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Objectives To report results of subgroup analyses of bone mineral density (BMD) and bone turnover markers from a randomised, double-blind, placebo-controlled, phase II study of denosumab, an investigational RANKL inhibitor, in patients with rheumatoid arthritis (RA) concurrently receiving treatment with bisphosphonates or glucocorticoids. Methods Patients received subcutaneous placebo (n=75), denosumab 60 mg (n=71) or denosumab 180 mg (n=72) at baseline and 6 months. Assessments included dual x-ray absorptiometry scans of the lumbar spine and hip, and determination of levels of serum type I C-telopeptide (sCTx-I) and serum procollagen 1N-terminal peptide (P1NP). Results Denosumab treatment increased mean lumbar spine and hip BMD and reduced sCTx-I and P1NP compared with placebo through 12 months, regardless of baseline BMD or marker levels or concomitant bisphosphonate or glucocorticoid use. Conclusions This study extends evidence that denosumab increases BMD and reduces bone turnover in patients with RA and may provide a new therapeutic option for reducing systemic bone loss in patients with RA.

Objective: In a multicentre study to explore the effects of licofelone as a disease-modifying osteoarthritis drug in comparison with naproxen in patients with knee osteoarthritis (OA), using MRI and x -ray examination. Methods: Patients with knee OA (n = 355) were randomised to receive either licofelone (200 mg twice a day) or naproxen (500 mg twice a day). MRI and x -ray examinations were performed at baseline, 6 months (MRI only), 12 and 24 months. MRI was used to assess quantitatively changes in cartilage volume, and x -ray examinations (Lyon–Schuss) to measure changes in the mean and minimum joint space width (JSW) in the medial compartment. Questionnaires probing symptoms were completed. Data were presented as intention to treat (ITT) and according to protocol (ATP). Results: Cartilage volume loss in the global joint and medial and lateral compartments was significantly less in the licofelone than in the naproxen group for ITT at 12 and 24 months and for ATP at all times except in the medial compartment. Patients with medial meniscal extrusion had a greater loss of cartilage volume. In these patients, licofelone markedly reduced the cartilage loss for both ITT and ATP at 12 and 24 months. Although licofelone showed less reduction in the JSW than naproxen, this did not reach significance. All clinical variables were improved at 24 months (p Conclusion: Licofelone and naproxen were equally effective in reducing OA symptoms; however, licofelone significantly reduced cartilage volume loss over time, thus having a protective effect in patients with knee OA. This study proves the superiority of quantitative MRI over x -ray examinations in a multicentre clinical trial.

Background Recent treat-to-target guidelines in PsA recommend that minimal disease activity (MDA) is achieved as early as possible. Patient reported outcomes (PROs) have been criticized for not accurately assessing PsA disease activity as they may reflect aspects not directly related to PsA such as fibromyalgia, depression or other comorbidities. Objectives The aim of this analysis was to assess the proportion of patients failing to achieve MDA based on PROs in a real-world, routine clinical care setting in Canada. Methods BioTRAC is an ongoing, prospective registry of patients initiating treatment for rheumatoid arthritis, ankylosing spondylitis, or PsA with infliximab (IFX) or golimumab (GLM). Eligible participants for this analysis included those with PsA treated with IFX who were enrolled since 2005 or with GLM enrolled since 2010 and with available MDA information at baseline, 6 months, and/or 12 months. MDA was defined as the fulfillment of ≥5 of the following criteria: TJC28≤1, SJC28≤1, PASI≤1, pain (VAS)≤15 mm, PtGA (VAS)≤20 mm, HAQ≤0.5, tender entheseal points ≤1. Near MDA was defined as fulfillment of 4 criteria. Results A total of 196 PsA patients (51.4% male) were included with a mean (SD) age of 49.8 (11.1) years and disease duration since diagnosis of 5.4 (6.3) years. The majority (62.2%) received concomitant DMARD therapy. The proportion of patients with MDA at baseline, 6 months and 12 months was 11.7%, 43.5%, and 