BackgroundLong-term registries are essential to evaluate new therapies in a patient population that differs from clinical trials and usually varies over time.ObjectivesTo 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.Methods1577 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.ResultsOf 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<0.001). Interestingly, baseline disease duration and disease activity scores for the GLM cohort (DAS, TJC, SJC, PtGA, Pain, CRP, ESR) were higher than in the IFX cohort from 2010-2012 when GLM was first introduced while the mean MDGA remained the same between the two groups.Treatment with IFX, GLM and GLM-IV significantly improved all disease parameters over time (P<0.001) from baseline to 6 months and up to 120, 78 and 42 months, respectively. The proportion of patients in SDAI remission at 12, 24 and 36 months reached 16.2%, 20.8% and 22.8% in IFX-patients; 34.7%, 47.5% and 52.7% in GLM-patients and 33.8%, 47.5% and 61.9% in GLM-IV-patients (p=0.1978 and p=0.0081 vs IFX).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.ConclusionIn 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/r...

BackgroundLong-term registries are essential to evaluate new therapies in a patient population that differs from clinical trial and usually varies over time.ObjectivesTo 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.Methods810 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.ResultsOf 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<0.001). A reduction in baseline BASFI score (6.3 vs. 5.9 vs 5.1; P=0.011) and in the proportion of patient in aSDAS very high disease activity (48.4%, 43.8%, 30.3%; p=0.004) were also observed. As for the GLM cohort, most disease parameters including median disease duration (1.6 years), mean baseline BASFI (5.3) and the proportion of patients in aSDAS very high disease activity (48%) remained similar from 2010-2017.Treatment with both IFX and GLM significantly improved all disease parameters over time (P<0.001) from baseline up to 120 and 84 months, respectively, with similar efficacy between agents.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.ConclusionBoth 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 interestsProton Rahman: None declared, Derek Haaland Grant/research support from: Janssen Sponsored Study, Dalton Sholter Grant/research support from: Ja...

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 (< 3), ASDAS-inactive disease (ID)(< 1.3), and ASDAS-low disease activity (LDA) in predicting sustained low Bath Ankylosing Spondylitis Functional Index (BASFI)(< 3) between 12 and 18 months. The adjusted impact of achieving low disease state at 6 and/or 12 months on BASFI at 18 months was analyzed by generalized linear models. 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 < 0.001), low BASDAI only at 6 or 12 months (p = 0.001), and baseline BASFI (p < 0.001) were the only predictors of sustained low BASFI. Sustained ASDAS-ID (p = 0.040) and ASDAS-LDA (p < 0.001) were also predictors when forced into the model. Similar results were obtained when evaluating the BASFI score at 18 months. Conclusion Sustained BASDAI < 3 may be a valid and feasible target for a treat-to-target strategy in axSpA having function as treatment goal.

ObjectiveTo characterize the long-term incidence of infection in rheumatoid arthritis (RA) patients treated with subcutaneous golimumab (GLM) in Canadian routine care, assess the impact of infections on GLM retention, and explore factors associated with infection incidence.MethodsRA patients enrolled in the BioTRAC registry (NCT00741793) initiating GLM treatment were included. The incidence density rates (IDRs) of total (TI), serious (SI), and nonserious (NSI) infections were calculated for the overall follow-up (90 months) and by 6-month intervals. Determinants of infection over time or within the first 6 months were explored using generalized estimating equation models and logistic regression, respectively.Results530 patients were included; mean baseline age was 57.7 years and RA duration of 8.0 years. Over an average follow-up of 27.0 months, the IDR for TI was 35.1 events/100 person-years (PY), the majority occurring during the first 6 months; IDRs for NSI and SI were 32.9 and 2.2 events/100PY, respectively. No predictors were identified for infection incidence within 6 months. Comorbid pulmonary disease was associated with significantly higher odds of TI and NSI over time, while higher age and high corticosteroid dose (≥5mg/day) predicted higher odds of SI. Incidence of SI, but not NSI, was associated with significantly higher odds of GLM discontinuation.ConclusionLong-term GLM treatment was associated with relatively low infection rates, most being non-serious and occurring during the first 6 months. Pulmonary disease, higher age, and high corticosteroid dose were identified as significant predictors of infections. SIs, but not NSIs, predicted higher odds of GLM discontinuation.

BackgroundLong-term registries are essential to evaluate new therapies in a patient population that differs from clinical trials and usually varies over time.ObjectivesTo 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.Methods462 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.ResultsOf 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<0.001). A reduction in mean baseline duration of morning stiffness was observed in the IFX cohort (from 69.8 to 42.6 to 23 min in 2006-2008 to 2009-2012 to 2013-2015; p=0.003). Most other baseline disease parameters remained similar over time in all three cohorts. However, UST-treated patients had lower mean baseline DAS28 CRP (3.4 vs 3.9; p=0.0031), SJC (3.8 vs 5.3; p=0.0046) and higher PASI (4.8 vs 2.2; p=0.0061) compared to patients treated with GLM.Treatment with IFX, GLM and UST was associated with significant improvements in all disease parameters over time (P<0.001) from baseline up to 84, 84 and 40 months, respectively with similar efficacy between agents. The only exception was the proportion of patients in minimal disease activity at 12, 24 and 36 months which reached 40.7%, 50.0% and 55% in IFX-patients; 64.7%, 68.8% and 78.9% in GLM-patients and 58.8%, 60.0% and 83.3% in UST-patients (p=0.004 and p<0.001 vs IFX).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.ConclusionDifferences 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.Disclos...