HOMEPRODUCTSCOMPANYCONTACTFAQResearchDictionaryPharmaSign Up FREE or Login

Randomized double-blind comparison of chimeric monoclonal antibody to tumor necrosis factor alpha (infliximab) versus placebo in active spondylarthropathy.

AbstractOBJECTIVE:
To confirm in a placebo-controlled trial the safety and efficacy profile of infliximab in short-term treatment of patients with active spondylarthropathy (SpA).
METHODS:
Forty patients with active SpA were randomly assigned to receive an intravenous loading dose (weeks 0, 2, and 6) of 5 mg/kg infliximab or placebo. Evaluations for efficacy and safety were performed at weeks 1, 2, 6, 8, and 12. The primary end points of this study were the improvements in patient and physician global assessments of disease activity on a 100-mm visual analog scale.
RESULTS:
Both primary end points improved significantly in the infliximab group compared with the baseline value, with no improvement in the placebo group. As early as week 2 and sustained up to week 12, there was a highly statistically significant difference between the values for these 2 end points in the infliximab versus the placebo group. In most of the other assessments of disease activity (laboratory measures, assessments of specific peripheral and/or axial disease), significant improvements were observed in the infliximab group compared with the baseline value and compared with placebo. Minor adverse events not causing discontinuation were equally observed in both treatment groups. There was one severe drug-related adverse event, in which a patient developed disseminated tuberculosis.
CONCLUSION:
Tumor necrosis factor alpha blockade with infliximab in patients with active SpA was well tolerated and resulted in significant clinical and laboratory improvements in this short-term, placebo-controlled study. However, the occurrence of tuberculosis in one patient necessitates strict inclusion criteria and long-term followup.
AuthorsFilip Van Den Bosch, Elli Kruithof, Dominique Baeten, Annemie Herssens, Filip de Keyser, Herman Mielants, Eric M Veys
JournalArthritis and rheumatism (Arthritis Rheum) Vol. 46 Issue 3 Pg. 755-65 (Mar 2002) ISSN: 0004-3591 [Print] United States
PMID11920412 (Publication Type: Clinical Trial, Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
Chemical References
  • Antibodies, Antinuclear
  • Antibodies, Monoclonal
  • Antirheumatic Agents
  • Placebos
  • Infliximab
Topics
  • Adult
  • Aged
  • Antibodies, Antinuclear (analysis)
  • Antibodies, Monoclonal (adverse effects, therapeutic use)
  • Antirheumatic Agents (adverse effects, therapeutic use)
  • Female
  • Humans
  • Infliximab
  • Male
  • Middle Aged
  • Placebos
  • Safety
  • Spondylarthropathies (drug therapy, physiopathology)
  • Tuberculosis (chemically induced)

Join CureHunter, for free Research Interface BASIC access!

Take advantage of free CureHunter research engine access to explore the best drug and treatment options for any disease. Find out why thousands of doctors, pharma researchers and patient activists around the world use CureHunter every day.
Realize the full power of the drug-disease research graph!


Choose Username:
Email:
Password:
Verify Password:
Enter Code Shown: