PMID: 16624120Apr 21, 2006Paper

A short-term efficacy and safety study of infliximab in active ankylosing spondylitis

Zhonghua nei ke za zhi
Feng HuangYong Hou

Abstract

To evaluate the efficacy and safety profile of a loading regimen of the anti-TNFalpha antibody infliximab in ankylosing spondylitis (AS). This was an open-labeled trial. Subjects eligible for this study were adults with a diagnosis of definite AS. Active disease was a Bath AS disease activity index (BASDAI) > or = 4 and spinal pain VAS > or = 4. Concurrent stable treatment with nonsteroidal anti-inflammatory drugs was permitted during the study. Subjects were not permitted to be on methotrexate, systemic corticosteroids, cytotoxic drugs or disease-modifying anti-rheumatic drugs for various time periods before screening. Infliximab 5 mg/kg was infused at weeks 0, 2, 6. All patients were followed up to 10 weeks. The primary endpoint was proportion of ASAS 20 responders at week 10. The secondary endpoints were the proportion of subjects achieving an ASAS partial remission, the change from baseline in bath AS functional index and in the physical component summary score of the short form-36 in health survey questionnaire at week 10. Other secondary endpoints, related to reducing signs and symptoms of AS and improving range of motion and physical function, were evaluated. 63 patients (79% males, 90% HLA-B(27)(+), median age 32 yr, me...Continue Reading

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