Table 1.
Risk factors of clinically important IOP elevation with difluprednate in patients with non-infectious uveitis.*
| Crude | Adjusted** | |||||
|---|---|---|---|---|---|---|
|
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| Variable | Events/At Risk | Hazard Ratio (95% CI) | P | Hazard Ratio (95% CI) | P | |
| Age group | Adult | 12/45 (26.7%) | 1 | 1 | ||
| Children | 5/9 (55.6%) | 1.98 (0.69 – 5.65) | .21 | 7.85 (1.48 – 41.56) | .02 | |
|
| ||||||
| Gender | Male | 8/26 (30.8%) | 1 | 1 | ||
| Female | 9/28 (32.1%) | 1.04 (0.40 – 2.69) | .94 | 1.32 (0.33 – 5.40) | .70 | |
|
| ||||||
| Uveitis category | Anterior | 1/7 (14.3%) | 1 | 1 | ||
| Intermediate | 4/19 (21.1%) | 1.26 (0.14 – 11.33) | .84 | 6.66 (0.21 – 216.44) | .29 | |
| Posterior | 3/8 (37.5%) | 2.05 (0.21 – 19.76) | .54 | 5.74 (0.25 – 134.08) | .28 | |
| Panuveitis | 9/20 (45.0%) | 2.42 (0.31 – 19.22) | .40 | 23.85 (0.82 – 692.45) | .07 | |
|
| ||||||
| Duration of uveitis history | <6 Months | 7/20 (35.0%) | 1 | 1 | ||
| 6 Months to <2 Years | 5/14 (35.7%) | 0.94 (0.30 – 2.98) | .92 | 5.76 (0.36 – 91.76) | .22 | |
| 2 to <5 Years | 2/8 (25.0%) | 0.71 (0.15 – 3.41) | .66 | 3.58 (0.38 – 33.95) | .27 | |
| 5+ years | 3/12 (25.0%) | 0.46 (0.12 – 1.77) | .26 | 3.49 (0.18 – 68.42) | .41 | |
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| Anterior chamber cell grade at baseline | Quiet | 7/22 (31.8%) | 1 | 1 | ||
| 0.5+ | 4/11 (36.4%) | 1.21 (0.35 – 4.16) | .76 | 3.24 (0.43 – 24.54) | .26 | |
| 1+ | 3/14 (21.4%) | 0.85 (0.22 – 3.28) | .81 | 2.45 (0.30 – 19.78) | .40 | |
| 2+ or worse | 3/7 (42.9%) | 1.87 (0.48 – 7.28) | .36 | 1.09 (0.12 – 9.94) | .94 | |
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| History of glaucoma/OHT | No | 11/38 (28.9%) | 1 | 1 | ||
| Yes | 6/16 (37.5%) | 1.23 (0.45 – 3.35) | .69 | 1.98 (0.55 – 7.12) | .30 | |
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| Prior cataract surgery | No | 15/42 (35.7%) | 1 | 1 | ||
| Yes | 2/12 (16.7%) | 0.35 (0.08 – 1.52) | .16 | 0.10 (0.005 – 2.18) | .14 | |
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| ||||||
| Difluprednate drops/day at baseline | 2 | 2/10 (20.0%) | 1 | 1 | ||
| 3 | 3/9 (33.3%) | 1.69 (0.28 – 10.18) | .57 | 0.48 (0.04 – 5.73) | .56 | |
| 4 or more*** | 12/35 (34.3%) | 2.50 (0.56 – 11.23) | .23 | 1.81 (0.29 – 11.33) | .52 | |
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| Concurrent systemic steroid use | No | 6/29 (20.7%) | 1 | 1 | ||
| Yes | 11/25 (44.0%) | 2.56 (0.94 – 6.99) | .07 | 5.31 (1.18 – 24.00) | .03 | |
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| ||||||
| Concurrent systemic immunosuppressive therapy/Biologics | No | 10/30 (33.3%) | 1 | 1 | ||
| Yes | 7/24 (29.2%) | 0.61 (0.23 – 1.60) | .31 | 0.30 (0.06 – 1.56) | .15 | |
*
Clinically important IOP elevation defined as having an IOP ≥21 mmHg and ≥10 mmHg increase from baseline at the same visit.
**
Adjusted by age group, gender, uveitis category, duration of prior uveitis, anterior chamber cell grading, history of glaucoma/OHT, prior cataract surgery, difluprednate dosage, concurrent systemic steroid use, concurrent immunosuppressive use.
***
Only 2 eyes received 6 drops/day regimen. The rest of the eyes received 4 drops/day regimen.
IOP; Intraocular pressure, OHT; Ocular hypertension, 95% CI; 95% confidence interval.