Pedro Machado, MD, PhD: COVID-19 Vaccine Safety in Patients With Rheumatic and Musculoskeletal Disease

Rheumatology Network sat down with Pedro Machado, MD, PhD, to discuss his EULAR 2021 presentation entitled, “COVID-19 vaccine safety in patients with rheumatic and musculoskeletal disease.” Dr. Machado is an Associate Professor at the University College London, in the UK. He explains to us the key findings of the study, common concerns for patients and physicians regarding the COVID-19 vaccine, and the clinical significance of these results.

Rheumatology Network: To begin, what first motivated you to investigate COVID-19 safety for this specific patient population?

Pedro Machado, MD, PhD: So with the introduction of the COVID-19 vaccination programs, there were specific concerns raised by the population with rheumatic diseases because they have either an underlying immune dysfunction or sometimes they're taking drugs that affect the immune system. And therefore, there were concerns because of the specificities that there could be certain type of adverse events that would be more common or more worrying among patients with immune mediated disease in general. So that was the motivation to create a registry specific for patients with rheumatic diseases.

RN: What are some of the common concerns for patients and physicians in regard to the COVID-19 vaccine?

PM: One of the concerns was that the vaccines could potentially lead to flares of the inflammatory rheumatic disease, or to certain that there could be certain side effects, especially the ones that are immune mediated that could be more common among patients with rheumatic diseases. There is a second concern that is not addressed by this registry, because this is a registry looking at the safety of the vaccines. But there is also a concern with regards to the efficacy of the vaccines, because potentially some of the drugs that are being used could decrease the immunological response to the vaccine, but that is being addressed by other types of studies because it requires the collection of biologic material and the assessment of the antibody production and also T cell responses in our patients. This registry is only about the safety of the vaccines. RN: What were the key findings of your study?

PM: I guess the key message of the of the results that we'll be presenting, the key takeaway message is that the COVID-19 vaccines are safe in patients with rheumatic diseases. Most of the observed adverse events were the same as in the general population. And they were non-serious symptoms involving short term, local or systemic reactions. So, things like pain in the sight of injection, fatigue, headaches, flu-like symptoms. So, the same type of thing that is observed in the general population, and in fact, the same type of thing that is observed with many other vaccines. The other thing is that the overwhelming majority of our patients, they tolerate the vaccination very well, with rare reports of inflammatory, rheumatic disease flare, and very rare reports of severe adverse events. Therefore, I think that these initial findings should provide reassurance to rheumatologists and to vaccine recipients, and they should promote confidence in COVID-19 vaccine safety in our patient population. You know, vaccines are one of the greatest medical advances of modern times. They prevent millions of deaths yearly, and many, many more million deaths will be prevented with COVID-19 vaccines and this includes patients with rheumatic diseases.

RN: Were you surprised by the results of your study?

PM: I wouldn't say surprised, no. I think it's important to monitor what is happening our patient population and in the general population in general because there can always be surprises; there can always be unexpected reactions. And so therefore it is really important to monitor the vaccination problems and the side effects that are being reported. I will say that I wasn’t surprised because I was quite confident about the safety of these vaccines in our patient population and the data from the registry is just corroborating that expectation.

RN: What is the clinical significance of these results?

PM: I think the clinical significance is that healthcare professionals in rheumatology should be confident when advising dear patients about the safety of the vaccines and they should encourage all patients to be vaccinated with any type of COVID-19 vaccine.

RN: Were there any strengths or limitations of the study that you would like to highlight?

PM: I think the one of the strengths is that the population that has been reported to the registry is highly representative of the of the type of population that we see now in our clinics. So more than 90% of the patients, whether inflammatory rheumatic disease such as rheumatoid arthritis, axial spondyloarthritis, psoriatic arthritis, systemic lupus, was also quite a diverse population. And the obvious limitation is that it is still a small number of patients. We are reporting around 1500 subjects, we now have close to 3000 reported to the registry. But it's still a small sample size for this type of study. But data collection is ongoing. And we'll be looking at the results periodically and updating the scientific community as the study proceeds.

RN: Is there anything else that you'd like our audience to know before we wrap up?

PM: Well, just 1 last message: get vaccinated and get vaccinated with any of the vaccines that are offered to you.

RN: Thank you so much for speaking with me today. I really appreciate it.

PM: No problem. It was a pleasure.