Table 2.
Study population inclusion medications and baseline patient-reported outcome measure scores.a
| Medications and outcome measure scores | ITTb | PPc | EPPd | ||||
| Control | Intervention | Control | Intervention | Control | Intervention | ||
| Participants who provided baseline data, N | 21 | 25 | 18 | 16 | 3 | 9 | |
| Inclusion medicationse |
|
|
|
|
|
|
|
|
|
Azathioprine | 2 (10) | 5 (20) | 1 (6) | 1 (6) | 1 (33) | 4 (44) |
|
|
Belimumab | 4 (19) | 7 (28) | 3 (17) | 4 (25) | 1 (33) | 3 (33) |
|
|
Hydroxychloroquine | 17 (81) | 19 (76) | 13 (72) | 13 (81) | 3 (100) | 6 (67) |
|
|
Immunoglobulin infusions | 1 (5) | 0 (0) | 1 (6) | 0 (0) | 0 (0) | 0 (0) |
|
|
Leflunomide | 0 (0) | 1 (4) | 0 (0) | 1 (6) | 0 (0) | 0 (0) |
|
|
Methotrexate | 4 (19) | 3 (12) | 4 (22) | 2 (13) | 0 (0) | 1 (11) |
|
|
Mycophenolate mofetil | 5 (24) | 2 (8) | 5 (28) | 2 (13) | 0 (0) | 0 (0) |
| HRQoLf , median (25th percentile, 75th percentile) | |||||||
|
|
FACITg-Fatigue | 20 (14, 26) | 16 (10, 23) | 20 (14, 27) | 20 (10, 26) | 7 (4, 18) | 13 (8, 19) |
|
|
BPI-SFh-Pain Severity | 4 (3, 5.7) | 5 (3, 6) | 3 (3, 5) | 4 (3, 6) | 5 (5, 7) | 6 (3, 7) |
|
|
BPI-SF-Pain Interference | 5 (5, 6) | 6 (4, 7) | 5 (4, 6) | 6 (4, 7) | 7 (3, 7) | 6 (6, 8) |
|
|
LupusQoLi-Physical Health | 50 (25, 59) | 46 (28, 56) | 51 (28, 65) | 51 (34, 60) | 25 (15, 28) | 25 (12, 50) |
|
|
LupusQoL-Pain | 41 (16, 66) | 41 (25, 66) | 58 (25, 75) | 50 (33, 66) | 16 (8, 33) | 25 (8, 50) |
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|
LupusQoL-Planning | 50 (25, 75) | 41 (8, 66) | 62 (25, 75) | 62 (25, 75) | 41 (0, 41) | 25 (8, 25) |
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LupusQoL-Intimate Relationships | 50 (25, 87) | 56 (25, 75) | 50 (25, 75) | 75 (25, 81) | 68 (50, 87) | 31 (25, 50) |
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LupusQoL-Burden to Others | 25 (0, 41) | 16 (0, 41) | 25 (0, 58) | 25 (4, 50) | 0 (0, 33) | 16 (0, 16) |
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LupusQoL-Emotional Health | 54 (37, 70) | 54 (29, 66) | 56 (37, 70) | 60 (35, 79) | 50 (20, 70) | 20 (16, 54) |
|
|
LupusQoL-Body Image | 37 (20, 56) | 50 (25, 69) | 31 (20, 65) | 65 (18, 75) | 40 (35, 50) | 31 (25, 45) |
|
|
LupusQoL-Fatigue | 25 (6, 37) | 25 (18, 31) | 25 (12, 43) | 28 (25, 50) | 6 (0, 31) | 18 (0, 18) |
aValues are n (%) unless stated otherwise.
bITT: intention to treat.
cPP: per protocol.
dEPP: ITT participants who were excluded from PP.
eTotals do not equal 100% as many patients were on multiple medications.
fHRQoL: health-related quality of life.
gFACIT-Fatigue: Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F); 52-point scale with 0 (worst).
hBPI-SF: Brief Pain Inventory-Short Form; 10-point scale with 0 (best).
iLupusQoL: Lupus Quality of Life; 100-point scale with 0 (worst).