ASAS/EULAR Recommendations for AS Management
Impact of TNF Therapy Assessed by MRI

OP0028 ASAS/EULAR RECOMMENDATIONS FOR THE MANAGEMENT OF ANKYLOSING SPONDYLITIS
J. Zochling, D. Van der Heijde, R. Burgos-Vargas, E. Collantes, J. Davis, B. Dijkmans, M. Dougados, P. Gher, R. Inman, M. A. Khan, T. Kvien, M. Leirisalo-Repo, I. Olivieri, K. Pavelka, J. Sieper, G. Stucki, R. Sturrock, S. Van der Linden, H. Bhm, B. Van Royen, D. Wendling, J. Braun

Because of the increase in therapeutic options in the treatment of ankylosing spondylitis, up to date evidence-based management guidelines need to be developed. To do this, the ASessment in AS (ASAS) and the European League Against Rheumatism (EULAR) formed a working group composed of 20 rheumatologists and 2 orthopedic surgeons.

Each member of the work group was able to submit up to 15 key points of AS management. From these, 10-15 questions were selected using the Delphi consensus approach. A systematic search was done to gather scientific evidence and outcomes for each question.

Results: From the literature search, 318 studies were included. As a result of 3 Delphi rounds, 10 key treatment questions were developed including 29 interventions. Evidence supported 11 treatment interventions: NSAIDs (conventional NSAIDs, coxibs, and co-prescription of gastro-protective agents), disease-modifying anti-rheumatic drugs (including sulfasalazine and methotrexate), bisphosphonates, thalidomide, biological therapies (TNF-alpha blockers, IL-1 antagonists), simple analgesics, muscle relaxants and anti-depressants, local and systemic steroids, non-pharmacological therapy (including education, exercise, physiotherapy, psychological intervention, smoking cessation and diet), and surgical interventions.

Conclusion: As a result of the combined efforts of ASAS and EULAR using research-based evidence, ten key recommendations for the management of AS have been developed. Several of the key recommendations are notable:

• There is no evidence to support the efficacy of DMARDs, including sulfasalazine and methotrexate, in the treatment of axial disease
• Sulfasalazine may be considered in patients with peripheral arthritis
• Anti-TNF therapy should be given to patients with persistently high disease activity, despite conventional treatment
• There is no evidence to support the prior or concomitant use of DMARDs with anti-TNF therapy in patients with axial disease

Editorial Comments: These recommendations are consistent with our clinical experience that DMARD agents other than anti-TNF therapies have only modest benefit for axial symptoms. Whether anti-TNF agents are disease modifying remains unknown and studies are hampered by the overall slow rate of radiographic progression in AS.

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FRI0218 TWO-YEAR FOLLOW UP OF ETANERCEPT THERAPY IN ACTIVE ANKYLOSING SPONDYLITIS - A CLINICAL AND MAGNETIC RESONANCE IMAGING STUDY
X. Baraliakos, M. Rudwaleit, J. Listing, J. Brandt, H. Haibel, J. Sieper, J. Braun

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FRI0201 THE EFFECT OF INFLIXIMAB THERAPY ON SPINAL INFLAMMATION ASSESSED BY MAGNETIC RESONANCE IMAGING IN A RANDOMIZED, PLACEBO-CONTROLLED TRIAL OF 279 PATIENTS WITH ANKYLOSING SPONDYLITIS
D. Van der Heijde, R. Landewe, K. Herman, J. Han, P. Williamson, J. Braun

While evaluating radiographic damage over time in ankylosing spondylitis using plain XRays has been difficult, several case series have demonstrated the effect of TNF antagonist therapy in decreasing the inflammatory changes seen with MRI imaging using STIR (short tau inversion recovery) and T1-Gd-DTPA (T1-gadolinium) enhanced imaging.

Methods for scoring MRI images in AS have been developed and standardized and have been used in two posters, FRI0201 and FR0218, in groups of AS patients enrolled in clinical trials for TNF antagonists.

In Abstract FRI0218, etanercept was continued in an open label over 2 years with 21 of an initial 30 patients completing 2 years. Clinical responses continued over this period with BASDAI 50% response achieved by 53.8% of patients at week 102.

During the initial 6 week placebo-controlled phase (FU1), only etanercept treated patients showed a significant improvement in spinal inflammation. During the open label follow up phase (FU2), MRI scores improved further with more than 90% of patients receiving etanercept demonstrating improvement. The table below shows mean MRI scores.

Abstract FRI0201 reported a much larger placebo-controlled study of 266 AS patients with treated with infliximab 5 mg/kg at weeks 0, 2, 6 and every 6 weeks over 24 weeks with evaluable pre and post MRI images of the spine. The mean score from the STIR and T1 methods are used for analysis. The table below represents the actual change in MRI activity scores from baseline to week 24.