44.8%, respectively. Overall, achievement of each individual MDA criterion was: TJC28: 43.0% of cases; SJC28: 51.3%; PASI 68.7%; pain: 27.7%; PtGA: 34.9%; HAQ: 36.8%; entheseal points: 79.4%. Among the 309 instances of non-MDA, 51 (16.5%) were near MDA cases. The most common reason for non-MDA in near MDA cases was patient-reported pain (82.4%) followed by PtGA (68.6%), and HAQ-DI (60.8%). Assuming that these criteria were met (i.e., not included in the MDA formula), the total number of MDA instances would increase from 29.6% to 36.7% (HAQ), 37.6% (PtGA), and to 39.2% (pain). Conclusions The results of the current analysis have shown that, similar to prior analyses in RA, the most common limiting factors in achieving MDA in PsA are PROs, including PtGA, pain, and HAQ-DI, accounting for as many as 82.4% of near MDA cases. Further analyses are required to identify the determinants of the differences in PROs and clinical outcomes. Disclosure of Interest P. Rahman: None declared, A. Avina-Zubieta: None declared, R. Arendse: None declared, W. Bensen: None declared, P. Baer: None declared, J. Kelsall: None declared, M. Starr: None declared, J. Stewart: None declared, D. Sholter: None declared, M. Zummer: None declared, L. Picard: None declared, E. Rampakakis: None declared, E. Psaradellis: None declared, K. Masolova Employee of: Janssen, A. Lehman Employee of: Janssen, F. Nantel Employee of: Janssen, C. Tkaczyk Employee of: Janssen, B. Osborne Employee of: Janssen

Background Early achievement of minimal disease activity (MDA) is recommended as a valid treat-to-target approach in psoriatic arthritis (PsA). Objectives The purpose of the current analysis was to evaluate predictors of MDA achievement in PsA patients treated with anti-TNF agents in Canadian routine clinical care. Methods BioTRAC is an ongoing, prospective registry of patients initiating treatment for rheumatoid arthritis, ankylosing spondylitis, or PsA with Infliximab (IFX) or Golimumab (GLM). Eligible people for this analysis included PsA patients treated with IFX who were enrolled since 2005 or with GLM enrolled since 2010 and with available MDA information at baseline, 6 months, and/or 12 months. MDA was defined as the fulfillment of ≥5 of the following criteria: TJC28≤1, SJC28≤1, PASI≤1, Pain (VAS)≤15mm, PtGA (VAS)≤20mm, HAQ ≤0.5, tender entheseal points ≤1. Independent predictors of MDA achievement were assessed with logistic regression. Results A total of 196 patients (51.4% male and 87.2% bionaive) were included with a mean (SD) age and disease duration of 49.8 (11.1) and 5.4 (6.3) years, respectively. The proportion of patients with MDA was 11.7% at baseline, 43.5% at 6 months, 44.8% at 12 months, and 49.1% at either 6 or 12 months. Among patients with MDA at 6 months, 75.7% had sustained MDA at 12 months. Patients achieving MDA during follow-up had significantly lower disease activity at baseline; mean (SD) disease parameters were: SJC28: 3.24 (3.58) vs. 5.47 (4.31), P Multivariate logistic regression analysis showed that lower baseline HAQ (OR=0.243; P Conclusions The results of the current analysis have shown that 50% of patients treated with IFX or GLM in routine clinical care achieve MDA within the first year of treatment. Lower baseline HAQ, lower TJC28, and lower enthesitis count were identified as significant predictors of MDA achievement. Disclosure of Interest M. Zummer: None declared, P. Rahman: None declared, M. Starr: None declared, J. Kelsall: None declared, A. Avina-Zubieta: None declared, P. Baer: None declared, D. Sholter: None declared, M. Teo: None declared, E. Rampakakis Employee of: JSS Medical Research Inc;, E. Psaradellis Employee of: JSS Medical Research Inc;, B. Osborne Employee of: Janssen, K. Maslova Employee of: Janssen, F. Nantel Employee of: Janssen, A. Lehman Employee of: Janssen, C. Tkaczyk Employee of: Janssen

