Patient demographics and baseline characteristics of the ITT population
| All patients | Weeks 20 and 24 remitters* | Weeks 20 and 24 non-remitters† | ||||
|---|---|---|---|---|---|---|
| Placebo (n=98) | CZP (n=96) | Prior placebo (n=6) | Prior CZP (n=18) | Prior placebo (n=74) | Prior CZP (n=66) | |
| Age (years), mean (SD), median (min–max) | 54.0 (12.4), 56.0 (18–78) | 53.6 (11.9), 55.0 (25–76) | 65.3 (4.5), 66.5 (58–70) | 55.4 (10.7), 55.5 (33–72) | 52.6 (11.7), 55.0 (18–74) | 51.9 (12.5), 54.0 (25–76) |
| Female (%) | 76.5% | 84.4% | 66.7% | 83.3% | 77.0% | 86.4% |
| Body mass index (kg/m3), mean (SD) | 27.3 (5.1) | 26.6 (5.6) | 28.9 (2.6) | 28.0 (6.3) | 27.3 (5.3) | 26.2 (5.8) |
| Disease duration (years), mean (SD), median (Q1—Q3) | 4.7 (3.3), 4.2 (1.7–7.8) | 4.5 (3.5), 3.5 (1.9–7.0) | 2.6 (2.4), 2.0 (0.9–3.0) | 3.6 (2.9), 2.8 (1.1–6.0) | 4.8 (3.1), 4.5 (1.9–8.0) | 4.7 (3.3), 4.0 (2.0–7.0) |
| Previous‡ DMARDs use (%) | ||||||
| 0 | 35.7% | 30.2% | 83.3% | 61.1% | 32.6%§ | 23.1%§ |
| 1 | 33.7% | 41.7% | 16.7% | 27.8% | 34.8%§ | 44.9%§ |
| 2 | 19.4% | 16.7% | 0% | 11.1% | 20.7%§ | 17.9%§ |
| >2 | 11.2% | 11.5% | 0% | 0% | 12.0%§ | 14.1%§ |
| Previous non-MTX DMARDs use (%) | 44.9% | 50.0% | 16.7% | 33.3% | 46.7% | 53.8% |
| Concomitant MTX use (%) | 80.6% | 84.4% | 100% | 88.9% | 78.4% | 81.8% |
| RF positive (≥14 IU/mL) (%) | 67.3% | 74.0% | 100% | 94.4% | 72.2% | 80.3% |
| TJC, mean (SD) | 3.9 (1.6) | 3.7 (1.5) | 5.5 (2.3) | 3.7 (1.3) | 3.8 (1.5) | 3.7 (1.5) |
| SJC, mean (SD) | 3.2 (1.3) | 3.4 (1.5) | 2.7 (0.5) | 3.3 (1.0) | 3.3 (1.4) | 3.4 (1.7) |
| CDAI, mean (SD) | 13.3 (1.9) | 13.5 (2.2) | 13.3 (2.6) | 13.0 (1.8) | 13.3 (1.9) | 13.6 (2.4) |
| SDAI, mean (SD) | 14.7 (2.6) | 14.6 (2.6) | 14.2 (2.6) | 14.5 (2.4) | 14.5 (2.4) | 14.7 (2.8) |
| DAS28(ESR), mean (SD) | 4.5 (0.3) | 4.5 (0.4) | 4.7 (0.4) | 4.5 (0.4) | 4.4 (0.3) | 4.5 (0.5) |
| HAQ-DI, mean (SD) | 1.0 (0.6) | 1.1 (0.6) | 0.5 (0.3) | 0.9 (0.6) | 1.1 (0.6) | 1.2 (0.6) |
| CRP (mg/L), median (min–max) | 8.0 (2.9–107.0) | 6.0 (2.9–70.0) | 10.0 (2.9–14.0) | 4.5 (2.9–70.0) | 7.0 (2.9–107.0) | 5.5 (2.9–57.0) |
| ESR (mm/h), median (min–max) | 30.5 (8.0–86.0) | 32.0 (6.0–98.0) | 37.0 (28.0–43.0) | 33.0 (16.0–58.0) | 30.0 (8.0–86.0) | 32.0 (6.0–98.0) |
*Baseline at study start for those patients in sustained remission at weeks 20 and 24 and had at least one visit in the open-label follow-up period.
†Baseline at study start for those patients who did not sustain remission at weeks 20 and 24 but were otherwise eligible to enter the open-label follow-up period.
‡Medications stopped more than 6 months prior to baseline visit.
§Baseline at study start for those patients who did not sustain remission at weeks 20 and 24, n=92 (placebo), n=78 (prior CZP).
CDAI, Clinical Disease Activity Index; CRP, C-reactive protein; CZP, certolizumab pegol; DAS28(ESR), disease activity score (ESR) based on 28-joint count; ESR, erythrocyte sedimentation rate; HAQ-I, Health Assessment Questionnaire-Disability Index; MTX, methotrexate; RF, rheumatoid factor; SDAI, Simplified Disease Activity Index; SJC, Swollen joint count; TJC, Tender joint count.