Table 2

Summary of clinical efficacy among randomised patients. Data presented are number (%) of patients or mean±SD and median (IQR)

Placebo+MTXGolimumab 2 mg/kg+MTX
Number of randomised patients197395
ACR20 at week 14 (1° endpoint)49/197 (24.9%)231/395 (58.5%)
 p value vs placebo+MTX<0.001
Sensitivity analyses of 1° endpoint (ACR20 at week 14)
Patients who discontinued study agent due to an adverse event considered ‘non-responders’49/197 (24.9%)229/395 (58.0%)
 p value vs placebo+MTX<0.001
Patients with insufficient data to determine ACR20 response considered ‘non-responders’48/197 (24.4%)226/395 (57.2%)
 p value vs placebo+MTX<0.001
Excluding patients whose treatment regimen was inadvertently unblinded48/192 (25.0%)230/391 (58.8%)
 p value vs placebo+MTX<0.001
Utilising the re-randomisation test49/197 (24.9%)231/395 (58.5%)
 p value vs placebo+MTX<0.001
Subgroup analysis of 1° endpoint (ACR20 at week 14)
Screening CRP<1.5 mg/dl8/34 (23.5%)42/69 (60.9%)
 p value vs placebo+MTX<0.001
Screening CRP≥1.5 mg/dl41/163 (25.2%)189/326 (58.0%)
 p value vs placebo+MTX<0.001
Baseline CRP<1.0 mg/dl19/63 (30.2%)58/99 (58.6%)
 p value vs placebo+MTX<0.001
Baseline CRP≥1.0 mg/dl30/134 (22.4%)173/294 (58.8%)
 p value vs placebo+MTX<0.001
EULAR (DAS28-CRP moderate/good) response at week 14 (major 2° endpoint)79/197 (40.1%)321/395 (81.3%)
 p value vs placebo+MTX<0.001
DAS28-CRP improvement from baseline
Week 14
 Mean±SD−0.7±1.35−2.0±1.23
 Median (IQR)−0.5 (−1.6, 0.2)−1.9 (−2.7, 1.2)
Week 24
 Mean±SD−0.8±1.43−2.0±1.40
 Median (IQR)−0.5 (−1.7, 0.2)−2.0 (−3.0, −1.1)
ACR50 response at week 24 (major 2° endpoint)26/197 (13.2%)138/395 (34.9%)
 p value vs placebo+MTX<0.001
CDAI improvement from baseline
Week 14
 Mean±SD7.6±16.1719.2±12.80
 Median (IQR)6.7 (−3.3, 17.2)18.5 (11.3, 26.2)
 p value vs placebo+MTX<0.001
Week 24
 Mean±SD8.1±17.6320.2±14.47
 Median (IQR)6.5 (−5.1, 20.0)20.1 (10.7, 28.8)
 p value vs placebo+MTX<0.001
SDAI improvement from baseline
Week 14
 Mean±SD8.1±16.5121.2±13.31
 Median (IQR)7.6 (−3.3, 17.8)20.8 (12.7, 27.6)
 p value vs placebo+MTX<0.001
Week 24
 Mean±SD8.6±18.0022.1±15.33
 Median (IQR)6.5 (−5.7, 20.5)22.3 (12.4, 30.7)
 p value vs placebo+MTX<0.001
Improvement from baseline in HAQ score at week 14 (major 2° endpoint)
 Mean±SD0.50±0.58
 Median (IQR)0.19±0.560.50 (0.13, 0.88)
 p value vs placebo+MTX0.13 (−0.13, 0.50)<0.001
Improvement in HAQ ≥0.25 units from baseline
Week 1485 (43.1%)270 (68.4%)
 p value vs placebo+MTX<0.001
Week 2489 (45.2%)266 (67.3%)
 p value vs placebo+MTX<0.001
  • ACR, American College of Rheumatology; CDAI, clinical disease activity index; CRP, C-reactive protein; DAS28, disease activity score employing 28 joints; HAQ, health assessment questionnaire; MTX, methotrexate; SDAI, simplified disease activity index.