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Objective

Little is known regarding the reactogenicity and related SARS-CoV-2 vaccine response in patients with chronic inflammatory disease (CID). Our objective was to characterize the adverse event (AE) profile of CID patients following SARS-CoV-2 vaccination and understand the relationship between reactogenicity and immunogenicity of SARS-CoV-2 vaccines.

Methods

CID patients and healthy controls eligible to receive mRNA SARS-CoV-2 vaccines participated in 3 study visits (pre-vaccine, after dose 1, after dose 2) where blood and clinical data were collected. Assessment of AEs were solicited within 7 days of receiving each dose. Serum anti-SARS-CoV-2 spike IgG+ antibody titers were quantified following vaccination. Statistical analysis was performed utilizing mixed models and tobit regressions, adjusting for covariates.

Results

441 participants (322 CID patients and 119 controls) were included. Compared to controls, CID patients reported greater symptom severity after dose 1 (P=0.0001), including more myalgia and fatigue (P<0.05). For immunogenicity, a higher symptom severity after dose 1 and higher number of symptoms after dose 2 was associated with higher antibody titers (P<0.05). Each increase of one symptom was associated with 15.1% increase in antibody titer. Symptom association was strongest with site pain after dose 1 (105%, P=0.03) and fatigue after dose 2 (113%, P=0.004).

Conclusions

CID patients have a distinct reactogenicity profile following SARS-CoV-2 vaccination compared to controls. Furthermore, there is an association between increased reactogenicity and increased vaccine response. This finding may speak to the more variable immunogenicity in CID patients and may be an important indicator of vaccine response to the novel SARS-CoV-2 vaccines.

Read a Q&A with the first study author here and expert commentary on the clinical implications here.