Table 1.
Demographic and clinical characteristics of patients enrolled in C‐EARLY period 2 at study baseline (entry to period 1) and week 52a
|
CZP standard dose (n = 84)b |
CZP reduced frequency (n = 126)b |
CZP stopped (n = 79)b |
MTX responders (n = 66)c |
|
|---|---|---|---|---|
| Baseline demographics | ||||
| Age, mean ± SD years | 49.1 ± 13.1 | 49.2 ± 12.5 | 47.6 ± 14.0 | 51.2 ± 13.7 |
| Women, no. (%) | 66 (78.6) | 86 (68.3) | 58 (73.4) | 54 (81.8) |
| BMI, mean ± SD kg/m2 | 28 ± 5.6d | 27 ± 6.0 | 26 ± 4.5 | 28 ± 5.0 |
| Time since RA diagnosis, mean ± SD months | 2.5 ± 2.5 | 2.6 ± 2.8 | 2.9 ± 3.1 | 2.7 ± 2.8 |
| Region, no. (%) | ||||
| Europe and Australia | 57 (67.9) | 85 (67.5) | 59 (74.7) | 42 (63.6) |
| Latin America and North America | 27 (32.1) | 41 (32.5) | 20 (25.3) | 24 (36.4) |
| Patient characteristics | ||||
| Oral corticosteroids, mean ± SD/median (range) mg/day | ||||
| Baseline | 1.9 ± 3.5/0 (0–10.0) | 1.6 ± 3.2/0 (0–10.0) | 2.0 ± 3.5/0 (0–10.0) | 1.4 ± 3.0/0 (0–10.0) |
| Taking oral corticosteroids, no. (%) | 22 (26.2) | 30 (23.8) | 22 (27.8) | 13 (19.7) |
| Week 52 | 1.3 ± 3.1/0 (0–10.0) | 1.3 ± 2.9/0 (0–10.0) | 1.5 ± 3.1/0 (0–10.0) | 1.0 ± 2.5/0 (0–10.0) |
| Taking oral corticosteroids, no. (%) | 13 (15.5) | 25 (19.8) | 18 (22.8) | 11 (16.7) |
| Oral MTX dose, mean ± SD/median (range) mg/weekc | 21.3 ± 4.3/24.1 (10.5–25.0)d | 20.3 ± 4.4/20.0 (10.0–25.0) | 20.9 ± 4.5/20.0 (10.0–25.0)e | 22.0 ± 3.9/25.0 (15.0–25.0) |
| Concomitant use of NSAIDs, no. (%)c | 52 (62.7)d | 77 (60.6)f | 46 (56.8)e | 43 (65.2) |
| RF positive (≥14 IU/ml) at baseline, no. (%) | 82 (97.6) | 120 (95.2) | 79 (100.0) | 63 (95.5) |
| ACPA positive (≥7 IU/ml) at baseline, no. (%) | 77 (91.7) | 112 (88.9) | 68 (86.1) | 59 (89.4) |
| TJC28, mean ± SD | ||||
| Baseline | 13.0 ± 6.0 | 15.4 ± 5.7 | 14.1 ± 6.3 | 15.5 ± 6.6 |
| Week 52 | 0.4 ± 0.7d | 0.7 ± 1.3 | 0.4 ± 0.8 | 0.6 ± 1.3g |
| SJC28, mean ± SD | ||||
| Baseline | 11.3 ± 5.3 | 12.4 ± 5.1 | 11.3 ± 4.8 | 11.9 ± 4.8 |
| Week 52 | 0.3 ± 1.2d | 0.5 ± 1.4 | 0.3 ± 0.7 | 0.7 ± 1.6g |
| ESR, mean ± SD mm/hour | ||||
| Baseline | 47.9 ± 23.6 | 46.6 ± 21.7 | 46.1 ± 19.3 | 43.5 ± 18.6 |
| Week 52 | 15.1 ± 13.2d | 12.3 ± 8.4 | 13.2 ± 9.4 | 15.7 ± 11.0g |
| High‐sensitivity CRP, mean ± SD/median (range) mg/liter | ||||
| Baseline | 20.8 ± 23.8/11.9 (0.2–131.9) | 21.0 ± 30.0/8.6 (0.2–171.0) | 17.3 ± 25.6/7.9 (0.4–156.7) | 16.0 ± 20.6/8.0 (0.3–97.2) |
| Week 52 | 3.1 ± 5.7/1.6 (0.2–41.3)d | 2.5 ± 4.7/1.3 (0.2–43.4) | 3.6 ± 9.5/1.6 (0.2–75.2) | 4.0 ± 7.2/1.6 (0.2–50.4)g |
| DAS28‐ESR, mean ± SD | ||||
| Baseline | 6.4 ± 1.0 | 6.6 ± 0.8 | 6.5 ± 0.8 | 6.6 ± 0.9 |
| Week 52 | 2.0 ± 0.7d | 2.0 ± 0.6 | 1.9 ± 0.7 | 2.2 ± 0.7g |
| SHS, mean ± SD/median (range) | ||||
| Baseline | 3.1 ± 5.4/1 (0–34) | 4.5 ± 9.2/1.5 (0–64) | 5.1 ± 8.5/1.5 (0–40) | 6.0 ± 12.4/2.0 (0–70) |
| Week 52 | 3.3 ± 5.1/1.8 (0–34) | 4.5 ± 8.9/1.5 (0–64)h | 5.0 ± 7.4/2.5 (0–38) | 6.8 ± 12.7/2.5 (0–70) |
| HAQ DI score, mean ± SD/median (range) | ||||
| Baseline | 1.6 ± 0.6/1.6 (0.0–2.9) | 1.6 ± 0.6/1.6 (0.1–3.0) | 1.5 ± 0.5/1.5 (0.4–2.5) | 1.5 ± 0.6/1.6 (0.0–2.6) |
| Week 52 | 0.3 ± 0.4/0.1 (0.0–1.6)d | 0.3 ± 0.5/0.1 (0.0–2.0) | 0.3 ± 0.5/0.1 (0.0–1.6) | 0.4 ± 0.5/0.1 (0.0–1.4)g |
Nonsteroidal antiinflammatory drugs (NSAIDs) were defined by the preferred term M01A from the World Health Organization Drug Dictionary. CZP = certolizumab pegol; MTX = methotrexate; BMI = body mass index; RA = rheumatoid arthritis; RF = rheumatoid factor; ACPA = anti–citrullinated protein antibody; TJC28 = tender joint count in 28 joints; SJC28 = swollen joint count in 28 joints; ESR = erythrocyte sedimentation rate; CRP = C‐reactive protein; DAS28‐ESR = Disease Activity Score in 28 joints using the ESR; SHS = modified Sharp/van der Heijde score; HAQ DI = Health Assessment Questionnaire disability index.
Full analysis set.
Safety set.
n = 83.
n = 81.
n = 127.
n = 65.
n = 123.