Table 2.
HRQoL assessments (EQ-5D, HADS, WPAI, TSQM) at baseline and end-of-study, both C1-INH(SC) doses combined (N = 126)
| HRQoL assessment | Scoring and interpretation | Baseline | End of study (week 53 or extension week 88) | Intra-subject change from baselinea | |||
|---|---|---|---|---|---|---|---|
| n | Mean (SD) | n | Mean (SD) | n | Mean (SD) | ||
| EQ-5D | |||||||
| Health state value |
Health state value: scored from 0 (dead) to 1 (full health); population norm in the US = 0.825 [34] VAS: scored from 0 (worst) to 100 (best imaginable health state); population norm in the US = 80.0 [34] |
114 | 0.90 (0.168) | 100 | 0.95 (0.098) | 92 | 0.05 (0.153) |
| VAS | 114 | 81.32 (17.600) | 100 | 87.72 (13.036) | 92 | 5.83 (14.601) | |
| HADS | |||||||
| Depression |
Both domains: 0–7 (normal) 8–10 (suggestive of the mood disorder) > 11 (probable presence of the mood disorder) Maximum (worst) score possible per domain = 21 |
114 | 2.88 (2.930) | 100 | 1.91 (2.629) | 92 | − 0.80 (2.641) |
| Anxiety | 114 | 5.48 (3.863) | 100 | 4.11 (3.533) | 92 | − 1.23 (3.089) | |
| WPAI | |||||||
| Absenteeism (% work time missed)b |
All domains Higher % = greater impairment (maximum score = 100%) |
69 | 6.15 (17.056) | 68 | 2.67 (11.670) | 52 | − 4.89 (23.296) |
| Presenteeism (% impairment while working)b | 68 | 19.71 (26.653) | 68 | 8.24 (18.604) | 51 | − 14.31 (31.765) | |
| Work productivity loss (% overall work impairment)b | 68 | 22.11 (29.018) | 68 | 9.45 (20.766) | 51 | − 15.97 (34.946) | |
| Activity impairment (% activity (non-work) impairment | 114 | 27.54 (29.436) | 100 | 14.40 (24.917) | 92 | − 14.35 (32.013) | |
| TSQM | |||||||
| Effectiveness |
Each domain Scoring range is 0–100; higher scores indicate better outcomes |
104 | 73.88 (25.000) | 100 | 83.67 (27.237) | 82 | 15.04 (29.854) |
| Convenience | 104 | 70.94 (16.965) | 100 | 80.56 (17.470) | 82 | 8.81 (17.632) | |
| Overall satisfaction | 104 | 78.79 (22.414) | 100 | 92.42 (13.253) | 82 | 14.57 (23.016) | |
C1-INH(SC) subcutaneous C1-inhibitor, EQ-5D European Quality of Life-5 Dimensions Questionnaire, HADS Hospital Anxiety and Depression Scale, HRQoL health-related quality of life, TSQM Treatment Satisfaction Questionnaire for Medication, WPAI Work Productivity and Activity Impairment Questionnaire, SD standard deviation, VAS visual analog scale
aThe Change from Baseline analysis included only patients with both Baseline and End of Study scores, thus the number of patients in this column may be smaller than that shown in the End of Study column as a consequence of missing baseline data
bAssessment completed only by employed patients