Ann Rheum Dis 2000;59:428-433 ( June )

Extended report

Effects of a loading dose regimen of three infusions of chimeric monoclonal antibody to tumour necrosis factor  (infliximab) in spondyloarthropathy: an open pilot study Filip Van den Bosch, Elli Kruithof, Dominique Baeten, Filip De Keyser, Herman Mielants, Eric M Veys

Ghent University Hospital, Department of Rheumatology, O K12 IB, De Pintelaan 185, B-9000 Gent, Belgium

Correspondence to: Dr Van den Bosch Email: eric.veys{at}rug.ac.be

Accepted for publication 27 March 2000

OBJECTIVETo evaluate the efficacy and safety of a loading dose regimen of three intravenous infusions with infliximab in patients with active spondyloarthropathy.
METHODSA 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 infusions of 5 mg/kg infliximab (at weeks 0, 2, and 6). Standard clinical assessments 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 spondylitis, axial assessment was performed at baseline and on days 14, 42, and 84.
RESULTSIn 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 maintained up to day 84. In patients with peripheral disease (n=18), tender and swollen joint count significantly decreased. In patients with axial disease (n=11), functional and disease activity indices significantly improved. Moreover in eight patients with psoriatic arthritis a significant decrease of the psoriasis area and severity index was observed. The treatment was well tolerated in all patients; no significant adverse events were seen.
CONCLUSIONIn this open-label pilot study of a loading dose regimen of three infusions of chimeric monoclonal antibody to tumour necrosis factor  in patients with active spondyloarthropathy, there was a fast and significant improvement of axial and peripheral articular manifestations, without major adverse experiences.

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© 2000 by Annals of the Rheumatic Diseases
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