Table 2.
Primary, key secondary and other secondary outcomes at 5 years
| MRI treat-to-target group | Conventional treat-to-target group | |||||
| No. | No. | Contrast between groups (95% CI) | P value | |||
| Primary endpoints | ||||||
| Clinical | ||||||
| DAS28-CRP remission (DAS28-CRP<2.6), no. (%) | 59 | 47 (80) | 72 | 54 (75) | 2.00 (0.76 to 5.28) | 0.161 |
| Radiographic(van der Heijde modified Sharp score, vdHSS) | ||||||
| No radiographic progression, No. (%) | 59 | 14 (24) | 72 | 19 (26) | 0.70 (0.28 to 1.71) | 0.431 |
| Key secondary endpoints | ||||||
| Clinical | ||||||
| DAS28-CRP, LSmean (SE) | 59 | 1.79 (0.08) | 72 | 1.94 (0.08) | −0.15 (−0.38 to 0.07) | 0.176 |
| Radiographic measures (vdHSS) | ||||||
| Change in total vdHSS, median (IQR) | 47 | 1.0 (0.0–3.0) | 56 | 2.0 (0.0–4.0) | −0.0 (−1.0 to 0.0) | 0.515 |
| Change in total vdHSS, LSmean (SE) | 58 | 2.3 (0.6) | 72 | 3.6 (0.5) | 1.3 (−2.9 to 0.2) | 0.094 |
| MRI, RA MRI scoring system | ||||||
| Change in osteitis, median (IQR) | 51 | 0.00 (−1.50;1.00) | 58 | 0.00 (−1.00;1.00) | −0.00 (−1.00 to 0.00) | 0.606 |
| Change in osteitis, LSmean (SE) | 59 | −0.17 (0.58) | 71 | 0.18 (0.54) | −0.35 (−1.96 to 1.25) | 0.663 |
| Function | ||||||
| Change in Health Assessment Questionnaire (HAQ) | 59 | −0.02 (0.03) | 71 | 0.05 (0.03) | −0.07 (−0.15 to 0.01) | 0.080 |
| Other secondary outcomes | ||||||
| Clinical | ||||||
| ACR-EULAR Boolean remission, No. (%) | 59 | 23 (39) | 72 | 28 (39) | 1.38 (0.63 to 3.03) | 0.425 |
| Simplified Disease Activity Index (SDAI) remission, No (SDAI≤3.3), No. (%) |
59 | 33 (56) | 72 | 40 (56) | 1.56 (0.70 to 3.46) | 0.275 |
| Clinical Disease Activity Index (CDAI) remission (CDAI≤2.8), No. (%) |
59 | 36 (61) | 72 | 39 (54) | 2.02 (0.89 to 4.54) | 0.091 |
| Tender joint count (0–28) | 59 | 0.3 (0.1) | 72 | 0.4 (0.1) | −0.1 (−0.5 to 0.3) | 0.599 |
| Swollen joint count (0–28) | 59 | 0.1 (0.1) | 72 | 0.2 (0.1) | −0.1 (−0.4 to 0.2) | 0.507 |
| Patient’s VAS global (0–100) | 59 | 15.6 (2.2) | 72 | 21.5 (2.0) | −5.9 (−11.9 to 0.0) | 0.051 |
| Patient’s VAS pain (0–100) | 59 | 12.9 (2.1) | 72 | 20.0 (1.9) | −7.0 (−12.8 to −1.2) | 0.018 |
| Patient’s VAS fatigue (0–100) | 59 | 21.8 (2.3) | 72 | 24.8 (2.1) | −3.0 (−9.3 to 3.3) | 0.341 |
| Investigator’s VAS global (0–100) | 58 | 4.1 (1.0) | 72 | 6.1 (0.9) | −2.0 (−4.7 to 0.7) | 0.147 |
| Radiographic (vdHSS) | ||||||
| Change in erosion, median (IQR) | 47 | 1.0 (0.0 –2.0) | 56 | 1.0 (0.0 –3.0) | 0.0 (−0.0 to 0.0) | 0.967 |
| Change in erosion, LSmean (SE) | 58 | 1.7 (0.3) | 72 | 2.3 (0.3) | −0.6 (−1.6 to 0.3) | 0.183 |
| Change in joint space narrowing, median (IQR) | 47 | 0.0 (0.0 –1.0) | 56 | 0.0 (0.0 –1.3) | −0.0 (−0.0 to 0.0) | 0.565 |
| Change in joint space narrowing, LSmean (SE) | 58 | 0.6 (0.3) | 72 | 1.3 (0.2) | −0.7 (−1.4 to 0.1) | 0.085 |
| MRI, RAMRIS | ||||||
| Change in synovitis, median (IQR) | 44 | 0.0 (−2.0 −2.0) | 50 | 0.0 (−2.0 –1.0) | 0.0 (−1.0 to 1.0) | 0.789 |
