C. Tkaczyk

Real-world validation of the minimal disease activity index in psoriatic arthritis: an analysis from a prospective, observational, biological treatment registry

Objective To describe the minimal disease activity (MDA) rate over time in patients with psoriatic arthritis (PsA) receiving antitumour necrosis factor agents, evaluate prognostic factors of MDA achievement and identify the most common unmet criteria among MDA achievers. Design Biologic Treatment Registry Across Canada (BioTRAC): ongoing, prospective registry of patients initiating treatment for rheumatoid arthritis, ankylosing spondylitis or PsA with infliximab (IFX), golimumab (GLM) or ustekinumab. Setting 46 primary-care Canadian rheumatology practices. Participants 223 patients with PsA receiving IFX (enrolled since 2005) and GLM (enrolled since 2010) with available MDA information at baseline, 6 months and/or 12 months. Primary and secondary outcome measures MDA was defined as ≥5 of the following criteria: 28-item tender joint count (TJC28) ≤1, 28-item swollen joint count (SJC28) ≤1, Psoriasis Area and Severity Index (PASI) ≤1 or body surface area≤3, Pain Visual Analogue Scale (VAS) ≤15 mm, patient’s global assessment (PtGA) (VAS) ≤20 mm, Health Assessment Questionnaire (HAQ) ≤0.5, tender entheseal points ≤1. Independent prognostic factors of MDA achievement were assessed with multivariate logistic regression. Results MDA was achieved by 11.7% of patients at baseline, 43.5% at 6 months, 44.8% at 12 months and 48.8% at either 6 or 12 months. Among MDA achievers at 6 months, 75.7% had sustained MDA at 12 months. Lower baseline HAQ (OR=0.210; 95% CI: 0.099 to 0.447) and lower TJC28 (OR=0.880; 95% CI: 0.804 to 0.964), were significant prognostic factors of MDA achievement over 12 months of treatment. The most commonly unmet MDA criteria among MDA achievers was patient reported pain (25%), PtGA (15%) and PASI (12%). Conclusions Almost 50% of patients treated with IFX or GLM in routine clinical care achieved MDA within the first year of treatment. Lower baseline HAQ and lower TJC28, were identified as significant prognostic factors of MDA achievement. The most commonly unmet criteria in patients who achieved MDA were pain, PtGA and PASI. Trial registration number BioTRAC (NCT00741793).

Adherence and dosing interval of subcutaneous antitumour necrosis factor biologics among patients with inflammatory arthritis: analysis from a Canadian administrative database

Objectives Subcutaneous tumour necrosis factor alpha TNFαinhibitors (SC-TNFis) such as golimumab (GLM), adalimumab (ADA), etanercept (ETA) and certolizumab pegol (CZP) have been used for many years for the treatment of inflammatory arthritis. Non-adherence to therapy is an important modifiable factor that may compromise patient outcomes. The aim of this analysis was to compare adherence and dosing interval of SC-TNFis in the treatment of people with inflammatory arthritis. Design We used the IMS Brogan database combining both Canadian private and public drug plan databases of Ontario and Quebec. Target drugs included SC-TNFis for inflammatory arthritis. The index period was from 1 January 2010 to 30 June 2012 and patients were followed for 24 months through 30 June 2014. Inclusion criteria were adult patients newly prescribed a SC-TNFis with at least three prescriptions and retained on therapy at 24 months. Dosing regimens as per the product monographs were used to compare actual versus expected drug utilisation. The mean possession ratio was used as a marker for adherence. Patients who scored >80% were considered adherent. The average days between units was estimated by taking the total days on therapy and divided by the number of units the patient received. Results 4035 patients were included: 683 (16.9%), 1400 (34.7%), 1765 (43.7%) and 187 (4.6%) were treated with GLM, ADA, ETA and CZP, respectively. The proportion of adherent patients in the GLM cohort (n=595/683, 87%, p<0.0001) was greater compared with ADA (n=1044/1400, 75%), ETA (n=1285/1765, 73%) and CZP-treated patients (132/187, 71%). In addition, the number of patients receiving biological drug at a shorter dosing interval was similar between cohorts, and was 5%, 6%, 12% and 4% in GLM (≤26 days), ADA (≤12 days), ETA (≤6 days) and CZP-treated patients (≤12 days), respectively. Conclusions In this real-life administrative database, GLM had better adherence compared with other SC-TNFis.

