Change between baseline and 18 months of ACR core-set variables and imaging outcomes, mean (SD)
| Control n=57 | Intervention n=54 | Difference (95% CI) | p Value | |
|---|---|---|---|---|
| Primary outcomes | ||||
| DAS44 | −2.6 (1.6) | −2.7 (1.4) | −0.1 (−0.7, 0.5) | 0.72 |
| RAMRIS Erosions—median (IQR) | 1.0 (0.0, 2.0) | 0.5 (0.0, 1.0) | 0.3 (−0.5, 1.0)* | 0.33† |
| Secondary outcomes | ||||
| Clinical | ||||
| HAQ | −0.8 (0.7) | −1.0 (0.8) | −0.2 (−0.5, 0.1) | 0.14 |
| 44 Swollen joint count | −9 (7) | −8 (5) | 0.4 (−2, 3) | 0.76 |
| Ritchie articular index | −16 (14) | −14 (12) | 1.6 (−3, 7) | 0.53 |
| ESR—mm/h | −20 (26) | −20 (25) | 0.6 (−9, 11) | 0.91 |
| CRP—mg/L | −29 (60) | −30 (41) | 0.6 (−20, 20) | 0.95 |
| Patient global Health—100 mmVAS | −40 (35) | −43 (29) | 3.0 (−16, 10) | 0.63 |
| Pain—100 mm VAS | −34 (32) | −32 (27) | 2 (−9, 14) | 0.74 |
| Physician Global—Likert | −1.7 (0.9) | −1.9 (0.8) | −0.2 (−0.5, 0.1) | 0.20 |
| EuroQoL5D-3L Index | 0.32 (0.33) | 0.50 (0.37) | 0.17 (0.04, 0.31) | 0.01 |
| Imaging | ||||
| MRI RAMRIS score | ||||
| Erosions—median (IQR) | 1.0 (0.0, 2.0) | 0.5 (0.0, 1.0) | 0.3 (−0.5, 1.0)* | 0.33† |
| Synovitis—median (IQR) | −2.3 (−10.3, 0.5) | −5.5 (−8.5, −2.0) | 1.5 (−1.5, 4.5)* | 0.33† |
| Osteitis—median (IQR) | −0.5 (−3.0, 0.0) | −1.0 (−3.5, 0.5) | 0.3 (−1.0, 1.5)* | 0.92† |
| Modified sharp score | ||||
| Erosions—median (IQR) | 0.5 (0.0, 1.0) | 0.0 (0.0, 0.5) | −0.3 (−0.5, 0.0)* | 0.07† |
| Joint space narrowing—median (IQR) | 0.0 (0.0, 0.0) | 0.0 (0.0, 0.0) | 0.0 (0.0, 0.0)* | 0.66† |
| Total score—median (IQR) | 0.5 (0.0, 1.5) | 0.0 (0.0, 1.0) | 0.3 (−0.5, 0.0)* | 0.17† |
| Number of DMARDs/biologics | ||||
| 6 months—median (IQR) | 1 (1–3) | 3 (1–3) | 0.011† | |
| 12 months—median (IQR) | 2 (1–3) | 3 (2–3) | 0.019† | |
| 18 months—median (IQR) | 2 (1–3) | 3 (2–3) | 0.021† | |
*Hodges–Lehmann's median methods.
†Wilcoxon–Mann–Whitney U test.
CRP, C reactive protein; DAS44, 44 joint disease activity score; DMARDs, disease-modifying antirheumatic drugs; ESR, erythrocyte sedimentation rate; HAQ, Health Assessment Questionnaire; VAS, visual analogue score.