BACKGROUND: In a pilot study, the anti-tumour necrosis factor alpha 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.
BACKGROUND: In a pilot study, the anti-tumour necrosis factor alpha 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.
Authors: M Dougados; A Gueguen; J P Nakache; P Velicitat; E M Veys; H Zeidler; A Calin Journal: Rheumatology (Oxford) Date: 1999-03 Impact factor: 7.580
Authors: R F Willkens; H J Williams; J R Ward; M J Egger; J C Reading; P J Clements; E S Cathcart; C O Samuelson; M A Solsky; S B Kaplan Journal: Arthritis Rheum Date: 1984-04
Authors: J Braun; T Pham; J Sieper; J Davis; Sj van der Linden; M Dougados; D van der Heijde Journal: Ann Rheum Dis Date: 2003-09 Impact factor: 19.103
Authors: J Braun; J Sieper; M Breban; E Collantes-Estevez; J Davis; R Inman; H Marzo-Ortega; H Mielants Journal: Ann Rheum Dis Date: 2002-12 Impact factor: 19.103