AB0684 Gender Specific Differences in Ankylosing Spondylitis at Treatment Initiation in Patients Treated with Infliximab or Golimumab

Background The prevalence of ankylosing spondylitis (AS) is 2–3 times higher in men compared to women. Recent studies have suggested that clinical differences exist between both genders with women experiencing a higher burden of disease. Objectives This analysis examined gender-specific differences with respect to patient and disease parameters at initiation of infliximab (IFX) or golimumab (GLM) for the treatment of AS in a Canadian routine clinical practice setting. Methods BioTRAC is an ongoing, prospective registry of patients initiating treatment for rheumatoid arthritis, ankylosing spondylitis, or psoriatic arthritis with IFX or GLM. Patients with AS treated with IFX who were enrolled since 2002 or with GLM enrolled since 2010 were included in this analysis. Between group differences were assessed with the Fishers Exact test or the independent samples t-test, while linear regression was used to assess the independent association of gender with HAQ-DI, ASDAS, BASDAI, and BASFI improvements at 12 months. Results A total of 539 AS patients were included in this analysis; 188 (34.9%) patients were treated with GLM and 351 (65.1%) with IFX. The majority of patients were male (61.8%). Mean age and disease duration were comparable between genders for both GLM and IFX, (Table 1). Overall, disease parameters (ESR, PtGA, MDGA, HAQ-DI, ASDAS, and BASFI) were similar for GLM with the exception of BASDAI where higher disease severity was observed among females. Among patients treated with IFX, between gender differences were observed for CRP with significantly lower levels in female patients; however BASDAI and HAQ-DI where significantly higher in females compared to males. Other parameters (ESR, PtGA, MDGA, ASDAS, and BASFI) were similar for IFX between genders. Regression analysis showed that, upon adjusting for baseline levels, female gender (ΔBASDAI=0.603; P=0.035) was associated with increased BASDAI at 12 months of treatment as compare to males. HAQ-DI, ASDAS, and BASFI, on the other hand, at 12 months were comparable between genders.Table 1. Patient characteristics at baseline by gender AS-GLM, mean (SD) Male (n=115) Female (n=73) P-value Age, years 46.3 (15.2) 44.4 (11.8) 0.498 Disease duration, yrs 5.2 (10.0) 6.0 (10.6) 0.704 CRP, mg/L 12.6 (15.2) 17.5 (50.5) 0.389 BASDAI 5.6 (2.3) 6.5 (1.7) 0.007 AS-IFX, mean (SD) Male (n=218) Female (n=133) P-value Age, years 45.1 (12.0) 47.0 (10.8) 0.163 Disease duration, years 9.6 (10.3) 8.8 (9.6) 0.505 CRP, mg/L 19.2 (26.9) 12.5 (17.6) 0.012 HAQ-DI 1.11 (0.58) 1.27 (0.63) 0.019 BASDAI 6.0 (2.1) 6.6 (2.1) 0.013 Conclusions Overall, at anti-TNF initiation, female AS patients experience greater disease activity relative to men at initiation of biologic therapy. Whether this represents a gender bias in prescribing, or a gender based difference in the acceptance of biologic treatment or disease assessment, requires additional research. Disclosure of Interest M. Starr: None declared, M. Zummer: None declared, D. Choquette: None declared, B. Haraoui: None declared, P. Rahman: None declared, M. Sheriff: None declared, E. Rampakakis Employee of: JSS Medical Research Inc;, E. Psaradellis Employee of: JSS Medical Research Inc;, B. Osborne Employee of: Janssen, A. Lehman Employee of: Janssen, K. Maslova Employee of: Janssen, F. Nantel Employee of: Janssen, C. Tkaczyk Employee of: Janssen

