OBJECTIVE: To evaluate the tolerability, effectiveness and utilization of tocilizumab for the treatment of @entity309 in a usual care setting. METHODS: ROUTINE was a prospective, non-interventional, observational 52-week study performed at 174 sites throughout Germany. @entity309 @entity1 were selected and treated according to label. Study objectives included the targeted documentation of @entity281 , other adverse events, and various effectiveness outcomes (e.g. DAS28, clinical disease activity). Statistical analyses were performed primarily based on the data as observed. RESULTS: A total of 850 @entity1 (75% @entity1 , mean age: 56    13 years, mean @entity309 duration: 10.3    8.6 years) were enrolled. Most @entity1 (79%) were pretreated with TNF-inhibitors, whereas 21% were pretreated with conventional DMARDs only. Most common DMARD pretreatments were @entity6822 (79%), LEF (68%), adalimumab (53%) and etanercept (50%). At baseline, 60.5% of @entity1 received tocilizumab in combination with any other @entity309 drugs, while 39.5% were treated in monotherapy. Mean baseline DAS28 was 5.5    1.3, and this decreased to 2.6    1.6 at week 52. At week 52, good EULAR response was achieved in 62.3%, low disease activity state in 66.4%, and DAS28 remission in 55.1% of @entity1 (adjusted relative frequencies). 35.3% of @entity1 discontinued the study prematurely; common reasons were lack of effectiveness (10.5%) and intolerability (7.3%). Any @entity281 and severe @entity281 occurred in 37.6% and 7.2% of @entity1 , respectively (N = 836); serious @entity281 were seen in 5.3% (N = 850). Event rates of any, severe and serious @entity281 were 70.3, 9.8 and 4.4 events/100 @entity1 -years, respectively. CONCLUSION: Tocilizumab administered in a real-life setting showed clinically meaningful improvements and a safety profile that was consistent with data reported from pre-approval Phase III studies.

ROUTINE-a prospective, multicentre, non-interventional, observational study to evaluate the safety and effectiveness of intravenous tocilizumab for the treatment of active XXXX in daily practice in Germany.

@entity1 :: ('9606', 'Species') :: ['women', 'patients', 'patient'] @entity281 :: ('MESH:D007239', 'Disease') :: ['infections'] @entity6822 :: ('D008727', 'Chemical') :: ['MTX'] @entity309 :: ('MESH:D001172', 'Disease') :: ['RA']
@entity309 :: (MESH:D001172,Disease) :: ['rheumatoid arthritis']
