Multicenter open-label study with infliximab in active ankylosing spondylitis over 28 weeks in daily practice.

OBJECTIVE The aim of this study was to prospectively investigate the therapeutic efficacy and safety of infliximab therapy in NSAID-refractory AS patients, with special emphasis on impact on quality of life in daily practice. PATIENTS AND METHODS 101 AS patients with active disease (mean Bath ankylosing spondylitis activity index (BASDAI) 6.3, range 4.0-9.8) were enrolled in an open label study. Infliximab 5 mg/kg body weight was administered intravenously at week 0, 2, 6, 12, 18 and 24 followed by a final assessment at week 28. Clinical assessments included quality of life (SF-36, primary endpoint), disease activity (BASDAI), function (BASFI), metrology (BASMI), patients' and physicians' global, pain, work productivity (WPAI) and CRP. RESULTS Using an intention to treat (ITT) analysis, the mean SF-36 physical health component improved from 27.6 at baseline to 40.9 at study end (p<0.001), the mean SF-36 mental health component improved from 44.4 at study entry to 53.0 at final assessment (p<0.001). The Assessment of AS (ASAS-) 20 short-term improvement criteria were reached by 80.2% of patients, ASAS 40 by 60.4% and the ASAS criteria for partial remission were reached by 27.7% of patients. A BASDAI 50% improvement was found in 66.3% of patients. Comparable significant improvements were found for mean BASDAI; BASFI, BASMI, patients' and physicians' global, general pain, CRP and WPAI. 11.8% of patients stopped therapy because of side effects. CONCLUSIONS Infliximab showed high efficacy and safety when used by non-specialised rheumatologists in daily practice.