Effectiveness table of the different treatment strategies in the CareRA trial including data from all participants as-observed up until and at the week 52 visit
| Total population | High risk | Low risk | ||||
|---|---|---|---|---|---|---|
| COBRA Classic | COBRA Slim (high risk) | COBRA Avant Garde | MTX-TSU | COBRA Slim (low risk) | ||
| Total patients in trial | N=379 | N=98 | N=98 | N=93 | N=47 | N=43 |
| Number of treatment adaptations | ||||||
| 1 | 114 (30.1%) | 21 (21.4%) | 38 (38.8%) | 22 (23.7%) | 17 (36.2%) | 16 (37.2%) |
| 2 | 42 (11.1%) | 3 (3.1%) | 16 (16.3%) | 5 (5.4%) | 9 (19.1%) | 9 (20.9%) |
| Cumulative prednisone dose (mg) mean±SD | 1789.7±587.1 | 2597.2±666.8 | 1526.9±378.7 | 1585.6±422.9 | 36.3±49.6 | 1554.0±307.6 |
| Average daily prednisone dose (mg) mean±SD | 4.9±1.6 | 6.5±2.7 | 3.8±1.6 | 4.0±1.6 | 0.1±0.1 | 3.8±1.6 |
| Patients with GC injections | 84 (22.2%) | 15 (15.3%) | 31 (31.6%) | 15 (16.1%) | 17 (36.2%) | 6 (13.9%) |
| Patients followed per protocol until W52 | N=263 (69.4%) | N=62 (63.2%) | N=75 (76.5%) | N=60 (64.5%) | N=36 (76.6%) | N=30 (69.9%) |
| Therapy at W52 | ||||||
| On MTX only | 220 (83.7%) | 58 (93.5%) | 68 (90.7%) | 36 (60.0%) | 31 (86.1%) | 27 (90.0%) |
| On LEF only | 20 (7.6%) | 20 (33.3%) | ||||
| On MTX + SSZ | 4 (1.1%) | 4 (6.5%) | ||||
| On MTX + LEF | 19 (7.2%) | 7 (9.3%) | 4 (6.7%) | 5 (13.9%) | 3 (10.0%) | |
| Patients in remission at W52 | 195 (74.1%) | 49 (79.0%) | 52 (69.3%) | 45 (75.0%) | 24 (66.7%) | 25 (83.3%) |
| Patients in low disease activity at W52 | 234 (89.0%) | 55 (88.7%) | 65 (86.7%) | 53 (88.3%) | 32 (88.9%) | 29 (96.7%) |
| Patients not followed per protocol until W52 | N=83 (21.9%) | N=28 (28.6%) | N=14 (14.3%) | N=25 (26.9%) | N=8 (17.0%) | N=8 (18.6%) |
| Therapy at W52 | ||||||
| Biological therapy | 26 | 10 | 2 | 6 | 4 | 4 |
| MTX + SSZ + GC | 6 | 5 | 1 | |||
| MTX + LEF + GC | 2 | 1 | 1 | |||
| MTX + LEF + HCQ | 1 | 1 | ||||
| MTX + SSZ | 5 | 5 | ||||
| MTX + LEF | 9 | 3 | 4 | 1 | 1 | |
| MTX + GC | 9 | 2 | 2 | 2 | 1 | 2 |
| LEF + GC | 1 | 1 | ||||
| MTX only | 16 | 4 | 3 | 7 | 2 | |
| LEF only | 6 | 1 | 1 | 4 | ||
| SSZ only | 1 | 1 | ||||
| NSAIDs | 1 | 1 | ||||
| Patients in remission at W52 | 32 (38.6%) | 12 (42.9%) | 2 (14.2%) | 11 (44.0%) | 3 (37.5%) | 4 (50.0%) |
| Patients in low disease activity at W52 | 44 (53.0%) | 15 (53.6%) | 4 (28.6%) | 16 (64.0%) | 5 (62.5%) | 4 (50.0%) |
| Patients missing for evaluation at W52 | N=33 (8.7%) | N=8 (7.1%) | N=9 (9.2%) | N=8 (8.6%) | N=3 (6.4%) | N=5 (11.6%) |
Remission was defined as a DAS28(CRP) <2.6. Low Disease Activity was defined as DAS(CRP) ≤3.2; Data are presented as mean±SD or percentages. Online supplementary table S4 gives additional information.
CRP, C-reactive protein; GC, glucocorticoid; HCQ, hydroxychloroquine; LEF, leflunomide; MTX, methotrexate; N, number of patients; NSAIDs, non-steroidal anti-inflammatory drugs; SSZ, sulfasalazine; TSU, tight step-up; W52, week 52.