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BackgroundBiologic tumour necrosis factor inhibitors (TNFi) are often used in combination with a conventional DMARD (cDMARD), mostly methotrexate, for the treatment of psoriatic arthritis (PsA). To date, there are no randomised controlled trials showing the superiority of TNFi in combination with cDMARDs versus TNFi monotherapy in PsA.ObjectivesTo investigate the efficacy of open-label etanercept (ETN) in patients treated by rheumatologists with ETN monotherapy or ETN+cDMARD combination therapy.MethodsA prospective, non-controlled, non-interventional, multicenter, observational study of patients with active PsA was conducted to assess the safety and efficacy of ETN in clinical practice. Patients aged ≥18 years in whom treatment with branded ETN had been initiated were enrolled. Standard clinical outcomes were assessed at baseline and at 6 visits over 52 weeks. In this subgroup analysis, the impact of concomitant use of cDMARDs on the efficacy of ETN in all patients and in those with exclusively peripheral arthritis was assessed. The treatment target of modified minimal disease activity (mMDA) was achieved when patients met 5/6 of the following criteria: tender/swollen joint counts (T/SJC (0 or 1), body surface area (BSA) ≤3%, patient pain visual analogue scale (VAS) ≤15, patient disease activity VAS ≤20, and SF-12 physical function >45.ResultsA total of 1431 subjects were investigated; 576 in the subanalysis of exclusively peripheral arthritis. Baseline demographics were similar between the ETN and ETN+cDMARD groups. Baseline disease activity related to the joints was similar in both treatment groups but patients in the ETN group had higher BSA involvement than those receiving ETN+cDMARD (16.5% vs. 7.0%). Over 52 weeks, improvement of the affected BSA and disease activity in 28-joints (DAS28) was similar in the two treatment groups. No difference in BSA or DAS28 was seen between all patients and patients with peripheral arthritis only (Table 1). In the ETN vs. ETN+cDMARD group, 37.5% vs. 32.6%, respectively, of patients with peripheral-arthritis-only achieved mMDA.Table 1VisitBSA %DAS28 scoreETNETN+cDMARDETNETN+cDMARDAllPeripheralAllPeripheralAllPeripheralAllPeripheralBaseline11.9 (408)11.4 (287)6.7 (187)7.5 (162)5.0 (361)5.0 (253)4.9 (239)4.8 (147)210.6 (371)10.2 (257)6.6 (162)7.5 (144)–-––38.3 (399)7.7 (264)4.9 (160)5.2 (151)––––46.4 (392)5.7 (280)3.8 (168)3.5 (158)3.0 (318)2.9 (224)3.1 (222)3.0 (138)55.1 (395)4.5 (280)3.9 (141)3.0 (154)2.9 (316)2.8 (215)2.1 (215)2.9 (129)64.7 (359)4.1 (271)2.4 (115)2.8 (153)2.7 (266)2.7 (202)2.9 (191)2.9 (129)74.1 (344)4.0 (285)2.3 (113)2.6 (156)2.6 (261)2.7 (218)2.8 (188)2.8 (139)Data are mean (number of patients). ConclusionsIn this large prospective observational study of patients with active PsA treated with etanercept, no additional effect of concomitant cDMARD was seen on clinical efficacy. This was also confirmed in a peripheral-arthritis-only subgroup. High numbers of patients reached mMDA, independent of the additional use of cDMARDs.AcknowledgementsWe wish to thank al...

BackgroundSince approval of the first biologic (b) DMARDs for the treatment of rheumatoid arthritis (RA) in 2001, bDMARDs have been utilized to treat patients with severe disease. However, characteristics of patients treated with bDMARDs in the first years after approval differ substantially from those receiving bDMARDs nowadays.ObjectivesTo investigate which clinical parameters influence the decision of rheumatologists to start the 1st bDMARD treatment in patients with RA over the past 15 years.MethodsWe used data of a prospectively observed cohort of RA patients from the German biologics register RABBIT. Since 2001, patients have been enrolled at start of a conventional synthetic (cs)DMARD or bDMARD after ≥1 csDMARD failure. 13,568 RA patients were included until April 2015. After exclusion of patients with prior biologic treatment (n=2558), insufficient information on prior treatment (n=579) or inclusion in 2007/2008 (n=918), where no patients with csDMARD start were recruited, 9.513 patients remained for the analyses. They were stratified according to their year of inclusion in RABBIT (2001–2003, 2004–2006, and 2009–2015). We applied a machine learning method of model-based boosting to select clinical parameters which have a relevant impact on treatment decisions in each of the three episodes and compared the results with multiple logistic regression models.ResultsN=1781 biologic-naive patients were included during 2001–3, n=2781 in 2004–6 and n=4951 after 2008. The proportion of patients included with the start of a bDMARD was consistently between 60–62%. Patient characteristics at start of the first bDMARD changed over time. Mean disease duration decreased from 11.9 to 9.1 years, mean number of DMARD failures declined from 3.6 to 2.2 and mean disease activity (DAS28) fell from 6.0 to 5.0. The proportion of patients with osteoporosis declined from 24.5% to 11.9%.High disease activity (DAS28), prior DMARD failures and high doses of glucocorticoids (GC) were associated with starting a biologic treatment independent from the enrollment year. Over time, more patients with only moderate disease activity, lower doses of GC and positive rheumatoid factor as well as those with more severe comorbidities like heart failure and chronic renal disease were included in the bDMARD cohort. Male sex was associated with the start of bDMARD in 2001–2003 but the effect receded in recent years of enrollment.ConclusionsThe increasing use of biologics in patients with moderate disease activity and GC treatment shows that new treatment guidelines recommending earlier use during disease course to prevent further damage are realized in daily care practice. Growing knowledge and experience with biologics increasingly allows rheumatologists to treat also patients with serious comorbidities like heart failure.DisclosureRABBIT is supported by a joint, unconditional grant from AbbVie, Bristol-Myers Squibb, Celltrion, Hospira, MSD Sharp & Dohme, Pfizer, Roche, and UCB.Disclosure of InterestNone declared