Table 4.
Change from baseline to Week 24 in disease activity measures and subject reported outcomes.
| FAS N = 52 |
SC-TCZM N = 17 |
SC-TCZC N = 35 |
|
|---|---|---|---|
| DAS28-ESR | |||
| n | 47 | 14 | 33 |
| Mean change (SD) | −4.4 (1.5) | −4.3 (1.1) | −4.4 (1.7) |
| p < 0.0001∗ | p = 0.0001∗ | p < 0.0001∗, p = 0.77∗∗ | |
| ACR20 response at Week 24 | |||
| n (%) | 43 (91.5%) | 12 (85.7%) | 31 (93.9%) |
| 95% CI | 79.6% to 97.6% | 57.2% to 98.2% | 79.8% to 99.2% |
| p = 0.57# | |||
| ACR50 response at Week 24 | |||
| n (%) | 36 (76.6%) | 11 (78.6%) | 25 (75.8%) |
| 95% CI | 62.0% to 87.7% | 49.2% to 95.3% | 57.7% to 88.9% |
| (p = 1.00#) | |||
| ACR70 response at Week 24 | |||
| n (%) | 25 (53.2%) | 9 (64.3%) | 16 (48.5%) |
| 95% CI | 38.1% to 67.9% | 35.1% to 87.2% | 30.8% to 66.5% |
| (p = 0.36#) | |||
| SDAI | |||
| n | 45 | 12 | 33 |
| Mean change (SD) | −31.6 (16.5) | −34.1 (14.2) | −30.7 (17.3) |
| CDAI | |||
| n | 46 | 13 | 33 |
| Mean change (SD) | −30.0 (15.1) | −33.6 (13.1) | −28.6 (15.8) |
| TJC28 | |||
| n | 47 | 14 | 33 |
| Mean change (SD) | −11.1 (7.6) | −11.4 (7.3) | −10.9 (7.8) |
| SJC28 | |||
| n | 47 | 14 | 33 |
| Mean change (SD) | −8.8 (6.0) | −9.5 (6.3) | −8.45 (5.9) |
| Physician's global assessment of disease activity (VAS) | |||
| n | 46 | 13 | 33 |
| Mean change (SD) | −48.8 (21.3) | −55.5 (24.4) | −46.2 (19.8) |
| Patient's global assessment of disease (VAS) | |||
| n | 47 | 14 | 33 |
| Mean change (SD) | −48.6 (25.9) | −52.3 (26.7) | −47.0 (25.8) |
| Patient's global assessment of pain (VAS) | |||
| n | 47 | 14 | 33 |
| Mean change (SD) | −41.9 (27.0) | −47.0 (31.0) | −39.7 (25.3) |
| FACIT-F | |||
| n | 47 | 14 | 33 |
| Mean change (SD) | 12.6 (10.5) | 15.6 (10.5) | 11.4 (10.5) |
| HAQ-DI | |||
| n | 47 | 14 | 33 |
| Mean change (SD) | −0.78 (0.59) | −0.79 (0.70) | −0.77 (0.54) |
∗Sign test used to test the hypothesis of no change from baseline to Week 24; ∗∗Wilcoxon Rank Sum test used to test the hypothesis of no change from baseline between the subgroups; #Fisher's Exact test used to test the hypothesis of no difference between subgroups at Week 24; ACR20/50/70 20%/50%/70% improvement in the American College of Rheumatology response scores; CDAI, Clinical Disease Activity Index; DAS28-ESR, disease activity score (28 joints)-erythrocyte sedimentation rate; FACIT-F, Functional Assessment of Chronic Illness Therapy-Fatigue; FAS, full analysis set; HAQ-DI, Health Assessment Questionnaire-Disability Index; SC-TCZC, subcutaneous tocilizumab combination therapy subgroup (including MTX); SC-TCZM, subcutaneous tocilizumab monotherapy subgroup (including DMARD(s) but excluding MTX); SDAI, Simplified Disease Activity Index; SJC28, swollen joint count (28 joints); TJC, tender joint count (28 joints); VAS, visual analogue scale; CI, confidence intervals.