Table 2 Eligibility criteria
Inclusion criteria | ||
1. Patients older than 18 years | ||
2. Patients with axial spondyloarthritis according to ASAS group classification criteria [28], classified as axial spondylitis if either of the two following sets of conditions is true: | ||
1. Full compliance of A and C, and 1 or more of B OR 2. Full compliance of A and D, and 2 or more of B | ||
A. Required criteria | 1. Low back pain >3 months duration | |
2. Age of onset <45 years | ||
B. Clinical criteria | 1. Inflammatory low back pain in patients with chronic low back pain (>3 months), meeting 4 of: | |
age of onset <40 years | ||
inconspicuous onset | ||
improvement with exercise | ||
no improvement with rest | ||
2. Peripheral arthritis | ||
3. Enthesitis | ||
4. Dactylitis | ||
6. Family history | ||
7. Anterior uveitis | ||
8. Current or previous Crohn’s disease or ulcerative colitis confirmed by gastroenterologist | ||
9. Current or previous physician-diagnosed psoriasis | ||
10. HLA-B27 | ||
11. Increased CRP | ||
C. Sacroiliitis by image | 1. Sacroiliitis (radiology, MRI): Definite sacroiliitis according to the modified New York criteria, or acute inflammation on MRI highly suggestive of sacroiliitis. | |
D. Genetic criteria | 1. HLA-B27 positive | |
3. Previous treatment with an anti-TNF (infliximab, adalimumab, etanercept, or golimumab) and with sustained clinical remission, as defined by absence of symptoms and signs of activity spondylitis: | ||
1. BASDAI score less than or equal to 2 | ||
2. Absence of clinically active arthritis or enthesitis | ||
3. CRP below or equal to the upper limit of normality, as set by local laboratory | ||
4. Signed informed consent | ||
Exclusion criteria | ||
1. Patients with secondary spondyloarthritis | ||
2. Patients with spondyloarthritis and predominantly peripheral arthritis, which have been the leading reason for starting anti-TNF treatment. | ||
3. Patients with spondyloarthritis and any associated pathology known to impair or affect the clinical assessment (for example, fibromyalgia, other associated chronic inflammatory diseases) | ||
4. Patients with inflammatory bowel disease | ||
5. Patients on chronic treatment with anti-TNF therapy who are currently treated at doses lower than those indicated by the product information. | ||
6. Pregnant or breastfeeding women | ||