Patient selection
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All patients must have had adequate therapeutic trials of at least 2 NSAIDs. An adequate therapeutic trial is defined as: Treatment for ⩾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3 months where treatment was withdrawn because of intolerance, toxicity, or contraindications
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Patients with symptomatic peripheral arthritis (normally having a lack of response to a local steroid injection for those with oligoarticular involvement) must have had adequate therapeutic trial of both NSAIDs and sulfasalazine‡
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Patients with symptomatic enthesitis must have had an adequate therapeutic trial of at least two local steroid injections unless contraindicated
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Women who are pregnant or breastfeeding; effective contraception must be practised
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Active infection
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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
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History of lupus or multiple sclerosis
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Malignancy or premalignancy states excluding:
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Assessment of disease
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Physical function (BASFI or Dougados functional index)
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Pain (VAS, past week, spine at night, due to AS and VAS, past week, spine due to AS)
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Spinal mobility (chest expansion and modified Schober test and occiput to wall distance and lateral lumbar flexion)
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Patient’s global assessment (VAS, past week)
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Stiffness (duration of morning stiffness, spine, past week)
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Peripheral joints and entheses (number of swollen joints (44 joint count), enthesitis score such as developed in Maastricht, Berlin, or San Francisco)
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Acute phase reactants (ESR or CRP)
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Fatigue (VAS)
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VAS overall level of fatigue/tiredness past week
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VAS overall level of AS neck, back, or hip pain past week
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VAS overall level of pain/swelling in joints other than neck, back or hips past week
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VAS overall discomfort from any areas tender to touch or pressure past week
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VAS overall level of morning stiffness from time of awakening past week
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Duration and intensity (VAS) of morning stiffness from time of awakening (up to 120 minutes)
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Assessment of response
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| BASDAI: 50% relative change or absolute change of 2 (scale 0–10) and expert opinion: Continuation yes/no |
| Between 6 and 12 weeks |