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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
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Arthritis Research & Therapy

ISSN: 1478-6362

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