Table 1.
Patient demographics and baseline characteristics
| Parameter | Safety population N=838 |
ITT population N=628 |
|---|---|---|
| Sociodemographics | ||
| Females*, % | 74.7 | 73.6 |
| Age (years), mean (SD) | 55.6 (13.5) | 55.8 (13.6) |
| Geographical zone†, % | ||
| Eastern Canada | 73.4 | 76.1 |
| Central Canada | 6.1 | 6.1 |
| Western Canada | 20.4 | 17.8 |
| Enrolment period, % | ||
| 1/2002 to 6/2005 | 45.2 | 45.9 |
| 7/2005 to 6/2008 | 34.1 | 34.6 |
| 7/2008 to 6/2011 | 20.6 | 19.6 |
| Disease parameters | ||
| Comorbidity‡, % | 12.4 | 11.3 |
| Disease duration (years), mean (SD) | 10.5 (9.8) | 10.2 (10.0) |
| RF positive, %* | 73.4 | 73.8 |
| Family history of RA, %* | 33.7 | 33.3 |
| DAS28, mean (SD) | 5.4 (1.3) | 5.4 (1.3) |
| SDAI, mean (SD) | 38.2 (16.9) | 37.9 (16.9) |
| CDAI, mean (SD) | 36.1 (16.1) | 35.9 (16.3) |
| TJC-28, mean (SD) | 12.5 (7.9) | 12.5 (7.9) |
| SJC-28, mean (SD) | 10.6 (7.0) | 10.6 (7.1) |
| PhGA (VAS cm), mean (SD) | 6.6 (2.1) | 6.6 (2.1) |
| PtGA (VAS cm), mean (SD) | 6.1 (2.4) | 6.0 (2.4) |
| AM stiffness§ (min), mean (SD) | 70.9 (43.8) | 70.4 (43.6) |
| HAQ-DI, mean (SD) | 1.7 (0.7) | 1.7 (0.7) |
| Pain (VAS mm), mean (SD) | 57.7 (24.1) | 57.4 (24.3) |
| ESR (mm/h), mean (SD) | 32.2 (23.9) | 32.2 (24.0) |
| CRP (mg/L), mean (SD) | 19.2 (24.3) | 19.5 (24.9) |
| RA medications | ||
| Infliximab dose (mg), mean (SD) | 3.4 (0.5) | 3.4 (0.5) |
| Number of previous DMARDs, % | ||
| 0 | 13.1 | 13.2 |
| 1 | 20.8 | 21.7 |
| 2 | 28.8 | 27.9 |
| 3 | 20.0 | 20.7 |
| ≥4 | 17.3 | 16.6 |
| Concomitant DMARD, % | 89.7 | 91.1 |
| Concomitant methotrexate, % | 70.4 | 72.1 |
| Concomitant corticosteroid use, % | ||
| No use | 61.8 | 61.8 |
| ≤5 mg/day | 7.9 | 8.1 |
| >5 mg/day | 29.5 | 29.6 |
| Missing dose | 0.8 | 0.6 |
| Corticosteroid dose¶, mean (SD) | 9.3 (11.0) | 9.3 (11.8) |
*Percentages based on responders.
†The geographical zone was categorised as: East=Maritimes, Ontario and Quebec; Central=Manitoba and Saskatchewan; West=Alberta and British Colombia.
‡Proxy based on the use of concomitant medications.
§Capped at 120 min.
¶Among patients taking a corticosteroid who had available information.
CDAI, Clinical Disease Activity Index; CRP, C reactive protein; DAS28, disease activity score 28; DMARD, disease-modifying antirheumatic drug; ESR, erythrocyte sedimentation rate; HAQ-DI, health assessment questionnaire disability index; ITT, intent to treat; PhGA, physician's global assessment; PtGA, patient's global assessment; RA, rheumatoid arthritis; RF; SDAI, Simplified Disease Activity Index; SJC, swollen joint count; TJC, tender joint count; VAS, visual analogue scale.