Patient demographics and disease characteristics at baseline and week 54 of patients enrolled in the PLANETRA extension study (ITT population)
| Variable* | Maintenance group† (n=158) | Switch group‡ (n=144) |
|---|---|---|
| Demographics at baseline | ||
| Age, years | 50.0 (18–73) | 49.0 (23–74) |
| Gender, n (%) | ||
| Male | 33 (20.9) | 22 (15.3) |
| Female | 125 (79.1) | 122 (84.7) |
| Ethnicity, n (%) | ||
| Caucasian | 119 (75.3) | 105 (72.9) |
| Black | 1 (0.6) | 1 (0.7) |
| Asian | 17 (10.8) | 10 (6.9) |
| Other | 21 (13.3) | 28 (19.4) |
| Height, cm | 163.5 (145.5–184.5) | 163.0 (142.0–188.0) |
| Weight, kg | 71.0 (43.0–134.0) | 68.3 (44.3–125.0) |
| Body mass index, kg/m2 | 26.8 (17.0–49.8) | 25.6 (17.3–44.8) |
| Disease characteristics at baseline | ||
| DAS28-CRP | 5.8 (3.4–8.1) | 5.8 (2.9–7.9) |
| DAS28-ESR | 6.5 (4.5–8.4) | 6.6 (4.1–8.6) |
| Swollen joint count (28 joints) | 11.0 (3–26) | 10.5 (2–26) |
| Tender joint count (28 joints) | 14.0 (3–28) | 15.0 (3–28) |
| Anti-CCP antibody positive, n (%) | 122 (77.2) | 111 (77.1) |
| IgA RF positive, n (%) | 71 (44.9) | 55 (38.2) |
| IgM RF positive, n (%) | 118 (74.7) | 103 (71.5) |
| IgG RF positive, n (%) | 90 (57.0) | 82 (57.0) |
| ESR (mm/h) | 38.0 (16.0–138.0) | 38.0 (28.0–112.0) |
| CRP (mg/dL) | 1.0 (0.02–9.3) | 0.8 (0.02–14.0) |
| Serum CRP concentration, n (%) | ||
| ≤2 mg/dL | 110 (69.6) | 104 (72.2) |
| >2 mg/dL | 47 (29.8) | 40 (27.8) |
| Disease characteristics at week 54 | ||
| DAS28-CRP | 3.3 (1.1–7.0) | 3.3 (1.1–7.2) |
| DAS28-ESR | 4.0 (1.1–8.0) | 4.0 (1.5–7.4) |
| Swollen joint count (28 joints) | 2.0 (0–17) | 2.0 (0–15) |
| Tender joint count (28 joints) | 3.0 (0–28) | 3.0 (0–26) |
| Anti-CCP antibody positive, n (%) | 124 (78.5) | 112 (77.8) |
| IgA RF positive, n (%) | 47 (29.8) | 51 (35.4) |
| IgM RF positive, n (%) | 105 (66.5) | 98 (68.1) |
| IgG RF positive, n (%) | 81 (51.3) | 77 (53.5) |
| ESR (mm/h) | 25.0 (2.0–120.0) | 25.0 (2.0–110.0) |
| CRP (mg/dL) | 0.4 (0.01–17.6) | 0.4 (0.02–27.1) |
| Serum CRP concentration, n (%) | ||
| ≤2 mg/dL | 141 (89.2) | 128 (88.9) |
| >2 mg/dL | 17 (10.8) | 14 (9.7) |
| ACR20 response, n (%) | 119 (75.3) | 111 (77.1) |
| ACR50 response, n (%) | 72 (45.6) | 72 (50.0) |
| ACR70 response, n (%) | 34 (21.5) | 34 (23.6) |
Data shown in the table were recorded at the baseline and week 54 visits of the preceding 54-week main study.
*Except where indicated otherwise, values are median (range).
†Patients treated with CT-P13 during the 54 weeks of the main study and the 48-week extension study.
‡Patients treated with RP during the 54 weeks of the main study and then switched to CT-P13 during the 48-week extension study.
ACR, American College of Rheumatology; CCP, cyclic citrullinated peptide; CRP, C reactive protein; DAS28, disease activity score in 28 joints; ESR, erythrocyte sedimentation rate; ITT, intent-to-treat; RF, rheumatoid factor; RP, reference product.