Dr. Barkham has received speaking fees and a travel grant (less than $10,000 each) from Centocor; the University of Leeds unit within which he works has received research funding from Centocor.
Clinical and imaging efficacy of infliximab in HLA–B27–Positive patients with magnetic resonance imaging–determined early sacroiliitis†
Article first published online: 30 MAR 2009
Copyright © 2009 by the American College of Rheumatology
Arthritis & Rheumatism
Volume 60, Issue 4, pages 946–954, April 2009
How to Cite
Barkham, N., Keen, H. I., Coates, L. C., O'Connor, P., Hensor, E., Fraser, A. D., Cawkwell, L. S., Bennett, A., McGonagle, D. and Emery, P. (2009), Clinical and imaging efficacy of infliximab in HLA–B27–Positive patients with magnetic resonance imaging–determined early sacroiliitis. Arthritis & Rheumatism, 60: 946–954. doi: 10.1002/art.24408
European Clinical Trials (EudraCT) Database: 2004-001880-23, DDX No MS8000MN/13157.
- Issue published online: 30 MAR 2009
- Article first published online: 30 MAR 2009
- Manuscript Accepted: 30 DEC 2008
- Manuscript Received: 13 MAY 2008
Vol. 62, Issue 10, 3005, Article first published online: 29 SEP 2010
To evaluate the efficacy of infliximab in HLA–B27–positive patients with magnetic resonance imaging (MRI)–determined early sacroiliitis, using both clinical and MRI assessments.
Forty patients with recent-onset inflammatory back pain, as assessed by the Calin criteria, HLA–B27 positivity, clinical disease activity as measured by the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI), pain and morning stiffness, and magnetic resonance imaging (MRI)–determined sacroiliac joint bone edema were randomized in a double-blind manner to receive infliximab 5 mg/kg or placebo at 0, 2, 6, and 12 weeks. MRI scans were performed at baseline and 16 weeks and scored by 2 observers (blinded to both the order of the scans and to treatment group), using the Leeds scoring system. Clinical assessments included the BASDAI, the Bath Ankylosing Spondylitis Functional Index (BASFI), the Ankylosing Spondylitis Quality of Life (ASQoL) instrument, the ASsessment in Ankylosing Spondylitis International Working Group criteria (ASAS) for improvement, and markers of inflammation.
The mean reduction in the total MRI score from week 0 to week 16 was significantly greater in infliximab-treated patients compared with placebo-treated patients (P = 0.033). On average, significantly more lesions resolved in the infliximab group (P < 0.001), while significantly more new lesions developed in the placebo group (P = 0.004). Significantly greater improvement in the infliximab group versus the placebo group was also observed for changes from week 0 to week 16 in the BASDAI (P = 0.002), BASFI (P = 0.004), and ASQoL (P = 0.007) scores. Responses according to the ASAS criteria for 40% improvement, the ASAS criteria for 20% improvement in 5 of 6 domains, and ASAS partial remission were achieved by 61%, 44%, and 56% of infliximab-treated patients, respectively. Infliximab was well tolerated, and no serious adverse events were observed.
Infliximab was an effective therapy for early sacroiliitis, providing a reduction in disease activity by week 16. This study is the first to show that infliximab is effective for reducing clinical and imaging evidence of disease activity in patients with MRI-determined early axial spondylarthritis.