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Background The results obtained with the novel biologic agents have increased the expectations of benefit of treatment of juvenile idiopathic arthritis (JIA), with disease remission being now the therapeutic goal in all patients. However, the assessment of remission has seldom been incorporated in clinical trials of biologics in JIA. Moreover, little information exists on the prediction of the efficacy of biologic medications. Objectives To evaluate the proportion of children with JIA treated with etanercept (ETN) who achieved the state of inactive disease (ID) and to search for predictors of ID. Methods The clinical chart of all consecutive JIA patients who were given ETN between 2002 and 2011, and had a follow-up of at least 6 months after ETN start were reviewed. The achievement of ID, defined by the Wallace criteria (J Rheum 2004;31:2290-4), was assessed at each visit from the start of ETN. The primary study outcomes were: 1) proportion of patients who had ID at last follow-up visit while still on ETN; 2) time to achievement of ID after ETN start. Predictors of treatment outcomes included demographic data, JIA subset, type of affected joints, medications received before and during ETN administration, and JIA activity measures at ETN start. The search for predictors was conducted by means of univariate and multivariate analyses. Results A total of 187 patients were given ETN at the standard dose of 0.8 mg/kg/week in the study period. The disease duration at ETN start ranged from 3 months to 21.2 years (median 5.0 years). Fourteen patients had received ETN for less than 6 months or were lost to follow-up. In the remaining 173 patients, treatment duration from baseline to last follow-up visit ranged from 6 months to 10.5 years (median 2.4 years). At last follow-up visit, 87 (50.3%) patients had ID. The time to ID ranged from 2 months to 6.3 years (median 0.7 years). An age at disease onset

Background Methotrexate (MTX) is the disease-modifying medication of first-choice for the treatment of juvenile idiopathic arthritis (JIA). Although serious adverse effects are rare, MTX intolerance, particularly gastrointestinal discomfort, is frequently observed. However, it is unclear whether the prevalence of adverse events varies across different routes of administration. Objectives To compare the rate of parent proxy-reported or child self-reported side effects of MTX administered orally, subcutaneously or intramuscularly. Methods The parents of children with JIA who were seen at our center from March 2007 and September 2011 and were receiving MTX therapy were asked to complete the proxy-report version of the Juvenile Arthritis Multidimensional Assessment Report (JAMAR), which includes a checklist of medication side effects. The self-report version of the same questionnaire was also completed by children, if aged more than 7-8 years. The JAMAR lists 18 side effects and offers the possibility to record up to 2 side effects not included in the list. MTX therapy was started in all patients, irrespective of the route of administration, at 15 mg/m2/week. All patents were given folate supplementation with folinic acid. Results The JAMAR was completed by 337 parents in 1007 visits and by 183 children in 419 visits. The frequency of parent proxy-reported side effects by route of administration is shown in the Table. Conclusions The frequency of nausea and vomiting was greater in children receiving MTX parenterally than in those on oral MTX. Children taking MTX orally had more frequently stomach pain/burning or sleep disturbances than those on parenteral MTX. Disclosure of Interest None Declared

Background In the last decade, there have been major advances in the management of juvenile idiopathic arthritis (JIA). A reliable documentation of these progresses creates the need for validated criteria that describe precisely patient states. We recently, developed the cut-off values for remission, minimal disease activity and acceptable symptom states in JIA based on the JADAS (1). Objectives To determine the JADAS cut-offs for high disease activity (HDA) in JIA. Methods For the selection of cut-offs, data from a clinical database including 618 children with JIA were used. Patients were defined as having HDA when the physician made one of the following therapeutic interventions: 1) start of methotrexate (MTX); 2) intra-articular corticosteroid injection; 3) start of a biologic medication; 4) start of systemic corticosteroids. Patients were defined as having low disease activity (LDA) when they were receiving no therapy or had therapy discontinued, tapered or left unchanged for >1 year. For each patient, 1 visit in HDA and 1 visit in LDA was retained for the analyses. “Optimal” JADAS cut-offs were determined by calculating the 25th percentile of cumulative score distribution in patients with HDA and by assessing their ability to discriminate between HDA and LDA through ROC curve analysis (including calculation of Youden index and fixed 90% specificity). Cross-validation of cut-offs was performed in 490 JIA patients enrolled in the PRINTO MTX trial (2) and was based on assessment of discriminant validity. Results The cut-offs were calculated separately for patients with oligoarticular and polyarticular course of joint disease (irrespective of ILAR category) owing to the different severity of these 2 JIA phenotypes. The table shows the cut-offs for HDA for JADAS-71 version, defined according to the different statistical methods. The cut-offs that showed the best trade-off between sensitivity and specificity were selected for cross-validation analyses. These analyses showed that at baseline visit of MTX trial 94.7% of patients had a JADAS-71 higher than the HDA cut-off for polyarthritis. At 6-month visit, the percentage of patients with a JADAS-71 higher than the cut-off was 85.6% among nonresponders and 23.8% among responders. Conclusions We developed the JADAS cut-offs for HDA in JIA. The cut-offs revealed strong discriminant ability in a clinical trial and are, therefore, potentially applicable in clinical practice, observational investigations, and therapeutic studies. References Consolaro A et al. AR50:2191-201 Disclosure of Interest None Declared

Background In the last decade, there have been major advances in the management of juvenile idiopathic arthritis (JIA), which include the shift towards early aggressive interventions and the development of new therapeutic agents and combination treatment strategies. A reliable documentation of the advances in therapeutic effectiveness creates the need for validated and clinically useful criteria that describe precisely the clinical states of the patient. Objectives To determine cut-off values for high disease activity (HDA) based on the original Juvenile Arthritis Disease Activity Score (JADAS) (1) and a simplified 3-item version of the JADAS (clinical JADAS- cJADAS), which does not include the acute phase reactant (2). Methods For the selection of cut-offs, data from a clinical database including 618 children with JIA followed at study center were used. ‘Optimal’ cut-offs were determined against external criteria by calculating the 25 th percentile of cumulative score distribution and through receiver operating characteristic curve analysis. Patients were identified as being in HDA when the physician decided a major therapeutic intervention, defined as follows: 1) start of methotrexate therapy; 2) intraarticular corticosteroid injection (IAC); 3) start of biologic treatment; 4) start of systemic corticosteroid therapy. For each patient, 1 visit with HDA and 1 visit with no-HDA (i.e. visit in which none of the major therapeutic interventions listed above was made) were retained. The choice of cut-offs was made on clinical and statistical grounds. Results A total of 364 visits for oligoarticular-course patients (134 with HDA) and 412 visits for polyarticular-course patients (147 with HDA) were retained. The table shows the cutoffs (sensitivity/specificity) defined according to the different statistical methods and the AUC of the ROC curve. Proposed HDA cutoffs in oligoarticular-course JIA are 7.9 for JADAS10 and JADAS71, 7.2 for JADAS27, 7 for cJADAS10 and cJADAS71, and 6.5 for cJADAS 27. Proposed HDA cutoffs in polyarticular-course JIA are 12 for JADAS10 and JADAS71, 11 for JADAS27, cJADAS10 and cJADAS71, and 10 for cJADAS27. Conclusions We developed the HDA cutoffs for the JADAS and the cJADAS. The cutoffs need a thorough validation before being introduced in daily practice and clinical trials. References Consolaro A et al. Arthritis Rheum. 2009 May 15;61(5):658-66 McErlane F et al. Ann Rheum Dis. 2012 Epub ahead of print Disclosure of Interest None Declared