Table 4.
Summary of ACR core components: baseline value and change from baseline to Visit 3 (Day 28) and Visit 5 (Day 84) PP population
| ACR core component | PP analysis | ITT analysis | ||
|---|---|---|---|---|
| Adalimumab (test) (N = 50) | Adalimumab (reference) (N = 53) | Adalimumab (test) (N = 60) | Adalimumab (reference) (N = 59) | |
| Tender joint count score (0–28) | ||||
| Baseline (Day 1) | 16.6 ± 6.09 | 17.4 ± 6.32 | 16.7 ± 5.98 | 17.2 ± 6.22 |
| Change from baseline at | ||||
| Week 4 (Day 28) | −6.4 ± 5.67† | −7.8 ± 6.21† | −6.5 ± 5.52† | −7.5 ± 6.12† |
| Week 12 (Day 84) | −10.5 ± 5.95† | −11.7 ± 7.19† | −10.7 ± 5.80† | −11.5 ± 6.98† |
| Swollen joint count score | ||||
| Baseline (Day 1) | 11.7 ± 5.57 | 12.4 ± 5.24 | 11.5 ± 5.42 | 12.1 ± 5.29 |
| Change from baseline at | ||||
| Week 4 (Day 28) | −5.5 ± 5.00† | −6.5 ± 5.81† | −5.5 ± 4.91† | −6.2 ± 5.75† |
| Week 12 (Day 84) | −8.2 ± 5.77† | −9.2 ± 6.02† | −8.1 ± 5.55† | −8.9 ± 5.94† |
| Patient assessment of pain | ||||
| Baseline (Day 1) | 66.5 ± 12.38 | 66.4 ± 11.11 | 67.0 ± 11.89 | 66.8 ± 11.53 |
| Change from baseline at | ||||
| Week 4 (Day 28) | −15.5 ± 11.18† | −15.8 ± 14.87† | −15.0 ± 11.84† | −16.2 ± 14.84† |
| Week 12 (Day 84) | −30.0 ± 17.66† | −28.4 ± 16.75† | −30.1 ± 17.52† | −29.1 ± 17.10† |
| Patient global assessment of disease activity | ||||
| Baseline (Day 1) | 66.2 ± 11.91 | 64.8 ± 10.57 | 65.3 ± 12.72 | 65.1 ± 10.96 |
| Change from baseline at | ||||
| Week 4 (Day 28) | −14.8 ± 11.47† | −16.5 ± 14.56† | −13.5 ± 13.89† | −16.7 ± 14.89† |
| Week 12 (Day 84) | −30.5 ± 16.75† | −28.3 ± 18.11† | −29.4 ± 18.18† | −28.8 ± 18.31† |
| Physician global assessment of disease activity | ||||
| Baseline (Day 1) | 63.4 ± 12.02 | 63.9 ± 10.39 | 63.1 ± 12.77 | 64.0 ± 10.63 |
| Change from baseline at | ||||
| Week 4 (Day 28) | −15.2 ± 13.86† | −16.8 ± 16.05† | −14.2 ± 14.80† | −16.5 ± 16.33† |
| Week 12 (Day 84) | −29.2 ± 18.35† | −28.6 ± 18.02† | −28.5 ± 19.71† | −29.1 ± 18.09† |
| Disability index of the HAQ | ||||
| Baseline (Day 1) | 1.7 ± 0.62 | 1.6 ± 0.61 | 1.7 ± 0.61 | 1.6 ± 0.58 |
| Change from baseline at | ||||
| Week 4 (Day 28) | −0.5 ± 0.48† | −0.5 ± 0.48† | −0.5 ± 0.45† | −0.5 ± 0.46† |
| Week 12 (Day 84) | −0.8 ± 0.63† | −0.7 ± 0.60† | −0.8 ± 0.61† | −0.8 ± 0.59† |
| CRP | ||||
| Baseline (Day 1) | 11.0 ± 12.72 | 10.5 ± 12.90 | 11.2 ± 12.39 | 10.5 ± 12.74 |
| Change from baseline at | ||||
| Week 4 (Day 28) | −2.5 ± 19.36 | −6.8 ± 12.77† | −3.0 ± 18.04 | −6.6 ± 12.69† |
| Week 12 (Day 84) | −5.5 ± 12.66† | 0.7 ± 26.98 | −5.8 ± 12.45† | 0.4 ± 26.38 |
| ESR | ||||
| Baseline (Day 1) | 53.9 ± 21.45 | 53.2 ± 20.33 | 11.2 ± 12.39 | 10.5 ± 12.74 |
| Change from baseline at | ||||
| Week 4 (Day 28) | −5.4 ± 16.82† | −2.5 ± 15.62 | −5.3 ± 15.55† | −1.9 ± 15.76 |
| Week 12 (Day 84) | −8.6 ± 19.76† | −5.4 ± 17.35† | −9.0 ± 19.88† | 6.1 ± 16.98† |
| DAS28‐CRP | ||||
| Baseline (Day 1) | 5.8 ± 0.88 | 5.8 ± 0.83 | 5.8 ± 0.87 | 5.8 ± 0.82 |
| Change from baseline at | ||||
| Week 4 (Day 28) | −1.3 ± 0.92† | −1.5 ± 1.04† | −1.2 ± 0.93† | −1.5 ± 1.04† |
| Week 12 (Day 84) | −2.1 ± 1.09† | −2.1 ± 1.21† | −2.1 ± 1.05† | −2.1 ± 1.17† |
| DAS28‐ESR | ||||
| Baseline (Day 1) | 6.8 ± 0.78 | 6.9 ± 0.81 | 6.8 ± 0.76 | 6.9 ± 0.80 |
| Change from baseline at | ||||
| Week 4 (Day 28) | −1.1 ± 0.83† | −1.2 ± 1.00† | −1.1 ± 0.82† | −1.2 ± 0.99† |
| Week 12 (Day 84) | −2.0 ± 1.10† | −2.1 ± 1.15† | −2.0 ± 1.04† | −2.1 ± 1.11† |
†Significant compared to baseline using paired t‐test. Values presented as mean ± SD. ACR, American College of Rheumatology; CRP, C‐reative protein; DAS28, Disease Activity Score of 28 joints; ESR, erythrocyte sedimentation rate; HAQ, Health Assessment Questionnaire; ITT, intention‐to‐treat; PP, per protocol.