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OP0063 Three months results of a double-blind placebo controlled, phase-iii clinical trial of infliximab in active ankylosing spondylitis
  1. J Brandt1,
  2. R Alten2,
  3. G Burmester3,
  4. E Gromnica-Ihle4,
  5. H Kellner5,
  6. M Schneider6,
  7. H Sörensen7,
  8. H Zeidler8,
  9. W Thriene9,
  10. J Sieper10,11,
  11. J Braun12
  1. 1Nephrology, Benjamin Franklin Hospital, Free University Berlin
  2. 2Schlosspark-Clinic, Berlin
  3. 3Rheumatology, Humboldt University, Berlin
  4. 4Rheumatology-Hospital Berlin-Buch
  5. 5Rheumatology, Ludwig-Maximilians-University, Munich
  6. 6Rheumatology, Heinrich Heine University, Duesseldorf
  7. 7Immanuel-Hospital, Berlin
  8. 8Rheumatology, University of Hannover
  9. 9Essex Pharma, Munich, Germany
  10. 10Gastroenterology/Rheumatology, Benjamin Franklin Hospital, Free University Berlin
  11. 11German Rheumatology Research Center, Berlin
  12. 12Rheumazentrum Ruhrgebiet, Herne

Abstract

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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