Table 1.

Characteristics of patients with RA participating in the FIRST Bio study.

CharacteristicsPatients receiving TCZ (N = 839)
Total PY718.4
Female, n (%)646 (77.0)
Age, years, mean (SD)59.6 (13.5)
 Median, range62 (15–90)
 ≥ 65, n (%)335 (39.9)
Body weight, kg, mean (SD)54.4 (10.7)
Body weight <40 kg, n (%)35 (4.2)
Disease duration, years, mean (SD)7.5 (8.9)
 Median, range3.5 (0.0–54.4)
History of comorbidities, n (%)319 (38.0)
 Appendicitis23 (2.7)
 Uterine leiomyoma18 (2.1)
 Interstitial lung disease18 (2.1)
 Tuberculosis16 (1.9)
 Pneumonia13 (1.5)
 Gastric ulcer13 (1.5)
 Breast cancer12 (1.4)
Comorbidities, n (%)483 (57.6)
 Hypertension154 (18.4)
 Osteoporosis153 (18.2)
 Hyperlipidemia91 (10.8)
 Diabetes mellitus70 (8.3)
 Interstitial lung disease52 (6.2)
 Gastritis48 (5.7)
 Gastroesophageal reflux disease34 (4.1)
 Anemia27 (3.2)
Clinical characteristics
 Steinbrocker radiographic stage, n (%)
  I216 (25.7)
  II290 (34.6)
  III184 (21.9)
  IV149 (17.8)
 Steinbrocker functional class, n (%)
  1156 (18.6)
  2524 (62.5)
  3145 (17.3)
  414 (1.7)
RF +, (%)64.5
Baseline DAS28-ESR, mean (SD)5.2 (1.2)
Baseline CDAI, mean (SD)23.3 (11.8)
Baseline HAQ-DI, mean (SD)1.0 (0.8)
Baseline CRP, mg/dl, mean (SD)2.4 (2.8)
Baseline ESR, mm/h, mean (SD)46.2 (30.1)
Concomitant csDMARD use, n (%)a681 (81.2)
Concomitant MTX, n (%)a526 (62.7)
 MTX dose, mg/week, mean (SD)9.1 (3.9)
 MTX dose, mg/week, min–max2.0–64.0b
Concomitant oral corticosteroid use, n (%)a440 (52.4)
 Corticosteroid dose, mg/d, mean (SD)5.4 (3.2)
 Corticosteroid dose, mg/d, min–max0.5–25.0
CharacteristicsPatients receiving TCZ (N = 839)
Total PY718.4
Female, n (%)646 (77.0)
Age, years, mean (SD)59.6 (13.5)
 Median, range62 (15–90)
 ≥ 65, n (%)335 (39.9)
Body weight, kg, mean (SD)54.4 (10.7)
Body weight <40 kg, n (%)35 (4.2)
Disease duration, years, mean (SD)7.5 (8.9)
 Median, range3.5 (0.0–54.4)
History of comorbidities, n (%)319 (38.0)
 Appendicitis23 (2.7)
 Uterine leiomyoma18 (2.1)
 Interstitial lung disease18 (2.1)
 Tuberculosis16 (1.9)
 Pneumonia13 (1.5)
 Gastric ulcer13 (1.5)
 Breast cancer12 (1.4)
Comorbidities, n (%)483 (57.6)
 Hypertension154 (18.4)
 Osteoporosis153 (18.2)
 Hyperlipidemia91 (10.8)
 Diabetes mellitus70 (8.3)
 Interstitial lung disease52 (6.2)
 Gastritis48 (5.7)
 Gastroesophageal reflux disease34 (4.1)
 Anemia27 (3.2)
Clinical characteristics
 Steinbrocker radiographic stage, n (%)
  I216 (25.7)
  II290 (34.6)
  III184 (21.9)
  IV149 (17.8)
 Steinbrocker functional class, n (%)
  1156 (18.6)
  2524 (62.5)
  3145 (17.3)
  414 (1.7)
RF +, (%)64.5
Baseline DAS28-ESR, mean (SD)5.2 (1.2)
Baseline CDAI, mean (SD)23.3 (11.8)
Baseline HAQ-DI, mean (SD)1.0 (0.8)
Baseline CRP, mg/dl, mean (SD)2.4 (2.8)
Baseline ESR, mm/h, mean (SD)46.2 (30.1)
Concomitant csDMARD use, n (%)a681 (81.2)
Concomitant MTX, n (%)a526 (62.7)
 MTX dose, mg/week, mean (SD)9.1 (3.9)
 MTX dose, mg/week, min–max2.0–64.0b
Concomitant oral corticosteroid use, n (%)a440 (52.4)
 Corticosteroid dose, mg/d, mean (SD)5.4 (3.2)
 Corticosteroid dose, mg/d, min–max0.5–25.0

aConcomitant use at baseline.

bOne patient received 64.0 mg/week of MTX for 1 week due to incorrect administration before starting TCZ treatment. After that, the patient received 4 mg/week of MTX.

CDAI, Clinical Disease Activity Index; CRP, C-reactive protein; csDMARD, conventional synthetic disease-modifying antirheumatic drug; DAS28-ESR, Disease Activity Score based on 28-joint-erythrocyte sedimentation rate; ESR, erythrocyte sedimentation rate; HAQ-DI, Health Assessment Questionnaire Disability Index; MTX, methotrexate; PY, patient-years; RA, rheumatoid arthritis; RF, rheumatoid factor; SD, standard deviation; TCZ, tocilizumab.

