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Background:COMPLETE-PsA was a Canadian observational study of biologic-naïve adults with active psoriatic arthritis (PsA) treated with adalimumab (ADA) or conventional systemic disease-modifying anti-rheumatic drugs (csDMARDs) after switch from a previous conventional therapy.Objectives:To compare the impact of ADA vs csDMARDs on clinical and patient-reported outcomes due to PsA over 24 months.Methods:Eligible patients were biologic naïve adults with active PsA who required change in their treatment due to inadequate response or non-tolerance, as per treating physician judgement. Patients were enrolled between July/2011 and December/2017 and followed for a maximum 24 months. Treatment was as per routine care. Outcome measures included tender/swollen joint count (TJC/SJC), morning stiffness (min/day), patient’s global assessment of disease activity (PtGA) and pain (both 100 mm VAS), quality of life (DLQI), and functional disability (HAQ-DI). Outcome changes over time were evaluated using multivariable models adjusting for baseline measures. Achievement of modified minimal disease activity [mMDA, 5/7 of: TJC and SJC ≤1 each, psoriasis BSA ≤3%, pain ≤15 (VAS, mm), PtGA ≤20, HAQ-DI ≤0.5, and no enthesitis], and presence of enthesitis and dactylitis, were assessed descriptively. Analyses were conducted in the intent-to-treat population.Results:A total of 277 ADA and 148 csDMARD-treated patients were included in the analysis. At baseline, 61.7% of ADA and 81.1% of csDMARD patients reported concomitant methotrexate. Compared to the csDMARD group, ADA-treated patients demonstrated significantly (p<0.05) greater baseline disease severity with respect to mean (SD) joint count [TJC: 8.9 (6.2) vs. 7.4 (6.6); SJC: 7.4 (5.0) vs. 5.9 (4.6)], morning stiffness [83.5 (98.2) vs. 61.8 (77.4) min/day], PtGA [56.1 (24.1) vs. 45.1 (24.7) mm], pain [58.5 (24.3) vs. 50.1 (24.0) mm], DLQI scores [6.1 (6.9) vs. 4.3 (5.3)] and HAQ-DI [1.1 (0.6) vs. 0.8 (0.6)]. The rate of baseline mMDA was slightly lower for ADA patients (4.3% vs. 7.4%; p=0.178). Baseline prevalence of enthesitis was comparable (ADA: 28.4% vs. csDMARD: 23.4%; p=0.276), while dactylitis was significantly more prevalent for csDMARD patients (26.2% vs. 36.3%; p=0.031).Overall effect of treatment group, over 24 months, significantly (p<0.05) favored the ADA vs. csDMARD-treated patients for TJC [estimate (95%CI): -2.4 (-3.4, -1.4)] SJC [-1.8 (-2.5, -1.2)], PtGA [-3.7 (-9.3, 1.9)], DLQI [-1.5 (-2.5, -0.5)], and HAQ-DI [-0.1 (-0.2, 0.0)] (Figure 1). There was no significant difference for morning stiffness and pain.At month 24, statistically comparable (p>0.05) baseline-adjusted values (the least square means: LSM) were observed for ADA- vs. csDMARD-treated patients for TJC [LSM (95%CI): 1.8 (1.2, 2.4) vs. 3.0 (2.1, 3.8)], SJC [1.2 (0.8, 1.7) vs. 2.1 (1.5, 2.7)], morning stiffness [32.4 (19.1, 45.6) vs. 29.9 (11.1, 48.6) min/day], PtGA [31.6 (28.1, 35.2) vs. 36.9 (31.8, 41.9) mm], pain [35.3 (31.5, 39.0) vs. 38.4 (33.1, 43.7) mm], DLQI [2.9 (2.2, 3.6) vs. 2.9 (2.0, 3.8)], and HAQ-DI [0.7 (0.6, 0.8) vs. 0.9 (0.8, 1.0)].Achievement of mMDA at month 24 was reported by 34.1% and 34.9% of ADA- and csDMARD-treated patients, respectively (p=0.892). Rates of dactylitis (10.6% vs. 10.0%) and enthesitis (9.6% vs. 14.4%) were comparable in the ADA vs. csDMARDs groups respectively.Conclusion:The results of this real-world Canadian study indicate a physician selection bias for treatment with ADA for PsA patients with more severe disease burden, indicated by greater baseline disease activity and PROs. ADA-treated patients experienced a greater treatment effect over 24 months compared to csDMARD-treated patients. However, despite the greater treatment effect of ADA, residual disease burden in the two groups was comparable at 24 months.Acknowledgements:The authors wish to acknowledge JSS Medical Research for their contribution to the statistical analysis, medical writing, and