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


CONCLUSIONS
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.
Van Den Bosch
Filip
F
Department of Rheumatology, Ghent University Hospital, Ghent, Belgium. f.vandenbosch@pi.be
Kruithof
Elli
E
Baeten
Dominique
D
Herssens
Annemie
A
de Keyser
Filip
F
Mielants
Herman
H
Veys
Eric M
EM
D000328:Adult; D000368:Aged; D000974:Antibodies, Antinuclear / Q000032:analysis; D000911:Antibodies, Monoclonal / Q000009:adverse effects / Q000627:therapeutic use*; D018501:Antirheumatic Agents / Q000009:adverse effects / Q000627:therapeutic use*; D005260:Female; D006801:Humans; D000069285:Infliximab; D008297:Male; D008875:Middle Aged; D010919:Placebos; D012449:Safety; D025242:Spondylarthropathies / Q000188:drug therapy* / Q000503:physiopathology*; D014376:Tuberculosis / Q000139:chemically induced
D000974:Antibodies, Antinuclear; D000911:Antibodies, Monoclonal; D018501:Antirheumatic Agents; D010919:Placebos; D000069285:Infliximab