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Rheumatology 2002; 41: 1280-1285
© 2002 British Society for Rheumatology
Original Papers |
Efficacy of infliximab in refractory ankylosing spondylitis: results of a six-month open-label study
1 Institut de Rhumatologie and
2 Département d'Immunologie, Hôpital Cochin, Université René Descartes, Paris,
3 Service de Rhumatologie, Centre Hospitalier Lyon Sud, Pierre-Bénite,
4 Service de Rhumatologie, Hôpital Henri Mondor, Créteil,
5 Service de Rhumatologie, Hôpital de la Cavale Blanche, Brest,
6 Service de Rhumatologie, Hôpital Jean Minjoz, Besançon,
7 Service de Rhumatologie, Centre Hospitalier Régional, Orléans,
8 Service de Rhumatologie, Hôpital Archet, Nice,
9 Service de Rhumatologie, Hôpital de Hautepierre, Strasbourg,
10 Service de Rhumatologie, Hôpital Sud, Rennes and
11 Service de Rhumatologie, Hôpital Bellevue, Saint-Etienne, France
Objective. To evaluate the efficacy and safety of a loading regimen of the anti-tumour necrosis factor 
(TNF-) antibody infliximab in predominantly axial severe ankylosing spondylitis (AS).
Methods. We enrolled in this study 50 patients (76% males, 87% HLA-B27+, median age 35 yr, median disease duration 13 yr) with active AS [Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) 
30/100 and serum C-reactive protein concentration 15 mg/l) despite treatment with a non-steroidal anti-inflammatory drug, and without peripheral arthritis, uveitis or active inflammatory bowel disease. Other disease-modifying anti-rheumatic drugs were discontinued 3 months before inclusion and were not allowed during the study. Patients received three infusions of infliximab (5 mg/kg) at weeks 0, 2 and 6 and were monitored clinically and biologically until week 24.
Results. Forty-eight patients completed the treatment. In intention-to-treat analysis, all parameters were significantly improved at week 2 and generally reached maximal improvement at week 8. The proportion of responders, defined by a reduction of 20% in the global assessment of pain (GAP) or by the AS Assessment Study Group (ASAS 20%) criteria, and the proportion of patients reaching partial remission were 98, 94 and 70% respectively. Relapse, defined as 50% loss of maximal GAP improvement, occurred in 73% of completers, with a median delay of 14 weeks after the third infusion. No serious adverse event related to the treatment was observed.
Conclusions. This study confirms, in a large group of severely affected AS patients, the remarkable efficacy of infliximab. Relapse usually occurred after discontinuation of the drug, but almost one-third of completers were still free of relapse 4 months after the last infusion.
Correspondence to: M. Breban, Institut de Rhumatologie and Department of Immunology, Hôpital Cochin, 27 rue du Faubourg Saint-Jacques, 75014, Paris, France.
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