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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
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Arthritis Research & Therapy

ISSN: 1478-6362

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