POS0192 PROGNOSTIC FACTORS ASSOCIATED WITH ACHIEVING MINIMAL DISEASE ACTIVITY IN EARLY PSORIATIC ARTHRITIS PATIENTS

Background:The goal of treat to target strategy (T2T) in psoriatic arthritis (PsA) is attaining remission or minimal disease activity (MDA). The benefits of T2T have been seen recently [1]. But prognostic factors for MDA achievement in PsA patients (pts) at an early-stage hasn’t been studied yet.Objectives:to determine the prognostic factors associated with MDA achievement within 12 months (mos.) of treatment according to T2T strategy in early PsA pts.Methods:77 pts (M/F=36/41) with early active PsA fulfilling the CASPAR criteria were included. Mean age 36.9±10.45 years (yrs.), PsA duration 11.1±10.0 mos., Psoriasis (PsO) duration 82.8±92.1 mos. At baseline (BL) and at 12 mos. of therapy PsA activity by tender joint count (TJC)/68, swelling joint count (SJC)/66, Pain (VAS), Patient global assessment disease activity (PtGA, VAS), CRP mg/l, dactylitis, enthesitis by LEI and plantar fascia, BSA (%), HAQ and fatigue by FACIT (Functional Assessment of Chronic Illness Therapy) Fatigue Scale (Version 4) were evaluated. A score FACIT <30 indicates severe fatigue and > 30 – less fatigue. All pts was given therapy with Methotrexate (MTX) s/c. After 3-9 mos. of ineffectiveness of MTX treatment 29 pts were given biologic DMARDs. By 12 mos. of therapy, the proportion of pts who had reached MDA (5/7) were calculated. Pts were split into 2 groups: MDA + (n=45) and MDA - (n=32). The one-factor model of logistic regression was used to identify a group of features that are associated with MDA achievement. M±SD, Me [Q25; Q75], Min-Max, %, t-test, Pierson-χ2, Manna-Whitney tests, ORs with 95% CI were performed. All p<0.05, were considered to indicate statistical significance.Results:Comparative analysis in both groups and one-factor model of logistic regression showed the following features at BL were associated with MDA achievement: TJC/SJC < 3 (p<0.001), PGA ≤ 20 mm (p<0.001), Pain (VAS) ≤ 15 mm (p<0.001), CRP ≤ 5 mg/l (p< 0.03), HAQ ≤ 0.5 (p< 0.001), FACIT > 30 (p< 0.021), absent of entesitis (p< 0.003), dactylitis (p< 0.029) and nail damage (p< 0.012). Early PsA pts with combination of these features at first visit have more chance to achieve MDA within 12 mos in comparison to PsA pts without them, OR=9.684 [CI 95% 4.6-20.4]. (Figure 1).Conclusion:It is a combination of features at first visit to clinic – TJC, SJC < 3, PGA ≤ 20 mm, pain ≤ 15 mm, CRP ≤ 5 mg/l, HAQ ≤ 0.5, FACIT > 30 points, absent of entesitis, dactylitis and nail PsO - that constitutes a clinical prognostic factors for MDA achievement within 12 mos of T2T strategy in early PsA pts.References:[1]Coates LC, et al. Lancet. 2015 Dec 19;386(10012):2489-98. doi: 10.1016/S0140-6736(15)00347-5Figure 1.The prognostic factors associated with achievement MDA within 12 months in early PsA ptsDisclosure of Interests:None declared

AB0558 CLINICAL EFFECTIVENESS AND SAFETY OF ADALIMUMAB VERSUS NON-BIOLOGIC THERAPY IN PSORIATIC ARTHRITIS PATIENTS OVER 24 MONTHS – RESULTS OF THE COMPLETE-PsA CANADIAN OBSERVATIONAL STUDY

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.

Outcome of children with oligoarticular juvenile idiopathic arthritis compared to polyarthritis on methotrexate- data of the German BIKER registry

