Table 1.
Baseline demographics and disease characteristics (safety population who started first [5] and second course of treatmenta)
| Characteristics | All patients | Received first course only | Received first and second courses | |||
|---|---|---|---|---|---|---|
| CT-P10 (n = 102) | RTX (n = 51) | CT-P10 (n = 42) | RTX (n = 28) | CT-P10 (n = 60) | RTX (n = 23) | |
| Age (years) | 49.8 ± 12.6 | 51.3 ± 10.9 | 48.4 ± 14.1 | 53.7 ± 10.6 | 50.8 ± 11.4 | 48.4 ± 10.8 |
| Sex | ||||||
| Female | 88 (86.3) | 46 (90.2) | 36 (85.7) | 26 (92.9) | 52 (86.7) | 20 (87.0) |
| Male | 14 (13.7) | 5 (9.8) | 6 (14.3) | 2 (7.1) | 8 (13.3) | 3 (13.0) |
| Ethnicity | ||||||
| Caucasian | 69 (67.6) | 35 (68.6) | 30 (71.4) | 18 (64.3) | 39 (65.0) | 17 (73.9) |
| Asian | 15 (14.7) | 9 (17.6) | 4 (9.5) | 5 (17.9) | 11 (18.3) | 4 (17.4) |
| Other | 18 (17.6) | 7 (13.7) | 8 (19.0) | 5 (17.9) | 10 (16.7) | 2 (8.7) |
| Height (cm) | 161.9 ± 8.1 | 162.1 ± 8.7 | 161.0 ± 7.1 | 159.6 ± 7.2 | 162.5 ± 8.7 | 165.0 ± 9.6 |
| Weight (kg) | 71.4 ± 17.7 | 72.4 ± 16.0 | 69.9 ± 14.8 | 73.5 ± 16.8 | 72.4 ± 19.5 | 71.0 ± 15.2 |
| Body mass index (kg/m2) | 27.2 ± 6.0 | 27.5 ± 5.5 | 27.0 ± 5.6 | 28.7 ± 5.6 | 27.3 ± 6.3 | 26.1 ± 5.0 |
| Disease duration (years) | 11.0 ± 7.8 | 10.3 ± 9.1 | 10.3 ± 6.4 | 9.9 ± 9.5 | 11.6 ± 8.7 | 10.7 ± 8.8 |
| CRP (mg/dl) | 1.8 ± 1.7 | 2.1 ± 3.0 | 1.4 ± 1.7 | 1.9 ± 2.9 | 2.0 ± 1.7 | 2.4 ± 3.2 |
| ESR (mm/h) | 49.5 ± 24.5 | 50.1 ± 26.7 | 45.0 ± 20.0 | 51.3 ± 28.3 | 52.7 ± 26.9 | 48.6 ± 25.3 |
| RF positive | 82 (80.4) | 40 (78.4) | 34 (81.0) | 22 (78.6) | 48 (80.0) | 18 (78.3) |
| Anti-CCP positive | 86 (84.3) | 43 (84.3) | 36 (85.7) | 26 (92.9) | 50 (83.3) | 17 (73.9) |
| Swollen joint count (66 joints assessed) | 16.5 ± 8.2 | 14.5 ± 7.0 | 13.9 ± 7.3 | 14.9 ± 7.2 | 18.3 ± 8.4 | 13.9 ± 6.9 |
| Tender joint count (68 joints assessed) | 27.4 ± 14.8 | 27.1 ± 14.2 | 25.6 ± 15.8 | 24.3 ± 14.3 | 28.7 ± 14.1 | 30.7 ± 13.5 |
| DAS28-CRP | 6.0 ± 0.9 | 6.0 ± 0.9 | 5.8 ± 0.9 | 5.9 ± 1.0 | 6.2 ± 0.8 | 6.0 ± 0.7 |
| DAS28-ESR | 6.8 ± 0.9 | 6.7 ± 0.9 | 6.6 ± 0.9 | 6.7 ± 0.9 | 6.9 ± 0.8 | 6.8 ± 0.8 |
| HAQ-DI score | 1.7 ± 0.7 | 1.7 ± 0.7 | 1.5 ± 0.7 | 1.6 ± 0.8 | 1.8 ± 0.6 | 1.8 ± 0.5 |
| Prior anti-TNF agents | ||||||
| 1 | 88 (86.3) | 42 (82.4) | 37 (88.1) | 25 (89.3) | 51 (85.0) | 17 (73.9) |
| ≥2 | 14 (13.7) | 9 (17.6) | 5 (11.9) | 3 (10.7) | 9 (15.0) | 6 (26.1) |
| Prior anti-TNF agent status | ||||||
| Failure | 93 (91.2) | 47 (92.2) | 37 (88.1) | 26 (92.9) | 56 (93.3) | 21 (91.3) |
| Intolerance | 9 (8.8) | 4 (7.8) | 5 (11.9) | 2 (7.1) | 4 (6.7) | 2 (8.7) |
| Duration of prior TNF-antagonist use (months) | 18.9 ± 20.3 | 23.7 ± 26.7 | 16.6 ± 17.7 | 24.0 ± 29.6 | 20.5 ± 22.0 | 23.3 ± 23.4 |
| Prior TNF antagonists usedb | ||||||
| Adalimumab | 37 (36.3) | 18 (35.3) | 16 (38.1) | 13 (46.4) | 21 (35.0) | 5 (21.7) |
| Certolizumabc | 3 (2.9) | 2 (3.9) | 1 (2.4) | 1 (3.6) | 2 (3.3) | 1 (4.3) |
| Etanercept | 30 (29.4) | 19 (37.3) | 13 (31.0) | 12 (42.9) | 17 (28.3) | 7 (30.4) |
| Golimumab | 12 (11.8) | 3 (5.9) | 7 (16.7) | 1 (3.6) | 5 (8.3) | 2 (8.7) |
| Infliximab | 32 (31.4) | 19 (37.3) | 9 (21.4) | 6 (21.4) | 23 (38.3) | 13 (56.5) |
| Investigational anti-TNF agentd | 3 (2.9) | 1 (2.0) | 1 (2.4) | 0 | 2 (3.3) | 1 (4.3) |
| Weekly dose of MTX at baseline (mg) | 15.4 ± 4.8 | 15.7 ± 4.1 | 14.4 ± 4.1 | 15.1 ± 3.8 | 16.3 ± 5.0 | 16.4 ± 4.4 |
Data are presented as mean ± standard deviation or n (%) unless otherwise indicated
CCP cyclic citrullinated peptide, CRP C-reactive protein, DAS28 Disease Activity Score using 28 joints, ESR erythrocyte sedimentation rate, HAQ-DI Health Assessment Questionnaire Disability Index, MTX methotrexate, RF rheumatoid factor, RTX innovator rituximab, TNF tumor necrosis factor
aSafety population for each treatment course included all patients who received at least one (full or partial) dose of CT-P10 or RTX during that course. Of these, 83 received a second course of treatment
bSome patients had previously received two anti-TNF agents
cIncludes certolizumab pegol
dRefers to any investigational anti-TNF agent