AB0303 Tocilizumab in rheumatoid arthritis – annual interim analysis of the german non-interventional study ichiban

Background The ICHIBAN study collects routine clinical data to evaluate the effectiveness and safety of tocilizumab (TCZ) in patients with rheumatoid arthritis (RA) in real world practice over a period of 2 years. Methods The start of this prospective, non-interventional study was in February 2010. The target recruitment is 4000 patients. Clinical data of RA patients, their therapies, therapeutic responses, patient reported outcomes and adverse events are collected in the process of normal practice using an online database with structured web forms. Results As of 1st December 2012, baseline data for 1895 patients were available. In 490 of these patients the observation period was at least 76 weeks under TCZ treatment, or treatment was interrupted or changed (analysis was performed according to LOCF method). The total TCZ exposure was 2299.8 patient years. 74.9% of the 1895 patients were female, the mean age was 56.3 years. Mean duration of RA was 10.0 years and baseline DAS28 was 5.1. 72.0% of the patients had concomitant diseases. 69.8% were pre-treated with TNF-alpha inhibitors, 28.0% exclusively with synthetic DMARDs. At baseline 40.1% of TCZ-treated patients did not receive any additional DMARD, while 46.0% were treated in combination with MTX. At W76, 34.0% of the patients (n=149/438) achieved DAS28 remission (