Key baseline characteristics of included patients (safety population)
| Prednisolone (n=224) | Placebo (n=225) | |
| General | ||
| Age: mean (SD; max) | 72.5 (5.3; 87) | 72.6 (5.4; 85) |
| BMI | 27.2 (4.5) | 27.2 (4.4) |
| Obese (BMI ≥30; %) | 24 | 23 |
| Female, n (%) | 160 (71) | 156 (69) |
| RA | ||
| Disease duration | 10.8 (10.4) | 10.4 (10.2) |
| DAS28* | 4.43 (1.04) | 4.60 (1.05) |
| RF/anti-CCP, n (%) | ||
| Both – | 57 (25) | 45 (20) |
| Anti-CCP + | 119 (53) | 134 (60) |
| Specific history, n (%) | ||
| Infections | 41 (18) | 47 (21) |
| Osteoporosis | 56 (25) | 61 (27) |
| Baseline DEXA T-score <–2.5 | 25 (11) | 38 (17) |
| Prevalent spine fractures† | 68 (32) | 78 (36) |
| Antirheumatic therapy | ||
| Previous | ||
| GC use | 105 (47) | 104 (46) |
| Ongoing | ||
| DMARD | 169 (75) | 187 (83) |
| MTX | 127 (57) | 153 (68) |
| Biologic | 36 (16) | 29 (13) |
| Anti-TNF | 26 (12) | 20 (9) |
| Monotherapy | 8 (4) | 8 (4) |
| NSAID | 57 (25) | 54 (24) |
| Actual baseline change therapy‡ | 28 (13) | 33 (15) |
| Start biologic | 3 | 5 |
| Stop biologic | 0 | 1 |
| Comorbidities (count/patient) | ||
| All (including history), mean (SD) median (q1–q3; max) | 3.3 (3.9) | 3.1 (3.3) |
| 6 (4-9; 21) | 5 (3-8; 26) | |
| Active, mean (SD) median (q1–q3; max) | 2.2 (2.8) | 2.0 (2.9) |
| 4 (2-6; 14) | 3 (2-5; 15) | |
| Medication (all indications) | ||
| Total number of drugs/pt, mean | 7.0 | 7.1 |
| median (range) | 7 (0 -17) | 7 (1-19) |
Data are reported as mean (SD) unless otherwise reported.
For further details, see online supplemental table 1.
*Five prednisolone and six placebo patients were included but found to have a DAS28 <2.60 at baseline. They were retained in the study and in the ITT analysis.
†Not all patients had vertebral form analysis, see table 5.
‡50 pts (25 in each group) were stratified into the change at baseline stratum, but only 42 of those actually changed therapy (18 pred, 24 placebo); of these, 2 versus 5 started, and one placebo patient stopped biologic therapy. In addition, 19 patients (10 v 9) changed therapy but were erroneously not stratified as such. Of these, 1 pred patientt started biologic therapy.
aCCP, anti-cyclic citrullinated peptide; BMI, body mass index; Ca/D, calcium + vitamin D supplement; DAS28, Disease Activity Score 28 joints; DEXA, dual X-ray absorptiometry; DMARD, disease-modifying antirheumatic drug; GC, glucocorticoid; NSAID, nonsteroidal anti-inflammatory drug; q1-q3, inner quartiles; RF, rheumatoid factor; TNF, tumour necrosis factor.