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Table 1 Demographic and baseline disease characteristics 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

  Tofacitinib
5 mg BID
(N = 826)
Tofacitinib
10 mg BID
(N = 821)
Adalimumab
40 mg Q2W
(N = 199)
Placebo
(N = 419)
Age, mean (SD) years 53.2 (11.7) 52.2 (11.6) 52.7 (11.6) 52.7 (11.9)
Female, n (%) 694 (84.0) 684 (83.3) 157 (78.9) 335 (80.0)
Race, n (%)
 Asian 267 (32.3) 265 (32.3) 27 (13.6) 137 (32.7)
 Black 22 (2.7) 18 (2.2) 3 (1.5) 9 (2.1)
 White 475 (57.5) 459 (55.9) 148 (74.4) 239 (57.0)
 Other 62 (7.5) 79 (9.6) 21 (10.6) 34 (8.1)
Geographic region, n (%)
 Canada/Europe 279 (33.8) 272 (33.1) 114 (57.3) 144 (34.4)
 Latin America 112 (13.6) 107 (13.0) 21 (10.6) 53 (12.6)
 USA 138 (16.7) 133 (16.2) 30 (15.1) 76 (18.1)
 Otherb 297 (36.0) 309 (37.6) 34 (17.1) 146 (34.8)
Disease duration, mean (SD) years 8.3 (7.5) 8.7 (8.0) 8.2 (7.6) 9.1 (8.6)
DAS28-4(ESR), mean (SD) 6.4 (1.0)e 6.4 (1.0)f 6.4 (0.9)g 6.3 (1.0)h
CDAI, mean (SD) 36.3 (12.1)i 36.1 (12.2)e 37.1 (12.8) 35.7 (12.6)j
HAQ-DI, mean (SD) 1.4 (0.7)k 1.4 (0.7) 1.5 (0.6) 1.4 (0.7)l
FACIT-F total score, mean (SD) 28.6 (10.8)m 29.0 (10.3)e 27.9 (10.1) 30.4 (10.1)l
MOS-SS domain, mean (SD)
 Sleep adequacy 46.1 (28.4)n 45.1 (27.4)o 44.1 (27.9)p 47.0 (25.9)l
 Awaken short of breath/with headache 18.5 (25.0)n 17.1 (23.6)o 20.0 (24.4)p 16.7 (22.5)l
 Sleep disturbance 43.3 (26.8)n 42.0 (25.8)e 46.6 (26.3)p 40.1 (26.6)l
 Sleep quantity (hours) 6.6 (1.7)k 6.6 (1.5)q 6.7 (1.8)r 6.7 (1.5)s
 Snoring 34.0 (31.6)q 31.5 (31.4)e 34.7 (30.7)r 31.4 (29.3)t
 Somnolence 35.7 (22.1)i 35.5 (21.9)o 33.4 (19.8)r 34.9 (19.9)l
MOS-SS Sleep Problems Index I scorec, mean (SD) 39.8 (20.9)i 39.5 (19.4)o 41.0 (19.7)p 37.6 (18.6)l
MOS-SS Sleep Problems Index II scored, mean (SD) 41.2 (20.3)i 40.8 (19.1)e 43.2 (19.5)p 39.2 (18.7)l
SF-36 domain score, mean (SD)
 Physical functioning 32.3 (9.7)u 31.9 (9.7) 31.7 (8.9) 32.9 (10.0)j
 Role-physical 34.1 (9.5)u 34.1 (9.5) 34.8 (8.7) 35.1 (9.7)j
 Bodily pain 33.6 (7.4)u 34.1 (7.6) 33.1 (7.3) 34.8 (7.5)j
 General health 34.7 (9.1)u 35.3 (8.8) 35.2 (8.0) 35.9 (8.3)j
 Vitality 40.7 (9.9)u 41.5 (9.3) 39.9 (9.6) 42.3 (9.5)j
 Social functioning 36.6 (11.0)u 37.7 (11.1) 36.2 (11.6) 38.4 (11.5)j
 Role-emotional 35.2 (13.0)u 35.2 (13.1) 35.6 (12.1) 36.6 (13.1)j
 Mental health 39.7 (11.8)u 40.4 (11.0) 39.7 (11.3) 41.6 (11.1)j
SF-36 MCS score, mean (SD) 40.7 (12.0)u 41.5 (11.3) 40.6 (11.7) 42.6 (11.5)j
SF-36 PCS score, mean (SD) 32.8 (7.9)u 32.8 (7.7) 32.7 (6.8) 33.5 (7.5)j
PtGA VAS, mean (SD) 58.9 (22.8)m 57.9 (23.1)v 57.1 (22.3) 55.6 (22.7)j
Pain VAS, mean (SD) 58.1 (22.9)u 58.3 (22.9) 56.3 (22.0) 55.8 (22.9)j
CRP levels, mean (SD) mg/L 16.1 (19.9)u 17.3 (23.4) 17.4 (22.5) 15.3 (16.6)
  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. bCountries in “Other” were Australia, China, India, Japan, Malaysia, Philippines, Republic of Korea, Taiwan, and Thailand
  4. cBased on six items of the MOS-SS: How often over the past 4 weeks did you … have trouble falling asleep; awaken during sleep; awaken short of breath/with headache; get enough sleep to feel rested upon waking; get amount of sleep needed; have trouble staying awake?
  5. dBased on the six items stated in footnote u and three additional items of the MOS-SS: How often over the past 4 weeks did you … feel that your sleep was not quiet; feel drowsy during day; how long did it usually take to fall asleep?
  6. e N = 818; f N = 813; g N = 192; h N = 413; i N = 822; j N = 418; k N = 824; l N = 417; m N = 825; n N = 823; o N = 819; p N = 198; q N = 817; r N = 197; s N = 415; t N = 416; u N = 825; v N = 820
  7. BID, twice daily; CDAI, Clinical Disease Activity Index; CRP, C-reactive protein; DAS28-4(ESR), Disease Activity Score in 28 joints, erythrocyte sedimentation rate; FACIT-F, Functional Assessment of Chronic Illness Therapy-Fatigue; HAQ-DI, Health Assessment Questionnaire-Disability Index; MCS, Mental Component Summary; MOS-SS, Medical Outcomes Study Sleep scale; PCS, Physical Component Summary; PtGA, Patient Global Assessment of Arthritis; Q2W, once every 2 weeks; SF-36, Short Form-36 Health Survey; SD, standard deviation; VAS, visual analog scale