Treatment, treatment responses, remission rates and radiographical outcome measures at baseline and after 3, 4 and 5 years
| Baseline | Year 3 | Year 4 | Year 5 | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Methotrexate plus placebo-ciclosporin | Methotrexate plus ciclosporin | p Value | Methotrexate plus placebo-ciclosporin | Methotrexate plus ciclosporin | p Value | Methotrexate plus placebo-ciclosporin | Methotrexate plus ciclosporin | p Value | Methotrexate plus placebo-ciclosporin | Methotrexate plus ciclosporin | p Value | |
| MTX or MTX+HCQ (%) | 100 | 100 | – | 65 | 49 | 0.07 | 56 | 45 | 0.27 | 52 | 47 | 0.67 |
| Triple therapy or other DMARD (%) | 0 | 0 | – | 26 | 24 | 0.96 | 23 | 26 | 0.81 | 16 | 16 | 1 |
| Biologic treatment (%) | 0 | 0 | – | 7 | 16 | 0.16 | 14 | 16 | 0.90 | 17 | 19 | 1 |
| Drug free remission (no treatment) (%)* | 0 | 0 | – | 1 | 11 | 0.05 | 7 | 12 | 0.44 | 14 | 19 | 0.68 |
| DAS28 (median (IQR))* | 5.31 (4.52–5.94) | 5.23 (4.22–5.93) | 0.39 | 2.08 (1.59–2.91) | 1.92 (1.48–2.64) | 0.31 | 2.05 (1.61–2.97) | 1.79 (1.41–2.81) | 0.16 | 1.95 (1.43–2.56) | 1.84 (1.45–2.44) | 0.48 |
| ACR20 (%)* | 0 | 0 | – | 89 | 87 | 0.99 | 91 | 88 | 0.82 | 85 | 94 | 0.17 |
| ACR50 (%)* | 0 | 0 | – | 73 | 80 | 0.42 | 74 | 81 | 0.47 | 74 | 88 | 0.08 |
| ACR70 (%)* | 0 | 0 | – | 61 | 67 | 0.60 | 62 | 69 | 0.50 | 63 | 72 | 0.38 |
| ACR remission (% )* | 0 | 0 | – | 45 | 55 | 0.40 | 44 | 55 | 0.28 | 52 | 60 | 0.45 |
| DAS remission (% )* | 0 | 0 | – | 70 | 74 | 0.81 | 71 | 69 | 0.94 | 76 | 80 | 0.74 |
| Sustained ACR remission (year 3, 4 and 5) | – | – | – | – | – | – | – | – | – | 27 | 28 | 1 |
| HAQ <0.25 (%)* | 13 | 14 | – | 54 | 58 | 0.84 | 56 | 64 | 0.41 | 57 | 56 | 1 |
| SJC=0 (%)* | 0 | 0 | – | 72 | 78 | 0.56 | 79 | 79 | 1 | 75 | 76 | 1 |
| TJC=0 (%)* | 1 | 4 | 0.62 | 57 | 60 | 0.78 | 53 | 66 | 0.16 | 65 | 67 | 0.95 |
| Pain <10 mm (%)* | 6 | 4 | – | 62 | 45 | 0.07 | 53 | 58 | 0.68 | 63 | 60 | 0.81 |
| Total Sharp score (median (IQR)) | 3 (0–7) | 2 (0–8) | 0.50 | 3* (0–10.5) | 4.5* (0–12) | 0.60 | 5.5 (0–11.75) | 5 (0–13) | 0.81 | 7 (0–13.5) | 5 (0–14) | 0.91 |
| Total Sharp score (mean±SD) | 4.76±5.90 | 5.31±7.38 | 7.76±11.0 | 8.94±11.4 | 8.43±11.2 | 9.33±11.6 | 9.63±11.93 | 10.18±13.37 | ||||
| ΔTSS since baseline (median (IQR)) | – | – | – | 0 (0–3.75) | 1 (0–3) | 0.48 | 1 (0–6) | 1.5 (0–4) | 0.88 | 1 (0–7) | 1.5 (0–4) | 0.75 |
| ΔTSS since baseline (mean±SD) | – | – | – | 3.19±7.74 | 3.04±6.21 | 3.94±7.99 | 3.45±6.26 | 4.92±8.71 | 4.09±8.30 | |||
| Erosion score (median (IQR)) | 2 (0–5) | 0 (0–4) | 0.24 | 3 (0–8) | 2.5 (0–6) | 0.99 | 3 (0–8.75) | 3 (0–6) | 0.59 | 3 (0–10.5) | 3 (0–6) | 0.30 |
| Erosion score (mean±SD) | 3.08±4.14 | 2.99±4.91 | 5.21±7.54 | 5.26±7.86 | 5.89±7.92 | 5.66±8.34 | 6.76±8.41 | 6.05±9.16 | ||||
| ΔES since baseline (median (IQR)) | – | – | – | 0 (0–2.75) | 0 (0–2) | 0.65 | 0 (0–3) | 0.5 (0–3.25) | 0.86 | 1 (0–4) | 0.5 (0–3) | 0.62 |
| ΔES since baseline (mean ± SD) | – | – | – | 2.23±5.78 | 2.07±4.19 | 2.80±6.27 | 2.44±4.39 | 3.52±6.92 | 2.88±5.75 | |||
| Joint space narrowing (median (IQR)) | 0 (0–1.5) | 0 (0–2) | 0.45 | 0 (0–3) | 0 (0–4) | 0.21 | 0 (0–3) | 0 (0–4) | 0.29 | 0 (0–4) | 0 (0–4) | 0.21 |
| Joint space narrowing (mean±SD) | 1.68±3.76 | 2.32±5.17 | 2.55±5.80 | 3.68±6.45 | 2.54±5.64 | 3.67±6.45 | 2.87±5.94 | 4.14±7.02 | ||||
| ΔJSN since baseline (median (IQR)) | – | – | – | 0 (0–0) | 0 (0–0) | 0.33 | 0 (0–0) | 0 (0–0.25) | 0.58 | 0 (0–0) | 0 (0–1) | 0.47 |
| ΔJSN since baseline (mean±SD) | – | – | – | 0.93±3.91 | 0.97±3.29 | 1.14±3.95 | 1.02±3.33 | 1.41±4.37 | 1.22±4.09 | |||
| Progression since baseline (ΔTSS >0) (% of patients) | – | – | – | 36% | 46% | 0.28 | 48% | 52% | 0.67 | 48% | 52% | 0.73 |
↵* Significant improvement from baseline (p<0.001).
ACR, American College of Rheumatology; ACR20/50/70, 20%/50%/70% improvement criteria; DAS28, disease activity score (28 joint count); DMARD, disease-modifying anti-rheumatic drug; ES, erosion score; HAQ, Health Assessment Questionnaire; HCQ, hydroxychlorochine; JSN, joint space narrowing; MTX, methotrexate; SJC, swollen joint count; TJC, tender joint count; TSS, total Sharp score.