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

• Published in: Rheumatology (Oxford, England) England), 2005-03, Vol.44 (3), p.342-348
• Main Authors: Brandt, J., Listing, J., Haibel, H., Sörensen, H., Schwebig, A., Rudwaleit, M., Sieper, J., Braun, J.
• Format: Article
• Language: English
• Subjects: Adult; Anti-Inflammatory Agents, Non-Steroidal - adverse effects; Anti-Inflammatory Agents, Non-Steroidal - therapeutic use; Antirheumatic Agents - adverse effects; Antirheumatic Agents - therapeutic use; Biological and medical sciences; Diseases of the osteoarticular system; Etanercept; Female; Humans; Immunoglobulin G - adverse effects; Immunoglobulin G - therapeutic use; Immunomodulators; Inflammatory joint diseases; Male; Medical sciences; Pharmacology. Drug treatments; Receptors, Tumor Necrosis Factor - therapeutic use; Recurrence; Retreatment - methods; Spondylitis, Ankylosing - drug therapy; Spondylitis, Ankylosing - physiopathology; Therapy of ankylosing spondylitis; Treatment Outcome; Tumour necrosis factor α
• ISSN: 1462-0324; 1462-0332
• DOI: 10.1093/rheumatology/keh475

Objectives. Treatment of ankylosing spondylitis (AS) with the tumour necrosis factor α (TNF-α) 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) ≥4 and pain ≥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.