Composite Indices Using 3 or 4 Components of the Core Data Set Have Similar Predictive Ability to Measure Disease Activity in RA: Evidence from the DANCER and REFLEX Studies
Table 1
Patients’ baseline characteristics for key efficacy measurements and rheumatoid arthritis Core Data Set measures in the DANCER [6] and REFLEX [7] clinical trials.
Mean (SD)
REFLEX
DANCER
Placebo ()
RTX ()
Placebo ()
RTX ()
DAS28-ESR (0–10)
6.8 (0.9)
6.9 (1.0)
6.8 (0.8)
6.7 (0.9)
DAS28 (3)-ESR (0–10)
6.5 (0.9)
6.5 (0.9)
6.5 (0.7)
6.4 (0.8)
CDAI (0–76)
44.6 (13.2)
45.9 (13.7)
45.9 (11.6)
43.8 (12.7)
RAPID3 (0–10)
5.8 (1.7)
5.7 (1.8)
5.4 (1.6)
5.3 (1.7)
DOCGL (0–10)
6.7 (1.6)
6.9 (1.6)
6.6 (1.5)
6.6 (1.6)
TJC (0–28)
16.5 (7.0)
17.2 (7.1)
18.5 (5.9)
17.4 (6.5)
SJC (0–28)
14.4 (5.9)
14.9 (5.9)
14.2 (5.3)
13.2 (5.7)
PATGL (0–10)
7.0 (2.0)
6.9 (2.1)
6.6 (1.9)
6.6 (2.0)
PAIN (0–10)
6.4 (2.1)
6.4 (2.2)
6.0 (1.9)
5.9 (2.0)
FN (HAQ) (0–3)
1.9 (0.5)*
1.9 (0.6)
1.7 (0.6)
1.7 (0.6)
CRP (mg/dL)
3.8 (4.1)
3.7 (3.8)
3.1 (3.0)
3.0 (3.5)
ESR (mm/h)
48.4 (27.7)
47.9 (25.6)
39.7 (20.8)
42.0 (23.3)
. CDAI: Clinical Disease Activity Index; CRP: C-reactive protein; DAS28: Disease Activity Score in 28 joints; DAS28 (3): Disease Activity Score in 28 joints excluding patient global health component; DOCGL: assessor global; ESR: erythrocyte sedimentation rate; FN: physical function; HAQ: Health Assessment Questionnaire; PAIN: pain; PATGL: patient global estimate; RAPID3: Routine Assessment of Patient Index Data 3; RTX: rituximab; SD: standard deviation; SJC: swollen joint count; TJC: tender joint count.
