Repeated infusions of infliximab, a chimeric anti-TNFalpha monoclonal antibody, in patients with active spondyloarthropathy: one year follow up

Abstract

Background: In a pilot study, the anti-tumour necrosis factor alpha monoclonal antibody, infliximab, induced a rapid and significant improvement in global, peripheral, and axial disease manifestations of patients with active spondyloarthropathy.

Objective: To determine whether repeated infusions of infliximab would effectively and safely maintain the observed effect.

Methods: Safety and efficacy of a maintenance regimen (5 mg/kg infliximab every 14 weeks) was evaluated using the measurements reported in the pilot study. Of the 21 patients, 19 completed the one year follow up for efficacy; two patients changed to another dosing regimen after week 12 owing to partial lack of efficacy. However, they are still being followed up for safety analysis.

Results: After each re-treatment a sustained significant decrease of all disease manifestations was observed. Before re-treatment, symptoms recurred in 3/19 (16%) at week 20, in 13/19 (68%) at week 34, and in 15/19 (79%) at week 48. No withdrawals due to adverse events occurred. Twelve minor infectious episodes were observed. Twelve patients (57%) developed antinuclear antibodies; in four of them (19%) anti-dsDNA antibodies were detected. However, no lupus-like symptoms occurred.

Conclusion: In this open study of infliximab in patients with active spondyloarthropathy, the significant improvement of all disease manifestations was maintained over a one year follow up period without major adverse events. Although recurrence of symptoms was noted in a rising number of patients before each re-treatment, no loss of efficacy was observed after re-treatment.

Figure 1

Evolution of patient assessments over time. The box plots show the median value (horizontal line) and range (first to third quartiles in boxes) of the chosen parameter (y axis) over time (weeks). Significance (p) was calculated by the Wilcoxon signed ranks test: *p≤0.05, **p≤0.01, ***p≤0.001, NS, not significant. (A) Patient global assessment (100 mm VAS); (B) C reactive protein (mg/l); (C) swollen joint count; (D) spinal pain assessment (100 mm VAS).