23. Etanercept in Early RA: HAQ-DI Scores at 24 Months ≥ 0.5 Improvement ≥ 1.0 Improvement % of Patients 0 10 20 30 40 50 60 37 * 55 25 29 Etanercept 25 mg MTX 20 mg Etanercept 25 mg MTX 20 mg 70 * P 0.001 Genovese MC, et al. Arthritis Rheum . 2002;46:1443 – 1450.
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26. TEMPO: Infections and Serious Infections Etanercept + Methotrexate (at 52 Weeks) *Fisher exact test; †No incidence of tuberculosis was noted in any treatment group. Klareskog L. Data presented at EULAR. Lisbon, Portugal, June 2003. 1.00 10 (4.3%) 10 (4.5%) 10 (4.4%) Serious infections 0.19 158 (68.4%) 134 (60.1%) 148 (64.9%) Any infection † P value* MTX + Etanercept (n = 231) Etanercept (n = 223) MTX (n = 228) Number of patients
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Notas do Editor
More than two thirds of the patients in Study DE010 (68%) achieved an ACR-20 response in the first year of treatment with HUMIRA® (adalimumab) and methotrexate (MTX), and 30% achieved an ACR-50 response. 1 ACR-20 response rates of >60% were sustained over 5 years of treatment. The ACR‑50 response rate increased over the first 3 years of treatment from 30% to 50%, and this rate was maintained through 5 years of treatment. Similarly, the ACR-70 response rate increased from 8% after 1 year of treatment to 28% after 3 years of treatment, and this rate was maintained through the fifth year of treatment. As suggested by the high and sustained ACR-20 and ACR-50 response rates and the patient retention rate of 68% after 5 years of treatment in this trial, most patients in this study exhibited significant levels of improvement in most clinical assessments of the signs and symptoms of rheumatoid arthritis, and dramatic improvements were observed in a number of patients. For example, the mean tender joint count at baseline was 12 and the mean swollen joint count at baseline was 15. At the end of 5 years of treatment, 23% of the patients in the study had 2 tender and swollen joints, and 8% of the patients had no tender or swollen joints. The disability index scores on the Health Assessment Questionnaire (HAQ-DI) decreased from a mean of 1.4 at baseline to 1.0 after 4 years of treatment. At year 5 of the study, 23% of the patients had HAQ-DI scores of 0.5. To put this in perspective, a population-based survey of more than 1,700 subjects demonstrated that the mean HAQ-DI score for individuals at high risk for health problems was approximately 1.0 and the mean score for individuals at low risk for health problems was approximately 0.5. 2 References 1. Breedveld FC, Rau R, van Riel PLC, et al. Sustained efficacy over 5 years with adalimumab (HUMIRA) in patients with active rheumatoid arthritis . Arthritis Rheum . 2003;48(Suppl):S118 [Abstract 198]. 2. Vita AJ, Terry RB, Hubert HB, et al. Aging, health risks, and cumulative disability . N Engl J Med . 1998;338:1035-1041.
