Therapeutic efficacy and safety of multiple intravenous infusions of infliximab in refractory ankylosing spondylitis patients with axial involvement.

ABSTRACT

OBJECTIVE: To evaluate the clinical response and safety profile of infliximab in refractory ankylosing spondylitis patients. METHODS: Patients with active ankylosing spondylitis, despite methotrexate therapy, were included in an open-label, single-centre study. Patients were given 3-5 mg/kg infliximab infusions at Weeks 0, 2, 6, and q8 etc up to Week 30, together with methotrexate at the dosage taken prior to study inclusion, and were followed-up for a 34-week period. RESULTS: Nine patients with mean age 43 years and mean disease duration 7 years, diagnosed with pure axial ankylosing spondylitis were included. Erythrocyte sedimentation rate (ESR), C-reactive protein (CRP), duration of morning stiffness, physician's global assessment of disease activity (PhGADA), visual analogue scale (VAS) pain, enthesis index, occiput-to-wall test, Bath Ankylosing Spondylitis Disease Activity Index (BASDAI), and Bath Ankylosing Spondylitis Functional Index (BASFI) significantly improved by Week 6. No adverse events related with the drug were recorded during the 34-week follow-up period. CONCLUSION: Efficacy results are similar to those previously published. No adverse events were seen during therapy, and antinuclear antibody profiles were negative. The association of methotrexate with infliximab can improve the safety profile.