Background In an open pilot study, the anti-TNF-alpha monoclonal antibody, infliximab, induced a rapid and significant improvement in global, peripheral and axial disease manifestations of patients (pts) with active spondyloarthropathy (SpA), without major side effects.1
Objectives The aim of this study was to determine whether repeated infusions of infliximab would effectively and safely maintain the observed effect.
Methods The safety and efficacy of a maintenance regimen (5 mg/kg IV infliximab every 14 weeks) was evaluated using the same measurements reported in the open label study.1 Of the initial 21 pts 19 completed the 1 year follow-up for efficacy. Two pts (1 psoriatic arthritis, 1 undifferentiated SpA) changed to another dosing regimen of infliximab after week 12 due to partial lack of efficacy. However, these pts are still in follow-up and are included in the safety analysis.
Results Efficacy: After every retreatment (at week 20, 34 and 48) a sustained significant decrease of global, peripheral and axial disease manifestations was observed (p < 0,05 compared to baseline). Before retreatment, recurrence of symptoms was observed in 3 pts (16%) at week 20, 13 pts (68%) at week 34 and 15 pts (79%) at week 48. Safety: No withdrawals due to adverse events occurred. No significant laboratory abnormalities were detected. No major peri-infusional allergic reactions were observed. Three infectious episodes (pyelonephritis, otitis media, and tooth abscess) were observed. During the 1 year follow-up 12 pts (57%) developed on at least 2 occasions antinuclear antibodies; in 4 of these pts (19%) antibodies to dsDNA were detected. However, no lupus-like syndromes occurred.
Conclusion In this open follow-up study of infliximab in pts with active SpA, the significant improvement of all disease manifestations was maintained over a 1 year follow-up period without major adverse events. Since recurrence of symptoms was observed in a rising number of patients with every retreatment, the maintenance regimen (5 mg/kg every 14 weeks) probably needs adjustment (shorter interval or higher dose).
Ann Rheum Dis. 2000;59:428–33