Table 8

 ASAS consensus for anti-TNF treatment

Patient selectionSpecification (definition of the terms)
*The expert is a physician, usually a rheumatologist, with expertise in inflammatory back pain and the use of biological agents. Expert should be locally defined; †an expert opinion comprises both clinical features (history and examination) and serum acute phase reactant levels and/or imaging results, such as radiographs demonstrating rapid progression or MRI scans indicating continuing inflammation; ‡sulfasalazine: treatment for at least 4 months at standard target dose or maximally tolerated dose unless contraindicated or not tolerated. Treatment for <4 months, where treatment was withdrawn because of intolerance or toxicity or contraindicated.
VAS, visual analogue scale; all VAS can be replaced by a numerical rating scale (NRS).
Diagnosis(a) Patients normally fulfilling modified New York Criteria for definitive AS
(b) Modified New York criteria 1984 (van der Linden et al)
Radiological criterion
 - Sacroiliitis, grade ⩾II bilaterally or grade III to IV unilaterally
Clinical criteria (two out of the following three)
 - Low back pain and stiffness for >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
Active disease(a) Active disease for ⩾4 weeks
(b) BASDAI ⩾4 (0–10) and an expert* opinion†
Treatment failure(a) All patients must have had adequate therapeutic trials of at least two NSAIDs. An adequate therapeutic trial is defined as:
 - Treatment for at least 3 months at maximal recommended or tolerated anti-inflammatory dose unless contraindicated
 - Treatment for <3 months where treatment was withdrawn because of intolerance, toxicity, or contraindications
(b) Patients with pure axial manifestations do not have to take DMARDs before anti-TNF treatment can be started
(c) Patients with symptomatic peripheral arthritis should have an insufficient response to at least one local corticosteroid injection, if appropriate
(d) Patients with persistent peripheral arthritis must have had a therapeutic trial of sulfasalazine‡
(e) Patients with symptomatic enthesitis for whom appropriate local treatment failed
Contraindication(a) Women who are pregnant or breast feeding; effective contraception must be practised
(b) Active infection
(c) 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 prosthesis remains in situ
 - Persistent or recurrent chest infections
 - Indwelling urinary catheter
(d) History of lupus or multiple sclerosis
(e) Malignancy or premalignancy 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 practice(a) Physical function (BASFI or Dougados functional index)
(b) Pain (VAS, past week, spine at night, due to AS and VAS, past week, spine due to AS)
(c) Spinal mobility (chest expansion and modified Schober and occiput to wall distance and lateral lumbar flexion)
(d) Patient’s global assessment (VAS, past week)
(e) Stiffness (duration of morning stiffness, spine, past week)
(f) Peripheral joints and entheses (number of swollen joints (44 joint count), enthesitis score such as developed in Maastricht, Berlin, or San Francisco)
(g) Acute phase reactants (ESR or CRP)
(h) Fatigue (VAS)
BASDAI(a) VAS overall level of fatigue/tiredness past week
(b) VAS overall level of AS neck, back, or hip pain past week
(c) VAS overall level of pain/swelling in joints other than neck, back, or hips past week
(d) VAS overall discomfort from any areas tender to touch or pressure past week
(e) VAS overall level of morning stiffness from time of awakening past week
(f) Duration and intensity (VAS) of morning stiffness from time of awakening (up to 120 minutes)
Assessment of response
Responder criteriaBASDAI: 50% relative change or absolute change of 20 mm (on a scale of 0–100) and expert opinion in favour of continuation
Time of evaluationBetween 6 and 12 weeks