COVID-19 Global Rheumatology Alliance registry to close after leaving ‘enormous impact’
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In the early days of the COVID-19 pandemic, a lack of data and sure knowledge left many in the rheumatic disease sphere — health care providers and patients alike — in the dark.
To shed some light in those dark times, rheumatologists from around the world came together in late March 2020 to launch the COVID-19 Global Rheumatology Alliance (GRA) patient registry. This registry enabled rheumatologists to collect information as quickly as possible and begin answering questions for providers and their patients.
Since that time, the COVID-19 Global Rheumatology Alliance has collected data on more than 22,000 cases of COVID-19 from more than 40 countries. Its data have contributed to influential and impactful papers on the risk for severe COVID-19 among patients receiving B-cell depleting drugs, as well as the nonimpact of hydroxychloroquine on the virus.
And now, after more than 2 years, the registry is scheduled to close at the end of the EULAR 2022 Congress on June 4, marking the termination of the inclusion of new cases into the system.
‘An incredible sense of urgency’
“At the start of the pandemic, we knew essentially nothing about how people with rheumatic disease would fare if they became infected with SARS-CoV-2,” Jinoos Yazdany, MD, MPH, the vice chair of real-world data infrastructure for the GRA, told Healio. “There was an incredible sense of urgency to answer our patients' questions and collect high quality evidence to inform clinical care.”
With the creation of the registry, it became much more feasible for rheumatologists, patients and various rheumatology organizations to work together to gather and disseminate information to patients as quickly as possible, Yazdany said.
“I remember very clearly the enthusiasm and momentum at the beginning of the GRA’s formation,” Jean Liew, MD, a clinical researcher at Boston University and the administrative lead for the GRA, told Healio. “Everyone first came together to create a registry, to mirror the IBD registry that was just launching at the time.
“Our mission was to collect data on people living with rheumatic disease as it related to COVID-19 and then disseminate those findings back to the community,” Liew added. “I believe we have done that.”
That said, launching the registry did not come without its challenges.
“One of the largest challenges in the beginning was navigating the complex landscape for Institutional Review Board procedures and data sharing,” Yazdany said. “We spent hundreds of hours sorting through these ethical issues, establishing dozens of data-use agreements, and making sure that patient privacy would be protected to the very highest standards.”
Meanwhile, as the pandemic stretched on, the sheer number of questions begging for answers seemed to multiply.
As the pandemic continued, we faced the issue of having many important clinical research questions that needed answers, but the sheer number of which overwhelmed our capacity to tackle them,” Liew said. “The importance of using the right study designs, data collection and methods to answer clearly defined research questions cannot be stated and reiterated enough. We understood that there was a need from the rheumatology community, especially from patients, to get answers as the pandemic evolved.”
A lasting impact
Throughout the course of the registry collecting and disseminating data, rheumatologists from more than 40 countries contributed more than 22,000 cases of patients with rheumatic diseases who contracted COVID-19, according to Yazdany.
“The GRA has had an enormous impact on how we think about risk of severe COVID-19 outcomes in people with rheumatic diseases,” she said.
Among the registry’s impacts are multiple papers and discoveries, such as the determination that hydroxychloroquine was not protective of COVID-19, according to Philip Robinson, MBChB, PhD, FRACP, MAICD, the GRA’s chair of governance and policy, told Healio. Additionally, Robinson said the registry helped to demonstrate that patients with rheumatic diseases are not adversely affected by those diseases overall. The registry also discovered that pregnant patients generally fared well, Robinson added.
“Very early on, we were able to demonstrate that hydroxychloroquine had no impact on COVID-19 outcomes; this was months before major randomized controlled trials came to the same conclusion,” Yazdany said.
In addition to investigating much-debated pharmacologic options, the registry worked to identify which comorbidities played a role in various COVID-19 outcomes, and how age impacted patients with the disease.
“We confirmed that older age and comorbidity burden were associated with these outcomes,” Liew said. “Specific to rheumatology, we found that higher disease activity, glucocorticoid use, and rituximab use were associated with these outcomes as well.”
According to Yazdany, the GRA was also among the first research efforts to identify that people taking B-cell depleting agents, such as rituximab (Rituxan, Genentech) were at risk for severe COVID-19.