Background The prevalence of ankylosing spondylitis (AS) is 2–3 times higher in men compared to women. Recent studies have suggested that clinical differences exist between both genders with women experiencing a higher burden of disease. Objectives This analysis examined gender-specific differences with respect to patient and disease parameters at initiation of infliximab (IFX) or golimumab (GLM) for the treatment of AS in a Canadian routine clinical practice setting. Methods BioTRAC is an ongoing, prospective registry of patients initiating treatment for rheumatoid arthritis, ankylosing spondylitis, or psoriatic arthritis with IFX or GLM. Patients with AS treated with IFX who were enrolled since 2002 or with GLM enrolled since 2010 were included in this analysis. Between group differences were assessed with the Fisher9s Exact test or the independent samples t-test, while linear regression was used to assess the independent association of gender with HAQ-DI, ASDAS, BASDAI, and BASFI improvements at 12 months. Results A total of 539 AS patients were included in this analysis; 188 (34.9%) patients were treated with GLM and 351 (65.1%) with IFX. The majority of patients were male (61.8%). Mean age and disease duration were comparable between genders for both GLM and IFX, (Table 1). Overall, disease parameters (ESR, PtGA, MDGA, HAQ-DI, ASDAS, and BASFI) were similar for GLM with the exception of BASDAI where higher disease severity was observed among females. Among patients treated with IFX, between gender differences were observed for CRP with significantly lower levels in female patients; however BASDAI and HAQ-DI where significantly higher in females compared to males. Other parameters (ESR, PtGA, MDGA, ASDAS, and BASFI) were similar for IFX between genders. Regression analysis showed that, upon adjusting for baseline levels, female gender (ΔBASDAI=0.603; P=0.035) was associated with increased BASDAI at 12 months of treatment as compare to males. HAQ-DI, ASDAS, and BASFI, on the other hand, at 12 months were comparable between genders. Conclusions Overall, at anti-TNF initiation, female AS patients experience greater disease activity relative to men at initiation of biologic therapy. Whether this represents a gender bias in prescribing, or a gender based difference in the acceptance of biologic treatment or disease assessment, requires additional research. Disclosure of Interest M. Starr: None declared, M. Zummer: None declared, D. Choquette: None declared, B. Haraoui: None declared, P. Rahman: None declared, M. Sheriff: None declared, E. Rampakakis Employee of: JSS Medical Research Inc;, E. Psaradellis Employee of: JSS Medical Research Inc;, B. Osborne Employee of: Janssen, A. Lehman Employee of: Janssen, K. Maslova Employee of: Janssen, F. Nantel Employee of: Janssen, C. Tkaczyk Employee of: Janssen

Background Recent studies have suggested that early and aggressive treatment of spondyloarthritis, including ankylosing spondylitis (AS) and psoriatic arthritis (PsA), may be associated with favorable patient outcomes, reducing synovial inflammation, delaying joint damage, and maintaining functional status. Objectives The objective of this analysis was to determine the predictive factors of ASDAS remission in AS patients treated with infliximab (IFX) or golimumab (GLM) in a Canadian routine clinical care setting. Methods BioTRAC is an ongoing, prospective registry of patients initiating treatment for rheumatoid arthritis (RA), ankylosing spondylitis, or psoriatic arthritis with IFX or GLM. Eligible patients for this analysis included AS patients treated with IFX or GLM between 2005 and 2015. Variables associated with ASDAS remission ( Results A total of 582 patients were included in the analysis with a mean (SD) age of 45.8 (12.2) years and a disease duration of 8.3 (10.2) years. The majority of patients were male (57.2%). Upon 12 months of treatment statistically significant and clinically meaningful improvements were observed in ASDAS (3.6 vs. 2.3; P Conclusions Twelve-month treatment with IFX or GLM in a real-world setting was associated with significant improvements in disease parameters. Prior exposure to a biologic and lower HAQ-DI were identified as independent predictors of ASDAS remission upon adjusting for potential confounders. Disclosure of Interest L. Bessette: None declared, S. Kapur: None declared, M. Zummer: None declared, M. Starr: None declared, D. Choquette: None declared, M. Sheriff: None declared, W. Olszynski: None declared, E. Rampakakis Employee of: JSS Medical Research Inc;, E. Psaradellis Employee of: JSS Medical Research Inc;, B. Osborne Employee of: Janssen, K. Maslova Employee of: Janssen, F. Nantel Employee of: Janssen, A. Lehman Employee of: Janssen, C. Tkaczyk Employee of: Janssen

