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.