Sensitivity and specificity of ASDAS cut-off values for disease activity states and levels of improvement against several external criteria in NOR-DMARD and ASSERT
NOR-DMARD (ASDAS-CRP) | NOR-DMARD (ASDAS-ESR) | ASSERT (ASDAS-CRP) | ||||||||
---|---|---|---|---|---|---|---|---|---|---|
ASDAS cut-offs and external criterion | Timepoint | SE | SP | n | SE | SP | n | SE | SP | n |
ASDAS <1.3: | ||||||||||
ASAS partial remission | 3 Months | 66.7 | 88.8 | 310 | 78.3 | 86.3 | 310 | 80.6 | 92.3 | 219 |
6 Months | 60.0 | 91.2 | 192 | 82.2 | 91.2 | 192 | 87.2 | 90.0 | 219 | |
Patient global <1 | 3 Months | 69.9 | 90.7 | 310 | 71.2 | 85.2 | 310 | 82.1 | 89.6 | 220 |
6 Months | 67.5 | 85.6 | 207 | 80.0 | 82.6 | 207 | 81.3 | 86.1 | 219 | |
Physician global <1 | 3 Months | 44.4 | 88.3 | 305 | 56.5 | 87.8 | 305 | – | – | – |
6 Months | 71.9 | 85.6 | 199 | 84.4 | 82.6 | 199 | – | – | – | |
ASDAS <2.1: | ||||||||||
Patient global <3 | 3 Months | 80.4 | 87.3 | 310 | 91.7 | 80.3 | 310 | 81.7 | 90.6 | 220 |
6 Months | 83.6 | 89.7 | 207 | 93.6 | 85.6 | 207 | 87.2 | 83.5 | 220 | |
Physician global <3 | 3 Months | 59.3 | 88.7 | 305 | 70.0 | 83.9 | 305 | – | – | – |
6 Months | 84.3 | 89.7 | 199 | 94.1 | 85.6 | 199 | – | – | – | |
ASDAS >3.5: | ||||||||||
Patient global >6 | Baseline | 74.8 | 79.2 | 442 | 59.4 | 88.3 | 442 | 85.2 | 58.0 | 223 |
Physician global >6 | Baseline | 79.2 | 59.4 | 432 | 67.9 | 71.5 | 432 | – | – | – |
ΔASDAS ≥1.1: | ||||||||||
Better or much better | 3 Months | 62.7 | 86.7 | 252 | 63.8 | 80.0 | 252 | – | – | – |
6 Months | 61.7 | 96.8 | 164 | 60.2 | 90.3 | 164 | – | – | – | |
ASAS20 | 3 Months | 84.5 | 83.8 | 258 | 86.2 | 80.3 | 258 | 83.6 | 87.0 | 220 |
6 Months | 83.3 | 79.3 | 165 | 85.9 | 81.6 | 165 | 84.1 | 90.3 | 219 | |
ΔASDAS ≥2.0: | ||||||||||
Much better | 3 Months | 56.4 | 90.2 | 252 | 59.0 | 93.7 | 252 | – | – | – |
6 Months | 53.8 | 90.2 | 164 | 50.0 | 91.1 | 164 | – | – | – | |
ASAS40 | 3 Months | 64.9 | 93.9 | 258 | 61.0 | 94.5 | 258 | 86.5 | 80.8 | 220 |
6 Months | 60.4 | 93.8 | 165 | 54.7 | 93.8 | 165 | 83.7 | 90.2 | 219 |
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. Range of patient and physician global assessment is 0–10.
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.