Differences in disease activity scores at 6 and 12 months
| 6 Months | 12 Months | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Placebo group | Glucocorticoid group | Placebo group | Glucocorticoid group | |||||||||
| N | Mean (SD) | N | Mean (SD) | Estimated difference (95% CI)* | p Value | N | Mean (SD) | N | Mean (SD) | Estimated difference (95% CI)* | p Value | |
| ESR | 100 | 21.0 (17.6) | 101 | 22.8 (19.3) | −2.96 (−6.89 to 1.15) | 0.165 | 107 | 21.4 (18.5) | 99 | 21.3 (17.4) | 0.06 (−4.67 to 4.68) | 0.982 |
| Swollen joints† | 104 | 3.0 (4.0) | 103 | 2.7 (3.7) | 0.25 (−0.92 to 1.27) | 0.652 | 105 | 2.7 (3.6) | 101 | 2.2 (3.1) | 0.42 (−0.55 to 1.35) | 0.364 |
| Tender joints† | 104 | 5.5 (6.7) | 103 | 5.3 (6.3) | −0.19 (−1.75 to 1.48) | 0.821 | 105 | 4.9 (6.2) | 101 | 4.2 (6.1) | 0.43 (−1.15 to 2.02) | 0.592 |
| DAS28(3) | 99 | 3.7 (1.4) | 100 | 3.7 (1.4) | −0.14 (−0.51 to 0.23) | 0.435 | 105 | 3.6 (1.4) | 97 | 3.4 (1.3) | 0.10 (−0.23 to 0.46) | 0.577 |
| VAS pain | 107 | 36.2 (28.4) | 101 | 35.5 (26.7) | 0.15 (−6.85 to 7.60) | 0.967 | 108 | 32.7 (26.9) | 104 | 29.7 (23.6) | 3.42 (−2.66 to 9.67) | 0.291 |
| VAS fatigue | 107 | 44.4 (29.1) | 101 | 38.5 (27.9) | 4.92 (−2.18 to 11.88) | 0.170 | 108 | 41.4 (29.0) | 104 | 38.7 (27.3) | 2.33 (−4.62 to 9.43) | 0.513 |
| VAS physician | NA | 105 | 24.7 (22.0) | 98 | 18.6 (18.5) | 4.85 (−0.73 to 10.56) | 0.082 | |||||
| Morning stiffness | 101 | 39.9 (81.1) | 100 | 48.7 (129.2) | −8.13 (−39.71 to 18.67) | 0.586 | 105 | 54.0 (140.5) | 102 | 37.4 (102.8) | 16.77 (−13.60 to 53.47) | 0.334 |
| HAQ-score | NA | 104 | 0.94 (0.74) | 103 | 0.77 (0.74) | 0.11 (−0.05 to 0.29) | 0.196 | |||||
| EQ-5D utility score | 104 | 0.60 (0.29) | 99 | 0.68 (0.22) | −0.06 (−0.12 to 0.00) | 0.068 | 105 | 0.63 (0.30) | 103 | 0.69 (0.24) | −0.06 (−0.12 to 0.01) | 0.072 |
| SF-36 PCS score | 102 | 41.1 (6.4) | 94 | 42.2 (6.6) | −0.93 (−2.63 to 0.59) | 0.260 | 105 | 42.0 (7.2) | 100 | 42.9 (6.4) | −0.89 (−2.56 to 0.78) | 0.294 |
| SF-36 MCS score | 102 | 43.9 (5.4) | 94 | 43.4 (5.5) | 0.48 (−1.00 to 1.95) | 0.523 | 105 | 43.8 (6.4) | 100 | 43.3 (5.3) | 0.52 (−1.04 to 1.95) | 0.505 |
N, number of patients with available data at baseline and follow-up.
↵* Adjusted for baseline value; {number of swollen or tender joints (0–28 maximum).
95% CI, 95% confidence interval obtained by bootstrapping.
DAS28(3), three-component 28 joint Disease Activity Score (maximum score=10); EQ-5D, EuroQol-5D dimension utility score (range 1 to 20.59=worst health); ESR, erythrocyte sedimentation rate; HAQ, Health Assessment Score (range 0–3=worst functional ability); MCS, SF-36 mental component summary score; PCS, SF-36 physical component summary score (higher scores indicate better health); VAS, visual analogue scale (range 0–100 mm, worst score).