“This finding was later confirmed in dozens of subsequent studies, but the speed at which we found this signal so early in the pandemic was remarkable and allowed us to counsel patients at the highest risk,” Yazdany said.
Additionally, researchers working with the registry compiled and published papers investigating the experience of patients in the early months of the pandemic. Eventually, these would include examinations of patients’ experiences with vaccinations for COVID-19.
“We also had separate surveys addressing the patient experience with vaccinations, including perceptions, side effects and rheumatic disease flares, and with providers, patients and trainees regarding use of telemedicine,” Liew said.
Beyond the specific findings regarding COVID-19 outcomes among patients with rheumatic diseases, the registry also proved the potential — and impact — of global collaboration.
“In addition to identifying risk factors for severe outcomes, the GRA has demonstrated the power of global collaboration,” Yazdany said. “We accomplished so much, so quickly, by working together as a global community of rheumatologists, patients with rheumatic disease and rheumatology organizations.”
A chance for mentorship
According to Robinson, one impact of the registry that might be less obvious to those not directly involved with it is how it helped integrate research to create a system where senior and junior clinicians, as well as patients, are able to come together to collaborate in the face of a pandemic.
“The significant and important integration of patients into the research effort,” Robinson said. “We have two patients who sit on the steering committee and are key members of our team.”
He added that the registry also formed a patient board and various subcommittees to create “patient-directed” summaries.
Beyond patient involvement, registry officials also created a system that allowed for younger clinicians and scientists to contribute meaningfully while receiving mentorship.
“The C19GRA allows a substantial mentoring effort to foster trainees and junior faculty and academics,” Robinson said. “We formed the Clinical and Scientific Committee, who complete projects proposed by the steering committee and propose their own projects. These project groups allow junior researchers and academics the opportunity to both work together on large important projects and learn from senior experienced clinicians and scientists, and build their skills and knowledge in clinical research and epidemiology.”
When the registry was founded, Liew was in training and eager to jump in and get involved.
“Regarding the involvement of trainees – this is something I feel strongly about since I was a trainee when the GRA was founded,” Liew said. “I was online, I was present, I was available, and I had training in clinical epidemiology. Despite being a trainee, I was able to play a large part in the development and maintenance of the GRA, and help get other trainees as well as early career rheumatologists into GRA projects.”
The virtual nature of the registry allowed willing and capable trainees to sign on and contribute, as long as they are able to handle the workload, Liew added.
On the front lines
For the registry’s leadership, the transition to managing clinic work, standard research efforts and a remote research team was an intense experience.
“We essentially stood up an entire global registry and started collecting global data within a few weeks of the start of the pandemic,” Yazdany said. “This meant many sleepless nights for me and other members of the leadership team. I remember going to clinic each week, having some intense clinical days, including worrying about the safety of our staff and patients, trying to keep my regular research afloat and learning to manage a remote research team, home-schooling my kids, and then working on the GRA late into the night.”
For Liew, working on the registry offered the opportunity to find answers to questions with no concrete solutions.
I chose this line of work because I wanted to be able to answer some of the unanswered questions that I come across in clinical settings,” Liew said. “Sometimes there is no published literature. A lot of these questions also cannot be answered through clinical trials. The GRA was another way in which I could use this training, and these experiences, to take patient questions and transform them into study design and analysis, and generate some answers.”
Looking toward the future
According to Robinson, the GRA will continue to analyze and publish its collected data, when that data can “add value and provide insights to patients and their doctors.”
However, beyond the immediate future, there are questions regarding all the data that has been collected in the 27 months the registry was open. More specifically, questions of data analysis and safeguarding are of importance, Liew said.
Additionally, the group is working on a summative paper that will highlight the registry’s key findings, according to Yazdany.
“We’ve learned that it’s possible to bring together a large international group with different skillsets and experiences and create a registry that collects valuable and granular data, and to be able to design studies that analyze those data in a scientifically rigorous way,” Liew said.
Lessons for the future are multifaceted — from the practicality of social media as a communication tool to learning to collaborate across industries and space, working in the registry goes a long way toward preparing clinicians for future endeavors in a similar vein, Yazdany said.
Robinson added: “It shows what is possible for a grassroots organization to achieve, when many people come together in a time of crisis.”
References:
@Rheum_Covid. https://twitter.com/rheum_covid/status/1512052777497022472. April 7, 2022. Accessed April 19, 2022.
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