Background Dactylitis is one of the most commonly reported features in spondyloarthritis. It has been hypothesized that dactylitis is a functional enthesitis at the proximal interphalangeal joints, resulting in synovitis, tenosynovitis, bone and soft tissue oedema to the digit, and may simultaneously involve more than one digit. Objectives Our objective was to identify the location of dactylitis in ankylosing spondylitis (AS) and psoriatic arthritis (PsA) patients and to determine their response to anti-TNF treatment. Methods BioTRAC is an ongoing, prospective registry of patients initiating treatment for rheumatoid arthritis (RA), ankylosing spondylitis (AS), or psoriatic arthritis (PsA) with infliximab (IFX) or golimumab (GLM). Eligible people for this analysis included AS and PsA patients treated with IFX who were enrolled since 2005 or with GLM enrolled since 2010 who had available information on dactylitis. The McNemar (paired Chi-square) test was used to compare the presence of dactylitis over time. Results A total of 260 AS patients and 261 PsA patients were enrolled with a mean (SD) age at baseline of 46.1 (13.0) vs. 50.0 (12.0) years, disease duration of 6.4 (9.8) vs. 5.2 (6.8) years, and proportion of females 40.6% vs. 48.5%, respectively. Among patients with AS, dactylitis was reported in 6.2% and 2.2% of patients at baseline and 6 months, respectively; at 6 months of treatment 73.3% of AS patients with dactylitis at baseline had no dactylitis and 1.6% developed dactylitis (P=0.057). For PsA higher proportions of dactylitis were observed with 30.7%, and 12.7%, respectively; at 6 months of treatment 69.0% of PsA patients with dactylitis at baseline had no dactylitis and 4.6% developed dactylitis (P Presence of dactylitis in hands or feet (any digit) was associated with significantly higher HAQ in AS and PsA (AS: ΔHAQ=1.36 (P≤0.001); PsA: ΔHAQ=0.64 (P≤0.001)). Conclusions A considerable proportion of PsA patients had dactylitis at anti-TNF initiation in this Canadian real-world cohort. Although a lower proportion of patients had dactylitis among AS patients, the presence of dactylitis was associated with higher functional disability in both AS and PsA patients. Treatment with IFX or GLM for 6 months was associated with significant reduction in the prevalence of dactylitis. Disclosure of Interest R. Arendse: None declared, P. Rahman: None declared, J. A. Avina-Zubieta: None declared, D. Choquette: None declared, M. Zummer: None declared, M. Baker: None declared, J. Stewart: None declared, I. Fortin: None declared, M. Teo: None declared, E. Rampakakis: None declared, E. Psaradellis: None declared, B. Osborne Employee of: Janssen Inc. Canada, C. Tkaczyk Employee of: Janssen Inc. Canada, K. Maslova Employee of: Janssen Inc. Canada, F. Nantel Employee of: Janssen Inc. Canada, A. Lehman Employee of: Janssen Inc. Canada

Background Despite the importance of the Health Assessment Questionnaire (HAQ) and Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) in assessing patient-reported functional status and disease activity, they have been critiqued for being time-consuming, not convenient on a daily-basis and thus not contributing to decisions in routine care. Objectives The aim of this analysis was to describe the correlation of individual HAQ and BASDAI questions with patient and physician reported measures used in AS and to examine whether the instruments could be reduced to better reflect routine clinical practice. Methods BioTRAC is an ongoing prospective registry of patients initiating infliximab or golimumab. Data from AS patients treated in 2005-2014 were used. The correlation of individual HAQ and BASDAI questions with patient (pain, BASDAI, HAQ and BASFI) and physician (MDGA) reported measures was described with the Pearson9s correlation coefficient. The impact of each question on the need for help in each HAQ domain was assessed with logistic regression. Factor analysis was used to assess the variability due to each individual question in HAQ and BASDAI. Results A total of 413 AS patients with 1660 BASDAI and 1654 HAQ assessments were included. HAQ and BASDAI questions correlated at different extents with each AS measure. Questions related to “eating” and “gripping” showed the lowest correlation with patient and physician reported