Demographics and baseline characteristics
| Patient characteristics: part 1 | Subcutaneous golimumab (N=3280) |
|---|---|
| Demographic characteristics | |
| Female, n (%) | 2716 (82.8%) |
| Age, years | |
| Mean (SD) | 52.3 (12.8) |
| Median (min, max) | 53.0 (18, 88) |
| Race, n (%) | |
| White | 2283 (69.6) |
| Multiracial | 444 (13.5) |
| Other | 211 (6.4) |
| Asian | 167 (5.1) |
| Not allowed to collect these data | 97 (3.0) |
| Black or African American | 57 (1.7) |
| American Indian or Alaska Native | 21 (0.6) |
| BMI (kg/m2), median (min, max) | 26.2 (14.0, 54.5) |
| Treatment history | |
| Concomitant methotrexate dose | n=3280 |
| Any dose, n (%) | 2663 (81.2) |
| Low (<10 mg/week), n (%) | 142 (4.3) |
| Medium (≥10 and <15 mg/week), n (%) | 526 (16.0) |
| High (≥15 mg/week), n (%) | 1995 (60.8) |
| Concomitant corticosteroid use | n=3280 |
| Received corticosteroids, n (%) | 2078 (63.4) |
| DMARD combinations | n=3270 |
| Methotrexate only, n (%) | 1681 (51.4) |
| Methotrexate+hydroxychloroquine, chloroquine, chloroquine phosphate, n (%) | 433 (13.2) |
| Methotrexate+leflunomide, n (%) | 216 (6.6) |
| Methotrexate+sulfasalazine, n (%) | 150 (4.6) |
| Methotrexate+hydroxychloroquine, chloroquine, chloroquine phosphate+sulfasalazine, n (%) | 106 (3.2) |
| Leflunomide only, n (%) | 303 (9.3) |
| Other DMARD combinations,* n (%) | 381 (11.7) |
| No of DMARD failed | n=3279 |
| 1, n (%) | 1129 (34.4) |
| 2, n (%) | 1176 (35.9) |
| ≥3, n (%) | 974 (29.7) |
| Disease characteristics | |
| Disease duration, years | n=3279 |
| Mean (SD) | 7.6 (7.9) |
| Median (min, max) | 4.9 (0.01, 56.6) |
| TJC28, mean (SD) | 13.0 (6.81) |
| SJC28, mean (SD) | 9.6 (5.56) |
| DAS28–ESR | n=3270 |
| Moderate disease activity (3.2–5.1), n (%) | 698 (21.3) |
| High disease activity (>5.1), n (%) | 2572 (78.7) |
| Mean (SD) | 5.97 (1.095) |
| DAS28–CRP | n=3236 |
| Mean (SD) | 5.41 (0.998) |
| CRP (mg/l) | n=3236 |
| Mean (SD) | 14.48 (20.376) |
| ESR (mm/h) | n=3280 |
| Mean (SD) | 34.9 (24.64) |
| Anti-CCP | n=3225 |
| Positive, (≥20 U/ml), n (%) | 2318 (71.9) |
| Rheumatoid factor | n=3234 |
| Positive (≥15 IU/ml), n (%) | 2344 (72.5) |
| HAQ–DI, mean (SD) | 1.44 (0.67) |
| N=490 | ||
|---|---|---|
| Patient characteristics: part 2 | IV+SC golimumab (N=242) | Subcutaneous golimumab (N=248) |
| Demographic characteristics | ||
| Female, n (%) | 211 (87.2) | 211 (85.1) |
| Age, years | ||
| Mean (SD) | 53.4 (12.65) | 52.7 (12.77) |
| Race, n (%) | ||
| White | 184 (76.0) | 182 (73.4) |
| Multiracial | 37 (15.3) | 45 (18.1) |
| Other | 7 (2.9) | 9 (3.6) |
| Asian | 5 (2.1) | 6 (2.4) |
| Black or African American | 3 (1.2) | 2 (0.8) |
| American Indian or Alaska Native | 1 (0.4) | 0 |
| Not allowed to collect data | 5 (2.1) | 4 (1.6) |
| BMI (kg/m2), median (min, max) | 26.57 (16.6, 54.5) | 26.76 (16.9, 52.3) |
| Disease characteristics | Part 1 baseline | Part 2 baseline† | Part 1 baseline | Part 2 baseline† |
|---|---|---|---|---|
| DAS28–ESR, mean (SD) | 6.23 (1.008) | 4.00 (0.810) | 6.27 (1.003) | 3.98 (0.834) |
| DAS28–CRP, mean (SD) | 5.59 (0.956) | 3.46 (0.822) | 5.68 (0.963) | 3.50 (0.837) |
| TJC28, mean (SD) | 14.4 (6.66) | 4.6 (3.89) | 14.3 (6.97) | 4.6 (4.08) |
| SJC28, mean (SD) | 10.6 (5.31) | 2.9 (2.93) | 11.3 (5.78) | 3.3 (3.06) |
| CRP (mg/l), mean (SD) | 14.69 (19.591) | 7.6 (13.371) | 15.49 (23.622) | 8.14 (18.048) |
| ESR (mm/h), mean (SD) | 36.5 (24.17) | 24.5 (18.30) | 35.2 (22.97) | 22.6 (17.02) |
| HAQ–DI, mean (SD) | 1.52 (0.574) | 0.92 (0.629) | 1.57 (0.643) | 0.96 (0.617) |
*Each additional combination used by less than 3% of patients.
†Part 2 baseline measurements were those taken at the start of study month 7 (visit 6).
BMI, body mass index; CCP, cyclic citrullinated peptide; CRP, C-reactive protein; DAS28, 28-joint disease activity score; DMARD, disease-modifying antirheumatic drug; ESR, erythrocyte sedimentation rate; HAQ–DI, health assessment questionnaire–disability index; IV+SC, intravenous plus subcutaneous; max, maximum; min, minimum; SJC28, swollen joint count 28; TJC28, tender joint count 28.