OP0058 Efficacy of infliximab in severe refractory ankylosing spondylitis (as). results of an open-label study

Background Early reports have emphasised the efficacy of the anti-TNF-alpha monoclonal antibody, infliximab, to treat spondylarthropathy patients. Further studies are required to evaluate the extent of such efficacy in large subgroups of well-defined patients. Objectives To examine the effect of infliximab, in severe AS with predominant axial symptoms. Methods Patients suffering of severe AS, with evidence of systemic inflammation (modified New-York criteria; BASDAI > = 30/100; CRP > = 15 mg/l)), and without present peripheral arthritis or extraskelettal manifestation were included. Previous DMARD’s had to be discontinued for > = 3 months. Intake of NSAID had to be stable. Eligible patients received 3 infusions of infliximab (5 mg/kg, weeks 0, 2 and 6). Clinical and biological monitoring was planned for 6 months. Results We enrolled 48 parents (36 M/12 F; mean age = 36 ± 9 yr); 41/46 (89%) were HLA-B27+; 43 (90%) completed the treatment, as scheduled, whereas 5 received only 2 infusions. Interim result (wk 8) is shown, and compared to baseline in the table. Altogether, 44 patients (92%) were responders, as defined by a reduction of global pain on VAS of at least 20%, as compared to baseline level. Conclusion Our data confirm the remarkable efficacy of infliximab in AS. It indicate that most, patients suffering of inflammatory active AS promptly and dramatically respond to this treatment.