measures. All HAQ questions had higher correlations with patient reported measures than with MDGA. The BASDAI question on “fatigue and tiredness” showed the highest correlation with BASFI, while the question on “other joints pain/swelling” showed the lowest correlation with MDGA. None of the HAQ and BASDAI questions were associated with needing help for eating. All other HAQ individual questions were significantly associated with the need for help within their corresponding category, with the exception of Q5C and Q7A. BASDAI question on level of discomfort was significantly associated with the need for help in all HAQ categories, with the exception of “eating” and “walking”. Q2A and Q7C accounted for 59.6% of the HAQ variance. The level of morning stiffness accounted for 73.8% of the BASDAI variance. When combining the HAQ and BASDAI, Q2A and Q3A from HAQ and Q1 from BASDAI accounted for 63.5% of the variance. Conclusions Variability exists in the correlation of HAQ and BASDAI questions with patient and physician reported AS measures. The results suggest that “standing up straight from an armless chair” and “turning faucets on/off” are the main drivers of HAQ, while the level of morning stiffness drives the BASDAI. Three questions were found to drive the combined HAQ and BASDAI which may have implications in the design of self-report instruments. Disclosure of Interest P. Rahman Consultant for: Abbott, AbbVie, Amgen, BMS, Celgene, Janssen, Novartis, Pfizer, Roche, M. Zummer: None declared, W. Olszynski: None declared, M. Khraishi: None declared, D. Sholter: None declared, R. Faraawi Consultant for: Janssen, W. Bensen Consultant for: Janssen, M. Baker: None declared, A. Chow: None declared, J. Vaillancourt Employee of: JSS Medical Research, J. Sampalis Shareholder of: JSS Medical Research, F. Nantel Employee of: Janssen, S. Otawa Employee of: Janssen, A. Lehman Employee of: Janssen, C. Tkaczyk Employee of: Janssen, M. Shawi Employee of: Janssen

Background Recent studies have suggested that early and aggressive treatment of spondyloarthritis, including ankylosing spondylitis (AS) and psoriatic arthritis (PsA), may be associated with favorable patient outcomes, reducing synovial inflammation, delaying joint damage, and maintaining functional status. Objectives The objective of this analysis was to determine the predictive factors of early DAS28 improvement in PsA patients treated with infliximab (IFX) or golimumab (GLM) in a Canadian routine clinical care setting. Methods BioTRAC is an ongoing, prospective registry of patients initiating treatment for RA, AS, or PsA with IFX or GLM. The analysis was based on PsA patients treated with IFX or GLM between 2005 and 2014. Variables associated with improved response were examined using general linear models and those showing a statistical trend (P Results A total of 176 patients were included in the analysis with a mean (SD) age of 49.4 (11.4) years and a disease duration of 5.2 (7.2) years. The majority of patients were male (54.1%). Upon 6 months of treatment statistically significant and clinically meaningful improvements were observed in DAS28 (4.1 vs. 2.9; P In univariate analysis, male gender (male vs. female: B=-0.806; P=0.029), not smoking (smokers vs. non-smokers: B=0.984; P=0.131), no previous use of a biologic (naive vs. experienced: B=-1.995; P Conclusions Six-month treatment with IFX or GLM in a real-world setting was associated with significant improvements in all disease parameters studied. Upon adjusting for potential confounders, no prior exposure to a biologic and male gender were identified as independent predictors of greater DAS28 improvement. Disclosure of Interest D. Sholter Consultant for: Janssen, J. Kelsall Consultant for: Janssen, R. Arendse Consultant for: Janssen, A. Avina-Zubieta Consultant for: Janssen, W. Bensen Consultant for: Janssen, M. Zummer Consultant for: Janssen, R. Faraawi Consultant for: Janssen, S. Dixit Consultant for: Janssen, M. Khraishi: None declared, I. Fortin Consultant for: Janssen, J. Sampalis: None declared, E. Psaradellis: None declared, F. Nantel Employee of: Janssen, C. Tkaczyk Employee of: Janssen, A. Lehman Employee of: Janssen

