Table 11 First update of the international Assessment of SpondyloArthritis international Society (ASAS) consensus statement for the use of anti-tumour necrosis factor (TNF)28
Patient selection:
DiagnosisPatients normally fulfilling modified New York criteria for definitive ankylosing spondylitis
Modified New York criteria 19843
    Radiological criterion: sacroiliitis, grade ⩾II bilaterally or grade III to IV unilaterally
    Clinical criteria (two of the following three): low back pain and stiffness for more than 3 months which improves with exercise but is not relieved by rest; limitation of motion of the lumbar spine in the sagittal and frontal planes; limitation of chest expansion relative to normal values correlated for age and sex
Active diseaseActive disease for ⩾4 weeks
BASDAI ⩾4 (0–10) and an expert* opinion†
Treatment failureAll patients should have had adequate therapeutic trials of at least two NSAIDs. An adequate therapeutic trial is defined as:
    Treatment for at least 3 months at maximum recommended or tolerated anti-inflammatory dose unless contraindicated
    Treatment for <3 months where treatment was withdrawn because of intolerance, toxicity, or contraindications
Patients with pure 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 corticosteroid injection if appropriate
Patients with persistent peripheral arthritis must have had a therapeutic trial of sulfasalazine‡
Patients with symptomatic enthesitis must have failed appropriate local treatment
ContraindicationsWomen who are pregnant or breast feeding; effective contraception must be practised
Active infection
Patients at high risk of infection including:
    Chronic leg ulcer
    Previous tuberculosis (note: please follow local recommendations for prevention or treatment)
    Septic arthritis of a native joint within the past 12 months
    Sepsis of a prosthetic joint within the past 12 months, or indefinitely if the joint remains in situ
    Persistent or recurrent chest infections
    Indwelling urinary catheter
History of lupus or multiple sclerosis
Malignancy or pre-malignancy states excluding:
    Basal cell carcinoma
    Malignancies diagnosed and treated more than 10 years previously (where the probability of total cure is very high)
Assessment of disease:
ASAS core set for daily practicePhysical function (BASFI)
Pain (NRS/VAS, past week, spine at night, from ankylosing spondylitis and NRS/VAS, past week, spine, from ankylosing spondylitis)
Spinal mobility (chest expansion, modified Schober, occiput to wall distance and lateral lumbar flexion)
Patient global assessment (NRS/VAS, past week)
Stiffness (duration of morning stiffness, spine, past week)
Peripheral joints and entheses (number of swollen joints (44 joints count), enthesitis score such as MASES, Berlin, or San Francisco)
Acute phase reactants (ESR or CRP)
Fatigue (NRS/VAS)
BASDAINRS/VAS overall level of fatigue/tiredness, past week
NRS/VAS overall level of ankylosing spondylitis neck, back or hip pain, past week
NRS/VAS overall level of pain/swelling in joints other than neck, back or hips, past week
NRS/VAS overall discomfort from any areas tender to touch or pressure, past week
VAS overall level of morning stiffness from time of awakening, past week
Duration and intensity (VAS) of morning stiffness from time of awakening (up to 120 min)
Assessment of response:
Responder criteriaBASDAI: 50% relative change or absolute change of 20 mm (on a scale between 0 and 100) and expert opinion in favour of continuation
Time of evaluationBetween 6 and 12 weeks
  • *The expert is a doctor, usually a rheumatologist, with expertise in ankylosing spondylitis and the use of biological agents (expert should be locally defined); †the expert should consider clinical features (history and examination), serum acute phase reactant levels and/or imaging results, such as radiographs demonstrating rapid progression or MRI indicating ongoing inflammation; ‡sulfasalazine: treatment for at least 4 months at standard target dose or maximally tolerated dose unless contraindicated or not tolerated. Treatment for less than 4 months, where treatment was withdrawn because of intolerance or toxicity or contraindicated.

  • BASDAI, Bath Ankylosing Spondylitis Disease Activity Index; BASFI, Bath Ankylosing Spondylitis Functional Index; CRP, C-reactive protein; DMARD, disease-modifying antirheumatic drug; ESR, erythrocyte sedimentation rate; MASES, Maastricht Ankylosing Spondylitis Enthesis Score; NSAID, non-steroidal anti-inflammatory drug; VAS, visual analogue scale (all VAS can be replaced by a numerical rating scale (NRS)).