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. 2019 Aug 29;2019(8):CD012893. doi: 10.1002/14651858.CD012893.pub2

Comparison 1. Certolizumab pegol versus placebo.

Outcome or subgroup title No. of studies No. of participants Statistical method Effect size
1 Clinical remission at week 8 4 1485 Risk Ratio (M‐H, Random, 95% CI) 1.36 [1.11, 1.66]
2 Clinical response at week 8 4 1485 Risk Ratio (M‐H, Random, 95% CI) 1.29 [1.09, 1.53]
3 CRP at week 8 (log‐scales of geometric mean CRP ratio between baseline and week 8) 4 1271 Mean Difference (IV, Random, 95% CI) ‐0.37 [‐0.49, ‐0.24]
4 IBDQ total score at week 8 (mean change from baseline) 4 1315 Mean Difference (IV, Random, 95% CI) 2.12 [‐1.27, 5.50]
5 Adverse events 4 1485 Risk Ratio (M‐H, Random, 95% CI) 1.03 [0.97, 1.10]
6 Serious adverse events 4 1485 Risk Ratio (M‐H, Random, 95% CI) 1.35 [0.93, 1.97]
7 Withdrawals due to adverse events 4 1485 Risk Ratio (M‐H, Random, 95% CI) 1.01 [0.57, 1.78]
8 Clinical remission at week 8 (Subgroup analysis based on CZP doses) 4   Risk Ratio (M‐H, Random, 95% CI) Subtotals only
8.1 Certolizumab pegol 100mg 1 99 Risk Ratio (M‐H, Random, 95% CI) 2.48 [0.81, 7.58]
8.2 Certolizumab pegol 200mg 2 142 Risk Ratio (M‐H, Random, 95% CI) 1.84 [0.75, 4.50]
8.3 Certolizumab pegol 400mg 4 1244 Risk Ratio (M‐H, Random, 95% CI) 1.30 [1.06, 1.60]
9 Clinical remission at week 8 (Subgroup analysis of no previous treatment with TNF‐α inhibitors) 1   Risk Ratio (M‐H, Random, 95% CI) Totals not selected
10 Clinical remission at week 8 (Subgroup analysis of CRP levels at baseline) 4   Risk Ratio (M‐H, Random, 95% CI) Subtotals only
10.1 CRP ≥ 10 mg/L 4 702 Risk Ratio (M‐H, Random, 95% CI) 1.59 [1.17, 2.16]
10.2 CRP < 10 mg/L 3 762 Risk Ratio (M‐H, Random, 95% CI) 1.15 [0.88, 1.50]
11 Clinical remission at week 8 (Sensitivity analysis of excluding studies with high risk of bias) 3 1193 Risk Ratio (M‐H, Random, 95% CI) 1.29 [1.05, 1.59]
12 Clinical remission at week 8 (sensitivity analysis of using available case data) 4 1463 Risk Ratio (M‐H, Random, 95% CI) 1.36 [1.11, 1.67]
13 Clinical remission at week 8 (Sensitivity analysis of studies with the approval dosing regimen) 3 1147 Risk Ratio (M‐H, Random, 95% CI) 1.28 [1.03, 1.57]