Efficacy and Safety of Anti-SARS-CoV-2 Antiviral Agents and Monoclonal Antibodies in Patients with SLE: A Case-Control Study.

Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)-related disease (COVID-19) has spread pandemically with high rates of morbidity and mortality. COVID-19 has also posed unprecedented challenges in terms of rapid development of pharmacological countermeasures to prevent or contrast SARS-CoV-2 pathogenicity. Anti-SARS-CoV-2 antiviral agents and monoclonal antibodies have been specifically designed to attenuate COVID-19 morbidity and prevent mortality in vulnerable subjects, such as patients with immune-mediated diseases, but evidence for the safe and effective use of these drugs in this latter population group is scarce. Therefore, we designed a retrospective, multicentre, observational, case-control study to analyse the impact of these treatments in COVID-19 patients with systemic lupus erythematosus (SLE), a paradigmatic, multi-organ autoimmune disease. We identified 21 subjects treated with antivirals and/or monoclonal antibodies who were matched with 42 untreated patients by age, sex, SLE extension and duration. Treated patients had higher baseline SLE disease activity index 2000 scores [SLEDAI-2K median (interquartile range) = 4 (1-5) vs. 0 (0-2); p = 0.009], higher prednisone doses [5 (0-10) mg vs. 0 (0-3) mg; p = 0.002], and more severe COVID-19 symptoms by a five-point World Health Organisation-endorsed analogue scale [1 (0-1) vs. 0 (0-1); p < 0.010] compared to untreated patients. There was no difference between groups in terms of COVID-19 outcomes and sequelae, nor in terms of post-COVID-19 SLE exacerbations. Three subjects reported mild adverse events (two with monoclonal antibodies, one with nirmatrelvir/ritonavir). These data suggest that anti-SARS-CoV-2 antivirals and monoclonal antibodies might be safely and effectively used in patients with SLE, especially with active disease and more severe COVID-19 symptoms at presentation.

Disease activity and disease-related factors are drivers of patient global assessment in rheumatoid arthritis: a real-life cross-sectional study.

Despite that the Patient Global Assessment (PGA) is widely used for measuring Rheumatoid Arthritis (RA) disease activity to define the remission state of the disease, the primary contributors influencing patients' ratings are still debated. This study aims to determine which clinical, sociodemographic and lifestyle-related contextual factors might be key drivers of PGA in RA. This single-center cross-sectional study recruited 393 consecutive adult RA patients. Median age 60 years, females 306 (77.9%). Data related to disease activity were assessed by using Simplified Disease Activity Index (SDAI), severity by Health Assessment Questionnaire (HAQ), and impact by RA Impact of Disease (RAID). Sociodemographic/lifestyle features were collected. Disease remission was calculated using Boolean-based criteria 1.0 and 2.0. Quantile regression models were used for univariate and multivariate analysis. The remission rate progressively increased from 15% by using SDAI with a Boolean 1.0-based definition to 43.5% using a Boolean 2.0-based remission. Among factors related to disease activity, the use of low-dose corticosteroids, the RAID items pain and sleep difficulties were predictive for worse PGA scores (p = 0.01). Among factors related to disease severity HAQ score and RAID total were independent factors associated with higher median PGA (p = 0.02 and p < 0.001). RAID's physical well-being was related to PGA scores (p = 0.01). An increasing trend in PGA was observed in longstanding diseases (> 15 years). Our results confirmed that there is no unambiguous interpretation of the PGA score. It is a measure related to some disease activity parameters, but it is also influenced by contextual factors related to disease severity and impact. These data highlighted that PGA should have a broad interpretation, thus supporting the proposal of a dual targets (biological and impact) approach to obtain a more accurate estimate of disease activity.

Anti-SARS-CoV-2 vaccination in adolescent and adult patients with juvenile-onset systemic lupus erythematosus: tolerability and impact on disease activity.

OBJECTIVES: JSLE has a severe presentation and a remitting course. Patients with JSLE carry an increased vulnerability to infections, which also act as triggers of disease flare. Thus, vaccination against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is an important tool in JSLE. The objective of this study is to evaluate the tolerability and the safety of anti-SARS-CoV-2 vaccination, including the booster, in a monocentric cohort of JSLE patients. METHODS: Clinical records of JSLE patients who received at least one dose of any anti-SARS-CoV-2 vaccine were retrospectively reviewed. Data about disease activity, treatment, anti-SARS-CoV-2 vaccination and COVID-19 infection were collected. RESULTS: Sixty-five JSLE patients received at least one dose of anti-SARS-CoV-2 vaccination, while 46 patients completed the schedule with the booster. The rate of mild-moderate adverse events was 66%, mainly comprising fever, fatigue, arthromyalgias and pain at injection site. The rate of adverse events after the booster was similar to that registered after the first two doses. No significant changes after SARS-CoV-2 vaccination in BILAG and SLEDAI were observed. Disease flare rate (mainly LN) after immunization was 10.8%. Flares occurred predominantly in patients with moderate disease activity before immunization; accordingly, SLEDAI ≥4 identified patients at risk of flare while Lupus Low Disease Activity State (LLDAS) plays a protective role against post-vaccination flare. CONCLUSIONS: This study confirms that anti-SARS-CoV-2 vaccination in JSLE is well tolerated; a strict clinical monitoring and a thoughtful choice of vaccination timing should be devoted to patients not in LLDAS due to the risk of post-vaccine flare.