on behalf of the BIOBADASER GroupObjective. The long-term safety of therapeutic agents that neutralize tumor necrosis factor (TNF) is uncertain. Recent evidence based on spontaneous reporting shows an association with active tuberculosis (TB). We undertook this study to determine and describe the long-term safety of 2 of these agents, infliximab and etanercept, in rheumatic diseases based on a national active-surveillance system following the commercialization of the drugs.Methods. We analyzed the safety data actively collected in the BIOBADASER (Base de Datos de Productos Biológicos de la Sociedad Española de Reumatología) database, which was launched in February 2000 by the Spanish Society of Rheumatology. For the estimation of TB risk, the annual incidence rate in patients treated with these agents was compared with the background rate and with the rate in a cohort of patients with rheumatoid arthritis (RA) assembled before the era of anti-TNF treatment.Results. Seventy-one participating centers sent data on 1,578 treatments with infliximab (86%) or etanercept (14%) in 1,540 patients. Drug survival rates (reported as the cumulative percentage of patients still receiving medication) for infliximab and etanercept pooled together were 85% and 81% at 1 year and 2 years, respectively. Instances of discontinuation were essentially due to adverse events. Seventeen cases of TB were found in patients treated with infliximab. The estimated incidence of TB associated with infliximab in RA patients was 1,893 per 100,000 in the year 2000 and 1,113 per 100,000 in the year 2001. These findings represent a significant increased risk compared with background rates. In the first 5 months of 2002, after official guidelines were established for TB prevention in patients treated with biologics, only 1 new TB case was registered (in January). Conclusion. Therapy with infliximab is associated with an increased risk of active TB. Proper measures are needed to prevent and manage this adverse event.

The aim of our study was to analyse the characteristics of haematogenous vertebral osteomyelitis (HVO) in the elderly. A retrospective comparative analysis of the medical records of 72 patients (38 younger than 63 years, group 1, and 34 aged 63 years and over, group 2) with haematogenous vertebral osteomyelitis of confirmed aetiology was carried out. Intravenous drug addiction and infection with the human immunodeficiency virus were seen in 4/38 (10%) and 5/38 (13%) patients from group 1 and 0/34 patients (0%) from group 2 (P = 0.05 and 0.035, respectively). Seven of 34 elderly (20%) and 0/38 (0%) young individuals had recently had surgery (P = 0.0036). Escherichia coli was isolated in 7/34 elderly (20%) and 0/38 (0%) young patients (P = 0.0036). The remaining studied data did not reach statistical significance. Recent surgery is a risk factor for developing HVO in the elderly, the urinary tract being the source of the pathogen in a large number of elderly patients with spinal infection.

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We present an update on the SER recommendations for the use of biologic therapy in patients with RA.