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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\u2010mm visual analog scale.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>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\u2010related adverse event, in which a patient developed disseminated tuberculosis.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusion<\/jats:title><jats:p>Tumor necrosis factor \u03b1 blockade with infliximab in patients with active SpA was well tolerated and resulted in significant clinical and laboratory improvements in this short\u2010term, placebo\u2010controlled study. However, the occurrence of tuberculosis in one patient necessitates strict inclusion criteria and long\u2010term followup.<\/jats:p><\/jats:sec>","DOI":"10.1002\/art.511","type":"journal-article","created":{"date-parts":[[2002,10,6]],"date-time":"2002-10-06T12:00:41Z","timestamp":1033905641000},"page":"755-765","source":"Crossref","is-referenced-by-count":286,"title":["Randomized double\u2010blind comparison of chimeric monoclonal antibody to tumor necrosis factor \u03b1 (infliximab) versus placebo in active spondylarthropathy"],"prefix":"10.1002","volume":"46","author":[{"given":"Filip","family":"Van den Bosch","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Elli","family":"Kruithof","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Dominique","family":"Baeten","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Annemie","family":"Herssens","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Filip","family":"de Keyser","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Herman","family":"Mielants","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Eric M.","family":"Veys","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2002,3,7]]},"reference":[{"key":"e_1_2_6_2_2","doi-asserted-by":"publisher","DOI":"10.1002\/art.1780210603"},{"key":"e_1_2_6_3_2","doi-asserted-by":"crossref","first-page":"187","DOI":"10.1016\/S0889-857X(21)00717-1","article-title":"Undifferentiated spondyloarthropathies","volume":"18","author":"Zeidler H","year":"1992","journal-title":"Rheum Dis Clin North Am"},{"key":"e_1_2_6_4_2","doi-asserted-by":"publisher","DOI":"10.1093\/rheumatology\/XXVII.suppl_2.95"},{"key":"e_1_2_6_5_2","first-page":"2266","article-title":"The evolution of the spondyloarthropathies in relation to gut histology. 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