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Presseberichte und Studien zu TNF-alpha-Blockern bei Morbus Bechterew
Neue und aktuelle Studien:
Efficacy of infliximab in refractory ankylosing spondylitis: results of a six-month open-label study
M. Breban 1,2, E. Vignon 3, P. Claudepierre 4, V. Devauchelle 5, D. Wendling 6, E. Lespessailles 7, L. Euller-Ziegler8, J. Sibilia 9, A. Perdriger 10, M. Mezie`res1, C. Alexandre 11 and M. Dougados1 1Institut de Rhumatologie and 2De´partement d’Immunologie, Hoˆpital Cochin, Universite´ Rene´ Descartes, Paris, 3 Service de Rhumatologie, Centre Hospitalier Lyon Sud, Pierre-Be´nite, 4Service de Rhumatologie, Hospital Henri Mondor, Cre´teil, 5Service de Rhumatologie, Hospital de la Cavale Blanche, Brest, 6Service de Rhumatologie, Hoˆpital Jean Minjoz, Besanc¸on, 7Service de Rhumatologie, Centre Hospitalier Re´gional, Orle´ans, 8Service de Rhumatologie, Hospital Archet, Nice, 9 Service de Rhumatologie, Hospital de Hautepierre, Strasbourg, 10 Service de Rhumatologie, Hospital Sud, Rennes and 11Service de Rhumatologie, Hospital Bellevue, Saint-Etienne, France
Abstract
Objective. To evaluate the efficacy and safety of a loading regimen of the anti-tumour necrosis factor a (TNF-a) 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 wBath Ankylosing Spondylitis Disease Activity Index (BASDAI) 030u100 and serum C-reactive protein concentration 015 mgul) 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 03 months before inclusion and were not allowed during the study. Patients received three infusions of infliximab (5 mgukg) 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 020% 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 050% 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. Rheumatology 2002;41:1280–1285
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