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

(2002) ARTHRITIS AND RHEUMATISM. 46(3). p.755-765
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Abstract
Objective. 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 a 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.
Keywords
RHEUMATOID-ARTHRITIS, ANKYLOSING-SPONDYLITIS, CROHNS-DISEASE, PSORIATIC-ARTHRITIS, SERONEGATIVE SPONDYLARTHROPATHIES, FUNCTIONAL INDEX, GUT HISTOLOGY, TRIAL, METHOTREXATE, SPONDYLOARTHROPATHIES

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Citation

Please use this url to cite or link to this publication:

Chicago
Van den Bosch, Filip, Elli Kruithof, Dominique Baeten, Annemie Herssens, Filip De Keyser, Herman Mielants, and Eric Veys. 2002. “Randomized Double-blind Comparison of Chimeric Monoclonal Antibody to Tumor Necrosis Factor α (infliximab) Versus Placebo in Active Spondylarthropathy.” Arthritis and Rheumatism 46 (3): 755–765.
APA
Van den Bosch, Filip, Kruithof, E., Baeten, D., Herssens, A., De Keyser, F., Mielants, H., & Veys, E. (2002). Randomized double-blind comparison of chimeric monoclonal antibody to tumor necrosis factor α (infliximab) versus placebo in active spondylarthropathy. ARTHRITIS AND RHEUMATISM, 46(3), 755–765.
Vancouver
1.
Van den Bosch F, Kruithof E, Baeten D, Herssens A, De Keyser F, Mielants H, et al. Randomized double-blind comparison of chimeric monoclonal antibody to tumor necrosis factor α (infliximab) versus placebo in active spondylarthropathy. ARTHRITIS AND RHEUMATISM. 2002;46(3):755–65.
MLA
Van den Bosch, Filip, Elli Kruithof, Dominique Baeten, et al. “Randomized Double-blind Comparison of Chimeric Monoclonal Antibody to Tumor Necrosis Factor α (infliximab) Versus Placebo in Active Spondylarthropathy.” ARTHRITIS AND RHEUMATISM 46.3 (2002): 755–765. Print.
@article{165107,
  abstract     = {Objective. 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 a 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.},
  author       = {Van den Bosch, Filip and Kruithof, Elli and Baeten, Dominique and Herssens, Annemie and De Keyser, Filip and Mielants, Herman and Veys, Eric},
  issn         = {0004-3591},
  journal      = {ARTHRITIS AND RHEUMATISM},
  keyword      = {RHEUMATOID-ARTHRITIS,ANKYLOSING-SPONDYLITIS,CROHNS-DISEASE,PSORIATIC-ARTHRITIS,SERONEGATIVE SPONDYLARTHROPATHIES,FUNCTIONAL INDEX,GUT HISTOLOGY,TRIAL,METHOTREXATE,SPONDYLOARTHROPATHIES},
  language     = {eng},
  number       = {3},
  pages        = {755--765},
  title        = {Randomized double-blind comparison of chimeric monoclonal antibody to tumor necrosis factor \ensuremath{\alpha} (infliximab) versus placebo in active spondylarthropathy},
  url          = {http://dx.doi.org/10.1002/art.511},
  volume       = {46},
  year         = {2002},
}

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