'Fire hydrant' of COVID-19 data tasks clinicians with conflicting evidence, mixed results
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Given the global deluge of data investigating COVID-19 in patients with rheumatic and immune-mediated diseases, clinicians continue to struggle with divergent evidence and recommendations, noted a speaker at the ACR State-of-the-Art Clinical Symposium.
“It was a real challenge to select what to cover,” Cassandra Calabrese, DO, of the Cleveland Clinic Foundation, said of the topics for her presentation. She described the amount of data emerging about all facets of the virus as a “fire hydrant.”
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Highlights of the talk included risk factors for worse outcomes with COVID-19 infection among patients with rheumatologic diseases, current therapeutic options and an update on when and whom to vaccinate.
Calabrese credited the COVID-19 Global Rheumatology Alliance for being a worthy contributor to the aforementioned fire hydrant, providing a much-needed, one-stop source of data for rheumatologists seeking guidance for managing their patients through the pandemic.
Some of these data have shown that certain patients with immune-mediated diseases (IMIDs) are at greater risk for worse outcomes with COVID-19, including men, older patients and those with moderate or high disease activity. Smokers with rheumatoid arthritis are at greater risk of morbidity and mortality from COVID-19, as are patients being treated with rituximab (Rituxan, Genentech), sulfasalazine or prednisone 10 mg or more.
“But it is still unclear whether patients with IMIDs are at greater risk of acquiring COVID in the first place,” Calabrese said.
Regarding therapeutic options, Calabrese compared the utility of interleukin-6 inhibitors with that of the MC Escher staircase drawing. “The role of IL-6 in the treatment of COVID can be different depending on which way you are looking at it,” she said.
Professional guidelines underscore this point. The NIH guidelines currently recommend against IL-6 inhibitors in COVID-19, while the Infectious Diseases Society of America (IDSA) provides room for “potential niche” use of tocilizumab (Actemra, Genentech) in patients who may not be candidates for other treatment options. “The recommendations are a little unclear.”
Moreover, the data supporting IL-6 drugs have also been mixed. Calabrese noted that a study conducted at the Cleveland Clinic had a “disappointing ending,” while the REMAP-CAP and RECOVERY studies showed some positive benefit for tocilizumab in COVID-19. One issue for consideration is that glucocorticoids have also been used in combination with tocilizumab, and it is unclear which drug is yielding the positive outcomes.
Ex vivo work with janus kinase inhibitors have sent a signal of some efficacy in COVID, according to Calabrese. However, the black box warning for blood clotting associated with this drug class may be of concern, given that COVID patients are hypercoagulable. “So, that is a worry,” Calabrese said.
Similarly, combination therapy with baricitinib (Olumiant, Eli Lilly & co.) and remdesivir (Veklury, Gilead Sciences) received emergency use authorization for COVID from the FDA in November 2020. However, recent findings from the COV-BARRIER study of baricitinib failed to meet expectations.
With these findings in mind, the NIH recommends that there are insufficient data for or against baricitinib with corticosteroids in COVID-19, while the IDSA suggested that baricitinib alone or with remdesivir may have utility in patients who are unable to receive dexamethasone.
Moving onto vaccines, Calabrese reported that no new safety signals have emerged for the Pfizer and Moderna products after several months in circulation. “mRNA vaccines are safe,” she said.
Clinicians are encouraged to let patients know that “they may not feel great” after their second dose of an mRNA vaccine. “I let my patients know that this is a sign of the immune system doing its job,” she said.
The single-dose Johnson & Johnson vaccine may be useful for coordinating a dose in patients being treated with rituximab, which carries with it a host of complications pertaining to vaccine efficacy.
Calabrese also addressed reports that the J&J product has lower efficacy than its mRNA counterparts. “Many of the mRNA vaccine trials were done in June and July of 2020, before variants had begun to emerge,” she said. “New variants have impacted vaccine efficacy. It is apples to oranges.”
“We remind all patients that all of the vaccines are excellent and effective,” she added.
For women who are pregnant or nursing, the CDC and the Society for Maternal Fetal Medicine, among other organizations, recommend that the benefits of vaccination outweigh the risks. “This is particularly true since pregnant women are at risk for more severe COVID,” Calabrese said.
Looking ahead, one key area of discussion pertains to the duration of vaccine protection, according to Calabrese. She suggested that a booster may be likely, but that it is a “really good question” that will hopefully be answered soon.
Calabrese closed with a brief comment on the ACR statement on COVID-19 vaccine use, which she encouraged all attendees to read. “Rheumatology providers have a big role in recommending and advocating vaccines for our patients,” she said. “It is our job.”
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Calabrese C. COVID Update: For Adults and Children. Presented at: American College of Rheumatology State-of-the-Art Clinical Symposium. April 9-11, 2021 (virtual meeting).
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