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This retrospective, observational study aimed to analyze and assess adherence, persistence, dosing, and use of concomitant medications of seven self-administered target drugs (abatacept, golimumab, secukinumab, tocilizumab, ustekinumab, apremilast, and tofacitinib) that are currently available in Canada for the treatment of inflammatory arthritis (IA).We used IQVIA's longitudinal claims databases, which include private drug plans and public plans. Patients with IA identified using a proprietary indication algorithm who initiated treatment with any of the target drugs between January 2015 and February 2019 were selected and followed for 12 months.Golimumab and apremilast had the highest proportion of patients (~ 75%) who were bio-naïve and secukinumab had the fewest bio-naïve patients (~ 43%). The oral therapies, apremilast and tofacitinib, had the lowest percentage of adherent patients (73% and 71%) followed by abatacept (83%), while the remaining drugs had adherence around 90%. Secukinumab and tofacitinib had the highest 12-month persistence rate (63% and 61%), while abatacept and apremilast had the lowest persistence rate (52% and 47%). Oral corticosteroid (OCS) use was not significantly associated with adherence. Tocilizumab, secukinumab, and ustekinumab had the highest proportion of patients ( 20%) with dose escalation at 3-4 months from index. OCS and conventional disease-modifying antirheumatic drugs (cDMARD) use decreased in post-index period across all target drugs.This study identified substantial differences in patient baseline characteristics. Patients on injectable biologics were more likely to be adherent compared with those on oral drugs, possibly owing to longer dosing intervals. Other outcomes at 12 months appeared similar as evidenced by tapering of concomitant medications, although differences in persistence and dose escalation were noted.

Objectives To (i) determine whether sustained disease activity states, as measured by Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) and Ankylosing Spondylitis Disease Activity Score (ASDAS), impact function, and (ii) evaluate characteristics predicting sustained low functional impairment in a prospective axial spondyloarthritis (axSpA) cohort. Methods Biologic Treatment Registry Across Canada (BioTRAC) was a multi-center, prospective registry that collected real-world data on axSpA patients receiving infliximab or golimumab between 2006 and 2017. Generalized estimating equations (GEE) were used to test baseline characteristics, treatment, and duration (at 6 and 12 months vs. only at 6 or 12 months vs. neither) of low BASDAI ( Results Eight hundred ten patients were enrolled. 33.7%, 13.4%, and 24.7% achieved sustained low BASDAI, ASDAS-ID, and ASDAS-LDA, respectively. In univariable GEE of baseline variables, age and baseline BASDAI, BASFI, and ASDAS significantly predicted sustained low BASFI. In multivariable GEE, sustained low BASDAI (p p = 0.001), and baseline BASFI (p p = 0.040) and ASDAS-LDA (p Conclusion Sustained BASDAI

Background The objectives of this study were to describe the profile of ankylosing spondylitis (AS) patients treated with either infliximab (IFX) or subcutaneous golimumab (GLM) treatment in Canadian routine care setting along with assessing long-term effectiveness and safety. Methods AS patients who were eligible for treatment with IFX or subcutaneous GLM as per their respective Canadian product monographs were enrolled into the BioTRAC registry from 2005 to 2017. The study visits occurred at baseline and every 6 months thereafter. Effectiveness was assessed by changes in clinical outcomes and acute phase reactants. Safety was evaluated by assessing the incidence of adverse events (AEs) and drug survival rates. Results A total of 389 IFX- and 421 GLM-treated patients were enrolled. A significant decrease in disease duration at baseline was observed in the IFX cohort, from a median of 8.0 in 2005–2008 to 1.0 years in 2009–2015 (p p = 0.011) and proportion of patients in ASDAS very high disease activity (p = 0.004) was also observed over time. Meanwhile, in the GLM cohort, most disease parameters remained similar from 2010 to 2017. Treatment with both agents significantly improved all disease parameters over time with similar efficacy between the two agents. The incidence of AEs and SAEs were 136 and 131 events/100 PYs and 10.5 and 8.45 events/100 PYs for IFX- and GLM-treated patients, respectively. Conclusion Both IFX and GLM treatment in AS significantly reduced disease activity in most outcome measures in a similar fashion and were well tolerated in Canadian routine care. Trial registration NCT00741793.

ObjectivesThe objectives of this study were to describe the demographic profile and baseline disease characteristics of patients with psoriatic arthritis (PsA) treated with either infliximab (IFX), subcutaneous golimumab (GLM) or ustekinumab (UST) treatment in Canadian routine care setting along with assessing long-term effectiveness and safety.MethodsPatients with PsA were enrolled into the Biologic Treatment Registry Across Canada registry (ClinicalTrials.gov Identifier: NCT00741793) from 2005 to 2017. The study visits occurred at study enrolment (baseline) and every 6 months thereafter. Effectiveness was assessed by changes in disease parameters (joint counts, Psoriasis Area Severity Index (PASI), Health Assessment Questionnaire, patient/physician global, minimal disease activity, enthesitis, dactylitis, erythrocyte sedimentation rate, C reactive protein). Improvements from baseline were explored with the paired t-test and the McNemar’s test. Safety was evaluated by assessing the incidence of adverse events (AEs) and drug survival rates.ResultsA total of 111 IFX-treated, 281 GLM-treated and 70 UST-treated patients were enrolled. Most baseline disease parameters remained similar over time in all three cohorts. UST-treated patients had lower mean baseline Disease Activity Score in 28 joints CRP, swollen joint based on 28 joints and higher PASI compared with patients treated with GLM. Treatment with IFX, GLM and UST was associated with significant improvements in all disease parameters over time (pAEs were reported for 74.8%, 69.8% and 52.9% (138, 114 and 115 events/100 patient-years (PYs)) covering 325, 567 and 87 years of exposure for IFX-treated, GLM-treated and UST-treated patients, respectively. Severe AEs were reported in 19.8%, 8.5% and 5.7% (8.8, 7.2 and 8.0 events/100 PYs) in IFX-treated, GLM-treated and UST-treated patients, respectively. The proportion of patients who discontinued treatment were 63.1%, 50.9% and 50.0%, respectively.ConclusionsIFX, GLM and UST treatment significantly reduced disease activity and improved functionality in patients with PsA followed by routine clinical practice and had a safety profile similar to that previously reported in the literature.Trial registration numberNCT00741793.

Background Long-term clinical registries are essential tools to evaluate new therapies in a patient population that differs from those in randomized clinical trials. The objectives are to describe the profile of rheumatoid arthritis (RA) patients treated with anti-TNF agents in Canadian routine care. Methods RA patients eligible for treatment with Infliximab (IFX), golimumab (GLM) or intravenous golimumab (GLM-IV) as per their respective Canadian product monographs were enrolled into the BioTRAC registry between 2002 and 2017. Study visits occurred at baseline and every 6 months thereafter. Effectiveness was assessed by changes in disease activity. Safety was evaluated by the incidence of adverse events (AEs) and drug survival. Results Of the 890 IFX-, 530 GLM- and 157 GLM-IV-treated patients, the proportion of females ranged from 77.0–86.6%, the mean ages from 55.8–57.7 and the mean disease duration from 6.5–8.6 years. A significant decrease in baseline disease duration and disease activity parameters (DAS, TJC, SJC, HAQ, AM stiffness, MDGA, PtGA, CRP, ESR) was observed over time. Treatment with IFX, GLM- and GLM-IV significantly improved all disease parameters over time. The incidence of AEs was 105, 113 and 82.6 /100 PYs and the incidence of SAEs was 11.7, 11.2 and 4.68 /100 PYs for IFX, GLM- and GLM-IV-treated patients, respectively. Conclusion Differences in baseline characteristics between patients treated with an anti-TNFs over time shows the evolution of treatment modalities over time. All treatments significantly reduced disease activity and improved functionality in a similar fashion. The incidence of adverse events was consistent with the safety profiles of IFX and GLM. Trial registration ClinicalTrials.gov Identifier: NCT00741793 (Retrospectively registered on August 26, 2008).

