Skip to main content

Table 1 Baseline values and changes from baseline at months 3 and 6 for patient-reported outcome measures

From: Effects of tofacitinib monotherapy on patient-reported outcomes in a randomized phase 3 study of patients with active rheumatoid arthritis and inadequate responses to DMARDs

  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           
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           
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)
  1. Co-primary endpoint at month 3. *p < 0.05; **p < 0.001; *** p < 0.0001 vs placebo. BID twice daily, FACIT-F Functional Assessment of Chronic Illness Therapy-Fatigue, HAQ-DI Health Assessment Questionnaire-Disability Index, LSM least squares mean, MCS Mental Component Summary, MOS Medical Outcomes Study, Pain Patient Global Assessment of Pain, PCS Physical Component Summary, PtGA Patient Global Assessment of Disease Activity, SD standard deviation, SE standard error, SF-36 Short Form-36