Changes in cardiovascular risk factors from baseline to final follow-up between treatment arms
| Cardiovascular risk factor | Baseline | Follow-up | Differences (Δ=baseline to follow-up) | |||||
| TNFi | Triple therapy | TNFi | Triple therapy | ΔTNFi | ΔTriple therapy | TNFi versus triple therapy | P value* | |
| Mean (SD) unless noted | β (95% CI) | |||||||
| Blood pressure, mm Hg | ||||||||
| Diastolic | 77.2 (8.7) | 77.4 (10.2) | 78.9 (7.3) | 78.7 (8.5) | 1.7 (9.8) | 1.3 (9.9) | 0.3 (−2.5 to 3.0) | 0.85 |
| Systolic | 129.1 (16.5) | 130.1 (17.2) | 131.6 (15.6) | 132.4 (13.4) | 2.5 (14.2) | 2.3 (18.1) | −0.4 (−5.2 to 4.3) | 0.85 |
| Total cholesterol, mg/dL | 202.2 (34.7) | 206.3 (37.9) | 210.4 (35.4) | 205.9 (43.0) | 8.1 (28.7) | −0.3 (35.8) | 7.0 (−4.5 to18.5) | 0.23 |
| Low density lipoprotein, mg/dL | 104.6 (27.7) | 104.1 (26.1) | 107.9 (28.3) | 104.1 (30.7) | 3.3 (20.8) | 0.01 (25.9) | 3.5 (−4.8 to 11.9) | 0.40 |
| High density lipoprotein, mg/dL | 58.3 (15.8) | 53.8 (18.3) | 58.4 (17.7) | 59.8 (18.0) | 0.2 (17.5) | 6.0 (14.0) | −3.8 (−9.1 to 1.6) | 0.16 |
| Trigylcerides, mg/dL | 113.0 (46.5) | 125.3 (52.8) | 121.3 (55.3) | 113.7 (46.3) | 8.3 (35.0) | −11.6 (44.1) | 16.8 (2.74 to 31.0) | 0.02 |
| Log(hsCRP), mg/L | 1.4 (1.3) | 1.4 (1.4) | 0.6 (1.4) | 1.3 (1.3) | −0.8 (1.2) | −0.1 (0.9) | −0.6 (−1.0 to 0.3) | <0.001 |
| hsTnT, ng/L | ||||||||
| All participants | 8.4 (5.0) | 8.3 (4.2) | 8.9 (6.2) | 8.0 (3.2) | 0.6 (2.1) | −0.3 (2.8) | 0.88 (−0.05 to 1.81) | 0.06 |
| Among those with values >6.0† | 11.1 (6.5) | 10.9 (5.3) | 12.0 (8.2) | 10.2 (3.7) | 1.0 (2.9) | −0.7 (3.9) | 1.7 (−0.3 to 3.8) | 0.10 |
Follow-up value is at study conclusion (approximately 24 weeks). Triple therapy refers to the use of weekly methotrexate, sulfasalazine 1000 mg two times per day and hydroxychloroquine 200–400 mg/day.
*P values for these outcomes are nominal and not corrected for multiple testing. All β estimates and p values are from ANCOVA models that estimate the change in cardiovascular risk factor as a function of the baseline value, treatment group and the randomisation strata. hsCRP p value is from a Wilcoxon rank sum test.
†Lower limits of detection.
ANCOVA, analysis of covariance; hsCRP, high-sensitivity CRP; hsTnT, high-sensitivity cardiac troponin T; TNFi, TNF inhibitor.