Table 3

Summary of clinical efficacy (randomised patients)

Capsular summary of clinical efficacy to week 246
Placebo+MTXGolimumab 2 mg/kg+MTX
Randomised patients (n)197395
Primary endpoint: ACR20 response at week 14 (n (%))49/197 (24.9)231/395 (58.5)
  p Value vs placebo+MTX<0.001
Major secondary endpoints reported previously
EULAR moderate/good (DAS28-CRP) response at week 14 (n (%))79/197 (40.1)321/395 (81.3)
  p Value vs placebo+MTX<0.001
 ACR50 response at week 24 (n (%))26/197 (13.2)138/395 (34.9)
  p Value vs placebo+MTX<0.001
 Improvement from baseline in HAQ-DI score at week 14 (mean±SD)0.19±0.560.50±0.58
   Median (IQ range)0.13 (−0.13, 0.50)0.50 (0.13, 0.88)
  p Value vs placebo+MTX<0.001
Clinical efficacy to week 52
Placebo→Golimumab 2 mg/kg+MTXGolimumab 2 mg/kg+MTXAll patients
Randomised patients (n)197395592
ACR response at week 52 (n (%))
 ACR20121 (61.4)260 (65.8)381 (64.4)
 ACR5062 (31.5)153 (38.7)215 (36.3)
 ACR7029 (14.7)72 (18.2)101 (17.1)
Maintenance of ACR response from week 24 to week 52 (n (%))
 ACR2053/63 (84.1)201/245 (82.0)254/308 (82.5)
 ACR5022/26 (84.6)99/138 (71.7)121/164 (73.8)
 ACR705/8 (62.5)42/69 (60.9)47/77 (61.0)
ACR response at week 52 among week 24 non-responders (n (%))
 ACR2068/128 (53.1)55/137 (40.1)123/265 (46.4)
 ACR5040/165 (24.2)54/244 (22.1)94/409 (23.0)
 ACR7024/183 (13.1)30/313 (9.6)54/496 (10.9)
DAS28–CRP moderate/good response (n (%))
 At week 52149 (75.6)321 (81.3)470 (79.4)
 Maintenance from week 24 to week 5283/89 (93.3)279/317 (88.0)362/406 (89.2)
HAQ-DI improvement ≥0.25 units (n (%))
 At week 52123 (62.4)253 (64.1)376 (63.5)
 Maintenance from week 24 to week 5280/88 (90.9)217/260 (83.5)297/348 (85.3)
CDAI score
 Improvement from baseline (mean±SD)20.9±15.122.3±14.121.8±14.4
   Median (IQ range)19.5 (11.1, 32.4)23.1 (12.9, 31.2)22.1 (12.3, 31.3)
 Disease activity (n (%))
  Remission (≤2.8)15 (7.6)33 (8.4)48 (8.1)
  Low (>2.8 and <10)54 (27.4)114 (28.9)168 (28.4)
  Moderate (≥10 and <22)73 (37.1)140 (35.4)213 (36.0)
  High (≥22)55 (27.9)108 (27.3)163 (27.5)
SDAI score
 Improvement from baseline (mean±SD)21.7±15.6323.7±15.1523.0±15.33
   Median (IQ range)20.3 (12.0, 33.8)24.3 (14.2, 33.1)22.9 (12.9, 33.3)
 Disease activity (n (%))
  Remission (≤3.3)16 (8.1)36 (9.1)52 (8.8)
  Low (>3.3 and <11)55 (27.9)114 (28.9)169 (28.5)
  Moderate (≥11 and <26)74 (37.6)153 (38.7)227 (38.3)
   High (≥26)52 (26.4)92 (23.3)144 (24.3)
  • ACR, American College of Rheumatology; CDAI, Clinical Disease Activity Index; CRP, C reactive protein; DAS28, 28 joint Disease Activity Score; EULAR, European League Against Rheumatism; HAQ-DI, Health Assessment Questionnaire-Disability Index; MTX, methotrexate; SDAI, Simplified Disease Activity Index.