Two-year maintenance of efficacy and safety of infliximab in the treatment of ankylosing spondylitis

J Braun ^1*, J Brandt ², J Listing ³, A Zink ³, R Alten ⁴, G Burmester ⁵, W Golder ², E Gromnica-Ihle ⁶, H Kellner ⁷, M Schneider ⁸, H Sörensen ⁹, H Zeidler ¹⁰, J Reddig ¹¹ and J Sieper ²

¹ Rheumazentrum Ruhrgebiet, Germany
² University Medicine Berlin, Germany
³ German Rheumatism Research Center, Berlin, Germany
⁴ Schlosspark Clinic, Berlin, Germany
⁵ Charité Hospital, Humboldt University, Berlin, Germany
⁶ Berlin-Buch Hospital, Berlin Germany
⁷ Ludwig-Maximilians-University, Germany
⁸ Heinrich-Heine-University, Germany
⁹ Immanuel Hospital, Germany
¹⁰ Medical University, Hannover, Germany
¹¹ Essex Pharma, Munich, Germany

^* To whom correspondence should be addressed. E-mail: j.braun{at}rheumazentrum-ruhrgebiet.de.

Accepted 20 June 2004

Abstract

Objective: This report provides results of the second-year extension of the original 3-month randomized, placebo-controlled trial (and the 1-year extension study) assessing the use of infliximab, a monoclonal antibody to tumour necrosis factor alpha (TNF- Ñ), for the treatment of patients with ankylosing spondylitis (AS).

Methods: Of the 54 AS patients who completed the first year of the study, 52 continued to receive infliximab 5 mg/kg every 6 weeks through week 102. The primary endpoint was the proportion of patients achieving at least 50% improvement from baseline in the Bath AS Disease Activity Index (BASDAI) at week 102. Other assessments included patient and physician global assessments, quality of life as assessed by Short Form- 36, Bath AS Functional Index, Bath AS Metrology Index, and C-reactive protein (CRP).

Results: Improvement in signs and symptoms of AS observed during the first year of the study was sustained during the second year. Forty-nine patients (71%, 49/69, of enrolled patients and 94%, 49/52, of patients who started year 2) completed the study through week 102. Thirty patients (58%) achieved at least 50% improvement from baseline in the BASDAI score at week 102. Scores for other efficacy assessments were similar at weeks 54 and 102. Median CRP levels remained low at weeks 54 and 102 (3.9 and 4.3 mg/L, respectively). The side effect profile during the second year of the study was similar to that of the first year of treatment with infliximab.

Conclusions: AS patients treated for 2 years with infliximab 5 mg/kg exhibited a good and durable clinical response.

Keywords: TNFalpha, ankylosing spondylitis, infliximab

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