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Background Assessment of functional (dis)ability in rheumatoid arthritis (RA) is subject to patient judgment when appraising their ability to do daily activities. Objectives The aim of this analysis was to describe the impact of specific joint involvement on patient reported outcomes (PROs) - functional activity, pain and patient global assessment of disease activity (PtGA) - and to identify joints most resistant to treatment over time. Methods Biologic Treatment Registry Across Canada (BioTRAC) is an ongoing, prospective, registry of patients initiating treatment for RA, AS, or PsA with infliximab or golimumab as first biologics or after having been treated with a biologic for less than six months. In this analysis, data were included from RA patients treated with infliximab between 2002 and 2012 or with golimumab between 2010 and 2012. Based on joint involvement seven groups were created: shoulder(s), elbow(s), metacarpophalangeal (MCP), wrist(s), proximal interphalangeal (PIP), knee(s), and thumb(s). The impact of specific joints on patient outcomes was assessed with the independent-samples t-test. Linear regression was used in order to produce adjusted estimates. Results A total of 935 RA patients with 4,854 assessments were included. Swelling, tenderness, and swelling and/or tenderness in all joint groups were associated with significantly (P Conclusions Significant variability in PROs exists based on the presence of swelling and/or tenderness in specific joint groups. Swelling/tenderness of shoulders, wrists, knees and elbows were the main drivers of HAQ-DI, PtGA and pain. The results have important implications for the achievement of disease remission and suggest that the joint type in addition to the number of affected joints has unique impact on PROs. Disclosure of Interest R. Arendse: None declared, W. Bensen: None declared, A. Chow: None declared, J. Rodrigues: None declared, S. Dixit: None declared, D. Sholter: None declared, P. Baer: None declared, M. Baker: None declared, D. Choquette: None declared, I. Fortin: None declared, A. Jovaisas: None declared, E. Rampakakis: None declared, J. Sampalis: None declared, F. Nantel Employee of: Janssen Inc Canada, S. Otawa Employee of: Janssen Inc Canada, M. Shawi Employee of: Janssen Inc Canada, A. Lehman Employee of: Janssen Inc Canada DOI 10.1136/annrheumdis-2014-eular.5185

Background The efficacy of anti-TNF in the management of psoriatic arthritis (PsA) and rheumatoid arthritis (RA) has been demonstrated in numerous controlled clinical trials. Objectives The objective of this analysis was to assess in Canadian routine clinical practice the durability of treatment with infliximab (IFX) in PsA and RA and the determinants associated with sustainability of IFX. Methods BioTRAC is an ongoing, prospective registry of patients initiating treatment for RA, AS, or PsA with infliximab or golimumab as first biologics or after having been treated with a biologic for less than six months. Patients with PsA or RA treated with IFX who were enrolled between 2002 (2005 for PsA patients) and 2012 were included in this analysis. Dose optimization was defined as an increase in the frequency and/or dosing of IFX. Kaplan Meier (KM) estimates and Cox proportional models were used in the analysis. Results A total of 92 PsA and 830 RA patients were included in the analysis. Mean (SD) age of the PsA and RA patient cohorts was 48.7 (9.9) and 55.8 (13.4) years, respectively, and mean (SD) duration since diagnosis was 6.8 (9.1) and 10.2 (10.1) years, respectively. Twenty seven (29.3%) PsA patients and 407 (49.0%) RA patients had discontinued treatment. Overall KM-based mean (SE) duration of treatment was 41.4 (3.6) months and 61.3 (2.2) months for PsA and RA patients, respectively. Longer treatment duration was associated with significantly greater improvements in pain (parameter estimate PsA: -0.21, P=0.020; RA: -0.27, P Conclusions The results of this observational study have shown a high durability of treatment with IFX for patients with PsA or RA in a real-world setting. Concomitant medication use significantly impacts treatment durability. Furthermore, longer disease duration, higher TJC, less severe skin disease at initiation and previous biologic use in PsA, and absence of IFX dose optimization in RA, may be associated with reduced treatment durability. Disclosure of Interest J. Kelsall: None declared, A. Jovaisas: None declared, P. Rahman: None declared, D. Sholter: None declared, M. Starr: None declared, W. Bensen: None declared, M. Sheriff: None declared, W. Olszynski: None declared, M. Zummer: None declared, R. Faraawi: None declared, A. Chow: None declared, S. Kapur: None declared, E. Rampakakis: None declared, J. Sampalis: None declared, F. Nantel Employee of: Janssen Inc Canada, S. Otawa Employee of: Janssen Inc Canada, M. Shawi Employee of: Janssen Inc Canada, A. Lehman Employee of: Janssen Inc Canada DOI 10.1136/annrheumdis-2014-eular.4013