Background Long-term registries are essential to evaluate new therapies in a patient population that differs from clinical trial and usually varies over time. Objectives To describe the profile of ankylosing spondylitis (AS) patients treated with infliximab (IFX) or golimumab (GLM) treatment in Canadian routine care along with its long-term effectiveness and safety. Methods 810 aS patients treated with IFX or GLM were enrolled into the Biologic Treatment Registry across Canada (BioTRAC) registry between 2005-2015 and 2010-2017, respectively. Study visits occurred at baseline and every 6 months thereafter, as needed per routine care. Effectiveness was assessed with changes in aSDAS, BASDAI, BASFI, MDGA, HAQ-DI, PtGA, back pain and acute phase reactants. Safety was evaluated with the incidence of adverse events (AEs) and drug survival rates. Results Of the 389 IFX- and 421 GLM-treated patients, the proportion of males were 62.7% and 59.1%, the mean age were 45.6 and 45.7 years and the mean disease duration were 8.6 and 6.0 years, respectively. Most patients were bio-naive (>82.7%). Interestingly, we observed a significant decrease in disease duration in the IFX cohort from a median of 8.0 to 3.5 and 1.0 years in 2005-2008, 2009-2012 and 2013-2015, respectively (p Treatment with both IFX and GLM significantly improved all disease parameters over time (P AEs were reported for 67.9% and 70.5% (136 and 131 events/100 PYs) and SAEs for 15.4% and 8.1% (10.5 and 22.7 events/100 PYs) covering 1251.3 and 674.8 years of exposure for IFX- and GLM-treated patients, respectively. The most frequently occurring aEs (>7% of patient in either group) were upper respiratory tract infection, arthralgia and back pain. Two deaths occurred in IFX-treated patients (myocardial infarct, drowning) and two among GLM-treated patients (oropharyngeal cancer; neutropenia, staphylococcal/pseudomonas infections, septic shock). The proportion of patients who discontinued treatment were 65.8% over a mean 3.2 years of exposure in the IFX cohort and 56.8% over 1.6 years in the GLM cohort. Conclusion Both IFX and GLM treatment significantly reduced disease activity and improved functionality in a similar fashion and were well tolerated in patients with aS. Differences in baseline characteristics over time demonstrate improvement in early diagnosis of aS and earlier access to biologic therapies. Disclosure of interests Proton Rahman: None declared, Derek Haaland Grant/research support from: Janssen Sponsored Study, Dalton Sholter Grant/research support from: Janssen Sponsored Study, Michael Starr: None declared, arthur Karasik: None declared, Michelle Teo Grant/research support from: Janssen Sponsored Study, Sanjay Dixit Grant/research support from: Janssen Sponsored Study, Consultant for: Janssen, Speakers bureau: Janssen, ariel Masetto Grant/research support from: amgen, Sanofi, Consultant for: Sanofi, Pfizer, Bristol-Myers Squibb, Novartis, Boehringer ingelheim, Speakers bureau: Novartis, anna Jarosynska Grant/research support from: Janssen Sponsored Study, Pauline Boulos Grant/research support from: Janssen Sponsored Study, Maqbool Sheriff Grant/research support from: Janssen Sponsored Study, Jacqueline Stewart Consultant for: Pfizer, abbvie, amgen, Celgene, Roche, Novartis, Merck, Emmanouil Rampakakis : None declared, Odalis asin MIilan Employee of: Employee of Janssen, allen Lehman Employee of: Employee of Janssen, Meagan Rachich Shareholder of: Janssen, Employee of: Employee of Janssen, Francois Nantel Shareholder of: Janssen, Employee of: Employee of Janssen

Background Long-term registries are essential to evaluate new therapies in a patient population that differs from clinical trials and usually varies over time. Objectives To describe the profile of rheumatoid arthritis (RA) patients treated with infliximab (IFX), golimumab subcutaneous (GLM) or intravenous (GLM-IV) in Canadian routine care, along with its effectiveness and safety. Methods 1577 RA patients treated with IFX, GLM or GLM-IV were enrolled into the Biologic Treatment Registry Across Canada (BioTRAC) between 2006-2015, 2010-2017 and 2014-2017, respectively. Study visits occurred at baseline and every 6 months thereafter. Effectiveness was assessed with changes in TJC28, SJC28, MDGA, PtGA, pain, HAQ, and acute phase reactants. Safety was evaluated with the incidence of adverse events (AEs) and drug survival. Results Of the 890 IFX-, 530 GLM- and 157 GLM-IV-treated patients, the proportion of females were 75.7%- 77.1%, the mean age were 55.8-57.7 and the mean disease duration were 6.5-8.6 years. Most patients were bio-naive (> 80%). A significant decrease in disease duration and disease activity scores (DAS, TJC, SJC, HAQ, AM stiffness, MDGA, PtGA, CRP, ESR) were observed in the IFX cohort over time (p Treatment with IFX, GLM and GLM-IV significantly improved all disease parameters over time (P AEs were reported for 61.5%, 67.4% and 59.2% (105, 113 and 82.6 events/100 PYs) and SAEs for 21.2%, 15.5% and 3.8% (11.7, 34.4 and 9.0 events/100 PYs) covering 2714, 1077 and 257 years of exposure for IFX, GLM and GLM-IV-treated patients, respectively. The most frequently occurring AEs were arthralgia and upper respiratory tract infection (>5%). Eighteen, 7 and 1 deaths occurred among IFX-, GLM- and GLM-IV-treated patients, respectively. The proportion of patients who discontinued treatment were 74.0% over a mean 3.0 years of exposure to IFX-, 52.8% over 2.0 years of exposure to GLM and 45.2% over 1.6 year of exposure to GLM-IV. Conclusion In this real-world study of Canadian patients with RA, differences in baseline characteristics between patients treated with an anti-TNF over time and between agents shows potential selection biases when selecting a given therapy and may impact the proportion of patients achieving a target-specific outcome. Treatment significantly reduced disease activity and improved functionality in a similar fashion and were also safe and well tolerated. Disclosure of Interests: Proton Rahman: None declared, Philip Baer Grant/research support from: Janssen sponsored study, Consultant for: Eli Lilly, Pfizer, Abbvie, Amgen, Merck, Novartis, Sanofi Genzyme, Paladin, Janssen, Johnson & Johnson, Speakers bureau: Eli Lilly, Pfizer, Abbvie, Amgen, Janssen, Denis Choquette Grant/research support from: Abbvie, Amgen, Eli Lilly, Novartis, Pfizer, Sandoz, Consultant for: Abbvie, Amgen, Eli Lilly, Novartis, Pfizer, Sandoz, Speakers bureau: Abbvie, Amgen, Eli Lilly, Novartis, Pfizer, Sandoz, Rafat Faraawi: None declared, Louis Bessette Grant/research support from: Amgen, BMS, Janssen, Roche, UCB, AbbVie, Pfizer, Merck, Celgene, Sanofi, Lilly, Novartis, Consultant for: Amgen, BMS, Janssen, Roche, UCB, AbbVie, Pfizer, Celgene, Lilly, Novartis, Speakers bureau: Amgen, BMS, Janssen, Roche, UCB, AbbVie, Pfizer, Merck, Celgene, Lilly, Novartis, Milton Baker Grant/research support from: Janssen Sponsored Study, Raman Rai Consultant for: Janssen, Amgen, BMS, Roche, Abbvie, Pfizer, Merck, Novartis, Speakers bureau: Janssen, Amgen, Roche, BMS, Abbvie, John Kelsall Grant/research support from: Janssen Sponsored Study, Larissa Lisnevskaia Grant/research support from: Janssen Sponsored Study, Jodie Reis Grant/research support from: Janssen Sponsored Study, Keltie Anderson Grant/research support from: Janssen Sponsored Study, Wojciech Olszynski Grant/research support from: Janssen sponsored study, Emmanouil Rampakakis : None declared, Odalis Asin MIilan Employee of: Employee of Janssen, Allen Lehman Employee of: Employee of Janssen, Meagan Rachich Shareholder of: Janssen, Employee of: Employee of Janssen, Francois Nantel Shareholder of: Janssen, Employee of: Employee of Janssen

