Please use this identifier to cite or link to this item:
http://hdl.handle.net/1942/1627
Title: | Etanercept and sulfasalazine, alone and combined, in patients with active rheumatoid arthritis despite receiving sulfasalazine: a double-blind comparison | Authors: | Combe, B. Codreanu, C. Fiocco, U. Gaubitz, M. GEUSENS, Piet Kvien, T. Pavelka, K; Sambrook, P. Smolen, J. Waydula, J. Fatenejad, S. |
Issue Date: | 2006 | Publisher: | Ovid | Source: | ANNALS OF THE RHEUMATIC DISEASES, 65(10). p. 1357-1362 | Abstract: | To compare the efficacy and safety of etanercept and sulfasalazine, alone and in combination, in patients with active rheumatoid arthritis despite sulfasalazine treatment.Methods: A double-blind, randomised study in adult patients with active rheumatoid arthritis despite stable sulfasalazine (2–3 g/day) treatment. The primary end point was a 20% response by the American College of Rheumatology (ACR) criteria at 24 weeks. Results: At baseline, the three treatment groups (sulfasalazine, n = 50; etanercept, n = 103; etanercept and sulfasalazine, n = 101) were comparable for demographic variables and disease activity. Lack of efficacy was the primary reason for discontinuation (sulfasalazine, n = 12; etanercept, n = 1; etanercept and sulfasalazine, n = 4; p<0.001). Significantly more patients receiving etanercept, alone or in combination (74% for each), achieved ACR 20 responses at 24 weeks than those receiving sulfasalazine (28%; p<0.01). Similarly, more patients in the etanercept groups achieved ACR 50 and ACR 70 responses than those in the sulfasalazine group (p<0.01). In the groups receiving etanercept, significant differences in the ACR core components were observed by week 2 compared with those receiving sulfasalazine alone (p<0.01). The incidences of several common adverse events (headache, nausea, asthenia) were lower with etanercept alone than with the combination (p<0.05), but infections and injection site reactions were higher with etanercept alone (p<0.05). The safety profiles of both etanercept treatment groups were comparable with previous experience of etanercept. Conclusions: For all efficacy variables assessed, etanercept alone or in combination with sulfasalazine resulted in substantial and similar improvement in disease activity from baseline to week 24 compared with sulfasalazine alone in patients with active rheumatoid arthritis despite their sulfasalazine treatment. All three treatments were generally well tolerated. | Keywords: | WEEK CLINICAL-TRIAL; QUALITY-OF-LIFE; COMBINATION THERAPY; SINGLE; COMPONENTS; FUNCTIONAL STATUS; FUSION PROTEIN; METHOTREXATE;; DISABILITY; MORTALITY; EFFICACY | Document URI: | http://hdl.handle.net/1942/1627 | ISSN: | 0003-4967 | e-ISSN: | 1468-2060 | DOI: | 10.1136/ard.2005.049650 | ISI #: | 000240508600016 | Category: | A1 | Type: | Journal Contribution | Validations: | ecoom 2007 |
Appears in Collections: | Research publications |
Show full item record
SCOPUSTM
Citations
93
checked on Sep 2, 2020
WEB OF SCIENCETM
Citations
92
checked on Oct 6, 2024
Page view(s)
52
checked on Jun 28, 2023
Google ScholarTM
Check
Altmetric
Items in DSpace are protected by copyright, with all rights reserved, unless otherwise indicated.