Search

Objectives To assess efficacy & safety of intravenous golimumab in pediatric patients with active polyarticular course juvenile idiopathic arthritis despite methotrexate therapy through 28 weeks of treatment. Methods A multicenter, Phase 3, single arm, open-label trial was conducted using intravenous golimumab at a dose of 80mg/m2 given at weeks 0 & 4, then every 8 weeks thereafter, in pediatric patients ages 2-17 years old with active polyarticular course juvenile idiopathic arthritis despite methotrexate therapy. Patients received commercial MTX weekly at same BSA-based dose as at time of study entry. All the results below are based on full analysis set which includes all patients who received at least 1 dose of study agent. Results 180 patients were screened (130 enrolled, 127 treated) with the first patient screened on 22Dec2014; last patient first treated 26Dec2017, & last patient’s Wk28 visit was 09Jul2018. Proportion of JIA ACR 30,50,70, & 90 responders at Wk28 was 83.5%,79.5%,70.1%, & 46.5%, respectively. 29.1% of patients met criteria for inactive disease at Wk28. Median change from baseline for JASDAS 10, 27, & 71 was -14.20, -16.60, & -20.32, respectively at Wk28. JADAS 10, 27, & 71 minimal disease activity was met by 15% of patients at Wk28. Proportion of patients experiencing at least 1 treatment-emergent AE through Wk28 was 77.2%. MedDRA system organ class with highest incidence of AEs was Infections & infestations (57.5%);most commonly reported AE upper respiratory tract infection(17.3%), then nasopharyngitis(15.0%).Six patients experienced serious AEs through Wk28: Herpes zoster disseminated, Infective exacerbation of bronchiectasis, Sepsis, Varicella, Mycosis fungoides, & Suicidal ideation. These events resulted in permanent discontinuation of intravenous golimumab, except for Varicella. Conclusion Intravenous golimumab delivered at a dose of 80mg/m2 at weeks 0 & 4, then every 8 weeks thereafter and appears to be effective in these patients with a safety profile similar to other TNF inhibitor therapies. Disclosure of Interests Nicolino Ruperto Grant/research support from: The Gaslini Hospital, where NR works as full-time public employee, has received contributions (> 10.000 USD each) from the following industries in the last 3 years: BMS, Eli-Lilly, GlaxoSmithKline, F Hoffmann-La Roche, Janssen, Novartis, Pfizer, Sobi. This funding has been reinvested for the research activities of the hospital in a fully independent manner, without any commitment with third parties., Consultant for: Received honoraria for consultancies or speaker bureaus (

Background An association between Rheumatoid arthritis(RA) and Periodontal Disease(PD) has been reported. However, predicting factors of PD progression in patients with eRA are lacking Objectives To establish the predictive factors for progression of PD in patients with eRA including clinical and serological active scores of RA and status of PD Methods This cohort study evaluated the progression of PD at 280 inter-proximal dental sites in 28 patients within 2 years of diagnosis with eRA and they were evaluated to establish their progression through one year of follow-up. Adult patients were classified according to the 2010 ACR and the EULAR criteria. Periodontal diagnosis was established based on the AAP and the CDC and Prevention criteria. Serum markers of RA (rheumatoid factor, erythrocyte sedimentation rate (ESR), C reactive protein (CRP), and anticitrullinated protein antibodies (APCAs) were evaluated, disease activity was assessed by disease activity score (DAS28-ESR) AND the simplified disease activity index (SDAI). Plaque index, gingival index, pocket depth, and clinical attachment loss (CAL) were evaluated at baseline and at one year follow-up. Data were analysed to establish predictive generalised linear mixed models (GLMM) for clinical attachment loss progression at each site with ≥2 or≥3 mm CAL Results The patients included had an average age of 47.5±12.69 and 75% were women. The comorbidity given by the habit of smoking actively occurred only in 1% of patients. The 35.71% had levels of ESR >20 mm3/h and 39% APCA positive while in 60.71% had CRP ≥3 mg/L and 67.86% of patients had a positive FR. Regarding the indices of activity of the disease, DAS28-PCR>2.6 was found in 67.86% of the patients and SDAI scale >3.3 in 75%. 71.43% of the patients were being treated with DMARD and corticoid therapy. 71.43% of patients had a diagnosis of periodontitis. CAL≥2 mm and ≥3 mm was observed at 15% and 7.5% of dental sites, respectively. Factors associated with CAL in dental sites were: age, ESR, RF, DAS28, treatment with DMARD-Corticoids, periodontal pocket, CAL and percentage of CAL>5 mm, plaque index, gingival index and haemorrhage. Variables RA associated with activity such as CRP, DAS28, and SDAI showed a similar behaviour and they were more frequently associated in periodontal progressive sites. The principal predictive periodontal factors were the percentage of sites with CAL>5 mm and high gingival inflammation at baseline. Patients receiving combined treatment with disease-modifying antirheumatic drugs (DMARD) and corticosteroids exhibited less CAL. The predictive values of the GLMM for CAL of ≥3 and≥2 mm were 98% and 82%, respectively Conclusions Systemic factors as disease activity score and serum biomarkers such as baseline periodontal status are associated with periodontal disease progression in early RA patients. It is known that the very low daily dose prednisolone in combination DMARD therapy substantially decreased radiographic progression and it could influence periodontal disease progression too in patients with RA in early stages of the disease Reference [1] Bello-Gualtero JM,et al.J Periodontol.2016;87:346 Disclosure of Interest None declared

