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.
Assessing clinical response and defining minimal disease activity in plaque psoriasis with the Physician Global Assessment and body surface area (PGA × BSA) composite tool: An analysis of apremilast phase 3 ESTEEM data
