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Infliximab Safe, Highly Effective In Treating Refractory Ankylosing Spondylitis
A DGReview of :"Efficacy of infliximab in refractory ankylosing spondylitis: results of a six-month open-label study."
Rheumatology Online
11/21/2002
By Andrew A. Skolnick
The anti-tumour necrosis factor alpha antibody, infliximab, appears to be a safe and highly effective therapy for patients with refractory ankylosing spondylitis.
Dr. Maxime Breban at the, Hopital Cochin, Universite Rene Descartes, in Paris, France, and colleagues evaluated the safety and efficacy of a loading regimen of infliximab in patients with predominantly axial severe ankylosing spondylitis.
The study involved 50 patients, 76 percent of whom were men and 87 percent of whom were HLA-B27+. Their mean age was 35 years and they had a median disease duration of 13 years. All had active ankylosing spondylitis despite treatment with a non-steroidal anti-inflammatory drug, but were without peripheral arthritis, uveitis or active inflammatory bowel disease.
Other disease-modifying anti-rheumatic drugs were discontinued at least three months before inclusion and were not allowed during the study. Patients received three infusions of infliximab (5 mg/kg) at the start of the study and at the second and sixth week. They were monitored clinically and biologically until the 24th week, the investigators noted.
Forty-eight of the 50 patients completed the treatment. In intention-to-treat analysis, all parameters were significantly improved by the second week and generally reached maximal improvement by the eight week.
The proportion of responders, defined by a reduction greater than or equal to 20 percent in the global assessment of pain or by the ankylosing spondylitis Assessment Study Group (ASAS 20 percent) criteria, and the proportion of patients reaching partial remission were 98, 94 and 70 percent respectively, the investigators reported.
Relapse, defined as greater than or equal to 50 percent loss of maximal global assessment of pain improvement, occurred in 73 percent of completers, with a median delay of 14 weeks after the third infusion. No serious adverse event related to the treatment was observed.
"This study confirms, in a large group of severely affected ankylosing spondylitis patients, the remarkable efficacy of infliximab," the researchers concluded. "Relapse usually occurred after discontinuation of the drug, but almost one-third of completers were still free of relapse four months after the last infusion."
Rheumatology (Oxford) 2002; 11: 1280-1285.
"Efficacy of infliximab in refractory ankylosing spondylitis: results of a six-month open-label study."
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