Background The ASAS-HI is a new instrument based in the International Classification of Functioning, Disability and Health to assess the impact of axSpA; ASAS-HI has been validated in Mexican patients. Objectives To investigate the status of health in Mexican patients with axSpA using the ASAS-HI Methods This is multicenter, cross-sectional study of 377/423 patients with axSpA (ASAS criteria) referred by 64 rheumatologists with private or institutional practice across the country in a period of six months. Sociodemographic and clinical data were collected at each site and analysed centrally. Results The ASAS imaging arm were fulfilled 87.5% and the clinical by 61.8%; HLA-B27 was positive in 80.1%; 71.6% were males; 51.9% received bDMARDs. Mean ages at onset and diagnoses were 25.8 (9.9) and 32.8 (11.7) years; median age was 41.6 (13.7) years. The correlation between ASAS-HI and BASDAI, BASFI, and EQ-5D was significant. ASAS-HI mean score was 6.4 (4.2); the cut off was six; values below six meant good health, which corresponded to 203 (53.84%) patients. Univariate analysis disclosed significant differences between groups in variables that were significant in the regression models (see below) and in health care coverage, enthesitis, joint counting, glucocorticoids, HLA-B27, sacroiliitis, BASMI, and ASDAS. In the multivariate analysis, two models were associated ASAS-HI: 1) sex, education, comorbidities, joint surgery, and physician global assessment; 2) BASDAI, BASFI, and EQ-5D Conclusions ASAS-HI cut off of six identified good health in 46.15% of patients with axSpA. ASAS-HI correlated with other measures of disease activity, functioning, and quality of life. In multivariate analysis, ASAS-HI associated with those measures as we all as with demographic and clinical variables. References [1] Kiltz U, van der Heijde D, Cieza A, Boonen A, Stucki G, Ustun B, et al. Developing and validating an index for measuring health in patients with ankylosing spondylitis. Rheumatology (Oxford). 2011;50(5):894–8. [2] Kiltz U, van der Heijde D, Boonen A, Bautista-Molano W, Burgos-Vargas R, Chiowchanwisawakit P, et al. Measuring impairments of functioning and health in patients with axial spondyloarthritis by using the ASAS Health Index and the Environmental Item Set: translation and cross-cultural adaptation into 15 languages. RMD Open. 2016;2(2):e000311. Acknowledgements We acknowledge 64 rheumatologists (grupo sacroiliacos) all over the country that participated in the study Disclosure of Interest None declared

Background In the last three decades, major advances in the spondyloarthritis (SpA) field have been achieved leading to new terminology. Whilst this terminology is well established in English, there is concern about the disparity of translated words and acronyms in Spanish, which is used by more than 437 million people in 21 countries. Objectives To develop a consensus to standardise the use of the Spanish terms, abbreviations and acronyms employed in the field of SpA. Methods An international task force was created comprising of all ASAS Spanish-speaking native members representing 5 countries, the executive committee members of GRESSER, two methodologists, two linguists from Real Academia Nacional de la Medicina Espanola (RANM) and two patients from CEADE. First, a literature review spanning the last 15 years was performed to identify the conflicting terms/abbreviations/acronyms. This review examined available written sources in Spanish including manuscripts, ICF and ICD, guidelines, recommendations and consensus. A three-round Delphi method including a face-to-face meeting, then followed. The recommendations from the RANM based on the Panhispanic dictionary in medical terms were consistently followed throughout the process. Results Consensus was reached for 44 terms, abbreviations or acronyms related to the field of SpA. A Spanish translation was accepted for 6 terms and 6 abbreviations to name the disease or its subgroups (SpA, axSpA, nr-axSpA, pSpA, AS, r-SpA, PsA) and for 6 terms and 4 abbreviations related with the disease (enthesitis, sacroiliitis, IBP, MRI-SIJ, BME, mNY). Additionally, it was agreed not to translate into Spanish 15 acronyms because they are very well established (ASDAS, BASDAI, BASFI, BASMI, mSASSS, RASS, BASRI, BAS-G, ASQoL, PsAQoL, MASES, MASEI, PASI, PARS, ASAS). However, when mentioning these acronyms, it is recommended that the following structure is used: type of variable in Spanish and acronym and expanded form in English. With regards to the terms or abbreviations attached to 7 acronyms (ASDAS-CI, ASDAS-MI, ASAS-HI, ASASpr, ASAS 5/6, ASAS20, ASAS40 improvement criteria), it was agreed to translate only the expanded form and a translation was also selected for all of them. Conclusions A consensus in Spanish nomenclature for SpA has been developed by ASAS group. The implementation of this consensus across the Spanish-speaking community will be of substantial benefit, avoiding misunderstandings and time-consuming processes. Acknowledgements GRESSER(E. Galindez, J. Gotor, M. Moreno, J. Quiros, A. Urruticoechea), CEADE(P. Plazuelo, M. Garrido), RANM(C. Gonzalez, C. Remacha) Disclosure of Interest None declared

