R. Arendse

FRI0473 What Proportion of Patients with PSA Fail To Achieve Mda Based on Patient Reported Outcomes? An Analysis from A Prospective, Observational Registry

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

SAT0394 Impact of Disease Duration on Patient Reported and Clinical Outcomes in Patients with Ankylosing Spondylitis Treated with Anti-TNF: An Analysis from A Prospective, Observational Registry

Background Previous studies have shown that treatment outcomes are affected by disease-related aspects and patient-related factors. Objectives The aim of this analysis was to compare ankylosing spondylitis (AS) patient profiles in terms of patient characteristics and disease parameters based on disease duration and to investigate the impact of disease duration on patient reported and clinical outcomes in patients treated with anti-TNF. Methods BioTRAC is an ongoing, prospective registry of pts initiating treatment for rheumatoid arthritis, AS, or psoriatic arthritis with infliximab (IFX) or golimumab (GLM). Eligible people for this analysis included AS patients treated with IFX and enrolled since 2005 or with GLM and enrolled since 2010. Patients were classified in three subgroups (≤1 yr, 2–10 yrs, >10 yrs) based on the tertile distribution of the time elapsed since their diagnosis. The impact of disease duration on outcomes upon adjusting for potential confounders was assessed with generalized linear models and logistic regression. Results A total of 580 AS patients were included in this analysis with a mean age of 45.8 yrs and disease duration of 8.3 yrs. The majority were male and 92.6% were biologic naïve. At baseline, mean BASFI was 5.6, BASDAI was 6.2, and ASDAS was 3.6. With the exception of age which was significantly higher among pts with longer disease duration (P<0.001) no significant between-group differences were observed in baseline demographics and disease parameters. Upon 6 mos of treatment, clinically meaningful and statistically significant improvements were observed in BASFI, BASDAI and ASDAS which were further enhanced at 12 mos. Upon adjusting for baseline age and respective parameter levels, pts diagnosed within ≤1 yr experienced significantly lower improvements in BASFI (P=0.030), BASDAI (P<0.001), and ASDAS (P=0.030) at 12 mos as compared to pts with disease duration >10 ys. For ASDAS, concomitant DMARD use was also identified as a significant predictor of improved outcome (P=0.042). Gender and prior biologic experience did not have a significant impact on outcomes. Inactive or moderate disease activity, based on ASDAS, was achieved by 47.2% of pts while clinically important and major improvements were observed for 54.9% and 32.7% of pts, respectively. Similarly to the absolute improvements, pts diagnosed within ≤1 yr were significantly less likely to achieve these endpoints. Conclusions The results of this real-world analysis have identified prior disease duration at anti-TNF initiation as a significant independent predictor of treatment outcome. Concomitant use of a DMARD was associated with significantly higher improvement in ASDAS. These results suggest that pts with early disease may be harder to treat and highlight the need for more aggressive treat-to-target approaches in this patient subgroup. Disclosure of Interest M. Starr: None declared, M. Zummer: None declared, D. Choquette: None declared, B. Haraoui: None declared, D. Sholter: None declared, R. Arendse: None declared, I. Fortin: None declared, L. Bessette: None declared, P. Rahman: None declared, E. Rampakakis Employee of: JSS Medical Research Inc;, E. Psaradellis Employee of: JSS Medical Research Inc;, A. Lehman Employee of: Janssen, K. Maslova Employee of: Janssen, B. Osborne Employee of: Janssen, F. Nantel Employee of: Janssen, C. Tkaczyk Employee of: Janssen

FRI0421 What Is The Location of Enthesitis in Ankylosing Spondylitis and Psoriatic Arthritis Patients and How Do They Respond To Anti-TNF Treatment?

