Difluprednate versus prednisolone for endogenous anterior uveitis
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Supplementary materials
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Table S1. Demographic data and baseline characteristics (intent-to-treat population)
Difluprednate 0.05%,
Prednisolone acetate 1%,
Overall,
n=57
n=53
n=110
49.0 ± 16.2
46.3 ± 17.5
47.7 ± 16.9
4, 87
12, 76
4, 87
2 to 11 years
2 (3.5)
0
2 (1.8)
12 to 17 years
1 (1.8)
1 (1.9)
2 (1.8)
18 to 64 years
47 (82.5)
40 (75.5)
87 (79.1)
65 or older
7 (12.3)
12 (22.6)
19 (17.3)
White
35 (61.4)
30 (56.6)
65 (59.1)
Black
19 (33.3)
20 (37.7)
39 (35.5)
Other
3 (5.3)
3 (5.7)
6 (5.5)
32 (56.1)
28 (52.8)
60 (54.5)
2.6 ± 0.66
2.5 ± 0.67
NA
2.1 ± 0.57
2.2 ± 0.62
NA
197.8 ± 35.6
198.0 ± 38.3
NA
Age, years
Mean ± SD
Min, max
Age groups, n (%)
Race, n (%)
Sex, n (%)
Female
Anterior chamber cell grade
Mean ± SD
Anterior chamber flare grade
Mean ± SD
OCT center thickness, µm
Mean ± SD
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OCT, optical coherence tomography; SD, standard deviation.
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Difluprednate versus prednisolone for endogenous anterior uveitis
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Difluprednate versus prednisolone for endogenous anterior uveitis
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Table S2. Work limitation questionnaire quality of life measures (intent-to-treat population
with LOCF)
Difluprednate 0.05%
Prednisolone acetate 1%
27.9
29.0
(n=42)
(n=34)
12.7
10.4
(n=37)
(n=34)
–13.8
–16.4
(n=35)
(n=30)
17.2
16.4
(n=46)
(n=41)
7.5
12.8
(n=40)
(n=34)
–9.3
1.4
(n=39)
(n=32)
19.2
21.4
(n=44)
(n=39)
12.8
7.8
(n=38)
(n=36)
–6.6
–10.1
(n=36)
(n=31)
16.0
22.1
(n=44)
(n=39)
13.1
10.3
P-value
Time management scale
Baseline, mean
Follow up, mean
Mean change
0.470
Physical scale
Baseline, mean
Follow up, mean
Mean change
0.132
Mental-interpersonal scale
Baseline, mean
Follow up, mean
Mean change
0.205
Output scale
Baseline, mean
Follow up, mean
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Difluprednate versus prednisolone for endogenous anterior uveitis
Mean change
(n=36)
(n=36)
–2.7
–8.4
(n=34)
(n=31)
0.055
0.062
(n=40)
(n=37)
0.034
0.027
(n=36)
(n=32)
–0.019
–0.022
(n=33)
(n=27)
5.21
5.86
(n=40)
(n=37)
3.24
2.60
(n=36)
(n=32)
–1.80
–2.08
(n=33)
(n=27)
0.515
Loss index
Baseline, mean
Follow up, mean
Mean change
0.642
Percent productivity
Baseline, mean
Follow up, mean
Mean change
1
2
3
4
5
6
7
0.654
The WLQ resulted in four composite sub-score scores on time management, physical, mentalinterpersonal and output scale. Scale scores range from 0 (limited none of the time) to 100 (limited all of
the time), and they indicate the percentage of time in the prior 2 weeks that the respondent was limited
in performing the specific dimension of a job. The WLQ index is a weighted sum of scores from the four
WLQ subscales. The WQL productivity loss score was based upon the index score and indicates the
percentage decrement in work output due to health problems.
LOCF, last patient carried forward; WLQ, work limitation questionnaire.
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Difluprednate versus prednisolone for endogenous anterior uveitis
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Study day
00
77
14
14
21
21
28
28
35
35
42
42
Mean change from baseline
anterior chamber cell grade
0.0
0
-1.0
-1
-2.0
-2
-3.0
-3
Difluprednate 0.05% (n=57)
Prednisolone acetate 1% (n=53)
-4.0
-4
2
Treatment
Taper 1
Taper 2
Observation
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Figure
S1. Mean
change4 drops/day
from baseline
in anterior
Difluprednate
0.05%
2 drops/day
1 drop/day chamber cell grades in patients receiving
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difluprednate 0.05% dosed four times daily (n=57) or prednisolone acetate 1% dosed eight
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times daily (n=53) (intent-to-treat population with LOCF)
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Filled data labels represent the results for the primary efficacy endpoint. The mean ± standard
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deviation change in anterior chamber cell grade from baseline to Day 14 was –2.1 ± 0.93 with
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difluprednate and –1.9 ± 0.95 with prednisolone acetate (P=0.29; mean difference=0.2; favoring
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difluprednate). Hollow data labels represent the secondary efficacy outcomes. Error bars represent
Prednisolone acetate 1%
8 drops/day
4 drops/day 2 drops/day
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standard deviations.
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Dosing schedule does not include placebo doses, which were interspersed with difluprednate
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drops to maintain masking. Anterior chamber cell grade was based on a 5-point scale from 0 (≤1
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cell) to 4 (≥50 cells).
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ITT, intent-to-treat; LOCF, last observation carried forward.
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Difluprednate versus prednisolone for endogenous anterior uveitis
A. Grade 0 anterior chamber cells
Difluprednate 0.05%, n=57
100%
100
Prednisolone acetate 1%, n=53
80.7%
80
80%
Proportion of patients, %
75.4%
73.6%
71.7%
71.9%
28
35
42
66.7%
60
60%
66.0%
36.8%
40
40%
20
20%
81.1%
77.2%
58.5%
32.1%
17.5%
9.4%
0
0%
3
7
14
21
B. Complete clearing of anterior chamber cells
1001
801
73.7%
73.7%
77.4%
66.7%
601
54.4%
40
*
69.8%
66.0%
66.7%
52.8%
0
26.3%
45.3%
20
0
0
26.4%
14.0%
5.7%
0
3
7
14
21
28
35
42
Day
1
2
Figure S2. Proportion of patients (A) achieving Grade 0 anterior chamber cells (1 or fewer
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cells per high power field); and (B) with complete clearing of anterior chamber cells (i.e.
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achieving 0 cells) during the study (intent-to-treat population with LOCF)
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*P=0.023.
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LOCF, last observation carried forward.
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8
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