Data from 166 patients who had completed 6 months of anakinra (Kineret, r-metHuIL-1Ra) therapy under the conditions of daily clinical practice showed an efficacy and safety profile comparable to the data known from clinical trials. Patients significantly responded as early as 1 month following initiation of therapy. The data suggest that anakinra may also be effective in patients who have failed tumor necrosis factor (TNF)-blocking agents. Injection-site reactions were reported less frequently than in clinical trials, indicating that these reactions seem to require less therapeutic attention under non-clinical trial conditions.