Table IV.
Effect of eculizumab on FACIT-Fatigue scores in patients with paroxysmal nocturnal haemoglobinuria.
TRIUMPH |
SHEPHERD |
||||
---|---|---|---|---|---|
Change from baseline median (mean ± SE) |
Change from baseline median (mean ± SE) |
||||
Week 26 placebo | Week 26 eculizumab | P-value | Week 52 eculizumab | P-value | |
Overall | −2·0 (−4·0 ± 1·71) | 4·0 (6·4 ± 1·19) | <0·001 | 10·0 (12·2 ± 1·09) | <0·001 |
0 or 1 transfusion episodes during pretreatment year | – | – | – | 11·0 (13·5 ± 2·13) | <0·001 |
Transfusion independent during study | –* | 3·0 (7·0 ± 1·93) | <0·001 | 8·5 (12·9 ± 1·71) | <0·001 |
Receiving transfusion during study | −2·0 (−4·0 ± 1·71) | 5·5 (5·7 ± 1·38) | <0·001 | 10·0 (11·5 ± 1·37) | <0·001 |
P-values are based on a signed rank test.
No placebo patients achieved transfusion independence.