Prednisolone is more effective than placebo: short-term (3 month) effects on disease activity in the per protocol population*
| Prednisolone (n=156) | Placebo (n=148) | |||||
| Baseline | Change | Baseline | Change | Difference | ||
| DAS28 | ||||||
| Model† | 4.40 (1.04) | –1.32 (1.06) | 4.46 (0.99) | –0.76 (1.12) | –0.62(–0.44)‡ | |
| Unadjusted | 4.40 (1.04) | –1.36 (1.14) | 4.46 (0.99) | –0.73 (1.21) | ||
| DAS components | unadjusted | |||||
| ESR | 28.5 (20.2) | –7.4 (15.9) | 28.4 (20.7) | –2.2 (12.8) | –5.2 | |
| Tender joint count | 4.9 (4.4) | –2.7 (3.6) | 5.5 (4.7) | –2.1 (5.0) | –0.6 | |
| Swollen joint count | 2.9 (3.3) | –2.1 (3.2) | 3.3 (3.5) | –1.6 (3.2) | –0.5 | |
| Patient global ass. | 5.6 (2.4) | –1.7 (2.8) | 5.2 (2.2) | –0.6 (2.5) | –1.1 | |
| Other core set | ||||||
| Pain | 5.4 (2.5) | –1.7 (2.7) | 5.1 (2.3) | –0.7 (2.5) | –1 | |
| Fatigue | 5.1 (2.6) | –0.8 (2.4) | 4.8 (2.8) | –0.4 (2.2) | –0.4 | |
| Physician global ass. | 4.4 (2.0) | –2.0 (2.2) | 4.5 (2.0) | –1.5 (2.2) | –0.5 | |
| HAQ | 1.2 (0.7) | –0.2 (0.5) | 1.1 (0.7) | 0.0 (0.4) | –0.2 | |
| CRP (mg/L) | 9.1 (13.4) | –3.5 (13.6) | 10.1 (13.8) | –2.1 (11.9) | –1.4 | |
| SDAI | 18.7 (8.7) | –8.7 (7.9) | 19.5 (9.4) | –6.2 (9.2) | –2.5 | |
| CDAI | 17.7 (8.6) | –8.4 (7.5) | 18.5 (9.2) | –6.1 (9.0) | –2.3 | |
| Response § | ||||||
| EULAR | NNT | |||||
| Good | 63 (41) | 22 (15) | 41 | 3.8 | ||
| Moderate | 48 (31) | 47 (33) | –1 | |||
| None | 43 (28) | 75 (52) | –14 | |||
| ACR§ | ||||||
| 20 | 53 (36) | 33 (24) | 12 | 8.3 | ||
| 50 | 30 (20) | 13 (9) | 17 | 9.2 | ||
| 70 | 12 (8) | 2 (1) | 12 | 14.9 | ||
| State | ||||||
| Minimal disease | 57 (37) | 20 (14) | 37 | 4.3 | ||
| Boolean remission | 5 (3.2) | 1 (0.7) | 4 | 40 | ||
Mean (SD) unless indicated otherwise.
Minimal disease activity: defined as DAS28 <2.60.
Remission: Boolean definition according to ACR-EULAR criteria. 45
* Only DAS28 change estimate is based on the primary analysis model. Other results are unadjusted.
† Model does not offer change estimates, these are calculated from the point estimates and provided as reference for the observed/unadjusted DAS28 data.
‡Difference estimate: mean [1–sided 95% confidence bound]. P value for difference in change:<0.0001.
§ Count (%).
ACR, American College of Rheumatology; CDAI, clinical disease activity index; CRP, C reactive protein; DAS28, Disease Activity Score 28 joints; ESR, erythrocyte sedimentation rate; EULAR, European League Against Rheumatism; HAQ, Health Assessment Questionnaire; NNT, number needed to treat; SDAI, simple disease activity index.