Background Enthesitis is characterized by inflammation at the insertion of ligaments, tendons, joint capsule, or fascia to bone, and represents a well-known characteristic feature of ankylosing spondylitis (AS) and related spondyloarthropathies. Objectives To identify the location of enthesitis 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, 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 enthesitis. The paired sampled t-test was used to compare the enthesitis count at baseline and 12 months. 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, respectively, and disease duration of 6.4 (9.8) vs. 5.2 (6.8) years. Among patients with AS, 28.1%, 21.7%, 22.4% had enthesitis at baseline, 6 months and 12 months, respectively. For PsA these numbers were 32.2%, 19.7%, and 22.6%, respectively. The presence of enthesitis by anatomical site and visit are described in Table 1 with higher proportions observed for the greater trochanter (GT) in AS patients and the lateral epicondyle humerus (LEH) in PsA patients.Table 1 : Presence of enthesitis by anatomical site AS PsA Baseline 6 Months 12 Months Baseline 6 Months 12 Months (N=260) (N=203) (N=134) (N=261) (N=189) (N=133) LEH, % 10.8 6.9 7.5 16.1 8.5 6.8 MEH, % 8.1 5.9 4.5 12.6 7.4 6.8 PA, % 10.8 5.4 3.0 13.0 6.4 6.8 GT, % 14.2 8.4 10.4 10.7 9.0 6.0 IPF, % 7.7 3.4 4.5 11.9 5.3 3.8 SI, % 11.5 8.9 7.5 10.7 8.0 8.3 QIP, % 6.9 3.9 1.5 9.6 5.9 6.0 PATT, % 6.9 4.4 1.5 13.8 5.9 8.3 LEH: Lateral epicondyle humerus; MEH: Medial epicondyle humerus; PA: Proximal achilles; GT: Greater trochanter; IPF: Insertion plantar fascia; SI: Suprapsinatus insertion; QIP: Quadriceps insertion patella; PATT: Inferior pole patella or tibial tubercle. Presence of enthesitis in all anatomical sites was significantly associated with higher HAQ among AS and PsA patients. The mean (SD) enthesitis count at baseline and 12 months was 4.4 (3.4) vs. 2.6 (2.3) (P=0.061) among AS patients and 5.0 (3.8) vs. 3.8 (3.0) (P=0.006) in PsA patients, respectively. Conclusions A considerable proportion of PsA and AS patients had enthesitis at anti-TNF initiation in this Canadian real-world cohort. Overall, presence of enthesitis was associated with significantly higher functional disability. Treatment with IFX or GLM for 12 months was associated with significant reduction in the mean enthesitis count. Disclosure of Interest J. Kelsall: None declared, D. Choquette: None declared, P. Rahman: None declared, R. Arendse: None declared, M. Teo: None declared, I. Fortin: None declared, J. A. Avina-Zubieta: None declared, E. Rampakakis: None declared, E. Psaradellis: None declared, K. Maslova Employee of: Janssen Inc., B. Osborne Employee of: Janssen Inc., C. Tkaczyk Employee of: Janssen Inc., F. Nantel Employee of: Janssen Inc., A. Lehman Employee of: Janssen Inc.

THU0365 Do Patterns of Joint Swelling or Tenderness in Rheumatoid Arthritis Patients Impact Disease Activity Outcomes and Pain? Implications for Clinical Practice

