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.

• Authors: E Kruithof, F Van den Bosch, D Baeten, A Herssens, F De Keyser, H Mielants, E M Veys
• Journal: Annals of the rheumatic diseases (Ann Rheum Dis) Vol. 61 Issue 3 Pg. 207-12 (Mar 2002) ISSN: 0003-4967 [Print] England
• PMID: 11830424 (Publication Type: Journal Article, Research Support, Non-U.S. Gov't)

Chemical References

• Antibodies, Antinuclear
• Antibodies, Monoclonal
• Antirheumatic Agents
• Infliximab

Topics

• Adult
• Aged
• Antibodies, Antinuclear (immunology)
• Antibodies, Monoclonal (administration & dosage)
• Antirheumatic Agents (administration & dosage)
• Female
• Fluorescent Antibody Technique, Indirect
• Follow-Up Studies
• Humans
• Infliximab
• Male
• Middle Aged
• Pilot Projects
• Retreatment
• Spondylarthropathies (drug therapy, immunology)
• Statistics, Nonparametric
• Treatment Outcome