
This has occurred despite limited data supporting its efficacy
in COVID-19 as well as considerable concern about its safety
when used at high doses (>400 mg daily) and in combination
with other QT interval prolonging drugs.1–4
An inaccurate narrative has emerged in recent weeks that
patients with systemic lupus erythematosus (SLE) who are
taking HCQ as a baseline therapy are less affected by or do
not develop COVID-19.5–7 This assumption has been challenged by Monti and Montecucco,8 referencing data from
the COVID-19 Global Rheumatology Alliance registry on
patients with rheumatic disease that previously identified
19/110 (17%) patients with SLE.9 A case series of 17 patients
with lupus or antiphospholipid syndrome who developed
COVID-19 on a median HCQ dose of 400 mg daily (median
HCQ blood level of 648 ng/mL) has since become available. 10
As of 17 April 2020, we have now identified 80 patients
with SLE and COVID-19 in the global physician-reported
registry. Patients were predominantly female (72/80, 90%)
and less than 65 years of age (69/80, 86%). Importantly,
64% (51/80) of patients with SLE were taking an antimalarial (HCQ or chloroquine) prior to infection with severe
acute respiratory syndrome coronavirus 2 (SARS-
CoV-2)
(30% as monotherapy). Notably, 21.1% (121/573) of all
reported patients with rheumatic disease in the registry were
treated with an antimalarial prior to onset of COVID-19,
yet 49.6% (60/121) required hospitalisation. In patients
with SLE, frequency of hospitalisation with COVID-19 did
not differ between individuals using an antimalarial versus
non-users (55% (16/29) vs 57% (29/51), p=ns; χ2 test). In
patients with lupus, escalation to maximum level of care
(non-invasive ventilation, invasive ventilation or extracorporeal membrane oxygenation (ECMO)) was required regardless of HCQ use (online supplementary table S1). Thus,
patients with lupus—even if they are using an antimalarial
such as HCQ as baseline therapy—can develop SARS-CoV-2
infection and severe COVID-19 at similar frequency as lupus
patients not on antimalarials.
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Ann Rheum Dis October 2020 Vol 79 No 10
Ann Rheum Dis: first published as 10.1136/annrheumdis-2020-217690 on 7 May 2020.
There are currently >40 ongoing clinical trials examining
HCQ in the prophylaxis or treatment of SARS-CoV-2 infection that employ highly variable strategies with regards to
dosing (total oral loading dose 400–1400 mg), duration and
time of initiation.11 However, dosing considerations of HCQ
in COVID-19 may be critical to understand why patients with
lupus may not be protected from SARS-CoV-2 infection.
Similar to in vitro studies indicating activity of antimalarial 4-aminoquinoline derivatives against SARS-CoV-1 and
MERS-CoV,12 13 a putative role for HCQ in the treatment
of COVID-19 has been suggested by its antiviral effect in
cell culture systems.14 15 Given the assumptions made when
moving from a cell-based model to a complex in vivo system,
in vitro potency cannot be expected to translate into in vivo
efficacy,16 as observed for chloroquine in a..
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