Background Long-term registries are essential to evaluate new therapies in a patient population that differs from clinical trials and usually varies over time. Objectives To describe the profile of psoriatic arthritis (PsA) patients selected for treatment with infliximab (IFX), golimumab (GLM) or ustekinumab (UST) treatment in Canadian routine care and to describe the long-term real-world effectiveness and safety of these agents. Methods 462 PsA patients treated with IFX, GLM or UST were enrolled into the Biologic Treatment Registry Across Canada (BioTRAC) registry between 2006-2015, 2010-2017 and 2014-2017, respectively. Study visits occurred at baseline and every 6 months thereafter. Effectiveness was assessed with changes in TJC28, SJC28, skin, enthesitis, dactylitis, pain, HAQ, acute phase reactants. Safety was evaluated with the incidence of adverse events (AEs) and drug survival rates. Results Of the 111 IFX-, 281 GLM- and 70 UST-treated patients, the proportion of males were 52.3%, 46.3% and 37.1%, the mean age was 48.4, 52.8 and 53.1 years and the mean disease duration was 5.8, 6.1 and 5.7 years, respectively. Most patients were bio-naive (85.6%, 77.9% and 55.7% for IFX, GLM and UST, respectively (p Treatment with IFX, GLM and UST was associated with significant improvements in all disease parameters over time (P AEs were reported for 74.8%, 69.8% and 52.9% (138, 114 and 115 events/100 PYs) and SAEs for 19.8%, 8.5% and 5.7% (8.8, 19.6 and 28.6 events/100 PYs) covering 325, 567 and 87 years of exposure for IFX-, GLM- and UST-treated patients, respectively. One, one and no death occurred IFX-, GLM- and UST-treated patients, respectively. The proportion of patients who discontinued treatment were 63.1%, 50.9% and 50.0% over a mean exposure of 2.9, 1.9 and 1.2 years to IFX, GLM and UST, respectively. Conclusion Differences in baseline characteristics between patients treated with an anti-TNF over an anti-IL12/23 agent suggest that the level of joint to skin involvement might be driving physician choice when the time comes to choose a biologic agent. IFX, GLM and UST treatment significantly reduced disease activity and improved functionality in a similar fashion and were well tolerated in patients with PsA. Disclosure of Interests Proton Rahman: None declared, Regan Arendse Grant/research support from: Janssen Sponsored Study, Isabelle Fortin Grant/research support from: ABBVIE, AMGEN, ASTRAZENECA, BMS, CELGENE, GSK, JANSSEN, PFIZER, SANOFI, UCB, Consultant for: LILLY, NOVARTIS, SANOFI, Speakers bureau: NOVARTIS, PFIZER, Andrew Chow Grant/research support from: Abbvie, Celgene, EliLilly, GSK, Janssen, Novartis, Pfizer, UCB, Consultant for: Abbvie, BMS, Celgene, EliLilly, GSK, Janssen, Novartis, Pfizer, Roche,UCB, Speakers bureau: Abbvie, BMS, EliLilly, Janssen, Novartis, Pfizer, Majed Khraishi Grant/research support from: Novartis, Consultant for: Amgen, Celgene, Gebro, Janssen, Novartis, Pfizer, Lilly, Merck, Suneil Kapur Grant/research support from: Abbvie, Merck, Janssen, Novartis, Eli Lilly, Amgen, Michel Zummer: None declared, Jon Chan Grant/research support from: Janssen, UCB, Novartis, Pfizer, Celgene, Consultant for: Amgen, Celgene, Eli Lilly, Janssen, Amgen, Abbvie, Novartis, Pfizer, UCB, Sandoz, Merck, Larissa Lisnevskaia Grant/research support from: Janssen Sponsored Study, Raheem Kherani Grant/research support from: Janssen, BMS, Abbvie, Consultant for: Abbvie, Amgen, BMS, Janssen, Lilly, Merck, Pfizer, Roche, Speakers bureau: Jannsen, BMS, Emmanouil Rampakakis : None declared, Odalis Asin MIilan Employee of: Employee of Janssen, Allen Lehman Employee of: Employee of Janssen, Meagan Rachich Shareholder of: Janssen, Employee of: Employee of Janssen, Francois Nantel Shareholder of: Janssen, Employee of: Employee of Janssen

ObjectivesTreat to target recommendations for PsA state that the target of treatment should be remission or, at the very least, low disease activity. Different clinical indexes have been proposed to define these disease states including the minimal disease activity criteria and the Disease Activity Index for PsA (DAPSA) scores, which have 7 and 4–5 domains, respectively. Using a Canadian cohort, the objectives were to calculate the proportion of patients achieving these criteria, their prognostic value and the overall patient impact of these disease states. MethodsBioTRAC is an ongoing, prospective registry of inflammatory arthritis patients. 188 PsA patients treated with golimumab were included. Data collected at baseline, 6 and 12 months were used. ResultsBetween 15.6% and 38.3% of patients achieved remission, and 37.4–77.7% achieved low disease activity at 6 and 12 months’ follow-up. Patients achieving any minimal disease activity target and DAPSA low disease activity had significantly lower swollen joint count, tender joint count, psoriasis area and severity index, dactylitis and enthesitis scores compared with non-achievers (P ≺ 0.05). Higher HAQ scores (P ≺ 0.03) were observed in patients achieving remission with remaining dactylitis or active skin disease. ConclusionVery low disease activity was the most stringent new potential target for remission in PsA. There was a high level of agreement between scores, although residual activity in dactylitis and skin despite DAPSA remission may affect patient function. Patients achieving either DAPSA endpoint, however, did not show a significant reduction in skin disease, indicating that those two criteria are more restricted to joint symptoms.

Background The Biologic Trial Registry Across Canada (BioTRAC) was a multi-centre, prospective, longitudinal, observational program that gathered and analysed data on inflammatory arthritis patients treated with infliximab (IFX), golimumab and ustekinumab. Patients specifically treated with IFX were recruited from July 2002 to June 2015 and followed up to June 2017. Objectives The objective of this abstract is to document the final consolidated safety data from the BioTRAC IFX cohort. Methods Treatment was prescribed by the physician per actual clinical practice or standard of care for rheumatoid arthritis (RA), ankylosing spondylitis (AS) and psoriatic arthritis (PsA); there was no randomised assignments to treatment. There were no restrictions on the use of concomitant medications. At enrolment (baseline) and approximately every 6 months thereafter, information was collected to assess safety, clinical outcomes, quality of life, comorbidities, pharmaco-economics and treatment regimens. Results A total of 1390 patients were enrolled and used for this analysis. The proportion of patients by indication was 59.2% for RA (n=890), 25.9% for AS (n=389) and 7.4% for PsA (n=111). The mean (SD) exposure was 3.10 (3.26) years for a sum of 4290.25 patient-years. Treatment with IFX was generally safe, with AEs and SAEs being reported for 64.3% and 19.5% of patients, respectively. The incidence rate of AEs and SAEs was 116.0 and 11.2 events per 100 pt-years, respectively. More specifically, 338 SAEs were reported by 189 (21.2%) RA patients [SAEs/100 pt-yrs: 11.7], 130 SAEs were reported by 60 (15.4%) AS patients [SAEs/100 pt-yrs: 10.5] and 28 SAEs were reported by 22 (19.8%) PsA patients [SAEs/100 pt-yrs: 8.82]. The most commonly reported AE identified was arthralgia, viral upper respiratory tract infection, upper respiratory tract infection and nausea. For SAEs, the most commonly reported SOC (≥3% of patients) was “Infections and infestations” [5.3% (n=73); 2.16 SAEs/100 pt-yrs] and “Neoplasms benign, malignant and unspecified” [3.5% (n=49); 1.24 SAEs/100 pt-yrs] which occurred at similar rates to the general RA patient population1 and included two lymphomas [0.1%; 0.05/100 pt-yrs]. Across 3 closely monitored categories of AEs, a total of 302 closely monitored AEs were reported by 293 (21.1%) patients, including cancer (3.7%), lack of efficacy (17.1%) and tuberculosis (0.2%). A total of 21 deaths were reported during the study in 18 RA, 1 AS and 2 PsA patients. Cause of death included MACE (x5), lung cancer (x2), pulmonary fibrosis (x2), pneumonia (x2), respiratory failure, bronchitis, intestinal cancer, throat cancer, intestinal gangrene, disseminated TB, septic shock, procedural complication and drowning. The cause of death was not known for one patient. Conclusions The results of this longitudinal observational study showed that treatment with IFX was well tolerated in people living with AS, PsA and RA over a 15 year period in a real-world setting. Reference [1] Askling, et al. Arthritis & Rheum2009;60:3180–9. Disclosure of Interest D. Choquette Grant/research support from: Janssen Inc., P. Rahman Grant/research support from: Janssen Inc., Consultant for: Janssen Inc., Speakers bureau: Janssen Inc., A. Chow: None declared, R. Faraawi Consultant for: Janssen Inc., Speakers bureau: Janssen Inc., W. Olszynski Consultant for: Janssen Inc., E. Rampakakis: None declared, O. Asin-Milan Employee of: Janssen Inc., B. Osborne Employee of: Janssen Inc., A. Lehman Employee of: Janssen Inc., F. Nantel Shareholder of: Johnson and Johnson, Employee of: Janssen Inc.

