Methotrexate in the Treatment of Axial Spondyloarthritis

Inclusion Criteria:

• Inflammatory back pain (definition in Calin et al. JAMA 1977;237:2613-4) as the presenting symptom,
• Positive laboratory test result for HLA-B27,
• Active sacroiliitis in MRI read by qualified radiologist,
• Active disease despite treatment with at least two NSAIDs.

Active disease is defined as:

1. a score of ≥ 30 mm for morning stiffness (average of 2 scores on a 100 mm visual analog scale [VAS] analysing duration and intensity of morning stiffness),
2. scores of ≥ 30 mm VAS for 2 of the following 3 parameters: patient's global assessment of disease activity, back pain and the Bath Ankylosing Spondylitis Functional Index (BASFI).

Exclusion Criteria:

• Known hypersensitivity to methotrexate
• Have received sulfasalazine within 4 weeks prior to the first administration of study agent
• Using oral corticosteroids on a dose equivalent to ≥10 mg of prednisone/day
• Any concomitant rheumatic disease other than spondyloarthritis
• Fibromyalgia
• Pregnant or breast feeding
• Have had a serious infection within 1 month
• Have any known malignancy or have a history of malignancy within the previous 5 years
• Have current signs or symptoms of severe or uncontrolled renal, hepatic, hematologic, gastrointestinal or pulmonary disease
• Grade 3 or 4 changes in radiographs of sacroiliac joints (grading of radiographs according to the New York criteria)