First update of the International ASAS Consensus Statement for the use of anti-TNF agents in patients with ankylosing spondylitis

Jürgen Braun ^1*, John Davis ², Maxime Dougados ³, Joachim Sieper ⁴, Sjef van der Linden ⁵ and Désirée van der Heijde ⁵

¹ Rheumazentrum Ruhrgebiet, Germany
² Division of Rheumatology, University of California San Francisco, San Francisco, United States
³ Department of Rheumatology, Hopital Cochin, University of Paris, France
⁴ Medical Department I, Rheumatology, Benjamin Franklin Hospital, Free University Berlin, Germany
⁵ Department of Internal Medicine, Division of Rheumatology, University of Maastricht, Netherlands

^* To whom correspondence should be addressed. E-mail: j.braun{at}rheumazentrum-ruhrgebiet.de.

Accepted 29 July 2005

Abstract

Background: In the first consensus statement on anti-TNF therapy in patients with ankylosing spondylitis (AS) published in 2003 the ASsessment in AS (ASAS) international working group decided to update the recommendations every 2 years. This is the first biyearly update for the initiation, monitoring, and discontinuation of such agents in AS.

Objective: To update the international consensus and recommendations for the use of anti-TNF agents in the clinical practice of treating patients with AS.

Methods: The published recommendations on anti- TNF therapy in AS patients formed the basis of this update. The update was facilitated by a questionnaire sent to the ASAS members before the final decisions were agreed upon at an international meeting of the ASAS working group.

Results: Overall, the participants were satisfied with the published recommendations. Consequently, only minor changes to the original consensus statement were required: 1.] For the initiation of anti-TNF therapy: a.) a diagnosis of definitive AS (normally based on modified New York criteria); b.) active disease for at least 4 weeks as defined by both a sustained Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) of > 4 on a 0-10 scale and an expert opinion based on clinical features, acute phase reactants, and imaging modalities; c.) refractory disease defined by failure of at least 2 nonsteroidal anti-inflammatory drugs (NSAIDs) during a 3 month period, failure of intraarticular steroids (if indicated), and failure of sulfasalazine in patients with predominantly peripheral arthritis; d.) application of the usual precautions and contraindications for biologic therapy should be followed. 2.] For the monitoring of anti-TNF therapy: both the ASAS core set for clinical practice and the BASDAI should be followed after the initiation of treatment. 3.] The discontinuation of anti-TNF therapy in non-responders should be considered after 6-12 weeks of therapy. Response is defined by improvement of a.) at least 50% or 2 units (on a 0-10 scale) of the BASDAI and b.) expert opinion that treatment should be continued.

Conclusion: This updated consensus statement is recommended in guiding clinical practice and may serve as a basis for development of national guidelines. Evaluation and regular update of this consensus statement is subject to further research by the ASAS group.

Keywords: adalimumab, ankylosing spondylitis, etanercept, infliximab, tumor necrosis factor (TNF)-a

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