| Baseline mean (SD) | Month 3 LSM change from baseline (SE) | Month 6 LSM change from baseline (SE) | |||||||
---|---|---|---|---|---|---|---|---|---|---|
 | Placebo (n = 122) | Tofacitinib 5 mg BID (n = 243) | Tofacitinib 10 mg BID (n = 245) | Placebo (n = 122) | Tofacitinib 5 mg BID (n = 243) | Tofacitinib 10 mg BID (n = 245) | Placebo → Tofacitinib 5 mg BID (n = 61) | Placebo → Tofacitinib 10 mg BID (n = 61) | Tofacitinib 5 mg BID (n = 243) | Tofacitinib 10 mg BID (n = 245) |
PtGA | 62.63 (21.91) | 61.66 (22.00) | 63.46 (23.23) | −11.19 (2.10) | −26.99 (1.45)*** | −30.94 (1.47)*** | −28.07 (2.97) | −29.62 (3.05) | −30.25 (1.47) | −33.99 (1.50) |
Pain | 61.79 (21.27) | 61.35 (22.27) | 62.03 (23.63) | −10.71 (2.14) | −26.94 (1.47)*** | −31.06 (1.50)*** | −26.01 (3.02) | −29.48 (3.10) | −29.19 (1.49) | −34.11 (1.52) |
HAQ-DI†| 1.53 (0.65) | 1.53 (0.66) | 1.50 (0.64) | −0.19 (0.05) | −0.50 (0.03)*** | −0.57 (0.03)*** | −0.43 (0.07) | −0.59 (0.07) | −0.62 (0.03) | −0.67 (0.04) |
SF-36 component summary scores | Â | Â | Â | Â | Â | Â | Â | Â | Â | Â |
SF-36 PCS score | 32.21 (8.35) | 31.23 (8.03) | 31.37 (7.39) | 2.63 (0.78) | 6.79 (0.53)*** | 8.55 (0.55)*** | 5.18 (1.09) | 6.14 (1.11) | 8.01 (0.53) | 9.66 (0.55) |
SF-36 MCS score | 39.87 (11.62) | 41.36 (11.68) | 42.19 (12.44) | 1.09 (0.89) | 4.11 (0.61)* | 5.39 (0.62)*** | 3.83 (1.23) | 8.01 (1.26) | 4.62 (0.60) | 4.80 (0.62) |
SF-36 domain scores | Â | Â | Â | Â | Â | Â | Â | Â | Â | Â |
Physical functioning | 31.41 (9.66) | 30.09 (9.31) | 30.51 (8.76) | 2.17 (0.88) | 6.15 (0.60)** | 6.97 (0.62)*** | 4.02 (1.22) | 5.15 (1.26) | 6.95 (0.60) | 8.17 (0.62) |
Role physical | 33.33 (8.97) | 32.84 (8.87) | 33.45 (8.69) | 1.88 (0.83) | 5.89 (0.57)*** | 7.53 (0.58)*** | 4.33 (1.16) | 6.31 (1.20) | 7.01 (0.57) | 7.85 (0.59) |
Bodily pain | 32.77 (7.67) | 32.41 (7.57) | 32.74 (7.55) | 3.91 (0.86) | 8.26 (0.58)*** | 10.84 (0.60)*** | 7.88 (1.21) | 10.28 (1.25) | 9.44 (0.59) | 11.30 (0.61) |
General health | 34.70 (9.00) | 34.86 (8.72) | 35.71 (8.86) | 2.44 (0.75) | 4.76 (0.51)* | 6.34 (0.53)*** | 5.26 (1.06) | 5.37 (1.10) | 6.51 (0.52) | 7.49 (0.54) |
Vitality | 40.13 (9.82) | 41.22 (10.06) | 41.04 (10.27) | 2.03 (0.81) | 6.56 (0.55)*** | 8.49 (0.57)*** | 4.67 (1.15) | 8.27 (1.18) | 6.87 (0.56) | 8.30 (0.58) |
Social functioning | 35.16 (10.34) | 36.78 (11.04) | 36.07 (11.27) | 0.62 (0.91) | 5.29 (0.62)*** | 7.51 (0.64)*** | 3.54 (1.29) | 8.21 (1.34) | 6.05 (0.63) | 6.83 (0.65) |
Role emotional | 35.17 (13.11) | 34.26 (12.63) | 36.70 (13.03) | 1.20 (1.05) | 4.07 (0.72)* | 5.50 (0.74)** | 4.54 (1.43) | 6.96 (1.47) | 5.95 (0.70) | 5.56 (0.72) |
Mental health | 38.43 (12.36) | 40.05 (11.49) | 40.50 (12.57) | 2.19 (0.88) | 4.71 (0.60)* | 5.52 (0.62)* | 4.09 (1.23) | 8.02 (1.27) | 4.52 (0.60) | 5.35 (0.62) |
FACIT-F | 27.17 (10.88) | 27.90 (10.70) | 27.72 (11.15) | 2.84 (0.82) | 6.70 (0.56)*** | 8.01 (0.58)*** | 6.57 (1.16) | 9.11 (1.20) | 6.98 (0.57) | 8.63 (0.58) |
MOS Sleep Scale | 47.32 (21.24) | 42.45 (18.38) | 43.09 (20.41) | −4.81 (1.48) | −7.13 (1.02) | −10.18 (1.04)* | −8.43 (2.06) | −10.50 (2.14) | −7.48 (1.02) | −9.98 (1.05) |