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Article Less radiographic progression with adalimumab plus methotrexate versus methotrexate monotherapy across the spectrum of clinical response in early rheumatoid arthritis. 2009
Emery P, Genovese MC, van Vollenhoven R, Sharp JT, Patra K, Sasso EH. · Leeds Teaching Hospital, Rheumatology, Leeds, United Kingdom. · J Rheumatol. · Pubmed #19369462 No free full text.
Abstract: OBJECTIVE: To determine the relationship between radiographic progression and clinical response for adalimumab plus methotrexate (MTX) versus either monotherapy in patients with early rheumatoid arthritis (RA) in the PREMIER study. METHODS: Patients with early RA who received adalimumab plus MTX (n = 240), adalimumab (n = 222), or MTX (n = 216) were grouped by American College of Rheumatology (ACR) response, 28-joint Disease Activity Score (DAS28), or remission-like state [tender joint count (TJC) = 0; DAS28 < 2.6; swollen joint count = 0; ACR100] at 26 and 104 weeks. Radiographic progression was assessed by cumulative probability plots, mean changes in total Sharp score (DeltaTSS), and percentages of progressors (DeltaTSS > 0.5). RESULTS: Across the spectrum of clinical outcomes, including ACR20 nonresponses and remission-like responses, therapy with adalimumab plus MTX permitted less radiographic progression at Weeks 26 and 104 than MTX monotherapy. Adalimumab monotherapy was generally intermediate. A strong, proportional relationship was observed between clinical response and radiographic efficacy only for MTX monotherapy. The monotherapies approximated the radiographic efficacy of adalimumab plus MTX only among remission-like responders, although progression was significantly greater with MTX monotherapy versus adalimumab plus MTX for patients with TJC = 0. Concurrent clinical (DAS28 < 2.6) and radiographic (DeltaTSS <or= 0.5) remission was significantly more frequent at Week 104 with adalimumab plus MTX (45%) than with adalimumab (25%) or MTX (18%) monotherapy. CONCLUSION: In patients with early RA, adalimumab plus MTX resulted in less radiographic progression than MTX monotherapy across the spectrum of clinical response, including ACR20 non-responses and remission-like responses.
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Article Adalimumab response in patients with early versus established rheumatoid arthritis: DE019 randomized controlled trial subanalysis. 2009
Jamal S, Patra K, Keystone EC. · University of Toronto, 30 Bond Street, Toronto, ON M5B 1W8, Canada. · Clin Rheumatol. · Pubmed #19067101 No free full text.
Abstract: In recent years, there has been a shift in the therapeutic approach to rheumatoid arthritis (RA), with emphasis on early therapy. The DE019 trial demonstrated adalimumab efficacy in patients with RA. This subanalysis compares response to adalimumab based on clinical, functional, and radiographic outcomes in patients with early versus established RA. Patients enrolled in the DE019 trial were divided into two groups based on disease duration (<or=3 years=early RA; >3 years=established RA). Data from 407 patients with RA were included, with 78 early (41 adalimumab, 37 placebo) and 329 established (166 adalimumab, 163 placebo) patients. Patients with early disease achieved slightly greater American College of Rheumatology 20 (20% or more improvement or ACR20), 50, and 70 responses of 61%, 46.3%, and 24.4%, respectively, at 52 weeks, compared with those with established disease, with ACR20, 50, and 70 responses of 56%, 37.3%, and 19.9%, respectively. The Health Assessment Questionnaire score improvement between adalimumab and placebo in patients with early disease (0.44) was greater than that for those with established disease (0.25). With adalimumab treatment, there was a statistically significant mean reduction in total Sharp score progression relative to placebo (5.32) in early disease compared with established disease (2.06). While adalimumab is effective for RA of all disease durations, there is a trend toward superior clinical, functional, and radiographic outcomes in patients with early disease.
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