Abstract
The aim of this study was to evaluate the clinical outcomes of etanercept in rheumatoid arthritis (RA) patients with moderate or severe disease activity. We analyzed data from the Italian biologics register Gruppo Italiano Studio Early Arthritides (GISEA) to investigate the rate of disease remission and functional improvement, based on the 28-Joint Disease Activity Score (DAS28) and the (Health Assessment Questionnaire (HAQ) score in RA patients with moderate or severe disease activity beginning etanercept therapy. Disease was defined as severe (H-RA) with DAS28 ≥5.1 and moderate (M-RA) with DAS28 ≥3.2 to 5.1 at baseline. Patients were considered in remission if DAS28 was ≤2.6, and HAQ ≤0.5 defined normal function. We enrolled 953 RA patients, 320 with M-RA and 633 H-RA. Age and disease duration were similar in the two cohorts, but H-RA patients had significantly more comorbidities (p < 0.01) and took significantly more disease-modifying antirheumatic drugs (p < 0.001) than M-RA patients. After 1 year, the percentage of patients achieving disease remission and normal function (DAS28 ≤2.6 plus HAQ ≤0.5) was higher in M-RA (21.4 %) than in H-RA patients (14.8 %, p = 0.007), regardless of the disease duration. Additionally, female gender (p = 0.006) and H-RA class (p = 0.002) negatively predicted disease remission at 1 year. However, the drug survival rate did not differ between the two subsets. This study confirms that etanercept was effective in the treatment of active RA, but best response, in terms of disease remission and normal function ability, was greater and easier to attain in M-RA patients. These findings may aid clinicians to choose the best strategy to treat RA.
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Florenzo Iannone has received consulting fees, speaking fees, or honoraria (less than €10,000) from Pfizer, Merck, Abbott, and Bristol-Myers Squibb.
Pfizer Italia Srl gave a financial support to CD Pharma Group Srl to extrapolate the clinical data from the GISEA register. The authors kept their independence in designing the study, interpreting the data, and writing the manuscript.
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Trial registry no. NCT01543594
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Gruppo Italiano di Studio sulle Early Arthritides (GISEA): Crescenzio Scioscia, Anna Laura Fedele, Gianfranco Ferraccioli, Fabiola Atzeni, Sara Bongiovanni, Leonardo Punzi, Livio Bernardi, Valentina Bagnari, Marcello Govoni, Walter Grassi, Fausto Salaffi, Stefania Manganelli, Elena Frati, Antonio Carletto, Cristian Caimmi, Alice Palloni, Laura Niccoli, Clodoveo Ferri, Ennio Giulio Favalli, Giovanni Triolo, Marcella Di Gangi
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Iannone, F., Gremese, E., Gallo, G. et al. High rate of disease remission in moderate rheumatoid arthritis on etanercept therapy: data from GISEA, the Italian biologics register. Clin Rheumatol 33, 31–37 (2014). https://doi.org/10.1007/s10067-013-2348-6
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DOI: https://doi.org/10.1007/s10067-013-2348-6