Long-term efficacy and safety of etanercept after readministration in patients with active ankylosing spondylitis.

Abstract

OBJECTIVES:

Treatment of ankylosing spondylitis (AS) with the tumour necrosis factor alpha (TNF-alpha) receptor fusion protein etanercept has shown efficacy in patients with active disease in randomized controlled trials (RCTs) for limited periods. The objective of the study was to assess the long-term efficacy and safety of etanercept over 1 yr, including discontinuation and readministration.

METHODS:

In this 54-week open observational study, 26 AS patients received 25 mg etanercept subcutaneously twice weekly after several months of discontinuation following a 6-month RCT with the same agent. All patients who developed high disease activity after cessation of etanercept, defined as a Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) > or = 4 and pain > or = 4 on a numerical rating scale, entered the study. Standard assessment tools, such as the Bath Ankylosing Spondylitis functional index (BASFI), were used. An intention-to-treat (ITT) and a completer analysis were performed. The results were compared with the baseline values of the open study.

RESULTS:

Out of the initial 30 patients, 26 (87%) were eligible for the open extension study after a mean of about 27 weeks. At week 54, 23/26 patients (88%) were still on treatment with etanercept. The ITT analysis showed that 58% (95% confidence interval 39-74%) of the patients achieved a 50% improvement of BASDAI at week 54. According to the Assessments in Ankylosing Spondylitis working group criteria, 8/26 patients (31%) were in partial remission at week 54. Function, metrology and quality of life improved significantly. Only one patient had a serious adverse event that resulted in discontinuation.

CONCLUSIONS:

This study shows that treatment with etanercept is efficacious and safe after readministration over 1 yr in patients with active AS not taking DMARDs or steroids.

• Authors: J Brandt, J Listing, H Haibel, H Sörensen, A Schwebig, M Rudwaleit, J Sieper, J Braun
• Journal: Rheumatology (Oxford, England) (Rheumatology (Oxford)) Vol. 44 Issue 3 Pg. 342-8 (Mar 2005) ISSN: 1462-0324 [Print] England
• PMID: 15561737 (Publication Type: Clinical Trial, Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• Anti-Inflammatory Agents, Non-Steroidal
• Antirheumatic Agents
• Immunoglobulin G
• Receptors, Tumor Necrosis Factor
• Etanercept

Topics

• Adult
• Anti-Inflammatory Agents, Non-Steroidal (adverse effects, therapeutic use)
• Antirheumatic Agents (adverse effects, therapeutic use)
• Etanercept
• Female
• Humans
• Immunoglobulin G (adverse effects, therapeutic use)
• Male
• Receptors, Tumor Necrosis Factor (therapeutic use)
• Recurrence
• Retreatment (methods)
• Spondylitis, Ankylosing (drug therapy, physiopathology)
• Treatment Outcome