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 | |
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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.