Background The prevalence of rheumatoid arthritis (RA) is 2-4 times higher in women compared to men. Furthermore, RA incidence in women increases from the age of menarche peaking around menopause, while it is rare in men younger than 45 years (1). Several studies have shown that treatment outcomes are worse in women (2). Objectives This analysis examined gender-specific differences with respect to disease parameters at initiation of the first anti-TNF agent for RA treatment in a Canadian routine clinical practice setting. Methods BioTRAC is an ongoing, prospective registry of patients initiating treatment for RA, AS, or PsA with infliximab or golimumab as first biologics or after having been treated with a biologic for less than six months. In this analysis, data were assessed from RA patients treated with golimumab subcutaneous as a first biologic who were enrolled between 2010 and 2012. Results 121 RA patients were included with mean (SD) disease duration of 9.3 (9.6) years. Eighty-nine patients (73.6%) were female. In the overall population, rheumatoid factor positivity was observed in 67% of patients and 17.5% were smokers, without any significant differences between genders. Patient reported disease parameters differed significantly between genders. Despite the younger age (56.6 vs. 62.0 years; P=0.051), female patients reported significantly higher pain (56.6 vs. 44.5 mm; P=0.045), patient global assessment (PtGA: 6.0 vs. 4.7 cm; P=0.034), tender joint count (10.2 vs. 6.8; P=0.022), and functional disability (HAQ-DI: 1.43 vs. 1.06; P=0.024). In addition, a statistical trend towards higher morning stiffness in female patients was observed (55.7 vs. 38.9; P=0.063). However, physician assessment of global disease activity (MDGA: 5.7 vs. 5.5; P=0.581), SJC (7.9 vs. 8.5; P=0.641), DAS28-ESR (5.3 vs. 4.7; P=0.086), CDAI (29.7 vs. 24.5; P=0.120) and SDAI (32.1 vs. 30.2; P=0.675) were statistically comparable between genders. Conclusions Objective measures (SJC, CRP/ESR), MDGA and composite outcomes were similar for male and female patients at golimumab initiation, with the exception of TJC being higher in women. Patient reported outcomes (PROs: pain, PtGA, HAQ-DI), however, were worse at baseline for female patients at biologic treatment initiation. These findings are similar to our previous research on patients initiating anti-TNF IV therapy (3). Overall, the results may suggest gender bias in the interpretation and use of PROs during the treatment decision making process in Canadian RA patients. References Wilder RL. J Rheumatol Suppl. 1996 Mar;44:10-2. Forslind K. et al. Ann Rheum Dis. 2007 Jan;66(1):46-52. Bensen W. et al. J Rheumatol Suppl. 2013 Jun:40:1020-1. Disclosure of Interest D. Sholter: None declared, W. Bensen: None declared, D. Choquette: None declared, I. Fortin: None declared, R. Arendse: None declared, J. Kelsall: None declared, M. Sheriff: None declared, R. Faraawi: None declared, J. Rodrigues: None declared, M. Zummer: None declared, S. Dixit: None declared, M. Starr: None declared, E. Rampakakis: None declared, J. Sampalis: None declared, F. Nantel Employee of: Janssen Inc Canada, M. Shawi Employee of: Janssen Inc Canada, S. Otawa Employee of: Janssen Inc Canada, A. Lehman Employee of: Janssen Inc Canada DOI 10.1136/annrheumdis-2014-eular.3979

Background Unlike rheumatoid arthritis (RA), the pattern of joint involvement in psoriatic arthritis (PsA) is usually asymmetric. Furthermore, PsA may demonstrate oligoarthritis or polyarthritis, while RA usually manifests in multiple joints. Objectives To describe the most commonly affected joints in patients with RA and PsA at baseline and after 6 months (mos) of treatment with infliximab (IFX) in a clinical practice setting. Methods BioTRAC is an ongoing, prospective registry of patients initiating treatment for RA, ankylosing spondylitis, or PsA with IFX as first biologics or after having been treated with a biologic for

