Objective: The objective of this study was to compare the effectiveness of a combination of tumour necrosis factor a (TNFa) inhibitors with either methotrexate or leflunomide in the treatment of patients with rheumatoid arthritis in a real-world setting. Methods: Data from 1769 outpatients enrolled in the German biologics register RABBIT who were treated with one of the TNFa inhibitors adalimumab, etanercept, or infliximab in combination with either methotrexate (n = 1375) or leflunomide (n = 394) were included in the analysis. Clinical status including disease activity as well as treatment data were documented by the treating rheumatologist at baseline and at 3, 6, 12, 18, 24, 30 and 36 months of follow-up. Results: Patients treated with a combination of biologics with leflunomide had significantly higher baseline disease activity than those treated with methotrexate. The highest disease activity was found for patients treated with the combination infliximab/leflunomide. After 36 months, the discontinuation rates were 46.3%, 51.3% and 61.5% for combinations of etanercept, adalimumab and infliximab with methotrexate and 53.4%, 63.1% and 67.1% for combinations with leflunomide, respectively. European League Against Rheumatism response rates after 24 months ranged from 74% to 81% for combinations with methotrexate and 72% to 81% for combinations with leflunomide. Conclusion: The current clinical practice is to use methotrexate as a first choice for the combination with TNFa antagonists. In a number of patients methotrexate has to be replaced by another disease-modifying antirheumatic drug. Our data support the view that leflunomide is a useful alternative if methotrexate is contraindicated.

This observational study assessed functional ability in patients treated with modified-release prednisone under conditions of normal clinical practice. Patients treated with modified-release prednisone were observed over 9 months. The primary outcome measure was the change from baseline total score using the Questionnaire on Activity Status (QAS); total QAS score ranges from 0 (severely impaired) to 100 (completely unimpaired). Other measures included Visual Analogue Scale (VAS) from 0 to 10 (where 10 = full daily performance) and Health Assessment Questionnaire Disability Index (HAQ-DI). There were no restrictions on dose of modified-release prednisone or use of concomitant therapy. A total of 1,733 patients were included in the study, with valid observations at baseline and study end for 1,185 patients (thereof 74 % female, median age 59 years, median disease duration 5 years). Mean total QAS score improved significantly after 9 months of treatment with modified-release prednisone from 54.3 to 70.2 (p < 0.001). There were also significant (p < 0.001) improvements in all three QAS dimensions (occupational performance: 66.6-78.9; household duties: 55.6-70.9; leisure activities: 51.6-69.4), daily performance (mean VAS 5.1-7.0; p < 0.001) and mean HAQ-DI score (1.35-1.00; p < 0.001). Dose of modified-release prednisone was significantly reduced (from 5.0 to 4.4 mg/day, p < 0.001) and fewer patients required biological rheumatoid arthritis (RA) treatments, analgesia and gastroprotectants. Functional ability in patients with RA improved significantly from baseline after 9 months of treatment with modified-release prednisone. This observational study, conducted under daily-practice conditions, confirms the beneficial effects of modified-release prednisone shown previously in randomised controlled trials.

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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