Objectives This analysis aimed to describe the pattern of specific joint involvement (tender and/or swollen) pre- and post-TNFi treatment and the impact of specific joint pattern involvement on composite score outcomes and pain. Methods BioTRAC is an ongoing, prospective registry of patients initiating treatment for RA, AS, or PsA with infliximab (IFX) or golimumab (GLM). In this analysis, RA patients included those treated with IFX between 2002-2014 or with GLM between 2010-2014. Based on 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 specific joints on disease activity indices and pain was assessed with the independent-samples t-test; linear regression produced adjusted estimates. Results A total of 1030 RA patients were included with 5177 assessments. At baseline, MCP(s) (84.8%) and wrist(s) (66.1%) were the most commonly swollen joints. Tenderness was most frequent at baseline in these two joint types (81.1% and 70.9% of patients, respectively). Swelling/tenderness rates in all joint groups were significantly lower (p<0.001) among patients enrolled in 2010-2013 vs. those enrolled in 2002-2005; no significant differences, however, were observed in joint involvement pattern. Swelling and tenderness in all joint groups were associated with significantly (P<0.001) higher pain. Upon adjusting for age, gender and the total number of swollen (SJC28) or tender (TJC28) joints, swollen shoulder(s) and knee(s), and tender shoulder(s) and elbow(s) had the biggest impact on pain. Swollen MCP(s), knee(s) and thumb(s) had the greatest impact on DAS28, while for CDAI and SDAI swollen thumb(s) and swollen thumb(s) and knee(s), respectively, showed the highest association. Tender wrist(s), shoulder(s), and knee(s) showed the highest association with DAS28, while tender MCP(s) had the greatest impact on CDAI and SDAI. However, all indices were significantly higher among cases with swollen thumb(s) (unstandardized coefficient (B): BDAS28=0.25, P=0.006; BCDAI=2.09, P=0.001; BSDAI=2.66, P=0.001). Conclusions Although joint swelling/tenderness documented at anti-TNF initiation has decreased over time, the profile of affected joints has remained stable. Swelling/tenderness in specific joint groups was differentially associated with pain, with larger joints having the greatest impact. Furthermore, differences were observed in levels of disease activity based on the type of affected joint which could be attributed to their impact on patient global assessment. These results suggest that location of joint involvement, in addition to the number of affected joints, has an independent impact on pain. Disclosure of Interest R. Arendse Consultant for: Janssen, J. Kelsall Consultant for: Janssen, A. Avina-Zubieta Consultant for: Janssen, P. Baer Consultant for: Janssen, J. Rodrigues Consultant for: Janssen, A. Jovaisas Consultant for: Janssen, I. Fortin Consultant for: Janssen, M. Sheriff Consultant for: Janssen, M. Khraishi Consultant for: Janssen, E. Rampakakis: None declared, J. Sampalis: None declared, F. Nantel Employee of: Janssen, M. Shawi Employee of: Janssen, C. Tkaczyk Employee of: Janssen, S. Otawa Employee of: Janssen, A. Lehman Employee of: Janssen

SAT0062 What is the Effect of TNF Inhibitors on Employment Status in Rheumatoid Arthritis Patients and what are the Predictors of Progression to Unemployment

Objectives The aim of this analysis was to evaluate the prevalence of unemployment due to work disability in RA patients initiating treatment with infliximab (IFX) or golimumab (GLM) and to identify determinants of disability. Methods BioTRAC is an ongoing, prospective registry of patients initiating treatment for RA, AS, or PsA with IFX or GLM as first biologics. Data were obtained from RA patients treated with IFX (2002-2014) or GLM (2010-2014). Between employment group differences were assessed for statistical significance with the independent samples t-test or the chi-square. Time to employment and time to unemployment were assessed with the Kaplan-Meier (KM) estimator of the survival function. Cox regression was used to identify predictors of time to unemployment. Results A total of 581 RA patients were included; 374 (64.4%) employed and 207 (35.6%) unemployed due to disability. The following baseline parameters were associated with significantly increased likelihood of being unemployed due to disability: female vs. male gender (40.1% vs. 27.6%; P=0.006), earlier enrolment period (2002-05 vs. 2006-09 vs. 2010-14: 49.3% vs. 30.5% vs. 22.4%; P<0.001), insurance type (provincial vs. private vs. both: 54.9% vs. 23.8% vs. 20.0%; P<0.001), older age (P=0.033), and increased disease activity as evidenced by the higher DAS28 (P<0.001), SJC (P<0.001), TJC (P<0.001), HAQ (P<0.001), MDGA (P<0.001), PtGA (P<0.001), CDAI (P<0.001), SDAI (P<0.001), pain (P<0.001), and ESR (P<0.001). Among disabled patients, 10.1% were able to return to work upon treatment with TNF a mean KM-based duration of 119.5 months from baseline; whereas 6.4% of employed patients became disabled (2002-05 vs. 2006-09 vs. 2010-14: 7.0% vs. 10.1% vs. 1.7%; P=0.021) with a mean time to unemployment of 113.4 months. Multivariate survival analysis showed that, upon adjusting for enrolment period, higher baseline HAQ [HR (95%CI): 3.59 (1.64, 7.87), P=0.001], and higher baseline SJC [HR (95%CI): 1.09 (1.02, 1.16), P=0.011] were significant predictors of unemployment due to disability. Conclusions A significant proportion of RA patients are unemployed due to disability. At anti-TNF initiation, work disability was associated with higher disease activity, female gender, earlier enrolment period, and provincial insurance. Increased HAQ and higher SJC were significant predictors of progression to unemployment. Anti-TNF treatment was effective in enabling a considerable portion of disabled patients to return to employment. Disclosure of Interest A. Chow: None declared, W. Bensen Consultant for: Janssen, R. Arendse Consultant for: Janssen, E. Keystone Consultant for: AbbVie, Amgen, BMS, Janssen, Pfizer, Roche, Speakers bureau: AbbVie, Amgen, BMS, Janssen, Pfizer, Roche, P. Baer Consultant for: AbbVie, Amgen, BMS, Janssen, Pfizer, Roche, Speakers bureau: AbbVie, Amgen, BMS, Janssen, Pfizer, Roche, J. Kelsall Consultant for: Janssen, W. Olszynski: None declared, J. Rodrigues: None declared, A. Avina-Zubieta: None declared, M. Baker: None declared, W. Olszynski: None declared, W. Bensen Consultant for: Janssen, P. Baer Consultant for: Janssen, D. Choquette Consultant for: AbbVie, Amgen, Celgene, BMS Canada, Janssen, Pfizer, S. Kapur: None declared, A. Jaroszynska: None declared, J. Sampalis Shareholder of: JSS Medical Research, Employee of: JSS Medical Research, D. Choquette Consultant for: AbbVie, Amgen, Celgene, BMS Canada, Janssen, Pfizer, E. Rampakakis Employee of: JSS Medical Research, S. Kapur: None declared, J. Stewart: None declared, C. Tkaczyk Employee of: Janssen, J. Sampalis Shareholder of: JSS Medical Research, Employee of: JSS Medical Research, M. Shawi Employee of: Janssen, E. Rampakakis Employee of: JSS Medical Research, A. Lehman Employee of: Janssen, F. Nantel Employee of: Janssen, S. Otawa Employee of: Janssen, C. Tkaczyk Employee of: Janssen, A. Lehman Employee of: Janssen

