Effects of a loading dose regimen of three infusions of chimeric monoclonal antibody to tumour necrosis factor alpha (infliximab) in spondyloarthropathy: an open pilot study

Objective-To evaluate the efficacy and safety of a loading dose regimen of three intravenous infusions with infliximab in patients with active spondyl oarthropathy. Methods-A monocentre, open-label pilot study of 21 patients with different subtypes of spondyloarthropathy was conducted. Treatment resistant patients with active disease (fulfilling inclusion criteria) received three infusio ns of 5 mg/kg infliximab (at weeks 0, 2, and 6). Standard clinical assessme nts were performed at baseline, and on days 3, 7, and 14, and from then on every two weeks. In patients who fulfilled criteria for ankylosing spondyli tis, axial assessment was performed at baseline and on days 14, 42, and 84. Results-In all global assessments (visual analogue scale of patient global assessment, patient pain assessment, doctor global assessment), erythrocyte sedimentation rate, and C reactive protein, a highly significant decrease could be seen already at day 3 (compared with baseline), which was maintain ed up to day 84. In patients with peripheral disease (n=18), tender and swo llen joint count significantly decreased. In patients with axial disease (n =11), functional and disease activity indices significantly improved. Moreo ver in eight patients with psoriatic arthritis a significant decrease of th e psoriasis area and severity index was observed. The treatment was well to lerated in all patients; no significant adverse events were seen. Conclusion-In this open-label pilot study of a loading dose regimen of thre e infusions of chimeric monoclonal antibody to tumour necrosis factor alpha in patients with active spondyloarthropathy, there was a fast and signific ant improvement of axial and peripheral articular manifestations, without m ajor adverse experiences.