Background Treat to target recommendations in psoriatic arthritis (PsA) stated that the target of treatment should be remission or inactive disease. At that time, no definitions of remission or inactive disease existed and the only validated target available was the minimal disease activity (MDA) criteria. Since then, other potential targets have been developed including very low disease activity (VLDA) and the Disease Activity in PsA (DAPSA) score remission. Objectives Using an existing dataset allowing calculation of DAPSA and clinical cDAPSA scores and the VLDA criteria, the objectives were to calculate the proportion of patients achieving these criteria, their prognostic value and the overall patient impact of these disease states. Methods BioTRAC is an ongoing, prospective registry of inflammatory arthritis patients initiating treatment with infliximab, golimumab (GLM) or ustekinumab. PsA patients treated with GLM were included. Data collected at baseline, 6 and 12 months (mts) were used. DAPSA remission was defined as: TJC + SJC + PtGA + Pt pain + CRP ≤4. cDAPSA Remission was defined as: TJC + SJC + PtGA+ Pt pain ≤4. Very low disease activity (VLDA) was achieved when all 7 MDA criteria were satisfied: TJC28≤1, SJC28≤1, PASI≤1, Pain (VAS) ≤15mm, PtGA (VAS) ≤20mm, HAQ ≤0.5 and tender entheseal points ≤1. Correlation between DAPSA, cDAPSA and VLDA were based on tetrachoric analysis. Results A total of 188 patients (53.2% female gender) were included with a mean (SD) disease duration of 5.46 (6.91) years. DAPSA remission was achieved in 5.1%, 24.2% and 30.0% of patients at baseline, 6 mts and 12 mts, respectively. Those patients had a significant reduction in the number of TJC, SJC, enthesitis and dactylitis (p Conclusions DAPSA, cDAPSA and VLDA represent new potential target for remission in PsA with VLDA being the most stringent criteria. There was a high level of correlation between these scores although residual activity in dactylitis and skin despite DAPSA remission has some impact on patients9 function. Disclosure of Interest L. Coates Grant/research support from: Abbvie, BMS, Celgene, Janssen, Lilly, MSD, Novartis, Pfizer, Sun Pharma, UCB, Consultant for: Abbvie, BMS, Celgene, Janssen, Lilly, MSD, Novartis, Pfizer, Sun Pharma, UCB, P. Rahman Consultant for: Abbott, AbbVie, Amgen, BMS, Celgene, Janssen, Novartis, Pfizer, Roche, E. Psaradellis Employee of: JSS Medical Research, A. Karellis Employee of: JSS Medical Research, E. Rampakakis Employee of: JSS Medical Research, B. Osborne Employee of: Janssen, C. Tkaczyk Employee of: Janssen, A. Lehman Employee of: Janssen, F. Nantel Shareholder of: Jonhson and Johnson, Employee of: Janssen

Objective To describe the profile of rheumatoid arthritis (RA) patients treated with infliximab in Canadian routine care and to assess the real-world effectiveness and safety of infliximab. Methods Biologics-naive RA patients from the Biologic Treatment Registry Across Canada were stratified based on their enrollment year. Effectiveness was assessed with the changes in clinical/laboratory parameters and patient-reported outcomes and the achievement of minimal disease activity and remission. Safety was assessed with the incidence of treatment-emergent adverse events (AEs). Results Among 628 patients, 45.9%, 34.6%, and 19.6% were enrolled between 2002–2005, 2005–2008, and 2008–2011, respectively. Patients recruited in more recent years had significantly lower Disease Activity Score with a 28-joint count using the C-reactive protein level (DAS28-CRP), Simplified Disease Activity Index (SDAI), Clinical Disease Activity Index (CDAI), swollen joint count in 28 joints, tender joint count in 28 joints, physician's global assessment of disease activity, patient's global assessment of disease activity, Health Assessment Questionnaire disability index, pain, erythrocyte sedimentation rate, and CRP level (P < 0.01 for all). Patient management also changed with a trend to initiate infliximab after failure of fewer disease-modifying antirheumatic drugs (DMARDs). Six-month treatment with infliximab resulted in statistically significant and clinically important improvements in all disease parameters examined, which were sustained over 36 months. The cumulative probability of achieving remission by 36 months, as defined by the DAS28, SDAI, and CDAI, was 56.2 (95% confidence interval [95% CI] 47.8–64.8), 31.0 (95% CI 23.8–39.8), and 36.2 (95% CI 28.5–45.3), respectively, which was significantly greater in patients with lower baseline disease activity. The profile and incidence of AEs were comparable to data previously reported for tumor necrosis factor α inhibitors. Conclusion RA patient characteristics at infliximab initiation changed over time toward lower disease activity. Furthermore, a trend to treat patients with fewer DMARDs before initiation of infliximab was observed. However, treatment with infliximab was effective in significantly reducing disease activity independent of the treatment initiation year.

Objective To examine the effects of depressive symptoms and spouse empathic responding on patient disability and marital quality over time and to identify factors that contribute to patients perceiving their spouses as responding empathically to their rheumatoid arthritis (RA). Methods Patients diagnosed with RA and their spouses (n = 133 couples) independently completed mailed questionnaires at baseline and 1 year later. Patients completed measures of functional impairment, marital quality, depressive symptoms, and perceived empathic responding from their spouse. Spouses reported their own depressive symptoms and empathic responding behavior. Results Perceived empathic responding was found to interact with spouse depressive symptoms, contributing significantly to the prediction of patient functional impairment at followup. Only when spouse empathic responding was low was spouse depression associated with greater patient functional impairment 1 year later. Similarly, in the model predicting patient marital quality at followup, there were significant 2-way interactions between perceived empathic responding and both spouse depressive symptoms and patient depressive symptoms. Only when spouse empathic responding was low did patient or spouse depression significantly predict poorer marital quality at followup. Patient perceptions of spouse empathic responding were found to depend on spouse reports of their own empathic responding, patient marital satisfaction, and the interaction of patient depressive symptoms and marital satisfaction. Conclusion Empathic responding from the spouse was found to buffer against the negative effects of spouse depression on functional and marital outcomes for patients with RA. In developing couple-oriented RA treatments, increasing perceived empathic responding could serve as a useful target for intervention.

Objective: To determine the magnitude of the risk of incident cardiovascular disease (CVD; fatal and non-fatal), including acute myocardial infarction (MI), cerebrovascular accidents (CVA) and congestive heart failure (CHF), in patients with rheumatoid arthritis (RA) compared to the general population through a meta- analysis of controlled observational studies. Methods: The authors searched the Medline, Embase, LILACS and Cochrane databases from their inception to June 2011. Observational studies meeting the following criteria were included: (1) prespecified RA criteria; (2) predefined CVD criteria for incident CVD (MI, CVA or CHF); (3) a comparison group; and (4) RR estimates, 95% CI or data for calculating them. The authors calculated the pooled RR using the random-effects model and tested for heterogeneity using the bootstrap version of the Q statistic. Results: Fourteen studies comprising 41 490 patients met the inclusion criteria. Overall, there was a 48% increased risk of incident CVD in patients with RA (pooled RR 1.48 (95% CI 1.36 to 1.62)). The risks of MI and CVA were increased by 68% (pooled RR 1.68 (95% CI 1.40 to 2.03)) and 41% (pooled RR 1.41 (95% CI 1.14 to 1.74)). The risk of CHF was assessed in only one study (RR 1.87 (95% CI 1.47 to 2.39)). Significant heterogeneity existed in all main analyses. Subgroup analyses showed that inception cohort studies were the only group that did not show a significantly increased risk of CVD (pooled RR 1.12 (95% CI 0.97 to 1.65)). Conclusions: Published data indicate that the risk of incident CVD is increased by 48% in patients with RA compared to the general population. Sample and cohort type influenced the estimates of RR.

