Table 3.
Subgroup analyses of FACIT-Fatigue scores in patients starting on eculizumab after enrollment
| Proportion with clinically meaningful change,an (%) |
||||||
|---|---|---|---|---|---|---|
| Variable Median (range), unless otherwise stated |
BLb | LFUc | Change (LFU ‒ BL) | Improvement | No change | Worsening |
| Overall (n = 23) | 29.0 (0.0–49.0) | 41.0 (4.0–52.0) | 9.0 (−28.0 to 47.0) | 17 (73.9) | 2 (8.7) | 4 (17.4) |
| Dialysis (n = 3) | 30.0 (6.0–30.0) | 36.0 (4.0–42.3) | 6.0 (−2.0 to 12.3) | 2 (66.7) | 1 (33.3) | 0 |
| No dialysis (n = 14) | 32.5 (0.0–49.0) | 44.5 (8.0–51.0) | 10.0 (−28.0 to 47.0) | 10 (71.4) | 3 (21.4) | 1 (7.1) |
| Kidney transplant (n = 5) | 31.0 (5.0–47.0) | 40.0 (21.0–51.0) | 9.0 (0.0 to 16.0) | 4 (80.0) | 1 (20.0) | 0 |
| No kidney transplant (n = 16) | 28.5 (0.0–49.0) | 40.1 (4.0–51.0) | 11.5 (−28.0 to 47.0) | 11 (68.8) | 3 (18.8) | 2 (12.5) |
| With recent hospitalization (n = 18) | 29.5 (0.0–49.0) | 39.6 (4.0–52.0) | 10.5 (−28.0 to 40.0) | 13 (72.2) | 4 (22.2) | 1 (5.6) |
| Without recent hospitalization (n = 5) | 25.0 (0.0–35.0) | 40.0 (8.0–47.0) | 11 (−13.0 to 47.0) | 4 (80.0) | 0 | 1 (20.0) |
BL, baseline; FACIT-Fatigue, Functional Assessment of Chronic Illness Therapy-Fatigue; LFU, last follow-up.
a
Clinically meaningful improvement is defined as an increase in FACIT-Fatigue score of more than 3 units from the baseline; worsening is a decrease of more than 3 units from baseline; and no change is any change in FACIT-Fatigue score from baseline of −3, −2, −1, 0, 1, 2, or 3. Missing data: dialysis/no dialysis, n = 6; kidney transplant/no kidney transplant, n = 2.
b
Baseline defined as the before eculizumab score closest to start of treatment.
c
Last score while on eculizumab.