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.

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.

Musculoskeletal ultrasound for treating rheumatoid arthritis to target-a systematic literature review.

OBJECTIVE: We aimed to systematically review the literature to retrieve evidence on the diagnostic and prognostic value of musculoskeletal ultrasound for a treat to target (T2T) approach in RA. METHODS: Eight research questions were developed addressing the role of ultrasound (including different ultrasound scores and elementary lesions) for diagnosis, monitoring and prognosis of RA. PubMed and EMBASE were searched (2005-2020). Articles on RA and reporting data on musculoskeletal ultrasound were included and extracted according to the underlying questions, and risk of bias assessed according to the study design. RESULTS: Out of 4632 records, 60 articles were included. Due to clinical heterogeneity, meta-analysis was not possible. Ultrasound better predicted disease relapses with respect to clinical examination in patients in remission, while both methods performed similarly in predicting response to therapy, achievement of remission and radiographic progression. Ultrasound was superior to clinical examination in diagnosing joint involvement using another imaging modality, such as magnetic resonance imaging, as reference. Limited ultrasound scores performed like more extensive evaluations for the detection of joint inflammation and for outcome prediction. Higher ultrasound scores of synovitis were linked to poor outcomes at all disease stages, but a specific cut-off distinguishing between low- and high-risk groups did not emerge. CONCLUSIONS: These data confirm the pivotal role of ultrasound when evaluating synovial inflammation and when identifying RA patients at higher risk of relapse. Further research is needed to better define the role of ultrasound in a T2T management strategy in moderately-to-highly active RA.