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. 2018 Aug 1;2018(8):CD006097. doi: 10.1002/14651858.CD006097.pub3

Comparison 4. Three infusions of natalizumab (300 mg) versus placebo.

Outcome or subgroup title No. of studies No. of participants Statistical method Effect size
1 Failure to induce remission at 10 weeks 1 905 Risk Ratio (M‐H, Fixed, 95% CI) 0.91 [0.81, 1.01]
2 Failure to induce remission at 12 weeks 2 1414 Risk Ratio (M‐H, Fixed, 95% CI) 0.85 [0.78, 0.92]
3 Failure to induce clinical response at 10 weeks 1 905 Risk Ratio (M‐H, Fixed, 95% CI) 0.85 [0.72, 1.00]
4 Failure to induce clinical response at 12 weeks 2 1414 Risk Ratio (M‐H, Fixed, 95% CI) 0.76 [0.67, 0.86]
5 Change in CDAI from baseline to 12 weeks 1 507 Mean Difference (IV, Fixed, 95% CI) ‐49.60 [‐67.35, ‐31.85]
6 Adverse events up to week 12 2 1415 Risk Ratio (M‐H, Fixed, 95% CI) 1.03 [0.98, 1.08]
7 Withdrawal due to adverse event 2 1415 Risk Ratio (M‐H, Fixed, 95% CI) 0.86 [0.59, 1.26]
8 Serious adverse events 2 1414 Risk Ratio (M‐H, Random, 95% CI) 0.76 [0.37, 1.56]
9 Failure to induce remission at 10 weeks (post hoc subgroup analyses) 1   Risk Ratio (M‐H, Fixed, 95% CI) Subtotals only
9.1 Patients with elevated CRP at baseline 1 660 Risk Ratio (M‐H, Fixed, 95% CI) 0.83 [0.73, 0.94]
9.2 Concurrent use of immunosuppressants 1 300 Risk Ratio (M‐H, Fixed, 95% CI) 0.80 [0.67, 0.96]
9.3 Previous use of anti‐TNF therapy 1 358 Risk Ratio (M‐H, Fixed, 95% CI) 0.85 [0.73, 0.98]
10 Failure to induce remission at 12 weeks (post hoc subgroup analyses) 1   Risk Ratio (M‐H, Fixed, 95% CI) Subtotals only
10.1 Patients with elevated CRP at baseline 1 660 Risk Ratio (M‐H, Fixed, 95% CI) 0.81 [0.71, 0.92]
10.2 Concurrent use of immunosuppressants 1 300 Risk Ratio (M‐H, Fixed, 95% CI) 0.79 [0.65, 0.96]
10.3 Previous use of anti‐TNF therapy 1 358 Risk Ratio (M‐H, Fixed, 95% CI) 0.85 [0.73, 0.98]
11 Failure to induce clinical response at 10 weeks (post hoc subgroup analyses) 1   Risk Ratio (M‐H, Fixed, 95% CI) Subtotals only
11.1 Patients with elevated CRP at baseline 1 660 Risk Ratio (M‐H, Fixed, 95% CI) 0.76 [0.63, 0.91]
11.2 Concurrent use of immunosuppressants 1 300 Risk Ratio (M‐H, Fixed, 95% CI) 0.67 [0.51, 0.89]
11.3 Previous use of anti‐TNF therapy 1 358 Risk Ratio (M‐H, Fixed, 95% CI) 0.68 [0.55, 0.84]
12 Failure to induce clinical response at 12 weeks (post hoc subgroup analyses) 1   Risk Ratio (M‐H, Fixed, 95% CI) Subtotals only
12.1 Patients with elevated CRP at baseline 1 660 Risk Ratio (M‐H, Fixed, 95% CI) 0.71 [0.58, 0.86]
12.2 Concurrent use of immunosuppressants 1 300 Risk Ratio (M‐H, Fixed, 95% CI) 0.68 [0.51, 0.91]
12.3 Previous use of anti‐TNF therapy 1 358 Risk Ratio (M‐H, Fixed, 95% CI) 0.67 [0.53, 0.83]