APPENDIX 2.

Baseline patient (DMARD-IR population) demographics and characteristics, stratified by response by Week 8.

Placebo + DMARD n = 1010TCZ 4 mg/kg + DMARD n = 612TCZ 8 mg/kg + DMARD n = 1406
≥ 50% Improvement in SJC66 by Week 8Yes, n = 386No, n = 624Yes, n = 328No, n = 284Yes, n = 754No, n = 652
Age, yrs, mean (SD)51.6 (12.5)52.4 (12.8)51.9 (12.8)50.9 (12.5)52.8 (12.5)52.8 (12.0)
Sex, n (%)
  Female313 (81.1)520 (83.3)266 (81.1)245 (86.3)610 (80.9)544 (83.4)
  Male73 (18.9)104 (16.7)62 (18.9)39 (13.7)144 (19.1)108 (16.6)
Race, n (%)
  American Indian or Alaska Native36 (9.3)33 (5.3)28 (8.5)13 (4.6)65 (8.6)51 (7.8)
  Asian25 (6.5)63 (10.1)19 (5.8)23 (8.1)70 (9.3)57 (8.7)
  Black19 (4.9)25 (4.0)9 (2.7)15 (5.3)22 (2.9)37 (5.7)
  Other45 (11.7)40 (6.4)37 (11.3)29 (10.2)55 (7.3)41 (6.3)
  White261 (67.6)463 (74.2)235 (71.6)204 (71.8)542 (71.9)466 (71.5)
Baseline DAS28, mean (SD)6.5 (0.9)6.7 (1.0)6.5 (1.0)6.7 (0.9)6.6 (1.0)6.8 (1.0)
Oral corticosteroids at baseline, n (%)235 (60.9)378 (60.6)215 (65.5)177 (62.3)424 (56.2)355 (54.4)
Baseline RF-positive, n (%)287 (74.4)489 (78.4)266 (81.1)223 (78.5)617 (81.8)508 (77.9)
Previous DMARD/anti-TNF, n, median (range)1 (0–10)1 (0–8)1 (0–8)1 (0–8)1 (0–8)1 (0–9)
Duration of RA, yrs, mean (SD)8.8 (8.4)9.2 (8.4)8.9 (7.9)8.6 (7.6)9.1 (8.2)9.6 (8.8)
At Least Moderate RAPID3 response by Week 8Yes, n = 499No, n = 511Yes, n = 381No, n = 231Yes, n = 937No, n = 469
Age, yrs, mean (SD)51.8 (12.7)52.4 (12.7)52.3 (12.6)50.0 (12.7)52.6 (12.5)53.3 (11.7)
Sex, n (%)
  Female412 (82.6)421 (82.4)313 (82.2)198 (85.7)777 (82.9)377 (80.4)
  Male87 (17.4)90 (17.6)68 (17.8)33 (14.3)160 (17.1)92 (19.6)
Race, n (%)
  American Indian or Alaska Native37 (7.4)32 (6.3)15 (3.9)26 (11.3)79 (8.4)37 (7.9)
  Asian40 (8.0)48 (9.4)26 (6.8)16 (6.9)88 (9.4)39 (8.3)
  Black27 (5.4)17 (3.3)18 (4.7)6 (2.6)38 (4.1)21 (4.5)
  Other32 (6.4)53 (10.4)34 (8.9)32 (13.9)47 (5.0)49 (10.4)
  White363 (72.7)361 (70.6)288 (75.6)151 (65.4)685 (73.1)323 (68.9)
Baseline DAS28, mean (SD)6.7 (0.9)6.6 (1.0)6.6 (0.9)6.6 (0.9)6.7 (1.0)6.5 (1.1)
Oral corticosteroids at baseline, n (%)328 (65.7)285 (55.8)248 (65.1)144 (62.3)528 (56.4)251 (53.5)
Baseline RF-positive, n (%)380 (76.2)396 (77.5)315 (82.7)174 (75.3)771 (82.3)354 (75.5)
Previous nonbiologic DMARD/anti-TNF, n, median (range)1 (0–7)1 (0–10)1 (0–8)1 (0–6)1 (0–9)1 (0–8)
Duration of RA, yrs, mean (SD)8.6 (8.3)9.5 (8.5)9.0 (8.2)8.4 (7.0)9.1 (8.3)9.8 (8.8)
  • DAS28: Disease Activity Score using 28 joints; DMARD: disease-modifying antirheumatic drug; DMARD-IR: DMARD inadequate response; RAPID3: Routine Assessment of Patient Index Data 3; RA: rheumatoid arthritis; SJC66: swollen joint count based on 66 joints; TCZ: tocilizumab; RF: rheumatoid factor; TNF: tumor necrosis factor.