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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...

Background:COMPLETE-PsA was an observational study of biologic-naïve Canadian adults with active psoriatic arthritis (PsA) treated with adalimumab or non-biologic disease-modifying anti-rheumatic drugs (nbDMARD) after switch from initial therapy.Objectives:The aim of this analysis was to assess the 24-month clinical effectiveness and safety of adalimumab vs. nbDMARD in the treatment of PsA in a real-life setting.Methods:Eligible patients were biologic naïve adults, with active PsA who required change in their treatment regimen due to inadequate response or intolerance, per the judgment of the treating physician. Patients were enrolled between July/2011 and December/2017 and followed for up to 24 months. Patients were treated as per routine care. The primary endpoint, change in DAS-28 to month 24, was assessed with baseline-adjusted multivariable models and the least square mean (LSM) estimates were generated; Physician’s Global Assessment of disease activity (PGA, 100mm VAS) was assessed using similar methodology. Probability of achieving the following therapeutic response thresholds was ascertained and odds ratios (ORs) were generated: 50%/70% improvement in the American College of Rheumatology criteria (ACR50/ACR70), DAS-28<3.2 (low disease activity or remission; LDA/remission), DAS-28<2.6 (remission), modified minimal disease activity (mMDA: achievement of 5/7 of: TJC and SJC ≤1 each, BSA ≤3%, pain ≤15 (VAS, mm), Patient Global Assessment [PtGA] ≤20, HAQ-DI ≤0.5, and no enthesitis), and psoriasis (PsO) BSA <3%.Results:A total of 277 adalimumab and 148 nbDMARD- treated patients were included as part of the intent-to-treat population. Baseline methotrexate was reported by 61.7% and 81.1% of adalimumab and nbDMARD-treated patients, respectively. PsO BSA at baseline was predominantly <3% for both adalimumab (60.2%) and nbDMARD (64.6%) patients. Adalimumab-treated patients reported significantly (p<0.05) higher mean (SD) disease activity for both DAS-28 [4.8 (1.2) vs. 4.3 (1.1)] and PGA [59.4 (19.5) vs. 51.0 (21.8) mm] at baseline.For the primary endpoint, baseline-adjusted month 24 DAS-28 levels were significantly lower for adalimumab vs. nbDMARD patients [LSM (95%CI): 2.4 (2.2-2.6) vs. 3.0 (2.7-3.3); p=0.037]. In addition, rapid and sustained reductions in DAS-28 were observed for adalimumab-treatment patients, with overall treatment effect significant (p<0.001) in favor of adalimumab [estimate (95%CI): -1.1 (-1.4, -0.7)]; similar results were observed for PGA [-12.9 (-1.7, -8.0)]. Adalimumab-treated patients were at significantly higher (p<0.001) odds of attaining therapeutic response thresholds compared to DMARD-treated patients, specifically: DAS-28 LDA/remission [OR (95%CI): 4.5 (2.8, 7.3)] or remission [OR (95% CI): 4.1 (2.7-6.3)], ACR50 [OR (95% CI): 3.0 (2.0-4.6)], ACR70 [OR (95% CI): 3.1 (2.0-4.9)], mMDA [OR (95% CI): 2.4 (1.6-3.6)], and PsO BSA <3% [OR (95% CI): 2.2 (1.2-3.7)].Overall, 32 (10.7%) of adalimumab-treated patients reported 86 AEs, the most common related to infections [16 events in 10 (3.3%) patients].Conclusion:Real-world treatment with adalimumab was more effective in improving disease activity and psoriasis severity, over 24 months when compared to nbDMARDs and was associated with significantly greater likelihood of achieving minimal disease activity. Observed AEs were consistent with the established safety profile of adalimumab.Disclosure of Interests:Majed Khraishi Speakers bureau: Speaker for AbbVie, Consultant of: Consultant for AbbVie, Grant/research support from: Principal Investigator for AbbVie, Jacqueline Stewart Speakers bureau: Speaker for Abbvie, Janssen, and Johnson & Johnson, Consultant of: Advisory Board Consultant for AbbVie, Amgen, Celgene, Merck, Novartis, Pfizer, and Sanofi-Genzyme;, Grant/research support from: Participated in research with AbbVie, Bristol Myers Squibb, Janssen, and Roche, 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, and Fresenius Kabi, Consultant of: Consultant for Amgen, BMS, Janssen, UCB, AbbVie, Pfizer, Celgene, Lilly, Novartis, Gilead, Sandoz, Samsung Bioepis, and Fresenius Kabi, Grant/research support from: Investigator for Amgen, BMS, Janssen, UCB, AbbVie, Pfizer, Merck, Celgene, Sanofi, Lilly, Novartis, and Gilead.

BackgroundExtra-articular manifestations (EAMs) in rheumatic diseases have been previously found to negatively impact health outcomes including quality of life and work capacity. Even though EAMs may be directly associated with worse response to treatment, differences in patient-reported outcomes (PROs) based on the presence of EAMs could be an important contributory variable.ObjectivesTo assess the impact of EAMs on PROs among patients with active AS or PsA followed in Canadian routine clinical care.MethodsPatients eligible for the COMPLETE studies are anti-TNFα naïve adults, with active AS or PsA per the judgment of the treating physician, who require change in their treatment regimen. In the current analysis patients enrolled between July/2011 - June/2017 were included. EAMs were defined as the presence of the following at baseline: enthesitis, uveitis, inflammatory bowel disease (IBD) or psoriasis (EAMAS1 for AS); enthesitis, uveitis, or IBD (EAMAS2 for AS); enthesitis or dactylitis (EAMPsA for PsA). PROs included the Short Form Health Survey (SF-12), Work Limitations Questionnaire (WLQ) and Beck’s Depression Inventory (BDI). PROs were compared between patients with and without EAMs using the independent samples t-test. The independent association between presence of EAMs and PROs at baseline was assessed with multivariate generalised linear models adjusting for disease state (high/very high vs. inactive/low/moderate disease based on the BASDAI for AS and the DAS28 for PsA), disease type, and ever smoking.ResultsA total of 609 AS and 406 PsA patients were included with a mean (SD) age of 43.1 (13.4) and 51.3 (12.3) years, respectively. EAMAS1 and EAMAS2 prevalence among AS patients was 33.9% and 25%, respectively, while among PsA patients EAMPsA prevalence was 45.4%.In univariate analysis, presence of EAMs in AS was associated with significantly higher disease activity, BDI total score, WLQ mental interpersonal demands (only for EAMAS1), WLQ physical demands, WLQ time demands, SF-12 physical function, SF-12 role physical, SF-12 bodily pain, SF-12 vitality, SF-12 mental health (only for EAMAS1), and the SF-12 physical component summary score (PCS). Among PsA patients, patients with EAMPsA had higher disease activity but no significant association was observed between EAMPsA and PROs.Upon adjusting for disease state, disease type, and ever smoking, presence of EAMAS1/EAMPsA for AS/PsA patients was associated with significantly higher BDI total score (14.0 vs. 12.6, p=0.046) and lower SF-12 physical function (38.4 vs. 44.8, p=0.047). When evaluating the impact of EAMAS2/EAMPsA for AS/PsA patients no significant differences were observed in PROs; however, BDI was notably higher among patients with EAMs (14.1 vs. 12.7, p=0.056).ConclusionsIn a Canadian routine clinical care setting, a substantial proportion of AS and PsA patients requiring a change in treatment report EAMs. Presence of EAMs, particularly psoriasis for AS patients, was found to be a significant independent predictor of depressive symptoms and reduce...