Background The prevalence of ankylosing spondylitis (AS) is 2-3 times higher in men compared to women whereas psoriatic arthritis (PsA) is generally considered a disease affecting both genders equally. Recent studies have suggested that clinical differences exist between men and women with the latter experiencing a higher burden of disease (1-4). Objectives This analysis examined gender-specific differences with respect to patient and disease parameters at initiation of the first anti-TNF agent (infliximab; IFX) for the treatment of AS and PsA in a Canadian routine clinical practice setting. Methods BioTRAC is an ongoing, prospective registry of patients initiating treatment for rheumatoid arthritis (RA), ankylosing spondylitis (AS), or psoriatic arthritis (PsA) with IFX or golimumab as first biologics or after having been treated with a biologic for Results Among the 303 AS patients and 91 PsA patients, 189 (62.4%) and 49 (53.3%) were male, respectively. Mean age and disease duration at initiation of IFX treatment were comparable between genders (Table 1). Overall, disease parameters in AS patients were similar between genders with the exception of CRP which was significantly lower in female patients and HAQ-DI which was significantly higher (Table 1). Among PsA patients, females reported a significantly greater functional disability and showed a higher DAS28 compared to men. Conclusions Overall, some significant differences in disease parameters were observed between genders in AS and PsA at anti-TNF initiation. Female AS patients experience greater functional impairment compared to men. Female PsA patients, in addition to higher HAQ, also show greater disease activity as measured by DAS28. These results suggest that female patients appear to be receiving their first biologics at a higher level of disease activity. Whether this represents a gender bias in prescribing, or a gender based difference in the acceptance of biologic treatment, requires additional research. References Lee W et al. Ann Rheum Dis. 2007 May;66(5):633-8. van der Horst-Bruinsma IE et al. Ann Rheum Dis. 2013 Jul;72(7):1221-4. Queiro R et al. Clin Dev Immunol. 2013;2013:482691. Eder L et al. Ann Rheum Dis. 2013 Apr;72(4):578-82. Disclosure of Interest W. Bensen: None declared, J. Kelsall: None declared, M. Sheriff: None declared, N. Jones: None declared, I. Fortin: None declared, A. Chow: None declared, S. Shaikh: None declared, D. Choquette: None declared, E. Rampakakis: None declared, J. Sampalis: None declared, F. Nantel Employee of: Janssen Inc Canada, M. Shawi Employee of: Janssen Inc Canada, S. Otawa Employee of: Janssen Inc Canada, A. Lehman Employee of: Janssen Inc Canada DOI 10.1136/annrheumdis-2014-eular.1911

Background Patient (PtGA) and physician (MDGA) global assessment of disease activity are standard outcome measures used in clinical practice and research to ascertain patient and physician subjective perception of disease activity in psoriatic arthritis (PsA). Given that the PtGA and MDGA measure the same construct from two different perspectives, assessing their concordance may provide valuable insight on patient and physician differences with respect to the relative importance placed on specific disease parameters. Objectives The aim of this analysis was to assess the agreement between PtGA and MDGA, and to compare the correlation of PtGA or MDGA with the Psoriasis Area and Severity Index (PASI) in PsA patients treated with infliximab (IFX) in a Canadian real-world, routine clinical practice setting. Methods BioTRAC is an ongoing, prospective registry of patients initiating treatment for rheumatoid arthritis, ankylosing spondylitis, or PsA with IFX or golimumab as first biologics or after having been treated with a biologic for Results A total of 92 patients (52.2% male) were included with a mean (SD) age of 48.7 (9.9) years and disease duration of 6.8 (9.1) years. At baseline, mean (SD) disease parameters were: PASI =3.3 (5.6); swollen joint count (SJC28) =4.0 (3.8); tender joint count (TJC28) =5.9 (5.3); PtGA =5.0 (2.8); MDGA =5.8 (2.2) cm. Prior to IFX initiation, 78 (84.8%) patients had been treated with a traditional DMARD (71.7% with methotrexate). Overall, a strong agreement was observed between PtGA and MDGA (r=0.632). The correlation of PASI with PtGA was low (r=0.213), whereas it was moderate with MDGA (r=0.343) (Figure 1). Overall, internal consistency was poor between PASI and both PtGA (CA =0.373, ICC =0.229) and MDGA (CA =0.445, ICC =0.286) although it was higher with the latter. Multivariate linear regression resulted in the exclusion of PtGA from the model, also supporting the stronger association of MDGA with PASI. When considering other disease parameters, PtGA showed a very strong correlation with pain (r=0.885) and strong with HAQ-DI (r=0.596), whereas a strong correlation was observed between MDGA and both pain and HAQ-DI (r=0.652 and r=0.520, respectively). Conclusions The results of this analysis shows that the association of PASI is stronger with MDGA when compared to PtGA. However, patient-reported pain and HAQ-DI were better correlated with PtGA and MDGA when compared to PASI, suggesting that both patients and rheumatologists place more emphasis on pain and functional activity than on skin symptoms when evaluating the global status of PsA. Disclosure of Interest : D. Sholter: None declared, P. Rahman: None declared, J. A. Avina-Zubieta: None declared, J. Kelsall: None declared, R. Arendse: None declared, M. Khraishi: None declared, S. Shaikh: None declared, W. Bensen: None declared, E. Rampakakis: None declared, J. Sampalis: None declared, F. Nantel Employee of: Janssen Inc Canada, M. Shawi Employee of: Janssen Inc Canada, S. Otawa Employee of: Janssen Inc Canada, A. Lehman Employee of: Janssen Inc Canada DOI 10.1136/annrheumdis-2014-eular.5316

Objectives Efficacy of TNFi agents in the management of rheumatoid arthritis (RA) has been demonstrated in clinical trials. Variations with respect to patient (pt) profile, extent of physician familiarization with TNFi agents, and pt management may affect real-world outcomes. The aim of this analysis is to compare the pt profile and outcomes of RA pts treated with infliximab under routine clinical practice in biologic treatment registry sites of different sizes. Methods BioTRAC is an ongoing, prospective registry of pts initiating treatment for RA with infliximab as first biologics or treated with a biologic for 35pts. Total pts enrolled in each type of practice site was; Group A:n=324, Group B:n=239, Group C:n=269. Results Mean age was 55.8 yrs with 76% of pts being female and 74.2% RF+. No significant differences in demographic characteristics and RF status were observed between the subgroups. Pts seen at larger sites had significantly shorter disease duration (Group A: 11.9 years, Group B: 10.9 years, Group C: 7.5 years; P Upon adjusting for baseline disease activity, DAS28-CRP remission (P=0.013) and clinically meaningful improvement in HAQ-DI (Δ≥0.25; P=0.025) over 24mons of treatment was significantly greater among pts seen in larger sites. Conclusions Consistent with findings from a Canadian early RA registry 1 , results of this real-world observational study demonstrate that significant variation in disease characteristics, pt management and outcomes exist within the BioTRAC registry based on the size of the site. A trend towards earlier infliximab initiation and improved outcomes was observed with larger enrolment sites. References Harris J, et al. Improving outcomes in early RA by determining best practices: Does site size matter or is best treatment early? An analysis of the Canadian ERA cohort. CRA 2013 Disclosure of Interest None declared DOI 10.1136/annrheumdis-2014-eular.3740

Background The prevalence of rheumatoid arthritis (RA) is 2-4 times higher in women compared to men. Furthermore, RA incidence in women increases from the age of menarche peaking around menopause, while it is rare in men younger than 45 years (1). Several studies have shown that treatment outcomes are worse in women (2). Objectives This analysis examined gender-specific differences with respect to disease parameters at initiation of the first anti-TNF agent for RA treatment in a Canadian routine clinical practice setting. Methods BioTRAC is an ongoing, prospective registry of patients initiating treatment for RA, AS, or PsA with infliximab or golimumab as first biologics