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Ann Rheum Dis 72:381-389 doi:10.1136/annrheumdis-2012-201411
  • Clinical and epidemiological research

Intravenous golimumab is effective in patients with active rheumatoid arthritis despite methotrexate therapy with responses as early as week 2: results of the phase 3, randomised, multicentre, double-blind, placebo-controlled GO-FURTHER trial

Table 2

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

Placebo+MTX Golimumab 2 mg/kg+MTX
Number of randomised patients 197 395
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 unblinded 48/192 (25.0%) 230/391 (58.8%)
 p value vs placebo+MTX <0.001
Utilising the re-randomisation test 49/197 (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/dl 8/34 (23.5%) 42/69 (60.9%)
 p value vs placebo+MTX <0.001
Screening CRP≥1.5 mg/dl 41/163 (25.2%) 189/326 (58.0%)
 p value vs placebo+MTX <0.001
Baseline CRP<1.0 mg/dl 19/63 (30.2%) 58/99 (58.6%)
 p value vs placebo+MTX <0.001
Baseline CRP≥1.0 mg/dl 30/134 (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±SD 7.6±16.17 19.2±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±SD 8.1±17.63 20.2±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±SD 8.1±16.51 21.2±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±SD 8.6±18.00 22.1±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±SD 0.50±0.58
 Median (IQR) 0.19±0.56 0.50 (0.13, 0.88)
 p value vs placebo+MTX 0.13 (−0.13, 0.50) <0.001
Improvement in HAQ ≥0.25 units from baseline
Week 14 85 (43.1%) 270 (68.4%)
 p value vs placebo+MTX <0.001
Week 24 89 (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.

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