Table 1.
Baseline demographics and disease characteristics (all-randomized populations).
| Part 1 |
Part 2a |
||||
|---|---|---|---|---|---|
| Parameter | CT-P10 (n = 64) |
US-RTX (n = 65) |
EU-RTX (n = 60) |
CT-P10 (n = 161) |
RTXb (n = 211) |
| Age, years | |||||
| Mean (SD) | 52.4 (10.58) | 52.8 (11.84) | 50.8 (10.86) | 51.5 (11.54) | 51.8 (11.14) |
| Gender, n (%) | |||||
| Male | 10 (15.6%) | 14 (21.5%) | 10 (16.7%) | 23 (14.3%) | 31 (14.7%) |
| Female | 54 (84.4%) | 51 (78.5%) | 50 (83.3%) | 138 (85.7%) | 180 (85.3%) |
| Race, n (%) | |||||
| White | 48 (75.0%) | 53 (81.5%) | 41 (68.3%) | 91 (56.5%) | 138 (65.4%) |
| Asian | 4 (6.3%) | 3 (4.6%) | 5 (8.3%) | 12 (7.5%) | 12 (5.7%) |
| Other | 12 (18.8%) | 9 (13.8%) | 14 (23.3%) | 58 (36.0%) | 61 (28.9%) |
|
Height, cm Mean (SD) |
163.8 (9.79) |
165.4 (10.68) |
162.1 (7.55) |
162.1 (9.08) |
162.5 (9.08) |
|
Weight, kg Mean (SD) |
70.6 (17.70) |
76.3 (20.21) |
69.8 (18.12) |
70.6 (17.12) |
71.0 (16.91) |
| Region, n (%) | |||||
| EU | 28 (43.8%) | 31 (47.7%) | 21 (35.0%) | 38 (23.6%) | 65 (30.8%) |
| Non-EU | 36 (56.3%) | 34 (52.3%) | 39 (65.0%) | 123 (76.4%) | 146 (69.2%) |
| RF or anti-CCP status, n (%) | |||||
| RF positive | 53 (82.8%) | 55 (84.6%) | 49 (81.7%) | 127 (78.9%) | 174 (82.5%) |
| Anti-CCP positive | 53 (82.8%) | 55 (84.6%) | 53 (88.3%) | 131 (81.4%) | 178 (84.4%) |
|
SJC at baseline Mean (SD) |
16.3 (7.84) |
14.4 (6.87) |
15.2 (10.42) |
15.3 (7.99) |
14.3 (8.11) |
|
TJC at baseline Mean (SD) |
24.2 (14.06) |
23.4 (13.80) |
22.0 (12.89) |
22.4 (12.84) |
21.8 (12.77) |
| Prior anti-TNF blocker status, n (%) | |||||
| Inadequate response | 55 (85.9%) | 55 (84.6%) | 55 (91.7%) | 137 (85.1%) | 187 (88.6%) |
| Intolerant case | 9 (14.1%) | 10 (15.4%) | 5 (8.3%) | 22 (13.7%) | 24 (11.4%) |
| Duration of prior TNF-antagonist use, months | |||||
| Mean (SD) | 16.4 (22.06) | 13.7 (23.49) | 16.6 (18.74) | 15.5 (19.98)c | 17.0 (27.08) |
| Number of prior TNF-antagonist use, n (%) | |||||
| 0 | 0 | 0 | 0 | 2 (1.2%)d | 0 |
| 1 | 56 (87.5%) | 58 (89.2%) | 49 (81.7%) | 142 (88.2%) | 183 (86.7%) |
| 2 | 8 (12.5%) | 7 (10.8%) | 11 (18.3%) | 17 (10.6%) | 28 (13.3%) |
|
Prior TNF-antagonist used, n (%) |
|||||
| Adalimumab | 23 (35.9%) | 28 (43.1%) | 30 (50.0%) | 52 (32.3%) | 80 (37.9%) |
| Certolizumab | 2 (3.1%) | 5 (7.7%) | 2 (3.3%) | 5 (3.1%) | 11 (5.2%) |
| Etanercept | 21 (32.8%) | 17 (26.2%) | 15 (25.0%) | 55 (34.2%) | 55 (26.1%) |
| Golimumab | 5 (7.8%) | 6 (9.2%) | 7 (11.7%) | 17 (10.6%) | 26 (12.3%) |
| Infliximab | 18 (28.1%) | 15 (23.1%) | 16 (26.7%) | 44 (27.3%) | 65 (30.8%) |
| Unspecifiede | 1 (1.6%)e | 0 | 0 | 1 (0.6%)e | 0 |
| Investigational drug | 2 (3.1%) | 1 (1.5%) | 1 (1.7%) | 2 (1.2%) | 2 (1.0%) |
| Baseline CRP, mg/dL | |||||
| Mean (SD) | 2.2 (3.56) | 2.1 (2.79) | 3.4 (4.99) | 2.2 (3.22) | 2.6 (3.91) |
| Baseline ESR, mm/h | |||||
| Mean (SD) | 54.1 (26.35) | 53.2 (25.38) | 51.5 (20.54) | 54.7 (27.89) | 54.9 (26.67) |
| Baseline B cell count, cells/mcL | |||||
| Mean (SD)f | 200.5 (161.83) | 187.0 (115.92) | 159.7 (119.09) | 201.1 (140.46) | 192.4 (134.36) |
| DAS28-CRP | |||||
| Mean (SD) | 5.8 (0.86) | 5.8 (0.82) | 6.0 (0.86) | 5.8 (0.89) | 5.8 (0.91) |
| DAS28-ESR | |||||
| Mean (SD) | 6.8 (0.76) | 6.7 (0.77) | 6.8 (0.74) | 6.7 (0.82) | 6.7 (0.81) |
| Time since RA diagnosis, yearg | |||||
| Mean (SD) | 9.4 (6.83) | 8.2 (5.34) | 9.9 (7.39) | 10.7 (8.01) | 9.1 (7.41) |
| MTX dose, mg/weekh | |||||
| Mean (SD) | 15.2 (4.93) | 15.5 (5.21) | 15.6 (5.01) | 14.6 (4.34) | 15.0 (4.66) |
CCP = cyclic citrullinated peptide. CRP = C-reactive protein. DAS28 = Disease Activity Score using 28 joints. ESR = erythrocyte sedimentation rate. EU = European Union. MTX = methotrexate. PK = pharmacokinetics. RA = rheumatoid arthritis. RF = rheumatoid factor. RTX = rituximab. SD = standard deviation. SJC = swollen joint count. TJC = tender joint count. TNF = tumour necrosis factor. US = United States.
aAll patients in Part 1 were included in Part 2.
bThe RTX group consists of data from the combined US-RTX and EU-RTX treatment groups.
cn = 159.
dTwo patients had not received prior TNF-antagonist therapy and discontinued due to noncompliance with the inclusion criteria. Patients were excluded from the PK population for not providing at least one post-treatment PK concentration result and were excluded from the primary efficacy analysis for not having information regarding prior anti-TNF blocker status, which was one of the covariates for analysis.
eResults did not report whether the patient received adalimumab or certolizumab in the prior blinded clinical trial.
fPart 1: CT-P10, n = 61; US-RTX, n = 62; EU-RTX, n = 56. Part 2: CT-P10, n = 148; RTX, n = 194.
gCalculated as (date of randomization – date of diagnosis)/365.25.
hAt first infusion of first course.