Global Rheumatology Alliance registry delivers 'reassuring' data, dispels COVID-19 myths
When the COVID-19 Global Rheumatology Alliance patient registry went live March 24, there was a lot of uncertainty in the air regarding the virus and its behavior, appropriate management strategies, survival rates, pathogenesis and transmission.
In addition, given that it was clear — even early on — that patients with underlying comorbidities tended to have poorer outcomes with COVID-19, there was significant concern among patients with rheumatic diseases, and their providers, about their potential risk for more severe COVID-19 infection.
With so many questions in mind, Jinoos Yazdany, MD, MPH, vice-chair of real-world data infrastructure, registry and IRB/Ethics for the Global Rheumatology Alliance, and colleagues, set about the one task that is certain to be the first step in alleviating those uncertainties: gathering information.
Three months later, it is time to check in.
“The enthusiastic participation of rheumatologists around the world has made the registry more successful than we ever thought possible,” Yazdany told Healio Rheumatology. “Nearly 2,000 cases of individuals with rheumatologic disease and COVID-19 have been entered across 6 continents to date.”
Perhaps the most important byproduct of the registry, for Yazdany, is the extent to which rheumatologists have come together in this time of crisis to find answers for their patients. “Hundreds have taken time to enter cases into the registry,” she said. “It is a very inspiring global effort.”
In addition to the clinical data, the registry has received more than 9,500 responses to its COVID-19 patient survey. The ACR has partnered with the Alliance, which will add a boost to everything from data collection to distribution of information. However, the virus rages on, and there is a significant amount of work to be done.
The effort has not come without setbacks, one of which is that the registry has received considerable scrutiny from institutional review boards (IRBs). “Although it was deemed ‘not human subjects research,’” many institutions required confirmatory IRBs, Yazdany said.
In addition to the time rheumatologists have taken to enter patient data in the registry, colleagues around the world have also spent time seeking these ancillary IRB approvals. “In every U.S. case, institutions have agreed with the original IRB determination,” Yazdany said. “In other countries, volunteers have helped navigate country-specific IRB procedures.”
As these regulatory issues become less problematic, the registry will be more effective at filling the many knowledge gaps surrounding COVID-19 and the rheumatic diseases, according to Yazdany. “We were able to examine factors associated with hospitalization in people with rheumatic disease and COVID-19 and found that some drugs were associated with a higher risk, like moderate to high dose steroids,” she said.
Yazdany added that patients being treated with biologic drugs “seem to do relatively well.” While she is encouraged that the registry has provided clinicians with this kind of useful — and occasionally, comforting — information, she believes that this is just the tip of the iceberg.
To that point, the registry has yielded its first peer-reviewed paper, which was published by Gianfrancesco and colleagues in Annals of the Rheumatic Diseases. The study addresses factors associated with hospitalization for COVID-19 in patients with rheumatic diseases.
As more papers move toward publication, Yazdany discussed some of the trends that are emerging from the registry’s data. “Although the distribution of patients is what we would expect in most rheumatology practices — that is to say, more women, more common rheumatic diagnoses like rheumatoid arthritis and systemic lupus — the fact that people on significant immunosuppression were largely recovering from COVID-19 is reassuring,” she said.
The registry has revealed that older age and comorbidities are the primary drivers of COVID-19 hospitalizations in people with rheumatologic diseases, just as they are in the general population.
Yazdany noted one of the key discoveries made about therapeutic options using registry findings. “Steroids were associated with more hospitalizations,” she said.
The stream of evidence-based information made possible by such a registry can help set the record straight on the glut of misinformation circulating the internet and other forums about COVID-19.
“This is exemplified by some of the early statements public leaders made regarding people with lupus not getting COVID-19 because they were on hydroxychloroquine,” Yazdany said. “We knew this was false early on from registry data.”
Yazdany added that findings from the registry also demonstrated that hospitalization rates were similar between those who did and did not use hydroxychloroquine.
“It is clear from registry data that hydroxychloroquine, at the doses typically used in rheumatology, is not a cure for COVID-19, since many people on the drug have become infected,” Yazdany said. “Only well-done, randomized, controlled trials will answer questions about efficacy and safety once and for all. We eagerly await those results.”
The hydroxychloroquine debacle notwithstanding, another trend is emerging as Alliance members review the findings: the rheumatology armamentarium is likely to play a pivotal role against the virus. “At this time, a number of drugs are being evaluated to treat COVID-19, particularly the late inflammatory stages of disease in which we see abnormal immune responses causing organ damage,” Yazdany said. However, she cautioned that it is too early to tell which of these drugs will be successful.
In what could be a key development, clinical trials are beginning to look at combination therapies, and this has generated some excitement among Yazdany and others who have been watching the registry closely. “For example, it may be possible to use antiviral drugs like remdesivir (Gilead) to reduce viral replication, and then anti-inflammatory drugs to dampen aberrant immune responses,” she said.
Rheumatologists are encouraged to visit the site regularly to find up-to-date information on these and other findings. In addition, data for patients treated for COVID-19 may be added at any time, from anywhere.
“As the case counts grow, we will be able to examine specific drug, disease and comorbidity interactions to identify the patients who are at highest risk for worse outcomes,” she said. “This information can be used to guide how rheumatologists counsel their patients.”
For more information:
- Jinoos Yazdany, MD, can be reached at 1001 Potrero Ave, Building 30, Suite 3300, San Francisco, CA, 94110; email: firstname.lastname@example.org.
- Gianfrancesco M, et al. Ann Rheum Dis. 2020;doi:10.1136/annrheumdis-2020-217871.