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. 2020 Oct;50(5):1182–1190. doi: 10.1016/j.semarthrit.2020.07.014

Table 4.

Clinical Assessments At 12 Months In Intention To Treat Population. Estimated treatment effects are shown between trial arms.

Assessment Intensive Management Standard Care Linear Regression*
Mixed Effect Models
N = 168 N = 167 Unadjusted P-value Adjusted P-value Unadjusted P-value Adjusted P-value
Mean (SE) Mean (SE) Coefficients Coefficient Coefficients Coefficient
(95% CI) (95% CI) (95% CI) (95% CI)
DAS28-ESR 3.4 (0.1) 3.8 (0.1) −0.6 (−0.9, −0.3) <0.001 −0.5 (−0.8, −0.2) 0.001 −0.4 (−0.7, −0.2) 0.001 −0.4 (−0.6, −0.1) 0.003
Tender Joints 7.5 (0.7) 10.8 (0.8) −2.4 (−4.4, −0.3) 0.023 −2.7 (−4.5, −0.8) 0.004 −1.4 (−3.4, 0.7) 0.187 −1.7 (−3.5, 0.2) 0.076
Swollen joints 3.5 (0.4) 4.9 (0.5) −1.9 (−3.0, −0.7) 0.002 −1.6 (−2.7, −0.5) 0.004 −1.5 (−2.6, −0.5) 0.005 −1.3 (−2.3, −0.4) 0.006
ESR 17 (1) 15 (1) −1.5 (−3.9, 1.0) 0.239 −1.1 (−3.4, 1.1) 0.329 −1.1 (−3.2, 1.0) 0.312 −0.7 (−2.7, 1.2) 0.463
CRP 9 (2) 7 (1) 0.9 (−2.6, 4.4) 0.628 1.5 (−1.8, 4.7) 0.372 0.6 (−2.0, 3.1) 0.666 1.3 (−0.9, 3.5) 0.239
Assessor Global 23 (2) 31 (2) −6 (−12, −0.2) 0.043 −8 (−13, −3) 0.003 −4 (−9, 2) 0.169 −5 (−10, −1) 0.015
Patient Global 29 (2) 41 (2) −9 (−15, −2) 0.010 −11 (−17, −6) <0.001 −6 (−12, −1) 0.026 −9 (−14, −4) <0.001
Fatigue 40 (2) 50 (2) −18 (−24, −11) <0.001 −15 (−21, −9) <0.001 −16 (−21, −10) <0.001 −13 (−18, −8) <0.001
Pain 28 (2) 37 (2) −6.5 (−13., 0.4) 0.064 −8.4 (−15, −2.3) 0.007 −4 (−11, 2) 0.161 −6 (−12, −1) 0.015
HAQ 1.0 (0.1) 1.1 (0.1) −0.1 (−0.2, 0.0) 0.055 −0.1 (−0.2, 0.0) 0.046 −0.1 (−0.1, 0.0) 0.136 −0.1 (−0.2, 0.0) 0.137
EQ5D-5L 0.76 (0.02) 0.72 (0.02) 0.02 (−0.02, 0.06) 0.248 0.03 (−0.01, 0.07) 0.078 0.02 (−0.01, 0.05) 0.275 0.02 (−0.01, 0.05) 0.121
Larsen score 13 (1) 10 (1) 0.5 (−0.1, 1.0) 0.095 0.4 (−0.2, 0.9) 0.175

Change from baseline analysed and adjustments made for demographics (age, gender, ethnicity, disease duration) design factors (NHS region) and baseline score; standard of care arm was the reference group; SE =standard errors; CI= 95% confidence Intervals.