or after having been treated with a biologic for less than six months. In this analysis, data were assessed from RA patients treated with golimumab subcutaneous as a first biologic who were enrolled between 2010 and 2012. Results 121 RA patients were included with mean (SD) disease duration of 9.3 (9.6) years. Eighty-nine patients (73.6%) were female. In the overall population, rheumatoid factor positivity was observed in 67% of patients and 17.5% were smokers, without any significant differences between genders. Patient reported disease parameters differed significantly between genders. Despite the younger age (56.6 vs. 62.0 years; P=0.051), female patients reported significantly higher pain (56.6 vs. 44.5 mm; P=0.045), patient global assessment (PtGA: 6.0 vs. 4.7 cm; P=0.034), tender joint count (10.2 vs. 6.8; P=0.022), and functional disability (HAQ-DI: 1.43 vs. 1.06; P=0.024). In addition, a statistical trend towards higher morning stiffness in female patients was observed (55.7 vs. 38.9; P=0.063). However, physician assessment of global disease activity (MDGA: 5.7 vs. 5.5; P=0.581), SJC (7.9 vs. 8.5; P=0.641), DAS28-ESR (5.3 vs. 4.7; P=0.086), CDAI (29.7 vs. 24.5; P=0.120) and SDAI (32.1 vs. 30.2; P=0.675) were statistically comparable between genders. Conclusions Objective measures (SJC, CRP/ESR), MDGA and composite outcomes were similar for male and female patients at golimumab initiation, with the exception of TJC being higher in women. Patient reported outcomes (PROs: pain, PtGA, HAQ-DI), however, were worse at baseline for female patients at biologic treatment initiation. These findings are similar to our previous research on patients initiating anti-TNF IV therapy (3). Overall, the results may suggest gender bias in the interpretation and use of PROs during the treatment decision making process in Canadian RA patients. References Wilder RL. J Rheumatol Suppl. 1996 Mar;44:10-2. Forslind K. et al. Ann Rheum Dis. 2007 Jan;66(1):46-52. Bensen W. et al. J Rheumatol Suppl. 2013 Jun:40:1020-1. Disclosure of Interest D. Sholter: None declared, W. Bensen: None declared, D. Choquette: None declared, I. Fortin: None declared, R. Arendse: None declared, J. Kelsall: None declared, M. Sheriff: None declared, R. Faraawi: None declared, J. Rodrigues: None declared, M. Zummer: None declared, S. Dixit: None declared, M. Starr: None declared, E. Rampakakis: None declared, J. Sampalis: None declared, F. Nantel Employee of: Janssen Inc Canada, M. Shawi Employee of: Janssen Inc Canada, S. Otawa Employee of: Janssen Inc Canada, A. Lehman Employee of: Janssen Inc Canada DOI 10.1136/annrheumdis-2014-eular.3979

Background Assessment of the real-world effectiveness of newer biologics such as abatacept is essential in determining true benefits in routine practice. Patient registries represent a valuable supplement to randomized controlled trials including real world durability, and improvement of function over time. Objectives A large Canadian database was used to determine effectiveness of abatacept in real world RA patients including how many people need to be treated to improve 1 RA patient by a minimally important difference (MID) of the HAQ. Methods RA patients administered abatacept via clinic or home infusions from the Orencia Response Program network, between 2006 and Feb. 2011 with follow-up evaluation(s) were included. The number needed to treat (NNT) to improve HAQ by at least the MID (≥0.22) and abatacept survival until last follow up were calculated overall; and for abatacept as first or subsequent biologic. Results Among the 2,929 patients enrolled, 1,771 (60.5%) were eligible for the study (79.2% had past TNFi) with a mean (SD) follow up of 13.8 (12.3) months. Mean (SE) durability of treatment was 26.8 (0.53) months; where 66% were still on abatacept at 12 and 53% at 24 months. The survival was longer where abatacept was the first biologic vs. post TNFi (P=0.0001). In abatacept as 1stbiologic, 70% achieved MID in HAQ vs. 71% if post TNFi (P=0.65) with NNT=1.4 in each group and there were also no differences in % achieving MID comparing no past biologic to 2, 3 or 4 pervious biologics. Increased baseline HAQ (OR 2.13 (1.89, 2.39)) and less years of RA (OR 0.98 (0.97, 0.99)) were significant predictors of achieving the MID for HAQ. For those staying on abatacept, the mean improvement in HAQ increased over time; changing at 6, 12, 18 and 24 months by -0.29, -0.41, -0.45 and – 0.51 respectively with no difference between