Change in disease activity variables and cardiovascular risk factors over 12 months. Data are median (interquartile range) or mean ± SD.
| Variables | Intention-to-treat Analysis | Posthoc Analysis | ||||
|---|---|---|---|---|---|---|
| Group 1 (SDAI remission group), n = 57 | Group 2 (DAS remission group), n = 60 | p | Non-SDR, n = 73 | SDR, n = 37 | p | |
| Disease activity | ||||||
| Tender joint count | −6 (−10 to −4) | −6 (−8 to −3) | 0.501 | −5 (−9 to −3) | −7 (−10 to −4) | 0.113 |
| Swollen joint count | −4 (−7 to −2) | −3 (−6 to −2) | 0.194 | −4 (−6 to −2) | −4 (−6 to −3) | 0.608 |
| ESR, mm/h | −24 (−38 to −9) | −22 (−32 to −3) | 0.279 | −23 (−38 to −3) | −19 (−32 to −9) | 0.702 |
| CRP, mg/l | −8.0 (−24.6 to −1.3) | −8.9 (−20.1 to −1.5) | 0.974 | −8.0 (−19.2 to −1.5) | −8.5 (−22.5 to −1.3) | 0.849 |
| VAS pain, NRS 0–10 | −4.0 (−5.5 to −3.0) | −4.0 (−5.3 to −2.0) | 0.580 | −3.8 (−5.0 to −1.5) | −5.0 (−6.5 to −3.0) | 0.002 |
| PtGA, NRS 0–10 | −4.0 ± 2.5 | −3.8 ± 2.4 | 0.760 | −3.2 ± 2.2 | −5.3 ± 2.2 | < 0.001 |
| PGA, NRS 0–10 | −4.5 (−7.0 to −3.0) | −4.0 (−6.3 to −2.0) | 0.308 | −4.0 (−6.5 to 2.0) | −5.0 (−7.5 to −3.5) | 0.026 |
| DAS28 | −2.47 ± 1.28 | −2.31 ± 1.28 | 0.509 | −2.05 ± 1.21 | −3.18 ± 0.97 | < 0.001 |
| SDAI | −22.2 ± 12.62 | −20.04 ± 11.80 | 0.348 | −19.47 ± 12.82 | −24.7 ± 10.11 | 0.033 |
| HAQ,0–3 | −0.63 (−1.13 to −0.38) | −0.50 (−1.13 to 0.00) | 0.247 | −0.50 (−1.13 to −0.13) | −0.88 (−1.25 to −0.50) | 0.021 |
| Cardiovascular risk factors | ||||||
| BMI, kg/m2 | 0.20 (−0.41 to 0.79) | 0.27 (−0.71 to 1.35) | 0.647 | 0.18 (−0.47 to 0.95) | 0.30 (−0.30 to 1.08) | 0.324 |
| Waist–hip ratio | 0.01 (−0.02 to 0.02) | 0.01 (−0.02 to 0.04) | 0.391 | 0.01 (−0.02 to 0.03) | 0.01 (−0.02 to 0.05) | 0.694 |
| Systolic BP, mmHg | 1 (−7 to 11) | −6 (−14 to 0) | 0.002 | −2 (−9 to 6) | −6 (−14 to 6) | 0.295 |
| Diastolic BP, mmHg | −1 (−6 to 6) | −5 (−10 to −1) | 0.022 | −4 (−8 to 3) | −1 (−8 to 3) | 0.512 |
| Fasting glucose, mmol/l | 0.00 (−0.20 to 0.20) | 0.00 (−0.30 to 0.30) | 0.672 | 0.0 (−0.2 to 0.2) | −0.1 (−0.3 to 0.2) | 0.276 |
| TC, mmol/l | 0.30 (−0.10 to 0.60) | 0.10 (−0.40 to 0.75) | 0.326 | 0.3 (−0.2 to 0.7) | 0.2 (−0.2 to 0.6) | 0.664 |
| HDL, mmol/l | 0.20 (0.00–0.50) | 0.20 (0.00–0.50) | 0.905 | 0.2 (0.0–0.5) | 0.1 (0.0–0.4) | 0.269 |
| LDL, mmol/l | 0.00 (−0.30 to 0.30) | −0.10 (−0.50 to 0.60) | 0.532 | −0.1 (−0.4 to 0.5) | 0.0 (−0.3 to 0.3) | 0.590 |
| Triglycerides, mmol/l | 0.10 (−0.10 to 0.40) | 0.00 (−0.20 to 0.30) | 0.502 | 0.0 (−0.2 to 0.3) | 0.0 (−0.1 to 0.2) | 0.626 |
| Framingham risk score, % | 0.1 (−0.8 to 1.0) | −0.6 (−3.6 to 0.6) | 0.043 | −0.12 (−1.72 to 0.53) | −0.22 (−2.3 to 0.83) | 0.922 |
| Arterial stiffness | ||||||
| PWV, cm/s*^ | 16 ± 160 | −30 ± 204 | 0.189 | 25 ± 183 | −71 ± 172 | 0.009 |
| AIx, %*† | 0 (−5 to 5) | −2 (−7 to 5) | 0.708 | 1 (−5.5 to 6) | −2 (−6 to 4) | 0.255 |
| Clinical response at 12 mos | ||||||
| DAS28 remission | 29 (50.9) | 33 (55.0) | 0.655 | 23 (31.5) | 37 (100) | < 0.001 |
| SDAI remission | 21 (36.8) | 24 (40.0) | 0.726 | 14 (19.2) | 30 (81.1) | < 0.001 |
| ACR20 | 47 (82.5) | 49 (81.7) | 0.911 | 57 (78.1) | 36 (97.3) | 0.008 |
| ACR50 | 38 (66.7) | 40 (66.7) | 0.999 | 41 (56.2) | 35 (94.6) | < 0.001 |
| ACR70 | 30 (52.6) | 32 (53.3) | 0.939 | 28 (38.4) | 33 (89.2) | < 0.001 |
| EULAR good response | 43 (75.4) | 41 (68.3) | 0.393 | 44 (60.3) | 37 (100) | < 0.001 |
↵* Data from 110 patients who completed Month 12 followup were analyzed.
↵^ Group 1: 54, Group 2: 56.
↵† Group 1: 31, Group 2: 38 for the per-protocol analysis; non-SDR: 44, SDR: 25 for the posthoc analysis. Data in bold face are statistically significant. SDAI: Simplified Disease Activity Index; DAS28: 28-joint count Disease Activity Score; SDR: achieved sustained DAS28 remission; ESR: erythrocyte sedimentation rate; CRP: C-reactive protein; VAS: visual analog scale; NRS: numerical rating scale; PtGA: patient’s global assessment; PGA: physician’s global assessment; HAQ: Health Assessment Questionnaire; BMI: body mass index; BP: blood pressure; TC: total cholesterol; HDL: high-density lipoprotein; LDL: low-density lipoprotein; PWV: pulse wave velocity; AIx: augmentation index. ACR20: American College of Rheumatology 20% response; EULAR: European League Against Rheumatism.