SAT0168 What is the Treatment Durability and Safety Profile of Rheumatoid Arthritis Patients Treated with Infliximab Plus Methotrexate and/or Leflunomide? An Analysis from a Real-World Registry

Objectives Clinical trials of anti-TNF therapies have shown that concurrent methotrexate (MTX) therapy enhances the efficacy of TNF inhibitors. A scarcity of data exists on the benefits of combination therapy with IFX and MTX vs. leflunomide (LEF) in a real-world setting; therefore the BioTRAC Registry database was used to explore this question. Methods BioTRAC is an ongoing, prospective registry of patients initiating treatment for RA, AS, or PsA with IFX or golimumab as first biologics or after having been treated with a biologic for <6 months. RA patients treated with IFX who were enrolled between 2002-2014 were included in this analysis. Treatment durability was assessed with the Kaplan Meier (KM) estimator of the survival function and Cox regression. Results 723 RA patients were included; at baseline 516 (71.4%) were on IFX+MTX, 115 (15.9%) on IFX+LEF, and 92 (12.7%) on IFX+MTX+LEF. The mean (SD) age was 55.5 (13.6) years, 76.2% were female and mean (SD) disease duration was 8.7 (9.2) years. The majority of patients were from Ontario (50.6%), followed by Western Canada (25.8%), and Quebec (20.9%). There were 217 (30.0%) patients who discontinued due to lack/loss of response, disease progression, adverse event (AE) or change in therapy with a KM-based mean (SE) time to discontinuation of 83.9 (3.0) months. Upon adjusting for potential confounders, higher durability was observed for the IFX+MTX group vs. IFX+LEF [hazard ratio -HR- (95% CI): 0.50 (0.25-1.01), P=0.055]. Moreover, factors independently associated with premature treatment termination were earlier enrolment period [HR2006-09 vs. 2002-05 (95% CI): 0.15 (0.02-1.15, P=0.068; HR2010-2014 vs. 2002-05 (95% CI): 0.09 (0.01-0.70), P=0.021], shorter baseline disease duration [HR (95% CI): 0.97 (0.93-1.00), P=0.054], and increased baseline pain levels [HR (95% CI): 1.14 (1.03-1.26), P=0.013]. 2,016 AEs were reported by 343 patients (106.8 events/100 patient-years) and 156 SAEs by 96 patients (8.3 events/100 patient-years). The incidence density ratio (IDR) (95% CI) was higher in the groups IFX+MTX vs. IFX+LEF for both AEs and SAEs with 1.44 (1.25-1.67) and 1.60 (0.94-2.73), respectively, however the latter was not statistically significant. When examining the triple combination therapy (IFX+MTX+LEF), higher durability was observed compared to both IFX+MTX [HR (95% CI): 3.68 (1.14-11.92); P=0.030] and IFX+LEF [HR (95% CI): 6.34 (1.72-23.34); P=0.006]. Conclusions The results of this real-world observational study have shown that combination therapy with IFX+MTX is associated with significantly higher treatment durability compared to IFX+LEF in RA patients with increased risk for AEs but not for SAEs. Disclosure of Interest R. Faraawi Consultant for: Janssen, Speakers bureau: Janssen, R. Joshi: None declared, W. Bensen Consultant for: Janssen, D. Choquette Consultant for: AbbVie, Amgen, Celgene, BMS Canada, Janssen, Pfizer, W. Olszynski: None declared, R. Arendse Consultant for: Janssen, M. Sheriff: None declared, P. Rahman Consultant for: Abbott, AbbVie, Amgen, BMS, Celgene, Janssen, Novartis, Pfizer, Roche, J. Sampalis Shareholder of: JSS Medical Research, Employee of: JSS Medical Research, E. Rampakakis Employee of: JSS Medical Research, C. Tkaczyk Employee of: Janssen, F. Nantel: None declared

