Table 2

2010 Update of recommendations for the use of anti-tumour necrosis factor agents in patients with axial SpA (including AS)

Recommendation
Patient selection
Diagnosis
  • Patients fulfilling modified New York Criteria for definitive AS* or the ASAS criteria for axial SpA

Active disease
  • Active disease for ≥4 weeks

  • BASDAI ≥ 4 (0–10) and a positive expert opinion§

Treatment failure
  • All patients should have had adequate therapeutic trials of at least two NSAIDs. An adequate therapeutic trial is defined as at least two NSAIDs over a 4-week period in total at maximum recommended or tolerated anti-inflammatory dose unless contraindicated

  • Patients with predominantly axial manifestations do not have to take DMARDs before anti-TNF treatment can be started

  • Patients with symptomatic peripheral arthritis should have an insufficient response to at least one local steroid injection if appropriate and should normally have had adequate a therapeutic trial of a DMARD, preferably sulfasalazine

  • Patients with symptomatic enthesitis must have failed appropriate local treatment

Assessment of disease
ASAS core set for daily practice and BASDAI
Assessment of response
Responder criteria
  • BASDAI: 50% relative change or absolute change of 2 (on 0–10 scale) and expert opinion in favour of continuation

Time of evaluation
  • After at least 12 weeks

  • * Modified New York criteria (van der Linden et al, 1984): Radiological criterion (sacroiliitis, grade ≥II bilaterally or grade III to IV unilaterally) and at least two out of three clinical criteria (low back pain and stiffness for more than 3 months that improves with exercise but is not relieved by rest; limitation of motion of the lumbar spine in both the sagittal and frontal planes; limitation of chest expansion relative to normal values correlated for age and sex).5

  • See figure 1 for the ASAS axial SpA criteria.6

  • BASDAI assessed on a 0–10 VAS or NRS.14

  • § The expert is a doctor, usually a rheumatologist, with expertise in inflammatory back pain and the use of biological agents. Experts should be locally defined. An expert opinion should consider clinical features (history and examination) as well as either serum acute phase reactant levels or imaging results, such as radiographs demonstrating rapid progression or MRI scans indicating inflammation.

  • ASAS core set for daily practice: physical function (BASFI); Pain (VAS/NRS, last week, spine at night, due to AS and VAS/NRS, last week, spine due to AS); spinal mobility (chest expansion, cervical rotation, occiput-to-wall distance, modified Schober, and (lateral lumbar flexion or BASMI); patient's global assessment (VAS/NRS, last week); stiffness (duration of morning stiffness, spine, VAS/NRS, last week); peripheral joints and entheses (number of swollen joints (44 joints count), enthesitis score such as developed in Maastricht, Berlin or San Francisco); acute phase reactants (preferably CRP); fatigue (VAS/NRS).

  • AS, ankylosing spondylitis; ASAS, Assessment in SpondyloArthritis international Society; BASDAI, Bath Ankylosing Spondylitis Disease Activity Index; BASFI, Bath Ankylosing Spondylitis Functional Index; BASMI, Bath Ankylosing Spondylitis Metrology Index; CRP, C-reactive protein; DMARD, disease-modifying antirheumatic drug; NRS, numerical rating scale; NSAID, non-steroidal anti-inflammatory drug; SpA, spondyloarthritis; TNF, tumour necrosis factor; VAS, visual analogue scale.