editorial support during the preparation of this abstract. AbbVie provided funding to JSS Medical Research for this work.Disclosure of Interests:Majed Khraishi Speakers bureau: Speaker for AbbVie, Consultant of: Consultant for AbbVie, Grant/research support from: Principal Investigator for AbbVie, Samuel Silverberg Consultant of: Consultant for AbbVie, Janssen, and Pfizer, Yatish Setty Consultant of: Advisory Board meetings with AbbVie and Janssen, Marie-Claude Laliberté Employee of: Employee of AbbVie, Louis Bessette Speakers bureau: Speaker for Amgen, BMS, Janssen, UCB, AbbVie, Pfizer, Merck, Celgene, Lilly, Novartis, Gilead, Sandoz, Fresenius Kabi, Consultant of: Consultant for Amgen, BMS, Janssen, UCB, AbbVie, Pfizer, Celgene, Lilly, Novartis, Gilead, Sandoz, Samsung Bioepis, Fresenius Kabi, Grant/research support from: Investigator for Amgen, BMS, Janssen, UCB, AbbVie, Pfizer, Merck, Celgene, Sanofi, Lilly, Novartis, Gilead.

BackgroundTreatment selection in routine clinical care is driven by treatment guidelines, physician judgment, patient preferences, and regional reimbursement policies, which may vary over time and among geographic regions.ObjectivesThe objective of this analysis is to investigate the regional and temporal variability of the profile of anti-TNF naïve psoriatic arthritis (PsA) patients at initiation of adalimumab (ADA) treatment following failure of initial non-biologic treatment.MethodsCOMPLETE-PsA is an ongoing Canadian observational study of anti-TNFα naïve adults with active PsA who require change in their current treatment as per the judgement of their treating physician. Patients are followed for up to 2 years. Regional variation was assessed for the following regions: British Columbia/Manitoba (BC/MB), Newfoundland/Nova Scotia (NL/NS), ontario (ON), and Quebec (QC). Temporal variation was assessed for the following periods: 2012-2014 and 2015-2017. Multivariate linear regression was used to evaluate the independent impact of region and time period on disease activity (DAS28) and patient function (HAQ).ResultsA total of 278 patients were included, of whom 68 (24.5%) were from BC/MB, 25 (9%) from NL/NS, 104 (37.4%) from on, and 81 (29.1%) from QC. One hundred fifty-three patients (55%) were enrolled in 2012-2014 and 125 (45%) in 2015-2017.Using univariate analysis, significant regional variation at aDA initiation was observed for the following disease parameters: BSA<3% (from 42.3% in on to 76% in NL/NS; p=0.003), morning stiffness (from 60.9 min in QC to 119.7 in BC/MB; p=0.049), WLQ productivity loss score (from 8.4% in BC/MB to 12.9% in NL/NS; p=0.028), and DLQI (from 3.5 in NL/NS to 7.9 in on; p=0.007); and for the initiation of aDA monotherapy vs. ADA combination therapy (range from 9.9% in QC to 27.9% in on; p=0.022). No differences were observed in demographics (other than race: Caucasian range from 85% to 100%; p=0.006), or other disease parameters (DAS28, HAQ, SJC, TJC, DAPSA, PtGA, BDI). A statistical trend towards lower DAS28 (2012-14 vs. 2015-17: 4.9 vs. 4.6; p=0.070), SJC (8.3 vs. 6.4; p=0.001), TJC (9.5 vs. 8.1; p=0.074), and DAPSA (30.8 vs. 27.8; p=0.083) at aDA initiation was observed for the more recent time period. Using multivariate analysis to adjust for age, gender, BSA levels, and corticosteroid use, there was no regional or temporal variation in DAS28 and HAQ.ConclusionThe results of this analysis demonstrate that there is significant regional and temporal variation in the profile of PsA patients initiated on aDA treatment in Canadian routine care. The impact of this profile variation on treatment outcomes requires further investigation.AcknowledgementThe authors wish to acknowledge JSS Medical Research, Montreal (QC) Canada for statistical analysis, medical writing and editorial assistance during the preparation of this abstract, and Nathalie Ross, PhD, for editorial assistance. AbbVie provided funding to JSS Medical Research and Nathalie Ross for this work.Disclosure of interestsMajed K...

