Variable | Abatacept | Placebo | p-value |
---|---|---|---|
n = 7 | n = 3 | ||
Adverse events | 7 | 7 | 1 |
Serious adverse events | 1 | 0 | |
Infectionsb | 2 | 4 | |
Pruritus | 2 | 0 | |
Lower extremity edema | 0 | 1 | |
Headache | 1 | 0 | |
Dry mouth | 0 | 1 | |
Nausea | 0 | 1 | |
Fever | 1 | 0 | |
Absolute change in mRSS, abatacept | −8.6 ± 7.5 | – | 0.0625 |
Absolute change in mRSS, placebo | – | −2.3 ± 15 | 0.75 |
Change in HAQ-DI | −0.04 ± 0.24 | 0.25 ± 0.25 | 0.16 |
Change in physician global VAS | −11.9 ± 18.1 | −17.3 ± 23.2 | 0.048 |
Change in patient global VAS | −8 ± 7.6 | −2.7 ± 6.7 | 0.023 |
Change in patient pain VAS | −11.4 ± 8.3 | −15 ± 25.1 | 0.18 |
Change in ESR | −6 ± 7.0 | 1.7 ± 7.6 | 0.37 |
Change in FVC % predicted | 1.3 ± 8.5 | 0.3 ± 8.5 | 0.72 |
Change in DLCO % predicted | 2.0 ± 6.3 | −7.4 ± 10.7 | 0.84 |