SAT0565 Correlation of Individual HAQ Questions with Disease Activity Measures in Psoriatic Arthritis: Implications for Instrument Reduction

Background The Health Assessment Questionnaire (HAQ) is commonly used for assessing patient-reported functional status and disease activity in psoriatic arthritis (PsA). However, it has been critiqued for being time-consuming, not easily scored and thus, not contributing to decisions in routine care (1) Objectives The aim of this analysis was to describe the correlation of individual HAQ questions with patient and physician reported measures used in PsA and to examine whether the instrument could be reduced to better reflect routine clinical practice. Methods BioTRAC is an ongoing, prospective registry of patients initiating treatment for RA, AS, or PsA with infliximab or golimumab. Data from PsA patients treated with infliximab or golimumab in 2006-2013 were used. The correlation of each HAQ question with patient and physician (pain, patient global assessment (PtGA), SJC28, TJC28 and physician global assessment (MDGA)) reported measures were described with the Pearsons correlation coefficient. The impact of each HAQ 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 question in HAQ. Results A total of 183 PsA patients with 596 HAQ assessments were included. Individual HAQ questions correlated at different extents with each PsA measures. All questions showed higher correlations with PtGA and pain compared to MDGA. Regarding patient reported outcomes, Question 5A (“Wash/dry your entire body”) showed the highest correlation, specifically with pain. The majority of HAQ questions were significantly associated with the need for help within their corresponding ability category, with the exception of questions Q3B, Q3C, Q4B, Q5C and Q8B. The results of factor analysis showed that 2 (Q1A and Q3B) out of the 20 HAQ questions accounted for 61.5% of its matrix variance, suggesting that the question on the ability to “dress, tie shoelaces and do buttons”, as well as the question on the ability to “lift a full cup or glass” may be the main drivers of HAQ in PsA. Conclusions Variability exists in the correlation of individual HAQ questions with patient and physician reported PsA measures. Pain and PtGA are significantly associated with the various domains of HAQ, while clinical outcomes (SJC28 and TJC28) and MDGA are less important. Among PsA patients, the HAQ is driven by components related to dressing and grooming and to eating abilities, suggesting that PsA patients may be facing different challenges than RA patients. This may have implications from an occupational health perspective and in the design of a shorter self-report instrument more suitable for PsA patients. References Khanna D, et al. Arthritis Care Res. 2011;63:S486-S490. Disclosure of Interest D. Choquette Consultant for: AbbVie, Amgen, Celgene, BMS Canada, Janssen, Pfizer, C. Thorne: None declared, M. Khraishi: None declared, I. Fortin: None declared, R. Arendse: None declared, A. Chow: None declared, J. Kelsall Consultant for: Janssen, M. Baker: 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

FRI0036 What is the Level of Agreement Between Disease Activity Indices and Response Criteria Among Rheumatoid Arthritis Patients Treated with TNF Inhibitors