Objective To determine whether perceptions of clinical manifestations (fatigue, pain, and physical limitation) of rheumatoid arthritis (RA) differ between spouses and their partners with RA, and to determine whether the differences are associated with the perception of beneficial and problematic spousal social support. Methods English-speaking adults with RA of ≥6 months' duration and their spouses (n = 222 couples) completed standardized questionnaires for fatigue, pain, physical limitation, beneficial spousal support, and problematic spousal support. Spouses completed questionnaires based on their perception of their partner with RA. Agreement scores for fatigue, pain, and physical limitation were calculated by subtracting spouse scores from the scores of the partner with RA. Agreement levels were defined a priori: agreement (within ± one-half of a minimum clinically important difference [MCID] unit), overestimator ( one-half an MCID). Separate hierarchical linear regression models were used to measure the association between beneficial support and problematic support after adjusting for RA duration, physical health, sex, educational level, relationship duration, and satisfaction. Results Response rate for couples was 82%. Relative to participants with RA, spouses overestimated fatigue (26%), pain (29%), and physical limitation (39%), and underestimated fatigue (11%), pain (17%), and physical limitation (34%). After statistically controlling for demographic, disease, and psychosocial variables, participants with RA whose spouses underestimated fatigue received more problematic support (R2 = 3.7%, P = 0.002), as did those whose spouses underestimated or overestimated physical limitation (R2 = 3.4%, P = 0.017). Conclusion Persons with RA perceived more problematic spousal support when their spouse underestimated fatigue, or underestimated or overestimated physical limitation levels.

Objective To examine the role of spouse mood in the disability and disease course of persons with rheumatoid arthritis (PWRA). Methods A total of 133 married PWRA completed questionnaires, including the Rheumatoid Arthritis Disease Activity Index and the Disabilities of the Arm, Shoulder, and Hand, assessing PWRA arthritis disease activity and disability, respectively, at 2 time points 1 year apart. In addition, both PWRA and their spouses completed the Center for Epidemiologic Studies Depression Scale, a standardized community measure of depression at both time points. Results Multiple regression analysis revealed spouse depressive symptoms at initial assessment to be predictive of followup PWRA disability and disease activity, even after controlling for initial levels of PWRA depression, disability, disease activity, age, number of years married, education, disease duration, and employment. Specifically, higher levels of spouse depression predicted worse disease course over a 1-year period for PWRA, as indicated by higher reports of subsequent PWRA disability and disease activity. Conclusion Our findings highlight the key role played by the spouse in PWRA disease course, and point to the importance of including the spouse in clinical interventions. Implications for theory, research, and treatment are discussed with a focus on examining pathways through which spouse depressive symptoms may affect PWRA disease course and disability.

Purpose of review People with arthritis play major roles in treatment and research. This review summarises the current knowledge on tools for enhancing shared-decision making in arthritis care; individual and family involvement in rehabilitation; and the consumer's role in arthritis research. Recent findings There are discrepancies in the use of appropriate arthritis treatment. To facilitate evidence-informed treatment choices, a number of decision aids have been developed. A recent systematic review concluded that decision aids could improve the shared-decision making process in a variety of diseases; but only one clinical trial was found on a musculoskeletal condition (back surgery). The evidence on family member participation in arthritis education programs is mixed, partly due to a lack of content specifically targeting family members in some studies. Finally, people with arthritis are playing important roles as collaborators in research. Early experience indicates a mutually beneficial relationship for both the individual and researchers. Summary This review offers three recommendations: First, further clinical trials are needed to test the effectiveness of decision aids in arthritis management. Second, education programs involving strong social support training for family members may improve client outcomes. Third, we encourage further studies to examine the experiences and challenges of people living with arthritis when participating as research partners.

ObjectiveTo 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.DesignBiologic 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.Setting46 primary-care Canadian rheumatology practices.Participants223 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 measuresMDA 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.ResultsMDA 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%).ConclusionsAlmost 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 numberBioTRAC (NCT00741793).

To examine the effects of depressive symptoms and spouse empathic responding on patient disability and marital quality over time and to identify factors that contribute to patients perceiving their spouses as responding empathically to their rheumatoid arthritis (RA).Patients diagnosed with RA and their spouses (n = 133 couples) independently completed mailed questionnaires at baseline and 1 year later. Patients completed measures of functional impairment, marital quality, depressive symptoms, and perceived empathic responding from their spouse. Spouses reported their own depressive symptoms and empathic responding behavior.Perceived empathic responding was found to interact with spouse depressive symptoms, contributing significantly to the prediction of patient functional impairment at followup. Only when spouse empathic responding was low was spouse depression associated with greater patient functional impairment 1 year later. Similarly, in the model predicting patient marital quality at followup, there were significant 2-way interactions between perceived empathic responding and both spouse depressive symptoms and patient depressive symptoms. Only when spouse empathic responding was low did patient or spouse depression significantly predict poorer marital quality at followup. Patient perceptions of spouse empathic responding were found to depend on spouse reports of their own empathic responding, patient marital satisfaction, and the interaction of patient depressive symptoms and marital satisfaction.Empathic responding from the spouse was found to buffer against the negative effects of spouse depression on functional and marital outcomes for patients with RA. In developing couple-oriented RA treatments, increasing perceived empathic responding could serve as a useful target for intervention.

To describe the profile of rheumatoid arthritis (RA) patients treated with infliximab in Canadian routine care and to assess the real-world effectiveness and safety of infliximab.Biologics-naive RA patients from the Biologic Treatment Registry Across Canada were stratified based on their enrollment year. Effectiveness was assessed with the changes in clinical/laboratory parameters and patient-reported outcomes and the achievement of minimal disease activity and remission. Safety was assessed with the incidence of treatment-emergent adverse events (AEs).Among 628 patients, 45.9%, 34.6%, and 19.6% were enrolled between 2002-2005, 2005-2008, and 2008-2011, respectively. Patients recruited in more recent years had significantly lower Disease Activity Score with a 28-joint count using the C-reactive protein level (DAS28-CRP), Simplified Disease Activity Index (SDAI), Clinical Disease Activity Index (CDAI), swollen joint count in 28 joints, tender joint count in 28 joints, physician's global assessment of disease activity, patient's global assessment of disease activity, Health Assessment Questionnaire disability index, pain, erythrocyte sedimentation rate, and CRP level (P0.01 for all). Patient management also changed with a trend to initiate infliximab after failure of fewer disease-modifying antirheumatic drugs (DMARDs). Six-month treatment with infliximab resulted in statistically significant and clinically important improvements in all disease parameters examined, which were sustained over 36 months. The cumulative probability of achieving remission by 36 months, as defined by the DAS28, SDAI, and CDAI, was 56.2 (95% confidence interval [95% CI] 47.8-64.8), 31.0 (95% CI 23.8-39.8), and 36.2 (95% CI 28.5-45.3), respectively, which was significantly greater in patients with lower baseline disease activity. The profile and incidence of AEs were comparable to data previously reported for tumor necrosis factor α inhibitors.RA patient characteristics at infliximab initiation changed over time toward lower disease activity. Furthermore, a trend to treat patients with fewer DMARDs before initiation of infliximab was observed. However, treatment with infliximab was effective in significantly reducing disease activity independent of the treatment initiation year.

