ABSTRACT
OBJECTIVE: The Trial of Etanercept and Methotrexate with Radiographic Patient Outcomes (TEMPO) is a 3-year, double-blind, multicenter study evaluating the efficacy and safety of etanercept, methotrexate, and the combination of etanercept plus methotrexate in patients with active rheumatoid arthritis (RA). The results after 1 and 2 years of the study have been previously reported. Here we provide the 3-year clinical and radiographic outcomes and safety of etanercept, methotrexate, and the combination in patients with RA. METHODS: In this randomized, double-blind, multicenter TEMPO study, 682 patients received etanercept 25 mg twice weekly, methotrexate < or =20 mg weekly, or the combination. Key efficacy assessments included the Disease Activity Score (DAS) and the DAS in 28 joints. RESULTS: Combination therapy resulted in significantly greater improvement in the DAS and in more patients with disease in remission than either monotherapy. This finding was confirmed by longitudinal analysis; patients receiving combination therapy were more than twice as likely to have disease in remission than those receiving either monotherapy. Independent predictors of remission included male sex, lower disease activity, lower level of joint destruction, and/or better physical function. Combination and etanercept therapy both resulted in significantly less radiographic progression than did methotrexate (P < 0.05). Etanercept and combination treatment were well tolerated, with no new safety findings. CONCLUSION: Etanercept plus methotrexate showed sustained efficacy through 3 years and remained more effective than either monotherapy, even after adjustment for patient withdrawal. Combination therapy for 3 years led to disease remission and inhibition of radiographic progression, 2 key goals for treatment of patients with RA.
Subject(s)
Antirheumatic Agents/therapeutic use , Arthritis, Rheumatoid/diagnostic imaging , Arthritis, Rheumatoid/drug therapy , Immunoglobulin G/therapeutic use , Methotrexate/therapeutic use , Receptors, Tumor Necrosis Factor/therapeutic use , Antirheumatic Agents/adverse effects , Arthritis, Rheumatoid/physiopathology , Disability Evaluation , Double-Blind Method , Drug Therapy, Combination , Etanercept , Female , Humans , Immunoglobulin G/adverse effects , Longitudinal Studies , Male , Methotrexate/adverse effects , Multivariate Analysis , Radiography , Remission Induction , Severity of Illness Index , Treatment OutcomeABSTRACT
BACKGROUND: The objective of this study was to evaluate the prevalence of osteoporosis and osteopenia in Czech women and men aged 50 to 75 years. METHODS AND RESULTS: Bone mineral density was assessed in an age-stratified random sample of 713 women and 429 men from two cities (Prague and Litomerice) in the lumbar spine, proximal femur and total body by dual X-ray absorptiometry and in the distal forearm by single X-ray absorptiometry. The proportion of women and men in each age group with bone density below specified levels at any of these skeletal sites was projected to the population structure of the Czech Republic. With advancing age, in women at 55 years and in men at 65 years of age the population with normal bone mineral density becomes smaller, and a greater proportion has osteopenia or osteoporosis. Overall, an estimated 428,000 women and 195,000 men over age 50 have osteoporosis and another 680,000 women and 435,000 men have osteopenia. CONCLUSIONS: The results of this first population-based cross sectional study in the Czech Republic document a high prevalence of osteoporosis and osteopenia which is comparable with that published for the Netherlands and the United States. The results offer a basis for economical considerations in diagnosis, treatment and consequences of osteoporosis.