Background Rheumatoid arthritis (RA) and periodontal disease (PD) have similar underlying pathologic processes and share a general deregulation of the inflammatory response. Objectives To evaluate PD markers in first-degree relatives (FDR) of consanguinity individuals of patients with rheumatoid arthritis to compared with controls and to establish an association to rheumatic activity according to age groups Methods 201 FDR individuals and 201 matched controls were included. Clinical evaluation of rheumatologic and periodontal condition was performed. P. gingivalis,P. gingivalis IgG1 and IgG2, ESR, CRP, RF, ACPAs, painful and swollen joints were assessed. A frequencies analysis, comparisons and a logistic regression model were made. The study was approved by local ethics committee. Results 37.3% of patients with overweight and 10.1% obsesses. Subjects with more than one swelling joint were 21 subjects 30, where 81.8% had periodontitis p=0.006. Regression analysis on the whole group shows a risk to present BMI>25 (OR 1.67 IC-95% 1.02 – 2.74 p=0.042), ACPAs (OR 3.7 IC-95% 1.34–10.22 p=0.012), at least one pain join (OR2.51 IC-95% 1.42–4.44 p=0.001) and gingival index (OR4.57 IC-95% 1.76–11.80 p=0.002) in FDR individuals. Based on age the risk to develop PD was increasing: individuals among 30 to 40 years shows OR 2.76 (IC-95% 1.24–6.18, p=0.013); among 41 to 50 years, OR 4.72 (IC-95% 1.81–12.32, p=0.001); and for >50 years individuals an OR 6.22 (IC-95% 2.55–15.1, p=0.0001). The discriminating analysis by age rank shows that FDR individuals 50 years (n=53) show high risk to present BMI>25 (OR 4.00 IC-95% 1.46–10.45 p=0.007). Conclusions Obesity, ACPA and periodontitis can be considered as relevant conditions associated with the development of RA in FDRs. However, the analysis based on age group shows that periodontal markers do not appear early in FDR individuals; however, clinical rheumatologic variables are manifested and maintained over time. References Bello-Gualtero JM et al. J Periodontol 2016;87:346–356. Disclosure of Interest None declared

Objectives To determine the impact of individual and regional variables on the geographic distribution of RD across six Latin-American countries Methods This is a secondary multilevel analysis of cross-sectional data of COPCORD studies that investigated the prevalence of RD in Argentina, Colombia, Ecuador, Mexico, Peru, and Venezuela. Individual factors were sex, age, comorbidities, job status, and Health Assessment Questionnaire (HAQ) score. Contextual level variables were country and subject9s identification as indigenous. RD predictors, including individual and regional variables, particularly indigenous status were identified with logistic regression models. The effect of contextual variables was estimated with median odds ratio9s (OR) estimation. Results Most individuals included in this analysis came from urban areas (82.40%); their mean age was 43.12 years (95% CI 43.01–43.35); and 56.0% were women. Nearly all of them reported >1 comorbidity (94.70%) and 72.19% were economically active. The prevalence of any RD varied from 1.55% in Peru to 26.09% in Argentina. The mean prevalence of Rheumatoid Arthritis (RA) was 1.58 (range 0.64 to 2.47) (table 1). Aside comorbidities, individual level variables associated to any RD were sex (OR: 1.35; 95% CI 1.28–1.43), age (OR: 1.02; 95% CI 1.01 -1.03), and HAQ score (OR: 3.71; 95% CI 3.22–4.28). Crude comparisons showed significant variations among countries (p Conclusions There common factors associated to the prevalence of RD in the region, however, the estimation of its impact varies in significant way across countries and related to the fact of belong to an indigenous group indicating an increase in the estimated ORs. Acknowledgements National Council for Science and Technology (CONACYT);Colegio Mexicano de Reumatologia (Mexico). EsSalud (Peru). Universidad de Cuenca (Ecuador).ASOREUMA (Colombia). Federico Wilhelm Agricola Foundation (Argentina). PDVSA East, SUELOPETROL and Bristol-Myers Laboratory (Venezuela) Disclosure of Interest None declared