Efficacy and safety of up to 192 weeks of etanercept therapy in patients with ankylosing spondylitis

John C. Davis ^1*, Desiree M van der Heijde ², Jürgen Braun ³, Maxime Dougados ⁴, Daniel O Clegg ⁵, Alan J Kivitz ⁶, Roy M Fleischmann ⁷, Robert D Inman ⁸, Liyun Ni ⁹, Shao-Lee Lin ¹⁰ and Wayne Tsuji ¹⁰

¹ UCSF, United States
² University Hospital Maastricht, Netherlands
³ Rheumazentrum Ruhrgebiet, Germany
⁴ Hospital Cochin, France
⁵ University of Utah Medical Center, United States
⁶ Altoona Center for Clinical Research, United States
⁷ University of Texas Southwestern Medical Center at Dallas, United States
⁸ Toronto Western Hospital, Canada
⁹ Amgen Inc., United States
¹⁰ Amgen, Inc., United States

^* To whom correspondence should be addressed. E-mail: jcdjr{at}sbcglobal.net.

Accepted 2 October 2007

Abstract

Objective: Evaluate long-term safety and efficacy of etanercept treatment in patients with ankylosing spondylitis (AS).

Methods: Patients with AS who previously participated in a randomized controlled trial (RCT) of etanercept were eligible to enroll in a 168-week open-label extension (OLE). Safety endpoints included rates of adverse events (AE), serious adverse events (SAE), infections, serious infections, and death. Efficacy endpoints included Assessment in Ankylosing Spondylitis (ASAS20) response, ASAS 5/6 response, and partial remission rates.

Results: A total of 257/277 patients (92%) enrolled in the OLE. After up to 192 weeks of treatment with etanercept, the most common AEs were injection site reactions, headaches, and diarrhea. The exposure-adjusted rate of SAEs was 0.08 per patient-year. The rate of infections was 1.1 per patient-year, and the rate for serious infections was 0.02 per patient-year. No deaths were reported. Of patients who received etanercept in both the RCT and OLE and were still in the trial, 71% were ASAS20 responders at week 96, and 81% were responders at week 192. ASAS 5/6 response rates were 61% at week 96 and 60% at week 144, and partial remission response rates were 41% at week 96 and 44% at week 192. Placebo patients who switched to etanercept in the OLE showed similar patterns of efficacy maintenance.

Conclusion: Etanercept was well tolerated for up to 192 weeks in patients with AS, with no unexpected AEs or SAEs observed. No deaths were reported. Improvements in the signs and symptoms of AS were maintained for up to 192 weeks.

Keywords: ankylosing spondylitis, anti-TNF Drugs, etancercept, long-term Extension Trial, randomized controlled trial

CiteULike    Complore    Connotea    Del.icio.us    Digg    Reddit    Technorati    What's this?

This article has been cited by other articles:

• Elewaut, D., Matucci-Cerinic, M. (2009). Treatment of ankylosing spondylitis and extra-articular manifestations in everyday rheumatology practice. Rheumatology (Oxford) 48: 1029-1035 [Abstract] [Full Text]  
• COLBERT, R. A., DEODHAR, A. A., FOX, D., GRAVALLESE, E. M., KHAN, M. A., McGONAGLE, D., REVEILLE, J. D., SCHETT, G., WEISMAN, M., CLEGG, D. O., for the SPARTAN Group, (2009). Entheses and Bones in Spondyloarthritis: 2008 Annual Research and Education Meeting of the Spondyloarthritis Research and Therapy Network (SPARTAN). The Journal of Rheumatology 36: 1527-1531 [Abstract] [Full Text]  
• DIJKMANS, B., EMERY, P., HAKALA, M., LEIRISALO-REPO, M., MOLA, E. M., PAOLOZZI, L., SALVARANI, C., SANMARTI, R., SIBILIA, J., SIEPER, J., Van Den BOSCH, F., van der HEIJDE, D., van der LINDEN, S., WAJDULA, J. (2009). Etanercept in the Longterm Treatment of Patients With Ankylosing Spondylitis. The Journal of Rheumatology 36: 1256-1264 [Abstract] [Full Text]