RESEARCH - Efficacy, safety, and patient reported outcomes of combination Enbrel and sulfasalazine

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Ann Rheum Dis. Published Online First: 15 September 2008.

doi:10.1136/ard.2007.087106

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Extended Report

Efficacy, safety, and patient-reported outcomes of combination

etanercept and sulfasalazine versus etanercept alone in patients with

rheumatoid arthritis: a double-blind randomized two-year study

B. Combe 1, C. Codreanu 2, U. Fiocco 3, M. Gaubitz 4, P. P. Geusens 5,

T. K. Kvien 6, K. Pavelka 7, P. N. Sambrook 8, J. S. Smolen 9, R.

Khandker 10, A. Singh 10, J. Wajdula 10* and S. Fatenejad 10

1 Service d'Immuno-Rhumatologie, Hopital Lapeyronie, Montpellier, France

2 Centrul Metodologic de Reumatologie, Bucuresti, Romania

3 Cattedra e Divisione di Reumatologia, Policlinico Universitario, Padova, Italy

4 Medical Clinic B Westfalian-Wilhelms-Univ, Munster, Germany

5 Biomedical Research Ctr, Univ Hasselt, Belgium & Dept of Internal

Med/Rheum Univ Maastricht, Netherlands

6 Department of Rheumatology, Diakonhjemmets Hospital, Oslo, Norway

7 Institute of Rheumatology, Praha, Czech Republic

8 Kolling Institute, University of Sydney, Sydney, Australia

9 2nd Dept of Med, Krankenhaus Lainz & Dept of Rheum, Internal Med II, Austria

10 Wyeth Research, Collegeville, Pennyslvania, United States

Abstract

Objective: To determine efficacy and safety of etanercept and

etanercept+sulfasalazine versus sulfasalazine in patients with

rheumatoid arthritis (RA) despite sulfasalazine therapy.

Methods: Patients were randomly assigned to etanercept (25 mg twice

weekly; sulfasalazine was discontinued at baseline),

etanercept+sulfasalazine (unchanged regimen of 2-3 g/day) or

sulfasalazine in a double-blind, randomised, 2-year study in adult

patients with active RA despite sulfasalazine therapy. Efficacy was

assessed using the American College of Rheumatology (ACR) criteria,

disease activity scores (DAS), and patient-reported outcomes (PROs).

Results: Demographic variables and baseline disease characteristics

were comparable among treatment groups; mean DAS was 5.1, 5.2 and 5.1,

for etanercept (n=103), etanercept+sulfasalazine (n=101), and

sulfasalazine (n=50) respectively. Withdrawal due to lack of efficacy

was highest with sulfasalazine (26 [52%] versus 6 [6%] for either

etanercept group, p<0.001). Patients receiving etanercept or

etanercept+sulfasalazine had a more rapid initial response, which was

sustained at 2 years, than those receiving sulfasalazine: mean DAS was

2.8, 2.5, versus 4.5 respectively (p<0.05); ACR 20 response was

achieved by 67%, 77%, versus 34% of patients respectively (p<0.01)

Overall, PROs followed a similar pattern; clinically significant

improvement in Health Assessment Questionnaire was achieved by 76%,

78%, versus 40% of patients respectively (p<0.01). Commonly reported

adverse events occurring in the etanercept groups were injection site

reactions and pharyngitis/laryngitis (p<0.01).

Conclusion: Etanercept and etanercept+sulfasalazine are efficacious

for the long-term management of patients with RA. Therefore, addition

of etanercept or substitution with etanercept should be considered as

treatment options for patients not adequately responding to

sulfasalazine.

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http://ard.bmj.com/cgi/content/abstract/ard.2007.087106v1?papetoc

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