Moreover, there is a possibility for disease flares or other adverse effects for rheumatology patients following vaccination. These adverse events were minimally evaluated in the vaccine clinical trials, which excluded AAIRD patients receiving systemic therapies. The rapid presentation of side effects for some patients receiving COVID-19 vaccinations suggest there is something proinflammatory in the nucleoside-modified RNA vaccines, Dr. Ernst said in the call.
Research Underway
RNA vaccines are new, with very little track record, so questions relative to the new COVID-19 vaccines highlight the importance of generating data on their impact on immunocompromised patients.
Four ongoing research initiatives were presented on the Dec. 18 conference call:
- A multidisciplinary effort led by Alfred Kim, MD, rheumatologist at Washington University School of Medicine, St. Louis, Mo., is studying antibody response to the vaccine by patients who have autoimmune diseases and are likely immunosuppressed. This study is not limited to rheumatic conditions, but includes neuroinflammatory diseases, such as multiple sclerosis, as well as uveitis and inflammatory bowel disease;
- Mariana Kaplan, MD, chief of the Systemic Autoimmunity Branch of the National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), part of the U.S. National Institutes of Health, is leading an internally funded natural history study of what happens to patients with a number of antibody-associated systemic autoimmunities when they are exposed to the virus or the vaccine;
- Kenneth Kalunian, MD, rheumatologist and professor of medicine at the University of California, San Diego, together with Virginia Pascual, MD, and Maria Dall’Era, MD, is exploring immunologic responses to a number of vaccine mechanisms in patients with systemic lupus erythematosus; and
- Dr. Curtis is part of a multi-site effort to conduct a comprehensive, prospective, observational, pragmatic, clinical study to understand how the vaccine affects rheumatology patients. This study will evaluate vaccine immunogenicity, efficacy, safety (including flare) and reactogenicity, and will test whether temporary interruption of short-acting rheumatic treatments may optimize vaccine response.
Rheumatologists likely won’t be the ones giving the vaccine to their patients, Dr. Curtis observed, but they are likely to get questions about it. “It’s good to be abreast of what’s happening in vaccine research, both within and beyond our field.” It may turn out, for example, that rheumatology patients will need to be vaccinated against COVID-19 repeatedly over time, more often than the general population.
“Are there certain considerations about the timing of administering or holding immunomodulatory medications that might make the vaccine work better or its protection last longer?” asks Dr. Curtis. “We don’t know, and that is why rheumatology-specific COVID-19 vaccine research is so important. In talking to many of my patients, I tell them that despite the excellent efficacy in the general population, COVID-19 vaccines were never studied on anyone with their condition or treated with their medications.”