Table 3.
Safety results meta-analysis.
| Anti-TNF vs. Placebo | |||
|---|---|---|---|
| Foster | VISUAL I | VISUAL II | |
| Serious infections (rate ratio and 95%CI) | N.S. | 1.17 (0.49, 2.76) | |
| TB (active and latent) (risk ratio and 95% CI) | N.S. | 3.59 (0.59, 21.81) | |
| Injection-site events (rate ratio and 95%CI) | N.S. | 2.16 (1.29, 3.60) | |
| Number of patients with anti-drug antibodies (risk ratio and 95% CI) | N.S. | 10.38 (1.34, 80.69) | |
| Allergic adverse events (rate ratio and 95%CI) | N.S. | 0.94 (0.28, 3.19) | |
| Adverse events (rate ratio and 95%CI) | 1.50 (0.60, 3.74)a | 1.02 (0.92, 1.14) | |
| Serious adverse events (rate ratio and 95%CI) | N.S. | 1.47 (0.69, 3.13) | |
| Adverse events leading to death (rate ratio and 95%CI) | 1.00 (0.02, 46.05)a | 3.68 (0.40, 33.55) | |
| Events of lupus or lupus-like events (rate ratio and 95%CI) | N.S. | 1.94 (0.16, 23.02) | |
| Events of demyelination (rate ratio and 95%CI) | N.S. | 1.94 (0.16, 23.02) | |
| Events of cancer (rate ratio and 95%CI) | N.S. | 3.99 (0.43, 37.03) | |
| Total number of withdrawals (risk ratio and 95% CI) | 1.63 (0.62, 4.26) | ||
| Withdrawals due to adverse events (risk ratio and 95% CI) | 2.04 (0.99, 4.21) | ||
| Withdrawals due to lost to follow-up (risk ratio and 95% CI) | 1.00 (0.02, 46.05) | 1.14 (0.02, 67.56) | |
| Withdrawals by patient (risk ratio and 95% CI) | 1.00 (0.02, 46.05) | 1.25 (0.19, 8.18) | |
| Withdrawals for other reasons (risk ratio and 95% CI) | 1.00 (0.02, 46.05) | 1.17 (0.39, 3.52) | |
| Withdrawal due to lack of efficacy (risk ratio and 95% CI) | 1.00 (0.02, 46.05) | 0.31 (0.05, 1.95) | |
BCVA, best corrected visual acuity; CI, confidence interval; TNF, tumor necrosis factor; N.S., non-available; OCT, optical coherence tomography; CME, cystoid macular edema; VFQ, visual function questionnaire; TB, tuberculosis;
a
calculated as risk ratio.