Percentage of patients achieving ASDAS improvement criteria and classical improvement criteria in NOR-DMARD and ASSERT
| NOR-DMARD (ASDAS-CRP) | NOR-DMARD (ASDAS-ESR) | ASSERT (ASDAS-CRP) | ASSERT (ASDAS-CRP) infliximab vs placebo | |||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Improvement criterion | 3 Months (n=258) | 6 Months (n=165) | 3 Months (n=258) | 6 Months (n=165) | 3 Months (n=220) | 6 Months (n=219) | 3 Months (n=164 vs 56) | χ2 (p value) | 6 Months (n=163 vs 56) | χ2 (p value) |
| ΔASDAS≥1.1 | 46.9 | 50.3 | 49.6 | 50.3 | 58.2 | 57.5 | 71.3 vs 19.6 | 45.9 (<0.001) | 69.3 vs 23.2 | 36.3 (<0.001) |
| ΔASDAS≥2.0 | 23.6 | 23.6 | 22.1 | 21.8 | 33.6 | 39.3 | 43.9 vs 3.6 | 30.4 (<0.001) | 50.9 vs 5.4 | 36.3 (<0.001) |
| ΔBASDAI≥2 | 43.0 | 43.6 | 43.0 | 43.6 | 50.9 | 51.6 | 60.4 vs 23.2 | 23.1 (<0.001) | 62.6 vs 19.6 | 30.8 (<0.001) |
| BASDAI50 | 36.8 | 39.4 | 36.8 | 39.4 | 40.5 | 41.6 | 50.6 vs 10.7 | 27.6 (<0.001) | 51.5 vs 12.5 | 26.1 (<0.001) |
| ASAS20 | 45.0 | 47.3 | 45.0 | 47.3 | 54.1 | 52.5 | 64.0 vs 25.0 | 25.6 (<0.001) | 63.2 vs 21.4 | 29.2 (<0.001) |
| ASAS40 | 29.8 | 32.1 | 29.8 | 32.1 | 41.8 | 38.8 | 50.6 vs 16.1 | 20.5 (<0.001) | 47.2 vs 14.3 | 19.1 (<0.001) |
ASAS20 and ASAS40 response criteria are based on four independent domains: spinal pain, physical function measured by the BASFI, patient global assessment and inflammation measured as the mean of the last two BASDAI questions (severity and duration of morning stiffness); ASAS20 treatment response is defined as improvement of ≥20% and ≥1 unit (range 0–10) in at least three of the four above domains, and no worsening of ≥20% and ≥1 unit in the remaining fourth domain; ASAS40 treatment response is defined as improvement of ≥40% and ≥2 units in at least three of the four above domains, and no worsening in the remaining fourth domain; ASAS partial remission criteria are fulfilled if the value for all four domains is below 2.
ASAS, Assessment of SpondyloArthritis international Society; ASDAS, Ankylosing Spondylitis Disease Activity Score; ASSERT, Ankylosing Spondylitis Study for the Evaluation of Recombinant Infliximab Therapy; BASDAI, Bath Ankylosing Spondylitis Disease Activity Index; BASFI, Bath Ankylosing Spondylitis Functional Index; CRP, C reactive protein; ESR, erythrocyte sedimentation rate; NOR-DMARD, Norwegian register of disease modifying antirheumatic drugs.