Guidelines for the Use of Anti-TNF Therapy in Patients with Ankylosing Spondylitis
BREAKDOWN OF CRITERIA
Therapy with biologics (anti-TNF agents) has been shown to provide significant clinical benefit in patients with AS and other forms of spondyloarthritis. Guidelines for their use have been developed by ASAS (Assessments in Ankylosing Spondylitis Working Group) and published in the September issue of Annals of Rheumatic Diseases.
As an international research group, ASAS recommended that the Guidelines be modified to meet the specific realities of clinical practice in each country. US modifications of the ASAS guidelines should be considered for the daily practice of rheumatologists in the United States.
Patient Assessment Downloads:
OVERVIEW OF ASAS & US Modifications of the ASAS Guidelines
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ASAS
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US Modifications of the ASAS Guidelines
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Diagnosis
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- Modified New York Criteria
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- Modified New York Criteria
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Disease Activity
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- BASDAI Score >4 (Scale 0-10cm)
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- Physician Global Assessment by "expert" opinion(yes/no)
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- BASDAI Score of > 4cm (Scale 0-10cm)
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- Physician Global Assessment of 2 or greater on Likert Scale (0=none, 1=mild, 2=moderate, 3=severe, 4=very severe)
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Previous Treatment
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- Failure by lack of response or intolerability to > 2 NSAIDS** for 3 months for all clinical 3 presentations: axial, peripheral arthritis and enthesitis
- Patients with peripheral arthritis also having a lack of response to a local steroid injection for those with oligoarticular involvement) must have had a lack of response to both NSAID's and sulfasalazine.
- Patients with enthesitis must have had an adequate trial of at least two local steroid injections unless contraindicated
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- Failure by lack of response or intolerability to > 2 NSAIDS** for 3 months for all clinical 3 presentations: axial, peripheral arthritis and enthesitis
- Patients with peripheral arthritis must have had a lack of response or intolerability to >1 DMARD (sulfasalazine preferred) for peripheral arthritis. Not required for axial disease or enthesitis (Steriod injection not required)
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Dosing
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- Etanercept 25 mg sq twice a week.
- Infliximab 5 mg/kg IV every 6-8 weeks.
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- Etanercept 25 mg sq twice a week.
- Infliximab 5 mg/kg IV every 6-8 weeks.
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Responder Criteria
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- 50% improvement of BASDAI or absolute change of 2 on 0-10 cm scale and "expert" opinion
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- Improvement in BASDAI by at least 2 Units and Physician Global of > 1
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Time of Evaluation
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TB Precaution
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- Use country specific guidelines
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- TB screening and treatment per the American Thoracic Association recommendations
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