Background A definition of minimal disease activity (MDA) in PsA was derived from the opinion of 60 PsA experts including fulfillment of ≥5 of the 7 following criteria: tender joint count (TJC) ≤1, swollen joint count (SJC) ≤1, PASI ≤1 or body surface area ≤3%, pain (VAS) ≤15, patient global disease activity (PtGA) (VAS) ≤20, HAQ ≤0.5, and tender entheseal points ≤1 (1). Objectives To describe the rate of MDA achievement over time and to assess the association between MDA achievement and DAS28 remission in PsA patients treated with anti-TNF in a routine clinical practice setting. Methods BioTRAC is an ongoing, prospective registry of patients initiating treatment for rheumatoid arthritis (RA), ankylosing spondylitis (AS), or PsA with infliximab or golimumab as first biologics or after having been treated with a biologic for Results A total of 123 PsA patients with mean (SD) age of 50.5 (10.5) yrs and mean (SD) duration since diagnosis of 6.1 (7.3) yrs were included in this analysis, providing information from 340 assessments. At the time of enrollment in the registry, mean (SD) patient parameters were: DAS28 =4.2 (1.5), PASI =2.7 (4.8), SJC28 =4.1 (3.5), TJC28 =6.1 (5.6), morning stiffness =45.4 (43.0) min, health assessment questionnaire (HAQ-DI) =1.09 (0.65), physician global assessment of disease activity (MDGA) =5.3 (2.1), patient global assessment of disease activity (PtGA) =49.3 (27.3) mm, and pain =46.5 (25.2) mm. By 6 mos of treatment, statistically significant (P The proportion of patients with MDA significantly increased from 12.3% at baseline to 45.0% after 6 months of treatment (P Conclusions MDA has high discriminatory power for remission as defined by the DAS28 criteria, while being more rigorous than DAS28. Furthermore, treatment with anti-TNF is effective in inducing MDA in 45% of patients as early as 6 mos from treatment initiation. References Coates LC, Cook R, Lee KA, Chandran V, Gladman DD. Arthritis Care Res (Hoboken). 2010 Jul;62(7):970-6. Disclosure of Interest P. Rahman: None declared, S. Shaikh: None declared, M. Starr: None declared, W. Bensen: None declared, D. Choquette: None declared, W. Olszynski: None declared, M. Sheriff: None declared, M. Zummer: None declared, E. Rampakakis: None declared, J. Sampalis: None declared, A. Lehman Employee of: Janssen, S. Otawa Employee of: Janssen, F. Nantel Employee of: Janssen, V. Letourneau Employee of: Janssen, M. Shawi Employee of: Janssen DOI 10.1136/annrheumdis-2014-eular.2382

Background The efficacy of anti-TNF in the management of psoriatic arthritis (PsA) and rheumatoid arthritis (RA) has been demonstrated in numerous controlled clinical trials. Objectives The objective of this analysis was to assess in Canadian routine clinical practice the durability of treatment with infliximab (IFX) in PsA and RA and the determinants associated with sustainability of IFX. Methods BioTRAC is an ongoing, prospective registry of patients initiating treatment for RA, AS, or PsA with infliximab or golimumab as first biologics or after having been treated with a biologic for less than six months. Patients with PsA or RA treated with IFX who were enrolled between 2002 (2005 for PsA patients) and 2012 were included in this analysis. Dose optimization was defined as an increase in the frequency and/or dosing of IFX. Kaplan Meier (KM) estimates and Cox proportional models were used in the analysis. Results A total of 92 PsA and 830 RA patients were included in the analysis. Mean (SD) age of the PsA and RA patient cohorts was 48.7 (9.9) and 55.8 (13.4) years, respectively, and mean (SD) duration since diagnosis was 6.8 (9.1) and 10.2 (10.1) years, respectively. Twenty seven (29.3%) PsA patients and 407 (49.0%) RA patients had discontinued treatment. Overall KM-based mean (SE) duration of treatment was 41.4 (3.6) months and 61.3 (2.2) months for PsA and RA patients, respectively. Longer treatment duration was associated with significantly greater improvements in pain (parameter estimate PsA: -0.21, P=0.020; RA: -0.27, P Conclusions The results of this observational study have shown a high durability of treatment with IFX for patients with PsA or RA in a real-world setting. Concomitant medication use significantly impacts treatment durability. Furthermore, longer disease duration, higher TJC, less severe skin disease at initiation and previous biologic use in PsA, and absence of IFX dose optimization in RA, may be associated with reduced treatment durability. Disclosure of Interest J. Kelsall: None declared, A. Jovaisas: None declared, P. Rahman: None declared, D. Sholter: None declared, M. Starr: None declared, W. Bensen: None declared, M. Sheriff: None declared, W. Olszynski: None declared, M. Zummer: None declared, R. Faraawi: None declared, A. Chow: None declared, S. Kapur: None declared, E. Rampakakis: None declared, J. Sampalis: None declared, F. Nantel Employee of: Janssen Inc Canada, S. Otawa Employee of: Janssen Inc Canada, M. Shawi Employee of: Janssen Inc Canada, A. Lehman Employee of: Janssen Inc Canada DOI 10.1136/annrheumdis-2014-eular.4013

