AB0935 Canadian adalimumab post-marketing observational epidemiological study assessing the effectiveness of adalimumab vs non-biologic dmards in psoriatic arthritis (COMPLETE-PSA): 12-month effectiveness data
Authors: M. Khraishi, L. Bessette, A. Chow, B. Haraoui, V. Pavlova, J. Stewart, V. Remple
Journal: Annals of the Rheumatic Diseases (2018)

<h3>Background</h3> To date, observational studies comparing the effectiveness of adalimumab (ADA) to non-biologic DMARDs (nbDMARD) in psoriatic arthritis (PsA) patients failing prior treatment are scarce. COMPLETE-PSA is a Canadian post-marketing observational study which assessed real-life effectiveness of ADA and non-biological therapies (NSAIDs and DMARDs) in PsA management following initial treatment failure. <h3>Objectives</h3> This analysis aimed to describe the baseline demographic and disease parameters of patients initiating nbDMARD or ADA and compare the 12 month real-life effectiveness of both treatments. <h3>Methods</h3> Patients eligible for COMPLETE PsA are anti-TNFα naïve adults, with active PsA who require change in their treatment regimen, per the judgment of the treating physician. In the current analysis patients enrolled during Jul/2011–Jun/2016 were included. Outcome measures analysed were: DAS28, SF-12, DLQI, presence of extra-articular manifestations (EAMs; enthesitis and dactylitis), psoriasis BSA, achievement of modified MDA (defined as achievement of [i] 4 of 6 (MDA 1) and [ii] 5 of the following 6 criteria (MDA 2): TJC ≤1, SJC ≤1, BSA ≤3%, pain VAS≤15 mm, PtGA ≤20 and HAQ ≤0.5), modified remission (defined as SJC=0, TJC=0, absence of enthesitis and dactylitis, BSA ≤3% and HAQ ≤0.5), DAPSA LDA (≤14), and DAPSA remission (REM;≤4). Analyses were conducted by initial group assignment (intent-to-treat approach). <h3>Results</h3> 406 patients were included (nbDMARD n=146, ADA n=260). Baseline demographics were comparable between treatment groups. However, patients initiating ADA were more likely to be unemployed (47.3% ADA vs 34.9% nbDMARD, p<i>=</i>0.015), had higher DAS28 (4.8 vs 4.4, p=0.002) and total DLQI score (6.1 vs 4.3, p=0.007), and were more likely to have BSA ≥3% (44.6% vs 35.0%, p=0.063) and high DAPSA disease activity (50.8% vs 32.3%, p=0.015). A higher proportion of nbDMARD patients had dactylitis (36.1% vs 25.3%, p=0.023). No differences were observed between groups in enthesitis, overall EAMs, or QoL at baseline. Upon 12 months of treatment, mean adjusted DAS28 (2.6 vs 3.4, p&lt;0.001) and DLQI (2.2 vs 2.9, p=0.530) scores, but not SF-12, were lower in the ADA group. Furthermore, although statistical significance was not always met, patients treated with ADA had lower DAPSA score (p=0.025) (LDA/REM: 64.9% vs 58.6%; REM: 37.7% vs 17.1%), were more likely to be in modified remission (14.7% vs 9.7%, p=0.311), and to have mMDA (mMDA 1: 15.6% vs 12.6%, p=0.529; mMDA 2: 17% vs 11.5%, p=0.253) and BSA &lt;3% (89.3% vs 83.9%, p=0.207). Also, EAM prevalence decreased in both groups but was significantly lower in the ADA group (17.4% vs 35.8%, p&lt;0.001). Over time, 9.6% of ADA patients initiated another biologic and 32.2% of patients in the nbDMARD group initiated biologic treatment (p&lt;0.001). <h3>Conclusions</h3> PsA patients initiating ADA in Canadian routine clinical care have significantly greater baseline disease severity compared with those initiating nbDMARDs. However, 12 month ADA treatment improved disease control and EAMs. DAPSA-REM evaluation seems more sensitive than mMDA in differentiating both populations. <h3>Acknowledgements</h3> JSS Medical Research, Montreal, Canada <h3>Disclosure of Interest</h3> M. Khraishi Consultant for: AbbVie, Speakers bureau: AbbVie, L. Bessette 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, A. Chow Consultant for: AbbVie, Amgen, BMS, Celgene, Janssen, Lilly, Merck, Novartis, Pfizer, Roche, Speakers bureau: AbbVie, BMS, Janssen, Pfizer, Takeda, B. Haraoui Grant/research support from: AbbVie, Amgen, BMS, Janssen, Pfizer, Roche, and UCB, Consultant for: AbbVie, Amgen, BMS, Celgene, Eli Lilly, Janssen, Merck, Pfizer, Roche, and UCB, Speakers bureau: Amgen, BMS, Janssen, Pfizer, and UCB, V. Pavlova Consultant for: Amgen, Abbvie, BMS, Janssen, Lilly, Merk, Novartis, Roche, UCB, Pfizer, Speakers bureau: Amgen, Abbvie, BMS, Janssen, Lilly, Merk, Novartis, Roche, UCB, Pfizer, J. Stewart Consultant for: Pfizer, Abbvie, Amgen, Celgene, Roche, Novartis, V. Remple Shareholder of: AbbVie, Employee of: AbbVie