Arthritis & Rheumatism, Volume 63,
November 2011 Abstract Supplement
Abstracts of the American College of
Rheumatology/Association of Rheumatology Health Professionals
Annual Scientific Meeting
Chicago, Illinois November 4-9, 2011.
Long Term Results of a Remission Induction Approach to Early Axial Spondyloarthritis: Still Looking for the Window of Opportunity.
Ash1, Zoe R., Barkham1, Nick, McGonagle1, Dennis, Hensor2, Elizabeth, Emery1, Paul, Marzo-Ortega1, Helena
We have previously reported on an RCT assessing the efficacy of infliximab in very early axial SpA. Importantly, the clinical improvements correlated with resolution of MRI inflammatory spinal lesions. However, the key question is whether this early suppression of inflammatory activity translates into arrest of new bone formation, the hallmark of AS. We now report on the long term outcome of these patients, followed up at five years.
In the initial study patients received infliximab or placebo for 16 weeks. Subjects were then observed up to week 40 and were eligible for open-label treatment with infliximab on disease flare (BASDAI>=4). In the current phase subjects underwent a clinical assessment and laboratory investigations. Current imaging included whole spine and SIJ MRI to assess for ongoing disease activity and radiographs of the SIJs, lumbar and cervical spine to assess for disease progression including fulfilment of the modified New York criteria (mNYC).
So far, 64% (25/39) of the patients who completed the original study have been assessed, 80% (20 patients) of whom are currently receiving an anti-TNF agent (8 adalimumab, 9 etanercept, 3 infliximab) and 52% are taking NSAIDs. The majority of patients have well controlled disease, with a median disease activity (BASDAI) of 0.65, median BASFI of 0.50. CRP is <5 mg/L in 88% (22/25) of the patients.
No substantive differences were seen in current disease activity or radiographic progression between patients who received infliximab in the initial randomised phase and those who received placebo. However, only 58% (7/12) of those who initially received infliximab are still on an anti-TNF agent, in comparison to 100% (13/13) of those who received placebo. Of those not on an anti-TNF agent, four remain well with minimal or no symptoms, one patient has active disease (BASDAI 4.52) but has defaulted from treatment.
Complete radiographic data was available for 15 patients (radiographs at baseline and follow up). Three patients fulfilled the mNYC for AS at baseline. The remaining 12 patients all have evidence of radiographic progression in the SIJs, with 8 patients now meeting the mNYC for AS. The median mSASSS score was low at 3.7, suggesting little progression within the spine. No patients have progressed to complete spinal ankylosis. Current MRI scans show very little active disease. No substantive differences were found in baseline disease activity scores or MRI findings between patients who now fulfil radiographic criteria for AS and those who do not. However a higher percentage of those with AS than those with non-radiographic axial SpA are now receiving NSAIDs (67% vs. 30%) and anti-TNF (92% vs. 70%).
A third of axial SpA patients treated early with a 3 month course of infliximab remain well and off treatment after 5 years, while all patients initially randomised to placebo continue to require anti-TNF treatment. Despite patients reporting a good clinical status with overall low disease activity and good function, it appears that there is ongoing SIJ radiographic progression in a significant proportion of patients. However this is a small study and these findings require confirmation in larger cohorts.
To cite this abstract, please use the following information:
Ash, Zoe R., Barkham, Nick, McGonagle, Dennis, Hensor, Elizabeth, Emery, Paul, Marzo-Ortega, Helena; Long Term Results of a Remission Induction Approach to Early Axial Spondyloarthritis: Still Looking for the Window of Opportunity. [abstract]. Arthritis Rheum 2011;63 Suppl 10 :1285