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

AbstractBACKGROUND: 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.
AuthorsE Kruithof, F Van den Bosch, D Baeten, A Herssens, F De Keyser, H Mielants, E M Veys (Affiliation: Department of Rheumatology, Ghent University Hospital, Belgium. elli.kruithof at rug.ac.be)
JournalAnnals of the rheumatic diseases (Ann Rheum Dis) Vol. 61 Issue 3 Pg. 207-12 (Mar 2002) ISSN: 0003-4967 England
PMID11830424 (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
  • Male
  • Middle Aged
  • Pilot Projects
  • Retreatment
  • Spondylarthropathies (drug therapy, immunology)
  • Statistics, Nonparametric
  • Treatment Outcome