Etanercept and sulfasalazine, alone and combined, in patients with active rheumatoid arthritis despite receiving sulfasalazine: a double-blind comparison

• Published in: Annals of the rheumatic diseases 2006-10, Vol.65 (10), p.1357-1362
• Main Authors: Combe, B, Codreanu, C, Fiocco, U, Gaubitz, M, Geusens, P P, Kvien, T K, Pavelka, K, Sambrook, P N, Smolen, J S, Wajdula, J, Fatenejad, S
• Format: Article
• Language: English
• Subjects: ACR; Adult; Aged; American College of Rheumatology; Anti-Inflammatory Agents, Non-Steroidal - adverse effects; Anti-Inflammatory Agents, Non-Steroidal - therapeutic use; Antirheumatic Agents - adverse effects; Antirheumatic Agents - therapeutic use; Arthritis, Rheumatoid - drug therapy; Biological and medical sciences; Bones, joints and connective tissue. Antiinflammatory agents; C reactive protein; CRP; DAS; Disease; Disease Activity Score; disease-modifying antirheumatic drug; Diseases of the osteoarticular system; DMARD; Double-Blind Method; Drug dosages; Drug Therapy, Combination; erythrocyte sedimentation rate; ESR; Etanercept; Extended Report; Female; HAQ; Health Assessment Questionnaire; Humans; Immunoglobulin G - adverse effects; Immunoglobulin G - therapeutic use; Immunomodulators; Inflammatory joint diseases; injection site reaction; ISR; Male; Medical sciences; Middle Aged; Mortality; Pharmacology. Drug treatments; Receptors, Tumor Necrosis Factor - therapeutic use; Response rates; Rheumatism; Rheumatoid arthritis; Severity of Illness Index; Studies; Sulfasalazine - adverse effects; Sulfasalazine - therapeutic use; TNF; Treatment Failure; Treatment Outcome; Tumor Necrosis Factor-alpha - antagonists & inhibitors; Tumor necrosis factor-TNF; tumour necrosis factor; VAS; Visual Analogue Scale; WBC; white blood cell
• ISSN: 0003-4967; 1468-2060
• DOI: 10.1136/ard.2005.049650

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