Arthritis & Rheumatism, Volume 62,
November 2010 Abstract Supplement
Abstracts of the American College of
Rheumatology/Association of Rheumatology Health Professionals
Annual Scientific Meeting
Atlanta, Georgia November 6-11, 2010.
Continued Efficacy of Infliximab in the Treatment of HLA B27 Positive Very Early Ankylosing Spondylitis Following Its Discontinuation; Clinical and Imaging Results of the 40 Week Follow-Up Study of a Three Month, Randomised, Placebo-Controlled Trial.
Barkham3, Nick, Keen4, Helen, Coates4, Laura, O'connor2, Phil, Hensor4, Elizabeth, McGonagle4, Dennis, Marzo-Ortega4, Helena
Treatment of early inflammatory back pain (AS in evolution) with infliximab, was shown to be efficacious during a 3 month treatment period. The current report describes the clinical and imaging outcomes following discontinuation of infliximab treatment.
Following an initial randomised, placebo controlled trial, all patients who had received either infliximab or placebo for 3 months discontinued treatment and were followed up to week 40 or time of clinical flare (BASDAI>4).
MRI scans of the spine and sacroiliac joints were performed at baseline, week 16, and week 40 or time of clinical flare. MRIs were scored by 2 observers blinded to treatment group and order using the Leeds 03 MRI grading system.
In the placebo group, 17/19 patients (89.5%) had a high BASDAI at some point between the end of treatment (12 weeks) and the end of observation (40 weeks), compared to 12/19 (60.0%) in the infliximab group (Chi-square=4.44, df=1, P=0.035). Time to BASDAI>4 was shorter in patients who had received placebo [median (IQR) 5.0 weeks (4.0 to 16.0)] than those who had received infliximab [20.0 weeks (7.9 to 28.0), Log-rank Chi-square=5.77, P=0.016]. Between baseline and endpoint (at first BASDAI>=4 or week 40), infliximab patients showed significantly greater improvements in ASQoL(p=0.05), BASFI (p=0.033) and BASDAI (p=0.045).
Considering MRI lesions >= grade 2 (lesions not seen in normal spine MRI scans), in the 10 patients who reached week 40 without clinical flare (8 infliximab treated, 2 placebo), there was only one lesion >= grade 2 present at week 16 and no new lesions developed on the follow-up scan. In the 11 patients who flared between wk 16 and week 40 (6 infliximab 5 placebo) there were 8 grade>1 lesions present at week 16 and 12 new lesions developed.
A short course of infliximab treatment results in prompt suppression of disease activity and improvement in quality of life in early AS, which is sustained on withdrawal of therapy. Fewer patients who had received active therapy flared by week 40, and those who did not flare demonstrated no progression of grade>1 lesions on MRI. This raises the possibility that the "remission induction" approach could work in a subset of patients with early AS. As previously reported for the SIJ, the prognostic value of persistent >=grade 2 lesions is demonstrated, and MRI could allow early identification of patients with subclinical disease prior to the onset of clinical flare.
To cite this abstract, please use the following information:
Barkham, Nick, Keen, Helen, Coates, Laura, O'connor, Phil, Hensor, Elizabeth, McGonagle, Dennis, et al; Continued Efficacy of Infliximab in the Treatment of HLA B27 Positive Very Early Ankylosing Spondylitis Following Its Discontinuation; Clinical and Imaging Results of the 40 Week Follow-Up Study of a Three Month, Randomised, Placebo-Controlled Trial. [abstract]. Arthritis Rheum 2010;62 Suppl 10 :1929