Background: In a pilot study, the anti-tumour necrosis factor α monoclonal antibody, infliximab, induced a rapid and significant improvement in global, peripheral, and axial disease manifestations of patients with active spondyloarthropathy.
Objective: To determine whether repeated infusions of infliximab would effectively and safely maintain the observed effect.
Methods: Safety and efficacy of a maintenance regimen (5 mg/kg infliximab every 14 weeks) was evaluated using the measurements reported in the pilot study. Of the 21 patients, 19 completed the one year follow up for efficacy; two patients changed to another dosing regimen after week 12 owing to partial lack of efficacy. However, they are still being followed up for safety analysis.
Results: After each re-treatment a sustained significant decrease of all disease manifestations was observed. Before re-treatment, symptoms recurred in 3/19 (16%) at week 20, in 13/19 (68%) at week 34, and in 15/19 (79%) at week 48. No withdrawals due to adverse events occurred. Twelve minor infectious episodes were observed. Twelve patients (57%) developed antinuclear antibodies; in four of them (19%) anti-dsDNA antibodies were detected. However, no lupus-like symptoms occurred.
Conclusion: In this open study of infliximab in patients with active spondyloarthropathy, the significant improvement of all disease manifestations was maintained over a one year follow up period without major adverse events. Although recurrence of symptoms was noted in a rising number of patients before each re-treatment, no loss of efficacy was observed after re-treatment.
- ankylosing spondylitis
- psoriatic arthritis
- ANA, antinuclear antibodies
- AS, ankylosing spondylitis
- CRP, C reactive protein
- ESR, erythrocyte sedimentation rate
- PsA, psoriatic arthritis
- RA, rheumatoid arthritis
- SpA, spondyloarthropathies
- TNFα, tumour necrosis factor α
- uSpA, undifferentiated spondyloarthropathy
- VAS, visual analogue scale
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