M. Starr

SAT0336 Change over Time in the Profile of Ankylosing Spondylitis Patients Treated with Infliximab in A REAL World Routine Care

Objectives The objective of this study was to describe and compare over time the demographics and disease parameters at infliximab treatment initiation and to assess the effectiveness of treatment at 6 and 12 months in real life cohort AS patients. Methods BioTRAC is an ongoing, prospective registry of patients initiating treatment for rheumatoid arthritis (RA), ankylosing spondylitis (AS), or psoriatic arthritis (PsA) with infliximab or golimumab as first biologics or after having been treated with a biologic for less than six months. People with AS treated with infliximab who were enrolled between 2002 and 2013 were included in this analysis (N=303) and stratified to two groups (2005-2007: n=135; 2008-2013: n=168) based on the year of enrolment in the registry. Results Patient demographics were comparable in the two cohorts with a mean (SD) age of 45.72 (11.74) years and the majority being males (62.4%). A significant change in the geographic distribution of patients enrolled in the BioTRAC registry was observed (P=0.001) and more patients with provincial coverage were enrolled in 2008-2013 compared to 2005-2007 (P=0.012). A trend towards earlier initiation of infliximab was observed in more recent years as indicated by the shorter disease duration (11.12 vs. 8.24 years; P=0.013) and the lower number of prior traditional DMARDs used (0.83 vs. 0.59; P=0.078). Furthermore, overall, patients recruited in 2008-2013 had lower disease activity compared to those enrolled in 2005-2007. ESR (29.96 vs. 19.91 mm/hr; P<0.001), physician global assessment (MDGA; 6.99 vs. 6.26; P=0.001) were significantly lower in the 2008-2013 cohort while a statistical trend was observed in morning stiffness (78.96 vs. 70.11 minutes; P=0.064) and ASDAS (3.90 vs. 3.70; P=0.103). Treatment for 6 months resulted in a greater proportion of patients in the 2008-2013 cohort achieving inactive disease (ASDAS<1.3) without reaching statistical significance (20.7% vs. 34.9%; P=0.140). Conclusions The results of this analysis show that the profile of the AS patient population in the BioTRAC registry has changed over time towards lower disease activity and earlier initiation in the patient management process. These results may reflect differences in patient management over time or may be related to earlier access to care. Irrespective of enrolment period, 6-month treatment with infliximab was effective in reducing disease activity in AS patients. Disclosure of Interest D. Choquette: None declared, M. Starr: None declared, M. Khraishi: None declared, W. Bensen: None declared, S. Shaikh: None declared, J. Rodrigues: None declared, D. Sholter: None declared, M. Sheriff: None declared, J. Vaillancourt: None declared, J. Sampalis: None declared, A. Lehman Employee of: Janssen, S. Otawa Employee of: Janssen, F. Nantel Employee of: Janssen, M. Shawi Employee of: Janssen DOI 10.1136/annrheumdis-2014-eular.2375

AB0302 Profile of Joint Involvement over Time in Rheumatoid Arthritis and Psoriatic Arthritis Patients Treated with Anti-TNF in A Real-World Setting

