The Use of COVID-19 Vaccines in Patients with SLE.

PURPOSE OF REVIEW: Three COVID-19 vaccines obtained emergency authorization from the Food and Drug Administration (FDA) and are widely used in the USA. Unfortunately, there is a paucity of evidence on the safety and efficacy of these vaccines in patients with autoimmune inflammatory rheumatic diseases (AIIRD), as these patients were excluded from all phases of vaccine development. Here we reviewed current data on COVID-19 vaccination in patients with AIIRD, with emphasis on systemic lupus erythematosus (SLE), and provided a comprehensive update on the benefits and risks of vaccination. RECENT FINDINGS: Patients with SLE have worse immune responses following SARS-CoV-2 vaccination than healthy controls. The efficacy of the COVID-19 vaccines seems to be further reduced by immunosuppressive medications, such as glucocorticoids (GC), methotrexate (MTX), mycophenolate/mycophenolic acid (MMF), and rituximab (RTX). However, these data do not substantiate that AIIRD patients are at greater risk of disease flares or have a higher incidence of side effects following vaccination. There is no significant safety concern for the use of COVID-19 vaccines in patients with AIIRD. The benefits of vaccination far outweigh the risks in patients with AIIRD, including SLE. More data are needed to determine the necessity of a booster vaccine dose and appropriate adjustment of immunosuppressants around the administration of vaccine.

Hydroxychloroquine use is not associated with QTc length in a large cohort of SLE and RA patients.

BACKGROUND: Hydroxychloroquine (HCQ) is a cornerstone therapy for systemic lupus erythematosus (SLE) and rheumatoid arthritis (RA). However, reports of its use and subsequent fatal arrhythmias in patients with coronavirus disease 19 (COVID-19) have raised concern regarding its cardiovascular (CV) safety. Therefore, we examined the relationship between HCQ use and corrected QT (QTc) length in SLE and RA patients without clinical CV disease (CVD). METHODS: SLE patients from the Columbia University Lupus Cohort registry (n = 352) and two RA cohorts (n = 178; ESCAPE-RA and RHYTHM-RA) with electrocardiograms (ECGs) collected as part of study data were analyzed. RA cohort participants were recruited from tertiary referral centers with additional referrals from community rheumatologists, while SLE subjects originated from the Columbia University Lupus Cohort. All patients met American College of Rheumatology (ACR) classification criteria for SLE or RA and lacked known CVD. The exposure of interest was HCQ use and main outcome measure was QTc length [continuous or categorical (≥ 440 ms and ≥ 500 ms)]. RESULTS: Of the combined SLE and RA cohorts (n = 530), 70% were HCQ users and 44% had a QTc ≥ 440 ms. The adjusted mean QTc length was comparable between HCQ users vs non-users (438 ms vs 437 ms). In multivariable logistic models, HCQ use was not a significant predictor of a QTc ≥ 440 ms for the entire cohort (OR 0.77; 95% CI 0.48-1.23; p = 0.27). Importantly, a QTc ≥ 500 ms was inversely associated with HCQ use and not associated with arrhythmias or deaths. A significant interaction was found between HCQ use and use of anti-psychotics. Ultimately, the use of HCQ combined with any QTc prolonging medication as a group was associated with a QTc length (434 ms; 95% CI 430, 439) which was comparable to that of use of HCQ alone (433 ms; 95% CI 429-437). CONCLUSION: In a combined cohort of SLE and RA patients without clinical CVD, adjusted QTc length was comparable between HCQ and non-HCQ users, supporting its CV safety in patients with rheumatic diseases.

The Rise and Fall of Hydroxychloroquine with the COVID-19 Pandemic: Narrative Review of Selected Data.

Since the first outbreak of Coronavirus Disease-2019 (COVID-19) in January 2020, the medical community has been pursuing effective countermeasures. Early in the pandemic, several small clinical and in vitro studies from France and China reported on the efficacy of chloroquine (CQ) and hydroxychloroquine (HCQ) against SARS-CoV-2 infections, which generated global attention towards these decades-old antimalarials (AM) and heralded numerous studies investigating their role in treating COVID-19. Despite several observational studies early in the pandemic affirming their beneficial role in treating COVID-19, 12 clinical studies reported no mortality benefits for CQ/HCQ in COVID-19 patients. The excitement over CQ/HCQ was ultimately quenched after three large randomized clinical trials, the COALITION-I trial in Brazil, the RECOVERY trial in the United Kingdom (UK), and the SOLIDARITY trial from World Health Organization (WHO) consistently reported no beneficial effects for CQ/HCQ in hospitalized COVID-19 patients. While initial studies suggested that CQ/HCQ might have a role in treating the early phases of infection, the results from three rigorously designed studies investigating their role in non-hospitalized COVID-19 patients were equivocal and inconsistent. Here we review the major social events related to the therapeutic use of CQ/HCQ in COVID-19, and the data from selected clinical studies evaluating their efficacy in hospitalized and non-hospitalized COVID-19 patients along with the major safety concerns.