Table 2.
Analysis of primary and secondary outcomes.
| ATT group | Control group | Relative risk or Hazard ratio (95% CI) | p | |
|---|---|---|---|---|
| Primary outcomes | ||||
| As intention-to-treat population | ||||
| N | 37 | 39 | ||
| Complete uveitis resolution | 30 (81.1%) | 20 (51.3%) | 1.58 (1.12–2.23) | 0.0060 |
| As per-protocol population | ||||
| N | 33 | 30 | ||
| Complete uveitis resolution | 27 (81.8%) | 16 (53.3%) | 1.53 (1.06–2.22) | 0.0150 |
| Secondary outcomes (intention-to-treat analysis) | ||||
| Details of uveitis resolution | ||||
| Complete | 30 (81.1%) | 20 (51.3%) | – | 0.0040 |
| Partial | 0 (0%) | 8 (20.5%) | – | |
| Non-responsive | 7 (18.9%) | 11 (28.2%) | – | |
| Estimated mean time-to-any resolution (in months) | 3.6 (2.1–5.7) | 3.0 (1.8–4.2) | 0.96 (0.59–1.58) | 0.8888 |
| Incidence of uveitis relapse | 2/34 (5.9%) | 7/24 (29.2%) | 0.20 (0.05–0.89) | 0.0210 |
| Estimated mean time-to-uveitis relapse (in months) | 17.7 (16.1–19.4) | 14.3 (9.2–19.4) | 0.14 (0.03–0.69) | 0.0160 |
| Ocular outcomes | ||||
| Visual acuity changes | ||||
| Increase | 8 (14.5%) | 11 (18.3%) | – | 0.7550 |
| Stable | 33 (60.0%) | 32 (53.3%) | – | |
| Decrease | 14 (25.5%) | 17 (28.3%) | – | |
| Secondary glaucoma or increased intraocular pressure | 18 (32.7%) | 18 (30.0%) | 1.05 (0.61–1.81) | 0.7530 |
The last observation carried forward (LOCF) method was used to handle missing outcomes in both the intention-to-treat (ITT) and per-protocol analyses.