OBJECTIVE: 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 theirsulfasalazine treatment. All three treatments were generally well tolerated.
RCT Entities:
OBJECTIVE: 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.
Authors: Lars Klareskog; Désirée van der Heijde; Julien P de Jager; Andrew Gough; Joachim Kalden; Michel Malaise; Emilio Martín Mola; Karel Pavelka; Jacques Sany; Lucas Settas; Joseph Wajdula; Ronald Pedersen; Saeed Fatenejad; Marie Sanda Journal: Lancet Date: 2004-02-28 Impact factor: 79.321
Authors: Daniel E Furst; Michael H Schiff; Roy M Fleischmann; Vibeke Strand; Charles A Birbara; Daniele Compagnone; Steven A Fischkoff; Elliot K Chartash Journal: J Rheumatol Date: 2003-12 Impact factor: 4.666
Authors: Mark C Genovese; Joan M Bathon; Richard W Martin; Roy M Fleischmann; John R Tesser; Michael H Schiff; Edward C Keystone; Mary Chester Wasko; Larry W Moreland; Arthur L Weaver; Joseph Markenson; Grant W Cannon; George Spencer-Green; Barbara K Finck Journal: Arthritis Rheum Date: 2002-06
Authors: Anna K Wong; Susan Kerkoutian; Jonathan Said; Hooman Rashidi; Sheeja T Pullarkat Journal: Clin Rheumatol Date: 2011-11-18 Impact factor: 2.980
Authors: Jasvinder A Singh; Alomgir Hossain; Amy S Mudano; Elizabeth Tanjong Ghogomu; Maria E Suarez-Almazor; Rachelle Buchbinder; Lara J Maxwell; Peter Tugwell; George A Wells Journal: Cochrane Database Syst Rev Date: 2017-05-08
Authors: Jasvinder A Singh; Alomgir Hossain; Elizabeth Tanjong Ghogomu; Ahmed Kotb; Robin Christensen; Amy S Mudano; Lara J Maxwell; Nipam P Shah; Peter Tugwell; George A Wells Journal: Cochrane Database Syst Rev Date: 2016-05-13
Authors: Jasvinder A Singh; Alomgir Hossain; Elizabeth Tanjong Ghogomu; Amy S Mudano; Lara J Maxwell; Rachelle Buchbinder; Maria Angeles Lopez-Olivo; Maria E Suarez-Almazor; Peter Tugwell; George A Wells Journal: Cochrane Database Syst Rev Date: 2017-03-10
Authors: P L C M van Riel; A J Taggart; J Sany; M Gaubitz; H W Nab; R Pedersen; B Freundlich; D MacPeek Journal: Ann Rheum Dis Date: 2006-02-07 Impact factor: 19.103
Authors: B Combe; C Codreanu; U Fiocco; M Gaubitz; P P Geusens; T K Kvien; K Pavelka; P N Sambrook; J S Smolen; R Khandker; A Singh; J Wajdula; S Fatenejad Journal: Ann Rheum Dis Date: 2008-09-15 Impact factor: 19.103