TABLE 3.
Therapeutic outcomes of adalimumab therapy expressed per eye ‘at risk’.
| Outcome (eyes) |
Characteristic required to be ‘at risk’ |
3 months |
6 months |
Overall |
|||
|---|---|---|---|---|---|---|---|
| Events/ At risk |
Percent with event (95% CI) |
Events/ At risk |
Percent with event (95% CI) |
Events/eye- year |
Incidence rate (95% CI) |
||
| Control of Inflammation | |||||||
| Improvement of AC cells by 2 grades | ≥1+ cells | 4/6 | 0.67 (0.22–0.93) | 4/5 | 0.80 (0.29–0.98) | 8/4.36 | 1.84 (0.77–4.35) |
| Improvement of vitreous cells by 2 grades |
≥1+ cells | 1/1 | 1.00 (NA) | 0/0 | 0 (NA) | 1/0.30 | 3.29 (NA) |
| Transition from ‘active’ to ‘inactive’ inflammation |
Active | 7/15 | 0.47 (0.20–0.76) | 7/15 | 0.47 (0.20–0.76) | 16/7.55 | 2.12 (1.29–3.49) |
| Transition from ‘inactive’ to ‘active’ inflammation |
Inactive | 6/23 | 0.26 (0.09–0.55) | 3/17 | 0.18 (0.06–0.42) | 10/22.0 | 0.46 (0.20–1.05) |
| Change in VA | |||||||
| Worsening of VA to ≤20/50 | VA ≥20/50 | 6/26 | 0.23 (0.10–0.44) | 1/21 | 0.05 (0.01–0.26) | 10/28.5 | 0.35 (0.15–0.80) |
| Worsening of VA to ≤20/200 | VA ≥20/200 | 1/31 | 0.03 (0.01–0.19) | 1/24 | 0.04 (0.01–0.24) | 1/32.9 | 0.03 (0.004–0.23) |
| Doubling of visual angle | Measurable VA | 8/36 | 0.22 (0.11–0.39) | 7/27 | 0.26 (0.10–0.53) | 10/29.7 | 0.34 (0.14–0.83) |
| Improvement of VA from ≤20/50 to >20/50 |
VA ≤20/50 | 4/16 | 0.25 (0.12–0.44) | 3/13 | 0.23 (0.09–0.46) | 7/11.4 | 0.62 (0.34–1.13) |
| Improvement of VA from ≤20/200 to >20/200 |
VA ≤20/200 | 5/11 | 0.45 (0.18–0.76) | 6/10 | 0.60 (0.28–0.85) | 8/7.21 | 1.11 (0.52–2.37) |
| Halving of visual angle | Measurable VA | 5/36 | 0.14 (0.05–0.32) | 0/27 | 0 (NA) | 9/35.0 | 0.26 (0.11–0.58) |
| Change in VA from baseline (lines) (mean ± SD) |
Measurable VA | –0.09 ± 0.41 | –0.13 ± 0.31 | – | |||
| Change in IOP | |||||||
| Increase to ≥24 mmHg | IOP<24 | 0/34 | 0.00 (NA) | 1/28 | 0.04 (0.01–0.21) | 2/28.9 | 0.07 (0.02–0.28) |
| Increase to ≥30 mmHg | IOP<30 | 0/36 | 0.00 (NA) | 0/30 | 0.00 (NA) | 0/32.8 | 0 (NA) |
| Decrease to ≤24 mmHg | IOP≥24 | 2/2 | 1.00 (NA) | 2/2 | 1.00 (NA) | 2/0.04 | 45.6 (NA) |
| Decreased to ≤30 mmHg | IOP≥30 | 0/0 | NA | 0/0 | NA | NA | NA (NA) |
| Glaucoma surgery | All eyes | 0/44 | 0.00 (NA) | 0/44 | 0.00 (NA) | 1/40.9 | 0.005 (0.001–0.04) |
| CME | |||||||
| Occurrence of CME | No CME at baseline | 4/27 | 0.15 (0.05–0.39) | 0/22 | 0 (NA) | 6/27.9 | 0.22 (0.07–0.63) |
| Resolution of CME | CME at baseline | 3/4 | 0.75 (0.32–0.95 | 3/4 | 0.75 (0.32–0.95) | 4/1.61 | 2.48 (1.57–3.91) |
| Cataract surgery | Phakic at baseline | 2/36 | 0.06 (0.02–0.23) | 2/36 | 0.06 (0.02–0.23) | 5/31.3 | 0.03 (0.01–0.12) |
Varying denominators are a result of varying numbers of eyes ‘at risk’. As the unit of analysis is per-eye, the correlation between paired eyes of the same patient was considered in the calculations of confidence intervals of prevalence and incidence by using generalized estimating equations (GEE).
AC, anterior chamber; NA, not applicable; VA, visual acuity; SD, standard deviation; CME, cystoid macular edema; IMT, immunomodulatory therapy. NA, confidence interval not available (no events).