Bruce, IN

Cohen, H

Cuadrado, MJ

Giles, I

Gordon, C

Hunt, BJ

Isenberg, D

Jacobsen, S

Middeldorp, S

Mosca, M

Pavord, S

Radin, M

Roccatello, D

Salmon, J

Schreiber, K

Sciascia, S

Vinet, E

Voss, A

Watkins, L

English

UCL Discovery

  Since January 2020 Elsevier has created a COVID-19 resource centre with free information in English and Mandarin on the novel coronavirus COVID-19. The COVID-19 resource centre is hosted on Elsevier Connect, the company's public news and information website.  Elsevier hereby grants permission to make all its COVID-19-related research that is available on the COVID-19 resource centre - including this research content - immediately available in PubMed Central and other publicly funded repositories, such as the WHO COVID database with rights for unrestricted research re-use and analyses in any form or by any means with acknowledgement of the original source. These permissions are granted for free by Elsevier for as long as the COVID-19 resource centre remains active.  Correspondencewww.thelancet.com/rheumatology   Published online October 29, 2020   https://doi.org/10.1016/S2665-9913(20)30382-9 1Hydroxychloroquine in patients with rheumatic diseases during the COVID-19 pandemic: a letter to cliniciansIn the initial phase of the COVID-19 pandemic, the immune modulator hydroxychloroquine received sub-stantial international scientific and media attention. We wish to express our concerns about the continuing implications of this increased attention for our patients with systemic lupus erythematosus (SLE) and antiphospho-lipid syndrome.Hydroxychloroquine is licensed for the treatment of rheumatoid arth-ritis, SLE, and juvenile idiopathic arthritis. In 2018, the drug gained an orphan designation for the treatment of patients with antiphospho lipid syn drome. From February, 2020, hydroxychloroquine attracted atten-tion for its potential antiviral and immunomodulatory effects in the treatment of COVID-19 and was suggested as a potential therapeutic agent for the treatment of COVID-19-associated pneumonia. This led to emer gency US Food and Drug Adminstration approval for use of hydroxychloroquine in patients with COVID-19.1In June, 2020, WHO published interim results from the SOLIDARITY trial, which showed no benefit (or harm) associated with hydroxychloroquine use in the treatment of COVID-19. Other studies suggested a potential cardiac risk associated with high-dose hydroxychloroquine (800 mg daily) in patients with COVID-19, especially when given with the pro-arrhythmogenic drug azithromycin.2 A systematic review of the effect of hydroxychloroquine in the treatment of COVID-19 showed highly variable outcomes of observational studies,3 leading the authors to conclude that the evidence was weak and conflicting with regard to the benefits and harms of using hydroxychloroquine to treat COVID-19.To achieve the immunomodula-tory effects of hydroxychloroquine, the prescribed dose usually varies between 200–400 mg daily, although recom mendations from the American Academy of Ophthalmology suggest a maximum dose of 5 mg/kg to avoid any retinal changes after 5 years of treatment. It is important to highlight and inform patients that the doses of hydroxychloroquine used in the acute settings of COVID-19 studies that reported cardiotoxicity were much higher (ie, exceeding 800 mg daily) than the doses used in rheuma tolo-gical practice.Our concerns go beyond the conflicting publicity that hydroxychlo-roquine has received during the COVID-19 pandemic. Hydroxy chlo-ro quine is clearly efficacious for many patients with SLE. It reduces organ damage accrual and disease flare rate and severity, is protec-tive against SLE renal damage, and improves overall survival. The British Society for Rheumatology (BSR) and the American College of Rheumatology (ACR) recom mend use of hydroxychloroquine in patients with SLE, including during preg nancy (unlike other disease-modifying anti-rheumatic drugs). Ongoing studies are evaluating the role of hydroxy -chloroquine in patients with anti-phospholipid antibodies.In our experience, patients taking hydroxychloroquine have an increased awareness of the drug, and as rheuma-tologists we are often confronted with questions around its safety. It is clear that patients feel confused as to whether hydroxychloroquine is effective, harmful, or has no effect in COVID-19. Accumulating evidence suggests that patients with rheumatic diseases who are treated with hydroxy-chloroquine long-term are not more likely to be infected with severe acute respiratory syndrome coronavirus 2 and do not have a more severe disease course or increased mortality. These patients are also unlikely to be protected from infection.4Initially, the publicity around a potential beneficial effect of hydroxy-chloroquine in patients with COVID-19 threatened the availably of the drug for patients with rheumatic diseases, while the publicity around potential harmful effects of the drug in patients with COVID-19 has led some patients with SLE and antiphospholipid syn-drome to stop taking it. Both publicity effects have had ongoing, potentially harmful effects on patients.Randomised controlled trials, such as the RECOVERY trial, have seen no benefit of hydroxychloroquine in hos-pitalised patients with COVID-19.5 We encourage clinicians to advise patients with SLE or anti phospholipid syndrome to adhere to any hydroxychloroquine medication prescribed for long-term disease con trol, in keeping with