| Change in synovitis, LSmean (SE) | 57 | −0.6 (0.4) | 63 | −0.3 (0.4) | −0.4 (−1.6 to 0.8) | 0.549 |
| Change in tenosynovitis, median (IQR) | 43 | 0.0 (−2.5 –1.0) | 48 | 0.0 (−2.0 –2.0) | −0.0 (−2.0 to 1.0) | 0.374 |
| Change in tenosynovitis, LSmean (SE) | 56 | −0.6 (0.4) | 62 | 0.0 (0.4) | −0.6 (−1.8 to 0.6) | 0.350 |
| Change in combined Inflammation score, median (IQR)* | 43 | −3.0(−4.5;3.0) | 47 | −1.0(−3.5;2.5) | −1.0 (−4.0 to 2.0) | 0.491 |
| Change in combined Inflammation score, LSmean (SE) | 56 | −1.4 (1.1) | 62 | 0.1 (1.1) | −1.4 (−4.6 to 1.8) | 0.378 |
| No progression in MRI erosion, No. (%)† | 59 | 28 (47) | 72 | 34 (47) | 1.21 (0.56 to 2.60) | 0.627 |
| Change in erosion, median (IQR) | 50 | 0.0 (0.0 –1.0) | 58 | 0.0 (0.0 –1.0) | 0.0 (−0.0 to 0.0) | 0.868 |
| Change in erosion, LSmeans (SE) | 59 | 1.5 (0.4) | 71 | 0.9 (0.4) | 0.6 (−0.5 to 1.7) | 0.255 |
| Change in JSN, median (IQR) | 50 | 0.0 (0.0 –0.0) | 58 | 0.0 (0.0 –0.0) | −0.0 (−0.0 to 0.0) | 0.453 |
| Change in JSN, LSmeans (SE) | 59 | 0.3 (0.1) | 71 | 0.4 (0.1) | −0.1 (−0.4 to 0.2) | 0.438 |
| Change in combined damage score, median (IQR)‡ | 50 | 0.0 (0.0 –1.8) | 58 | 0.0 (0.0 –1.0) | −0.0 (−0.0 to 0.0) | 0.812 |
| Change in combined damage score, LSmeans (SE) | 59 | 1.7 (0.5) | 71 | 1.3 (0.4) | 0.5 (−0.9 to 1.8) | 0.495 |
| Function and quality of life | ||||||
| Change in EQ-5D score | 56 | 0.02 (0.02) | 68 | −0.02 (0.01) | 0.04 (−0.01 to 0.08) | 0.097 |
| Change in SF-36 Physical Component Summary | 59 | −0.3 (1.0) | 68 | −2.7 (0.9) | 2.4 (−0.4 to 5.2) | 0.091 |
| Change in SF-36 Mental Component Summary | 59 | −1.4 (1.1) | 68 | −0.7 (1.0) | −0.8 (−3.8 to 2.3) | 0.627 |
| Patient with normal function (HAQ≤0.5), No. (%) | 59 | 35 (59) | 72 | 49 (68) | 1.09 (0.48 to 2.49) | 0.832 |
| Treatment | ||||||
| csDMARD monotherapy, No. (%) | 59 | 20 (34) | 72 | 44 (61) | 0.51 (0.23 to 1.11) | 0.090 |
| csDMARD combination therapy, No. (%) | 59 | 13 (22) | 72 | 13 (18) | 1.04 (0.40 to 2.73) | 0.937 |
| Biological treatment, No. (%) | 59 | 22 (37) | 72 | 6 (8) | 4.80 (1.66 to 13.86) | 0.004 |
| No treatment, No. (%) | 59 | 1 (2) | 72 | 3 (4) | 0.16 (0.01 to 2.55) | 0.196 |
Group contrasts are presented as No. (%), OR (95% CI) for dichotomous outcomes, estimated from logistic regression adjusted for a propensity score and with non-responder imputation. For continuous outcomes groups, contrasts are presented as median differences (95% CI) or LSmeans (SE), based on the ITT population (no manual imputation done).
*Sum score of MRI synovitis, osteitis and tenosynovitis.
†Progression defined as change in RAMRIS erosion score ≥1.
‡Sum score of MRI erosion and joint space narrowing.
csDMARD, conventional synthetic disease-modifying antirheumatic drug; DAS28-CRP, Disease Activity Score in 28 joints C reactive protein; EQ-5D, EuroQol-5 Dimensions; ITT, intention to treat; RA, rheumatoid arthritis; RAMRIS, Rheumatology RA MRI scoring system; SF-36, 36-Item Short Form; VAS, Visual Analogue Scale.