ASAS consensus for anti-TNF treatment
| Patient selection | Specification (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4 months, where treatment was withdrawn because of intolerance or toxicity or contraindicated.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3 months where treatment was withdrawn because of intolerance, toxicity, or contraindications | |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 criteria | BASDAI: 50% relative change or absolute change of 20 mm (on a scale of 0–100) and expert opinion in favour of continuation |
| Time of evaluation | Between 6 and 12 weeks |