ADALIMUMAB (HUMIRA®) THERAPY FOR PATIENTS WITH RHEUMATOID ARTHRITIS (RA): IMPACT OF BASELINE CHARACTERISTICS ON THERAPEUTIC SUCCESS FROM A GERMAN NON-INTERVENTIONAL STUDY

Background: TNF antagonists are effective and safe for substantial percentages of patients with various rheumatic diseases (RA, PsA and AS). In Germany, tumor necrosis factor (TNF) antagonists are recommended and commonly used for the treatment of moderate to severe rheumatoid arthritis (RA) after patients have failed (for lack of efficacy or intolerance) ≥2 traditional disease-modifying antirheumatic drugs (DMARDs), one of which must have been methotrexate (MTX). Objectives: In a non-interventional study (NIS), we evaluated the effectiveness and safety of adalimumab in RA patients under conditions of routine rheumatology practice in Germany. In addition, the impact of patient and disease characteristics on adalimumab's effectiveness was evaluated. Methods: Patients with RA receiving adalimumab (ADA) were regularly evaluated in a multi-centre prospective NIS for 5 years. Patients received ADA according to label (40 mg every other week). According to the recommendation of the German Society of Rheumatology, efficacy and safety parameters were evaluated routinely at baseline and after 3, 6, 12, 18, and 24 months of therapy. Physical function was assessed by the Hannover Functional Status Questionnaire (FFbH), an 18-item, patient self-questionnaire (scores range from 0% to 100%; 0%=worst functional status, 100%=best functional status). Results: Data from an interim analysis (Aug. 2007) are presented here (4,640 patients enrolled from 490 sites, with 24-month data available for 824 patients). After 2 years of ADA therapy, mean DAS28 scores improved from 5.8 at baseline to 3.8, while physical function improved (change in mean FFbH from 58.2 percentage points to 67.4). Baseline DAS28 and FFbH values had the greatest impact on therapeutic success. Further significant predictors of the therapeutic success were — among others — the number of previous therapies with other TNF inhibitors, number of tender joints, age, sex, and concomitant MTX. Patient and disease characteristics at baseline and after 24 months of ADA therapy* Baseline N=4,64024 Months N=824 Age [years]54.5±12.7 Disease Duration [years]11.9±9.4 Females [%]77.3 DAS285.8±1.33.8±1.4 SJC9.6±6.43.3±4.4 TJC12.2±7.44.4±5.7 FFbH [%]58.2±23.467.4±24.2 *All values are mean values unless otherwise indicated. Conclusion: Adalimumab reduces disease activity and leads to clinically relevant improvements in physical function in patients. This therapeutic success was impacted by patients and disease characteristics, such as degree of disease activity at baseline, sex, age, and number of prior anti-TNF therapies. Disclosure of Interest: H. Tony, Investigator, Abbott-sponsored study K. Babinsky, Investigator, Abbott-sponsored study J. Georgi, Investigator, Abbott-sponsored study R. Dockhorn, Investigator, Abbott-sponsored study K. Lüthke, Investigator, Abbott-sponsored study F. Klein, Abbott, Employee G. Greger, Abbott, EmployeeCitation: Annals of the Rheumatic Diseases, volume 68, supplement 3, year 2009, page 395Session: Rheumatoid arthritis Prognosis, predictors and outcome (Poster Presentations )