the cur rent BSR, European League Against Rheumatism, and ACR guidance. We recommend that physicians actively inform and guide patients on how to find relevant information from reliable sources to avoid misleading information on the use and safety of hydroxychloroquine.IG reports an unrestricted educational grant from UCB, speaker and travels fees from UCB, and speaker fees from Lupus Academy. HC reports institutional research support to attend scientific meetings from Bayer Healthcare, honoraria from Bayer Healthcare, and consultancy fees from UCB paid to University College London Hospital Charity. SM reports grants and personal fees from Aspen, Daiichi Sankyo, and Bayer, and personal fees from Bristol Myers Squibb-Pfizer, Boehringer-Ingelheim, Portola, and AbbVie, outside the submitted work. All other authors declare no competing interests.*Karen Schreiber, Savino Sciascia, Ian N Bruce, Ian Giles, Maria J Cuadrado, Hannah Cohen, Caroline Gordon, David Isenberg, Søren Jacobsen, Saskia Middeldorp, Marta Mosca, Sue Pavord, Massimo Radin, Dario Roccatello, Jane Salmon, Evélyne Vinet, Anne Voss, Linda Watkins, Beverley J Huntkschreiber@danskgigthospital.dkDanish Hospital for Rheumatic Diseases, 6200 Sonderborg, Denmark (KS); Thrombosis and Haemostasis, Guy’s and St Thomas’ NHS Foundation Trust, London, UK (KS, BJH); Center of For European League Against Rheumatism guidance for patients during COVID-19 see https://www.eular.org/eular_guidance_for_patients_covid19_outbreak.cfmFor American College of Rheumatology guidance for patients during COVID-19 see Arthritis Rheumatol 2020; published online April 29. https://doi.org/10.1002/art.41301Lancet Rheumatol 2020Published Online October 29, 2020 https://doi.org/10.1016/S2665-9913(20)30382-9Correspondence2 www.thelancet.com/rheumatology   Published online October 29, 2020   https://doi.org/10.1016/S2665-9913(20)30382-95 The RECOVERY Collborative Group. Effect of hydroxychloroquine in hospitalized patients with COVID-19. N Engl J Med 2020; published online Oct 8. https://doi.org/10.1056/NEJMoa2022926.Research of Immunopathology and Rare Diseases—Coordinating Center of Piemonte and Aosta Valley Network for Rare Diseases (MR, DR, SS), Nephrology and Dialysis (MR, DR, SS), and School of Specialization of Clinical Pathology (MR, DR, SS), Department of Clinical and Biological Sciences, University of Turin, Italy; Arthritis Research UK Epidemiology Unit, Faculty of Biology, Medicine and Health, Manchester Academic Health Sciences Centre, The University of Manchester, NIHR Manchester Musculoskeletal Biomedical Research Centre, Manchester University NHS Foundation Trust, Manchester Academic Health Science Centre Manchester, Manchester, UK (INB); Centre for Rheumatology Research, UCL Division of Medicine (IG), Department of Haematology, Haemostasis Research Unit (HC) and Centre for Rheumatology, Division of Medicine (DI), University College London, London, UK; Women’s Health, University College London Hospital, London, UK (IG); Department of Haematology, University College London Hospitals NHS Foundation Trust, London, UK (HC); Rheumatology Department, Clinica Universidad de Navarra, Madrid, Spain (MJC); University of Birmingham College of Medical and Dental Sciences, Birmingham, UK (CG); Copenhagen Lupus and Vasculitis Clinic, Copenhagen University Hospital, Copenhagen, Denmark (SJ); Department of Vascular Medicine, Academic Medical Center, Amsterdam, Netherlands (SM); Department of Clinical and Experimental Medicine, University of Pisa, Pisa, Italy (MM); Department of Haematology, Oxford University Hospitals NHS Foundation Trust, Oxford, UK (SP); Department of Medicine, Hospital for Special Surgery, Weill Cornell Medicine, New York, NY, USA (JS); Division of Rheumatology, McGill University Health Centre, Montreal, QC, Canada (EV); Centre for Outcomes Research and Evaluation, Research Institute of the McGill University Health Centre, Montreal, QC, Canada (EV); Department of Rheumatology, Odense University Hospital, Odense, Denmark (AV); and Liverpool Women’s Hospital, Liverpool Women’s NHS Foundation Trust, Liverpool, UK (LW)1 US Food and Drug Administration. Fact sheet for health care providers emergency use authorization (EUA) of hydroxychloroquine sulfate supplied from the strategic national stockpile for treatment of COVID-19 in certain hospitalised patients. June 15, 2020. https://www.fda.gov/media/136537/download (accessed Oct 10, 2020).2 Tleyjeh I, Kashour Z, AlDosary O, et al. The cardiac toxicity of chloroquine or hydroxychloroquine in COVID-19 patients: a systematic review and meta-regression analysis. medRxiv 2020; published online June 18. https://doi.org/10.1101/2020.06. 16.20132878 (preprint).3 Hernandez AV, Roman YM, Pasupuleti V, Barboza JJ, White CM. Update alert: hydroxychloroquine or chloroquine for the treatment or prophylaxis of COVID-19. Ann Intern Med 2020; 173: W78–79.4 Gentry CA, Humphrey MB, Thind SK, Hendrickson SC, Kurdgelashvili G, Williams RJ II. Long-term hydroxychloroquine use in patients with rheumatic conditions and development of SARS-CoV-2 infection: a retrospective cohort study. Lancet Rheumatol 2020; 2: e689–97.

Hydroxychloroquine in patients with rheumatic diseases during the COVID-19 pandemic: a letter to clinicians.

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Hydroxychloroquine in patients with rheumatic diseases during the COVID-19 pandemic: a letter to clinicians.

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