medwireNews: The American College of Rheumatology (ACR) has issued guiding principles for the allocation of hydroxychloroquine, interleukin (IL)-1 and 6 antagonists, Janus kinase (JAK) inhibitors, and eculizumab during the COVID-19 pandemic.
“All recommendations are based on current knowledge and are subject to revision as circumstances evolve,” says the ACR.
The hydroxychloroquine guidance emphasizes that the agent is “an essential medicine” for people with systemic lupus erythematosus (SLE), particularly pregnant women, as well as “a mainstay of therapy for many patients with rheumatoid arthritis [RA].”
It says that hydroxychloroquine shortages followed preliminary research suggesting possible antiviral activity of the agent against severe acute respiratory syndrome coronavirus 2 (SARS-CoV2), despite “[s]erious flaws in the methodology and interpretation of the data.”
The detailed recommendations include making every effort to ensure adequate supply of hydroxychloroquine to people who need it, particularly pregnant women with SLE, and ensuring that rheumatology health professionals are involved in decisions about hydroxychloroquine allocation.
In the context of COVID-19, the ACR says that “allocation of adequate supplies of [hydroxychloroquine] should be prioritized (but not limited) to support clinical trials designed to test the efficacy of [the agent],” emphasizing that “[u]nrestricted access to [hydroxychloroquine] for COVID-19 prophylaxis in the absence of clinical trial data supporting its use is inappropriate.”
The guidance for IL-1, IL-6, and JAK inhibitors similarly states that an adequate supply must be maintained for patients who need these agents, given that they are used to treat a variety of rheumatic diseases including RA, giant cell arteritis, and juvenile idiopathic arthritis.
It explains that some people with severe COVID-19 “appear to display a ‘cytokine storm’ syndrome similar to that seen in secondary hemophagocytic lymphohistiocytosis or macrophage activation syndrome,” which has led to interest in IL-1, IL-6, and JAK inhibitors as potential treatments for severe COVID-19, with randomized controlled trials underway in the USA, Europe, and Asia.
“The potential therapeutic benefits of IL-1 and IL-6 and JAK antagonists in COVID-19, and the urgent need for effective therapy against SARS-CoV-2, justifies expedited controlled trials in humans,” says the ACR, adding that “[s]uch trials should be carried out by experienced investigators equipped to generate and interpret reliable results while safeguarding patient safety and informed consent.”
The ACR says that eculizumab – a complement inhibitor used in the treatment of various conditions including SLE- and systemic sclerosis-related renal failure – has also entered clinical trials for COVID-19 based on evidence suggesting a role for complement activation in acute respiratory distress syndrome.
As with hydroxychloroquine and IL-1, IL-6, and JAK inhibitors, the ACR says that eculizumab access should be prioritized for those who need it, with rheumatologists being involved in decisions on allocation.
The guiding principles for all the agents emphasize that pharmacy-level restrictions on new prescriptions for people with appropriate rheumatic conditions should not be in place, and that predatory price increases “should be vigorously opposed by regulatory bodies.”
medwireNews is an independent medical news service provided by Springer Healthcare. © 2020 Springer Healthcare part of the Springer Nature Group
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