Atsumi T, Tanaka Y, Yamamoto K, et al. Clinical benefit of 1-year certolizumab pegol (CZP) add-on therapy to methotrexate treatment in patients with early rheumatoid arthritis was observed following CZP discontinuation: 2-year results of the C-OPERA study, a phase III randomised trial. Ann Rheum Dis 2017;76:1348–56. doi:10.1136/annrheumdis-2016-210246.
There are some minor errors in the numbers report in table 1. The correct values are:
Table 1.
Baseline demographics and patient characteristics
| CZP+MTX®MTX | PBO+MTX®MTX | |||||
| Total patients | Patients entering PT period | Total patients | Patients entering PT period | |||
| n=159 | n=108 | n=157 | n=71 | |||
| DB baseline(Week 0) | DB baseline(Week 0) | PT baseline(Week 52) | DB baseline(Week 0) | DB baseline(Week 0) | PT baseline(Week 52) | |
| Age (years) | 49.4±10.6 | 48.8±11.2 | – | 49.0±10.3 | 48.6±10.8 | – |
| Female, n (%) | 129 (81.1) | 85 (78.7) | – | 127 (80.9) | 58 (81.7) | – |
| Weight (kg) | 57.4±11.3 | 57.0±11.5 | – | 57.4±10.6 | 57.4±10.3 | – |
| BMI (kg/m2) | 22.4±3.9 | 22.2±3.7 | – | 22.5±3.7 | 22.4±3.7 | – |
| RA duration (months)* | 4.0±2.9 | 4.4±3.1 | – | 4.3±2.8 | 4.4±3.1 | – |
| Anti-CCP antibody positive, n (%) | 159 (100.0) | 108 (100.0) | – | 157 (100.0) | 71 (100.0) | – |
| RF positive, n (%) | 153 (96.2) | 104 (96.3) | – | 146 (93.0) | 68 (95.8) | – |
| Bone erosion (judged by physician), n (%) | 79 (49.7) | 51 (47.2) | – | 80 (51.0) | 34 (47.9) | – |
| TJC (/28 joints) | 8.4±6.1 | 7.5±5.8 | 0.5±1.1 | 8.9±6.5 | 7.3±6.1 | 0.6±1.6 |
| SJC (/28 joints) | 8.3±5.3 | 7.6±4.6 | 0.3±0.7 | 8.4±5.3 | 7.0±4.2 | 0.4±1.4 |
| ESR (mm/h) | 38.4±25.3 | 36.3±23.7 | 12.8±9.9 | 43.7±28.2 | 36.5±22.2 | 15.5±14.3 |
| CRP (mg/dl) | 1.29±1.82 | 1.12±1.51 | 0.06±0.13 | 1.52±1.91 | 1.03±1.39 | 0.17±0.37 |
| MMP-3 (ng/ml) | 130.4±135.4 | 125.3±135.4 | 47.7±25.7 | 185.4±214.9 | 167.3±204.3 | 52.5±31.1 |
| DAS28(ESR) | 5.4±1.1 | 5.2±1.1 | 1.9±0.8 | 5.5±1.2 | 5.1±1.0 | 2.2±0.7 |
| SDAI | 28.7±12.5 | 27.0±11.2 | 2.4±2.6 | 30.0±13.6 | 24.6±11.3 | 2.7±3.1 |
| HAQ-DI score | 1.01±0.64 | 1.04±0.63 | 0.14±0.26 | 1.05±0.69 | 0.79±0.57 | 0.07±0.14 |
| mTSS | 4.1±7.4 | 3.8±7.4 | 3.7±7.4 | 5.5±15.0 | 3.2±6.2 | 3.4±6.3 |
| Erosion score | 1.9±4.0 | 1.6±3.9 | 1.6±3.7 | 2.5±7.8 | 1.6±3.3 | 1.8±3.2 |
| Joint space narrowing score | 2.1±4.6 | 2.2±4.8 | 2.2±4.8 | 2.9±8.3 | 1.5±4.0 | 1.6±4.1 |
| Average weekly MTX dose (mg/week)† | 11.4±3.1 | 11.3±3.2 | 10.9±4.1 | 11.5±2.8 | 11.5±3.1 | 11.1±3.7 |
Values are mean ±SD unless otherwise indicated. Data in DB baseline columns represent average during weeks 0–104, whereas data in PT baseline columns represent average during weeks 52–104.
*Time from onset of persistent arthritic symptoms.
†MTX dose was initiated at 8 mg/week and escalated to the maximum tolerated dose (up to 16 mg/week) by week 8.
BMI, body mass index; CCP, cyclic citrullinated peptide; CRP, C reactive protein; CZP, certolizumab pego; DB, double blind; ESR, erythrocyte sedimentation rate; HAQ-DI, Health Assessment Questionnaire Disability Index; MMP-3, matrix metalloproteinase-3; mTSS, modified total Sharp score; MTX, methotrexate; PBO, placebo; PT, post treatment; RA, rheumatoid arthritis; RF, rheumatoid factor; SJC, swollen joint count; TJC, tender joint count.