Table 1.

Characteristics of patients with RA participating in the FIRST Bio study.

CharacteristicsPatients receiving TCZ (N = 839)
Total PY718.4
Female, n (%)646 (77.0)
Age, years, mean (SD)59.6 (13.5)
 Median, range62 (15–90)
 ≥ 65, n (%)335 (39.9)
Body weight, kg, mean (SD)54.4 (10.7)
Body weight <40 kg, n (%)35 (4.2)
Disease duration, years, mean (SD)7.5 (8.9)
 Median, range3.5 (0.0–54.4)
History of comorbidities, n (%)319 (38.0)
 Appendicitis23 (2.7)
 Uterine leiomyoma18 (2.1)
 Interstitial lung disease18 (2.1)
 Tuberculosis16 (1.9)
 Pneumonia13 (1.5)
 Gastric ulcer13 (1.5)
 Breast cancer12 (1.4)
Comorbidities, n (%)483 (57.6)
 Hypertension154 (18.4)
 Osteoporosis153 (18.2)
 Hyperlipidemia91 (10.8)
 Diabetes mellitus70 (8.3)
 Interstitial lung disease52 (6.2)
 Gastritis48 (5.7)
 Gastroesophageal reflux disease34 (4.1)
 Anemia27 (3.2)
Clinical characteristics
 Steinbrocker radiographic stage, n (%)
  I216 (25.7)
  II290 (34.6)
  III184 (21.9)
  IV149 (17.8)
 Steinbrocker functional class, n (%)
  1156 (18.6)
  2524 (62.5)
  3145 (17.3)
  414 (1.7)
RF +, (%)64.5
Baseline DAS28-ESR, mean (SD)5.2 (1.2)
Baseline CDAI, mean (SD)23.3 (11.8)
Baseline HAQ-DI, mean (SD)1.0 (0.8)
Baseline CRP, mg/dl, mean (SD)2.4 (2.8)
Baseline ESR, mm/h, mean (SD)46.2 (30.1)
Concomitant csDMARD use, n (%)a681 (81.2)
Concomitant MTX, n (%)a526 (62.7)
 MTX dose, mg/week, mean (SD)9.1 (3.9)
 MTX dose, mg/week, min–max2.0–64.0b
Concomitant oral corticosteroid use, n (%)a440 (52.4)
 Corticosteroid dose, mg/d, mean (SD)5.4 (3.2)
 Corticosteroid dose, mg/d, min–max0.5–25.0
CharacteristicsPatients receiving TCZ (N = 839)
Total PY718.4
Female, n (%)646 (77.0)
Age, years, mean (SD)59.6 (13.5)
 Median, range62 (15–90)
 ≥ 65, n (%)335 (39.9)
Body weight, kg, mean (SD)54.4 (10.7)
Body weight <40 kg, n (%)35 (4.2)
Disease duration, years, mean (SD)7.5 (8.9)
 Median, range3.5 (0.0–54.4)
History of comorbidities, n (%)319 (38.0)
 Appendicitis23 (2.7)
 Uterine leiomyoma18 (2.1)
 Interstitial lung disease18 (2.1)
 Tuberculosis16 (1.9)
 Pneumonia13 (1.5)
 Gastric ulcer13 (1.5)
 Breast cancer12 (1.4)
Comorbidities, n (%)483 (57.6)
 Hypertension154 (18.4)
 Osteoporosis153 (18.2)
 Hyperlipidemia91 (10.8)
 Diabetes mellitus70 (8.3)
 Interstitial lung disease52 (6.2)
 Gastritis48 (5.7)
 Gastroesophageal reflux disease34 (4.1)
 Anemia27 (3.2)
Clinical characteristics
 Steinbrocker radiographic stage, n (%)
  I216 (25.7)
  II290 (34.6)
  III184 (21.9)
  IV149 (17.8)
 Steinbrocker functional class, n (%)
  1156 (18.6)
  2524 (62.5)
  3145 (17.3)
  414 (1.7)
RF +, (%)64.5
Baseline DAS28-ESR, mean (SD)5.2 (1.2)
Baseline CDAI, mean (SD)23.3 (11.8)
Baseline HAQ-DI, mean (SD)1.0 (0.8)
Baseline CRP, mg/dl, mean (SD)2.4 (2.8)
Baseline ESR, mm/h, mean (SD)46.2 (30.1)
Concomitant csDMARD use, n (%)a681 (81.2)
Concomitant MTX, n (%)a526 (62.7)
 MTX dose, mg/week, mean (SD)9.1 (3.9)
 MTX dose, mg/week, min–max2.0–64.0b
Concomitant oral corticosteroid use, n (%)a440 (52.4)
 Corticosteroid dose, mg/d, mean (SD)5.4 (3.2)
 Corticosteroid dose, mg/d, min–max0.5–25.0

aConcomitant use at baseline.

bOne patient received 64.0 mg/week of MTX for 1 week due to incorrect administration before starting TCZ treatment. After that, the patient received 4 mg/week of MTX.

CDAI, Clinical Disease Activity Index; CRP, C-reactive protein; csDMARD, conventional synthetic disease-modifying antirheumatic drug; DAS28-ESR, Disease Activity Score based on 28-joint-erythrocyte sedimentation rate; ESR, erythrocyte sedimentation rate; HAQ-DI, Health Assessment Questionnaire Disability Index; MTX, methotrexate; PY, patient-years; RA, rheumatoid arthritis; RF, rheumatoid factor; SD, standard deviation; TCZ, tocilizumab.

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