Background Several standardized response criteria and disease activity indices are used to assess treatment efficacy in rheumatoid arthritis (RA). These measures comprise different types and number of variables resulting in different weighting of individual variables within each of them. Objectives The aim of this analysis was to compare the performance of ACR, SDAI major and minor, and HAQ response criteria and to determine their level of agreement with the DAS28, SDAI, and CDAI definitions of low disease activity (LDA) and remission in RA patients treated with infliximab (IFX) or golimumab (GLM) in a real-world, Canadian, clinical practice 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 RA patients treated with IFX between 2002-2014 or GLM between 2010-2014. Response was assessed with ACR20, ACR50, ACR70, HAQ improvement of 0.22 and 0.5, SDAI major (≥22) and minor improvement (≥10). Disease state was assessed with DAS28, SDAI, and CDAI definitions of LDA (<3.2, ≤11, ≤10, respectively) and remission (<2.6, ≤3.3, ≤2.8, respectively). The level of agreement was assessed with the proportion of concordant pairs over the total number of cases in each cross-tabulation and the Kappa statistic. Results A total of 830 RA patients with 4,100 available observations were included. The criteria for each definition of response/disease state were met for the following proportion of cases: ACR20 (66.4%), ACR50 (44.5%), ACR70 (26.4%), ΔHAQ≥0.22 (65.5%), ΔHAQ≥0.5 (53.4%), SDAI major improvement (55.8%), SDAI minor improvement (80.8%), DAS28 remission (29.4%), CDAI remission (20.4%), SDAI remission (21.8%), CDAI LDA (57.5%), SDAI LDA (58.1%), and DAS28-ESR LDA (46.0%). Statistically significant (Kappa P<0.001) associations were observed for all combinations of variables examined. Overall, the ACR response criteria performed better than the HAQ and SDAI response criteria in their agreement with LDA and remission. In general, higher levels of response in all three measures (ACR20 vs. ACR50 vs. ACR70; ΔHAQ≥0.22 vs. ΔHAQ≥0.5; SDAI minor vs. major) showed better agreement with LDA and remission. The highest level of agreement between response criteria and disease state was observed between the strictest definitions, namely between ACR70 and CDAI/SDAI remission; whereas, SDAI minor improvement showed the lowest level of agreement with remission, irrespective of definition. Conclusions This analysis showed that significant variation exists in the agreement between the various efficacy outcome measures. Thus, the choice of outcome measure used to make treatment decisions could have a significant impact on patient management. Disclosure of Interest E. Keystone Consultant for: AbbVie, Amgen, BMS, Janssen, Pfizer, Roche, Speakers bureau: AbbVie, Amgen, BMS, Janssen, Pfizer, Roche, P. Baer Consultant for: AbbVie, Amgen, BMS, Janssen, Pfizer, Roche, Speakers bureau: AbbVie, Amgen, BMS, Janssen, Pfizer, Roche, A. Avina-Zubieta: None declared, A. Jaroszynska: None declared, J. Rodrigues: None declared, R. Arendse Consultant for: Janssen, D. Sholter: None declared, M. Starr Consultant for: Janssen, A. Masetto: None declared, J. Sampalis Shareholder of: JSS Medical Research, Employee of: JSS Medical Research, E. Rampakakis Employee of: JSS Medical Research, C. Tkaczyk Employee of: Janssen, M. Shawi Employee of: Janssen, A. Lehman Employee of: Janssen, F. Nantel Employee of: Janssen, S. Otawa Employee of: Janssen

SAT0557 Predictors of Response in Patients with Psoriatic Arthritis Treated with Anti-TNF in a Real-World Setting