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

AB0661 Predictors of Response in Patients with Ankylosing Spondylitis Treated with Infliximab or Golimumab 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 ASDAS remission in AS patients treated with infliximab (IFX) or golimumab (GLM) in a Canadian routine clinical care setting. Methods BioTRAC is an ongoing, prospective registry of patients initiating treatment for rheumatoid arthritis (RA), ankylosing spondylitis, or psoriatic arthritis with IFX or GLM. Eligible patients for this analysis included AS patients treated with IFX or GLM between 2005 and 2015. Variables associated with ASDAS remission (<1.3) were examined using univariate analysis and those showing a statistical trend (P<0.150) were considered in multivariate logistic regression analysis to identify independent predictors. Results A total of 582 patients were included in the analysis with a mean (SD) age of 45.8 (12.2) years and a disease duration of 8.3 (10.2) years. The majority of patients were male (57.2%). Upon 12 months of treatment statistically significant and clinically meaningful improvements were observed in ASDAS (3.6 vs. 2.3; P<0.001), BASDAI (6.2 vs. 3.8; P<0.001), BASFI (5.6 vs. 3.9; P<0.001), morning stiffness (74.2 vs. 42.8; P<0.001), and HAQ-DI (1.12 vs. 0.77; P<0.001). The proportion of patients who achieved ASDAS remission was 22.3% and 22.2% at 6 and 12 months, respectively. Sustained remission was achieved by 16.0%. In univariate analysis, male gender (male vs. female: 25.2% vs. 14.1%; P=0.073), previous use of a biologic (experienced vs. naive: 37.5% vs. 20.9%; P=0.129), lower ESR (P=0.096), lower BASFI (P=0.003), lower BASDAI (P=0.002), lower morning stiffness (P=0.120) and lower HAQ-DI (P=0.001) showed a statistical trend in their association with ASDAS remission at 12 months of treatment. Age, disease duration, CRP, psoriasis, peripheral arthritis, inflammatory bowel disease, uveitis, HLA-B27 and presence of enthesitis did not have an impact of ASDAS remission. Multivariate logistic regression analysis showed that, upon adjusting for covariates, non-exposure to a previous biologic (OR=3.40; P=0.078) approached statistical significance and lower HAQ-DI (OR=0.36; P=0.004) was a significant independent predictor of ASDAS remission. Conclusions Twelve-month treatment with IFX or GLM in a real-world setting was associated with significant improvements in disease parameters. Prior exposure to a biologic and lower HAQ-DI were identified as independent predictors of ASDAS remission upon adjusting for potential confounders. Disclosure of Interest L. Bessette: None declared, S. Kapur: None declared, M. Zummer: None declared, M. Starr: None declared, D. Choquette: None declared, M. Sheriff: None declared, W. Olszynski: None declared, E. Rampakakis Employee of: JSS Medical Research Inc;, E. Psaradellis Employee of: JSS Medical Research Inc;, B. Osborne Employee of: Janssen, K. Maslova Employee of: Janssen, F. Nantel Employee of: Janssen, A. Lehman Employee of: Janssen, C. Tkaczyk Employee of: Janssen

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.

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

FRI0172 Primary and Secondary Non-Response in RA Patients Treated with An anti-TNF: An Analysis from A Prospective, Observational Registry

Background Despite the well documented effectiveness of anti-TNF treatment in rheumatoid arthritis (RA), some patients can be refractory to treatment (primary [1ry] failure) or may lose responsiveness (secondary [2ry] failure). In such cases, switching to another anti-TNF or a different biologic class can often restore therapeutic response. Objectives The aim of this analysis was to assess the rate of non-response among RA patients treated with anti-TNFs in Canadian routine clinical practice. Methods BioTRAC is an ongoing, prospective registry of patients initiating treatment for RA, ankylosing spondylitis, or psoriatic arthritis with infliximab (IFX) or golimumab (GLM). RA patients treated with IFX since 2002 or with GLM since 2010 who had at least one post-baseline assessment were eligible. Patients with available information on DAS28 or EULAR response in at least one post-baseline visit were included in the respective analyses. Results 1,127 patients (75.6% female) were included with mean (SD) age of 56.1 (13.4) years and disease duration of 8.4 (8.9) years at baseline. The majority were biologic naïve (93.2%), treated with IFX (76.0%), and received a concomitant DMARD (86.2%) at baseline. Mean (SD) disease parameters at baseline were: CDAI: 33.9 (17.6); HAQ: 1.6 (0.7); SJC: 9.8 (6.8); TJC: 11.5 (8.0). After a mean (SD) follow-up of 35.5 (36.8) mos, 764 (67.8%) patients were discontinued overall and 226 (20.1%) due to effectiveness reasons (lack of response: n=67; loss of response: n=83; disease progression: n=76). Among the patients discontinued due to effectiveness reasons, the majority were discontinued after 12 months (54.4%) and had achieved prior good EULAR response (66.2%). Among patients discontinued due to lack of response, 17.7% and 45.5% had previously achieved DAS28 low disease activity (LDA) and good EULAR response, respectively; whereas, among patients discontinued due to loss of response, 46.9% and 76.8% had a previously documented achievement of the two targets, respectively. Conclusions The results of this analysis have shown a low rate of failure during treatment with IFX and GLM. Non achievement of DAS28 LDA was a good predictor of lack of response and more predictive than good EULAR response; non-achievement of good EULAR response, on the other hand, was a better predictor of loss of response. Overall, significant variation exists depending on each investigators definition of 1ry and 2ry failure, which highlights the importance of establishing standardized definitions of these terms. Disclosure of Interest E. Keystone: None declared, P. Baer: None declared, W. Olszynski: None declared, M. Baker: None declared, B. Haraoui: None declared, W. Bensen: None declared, R. Faraawi: None declared, E. Rampakakis: None declared, J. Sampalis: None declared, A. Lehman Employee of: Janssen Inc., F. Nantel Employee of: Janssen Inc., B. Osborne Employee of: Janssen Inc., C. Tkaczyk Employee of: Janssen Inc., K. Maslova Employee of: Janssen Inc.

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