Background The Health Assessment Questionnaire (HAQ) remains the gold standard for measuring patient-reported functional status in rheumatoid arthritis (RA) and is included among the measures suggested by the American College of Rheumatology for making treatment decisions in routine care. We have previously shown that significant variability exists in the correlation of individual HAQ questions with patient-reported and clinical outcomes. Objectives The aim of this analysis was to assess, in routine care, the timelines of HAQ improvement as compared to clinical improvement and to examine possible differences in the improvement of individual questions. Methods BioTRAC is an ongoing, prospective registry of patients initiating treatment for RA, ankylosing spondylitis, or psoriatic arthritis with infliximab (IFX) or golimumab (GLM). Eligible people for this analysis included RA patients treated with IFX who were enrolled since 2002 or with GLM enrolled since 2010. Time to achieving minimal important difference (MID; Δ≥0.22) in HAQ, HAQ≤1, minimal disease (MD) in individual HAQ questions (no or some difficulty), CDAI low disease activity (LDA), or CDAI remission was assessed with the Kaplan-Maier estimator of the survival function and cox regression. Results 1205 patients (75.3% female) were included with mean (SD) age of 56.0 (13.6) years and disease duration of 8.4 (8.9) years at baseline. Mean (SD) HAQ and CDAI were 1.55 (0.72) and 33.8 (17.4), respectively. Statistically significant and clinically meaningful improvements in both HAQ and CDAI were observed over time. The cumulative probability of achieving HAQ MID, HAQ≤1, CDAI LDA, and CDAI remission by 12 months was 69.5%, 54.5%, 54.1%, and 18.1%, respectively. Time to achieving HAQ MID [Hazard Ratio (95% CI): 3.6 (3.2–4.2)], HAQ≤1 [2.9 (2.6–3.4)], and CDAI LDA [3.1 (2.7–3.6)] was significantly lower as compared to CDAI remission. With respect to individual HAQ questions, at baseline, the most predominant usual activities that patients were unable to do were taking a tub bath (27.9%), reaching and getting down a 5-pound object from the head (21.8%), and doing chores such as vacuuming or yard work (23.2%). In accordance, time to having no or some difficulty in these activities was significantly higher compared to the remaining HAQ items. Conclusions The results of this analysis show that the timelines for achieving HAQ targets in routine care is comparable to that of achieving CDAI LDA. Significant differences were observed in terms of improvement in individual HAQ items with the inability to take a tub bath, getting heavy overhead objects down, and doing chores being the most persistent. Disclosure of Interest R. Arendse: None declared, B. Haraoui: None declared, D. Choquette: None declared, J. Kelsall: None declared, P. Baer: None declared, D. Sholter: None declared, W. Bensen: None declared, M. Bell: None declared, M. Teo: None declared, E. Rampakakis: None declared, E. Psaradellis: None declared, B. Osborne Employee of: Janssen Inc., C. Tkaczyk Employee of: Janssen Inc., K. Maslova Employee of: Janssen Inc., F. Nantel Employee of: Janssen Inc., A. Lehman Employee of: Janssen Inc.

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

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

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

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

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

Background 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 naive (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 investigator9s 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.

Objectives To describe the profile of patients with ankylosing spondylitis (AS) treated with infliximab in Canadian routine care and to assess the effectiveness and safety of infliximab in real world. Setting 46 primary care rheumatology practices across Canada. Participants 303 biological-naïve patients with AS or patients previously treated with a biological for

To determine whether perceptions of clinical manifestations (fatigue, pain, and physical limitation) of rheumatoid arthritis (RA) differ between spouses and their partners with RA, and to determine whether the differences are associated with the perception of beneficial and problematic spousal social support.English-speaking adults with RA of ≥ 6 months' duration and their spouses (n = 222 couples) completed standardized questionnaires for fatigue, pain, physical limitation, beneficial spousal support, and problematic spousal support. Spouses completed questionnaires based on their perception of their partner with RA. Agreement scores for fatigue, pain, and physical limitation were calculated by subtracting spouse scores from the scores of the partner with RA. Agreement levels were defined a priori: agreement (within ± one-half of a minimum clinically important difference [MCID] unit), overestimator (one-half an MCID), and underestimator (one-half an MCID). Separate hierarchical linear regression models were used to measure the association between beneficial support and problematic support after adjusting for RA duration, physical health, sex, educational level, relationship duration, and satisfaction.Response rate for couples was 82%. Relative to participants with RA, spouses overestimated fatigue (26%), pain (29%), and physical limitation (39%), and underestimated fatigue (11%), pain (17%), and physical limitation (34%). After statistically controlling for demographic, disease, and psychosocial variables, participants with RA whose spouses underestimated fatigue received more problematic support (R(2) = 3.7%, P = 0.002), as did those whose spouses underestimated or overestimated physical limitation (R(2) = 3.4%, P = 0.017).Persons with RA perceived more problematic spousal support when their spouse underestimated fatigue, or underestimated or overestimated physical limitation levels.

To determine the minimal clinically important difference (MCID) for 7 measures of fatigue in patients with systemic lupus erythematosus (SLE).Study subjects completed 7 fatigue instruments [Fatigue Severity Scale (FSS), Multidimensional Assessment of Fatigue (MAF), Multidimensional Fatigue Inventory (MFI), Vitality scale of the MOS-SF-36, Chalder Fatigue Scale (CFS), Functional Assessment of Chronic Illness Therapy-Fatigue, and a global Rating Scale (RS)] and then participated in a series of interviews with other study participants comparing their fatigue with one another. Each interview participant rated the difference in their fatigue levels on a 7-point transition scale. The MCID was estimated from the mean difference in fatigue scores between each pair of interview participants based on their subjective rating of fatigue contrast. The MCID was also estimated using linear regression modeling.Eighty patients with SLE participated. Patients reported significant levels of fatigue [mean normalized (0 = none, 100 = maximum) fatigue scores for the 7 instruments ranged from 49.8 (CFS) to 71.1 (FSS)]. The MCID of "a little more" fatigue tended to be greater than the MCID for a "little less fatigue" and differed significantly for FSS and MAF. The MCID of normalized scores estimated by linear regression ranged from 7.0 (CFS) to 14.3 (MFI).Fatigue is a common and debilitating component of SLE. Estimates of MCID will help to interpret changes observed in a fatigue score and will be critical in estimating sample size requirements for clinical trials including fatigue as an outcome.

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 Swelling and tenderness in all joint groups were associated with significantly (P DAS28 =0.25, P=0.006; B CDAI =2.09, P=0.001; B SDAI =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

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

Background 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 Pearson9s 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 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

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 ( 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 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

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 Pearson9s 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

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 Pearson9s 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 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

Background Two versions of DAS28 are available, DAS28-4 comprising 4 variables [tender and swollen joint counts, acute phase reactant (APR), and patient global assessment] and DAS28-3 where patient global has been omitted. Despite the difference between DAS28-4 and DAS28-3 thresholds for remission and low disease activity (LDA) are the same. The APR used to calculate DAS may be either ESR or CRP. Objectives This analysis describes the agreement between these four possible indices, DAS28-4-ESR, DAS28-4-CRP, DAS28-3-ESR and DAS28-3-CRP and compares them in terms of classifying remission and LDA in a real-world, routine clinical care setting. Methods BioTRAC is a prospective registry of patients initiating treatment with infliximab or golimumab. In this analysis, data from RA patients who were treated with infliximab between 2002-2014 or with golimumab between 2010-2014 and had available information in all indices were used. The definitions for remission were: DAS28-3/4 Results 869 RA patients who had 3,517 complete assessments were included in the analysis. Non-remission was classified by all indices in 61.4% of cases, while remission was achieved in one (5.9%), two (10.3%), three (5.3%), or all four (17.2%) indices. Similarly, non-LDA was classified by all indices in 46.1% of cases, while LDA was achieved in one (6.2%), two (10.9%), three (5.4%), or all four (31.3%) indices. Overall, a strong linear positive correlation (r>0.8) was observed between all indices. When looking at the internal consistency in terms of classifying disease state, the CA was 0.905 for remission and 0.923 for LDA suggesting an overall high internal consistency. However, when looking at individual inter-item correlations, agreement between indices was variable with DAS28-3CRP and DAS28-4CRP showing highest correlation and DAS28-3-ESR and DAS28-4-CRP showing lowest correlation. When comparing DAS28-4-ESR with DAS28-3-ESR, the latter categorized 16.5% of DAS28-4-ESR remission cases as non-remission and 3.0% of DAS28-4-ESR non-remission cases as remission. With respect to LDA, DAS28-3-ESR categorized 9.1% of DAS28-4-ESR LDA cases as non-LDA and 4.7% of DAS28-4-ESR non-LDA cases as LDA. Similar results were observed with DAS28CRP. Conclusions The results of this analysis show that, despite being highly correlated, variability exists in the classification of remission and LDA by the various DAS indices. Decision making based on disease state achieved may vary significantly based on type of APR used in the DAS index. Disclosure of Interest W. Bensen 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. Rodrigues: None declared, A. Avina-Zubieta: None declared, W. Olszynski: None declared, D. Choquette Consultant for: AbbVie, Amgen, Celgene, BMS Canada, Janssen, Pfizer, S. Kapur: 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

