Objective: To evaluate the efficacy and safety of long term infliximab therapy in patients with severe refractory ankylosing spondylitis (AS).
Patients and methods: Twenty five patients (24 male, 1 female; mean (SD) age 36.0 (10.5); disease duration 13.8 (8.5) years) with AS fulfilling the modified New York criteria for AS were investigated. Twenty two (88%) patients were HLA-B27 positive. All patients had active axial disease (Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) >/=30/100) and C reactive protein (CRP) >/=10 mg/l, despite adequate treatment. Intravenous infliximab (5 mg/kg) was given at weeks 0, 2, 6, and every eight weeks thereafter for 12 months. The primary end point was the reduction of the patient's global assessment of pain (GAP) by >20% on a 100 mm visual analogue scale.
Results: GAP was reduced by >20% in 23 (92%) patients, by 50% in 21 (84%) patients, and by 70% in 13 (52%). The change in BASDAI and CRP from baseline was statistically significant. The treatment was well tolerated with minimal side effects. One patient dropped out owing to inefficacy and one stopped treatment owing to an allergic reaction.
Conclusion: This longer length study confirms the efficacy of infliximab and the good safety profile in patients with AS.