Full Papers
Reactogenicity, safety and disease flares following BNT162b2 mRNA COVID-19 vaccine in patients with chronic immune-inflammatory arthritis treated with biological and targeted synthetic disease-modifying anti-rheumatic drugs
L. De Stefano1, S. Balduzzi2, L. Bogliolo3, B. D'onofrio4, M. Di Lernia5, E. Mauric6, A. Milanesi7, F. Brandolino8, C. Rocca9, S. Chiricolo10, A. Manzo11, C. Montecucco12, S. Bugatti13
- Division of Rheumatology, IRCCS Policlinico San Matteo Foundation, Pavia, and Department of Internal Medicine and Therapeutics, University of Pavia, Italy.
- Division of Rheumatology, IRCCS Policlinico San Matteo Foundation, Pavia, Italy.
- Division of Rheumatology, IRCCS Policlinico San Matteo Foundation, Pavia, Italy.
- Division of Rheumatology, IRCCS Policlinico San Matteo Foundation, Pavia, and Department of Internal Medicine and Therapeutics, University of Pavia, Italy.
- Division of Rheumatology, IRCCS Policlinico San Matteo Foundation, Pavia, and Department of Internal Medicine and Therapeutics, University of Pavia, Italy.
- Division of Rheumatology, IRCCS Policlinico San Matteo Foundation, Pavia, and Department of Internal Medicine and Therapeutics, University of Pavia, Italy.
- Division of Rheumatology, IRCCS Policlinico San Matteo Foundation, Pavia, and Department of Internal Medicine and Therapeutics, University of Pavia, Italy.
- Division of Rheumatology, IRCCS Policlinico San Matteo Foundation, Pavia, and Department of Internal Medicine and Therapeutics, University of Pavia, Italy.
- Division of Rheumatology, IRCCS Policlinico San Matteo Foundation, Pavia, and Department of Internal Medicine and Therapeutics, University of Pavia, Italy.
- Division of Rheumatology, IRCCS Policlinico San Matteo Foundation, Pavia, and Department of Internal Medicine and Therapeutics, University of Pavia, Italy.
- Division of Rheumatology, IRCCS Policlinico San Matteo Foundation, Pavia, and Department of Internal Medicine and Therapeutics, University of Pavia, Italy.
- Division of Rheumatology, IRCCS Policlinico San Matteo Foundation, Pavia, and Department of Internal Medicine and Therapeutics, University of Pavia, Italy.
- Division of Rheumatology, IRCCS Policlinico San Matteo Foundation, Pavia, and Department of Internal Medicine and Therapeutics, University of Pavia, Italy. serena.bugatti@unipv.it
CER15485
2023 Vol.41, N°3
PI 0667, PF 0675
Full Papers
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PMID: 36135948 [PubMed]
Received: 15/01/2022
Accepted : 23/05/2022
In Press: 21/09/2022
Published: 23/03/2023
Abstract
OBJECTIVES:
The safety of COVID-19 vaccination in rheumatic patients treated with biological (b) and targeted synthetic (ts) disease-modifying anti-rheumatic drugs (DMARDs) remains poorly explored.
METHODS:
Reactogenicity, safety and disease flares following each of the two doses of the BNT162b2 mRNA vaccine was evaluated in 186 patients with rheumatoid arthritis, psoriatic arthritis and spondyloarthritis treated with b/tsDMARDs, who discontinued anti-rheumatic treatments around vaccination. A group of 53 healthy controls was used for comparison.
RESULTS:
The frequency and severity of systemic events was similar to that reported in the general population, and no particular safety concerns emerged. The use of methotrexate reduced systemic reactogenicity (adjORs [95% CI] 0.49 [0.25–0.94] and 0.63 [0.32–0.99] after each vaccine dose), whilst no specific effects of different b/tsDMARDs were seen. Flares around vaccination were reported by 24.5% of the patients. Factors associated with flares were active disease (adjORs [95% CI] 2.8 [1.01–8.09] and 1.86 [0.99–6.03] after each vaccine dose) and use of JAKi (adjORs [95% CI] 3.96 [1.39–11.27] and 3.10 [0.99–7.85]). The percentage of cases requiring change or increase in DMARD therapy due to persistent worsening of disease activity at follow-up visits was low (3.2%).
CONCLUSIONS:
The safety of mRNA COVID-19 vaccination in arthritis patients on treatment with b/tsDMARDs is reassuring. In a regimen of peri-vaccine drug interruption, transient flares of the disease more commonly occur in association with active arthritis and use of shorter half-life drugs. Most flares do not require treatment escalation or change.