Background Patient (PtGA) and physician (MDGA) assessment of global disease activity have been used as outcome measures individually or as part of composite scores in the measurement of rheumatoid arthritis (RA) disease severity and the evaluation of treatment effectiveness. However, discordance between the two is common 1 . The question arising is which global measure is a more valid predictor of disease remission. Objectives The aim of the analysis was to compare PtGA and MDGA with respect to their association with remission based on DAS-28, SDAI and CDAI, using a sequential cross-sectional analysis. Methods BioTRAC is an ongoing, prospective registry of patients initiating treatment for RA, ankylosing spondylitis (AS), or psoriatic arthritis (PsA) with infliximab (IFX) or golimumab as first biologics or after having been treated with a biologic for Results A total of 657 patients were included with mean (SD) age of 56.2 (13.5) years and disease duration of 10.1 (10.0) years. Significant (P Conclusions The results of this analysis show that PtGA is a better predictor of DAS28 disease remission compared to MDGA. This could be explained by the fact that DAS28 includes PtGA and not MDGA. However, for CDAI and SDAI, physicians were better in predicting remission although the superiority of the MDGA was not consistent over time. References Bensen WG et al. Identification of Four Parameters that Drive the Discordance Between the Patient and Physician Global Assessment in Rheumatoid Arthritis. Canadian Rheumatology Association Annual Scientific Meeting, 2013, Ottawa, ON, Canada. Disclosure of Interest None declared DOI 10.1136/annrheumdis-2014-eular.4276

Background Clinical trials of anti-TNF therapies have shown that concurrent methotrexate (MTX) therapy enhances the efficacy of infliximab (IFX) 1 . Data on the benefits of combination therapy with MTX and IFX in a real-life clinical setting are scarce. Objectives Describe changes in the use of MTX at IFX initiation in patients enrolled in routine clinical practice and assess the impact of the MTX dose on the real-life effectiveness of IFX. Methods BioTRAC is an ongoing, prospective registry of RA, AS or PSA patients initiating treatment with IFX or golimumab as first biologics or after having been treated with a biologic Results 790 RA patients were included with a mean (SD) age of 55.75 (13.46) yrs, mean (SD) disease duration of 10.15 (10.08) yrs. The concomitant use of MTX at infliximab initiation increased across enrolment periods (66.5% vs. 73.3% vs. 77.6%; P=0.022) which was also associated with decreased disease activity at baseline. Concomitant use of azathioprine (5.2% vs. 0.2%; P 25mg/week of MTX in recent yrs. Survival analysis shows that, upon adjusting for baseline disease activity, use of MTX over time was associated with an increased hazard ratio [HR (95%CI)] of attaining disease DAS28-CRP [1.35 (1.06-1.71)], CDAI [1.33 (1.02-1.72)], and SDAI [1.62 (1.14-2.32)] remission. This effect was observed across all MTX dose categories except for DAS28-CRP and CDAI in the >25mg/week dose category. Conclusions Clinical practice has changed over time with physicians using concomitant MTX at IFX initiation more frequently in recent years despite lower disease activity in patients today. The data support improved outcomes among patients treated with IFX in routine clinical care when receiving concomitant MTX. This is consistent with the current label and recent recommendations of the Canadian Rheumatology Association. References Arthritis Rheum 1998;41:1552–63 Disclosure of Interest D. Choquette: None Declared, C. Thorne: None Declared, J. Kelsall: None Declared, M. Zummer: None Declared, M. Starr: None Declared, M. Sheriff: None Declared, W. Bensen: None Declared, A. Chow: None Declared, P. Baer: None Declared, E. Rampakakis Employee of: JSS Medical Research, J. Sampalis Employee of: JSS Medical Research, F. Nantel Employee of: Janssen, A. Lehman Employee of: Janssen, S. Otawa Employee of: Janssen, M. Shawi Employee of: Janssen