Primary and secondary outcome parameters | TNFα-inhibitor-naive patients (n=15) | TNFα-inhibitor-failure patients (n=15) | ||
---|---|---|---|---|
Screening | Week 24 | Screening | Week 24 | |
ASAS20, % (number of patients) (95% CIs) | NA | 26.7% (4/15) (9.7% to 55.1%) | NA | 20.0% (3/15) (5.7% to 44.9%) |
ASAS40, % (number of patients) (95% CIs) | NA | 13.3% (2/15) (2.4% to 38.4%) | NA | 0% (0/15) (0% to 21.3%) |
ASAS partial remission, % (number of patients) (95% CIs) | NA | 6.7% (1/15) (0.4% to 31.2%) | NA | 0% (0/15) (0% to 21.3%) |
BASDAI50, % (number of patients) (95% CIs) | NA | 6.7% (1/15) (0.3% to 30.2%) | NA | 0% (0/15) (0% to 21.3%) |
BASDAI (0–10), mean (±SD) | 5.9 (±1.4) | 5.1 (±2.1) | 6.8 (±1.2) | 6.7 (±1.5) |
ASDAS, mean (±SD) | 3.6 (±0.5) | 3.2 (±1.1) | 4.1 (±0.8) | 4.2 (±0.8) |
Patient's global assessment (0–10), mean (±SD) | 6.6 (±1.7) | 6.0 (±2.5) | 7.6 (±1.3) | 7.6 (±1.5) |
BASFI (0–10), mean (±SD) | 5.4 (±2.0) | 4.8 (±2.3) | 6.8 (±1.7) | 6.7 (±2.0) |
BASMI (0–10), mean (±SD) | 2.9 (±2.4) | 3.3 (±2.0) | 5.0 (±1.8) | 4.8 (±1.7) |
Physician global assessment (0–10), mean (±SD) | 6.1 (±1.6) | 5.8 (±2.0) | 6.4 (±0.6) | 6.7 (±1.9) |
Arthritis joint count (0–64), mean (±SD) | 0.4 (±1.6) | 0.5 (1.1) | 0.7 (±1.1) | 0.1 (±0.5) |
Enthesitis score (range 0–17), mean (±SD) | 0.8 (±1.7) | 1.2 (±2.8) | 2.9 (±3.8) | 2.0 (±3.1) |
CRP (reference value 5 mg/litre), mean (±SD) | 14.6 (±10.9) | 13.5 (±10.9) | 30.7 (±31.0) | 31.3 (±25.1) |
ASDAS, Ankylosing Spondylitis Disease Activity Score; ASAS20, 20% improvement according to the Assessment of SpondyloArthritis international Society criteria; ASAS40, 40% improvement according to the ASAS criteria; BASDAI, Bath Ankylosing Spondylitis Disease Activity Index; BASFI, Bath Ankylosing Spondylitis Diseases Functional Index; BASMI, Bath Ankylosing Spondylitis Metrology Index; CRP, C reactive protein; NA, not applicable.