BackgroundWork disability is an important functional outcome among patients with chronic inflammatory diseases such as ankylosing spondylitis (AS) and psoriatic arthritis (PsA). Maintenance of patients in the work force and return to employment are important treatment outcomes with implications for both patients and the healthcare system.ObjectivesThe aim of this analysis is to describe the prevalence of unemployment due to disability at baseline and to identify factors associated with work productivity loss in patients with AS and PsA followed in Canadian routine clinical care.MethodsPatients eligible for the COMPLETE studies were anti-TNFα naïve adults, with active AS or PsA per the judgment of the treating physician, who required change in their treatment regimen. This interim analysis included patients that were treated with adalimumab or non-biologic DMARDs and, were either employed or on disability at baseline. Work productivity was measured by the Work Limitations Questionnaire (WLQ). Depression was defined as a Beck’s Depression Inventory (BDI) score ≥20 and/or treatment with an antidepressant/anxiolytic at baseline. Multivariate generalized linear models were used to identify determinants of% WLQ productivity loss (WLQ-PL) scores at 6 and 12 months of treatment, along with the respective changes from baseline. Least Square Means (LSM) for the WLQ-PL improvement were reported from the multivariate model.ResultsA total of 486 AS patients and 292 PsA patients were included in the analysis. The mean (SD) disease duration was 5.2 (8.6) and 12.8 (12.1) years, mean (SD) age was 41.7 (11.6) and 48.3 (10.5) years, and male predominance was 58.4% and 54.5%, in the AS and PsA groups, respectively. At baseline, 13.4% of AS patients and 17.8% of PsA patients were unemployed due to disability.Among employed patients, the mean (SD) WLQ-PL score at baseline was 9.2% (5.7) in the AS patient group and 8.3% (6.0) in the PsA patient group. After 6 months of treatment significant improvement was observed in both patient populations (ΔAS [95% CI]: -2.7% [-3.4,-2.0]; ΔPsA [95% CI]: -2.1% [-2.9,-1.3]) which was maintained until 12 months.Among AS patients, after adjusting for baseline parameters including age, sex, tobacco use, HLA B27 status, treatment group, depression, and baseline scores for BASFI and WLQ-PL using multivariate analysis, presence of depression (LSM: -0.2% vs. -2.5%; p=0.016) and female sex (LSM: -0.7% vs. -2.0%; p=0.047) were identified as significant negative predictors of improvement in work productivity at 6 months, while increased baseline work productivity was a positive predictor of improvement. In the PsA group, other than higher baseline work productivity (positive predictor of improvement), no significant predictors were identified at 6 months. However, a negative trend was observed for the presence of depression (LSM: -0.4% vs. -2.5%; p=0.068).ConclusionWe observed a significant proportion of AS and PsA patients unemployed in this real-world Canadian cohort. Treatment with adalimumab or non-biologic...