Table 2.
Mean CDAI and PRO values at baseline, 6 and 12 months by disease activity groups
| Overall population (N = 1570)a | Disease activity group | p value | |||||
|---|---|---|---|---|---|---|---|
| Sustained remission/LDA (N = 585) | Improving remission/LDA (N = 239) | Worsening M/HDA (N = 190) | Sustained M/HDA (N = 556) | ||||
| CDAI (0–76) mean ± SD | Baseline | 26.8 ± 12.8 | 23.0 ± 11.1 | 26.9 ± 13.0 | 25.8 ± 12.9 | 31.0 ± 12.9 | < 0.0001 |
| 6-Month | 13.8 ± 12.1 | 4.1 ± 2.8 | 19.0 ± 8.5 | 5.9 ± 2.9 | 24.5 ± 11.1 | < 0.0001 | |
| 12-Month | 12.8 ± 11.9 | 3.7 ± 2.9 | 5.5 ± 2.9 | 19.3 ± 9.7 | 23.3 ± 10.9 | < 0.0001 | |
| Change in mean ± SD (N = 1570)b | − 14.0 ± 14.4 | − 19.3 ± 11.4 | − 21.4 ± 13.7 | − 6.5 ± 13.9 | − 7.7 ± 13.8 | < 0.0001 | |
| mHAQ (0–3) mean ± SD | Baseline | 0.56 ± 0.50 | 0.42 ± 0.45 | 0.54 ± 0.50 | 0.59 ± 0.46 | 0.70 ± 0.51 | < 0.0001 |
| 6-Month | 0.41 ± 0.46 | 0.19 ± 0.30 | 0.41 ± 0.42 | 0.36 ± 0.41 | 0.66 ± 0.51 | < 0.0001 | |
| 12-Month | 0.40 ± 0.46 | 0.18 ± 0.30 | 0.29 ± 0.38 | 0.52 ± 0.51 | 0.64 ± 0.48 | < 0.0001c | |
| Change in mean ± SD (N = 1544)b | − 0.16 ± 0.44 | − 0.25 ± 0.43 | − 0.25 ± 0.44 | − 0.08 ± 0.47 | − 0.06 ± 0.42 | < 0.0001 | |
| Patient pain (0–100) mean ± SD | Baseline | 50.9 ± 26.9 | 44.3 ± 27.1 | 46.6 ± 26.1 | 55.6 ± 25.1 | 57.9 ± 25.7 | < 0.0001 |
| 6-Month | 35.9 ± 27.9 | 19.4 ± 20.5 | 40.7 ± 26.1 | 28.7 ± 23.6 | 53.6 ± 25.4 | < 0.0001 | |
| 12-Month | 36.7 ± 28.3 | 19.6 ± 20.8 | 29.8 ± 23.7 | 46.1 ± 28.7 | 54.4 ± 24.9 | < 0.0001c | |
| Change in mean ± SD (N = 1565)b | − 14.2 ± 29.8 | − 24.7 ± 28.0 | − 16.9 ± 29.3 | − 9.5 ± 34.1 | − 3.5 ± 26.2 | < 0.0001 | |
| Patient fatiguea (0–100) mean ± SD | Baseline | 49.9 ± 29.1 | 41.1 ± 28.5 | 47.1 ± 27.4 | 52.4 ± 27.1 | 58.8 ± 28.2 | < 0.0001 |
| 6-Month | 41.1 ± 29.8 | 26.1 ± 25.0 | 41.7 ± 27.2 | 35.1 ± 27.1 | 57.5 ± 27.6 | < 0.0001 | |
| 12-Month | 40.1 ± 29.9 | 24.3 ± 24.4 | 31.2 ± 26.0 | 48.2 ± 29.1 | 56.5 ± 26.9 | < 0.0001c | |
| Change in mean ± SD (N = 981)b | − 9.6 ± 29.4 | − 17.6 ± 28.7 | − 15.3 ± 29.0 | − 4.9 ± 31.3 | − 1.3 ± 27.0 | < 0.0001 | |
| Morning stiffness (h) mean ± SD | Baseline | 2.2 ± 4.3 | 2.0 ± 4.4 | 1.6 ± 2.2 | 2.9 ± 5.1 | 2.6 ± 4.6 | 0.0018 |
| 6-Month | 1.3 ± 3.9 | 0.6 ± 1.8 | 1.7 ± 6.9 | 1.4 ± 3.6 | 2.0 ± 3.8 | < 0.0001 | |
| 12-Month | 1.3 ± 3.3 | 0.6 ± 1.4 | 0.9 ± 2.4 | 1.8 ± 3.9 | 2.1 ± 4.4 | < 0.0001 | |
| Change in mean ± SD (N = 1483)b | − 1.0 ± 4.4 | − 1.5 ± 4.4 | − 0.7 ± 3.1 | − 1.1 ± 5.3 | − 0.5 ± 4.5 | 0.0022 | |
| PtGA (0–100) mean ± SD | Baseline | 49.2 ± 25.7 | 42.6 ± 26.4 | 46.3 ± 24.6 | 53.7 ± 22.0 | 55.8 ± 24.6 | < 0.0001 |
| 6-Month | 34.2 ± 26.7 | 18.2 ± 18.7 | 39.6 ± 24.7 | 26.9 ± 23.6 | 51.2 ± 24.6 | < 0.0001 | |
| 12-Month | 33.8 ± 26.8 | 17.0 ± 18.3 | 24.7 ± 20.1 | 45.6 ± 26.1 | 51.4 ± 24.1 | < 0.0001 | |
| Change in mean ± SD (N = 1570)b | − 15.4 ± 29.7 | − 25.6 ± 27.6 | − 21.6 ± 27.6 | − 8.1 ± 29.7 | − 4.4 ± 28.2 | < 0.0001 | |
| EQ-5D-3L US Index Scorea (− 0.102 to 1.0) mean ± SD | Baseline | 0.68 ± 0.19 | 0.72 ± 0.17 | 0.70 ± 0.17 | 0.66 ± 0.17 | 0.63 ± 0.20 | < 0.0001 |
| 6-Month | 0.76 ± 0.16 | 0.83 ± 0.14 | 0.74 ± 0.14 | 0.78 ± 0.13 | 0.68 ± 0.17 | < 0.0001 | |
| 12-Month | 0.74 ± 0.18 | 0.83 ± 0.14 | 0.78 ± 0.14 | 0.69 ± 0.19 | 0.65 ± 0.18 | < 0.0001c | |
| Change in mean ± SD (N = 898)b | 0.06 ± 0.19 | 0.10 ± 0.18 | 0.07 ± 0.16 | 0.04 ± 0.20 | 0.02 ± 0.20 | < 0.0001 | |
CDAI Clinical Disease Activity Index, EQ-5D-3L EuroQol-5 dimension-3 level, h hours, LDA low disease activity, mHAQ modified Health Assessment Questionnaire, M/HDA moderate or high disease activity, PRO patient-reported outcome, PtGA Patient’s Global Assessment of Disease Activity, SD standard deviation
aCounts may be reduced because of missing data for some variables (e.g., patient fatigue and EQ-5D US Index Score were not included in the Corrona RA questionnaire until October 2010)
bChange from baseline to 12 months; calculated for patients with values at both baseline and 12 months
cStatistical significance of comparisons across disease activity groups did not change after adjustment for baseline value of the corresponding outcome. Unadjusted and adjusted regression coefficients (linear) or odds ratios (ordinal logistics) estimates shown in Supplemental Tables 2 and 3