Background Infliximab, a chimeric anti-TNF-alpha antibody has been used successfully for the treatment of rheumatoid arthritis in combination with methotrexate. Open studies with a few number of patients suggested that infliximab as monotherapy is also effective in active spondyloarthropathies.
Objectives To evaluate the efficacy of infliximab as monotherapy in patients with refractory and active spondyloarthropathy.
Methods Thirty-eight week, open, multicentric and prospective trial, in 42 patients with spondyloarthropathy, according the ESSG and/or Amor criteria. All patients have disease duration of more than one year and persistent disease activity despite use of different drugs (NSAIDs, sulfasalazine, methotrexate or pamidronate). Infliximab is administered at a dose of 5 mg/kg, at 0, 2, 6, 14, 22 and 30 weeks. Clinical assessment was performed at these weeks at a week 38. Different clinical disease activity measures are performed, including BASDAI and patient global assessment of disease status. Disability is measured by BASFI and HAQ-Sp. ESR and CRP is used as laboratory parameters of inflammation.
Results Preliminary results at week 0, 2 and 6 in 10 patients (3F/7M): 8 AS patients and 2 undifferentiated spondyloarthropathy; mean age: 36 ± 7 yr, mean disease duration: 14 ± 6 yr are presented in this Table 1.
In all patients a significant improvement in clinical, functional and laboratory parameters were observed. This improvement was seen at week 2 (after the first dose) and is maintained at week 6.
Conclusion Preliminary results of this open study show that infliximab provides a quick and significant clinical improvement in refractory spondyloarthropathies.
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