Reassurance on COVID Vax Safety in Rheumatic Diseases

Registry data collected in 30 European countries indicate that reactions to COVID-19 vaccines were no different in individuals with inflammatory rheumatic illnesses versus non-inflammatory conditions such as osteoporosis, researchers said.

In physician-filed reports on 5,121 patients from Feb. 5 to July 27, 2021, adverse event rates stood at 37% in those with inflammatory rheumatic and musculoskeletal diseases (I-RMD) compared with 40% among patients with non-inflammatory conditions (NI-RMD), according to Pedro Machado, MD, of University College London in England, and colleagues.

Serious adverse events were seen in 0.4% of I-RMD patients versus 1.9% of NI-RMD patients, the group reported in Annals of the Rheumatic Diseases.

In addition, vaccine efficacy did not appear compromised in either group, with breakthrough infections reported for 0.7% and 1.1% of I-RMD and NI-RMD patients, respectively.

“These findings should provide reassurance to rheumatologists and vaccine recipients and promote confidence in SARS-CoV-2 vaccine safety in I-RMD patients,” the group concluded.

Data for the analysis came from the COVAX registry, organized by the European Alliance of Associations for Rheumatology. Physicians treating patients with rheumatic conditions are asked to complete a survey for patients receiving COVID-19 vaccines, covering adverse events potentially associated with immunization. These may include breakthrough infections, short- and medium-term reactions, and disease flares. They could file such reports at any time after the first or second doses of authorized vaccines.

Disease flares were seen following vaccination in 4.4% of I-RMD patients, of which about one in seven were rated as severe. About 1.5% of I-RMD patients had their medication regimens changed as a result.

Machado and colleagues did not find those rates concerning, however, calling them “rare” with the “observed percentages being compatible with the natural history of the disease rather than necessarily caused by vaccines against SARS-CoV-2,” the group wrote.

Of the 5,000-plus patients in the registry, about 4,600 had I-RMD conditions; the countries contributing the most patients to the registry were France (2,070), Italy (809), and Portugal (737). Inflammatory joint diseases were the biggest category of I-RMD (2,979), with rheumatoid arthritis accounting for more than half of these. Others in the I-RMD category included connective tissue diseases such as lupus, systemic sclerosis, and Sjögren’s syndrome; various types of vasculitis; and a broad “other” classification for conditions including sarcoidosis and IgG4-related disease. Most I-RMD patients were reported to have minimal or low disease activity.

In the NI-RMD category were gout, osteoporosis, osteoarthritis, fibromyalgia, and mechanical back pain.

By far the most common vaccine received by patients was the Pfizer-BioNTech mRNA product (70%), followed by AstraZeneca’s adenovirus-based vaccine (17%) and Moderna’s mRNA vaccine (8%). Most of the reports covered two doses of these products.

About two-thirds of I-RMD patients were on biologic therapies at the time of vaccination, with just a handful having drug “holidays” in preparation for the COVID shots. Also, about half of the I-RMD group were on traditional immunosuppressants (including steroids), also with nearly all continuing normal dosing.

In terms of adverse events, the vast majority were mild and among those expected with the COVID vaccines, such as injection-site pain and transient flu-like symptoms. There were a total of 149 “adverse events of special interest,” i.e., those that could become serious such as cardiovascular and neurological abnormalities, immune disturbances, and viral infections. Of those, 16 were rated as “important,” eight required hospitalization, and three were considered life-threatening. None were fatal, as far as Machado and colleagues could determine. Most special-interest events were seen in patients receiving the Pfizer-BioNTech product, which was not surprising given that it was the dominant vaccine provided.

A total of 199 patients experienced disease flares. About half were moderate in severity and some 20 were major, including six patients who had to be hospitalized.

Machado and colleagues cautioned that these data were not the last word on COVID vaccine outcomes in rheumatic disease patients, especially given their study’s limitations. Follow-up times were not standardized and the registry relied on individual physicians’ judgment in many instances. Also, most of the data came from a few countries, with some large nations such as Great Britain, Spain, and Germany severely underrepresented.