Persistent clinical efficacy and safety of anti-tumour necrosis factor α therapy with infliximab in patients with ankylosing spondylitis over 5 years: evidence for different types of response
- J Braun1,
- X Baraliakos1,
- J Listing2,
- C Fritz2,
- R Alten3,
- G Burmester4,
- A Krause5,
- S Schewe6,
- M Schneider7,
- H Sörensen8,
- H Zeidler9,
- J Sieper10
- 1Rheumatology Medical Center Ruhrgebiet, Herne
- 2German Rheumatism Research Center, Berlin
- 3Schlosspark Clinic, Berlin
- 4Charité Hospital, Humboldt University, Berlin
- 5Berlin-Buch Hospital, Berlin
- 6Ludwig-Maximilians-University, Munich
- 7Heinrich-Heine-University, Düsseldorf
- 8Immanuel Hospital, Berlin
- 9Medical University, Hannover
- 10University Medicine Berlin, Campus Benjamin Franklin, all Germany
- Prof.Dr. J Braun, Rheumazentrum Ruhrgebiet, Landgrafenstr. 15, 44652 Herne, Germany;
- Received 2 October 2007
- Published Online First 29 October 2007
Background: There is insufficient evidence for the long-term efficacy and safety of anti-tumour necrosis factor therapy in patients with ankylosing spondylitis (AS). This is the first report on the treatment with infliximab over 5 years.
Methods: As part of a multicentre randomised trial, 69 patients with active AS at baseline (BL) have been continuously treated with infliximab (5 mg/kg i.v. every 6 weeks)—except for a short discontinuation after 3 years (FU1). The primary outcome of this extension was remission according to the ASsessment in Ankylosing Spondylitis (ASAS) criteria at the end of year 5 of the study (FU2).
Results: Of the 43 patients who completed year 3, 42 agreed to continue, 38 of which (90.5%) finished year 5 (55% of 69 initially). Partial clinical remission was achieved in 13 of 38 patients (34.2%) at FU1 and FU2. At FU2, the mean Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) was 2.5±1.9 (BL:6.4, FU1:2.5). BASDAI values <4 were seen in 79% of patients at both, FU1 and FU2. ASAS 20% and 40% responses were seen in 32 (84%) and 24 (63%) patients at FU2, respectively. Most patients classified as non-responders at FU2 were part-time responders, as all but one patient achieved an ASAS 20% response at least once within the last 2 years. Three types of responders were identified. No major side effects occurred during years 4 and 5 of infliximab therapy.
Conclusions: Infliximab is safe and efficacious in AS patients over 5 years. The majority of the patients remained on treatment and had rather persistent levels of low disease activity. Different response types could be identified.
Competing interests: Professors Braun and Sieper have received honoraria and grants from Centocor, Schering-Plough, Wyeth, Amgen, and Abbott.