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<0.150) were considered in multivariate analysis to identify independent predictors. 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<0.001), HAQ (1.05 vs. 0.78; P<0.001), TJC (5.0 vs. 2.6; P<0.001), SJC (3.7 vs. 1.6; P<0.001), pain (46.8 vs. 30.7 mm; P<0.001), PtGA (48.6 vs. 29.7 mm; P<0.001), MDGA (5.3 vs. 2.3 cm; P<0.001), and morning stiffness (65.8 vs. 45.0 min; P<0.001). 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 (naïve vs. experienced: B=-1.995; P<0.001), presence of dactylitis (no vs. yes: B=0.746; P=0.073), and higher disease activity (DAS28 B=-0.525; P<0.001) were associated with greater improvements in DAS28 at six months of treatment. Age, disease duration, number of prior DMARDs, ongoing DMARD use, ongoing steroid use, ongoing NSAID use, presence of enthesitis, presence of nail pitting, and number of peri-articular manifestations did not show any effect on the change in DAS28. Multivariate analysis showed that, upon adjusting for baseline disease severity, male gender (B=-0.838; P=0.056) and no prior exposure to a biologic (B=-2.693; P=0.001) were significant predictors of improved response. 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

AB0220 What Proportion of Patients Fail To Achieve CDAI and SDAI Remission Based on Physician Global Assessment? An Analysis from A Prospective, Observational Registry

Background PtGA is included in the formula of all disease activity indices despite the fact that it may not accurately reflect RA disease activity, but rather reflect symptoms related to fibromyalgia, low back pain, depression or other conditions. We previously assessed the impact of the PtGA on the ability to achieve Boolean ACR/EULAR remission state. Objectives The aim of this analysis was to assess the proportion of patients failing to achieve DAS, CDAI and SDAI remission based on a real-world, routine clinical care setting in Canada. Methods BioTRAC is an ongoing, prospective registry of patients initiating treatment for RA, AS, or PsA with IFX or GLM. In this analysis, RA patients treated with infliximab between 2002-2014 or with golimumab between 2010-2014 were included. Modified versions of DAS28 (mDAS28), CDAI (mCDAI), and SDAI (mSDAI) were calculated by omitting PtGA from the formulas. Correlation of the standard and modified versions of each index was assessed with the Pearsons correlation coefficient. In the absence of validated thresholds for remission and LDA for the modified versions, the standard definitions were considered as the gold standard and ROC curve analysis was used to identify new thresholds for the modified versions. Cross-tabulations with the Chi-square test were used to assess the agreement between the standard and modified definitions of remission and LDA. Results One thousand nineteen RA patients with a mean (SD) age of 56.1 (13.5) years and disease duration of 8.5 (9.1) were included in the analysis. A strong correlation was observed between the standard and modified versions of DAS28 (r=0.98; P<0.001), CDAI (r=0.99; P<0.001), and SDAI (r=0.99; P<0.001). Based on ROC analysis the new thresholds for remission and LDA were: DAS28 (remission=2.6, LDA=3.1), CDAI (remission=2.5, LDA=10.5), SDAI (remission=3.3, LDA=10.9). Cross-tabulation of the standard and modified thresholds showed that an additional 10.1%, 10.6%, and 17.8% of non-remission cases for DAS28, CDAI and SDAI, respectively, would be classified as remission with the modified definitions. Similarly, an additional 11.5%, 21.2%, and 20.6% of non-LDA cases for DAS28, CDAI and SDAI, respectively, would be classified as LDA. Conclusions The results of this analysis have shown that PtGA could account for up to 10% of non-remission cases and up to 20% of non-LDA cases as measured by DAS, CDAI and SDAI. Further analyses are required to identify the determinants of patient global assessment. Disclosure of Interest P. Baer Speakers bureau: AbbVie, Amgen, BMS, Janssen, Pfizer, Roche, E. Keystone Speakers bureau: AbbVie, Amgen, BMS, Janssen, Pfizer, Roche, W. Bensen: None declared, C. Thorne Consultant for: Janssen, B. Haraoui Grant/research support from: AbbVie, Amgen, BMS, Janssen, Pfizer, Roche, UCB, Consultant for: AbbVie, Amgen, BMS, Janssen, Pfizer, Roche, UCB, D. Choquette Consultant for: AbbVie, Amgen, Celgene, BMS Canada, Janssen, Pfizer, R. Arendse Consultant for: Janssen, J. Kelsall Consultant for: Janssen, M. Sheriff Consultant for: Janssen, J. Sampalis Shareholder of: JSS Medical Research, Employee of: JSS Medical Research, E. Rampakakis Employee of: JSS Medical Research, C. Tkaczyk Employee of: Janssen, M. Shawi: None declared, A. Lehman Employee of: Janssen, F. Nantel Employee of: Janssen, S. Otawa: None declared