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

Background The present standard for measuring disease activity in Ankylosing Spondylitis (AS) is the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) which focuses on five major symptoms including fatigue, axial pain, peripheral pain, enthesitis and morning stiffness (severity and duration). Objectives Given that the BASDAI instrument contains two pain questions, the objective was to assess whether pain symptoms are the main drivers of BASDAI scores among AS patients treated with anti-TNFs in routine clinical practice. Methods BioTRAC is an ongoing, prospective registry of patients initiating treatment for RA, AS, or PsA with infliximab (IFX) or golimumab (GLM). Patients with AS treated with IFX or GLM and enrolled between 2005 and 2014 were included in this analysis. A modified weighted BASDAI score (m-BASDAI) was calculated excluding the axial (Q2) and peripheral (Q3) pain questions of the BASDAI. The correlation of BASDAI, each of its components, and the modified BASDAI (m-BASDAI) was assessed with the Pearson correlation coefficient. BASDAI low disease activity (LDA) and m-BASDAI LDA were defined as a score ≤3. The association between the number of administered analgesics (0, 1, >1) and BASDAI/m-BASDAI was assessed with one-way ANOVA. Results A total of 413 AS patients with 1,709 assessments were included in this analysis. Correlation analysis showed a strong correlation between the full BASDAI and m-BASDAI scores (r=0.98, P Increased use of analgesics (0 vs. 1 vs. >1) over 2 years of follow-up was associated with significantly (P Conclusions Higher levels of AS pain are significantly associated with a higher BASDAI score and increased use of analgesic medications among patients treated with anti-TNFs. In addition to pain, fatigue, tenderness, and morning stiffness are likewise important contributing components in the BASDAI score and the disease burden of AS. Disclosure of Interest P. Rahman Consultant for: Abbott, AbbVie, Amgen, BMS, Celgene, Janssen, Novartis, Pfizer, Roche, A. Jovaisas: None declared, W. Bensen Consultant for: Janssen, W. Olszynski: None declared, A. Jaroszynska: None declared, P. Baer Consultant for: AbbVie, Amgen,BMS, Janssen, Pfizer, Roche, M. Sheriff: None declared, D. Sholter: None declared, E. Psaradellis 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

Objective To describe the rate of concomitant oral corticosteroid use at antitumour necrosis factor (TNF) initiation and at disease remission, and to assess its effect on incidence of infection and sustainability of remission among patients with rheumatoid arthritis (RA) treated with infliximab in Canadian routine care. Methods Biological naive patients with RA followed in the Biologic Treatment Registry Across Canada (BioTRAC) were included. The time-dependent association between corticosteroid dose (no use, ≤5 mg/day, >5 mg/day) and the incidence of first infection, while considering possible confounders, remission sustainability and the incidence of subsequent infections were assessed with Cox regression. Results 838 patients were included; mean (SD) baseline age and disease duration were 55.6 (13.5) and 10.5 (9.8) years, respectively. After a mean (SD) of 51.3 (43.6) months, the total incidence of adverse events (AEs) and infections were 110.2 and 19.6 per 100 person-years (PY), respectively. In multivariate analysis, the HR (95% CI) for acquiring an infection was 2.48 (1.24 to 4.98) with >5 mg/day of corticosteroids versus no corticosteroids. Similarly, ≤5 mg/day of corticosteroids was associated with increased hazard for infection (2.12 (0.97 to 4.66)). Despite DAS28 (disease activity score 28) or Clinical Disease Activity Index (CDAI) remission, corticosteroids were continued in 16.4% and 16.7% of cases, respectively. Continued corticosteroid treatment was not associated with sustainability of remission (HRDAS28 (95% CI) 1.40 (0.95 to 2.06); HRCDAI 1.19 (0.75 to 1.88)), however, it had a significant impact on development of infection (HRDAS28 (95% CI) 1.78 (1.00 to 3.19); HRCDAI 2.38 (1.14 to 4.99)). Conclusions Oral corticosteroid treatment was associated with increased risk of development of infection without impacting sustainability of remission. These results support the notion that corticosteroids should be used concomitantly with anti-TNF for the shortest period possible to achieve remission, and then tapered. Trial registration number NCT00741793.

Objective To estimate the minimal clinically important difference (MCID) of seven measures of fatigue in rheumatoid arthritis. Study Design and Setting A cross-sectional study design based on interindividual comparisons was used. Six to eight subjects participated in a single meeting and completed seven fatigue questionnaires (nine sessions were organized and 61 subjects participated). After completion of the questionnaires, the subjects had five one-on-one 10-minute conversations with different people in the group to discuss their fatigue. After each conversation, each patient compared their fatigue to their conversational partners on a global rating. Ratings were compared to the scores of the fatigue measures to estimate the MCID. Both nonparametric and linear regression analyses were used. Results Nonparametric estimates for the MCID relative to “little more fatigue” tended to be smaller than those for “little less fatigue.” The global MCIDs estimated by linear regression were: Fatigue Severity Scale, 20.2; Vitality scale of the MOS-SF36, 14.8; Multidimensional Assessment of Fatigue, 18.7; Multidimensional Fatigue Inventory, 16.6; Functional Assessment of Chronic Illness Therapy–Fatigue, 15.9; Chalder Fatigue Scale, 9.9; 10-point numerical Rating Scale, 19.7, for normalized scores (0–100). The standardized MCIDs for the seven measures were roughly similar (0.67–0.76). Conclusion These estimates of MCID will help to interpret changes observed in a fatigue score and will be critical in estimating sample size requirements.

Objective To evaluate the efficacy and safety of adding intramuscular (IM) gold to the treatment regimen of patients with rheumatoid arthritis (RA) who have a suboptimal response to methotrexate (MTX). Methods A randomized, double-blind, double-observer, placebo-controlled multicenter trial of 48 weeks was conducted. Sixty-five RA patients who had a suboptimal response to ≥12 weeks of MTX therapy were randomly assigned to receive weekly IM gold or placebo in addition to MTX. Gold was administered according to a standard protocol developed for the study. The primary outcome measure was the percentage of patients who met the American College of Rheumatology (ACR) 20% improvement criteria (achieved an ACR20 response) at week 48. Secondary outcomes included the percentages of patients achieving ACR50 and ACR70 responses, the individual criteria that make up the primary outcome, quality of life, direct and indirect health care costs, intraarticular steroid use, and adverse events, among other measures. Statistical analyses were based on an intent-to-treat strategy. Results Sixty-one percent of patients receiving gold achieved an ACR20 response compared with 30% of patients receiving placebo (χ2 = 6.04, P = 0.014; logistic regression odds ratio 3.64 [95% confidence interval 1.3, 10.4], P = 0.016). Twenty-six percent of patients receiving gold achieved an ACR50 response compared with 4% of patients receiving placebo (P = 0.017), and 21% of patients receiving gold achieved an ACR70 response compared with 0% of patients receiving placebo (P = 0.011). From both clinical and cost-effectiveness perspectives, gold was the preferred and dominant strategy. Study treatment was discontinued in 23 patients (14 in the placebo group compared with 9 in the gold group; P = 0.022) due to loss to followup, adverse events, or lack of efficacy. Conclusion In RA patients with a suboptimal response to MTX, adding weekly IM gold causes significant clinical improvement. Adverse events were minor, and IM gold–related adverse events led to discontinuation in only 11% of the gold group over 48 weeks.

To assess the efficacy of topical Tripterygium wilfordii (TW), a Chinese herbal therapy, in rheumatoid arthritis (RA).A 6 week randomized double blind placebo controlled study of 61 patients with RA meeting American College of Rheumatology (ACR) criteria was conducted in China. The primary outcome was a modified ACR-20 response rate, analyzed by logistic regression analysis.The modified ACR-20 response rate differed significantly (topical TW 58% vs placebo 20%; p = 0.002). There was an 8.1-fold (95% CI 1.9-35.4) increase in the modified ACR-20 response for the TW compared to the placebo group, adjusted for age and erythrocyte sedimentation rate.Topical TW appears efficacious for the treatment of RA, but larger studies are needed.

