Table 2.
Efficacy and Safety results by individual study.
| Foster | VISUAL I | VISUAL II | |
|---|---|---|---|
| Anti-TNF Placebo | Anti-TNF Placebo | Anti-TNF Placebo | |
| Risk of not worsening BCVA risk ratio (95% CI) | 0.90 (0.69−1.18) | 1.75 (1.32, 2.32) | 1.31 (1.12, 1.53) |
| Mean change in anterior chamber cell grade MD (95%CI) | N.S. | −0.29 (−0.51, −0.07) | −0.14 (−0.37, 0.08) |
| Mean change in vitreous haze grade (mean between group difference, 95%CI) | N.S. | −0.27 (−0.43, −0.11) | −0.13 (−0.28, 0.01) |
| Median time to OCT evidence of CME on or after week 6 (months) | N.S. | 11.1a 6.2b | N.S. |
| Change in VFQ-25 total score | N.S. | 4.20 (1.02, 7.38) | 2.12 (−0.84, 5.08) |
| Serious infections (rate ratio and 95%CI) | N.S. | 1.18 (0.42, 3.27) | 1.14 (0.23, 5.68) |
| TB (active and latent) (risk ratio and 95% CI) | N.S. | 5.04 (0.24, 103.90) | 2.97 (0.31, 28.17) |
| Injection-site events (rate ratio and 95%CI) | N.S. | 2.84 (1.60, 5.05) | 1.69 (1.00, 2.84) |
| Number of patients with anti-drug antibodies (risk ratio and 95% CI) | N.S. | 7.06 (0.37, 135.16) | 14.87 (0.86, 257) |
| Allergic adverse events (rate ratio and 95%CI) | N.S. | 1.65 (0.84, 3.23) | 0.47 (0.17, 1.31) |
| Adverse events (rate ratio and 95%CI) | 1.50 (0.60, 3.74)c | 1.08 (0.99, 1.18) | 0.97 (0.89, 1.06) |
| Serious adverse events (rate ratio and 95%CI) | N.S. | 2.12 (1.11, 4.04) | 0.98 (0.47, 2.06) |
| Adverse events leading to death (rate ratio and 95%CI) | 1.00 (0.02, 46.05)c | 3.20 (0.13, 76,58) | 4.20 (0.19, 91.13) |
| Events of lupus or lupus-like events (rate ratio and 95%CI) | N.S. | 3.00 (0.12, 73.21) | 1.00 (0.02, 50.40) |
| Events of demyelination (rate ratio and 95%CI) | N.S. | 3.00 (0.12, 73.21) | 1.00 (0.02, 50.40) |
| Events of cancer (rate ratio and 95%CI) | N.S. | 6.40 (0.33, 125.89) | 2.20 (0.08–62.81) |
| Total number of withdrawals (risk ratio and 95% CI) | 5.00 (0.27, 92.62) | 2.59 (1.13, 5.97) | 0.87 (0.44, 1.69) |
| Withdrawals due to adverse events (risk ratio and 95% CI) | 5.00 (0.27, 92.62) | 3.36 (0.95, 11.90) | 1.42 (0.56, 3.59) |
| Withdrawals due to lost to follow-up (risk ratio and 95% CI) | 1.00 (0.02, 46.05) | 9.08 (0.49, 166.69) | 0.14 (0.01, 2.71) |
| Withdrawals by patient (risk ratio and 95% CI) | 1.00 (0.02, 46.05) | 5.04 (0.24, 103.90) | 0.66 (0.11, 3.88) |
| Withdrawals for other reasons (risk ratio and 95% CI) | 1.00 (0.02, 46.05) | 1.68 (0.41, 6.87) | 0.66 (0.11, 3.88) |
| Withdrawal due to lack of efficacy (risk ratio and 95% CI) | 1.00 (0.02, 46.05) | 0.50 (0.05, 5.48) | 0.14 (0.01, 2.71) |
BCVA, best corrected visual acuity; CI, confidence interval; TNF, tumor necrosis factor; N.S., non-stated; OCT, optical coherence tomography; CME, cystoid macular edema; VFQ, visual function questionnaire; TB, tuberculosis; MD, mean difference.
a
evaluated in 55 patients (CME was included only for patients who did not have CME at baseline).
b
evaluated in 45 patients (CME was included only for patients who did not have CME at baseline).
c
calculated as risk ratio.