Abstract
Objective: To obtain results of the second year extension of an original 3 month randomised, placebo controlled trial (and the 1 year extension study) assessing the use of infliximab, a monoclonal antibody to tumour necrosis factor α, for the treatment of patients with ankylosing spondylitis (AS).
Methods: Of the 54 patients with AS who completed the first year of the study, 52 continued to receive infliximab 5 mg/kg every 6 weeks up to week 102. The primary end point 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 seen during the first year of the study was sustained during the second year. Forty nine patients (71% of 69 enrolled patients and 49/52 (94%) patients who started year 2) completed the study up to week 102. Thirty (58%) patients 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). Side effects during the second year of the study were similar to those of the first year of treatment with infliximab.
Conclusions: Patients with AS treated for 2 years with infliximab 5 mg/kg exhibited a good and durable clinical response.
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Figure 1.
Summary of patient disposition up to week 102.
Figure 2.
Maintenance of response to infliximab treatment (ITT study group), as assessed by (A) at least 50% improvement in the BASDAI; (B) at least 40% improvement in the criteria of the ASAS working group; and (C) improvement of at least 20% in the ASAS 5 out of 6 criteria for AS.
Figure 3.
Sustained improvement of patients of the second year study group over 2 years of follow up, as assessed by the mean BASDAI, mean BASFI, and mean BASMI.
Selected References
These references are in PubMed. This may not be the complete list of references from this article.
- Anderson J. J., Baron G., van der Heijde D., Felson D. T., Dougados M. Ankylosing spondylitis assessment group preliminary definition of short-term improvement in ankylosing spondylitis. Arthritis Rheum. 2001 Aug;44(8):1876–1886. doi: 10.1002/1529-0131(200108)44:8<1876::AID-ART326>3.0.CO;2-F. [DOI] [PubMed] [Google Scholar]
- Baert Filip, Noman Maja, Vermeire Severine, Van Assche Gert, D' Haens Geert, Carbonez An, Rutgeerts Paul. Influence of immunogenicity on the long-term efficacy of infliximab in Crohn's disease. N Engl J Med. 2003 Feb 13;348(7):601–608. doi: 10.1056/NEJMoa020888. [DOI] [PubMed] [Google Scholar]
- Brandt J., Listing J., Sieper J., Rudwaleit M., van der Heijde D., Braun J. Development and preselection of criteria for short term improvement after anti-TNF alpha treatment in ankylosing spondylitis. Ann Rheum Dis. 2004 Mar 25;63(11):1438–1444. doi: 10.1136/ard.2003.016717. [DOI] [PMC free article] [PubMed] [Google Scholar]
- Braun J., Brandt J., Listing J., Zink A., Alten R., Burmester G., Golder W., Gromnica-Ihle E., Kellner H., Schneider M. Long-term efficacy and safety of infliximab in the treatment of ankylosing spondylitis: an open, observational, extension study of a three-month, randomized, placebo-controlled trial. Arthritis Rheum. 2003 Aug;48(8):2224–2233. doi: 10.1002/art.11104. [DOI] [PubMed] [Google Scholar]
- Braun J., Brandt J., Listing J., Zink A., Alten R., Golder W., Gromnica-Ihle E., Kellner H., Krause A., Schneider M. Treatment of active ankylosing spondylitis with infliximab: a randomised controlled multicentre trial. Lancet. 2002 Apr 6;359(9313):1187–1193. doi: 10.1016/s0140-6736(02)08215-6. [DOI] [PubMed] [Google Scholar]
- Braun J., de Keyser F., Brandt J., Mielants H., Sieper J., Veys E. New treatment options in spondyloarthropathies: increasing evidence for significant efficacy of anti-tumor necrosis factor therapy. Curr Opin Rheumatol. 2001 Jul;13(4):245–249. doi: 10.1097/00002281-200107000-00001. [DOI] [PubMed] [Google Scholar]
- Calin A., Garrett S., Whitelock H., Kennedy L. G., O'Hea J., Mallorie P., Jenkinson T. A new approach to defining functional ability in ankylosing spondylitis: the development of the Bath Ankylosing Spondylitis Functional Index. J Rheumatol. 1994 Dec;21(12):2281–2285. [PubMed] [Google Scholar]
- Clegg D. O., Reda D. J., Weisman M. H., Blackburn W. D., Cush J. J., Cannon G. W., Mahowald M. L., Schumacher H. R., Jr, Taylor T., Budiman-Mak E. Comparison of sulfasalazine and placebo in the treatment of ankylosing spondylitis. A Department of Veterans Affairs Cooperative Study. Arthritis Rheum. 1996 Dec;39(12):2004–2012. doi: 10.1002/art.1780391209. [DOI] [PubMed] [Google Scholar]
- Garrett S., Jenkinson T., Kennedy L. G., Whitelock H., Gaisford P., Calin A. A new approach to defining disease status in ankylosing spondylitis: the Bath Ankylosing Spondylitis Disease Activity Index. J Rheumatol. 1994 Dec;21(12):2286–2291. [PubMed] [Google Scholar]
- Jenkinson T. R., Mallorie P. A., Whitelock H. C., Kennedy L. G., Garrett S. L., Calin A. Defining spinal mobility in ankylosing spondylitis (AS). The Bath AS Metrology Index. J Rheumatol. 1994 Sep;21(9):1694–1698. [PubMed] [Google Scholar]
- Maini R. N., Breedveld F. C., Kalden J. R., Smolen J. S., Furst D., Weisman M. H., St Clair E. W., Keenan G. F., van der Heijde D., Marsters P. A. Sustained improvement over two years in physical function, structural damage, and signs and symptoms among patients with rheumatoid arthritis treated with infliximab and methotrexate. Arthritis Rheum. 2004 Apr;50(4):1051–1065. doi: 10.1002/art.20159. [DOI] [PubMed] [Google Scholar]
- Ware J. E., Jr, Sherbourne C. D. The MOS 36-item short-form health survey (SF-36). I. Conceptual framework and item selection. Med Care. 1992 Jun;30(6):473–483. [PubMed] [Google Scholar]