COVID-19 Vaccine Did Not Increase Flares or Adverse Reactions for Patients with Rheumatic Disease

Only 11% of patients reported a flare that required treatment and no participants experienced severe flares. Approximately 60% of flares occurred after D2.

Patients with rheumatic and musculoskeletal disease (RMD) did not report severe flare or experience adverse reactions that impacted daily activity following COVID-19 vaccination, according to a study published in Arthritis and Rheumatology.1 Overall flares after vaccination were also uncommon.

“Patients with RMD were not well represented in [previous] trials, and despite the significant morbidity and mortality associated with SARS-CoV-2 infection, studies have found that many patients with RMD remain hesitant about getting vaccinated due to concerns related to the risk of disease flare,” investigators stated.

In this prospective observational study, 1377 patients aged ≥18 years with RMD who received 2 doses of the COVID-19 vaccine completed comprehensive online questionnaires regarding symptoms and flares experienced within 7 days of each dose as well as 1 month following a flare after the second dose (D2). Questions included details of both local and system reactions.

Demographics, RMD diagnosis, and prior COVID-19 diagnosis were collected. The mean age was 47 (36-59), 92% of participants were female, and 90% were White. Inflammatory arthritis (47%) and systemic lupus erythematous (SLE) (20%) were the most commonly reported RMDs. Therapies included combination therapy (50%), conventional disease modifying anti-rhematic drugs (cDMARDs) (26%) and biologic therapy (22%).

Local reactions were pain, swelling, and redness and systemic adverse events were listed as fever, fatigue, headache, vomiting, diarrhea, chills, and myalgia. Participants also graded the impact these symptoms had on their daily activities, with categories ranging from “no interference,” “some interference,” and “prevention of daily activity.”

In the 1-month follow-up questionnaire, participants were asked additional questions about their prior history of flare, as well as their symptoms, duration of the flare, and treatment. Open-ended responses were also accepted.

Only 11% of patients reported a flare that required treatment and no participants experienced severe flares. Approximately 60% of flares occurred after D2. A total of 767 (56%) participants that had at least 1 flare in the 6 months before their first dose (D1) and there were no allergic reactions.

Flares were reported as a worsening of pre-existing symptoms of joint pain, swelling, fatigue, and myalgia (91%) as well as new onset of symptoms (72%). Flares requiring treatment were most frequently treated with oral corticosteroids (75%) and none of the participants were admitted to a hospital or ICU. Investigators noted an increased risk of flare for patients with a prior COVID-19 diagnosis (IRR 2.09 95%, CI 1.21-3.60), recent flares prior to vaccination (IRR 2.36, 95% CI 1.66-3.36), and receiving combination immunomodulatory therapy (IRR 1.95 95% CI 1.41-2.68).

Adverse reactions after D1 and D2 included injection site pain (87%, 86%, respectively) and fatigue (60%, 80%, respectively). However, exhibiting symptoms that prevented daily activities was uncommon.

Strengths of the study were the nation-wide sample size, however, as most participants were female and white, generalizability is limited. Further, there was a lack of data on immunomodulatory timing and dosing, and baseline disease activity was not analyzed. The study may have been susceptible to responder bias, as all data was patient-reported.

“Local and systemic reactions should be anticipated and setting expectations with patients may alleviate anxiety. This is particularly relevant given periodical revaccination may be required in future,” investigators concluded. “These early, reassuring results may ameliorate concern among patients and inform critical discussions regarding vaccine hesitancy or refusal.”

Reference:

Connolly CM, Ruddy JA, Boyarsky BJ, et al. Disease Flare and Reactogenicity in Patients with Rheumatic and Musculoskeletal Diseases Following Two-Dose SARS-CoV-2 Messenger RNA Vaccination [published online ahead of print, 2021 Aug 4]. Arthritis Rheumatol. 2021;10.1002/art.41924. doi:10.1002/art.41924