abatacept as first biologic vs. post TNFi (unadjusted) and if adjusting for baseline differences, change in HAQ was better as first biologic (p Conclusions Abatacept is effective in improving HAQ in RA despite long disease duration. For those still on abatacept, HAQ continued to improve over the first 2 years. The durability of abatacept is better as first biologic but NNT to improve HAQ is the same post DMARDs and TNFi. This can help to inform treatment decisions. Disclosure of Interest J. Pope Grant/Research support from: This study was supported by a grant from BMS. The protocol was developed by the authors for data analysis., E. Rampakakis: None Declared, J. Sampalis: None Declared, O. Desjardins: None Declared

Background Psoriatic arthritis (PsA) disease duration and severity of joint inflammation significantly affect the radiographic outcome which can be used as a prognostic factor for PsA progression. Objectives To describe the radiographic changes in early PsA (EPsA), defined as Methods EPsA patients were assessed at a rheumatology clinic specializing in PsA. Standard clinical and laboratory assessments, including conventional radiography of peripheral (hands, wrists and feet) and sacroiliac joints were conducted. Radiographic changes were classified as normal, abnormal-not clinically relevant, and abnormal-clinically relevant. Results A total of 81 patients with EPsA (mean (SD) disease duration =1.0 (0.8) years) were included in this analysis. The most common joint involvement was polyarticular (60.5% of patients) presentation (symmetric or asymmetric) and Distal Interphalangeal Predominant (DIP) involvement (56.8% of patients). Among the 81 patients, radiographic damage (clinically relevant) was identified in 23 (28.4%) patients, of whom 9 (39.1%) had changes in 2 joints and 7 (30.4%) in ≥3 joints. The vast majority of these patients (73.9%) experienced joint damage within the 1st year of symptoms. The observed radiographic changes included new bone formation (often interpreted by radiologists as degenerative), slight-to-moderate narrowing of the joint space, and marginal and central bone erosions. Overall, 14 (17.3%) patients had clinically relevant abnormalities in hands (10 (71.4%) in both hands), 11 (13.6%) in feet (9 (81.8%) in both legs), 4 (4.9%) in sacroiliac joints, and 1 (1.2%) in wrists. Follow-up (12-18 months) information was available for 68 patients. Among these, 7 (10.3%) patients displayed radiographic progression and 61 (89.7%) remained stable. Radiographic progression included worsening of joint erosion and space narrowing in patients with [2 (28.6%)] or without [5 (71.4%)] prior clinically relevant abnormalities. Conclusions Radiographic damage was detected in 28% of EPsA patients, the vast majority of whom acquired the damage as early as the 1st year of symptom onset. The increased incidence of axial and DIP joint involvement are in agreement with previous studies showing that they represent the most common sites in PsA. Radiographic progression was only observed in 10% of patients highlighting the importance of early PsA diagnosis and intervention. Disclosure of Interest None Declared

Objectives To compare the efficacy and safety of an individualized treatment-simplification strategy consisting of switching from a highly-active anti-retroviral treatment (HAART) with a ritonavir-boosted protease inhibitor (PI/r) and 2 nucleoside reverse-transcriptase inhibitors (NRTIs) to lopinavir/ritonavir (LPV/r) monotherapy, with intensification by 2 NRTIs if necessary, to that of continuing their HAART. Methods This is a one-year, randomized, open-label, multi-center study in virologically-suppressed HIV-1-infected adults on their first PI/r-containing treatment, randomized to either LPV/r-monotherapy or continue their current treatment. Treatment efficacy was determined by plasma HIV-1 RNA viral load (VL), time-to-virologic rebound, patient-reported outcomes (PROs) and CD4+T-cell-count changes. Safety was assessed with the incidence of treatment-emergent adverse events (AE). Results Forty-one patients were randomized to LPV/r and 39 to continue their HAART. No statistically-significant differences between the two study groups in demographics and baseline characteristics were observed. At day-360, 71(39:LPV/r;32:HAART) patients completed treatment, while 9(2:LPV/r;7:HAART) discontinued. In a Last Observation Carried Forward Intent-to-Treat analysis, 40(98%) patients on LPV/r and 37(95%) on HAART had VL