Andrea Doria

Objectives We investigated the effectiveness and safety of very-low-dose (<5 mg/day) glucocorticoids (GCs) in patients with RA treated with biologic and targeted synthetic DMARDs (b/tsDMARDs). Methods In this prospective cohort study, we included all RA patients who started their first b/tsDMARDs at our institution between 2015 and 2020 and were monitored every 6 months for 3 years. Relationships between exposure to very-low-dose GCs and disease activity were examined through multivariable logistic regression and repeated-measures analysis of variance. The impact of very-low-dose GCs on safety was also evaluated. Results We enrolled 229 RA patients, of whom 68% were prescribed very-low-dose GCs and 32% received no GCs. After 3 years on b/tsDMARDs, 32% had never abandoned, 20% had gone on and off and 23% had permanently discontinued very-low-dose GCs, while 25% had never taken GCs. Shorter disease duration at b/tsDMARD initiation was the single modifiable predictor of very-low-dose GC cessation [odds ratio 1.1 (95% CI 1.03, 1.14) for any 1-year decrease; P = 0.001]. A significant association existed between ongoing utilization of very-low-dose GCs and persistent moderate disease activity. Use of very-low-dose GCs was associated with hypertension (20% vs 11%) and myocardial infarction (2.3% vs 0%). Conclusion A substantial proportion of RA patients treated with b/tsDMARDs continue to receive very-low-dose GCs without significantly improving disease control. However, this appears to increase cardiovascular morbidity.

The purpose of the study was to evaluate the antibody response after COVID-19 vaccination in patients affected by systemic autoinflammatory diseases (SAID) undertaking IL-1 inhibitors (IL-1i) compared to healthy vaccinated controls (HC). The course of COVID-19 in vaccinated patients on IL-1i was also assessed. The serological response was evaluated in SAID patients using the CLIA MAGLUMI TM 2000 Plus test after the first vaccination cycle and the booster dose. Fifty-four fully vaccinated healthcare workers were enrolled as HCs. GraphPad Prism 8 software was used for statistical analysis. All patients developed an adequate antibody response. No differences were observed between the antibody titers of patients on IL-1i and those not on IL-1i, either after the first vaccination cycle or the booster dose (p = 0.99), and to HC (p = 0.99). With increasing age, a decrease in antibody production was assessed after the second vaccine in SAID (r = 0.67, p = 0.0003). In general, 11.6% of SAID patients had COVID-19 after receiving vaccination. None of them developed severe disease or experienced flares of their autoinflammatory disease. In conclusion, patients receiving IL-1i develop an antibody response comparable to HC. No side effects after vaccination were observed; IL-1i was continued before and after injections to avoid flare-ups.