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 <6 mos. RA patients treated between 2002-2012 and PsA patients treated with IFX between 2005-2012 were included. Based on the 28-joint involvement 7 groups were created: shoulder(s), elbow(s), metacarpophalangeal (MCP(s)), wrist(s), proximal interphalangeal (PIP(s)), knee(s), and thumb(s). The impact of treatment on joint swelling/tenderness was assessed with the McNemar test while the Chi-square test was used to compare the affected joints between disease groups. Results 832 RA patients (mean age: 55.8 yrs disease duration: 10.2 yrs) and 92 PsA patients (age: 48.7 yrs; disease duration: 6.8 yrs) were included. At baseline, mean DAS28, SJC28 and TJC28 in RA vs. PsA patients were 5.8 vs. 4.1 (P<0.001), 10.7 vs. 4.0 (P<0.001), and 12.6 vs. 5.9 (<0.001), respectively. Among RA patients, the joints most commonly swollen at baseline were MCPs (86.8% of patients), wrists (70.5%), and PIPs (53.2%). Knees, thumbs, elbows and shoulders were swollen in 42.3%, 33.7%, 30.5%, and 16.7% of patients, respectively (Figure 1A). With respect to tenderness, MCPs were tender in 83.8% of patients, wrists in 75.3%, shoulders in 57.8%, knees in 54.8%, PIPs in 55.3%, thumbs in 38.8%, and elbows in 41.0% (Figure 1B). Statistically significant differences were observed between RA and PsA patients both in the frequency of joint swelling/tenderness, which were lower in PsA, and the profile of affected joints. Among PsA patients, MCPs, wrists, and knees were the joints most commonly swollen, affected in 57.6%, 34.8%, and 31.5% of patients, respectively; MCPs, knees, and wrists were the joints most commonly tender (63.0%, 43.5%, and 42.4% of patients, respectively). Upon 6 mos of treatment, significant improvement in swelling/tenderness in all the most commonly affected joints in both RA and PsA patients was observed. The joints most resistant to treatment, still remaining affected at 6 mos, were MCPs in both patient groups. Figure 1. Types of swollen (A) and tender (B) joints at anti-TNF treatment initiation in RA and Psa Conclusions Significant differences exist in both the frequency and the profile of swollen and tender joints in RA and PsA patients although both diseases shared the MCPs as the joint most commonly affected and most resistant to treatment. Treatment with IFX for 6 mos resulted in a significant reduction in the 28-swollen and tender joint counts in both RA and PsA patients. Disclosure of Interest A. Jovaisas: None declared, M. Starr: None declared, D. Choquette: None declared, M. Zummer: None declared, R. Arendse: None declared, D. Sholter: None declared, R. Faraawi: None declared, J. Rodrigues: None declared, S. Kapur: None declared, E. Rampakakis: None declared, J. Sampalis: None declared, F. Nantel Employee of: Janssen, A. Lehman Employee of: Janssen, S. Otawa Employee of: Janssen, M. Shawi Employee of: Janssen DOI 10.1136/annrheumdis-2014-eular.2385

AB1044 Are There Gender Specific Differences in Patient Reported Outcomes at Initiation of Golimumab Treatment in Rheumatoid Arthritis

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

AB1059 Assessing Treatment Durability of Infliximab in the Management of Psoriatic Arthritis and Rheumatoid Arthritis Patients in A Canadian Setting

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<0.001), patient global (PsA: -0.35, P<0.001; RA: -0.28, P<0.001) and HAQ-DI (PsA: -0.01, P<0.001; RA: -0.01, P<0.001). Significant associations with duration of treatment in PsA patients were observed for disease duration (HR=1.04), previous biologic (HR=2.10), baseline TJC28 (HR=1.10), baseline PASI (HR=0.86) and concomitant use of traditional DMARD(s) (HR=0.16) or NSAID(s) (HR=0.38). For RA patients, IFX dose optimization (HR=0.72) and concomitant use of steroids (HR=1.78) were identified as significant predictors of treatment durability. 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

THU0247 What is More Predictive of Achieving Remission at 12 Months: the Percentage of Baseline Improvement or the Actual Disease State Achieved?

