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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

Aim of the study:To evaluate the current disease characteristics, treatment and comorbidities of rheumatoid arthritis (RA) in Greece. Methods: Multicenter, cross-sectional study with a 9-month recruitment period between 2015 and 2016. Demographics, disease characteristics, treatment and comorbidities were collected via a web-based platform. Results: 2.491 RA patients were recruited: 96% from tertiary referral centers, 79% were females with a mean age of 63.1 years and disease duration of 9.9 years. Fifty-two percent were rheumatoid factor and/or anti-CCP positive, while 41% had erosive disease. Regarding treatment, 82% were on conventional synthetic disease modifying anti-rheumatic drugs (csDMARDs), 42% on biologic DMARDs (TNFi: 22%, non-TNFi: 20%) and 40% on corticosteroids (mean daily dose: 5.2 mg). Despite therapy, 36% of patients had moderate and 12% high disease activity. The most frequent comorbidities were hypertension (42%), hyperlipidemia (33%), osteoporosis (29%), diabetes mellitus (15%) and depression (12%). Latent tuberculosis infection (positive tuberculin skin test or interferon gamma release assay) was diagnosed in 13 and 15.3% of patients, respectively. Regarding chronic viral infections, 6.2% had history of herpes zoster while 2% and 0.7% had chronic hepatitis B and C virus infection, respectively. A history of serious infection was documented in 9.6%. Only 36% and 52% of the participants had ever been vaccinated

Background: Data regarding the real-life predictors of low disease activity (LDA) in rheumatoid arthritis (RA) patients are limited. Our aim was to evaluate the rate and predictors of LDA and treatment patterns in RA. Methods: This was a multicenter, prospective, RA cohort study where patients were evaluated in two different time points approximately 12 months apart. Statistical analysis was performed in order to identify predictors of LDA while patterns of disease-modifying anti-rheumatic drug [DMARDs; conventional synthetic (csDMARD) or biologic (bDMARD)] and glucocorticoid (GC) use were also recorded. Results: The total number of patients included was 1317 (79% females, mean age: 62.9 years, mean disease duration: 10.3 years). After 1 year, 57% had achieved LDA (DAS28ESR<3.2) while 43% did not (34%: moderate disease activity: DAS28ESR ⩾3.2 to <5.1, 9%: high disease activity, DAS28ESR ⩾5.1). By multivariate analysis, male sex was positively associated with LDA [odds ratio (OR) = 2.29 p < 0.001] whereas advanced age (OR = 0.98, p = 0.005), high Health Assessment Questionnaire (HAQ) score (OR = 0.57, p < 0.001), use of GCs (OR = 0.75, p = 0.037) or ⩾2 bDMARDs (OR = 0.61, p = 0.002), high co-morbidity index (OR = 0.86, p = 0.011) and obesity (OR = 0.62, p = 0.002) were negative predictors of LDA. During follow-up, among active patients (DAS28ESR >3.2), 21% initiated (among csDMARDs users) and 22% switched (among bDMARDs users) their bDMARDs. Conclusion: In a real-life RA cohort, during 1 year of follow-up, 43% of patients do not reach treatment targets while only ~20% of those with active RA started or switched their bDMARDs. Male sex, younger age, lower HAQ, body mass index and co-morbidity index were independent factors associated with LDA while use of GCs or ⩾2 bDMARDs were negative predictors.

BackgroundIdentification of the risk factors for the development of serious infections in patients with rheumatoid arthritis (RA) is critical for designing preventive measures and early treatment.ObjectivesTo identify risk factors for serious infections and to validate the RABBIT risk score in RA patients in daily clinical practice.MethodsMulticenter, prospective study of RA patients in Greece. Demographics, disease characteristics, treatments and co-morbidities were prospectively collected via a web-based platform at baseline and one year later. The observed incidence of serious infections was compared to the one estimated by the RABBIT score.Results1.549 RA patients were included (women: 78%, mean age: 63 years, mean disease duration: 10.4 years, RF and/or anti-CCP positive: 54%, mean DAS28: 3.4, mean HAQ: 0.5, bDMARD use: 46%, corticosteroid use: 36%). During follow-up, 38 serious infections were recorded (incidence: 2.3/100 patient-years). Patients who developed a serious infection had longer disease duration (14.2 vs. 10.3 years, p=0.02), higher HAQ at baseline (0.85 vs. 0.5, p=0.006), a history of previous serious infection (26% vs. 10%, p=0.002) and were more likely to have chronic lung disease (23% vs. 9%, p=0.008) or cardiovascular disease (23% vs. 11%, p=0.04). Disease duration (OR: 1.04, CI: 1.01-1.08, p=0.025), history of previous infection (OR: 3.3, CI: 1.3-8.1, p=0.01) and chronic lung disease (OR: 3.03, CI: 1.17-7.85, p=0.023) remained statistical significant in multivariate logistic regression analysis. bDMARD use was not associated with increased risk in uni-or multi-variate analysis. Data for RABBIT score calculation were available in 1.349 patients. Estimated incidence per 100 patient-years was divided in Q1-Q4 quartiles (25-50-75th percentiles: 0.94-1.35-2.15). Estimated and observed incidence rates were in Q1: 0.8 and 0.54, Q2: 1.14 and 0.79, Q3: 1.76 and 1.84 and Q4: 3.7 and 5.6, respectively (Hosmer Lemeshaw test, p=0.9).ConclusionIn this large, real life, prospective study of RA patients, the incidence of serious infections was 2.3/100 patient-years. Longer disease duration, history of previous serious infections and chronic lung disease were independently associated with the development of serious infections. RABBIT score predicted rather accurately the risk for serious infections in our cohort.References[1] Zink et al, Ann Rheum Dis. 2014 Sep; 73(9): 1673–1676.AcknowledgementSupported by grants from the Greek Rheumatology Society and Professional Association of Rheumatologists.Disclosure of InterestsKonstantinos Thomas: None declared, Argyro Lazarini: None declared, Evripidis Kaltsonoudis: None declared, Alexandros Drosos: None declared, Ioannis Papalopoulos: None declared, Prodromos Sidiropoulos: None declared, Panagiota Tsatsani: None declared, Sousana Gazi: None declared, Lina Pantazi: None declared, Kyriaki Boki: None declared, Pelagia Katsimbri: None declared, Dimitrios Boumpas: None declared, Kalliopi Fragkiadaki: None declared, Maria Tektonidou: None declared, Petros Sfikakis: None...