Background Recently, patients with severe ankylosing spondylitis (AS) significantly improved upon treatment with the anti-tumour necrosis factor a (TNFa) antibody infliximab (RemicadeR) in an open pilot study (A&R June 2000). Therefore, a placebo-controlled trial was designed to prove that the administration of infliximab has a beneficial effect on the short and long term course of severe AS.
Methods Seventy patients (47 men, 23 women) with a mean age of 39.2 years and proven AS (1984 New York criteria) in an active stage of disease were included in the study. Active disease was defined as a Bath AS Disease Activity Index (BASDAI) > 4 and pain > 4 on a numeric rang scale (NRS). The patients were randomised into two groups of 35 patients each which received either infliximab in a dosage of 5 mg/kg i.v. or placebo. Infusions were given at week 0, 2 and 6 and then every 6 weeks until week 48. The BASDAI, BASFI (Functional Index), BASMI (Metrology Index), pain on a NRS, quality of life by the SF36 and CRP were measured. Patients with > 50% improvement of BASDAI was defined as a responder. The study started on August 15th 2000; the last patient was included on 19th October 2000.
Results The last patient has finished the placebo-controlled part of the study on January 25th 2001. Sixty-six patients have completed the three-months placebo-controlled period. One patient developed tuberculosis. The three-months-follow up data which are just being analysed are presented at the EULAR-Meeting in June 2001.
Conclusion The subjective therapeutic efficacy in some of the patients was impressive but the results of the ongoing analysis have to be awaited.
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