J. Kelsall

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

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.

FRI0467 Predictors of Early Minimal Disease Activity in PSA Patients Treated with Anti-TNF in A Real-World Registry

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<0.001; TJC28: 3.75 (4.00) vs. 8.66 (6.53), P<0.001; pain: 35.39 (25.11) vs. 55.70 (22.93), P<0.001; PtGA: 38.51 (25.00) vs. 56.15 (25.13), P<0.001; HAQ-DI: 0.71 (0.61) vs. 1.33 (0.57), P<0.001; MDGA: 4.25 (2.38) vs. 5.84 (2.07), P<0.001); enthesitis count: 2.62 (1.60) vs. 4.97 (3.48), P=0.008. Multivariate logistic regression analysis showed that lower baseline HAQ (OR=0.243; P<0.001), lower TJC28 (OR=0.889; P=0.008), and lower enthesitis count (OR=0.817; P=0.817) were significant predictors of MDA achievement over 12 months of treatment. 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

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

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

AB1163 Prevalence of Smoking and Impact on Disease Parameters Among Ankylosing Spondylitis, Rheumatoid Arthritis and Psoriatic Arthritis Patients Treated with Infliximab or Golimumab

Background Smoking can compromise the response to biologic treatment in rheumatoid arthritis (RA) patients. Objectives The aim of this analysis was to compare patient characteristics and baseline disease parameters based on smoking status at initiation of anti-TNF treatment and to assess the impact of smoking on anti-TNF effectiveness in RA, ankylosing spondylitis (AS), and psoriatic arthritis (PsA) patients treated with infliximab (IFX) or golimumab (GLM). 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 patients with available smoking status treated with IFX or GLM between 2010-2014. Between-group differences were assessed for statistical significance with the independent-samples t-test or Chi-square test. Results Among the 478 patients included in the analysis, there were 143 (29.9%) AS, 237 (49.6%) RA, and 98 (20.5%) PsA patients. At baseline, the proportion of current smokers was 27.3% in AS, 19.8% in RA, and 19.4% in PsA (P=0.186). Overall, no significant differences in baseline characteristics were observed based on smoking status except for gender among AS patients and TJC28 which was higher among smoking PsA patients. Upon 6 months of treatment, statistically significant and clinically meaningful improvements in almost all parameters were observed, regardless of smoking status and diagnosis. Although statistical significance was not achieved, a greater proportion of non-smokers achieved CDAI LDA (RA: 49.0% vs. 34.8%, P=0.252; PsA: 68.3% vs. 50.0%, P=0.296), SDAI LDA (RA: 56.7% vs. 33.3%, P=0.152; PsA: 69.0% vs. 57.1%, P=0.664) and DAS28 LDA (RA: 50.0% vs. 38.1%, P=0.458; PsA: 59.4% vs. 37.5%, P=0.430) at 6 months. After 6 months of treatment, no significant between-group differences were observed in the improvement of disease parameters in all diagnoses with the exception of PtGA in RA patients which was greater among non-smokers (-21.8 vs. -6.2, P=0.047), and ESR (-21.2 vs. -6.4, P=0.006) and CRP (-19.8 vs. -7.9, P=0.052) levels in AS patients which were greater among smokers. Conclusions The results showed that the rate of smoking among Canadian RA and PsA patients treated with anti-TNF is comparable to the general population. Smoking rates among AS patients, however, were greater. Numerical, although not statistically significant, differences were observed in the response to 6 months treatment based on smoking status. Regardless of smoking status, treatment with IFX or GLM was effective in improving disease severity outcomes and reducing symptom severity among AS, RA or PsA patients. Disclosure of Interest R. Faraawi Consultant for: Janssen, S. Dixit: None declared, M. Mulgund: None declared, W. Bensen Consultant for: Janssen, J. Kelsall Consultant for: Janssen, D. Choquette Consultant for: AbbVie, Amgen, Celgene, BMS Canada, Janssen, Pfizer, M. Baker: None declared, I. Fortin 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, A. Lehman Employee of: Janssen, F. Nantel 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

SAT0338 Does Treatment Improve HAQ or Do Patients Adjust How They Do Things? An Exploration of the HAQ-DI Vs the HAQ-ADI Over Time

Background People with rheumatoid arthritis (RA) and other chronic diseases adjust their lifestyle to accommodate symptoms and limitations. Objectives The aim of the current analysis was to assess the utilization of aids/devices or help over time and to determine whether development of self-management behavior is responsible for HAQ improvement in RA patients on anti-TNF treatment in a real-world clinical practice setting. Methods BioTRAC is an ongoing, prospective registry of patients initiating treatment for RA, AS, or PsA with IFX or GLM. Data were used from RA patients treated with infliximab (IFX) between 2002-2014 or with golimumab (GLM) between 2010-2014. The correlation between the standard HAQ disability index (HAQ-DI) and the alternative disability index (HAQ-ADI), incorporating or not the use of aids/devices/help, respectively, was assessed with the Pearsons correlation coefficient. Changes in HAQ-DI, HAQ-ADI, the individual HAQ domain scores, or the difference between HAQ-DI and HAQ-ADI over time, were assessed with general linear models. The slope of HAQ-DI and HAQ-ADI improvement in each patient was assessed with the paired-samples t-test. Results 1030 RA patients were included with a mean (SD) age of 56.1 (13.5) years and time since diagnosis of 8.5 (9.1) years. Mean (SD) DAS28, CDAI, HAQ-DI and HAQ-ADI scores at baseline were 5.6 (1.5), 34.3 (16.6), 1.59 (0.71), 1.47 (0.73), respectively. At baseline, highest HAQ domain scores included “Activities”, “Reach”, “Hygiene”, and “Grip”. The use of aids/devices/help was highest for these activities (49.2%, 47.5%, 38.0%, 73.1% of patients, respectively), with females requesting significantly more aids/devices/help than males. Treatment for 60 months resulted in statistically significant and clinically meaningful improvements in HAQ-DI and HAQ-ADI, and in significantly lower utilization of aids/devices/help. A statistically significant difference (P=0.001) was observed in the slope of HAQ-DI (Δ=-0.034/month) and HAQ-ADI (Δ=-0.038/month) improvement over time which could be attributed to the differential rate of use of aids/devices/help over time resulting in the inflation of HAQ-DI. The duration of follow-up was significantly (P<0.001) associated with a greater difference between HAQ-DI and HAQ-ADI changing from 0.12 at baseline to 0.18 at 60 months. Conclusions Our results have shown that problems with “Activities”, “Reaching”, “Hygiene”, and “Gripping” represent primary challenges in RA. Anti-TNF treatment resulted in significant improvements in all HAQ domains. Significant differences were observed over time, however, between HAQ-DI and HAQ-ADI suggesting that RA patients may also adjust their lifestyle to accommodate their symptoms. These findings highlight the importance of educational programs focused on self-management behaviors in RA. Disclosure of Interest D. Sholter Consultant for: Janssen, W. Olszynski Consultant for: Janssen, P. Baer Consultant for: Janssen, M. Sheriff Consultant for: Janssen, S. Dixit Consultant for: Janssen, A. Chow: None declared, B. Haraoui Consultant for: Janssen, D. Choquette Consultant for: Janssen, J. Kelsall Consultant for: Janssen, J. Sampalis: None declared, E. Rampakakis: None declared, F. Nantel Employee of: Janssen, C. Tkaczyk Employee of: Janssen, A. Lehman Employee of: Janssen