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ObjectiveTo develop and validate the evidence-based and consensus-based Behçet’s Syndrome Overall Damage Index (BODI).MethodsStarting from 120 literature-retrieved preliminary items, the BODI underwent multiple Delphi rounds with an international multidisciplinary panel consisting of rheumatologists, internists, ophthalmologists, neurologists, and patient delegates until consensus was reached on the final content. The BODI was validated in a cross-sectional multicentre cohort of 228 patients with Behçet’s syndrome (BS) through the study of (a) correlation between BODI and Vasculitis Damage Index (VDI) and (b) correlation between BODI and disease activity measures (ie, Behçet’s Disease Current Activity Form (BDCAF), Physician Global Assessment (PGA), Patient Global Assessment (PtGA)), c) content and face validity and (d) feasibility.ResultsThe final BODI consists of 4 overarching principles and 46 unweighted-items grouped into 9 organ domains. It showed good to excellent reliability, with a mean Cohen’s k of 0.84 (95% CI 0.78 to 0.90) and a mean intra-class correlation coefficient of 0.88 (95% CI 0.80 to 0.95). Overall, 128 (56.1%) patients had a BODI score ≥1, with a median score of 1.0 (range 0–14). The BODI significantly correlated with the VDI (r=0.693, p<0.001), demonstrating to effectively measure damage (construct validity), but had greater sensitivity in identifying major organ damage and did not correlate with disease activity measures (ie, BDCAF: p=0.807, PGA: p=0.820, PtGA: p=0.794) discriminating damage from the major confounding factor. The instrument was deemed credible (face validity), complete (content validity) and feasible by an independent group of clinicians.ConclusionsPending further validation, the BODI may be used to assess organ damage in patients with BS in the context of observational and controlled trials.

ObjectiveΤo report outcomes of breakthrough COVID-19 in comparison with COVID-19 in unvaccinated patients with systemic rheumatic diseases (SRDs).MethodsPatients with SRD with COVID-19 (vaccinated and unvaccinated) were included by their rheumatologists in a registry operated by the Greek Rheumatology Society in a voluntarily basis. Type, date and doses of SARS-CoV-2 vaccines were recorded, and demographics, type of SRD, concurrent treatment, comorbidities and COVID-19 outcomes (hospitalisation, need for oxygen supplementation and death) were compared between vaccinated and unvaccinated patients.ResultsBetween 1 March 2020 and 31 August 2021, 195 patients with SRD with COVID-19 were included; 147 unvaccinated and 48 vaccinated with at least one dose of a SARS-CoV-2 vaccine (Pfizer n=38 or AstraZeneca n=10). Among vaccinated patients, 29 developed breakthrough COVID-19 >14 days after the second vaccine dose (fully vaccinated), while 19 between the first and <14 days after the second vaccine dose (partially vaccinated). Despite no differences in demographics, SRD type, treatment or comorbidities between unvaccinated and vaccinated patients, hospitalisation and mortality rates were higher in unvaccinated (29.3% and 4.1%, respectively) compared with partially vaccinated (21% and 0%) or fully vaccinated (10.3% and 0%) patients.ConclusionsVaccinated patients with SRD with breakthrough COVID-19 have better outcomes compared with unvaccinated counterparts with similar disease/treatment characteristics.

BackgroundThe safety of newer non anti-TNF biologic agents [abatacept (ABA), tocilizumab (TCZ) and rituximab (RTX)] in patients with autoimmune rheumatic diseases and past HBV infection [defined as HBsAg(−), anti-HBc(+), anti-HBs(±)] has not been firmly established.ObjectivesTo assess the safety [reactivation of hepatitis B virus (HBV)] of non anti-TNF biologic agents in patients with serologic evidence of past HBV infection in real-life clinical settings.MethodsRetrospective chart review of patients followed in the Department of Rheumatology of the University Hospital of Crete. Patients who received ABA, TCZ or RTX during the period 2005–2015 and were HBsAg(−), anti-HBc(+), anti-HBs(±) at baseline were identified and reviewed for cases of HBV reactivation (defined as increased ALT accompanied by an increase of serum HBV DNA levels by >1 log10 compared with baseline or a switch in HBV DNA detection from negative to positive). Changes in anti-HBs titers during biologic therapy in patients who were anti-HBs(+) at baseline were also documented.Results83 different cases of non anti-TNF biologic therapy (34 ABA, 26 RTX and 23 TCZ) from 58 patients (56 RA - 2 ANCA-associated vasculitis) were identified. 64 cases (77.1%) were anti-HBc(+) anti-HBs(+) and 19 (22.9%) were anti-HBc(+) anti-HBs(−). Mean (SD) age at disease diagnosis and at non anti-TNF initiation was 53.6 (13.1) and 63.4 (9.2) years, respectively. All cases with RA had received prior anti-TNF agents [mean (SD) number of anti-TNF agents 1.1 (0.8)]. During treatment with non anti-TNF, concomitant synthetic disease modifying drugs or glucocorticoids were received by 91.5% and 46.3% of cases, respectively. Only 7 cases (8.4%) received antiviral prophylaxis concomitant with non anti-TNF treatment (4 with lamivudine - 3 with entecavir). After a mean (SD) of 41.9 (24.6) months of follow-up and a mean (SD) of 18.0 (15.9) therapy cycles, one anti-HBc(+) anti-HBs(−) case experienced HBV reactivation 12 months after treatment with abatacept and was treated with tenofovir with good outcome. Of anti-HBs(+) patients at baseline, titers of anti-HBs antibodies did not show statistically significant delay from baseline to most recent follow-up (456.9 mIU/ml vs. 390.7 mIU/ml, respectively, p=0.08) (Figure 1).Figure 1ConclusionsOne case of HBV reactivation underlines the need for diligent monitoring in patients with serologic evidence of past HBV infection receiving non anti-TNF biologic agents. More data are needed to determine the need for universal prophylactic antiviral therapy in this subset of patients.Disclosure of InterestNone declared

Cognitive deficits on several domains are frequently encountered in relatively young RA patients during the first few years of the disease and may need to be taken into account as important correlates of disease severity and progression.