Suzanne Arends1, Elisabeth Brouwer2, Monique Efde3, Eveline van der Veer4, Hendrika Bootsma2, Freke Wink3, Anneke Spoorenberg5. 1. Rheumatology and Clinical Immunology, University of Groningen, University Medical Center Groningen; and Rheumatology, Medical Center Leeuwarden, The Netherlands. s.arends@umcg.nl. 2. Rheumatology and Clinical Immunology, University of Groningen, University Medical Center Groningen, The Netherlands. 3. Rheumatology, Medical Center Leeuwarden, The Netherlands. 4. Laboratory Medicine, University of Groningen, University Medical Center Groningen, The Netherlands. 5. Rheumatology and Clinical Immunology, University of Groningen, University Medical Center Groningen; and Rheumatology, Medical Center Leeuwarden, The Netherlands.
Abstract
OBJECTIVES: Randomised controlled trials and open-label extension studies have demonstrated the clinical efficacy and safety of tumour necrosis factor-alpha (TNF-α) blocking therapy in pre-selected study patients with ankylosing spondylitis (AS). Our aim was to investigate the 7-year drug survival and clinical effectiveness of etanercept treatment in AS patients in daily clinical practice. METHODS: Consecutive AS patients from the prospective observational GLAS cohort who started etanercept because of active disease were included and evaluated over 7 years according to a fixed protocol. Continuation of treatment was based on BASDAI improvement and/or expert opinion. RESULTS: Of the 89 included AS patients, 45 (51%) were still using etanercept at 7 years of follow-up. Reasons for treatment discontinuation were adverse events (n=22), inefficacy (n=13), or other reasons although good clinical response (n=9). Etanercept treatment resulted in a rapid (after 6 weeks) and sustained improvement in disease activity (BASDAI, ASDAS, CRP, physician GDA), spinal mobility, physical function (BASFI), quality of life (ASQoL), and extra-spinal manifestations (swollen joints, tender joints and tender entheses). Furthermore, concomitant NSAID or DMARD use decreased significantly during follow-up. At 7 years, low disease activity and remission were present in 67-73% and 29-30% of the 45 patients, respectively. Of the patients who discontinued etanercept, 18 switched successfully to a second or third TNF-α blocker during follow-up. CONCLUSIONS: In a large cohort of AS patients treated with etanercept, approximately 50% continued this treatment for 7 years. Our broad evaluation of clinical endpoints proves the long-term effectiveness of etanercept treatment in daily clinical practice.
OBJECTIVES: Randomised controlled trials and open-label extension studies have demonstrated the clinical efficacy and safety of tumour necrosis factor-alpha (TNF-α) blocking therapy in pre-selected study patients with ankylosing spondylitis (AS). Our aim was to investigate the 7-year drug survival and clinical effectiveness of etanercept treatment in AS patients in daily clinical practice. METHODS: Consecutive AS patients from the prospective observational GLAS cohort who started etanercept because of active disease were included and evaluated over 7 years according to a fixed protocol. Continuation of treatment was based on BASDAI improvement and/or expert opinion. RESULTS: Of the 89 included AS patients, 45 (51%) were still using etanercept at 7 years of follow-up. Reasons for treatment discontinuation were adverse events (n=22), inefficacy (n=13), or other reasons although good clinical response (n=9). Etanercept treatment resulted in a rapid (after 6 weeks) and sustained improvement in disease activity (BASDAI, ASDAS, CRP, physician GDA), spinal mobility, physical function (BASFI), quality of life (ASQoL), and extra-spinal manifestations (swollen joints, tender joints and tender entheses). Furthermore, concomitant NSAID or DMARD use decreased significantly during follow-up. At 7 years, low disease activity and remission were present in 67-73% and 29-30% of the 45 patients, respectively. Of the patients who discontinued etanercept, 18 switched successfully to a second or third TNF-α blocker during follow-up. CONCLUSIONS: In a large cohort of AS patients treated with etanercept, approximately 50% continued this treatment for 7 years. Our broad evaluation of clinical endpoints proves the long-term effectiveness of etanercept treatment in daily clinical practice.