ACR20/50/70 responders in the total population and TNFi-naïve and TNFi-exposed subgroups (ITT population)
Week 24 | Week 44 | ||||
Abatacept | Placebo | Estimated difference (95% CI) | Abatacept/open-label abatacept | Placebo/open-label abatacept | |
Total population | n=213 | n=211 | n=213 | n=211 | |
ACR20 | 39.4 | 22.3 | 17.2 (8.7 to 25.6)* | 48.4 | 49.3 |
ACR50 | 19.2 | 12.3 | 6.9 (0.1 to 13.7) | 28.2 | 32.2 |
ACR70 | 10.3 | 6.6 | 3.7 (–1.5 to 8.9) | 15.5 | 17.5 |
TNFi naïve | n=84 | n=81 | n=84 | n=81 | |
ACR20 | 44.0 | 22.2 | 21.9 (8.3 to 35.6)† | 54.8 | 56.8 |
ACR50 | 25.0 | 14.8 | 10.2 (–1.5 to 22.0) | 35.7 | 38.3 |
ACR70 | 11.9 | 8.6 | 3.3 (–5.8 to 12.4) | 14.3 | 23.5 |
TNFi exposed | n=129 | n=130 | n=129 | n=130 | |
ACR20 | 36.4 | 22.3 | 14.0 (3.3 to 24.8)‡ | 44.2 | 44.6 |
ACR50 | 15.5 | 10.8 | 4.7 (–3.4 to 12.8) | 23.3 | 28.5 |
ACR70 | 9.3 | 5.4 | 3.9 (–2.4 to 10.2) | 16.3 | 13.8 |
Data are presented as percentages of patients.
Early escape patients were imputed as non-responders in the week 24 analysis. Estimated differences between original treatment arms were not calculated in the week 44 analysis.
*p<0.001 versus placebo.
†Nominal p=0.003 versus placebo.
‡Nominal p=0.012 versus placebo.
ACR20, ≥20% improvement in American College of Rheumatology criteria; ACR50, ≥50% improvement in American College of Rheumatology criteria; ACR70, ≥70% improvement in American College of Rheumatology criteria; ITT, intent-to-treat; TNFi, tumour necrosis factor inhibitor.