Background The aim of rheumatoid arthritis (RA) treatment is to optimize symptom control and, when possible, achieve sustained remission. Therefore, identification of clinical signs predicting future remission is valuable to clinical decision making. One question faced by clinicians is whether the achievement of a lower disease activity value or a higher rate of change of disease activity is indicative of better future disease outcomes. Objectives To determine whether change in disease activity measures or the actual values achieved at 6 months were more predictive of remission at 12 months in RA patients treated with infliximab (IFX) in a real-world, clinical practice setting. Methods BioTRAC is an ongoing, prospective registry of patients initiating treatment for RA with IFX or golimumab as first biologics or after having been treated with a biologic for <6 months. Eligible people for this study included RA patients treated with IFX enrolled between 2002-2012 with available 12-month information on remission. Multivariate logistic regression models with the parametric Wald statistic and the log-likelihood ratio were used to assess the independent contribution of the actual value and the change at 6 months in predicting 12-month remission as defined by DAS28 (<2.6), SDAI (≤3.3) and CDAI (≤2.8) criteria. These two statistics assess the extent of contribution of an individual predictor to an outcome of interest - higher values signify greater contribution - and can be used to compare the contribution of different predictors in a standardized fashion. Results 436 patients were included with mean age of 56.1 yrs and disease duration of 10.4 yrs. With respect to 12-month DAS28 remission, a stronger association was observed with the actual DAS28 score compared to the percent improvement in DAS28 at 6 months. The Wald statistic for the percent change and actual value of DAS28 at 6 months was 5.38 and 46.88, respectively, while the change in log-likelihood was 4.98 (P=0.026) and 61.64 (P<0.001), respectively, indicating that the actual DAS value achieved is significantly more predictive of remission when compared to percent change in DAS from baseline. For SDAI remission at 12 months, the respective Wald values for percent change and actual value at 6 months were 0.075 and 18.28 and log-likelihood changes were 0.07 (P=0.788) and 24.08 (P<0.001). For CDAI remission at 12 months, the Wald statistic was 0.01 and 34.42 for 6 month percent change and actual value, respectively, and change in log-likelihood was 0.01 (P=0.934) and 34.23 (P<0.001). Similar results were obtained when predicting low disease activity at 12 months. Conclusions These results demonstrate that the actual disease outcome value achieved at 6 months is a stronger predictor of remission at 12 months than the percent change in disease activity. These findings suggest that the treatment target in a real-world setting should be set as specific endpoints and not as change over time. Disclosure of Interest : None declared DOI 10.1136/annrheumdis-2014-eular.4443

THU0241 Predictors of Acr/Eular Boolean and SDAI Remission in Patients with Established Rheumatoid Arthritis Treated with Anti-TNF: an Analysis from the Prospective, Observational Registry, Biotrac

Background Early achievement of remission is associated with improved clinical, functional and radiographic outcomes1. Recent recommendations of the Canadian Rheumatology Association dictate that treatment target should be remission or, when not possible, low disease activity. Objectives To define the predictive factors of time to disease remission in established rheumatoid arthritis (RA) patients treated with infliximab. Methods BioTRAC is an ongoing, prospective registry of patients initiating treatment for RA, ankylosing spondylitis (AS), or psoriatic arthritis (PsA) with infliximab or golimumab as first biologics or after having been treated with a biologic for <6 months. RA patients treated with infliximab who were enrolled between 2002-2012 and had ≥1 follow-up assessment were included. Remission was defined according to the ACR/EULAR Boolean criteria (TJC28≤1, SJC28≤1, CRP≤1 mg/dL, and PtGA≤1) or CDAI≤2.8. Independent predictors of remission were identified by multivariate Cox regression considering as potential confounders parameters showing a statistical trend (P<0.150) in univariate analyses. Results A total of 671 patients were included of whom 494 (73.6%) were female. At baseline, mean (SD) age was 56.0 (13.5) years and mean (SD) disease duration was 10.3 (10.1) years. Median time to CDAI and Boolean remission was 47.3 and 54.1 months, respectively. In univariate analysis, the following factors showed a statistical trend in their association with longer time to CDAI remission: earlier enrolment period (P=0.117), increased age (P=0.070), longer disease duration (P=0.008), female gender (P=0.143), and increased baseline disease activity as indicated by TJC28 (P<0.001), SJC28 (P<0.001), morning stiffness (P=0.003), pain (P<0.001), PtGA (P<0.001), MDGA (P<0.001), HAQ-DI (P<0.001), and CDAI (P<0.001). Rheumatoid factor (RF) status, number of previous DMARDs, and initial (first 6 months) treatment with DMARD(s), NSAID(s) or steroid(s) did not predict achievement of remission. In multivariate analysis, baseline CDAI [HR (95%CI): 0.97 (0.96,0.98); P<0.001] and disease duration [0.98 (0.97,1.00); P=0.018] were identified as independent predictors of time to CDAI remission. Similarly, multivariate survival analysis showed that increased disease duration [0.98 (0.96,1.00); P=0.047] and increased pain [0.98 (0.98,0.99); P<0.001] at baseline were associated with a lower chance of achieving ACR/EULAR Boolean remission. Conclusions Upon adjusting for potential confounders, increased disease duration before anti-TNF initiation is an independent predictor of longer time to remission. The results of these real-world Canadian data support findings that earlier initiation of anti-TNF agents may be associated with increased remission rates when stringent definitions of remission are considered. References Smolen JS et al. Ann Rheum Dis. 2009;68:823-7. Disclosure of Interest : B. Haraoui: None declared, M. Sheriff: None declared, M. Khraishi: None declared, M. Starr: None declared, J. Kelsall: None declared, M. Baker: None declared, R. Arendse: None declared, S. Dixit: None declared, W. Bensen: None declared, P. Baer: None declared, R. Faraawi: None declared, E. Rampakakis: None declared, J. Sampalis: None declared, S. Otawa Employee of: Janssen, A. Lehman Employee of: Janssen, F. Nantel Employee of: Janssen, M. Shawi Employee of: Janssen DOI 10.1136/annrheumdis-2014-eular.2365

