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Table 2 LS mean change from baseline in PRO domain scores at month 3 across treatment groupsa

From: The impact of tofacitinib on fatigue, sleep, and health-related quality of life in patients with rheumatoid arthritis: a post hoc analysis of data from Phase 3 trials

Outcome Tofacitinib 5 mg BID
(N = 826)
Tofacitinib 10 mg BID
(N = 821)
Adalimumab
40 mg Q2W
(N = 199)
Placebo
(N = 419)
n LS mean change SE n LS mean change SE n LS mean change SE n LS mean change SE
MOS-SS domain scores
 Sleep adequacy 768 7.56***† 0.86 773 6.67** 0.86 187 3.37 1.81 387 1.86 1.19
 Awaken short of breath/with headache 768 0.20 0.69 773 −1.76* 0.69 187 −1.07 1.47 387 0.55 0.96
 Sleep disturbance 767 −7.58* 0.68 772 −8.72**† 0.68 187 −4.66 1.43 387 −5.25 0.94
 Sleep quantity (hours) 771 0.18* 0.04 771 0.27** 0.04 186 0.16 0.09 386 0.01 0.06
 Snoring 761 −0.65 0.78 771 0.09 0.77 186 0.76 1.64 385 −0.57 1.07
 Somnolence 767 −5.25*** 0.62 773 −5.91***† 0.62 186 −3.03 1.32 387 −0.26 0.86
SF-36 domain scores
 Physical functioning 772 4.77*** 0.30 774 6.67***†† 0.30 188 4.44** 0.64 389 2.16 0.42
 Role-physical 773 5.42*** 0.31 775 7.28***†† 0.31 188 5.37** 0.66 389 2.50 0.43
 Bodily pain 772 7.41*** 0.30 775 9.43***†† 0.30 188 7.19*** 0.62 389 3.54 0.41
 General health 772 4.73*** 0.26 774 5.59*** 0.26 187 4.55*** 0.65 389 1.65 0.36
 Vitality 773 5.77*** 0.31 775 6.65***† 0.31 188 5.02** 0.65 389 2.18 0.42
 Social functioning 773 5.11***† 0.33 775 6.31***†† 0.33 188 3.51 0.71 389 2.26 0.46
 Role-emotional 772 3.79** 0.39 774 6.24***† 0.39 188 4.09* 0.83 388 1.93 0.54
 Mental health 773 3.93*** 0.33 775 5.03*** 0.33 188 3.54* 0.69 389 1.59 0.45
  1. Data were pooled from Phase 3 ORAL Scan, ORAL Standard, and ORAL Sync study datasets, and are presented for the full analysis set
  2. aAll treatments were administered in combination with background conventional synthetic disease-modifying antirheumatic drugs
  3. * p < 0.05, ** p < 0.01, and *** p < 0.001 for tofacitinib and adalimumab vs placebo; p < 0.05 and †† p < 0.01 for tofacitinib vs adalimumab
  4. BID, twice daily; LS, least squares; MOS-SS, Medical Outcomes Study Sleep scale; PRO, patient-reported outcome; Q2W, once every 2 weeks; SE, standard error; SF-36, Short Form-36 Health Survey