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Table 1 Baseline demographics and disease characteristics (TP2 full analysis set)

From: Switch from reference etanercept to SDZ ETN, an etanercept biosimilar, does not impact efficacy, safety, and immunogenicity of etanercept in patients with moderate-to-severe rheumatoid arthritis: 48-week results from the phase III, randomized, double-blind EQUIRA study

Characteristics

Continued SDZ ETN (n = 175)

Switched to SDZ ETN (n = 166)

Age (years)

55.1 (10.99)

52.2 (12.84)

Female, n (%)

149 (85.1)

131 (78.9)

Race,a n (%)

 Caucasian

169 (96.6)

164 (98.8)

Functional RA status, n (%)

 Class I

20 (11.4)

25 (15.1)

 Class II

122 (69.7)

121 (72.9)

 Class III

33 (18.9)

20 (12.0)

DAS28-CRP

5.42 (0.92)

5.54 (0.78)

DAS28-ESR

6.34 (0.88)

6.42 (0.76)

Tender 28 joint count

14.1 (6.21)

14.5 (5.57)

Swollen 28 joint count

10.6 (5.22)

11.0 (5.39)

C-reactive protein (mg/L)

12.0 (21.63)

11.3 (16.34)

HAQ-DI score

1.45 (0.55)

1.47 (0.56)

FACIT-fatigue score

26.82 (9.55)

25.32 (10.14)

Duration of rheumatoid arthritis (years)

8.75 (8.22)

8.11 (6.93)

Rheumatoid factor, positive,b n (%)

130 (74.30)

118 (71.10)

Anti-CCP, positive, b n (%)

138 (78.90)

119 (71.70)

Prior therapy,c n (%)

MTX only

53 (30.3)

46 (27.7)

MTX + any DMARDs

68 (38.9)

69 (41.6)

 MTX + any anti-TNF

30 (17.1)

28 (16.9)

 MTX + any other biologic

24 (13.7)

23 (13.9)

Previous DMARDs used, n (%)

 1

53 (30.3)

46 (27.7)

 2

69 (39.4)

62 (37.3)

 3

34 (19.4)

39 (23.5)

 4 or more

19 (10.9)

19 (11.4)

MTX dose (mg/week)

16.0 (4.9)

17.0 (4.7)

Duration of MTX (months)

56.3 (49.9)

59.3 (52.4)

  1. Values are mean (SD) unless stated otherwise
  2. CCP cyclic citrullinated peptide, DAS28-CRP disease activity score 28-joint count, C-reactive protein, DMARDs disease-modifying anti-rheumatic drugs, ESR erythrocyte sedimentation rate, ETN reference etanercept, FACIT Functional Assessment of Chronic Illness Therapy, HAQ-DI Health assessment questionnaire disability index, MTX methotrexate, RA rheumatoid arthritis, SDZ ETN Sandoz etanercept, SD standard deviation, TNF tumor necrosis factor, TP2 treatment period 2
  3. aOther race categories in “continued SDZ ETN” group included Black or African American (n = 5), and American Indian or Alaska Native (n = 1), and in “switched to SDZ ETN” group included Asian (n = 1) and American Indian or Alaska Native (n = 1)
  4. bRheumatoid factor ≤ 10 UI/mL and anti-CCP < 17 U/mL are considered negative
  5. cPrior therapy strata is arranged according to the hierarchy