AB0234 Differential Relative Contribution of Individual Components on DAS28 over Time. an Analysis from the Prospective, Observational Registry, Biotrac

Background DAS28 is an important outcome for clinical research and practice assisting with therapeutic decisions. The main contributors to DAS28 are joint tenderness and acute-phase reactants. A simulation analysis showed that, due to its logarithmic transformation in the DAS28 formula, the ESR contribution is greater in the lower than in the higher DAS28 range. Objectives This analysis assessed the relative contribution of individual DAS28 components and examined its clinimetric properties in rheumatoid arthritis (RA) patients treated with infliximab in a Canadian real-world setting. Methods BioTRAC is an ongoing, prospective registry of patients initiating treatment for RA, ankylosing spondylitis (AS), or psoriatic arthritis (PsA) with infliximab or golimumab as first biologics or after treatment with a biologic for <6 months (M). RA patients treated with infliximab between 2002-2012 and with ≤60M of follow-up were included. The association between treatment duration and parameter improvement was assessed using linear regression. Slope correlation was assessed with the Pearsons correlation coefficient. Results 832 patients evaluated over 4,002 visits were included. Longer treatment duration was associated with significant (P<0.001) improvements in DAS28, TJC28, SJC28, PtGA, ESR, and CRP. Correlation analysis of the rate of change over time showed a high correlation (0.7-0.9) of DAS28 with TJC28, SJC28, and PtGA but low correlation with ESR (r=0.418) and CRP (r=0.411). Overall, the relative contribution of TJC28, SJC28, PtGA, and ESR in DAS28-ESR was 22%, 9%, 12%, and 57%, respectively. For DAS28-CRP, the relative TJC28, SJC28, PtGA, and CRP contributions were 25%, 10%, 12%, and 20%. Over 60M of treatment, the mean relative contribution of TJC28 (M0:31%, M60:17%), SJC28 (M0:15%, M60:5%), and PtGA (M0:15%, M60:9%) significantly (P<0.001) decreased whereas the weight of ESR contribution increased (M0:39%, M60:69%). Similar results were obtained with DAS28-CRP although the CRP contribution was lower compared to ESR. Increased DAS28-ESR was associated with higher relative contributions (per unit of DAS28-ESR increase) of TJC28 [parameter estimate (B) =5.3], SJC28 (B=2.1), and PtGA (B=0.7) but lower ESR contribution (B=-8.1). Similarly, increased DAS28-CRP was associated with lower relative CRP contribution (B=-2.0). Conclusions This analysis shows that TJC28 and acute-phase reactants have a greater weight than SJC28 and PtGA within DAS28. Furthermore, the relative contribution of acute-phase reactants is greater with lower DAS28, due to their logarithmic nature. These findings suggest that biologic variability and variability in laboratory techniques may have significant impact on classifying remission or DAS28 changes among patients with low DAS28 and on therapeutic plan changes. Disclosure of Interest D. Choquette: None declared, D. Sholter: None declared, I. Fortin: None declared, M. Starr: None declared, C. Thorne: None declared, M. Baker: None declared, R. Arendse: None declared, P. Baer: None declared, M. Zummer: None declared, J. Rodrigues: None declared, M. Sheriff: None declared, E. Rampakakis: None declared, J. Sampalis: None declared, F. Nantel Employee of: Janssen, A. Lehman Employee of: Janssen, S. Otawa Employee of: Janssen, M. Shawi Employee of: Janssen DOI 10.1136/annrheumdis-2014-eular.2379

