Table 3

Differences between treatment groups in the change in primary and secondary outcome measures between baseline and 12 weeks (after adjustment for baseline values)

OutcomeDifference from placebo
Budesonide 3 mgBudesonide 9 mgPrednisolone 7.5 mg
Mean(95% CI)Mean(95% CI)Mean(95% CI)
Tender joint count2.23(−0.63 to 5.1)3.65*(0.75 to 6.54)4.83***(2.01 to 7.65)
Swollen joint count1.53(0.92 to 3.98)3.81**(1.3 to 6.52)3.67**(1.25 to 6.09)
Pain6.6(−5.8 to 18.9)11.4(−1.3 to 24)22.3***(10 to 34.6)
Disease activity (patient)7.9(−4.7 to 20.5)16.4*(3.6 to 29.3)24.5***(12.1 to 37)
Disease activity (physician)0.25(−0.12 to 0.62)0.45*(0.07 to 0.82)0.66***(0.3 to 1.03)
EMS35(−9 to 80)17(−28 to 62)21(−23 to 64)
Geometric EMS (log10)0.21(−0.08 to 0.5)0.37*(0.07 to 0.67)0.47**(0.18 to 0.77)
HAQ0.009(−0.19 to 0.21)0.107(−0.31 to 0.09)0.383***(0.188 to 0.578)
CRP (mg/dl)6.6(−4.8 to 18.1)1.9(−9.7 to 13.4)21.8***(10.5 to 33.1)
Geometric CRP (log10)0.23*(0.05 to 0.41)0.14(−0.04 to 0.32)0.46***(0.3 to 0.65)
PCS of SF-362(−2 to 6)3.7(−0.4 to 7.8)7.4***(3.5 to 11.4)
MCS of SF-364.8(−0.8 to 10.4)6.0*(0.4 to 11.7)7.2**(1.7 to 12.8)
ESR (mm/h)3(−4 to 10)4(−3 to 11)16***(9 to 23)
ACR20 response (%)–3(–17 to 23)17*(5 to 29)31**(16 to 46)
OutcomeDifference from budesonide 3 mgDifference from budesonide 9 mg
Budesonide 9 mgPrednisolone 7.5 mgPrednisolone 7.5 mg
Mean(95% CI)Mean(95% CI)Mean(95% CI)
*p<0.05, **p<0.01, ***p<0.001.
ACR, American College of Rheumatology; CRP, C reactive protein; EMS, early morning stiffness; ESR, erythrocyte sedimentation rate; HAQ, health assessment questionnaire; MCS, mental condition subscale of SF-36; PCS, physical condition subscale of SF-36; SF-36, 36 item short form health survey.
Tender joint count1.42(−1.35 to 4.19)2.59(−0.86 to 5.28)1.18(−1.52 to 3.88)
Swollen joint count2.28(−0.13 to 4.69)2.14(−0.16 to 4.44)0.14(−2.2 to 2.48)
Pain4.8(−7.3 to 16.9)15.7**(4.1 to 27.4)10.9(−1.2 to 23.1)
Disease activity (patient)8.5(−3.7 to 20.8)16.6**(4.8 to 28.5)8.1(−4 to 20.2)
Disease activity (physician)0.2(−0.15 to 0.55)0.42*(0.08 to 0.77)0.22(−0.13 to 0.57)
EMS19(−24 to 61)15(−27 to 56)4(−39 to 47)
Geometric EMS (log10)0.16(−0.13 to 0.45)0.26(−0.01 to 0.54)0.1(−0.18 to 0.39)
HAQ0.117(−0.31 to 0.07)0.393***(0.21 to 0.58)0.276**(0.089 to 0.464)
CRP (mg/dl)4.8(−6.3 to 15.8)15.2**(4.4 to 25.9)19.9***(9.1 to 30.8)
Geometric CRP (log10)0.09(−0.08 to 0.27)0.24**(0.07 to 0.41)0.33***(0.16 to 0.5)
PCS of SF-361.7(−2.1 to 5.5)5.4**(1.8 to 9.1)3.7*(0 to 7.5)
MCS of SF-361.2(−4.1 to 6.5)2.4(−7.5 to 2.6)1.2(−6.5 to 4)
ESR (mm/h)1(−6 to 8)13***(7 to 20)12***(6 to 19)
ACR20 response (%)20**( 6 to 34 )28**(12 to 44 )14(−4 to 32)