Background Oligoarticular juvenile idiopathic arthritis (oligoJIA) is the most commonly diagnosed category of chronic arthritis in children. Nevertheless, there are no evidence- based guidelines for its treatment, in particular for the use of methotrexate (MTX). The primary objective of this analysis is to evaluate the outcomes in patients with persistent oligoJIA compared to those with extended oligoJIA and rheumatoid factor (RF) negative polyarthritis treated with methotrexate. Methods Patients with persistent or extended oligoJIA or RF negative PA recorded in the Biologics in Pediatric Rheumatology Registry (BiKeR), receiving methotrexate for the first time were included in the analyses. Efficacy was determined using the Juvenile Arthritis Disease Activity Score 10 (JADAS 10). Safety assessment included the documentation of adverse and serious adverse events. Results From 2005 through 2011, 1056 patients were included: 370 patients with persistent oligoJIA, 221 patients with extended oligoJIA and 467 patients with RF negative PA. Therapeutic efficacy was observed following the start of methotrexate. Over a period of 24 months JADAS-minimal disease activity (JADAS ≤2) was reached in 44% of patients with persistent oligoJIA, 38% with extended oligoJIA, 46% with RF negative PA, JADAS-remission defined as JADAS ≤1 was reached in 33% of patients with persistent oligoJIA, 29% with extended oligoJIA and 35% (RF negative PA). Patients with extended oligoJIA achieved JADAS remission significantly later and received additional biologic disease-modifying drugs significantly more often than patients with persistent oligoJIA or RF negative PA (p < 0.001). Tolerability was comparable. New onset uveitis occurred in 0.3 to 2.2 per 100 patient years. Conclusions Patients with persistent oligoJIA taking methotrexate are at least as likely to enter remission as patients with extended oligo JIA or polyarticular JIA. Patients with extended oligoJIA achieved JADAS remission significantly later. Within 2 years, almost half of the patients with persistent oligoJIA achieved JADAS-minimal disease activity.

Achievement of minimal disease activity in psoriatic arthritis according to the time of administration of synthetic disease-modifying antirheumatic drugs, a comparative analysis of the efficacy of oral and subcutaneous methotrexate. Data from the All-Russian Psoriatic Arthritis Registry

The goal of psoriatic arthritis (PsA) therapy is to achieve remission or minimal disease activity (MDA). According to the EULAR guidelines, synthetic disease-modifying antirheumatic drugs (sDMARDs), methotrexate (MTX) in particular, are first-line therapy for PsA.Objective: to study the rate of MDA achievement after initiation of sDMARD therapy in patients with early- and late-stage PsA and the efficacy of oral and parenteral MTX.Patients and methods. The investigation enrolled 253 patients (93 men and 160 women) diagnosed with PsA who met the appropriate 2006 CASPAR (ClASsification criteria for Psoriatic ARthritis) criteria and were recorded in the All-Russian PsA Registry. The median (Me) age was 47 (Min 20 – Max 82) years. All the patients took sDMARDs: MTX (n=211) that was received orally (as tablets) (n=102) and parenterally (n=109); leflunomide (n=7); sulfasalazine (n=24); apremilast (n=10); and tofacitinib (n=1). According to the disease duration at sDMARD treatment initiation, the patients were divided into two groups. Group 1 included 165 patients with an early PsA duration of less than 2 years and Group 2 consisted of 88 patients with a disease duration of >2 years. The efficiency of oral and parenteral MTX was evaluated in 182 patients (68 men and 114 women). Every 6 months, the patients underwent a standard rheumatology examination that included PsA activity assessment. The efficiency of MTX therapy was evaluated from MDA achievement (5 out of the 7 criteria) in the patients.Results and discussion. After sDMARD prescription, MDA was achieved in 39 (24%) of the 165 patients with early PsA and in 4 (5%) of the 88 long-term patients. The patients who started sDMARD at an early stage of the disease were significantly more likely to achieve MDA than those with late-stage PsA (odds ratio (OR) 6.5; 95% confidence interval (CI) 2.2–18.9). At 11 years after sDMARD therapy initiation, the cumulative MDA achievement rate in the patients with late-stage disease was 5% (p<0.05). MDA was achieved by 16.5% of the 182 patients receiving oral or subcutaneous MTX. MDA was observed in 25 (31%) patients who received parenteral MTX and in only 5 (5%) patients who took oral MTX. The patients who received parenteral MTX were significantly more likely to achieve MDA than those who took oral MTX as tablets (OR 8.8; 95% CI 3.2–24.3). Following 27-month parenteral MTX therapy, the cumulative rate of MDA achievement was 48%, whereas after oral MTX treatment, that was 7% (p<0.05). In the patients who achieved MDA, the mean dose of parenteral MTX was 17 mg/week, and in those who failed, that was 15 mg/week. The mean dose of oral MTX was 15 mg/week, regardless of MDA achievement.Conclusion. The administration of sDMARD at an early stage of PsA lasting less than 2 years allows MDA to be achieved significantly more often and faster than at later stages of the disease. Among sDMARDs, preference is mostly given to the use of MTX in real clinical practice; the treatment with the latter enables 16.5% of patients to achieve MDA. Parenteral MTX significantly enhances the efficiency of therapy and can achieve MDA in almost one third (31%) of patients.