AB0760 Real-World Validation of the Minimal Disease Activity Index in Psoriatic Arthritis: an Analysis from the Prospective, Observational Registry, Biotrac

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 <6 months. Data from PsA patients treated with infliximab (enrolled in 2005-2013) or golimumab (enrolled in 2010-2013) who had available MDA information at baseline, 6 months, and/or 12 months were included. Improvement in patient parameters over time was assessed for statistical significance with the paired-samples t-test. Agreement between MDA and remission as defined by the DAS28 (<2.6) criteria was assessed with the sensitivity, specificity, as well as the positive (PPV) and negative (NPV) predictive value. 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<0.05) improvements were observed in all clinical and patient outcome parameters studied, which were sustained or further enhanced over 12 months of treatment. The proportion of patients with MDA significantly increased from 12.3% at baseline to 45.0% after 6 months of treatment (P<0.001), and 41.9% at 12 mos (P=0.021). Similarly, DAS28 remission was observed in 15.9%, 47.8% and 45.1% of patients at baseline, 6 mos, and 12 mos, respectively. Using DAS28 as reference standard, sensitivity was 69.8%, specificity 93.0%, NPV 88.2%, and PPV 80.4%. 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

SAT0551 What is the Real World Relationship between Patient-Reported Pain or Patient Global Assessment and Disease Activity Indices in Rheumatoid Arthritis? An Analysis from the Prospective, Observational Registry, Biotrac

Background Patient-reported outcomes such as pain and patient global assessment of disease activity (PtGA) have been critiqued for not accurately assessing RA disease activity as they may reflect aspects not directly related (e.g. fibromyalgia, low back pain, depression) or related to non-RA conditions. Objectives To describe the relationship between patient-reported pain and RA disease activity levels in a real-world, routine clinical care setting; To assess the occurrence of non-remission driven solely by pain using PtGA as a proxy for pain. Methods BioTRAC is an ongoing, Canadian prospective registry of rheumatology patients initiating infliximab (IFX) or golimumab. Data from RA patients treated with IFX between Jan 2002 and Jun 2011 were used. Correlation of pain (VAS mm) with DAS28-ESR, CDAI and SDAI in a continuous or binary (low disease activity: yes vs no; remission: yes vs no) scale was assessed with linear regression and logistic regression, respectively. For assessment of non-remission due to PtGA, DAS28-ESR, CDAI, and SDAI, remission rates were compared to “non-PtGA” remission rates, calculated by subtracting the relative contribution of PtGA to the index. Results Analyses included 838 RA patients with 4,582 assessments. A significant (P<0.001) positive linear relationship was found between pain and DAS28-ESR (standardized coefficient (β) = 0.662), CDAI (β = 0.660), and SDAI (β = 0.659). Increased pain was associated with reduced odds of achieving remission or low disease activity as defined by DAS28-ESR, CDAI, and SDAI (Table 1). Correlation analysis showed a strong positive linear correlation existed between pain and PtGA (r = 0.914), supporting the use of PtGA as a proxy for pain. Cross-tabulation of remission achievement with “non-PtGA” remission achievement revealed that omission of PtGA from the DAS28-ESR, CDAI, and SDAI indices would result in the re-classification of an additional 2.0%, 9.3%, and 9.6% of the cases as remission. Conclusions Increased pain is associated with higher disease activity as measured by the DAS28-ESR, CDAI and SDAI, which may be due to the strong correlation of pain with PtGA. Omission of PtGA from these indices resulted in classification of additional cases as remission cases to an extent that paralleled the strictness of the remission criteria (i.e., from the less “strict” DAS28-ESR to the more “strict” SDAI). Therefore, the CDAI and SDAI might be more sensitive to pain not directly related to RA. References N/A Disclosure of Interest R. Arendse: None Declared, M. Starr: None Declared, P. Rahman: None Declared, J. Kelsall: None Declared, M. Baker: None Declared, W. Bensen: None Declared, C. Thorne: None Declared, P. Baer: None Declared, D. Choquette: None Declared, I. Fortin: None Declared, E. Rampakakis Employee of: JSS, J. Sampalis Employee of: JSS, S. Otawa Employee of: Janssen, M. Shawi Employee of: Janssen, F. Nantel Employee of: Janssen, A. Lehman Employee of: Janssen

