Prednisolone is more effective than placebo: long-term effects on disease activity state and damage (24 months, modified ITT population)
| Prednisolone (n=221) | Placebo (n=223) | |||||
| Disease activity state† | D uring study | D uring study | NNT | |||
| Patients with at least one occurrence of: | ||||||
| Minimal disease activity | 62 (44) | 35 (26) | 5.6 | |||
| Lasting ≥ 6 months | 64 (29) | 39 (17) | 8.3 | |||
| Remission | 25 (17) | 20 (15) | 50 | |||
| Lasting ≥ 6 months | 15 (7) | 12 (5) | 33 | |||
| Damage | baseline | change | baseline | change | difference in change ‡ | p |
| n | 200 | 132 | 206 | 125 | ||
| T otal score | ||||||
| Mean (SD) | 20.0 (34.6) | 0.3 (1.0) | 17.2 (33.4) | 1.9 (6.4) | 1.7 (0.7) | 0.003 |
| Median (Q1; Q3) | 7 (2; 20) | 0 (0; 0) | 6 (2; 15) | 0 (0; 1) | ||
| (Min; max) | (0; 196) | (–4; 4) | (0; 276) | (–1; 64) | ||
| E rosions | ||||||
| Mean (SD) | 8.6 (17.7) | 0.1 (0.6) | 7.3 (17.7) | 0.7 (1.9) | ||
| Median | 3 | 0 | 2 | 0 | ||
| J oint space narrowing | ||||||
| Mean (SD) | 11.5 (18.2) | 0.2 (0.7) | 9.9 (16.5) | 1.2 (5.0) | ||
| Median | 4 | 0 | 5 | 0 | ||
| Patients with no damage | 21 (11) | 21 (10) | ||||
| P rogression (total score) | ||||||
| Negative | 14 (11) | 2 (2) | ||||
| Zero | 88 (67) | 84 (67) | ||||
| 1-4 point/year | 30 (23) | 27 (22) | ||||
| ≥5/year | 0 (0) | 12 (10) | ||||
Sensitivity analyses:
Model on complete cases (n=257): difference 1.70 (0.78), p=0.001;
Linear imputation from baseline given disease duration: difference 0.69 (–0.32), p=0.13.
* Count (%) unless otherwise indicated. Due to rounding errors, % may not add up to 100.
† Minimal disease activity: defined as DAS28 <2.60. Remission: Boolean definition according to ACR-EULAR (European League Against Rheumatism-American College of Rheumatology) criteria.45
‡ Model estimate: mean, one-sided 95% confidence bound.
DAS28, Disease Activity Score 28 joints; ITT, intention to treat; NNT, number needed to treat.