Background The aim of rheumatoid arthritis (RA) treatment is to optimize symptom control and, when possible, achieve sustained remission. Therefore, identification of clinical signs predicting future remission is valuable to clinical decision making. One question faced by clinicians is whether the achievement of a lower disease activity value or a higher rate of change of disease activity is indicative of better future disease outcomes. Objectives To determine whether change in disease activity measures or the actual values achieved at 6 months were more predictive of remission at 12 months in RA patients treated with infliximab (IFX) in a real-world, clinical practice setting. Methods BioTRAC is an ongoing, prospective registry of patients initiating treatment for RA with IFX or golimumab as first biologics or after having been treated with a biologic for Results 436 patients were included with mean age of 56.1 yrs and disease duration of 10.4 yrs. With respect to 12-month DAS28 remission, a stronger association was observed with the actual DAS28 score compared to the percent improvement in DAS28 at 6 months. The Wald statistic for the percent change and actual value of DAS28 at 6 months was 5.38 and 46.88, respectively, while the change in log-likelihood was 4.98 (P=0.026) and 61.64 (P For SDAI remission at 12 months, the respective Wald values for percent change and actual value at 6 months were 0.075 and 18.28 and log-likelihood changes were 0.07 (P=0.788) and 24.08 (P Conclusions These results demonstrate that the actual disease outcome value achieved at 6 months is a stronger predictor of remission at 12 months than the percent change in disease activity. These findings suggest that the treatment target in a real-world setting should be set as specific endpoints and not as change over time. Disclosure of Interest : None declared DOI 10.1136/annrheumdis-2014-eular.4443

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

Objectives To assess in a clinical practice the 4-year outcomes in patients with AS treated with infliximab and the performance of ASDAS, a new disease activity measure in AS. Methods BioTRAC is an ongoing, prospective registry of patients initiating treatment for RA, AS, or PsA with infliximab or golimumab as first biologics or after having been treated with a biologic for less than 6 mos. AS patients treated with infliximab between 2005 and 2012 were included. Descriptive statistics were produced for clinical outcome measures and patient reported outcomes at baseline and follow-up assessments over four years. Within-group changes were assessed for statistical significance with the paired-samples Student9s t-test. The correlation of ASDAS with BASDAI and BASFI was assessed with the Pearson correlation coefficient. The correlation of these measures with MDGA was assessed with the Spearman9s rho. Results A total of 230 AS patients who had at least one follow-up assessment were included in this analysis, with a mean (SD) age of 45.7 (11.5) years and mean (SD) disease duration since diagnosis of 10.0 (10.1) years. At the time of enrollment, mean (SD) patient parameters were: C-reactive protein (CRP) =16.9 (20.2) mg/dL, erythrocyte sedimentation rate (ESR) =25.8 (20.2) mm/hr, morning stiffness =74.6 (40.2), health assessment questionnaire (HAQ-DI) =1.20 (0.61), physician global assessment of disease activity (MDGA) =6.6 (1.9), BASDAI =6.4 (2.1), BASFI =6.1 (2.5), and ASDAS =3.8 (1.0). By 6 mos of treatment significant improvements (P Similar significant changes were observed in ASDAS, BASDAI, and BASFI over time providing evidence of construct validity and sensitivity to change. A strong positive linear correlation between ASDAS and BASDAI (r=0.85; P 3.5) decreased from 62.4% at baseline to 6.9% at 48 months. Conclusions Treatment with infliximab over four years is effective in reducing symptom severity and improving outcomes in patients with AS. Furthermore, the data from this registry confirm the validity and sensitivity to change of the ASDAS score in a real-world AS cohort. Disclosure of Interest P. Rahman: None declared, D. Choquette: None declared, M. Khraishi: None declared, W. Bensen: None declared, S. Shaikh: None declared, D. Sholter: None declared, M. Sheriff: None declared, E. Rampakakis: None declared, J. Sampalis: None declared, F. Nantel Employee of: Janssen, S. Otawa Employee of: Janssen, A. Lehman Employee of: Janssen, M. Shawi Employee of: Janssen DOI 10.1136/annrheumdis-2014-eular.2381

Background Early achievement of remission is associated with improved clinical, functional and radiographic outcomes1. Recent recommendations of the Canadian Rheumatology Association dictate that treatment target should be remission or, when not possible, low disease activity. Objectives To define the predictive factors of time to disease remission in established rheumatoid arthritis (RA) patients treated with infliximab. Methods BioTRAC is an ongoing, prospective registry of patients initiating treatment for RA, ankylosing spondylitis (AS), or psoriatic arthritis (PsA) with infliximab or golimumab as first biologics or after having been treated with a biologic for Results A total of 671 patients were included of whom 494 (73.6%) were female. At baseline, mean (SD) age was 56.0 (13.5) years and mean (SD) disease duration was 10.3 (10.1) years. Median time to CDAI and Boolean remission was 47.3 and 54.1 months, respectively. In univariate analysis, the following factors showed a statistical trend in their association with longer time to CDAI remission: earlier enrolment period (P=0.117), increased age (P=0.070), longer disease duration (P=0.008), female gender (P=0.143), and increased baseline disease activity as indicated by TJC28 (P Conclusions Upon adjusting for potential confounders, increased disease duration before anti-TNF initiation is an independent predictor of longer time to remission. The results of these real-world Canadian data support findings that earlier initiation of anti-TNF agents may be associated with increased remission rates when stringent definitions of remission are considered. References Smolen JS et al. Ann Rheum Dis. 2009;68:823-7. Disclosure of Interest : B. Haraoui: None declared, M. Sheriff: None declared, M. Khraishi: None declared, M. Starr: None declared, J. Kelsall: None declared, M. Baker: None declared, R. Arendse: None declared, S. Dixit: None declared, W. Bensen: None declared, P. Baer: None declared, R. Faraawi: None declared, E. Rampakakis: None declared, J. Sampalis: None declared, S. Otawa Employee of: Janssen, A. Lehman Employee of: Janssen, F. Nantel Employee of: Janssen, M. Shawi Employee of: Janssen DOI 10.1136/annrheumdis-2014-eular.2365

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

Background Spondyloarthritis, including psoriatic arthritis (PsA), is characterized by inflammatory arthritis affecting axial and peripheral joints. It is commonly associated with extra-articular and peri-articular manifestations (PAMs) including dactylitis and enthesitis. Objectives To evaluate the point prevalence of enthesitis and dactylitis at the time of anti-TNF initiation, their impact on disease severity, and their evolution over time in patients with active PsA treated in a routine clinical practice setting. Methods BioTRAC is an ongoing, prospective registry of patients initiating treatment for rheumatoid arthritis (RA), ankylosing spondylitis (AS), or PsA with infliximab or golimumab as first biologics or after having been treated with a biologic for

Objectives Patient (PtGA) and physician (MDGA) global assessment of disease activity measure the same construct from two different perspectives. The objective of this study was to assess the agreement between these two measures over time as ascertained in Canadian routine clinical practice in patients with RA treated with infliximab or golimumab. Methods BioTRAC is an ongoing, prospective registry of patients initiating treatment for rheumatoid arthritis (RA), ankylosing spondylitis (AS), or psoriatic arthritis (PsA) with infliximab or golimumab as first biologics or after having been treated with a biologic for less than six months. In this analysis, people with RA treated with infliximab who were enrolled between 2002 and 2012 and had at least one follow-up assessment and up to 60 months of follow up were included. PtGA and MDGA were measured on a 10-point Numerical rating scale (NRS) and 10 cm visual analog scale (VAS), respectively. The association between treatment duration and difference between MDGA and PtGA was assessed with linear regression. Internal consistency was assessed with the intra-class correlation coefficient (ICC) and Cronbach9s alpha (CA). Results A total of 675 patients assessed over 4193 visits during a mean follow up time of 20 months were included in the analyses. The overall mean (SD) PtGA and MDGA was 3.73 (2.89) and 3.38 (2.67), respectively (P Conclusions The results of this Canadian longitudinal observational registry have shown that there is poor agreement between physician-based and patient-based assessments of disease activity. In addition, the rate of reduction in disease activity over time is considerably higher when rated by physicians when compared to patients. In this chronic condition, physicians should be aware of this increasing discordance between the patient and physician global when making treatment decisions and managing patient expectations over time. Acknowledgements We thank Dr. Mary Bell, Sunnybrook Health Sciences Centre, for her contribution to the development of this analysis. Disclosure of Interest None declared DOI 10.1136/annrheumdis-2014-eular.3902