SAT0035 Variability in the Classification of Remission among Disease Activity Indices and Their Correlation: An Analysis From a Prospective, Observational Registry

Background In recent years, disease remission in rheumatoid arthritis (RA) has been assessed using various disease activity indices such as the DAS28, SDAI, CDAI, ACR/EULAR-recommended Boolean definition and the Patient Activity Scale (PAS). Objectives The aim of this analysis is to describe the agreement between these five indices in classifying remission as well as to assess their correlation in a routine clinical care setting. Methods BioTRAC is an ongoing, prospective Canadian registry of rheumatology patients initiating treatment with infliximab or golimumab. In this analysis, data from RA patients who were treated with infliximab between January 2002 and June 2011 and had available information in all indices were used. The definitions for remission were as follows: DAS28-ESR < 2.6; SDAI ≤ 3.3, CDAI ≤ 2.8; PAS ≤ 1.0. Factor analysis was used to assess the variability due to each of the indices while inter-item correlation was measured with the Pearson correlation coefficient. Results Seven hundred twenty five RA patients who had 2,897 complete assessments were included in the analysis. Non-remission was classified by all indices in 68.8% of the cases, while 31.2% achieved remission in one (12.4%), two (3.5%), three (3.4%), four (4.2%) and all five types (7.7%) of indices. Factor analysis showed that PAS accounted for 71.5% of the matrix variance, followed by DAS28-ESR (12.4%), SDAI (9.2%), CDAI (5.2%), and Boolean remission (1.6%), suggesting that PAS may reflect different aspects than the clinical indices. PAS remission revealed the lowest correlation with remission classified by the remaining indices (Table 1) and removal of any index, except PAS, would result in a lower overall Cronbach’s alpha. Conclusions The results of this analysis show that variability exists in the classification of remission by various disease activity indices. This variability was found to be predominantly due to the Patient Activity Scale, a patient-driven composite tool, suggesting that the patient perception of disease activity may differ from that captured by clinical outcome measures. Disclosure of Interest W. Bensen: None Declared, A. Jovaisas: None Declared, C. Thorne: None Declared, P. Baer: None Declared, M. Khraishi: None Declared, S. Dixit: None Declared, D. Choquette: None Declared, M. Starr: None Declared, I. Fortin: None Declared, D. Sholter: None Declared, E. Rampakakis Employee of: JSS Medical Research, J. Sampalis Employee of: JSS Medical Research, A. Lehman Employee of: Janssen, F. Nantel Employee of: Janssen, M. Shawi: None Declared, S. Otawa Employee of: Janssen