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Table 1 Baseline characteristics for patients randomized to double-blind adalimumab (ADA) 40 mg every 2 weeks or tofacitinib 10 mg twice daily (BID) in the phase 3 study [10] and for the subgroup who then received open-label tofacitinib 10 mg BID in the extension study [13]

From: Switching from adalimumab to tofacitinib in the treatment of patients with rheumatoid arthritis

 

Double-blind study

Double-blind to open-label extensiona

ADA 40 mg

Tofacitinib 10 mg

ADA to tofacitinib

Tofacitinib to tofacitinib

n = 204

n = 201

n = 107

n = 126

Female, n (%)

162 (79.4)

168 (83.6)

83 (77.6)

107 (84.9)

White, n (%)

148 (72.5)

143 (71.1)

90 (84.1)

98 (77.8)

Age in years, mean ± SD

52.5 ± 11.7

52.9 ± 11.8

52.2 ± 11.4

51.6 ± 11.2

Region of origin, %

 North America

25.5

24.9

16.8

20.6

 South America

2.9

1.5

4.7

1.6

 Europe

53.9

55.7

60.7

59.5

 Rest of world

17.6

17.9

17.8

18.3

Tender and swollen joints, mean

 Tender

26.7

26.1

28.0

25.6

 Swollen

16.4

15.8

16.8

16.1

Mean HAQ-DI score

1.5

1.5

1.5

1.5

Mean DAS28-4(ESR)

6.4

6.5

6.4

6.4

Mean CRP (mg/L)

17.5

17.3

16.2

17.9

Positive for rheumatoid factor, %

68.2

66.2

66.4

65.9

Positive for anti-CCP, %

74.8

64.0

74.8

65.1

Prior therapy, n (%)

 TNF inhibitor

16 (7.8)

14 (7.0)

12 (11.2)

10 (7.9)

 Non-TNF inhibitor biologic agent

3 (1.5)

4 (2.0)

1 (0.9)

3 (2.4)

 Disease-modifying drug other than MTX

114 (55.9)

115 (57.2)

66 (61.7)

80 (63.5)

Concomitant therapy, n (%)

 Glucocorticoids

125 (61.3)

129 (64.2)

63 (58.9)

77 (61.1)

 Lipid-lowering medication

10 (4.9)

10 (5.0)

6 (5.6)

6 (4.8)

  1. aBaseline values at the start of the double-blind study; includes patients who completed treatment with ADA 40 mg every 2 weeks or tofacitinib 10 mg BID in the blinded study (or discontinued treatment for reasons other than a tofacitinib-related serious adverse event (AE)) and then enrolled in the extension study and switched treatment with minimal washout (≤2 weeks after their last dose of study drug in the blinded study). CCP cyclic citrullinated peptide, CRP C-reactive protein, DAS28-4(ESR) Disease Activity Score for 28-joint counts based on the erythrocyte sedimentation rate, HAQ-DI Health Assessment Questionnaire-Disability Index, MTX methotrexate, RA rheumatoid arthritis, SD standard deviation, TNF tumor necrosis factor