Etrolizumab for induction of remission in ulcerative colitis

Greg Rosenfeld; Claire E Parker; John K MacDonald; Brian Bressler

doi:10.1002/14651858.CD011661.pub2

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Figure 1

Study flow diagram.

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Figure 2

Risk of bias summary: review authors' judgements about each risk of bias item for each included study.

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Analysis 1.1

Comparison 1 Etrolizumab versus placebo, Outcome 1 Failure to enter clinical remission at week 6.

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Analysis 1.2

Comparison 1 Etrolizumab versus placebo, Outcome 2 Failure to enter clinical remission at week 10 (Phase 1 study).

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Analysis 1.3

Comparison 1 Etrolizumab versus placebo, Outcome 3 Failure to enter clinical remission at week 10.

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Analysis 1.4

Comparison 1 Etrolizumab versus placebo, Outcome 4 Failure to respond at week 6.

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Analysis 1.5

Comparison 1 Etrolizumab versus placebo, Outcome 5 Failure to respond at week 10 (Phase 1 study).

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Analysis 1.6

Comparison 1 Etrolizumab versus placebo, Outcome 6 Failure to respond at week 10.

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Analysis 1.7

Comparison 1 Etrolizumab versus placebo, Outcome 7 Failure to enter endoscopic remission at week 6.

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Analysis 1.8

Comparison 1 Etrolizumab versus placebo, Outcome 8 Failure to enter endoscopic remission at week 10.

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Analysis 1.9

Comparison 1 Etrolizumab versus placebo, Outcome 9 Adverse events.

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Analysis 1.10

Comparison 1 Etrolizumab versus placebo, Outcome 10 Serious adverse events.

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Analysis 1.11

Comparison 1 Etrolizumab versus placebo, Outcome 11 Withdrawal due to adverse events.

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Summary of findings for the main comparison. Etrolizumab versus placebo for induction of remission in ulcerative colitis

Etrolizumab versus placebo for induction of remission in ulcerative colitis
Patient or population: patients with induction of remission in ulcerative colitis Settings: Intervention: Etrolizumab versus placebo
Outcomes	*Illustrative comparative risks (95% CI)**		Relative effect (95% CI)	No of Participants (studies)	Quality of the evidence (GRADE)	Comments
	Assumed risk	Corresponding risk
	Control	Etrolizumab versus placebo
Failure to enter clinical remission at week 10	1000 per 1000¹	860 per 1000 (770 to 950)	RR 0.86 (0.77 to 0.95)	119 (1 study)	⊕⊕⊕⊝ moderate²
Failure to enter clinical remission at week 10 ‐ 100 mg	1000 per 1000¹	810 per 1000 (680 to 960)	RR 0.81 (0.68 to 0.96)	59 (1 study)	⊕⊕⊕⊝ moderate³
Failure to respond at week 10	707 per 1000¹	679 per 1000 (530 to 870)	RR 0.96 (0.75 to 1.23)	119 (1 study)	⊕⊕⊕⊝ moderate⁴
Failure to enter endoscopic remission at week 6	976 per 1000¹	956 per 1000 (878 to 1000)	RR 0.98 (0.9 to 1.06)	119 (1 study)	⊕⊕⊕⊝ moderate⁵
Failure to enter endoscopic remission at week 10	1000 per 1000¹	920 per 1000 (850 to 1000)	RR 0.92 (0.85 to 1)	119 (1 study)	⊕⊕⊕⊝ moderate⁶
Adverse events	721 per 1000¹	541 per 1000 (411 to 714)	RR 0.75 (0.57 to 0.99)	124 (1 study)	⊕⊕⊕⊝ moderate⁷
Serious adverse events	122 per 1000¹	113 per 1000 (44 to 287)	RR 0.92 (0.36 to 2.34)	165 (2 studies)	⊕⊕⊝⊝ low⁸
The basis for the assumed risk* (e.g. the median control group risk across studies) is provided in footnotes. The corresponding risk (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI). CI: Confidence interval; RR: Risk ratio;
GRADE Working Group grades of evidence High quality: Further research is very unlikely to change our confidence in the estimate of effect. Moderate quality: Further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate. Low quality: Further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate. Very low quality: We are very uncertain about the estimate.
¹ Control group risk estimates come from control arm of meta‐analysis, based on included trials. ² Downgraded one level due to sparse data (107 events). ³ Downgraded one level due to sparse data (51 events). ⁴ Downgraded one level due to sparse data (82 events). ⁵ Downgraded one level due to sparse data (114 events). ⁶ Downgraded one level due to sparse data (112 events). ⁷Downgraded one level due to sparse data (75 events). ⁸ Downgraded two levels due to very sparse data (20 events).

Summary of findings for the main comparison. Etrolizumab versus placebo for induction of remission in ulcerative colitis

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Comparison 1. Etrolizumab versus placebo

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Failure to enter clinical remission at week 6 Show forest plot	1	119	Risk Ratio (M‐H, Fixed, 95% CI)	0.96 [0.87, 1.06]

1.1 100 mg	1	59	Risk Ratio (M‐H, Fixed, 95% CI)	0.94 [0.82, 1.09]
1.2 300 mg	1	60	Risk Ratio (M‐H, Fixed, 95% CI)	0.97 [0.85, 1.11]
2 Failure to enter clinical remission at week 10 (Phase 1 study) Show forest plot	1	23	Risk Ratio (M‐H, Fixed, 95% CI)	1.04 [0.64, 1.69]

3 Failure to enter clinical remission at week 10 Show forest plot	1	119	Risk Ratio (M‐H, Fixed, 95% CI)	0.86 [0.77, 0.95]

3.1 100 mg	1	59	Risk Ratio (M‐H, Fixed, 95% CI)	0.81 [0.68, 0.96]
3.2 300 mg	1	60	Risk Ratio (M‐H, Fixed, 95% CI)	0.91 [0.80, 1.03]
4 Failure to respond at week 6 Show forest plot	1	119	Risk Ratio (M‐H, Fixed, 95% CI)	0.86 [0.64, 1.15]

4.1 100 mg	1	59	Risk Ratio (M‐H, Fixed, 95% CI)	0.79 [0.51, 1.23]
4.2 300 mg	1	60	Risk Ratio (M‐H, Fixed, 95% CI)	0.92 [0.62, 1.36]
5 Failure to respond at week 10 (Phase 1 study) Show forest plot	1	23	Risk Ratio (M‐H, Fixed, 95% CI)	1.67 [0.26, 10.82]

6 Failure to respond at week 10 Show forest plot	1	119	Risk Ratio (M‐H, Fixed, 95% CI)	0.96 [0.75, 1.23]

6.1 100 mg	1	59	Risk Ratio (M‐H, Fixed, 95% CI)	0.95 [0.66, 1.37]
6.2 300 mg	1	60	Risk Ratio (M‐H, Fixed, 95% CI)	0.97 [0.69, 1.36]
7 Failure to enter endoscopic remission at week 6 Show forest plot	1	119	Risk Ratio (M‐H, Fixed, 95% CI)	0.98 [0.90, 1.06]

7.1 100 mg	1	59	Risk Ratio (M‐H, Fixed, 95% CI)	0.93 [0.83, 1.05]
7.2 300 mg	1	60	Risk Ratio (M‐H, Fixed, 95% CI)	1.02 [0.92, 1.14]
8 Failure to enter endoscopic remission at week 10 Show forest plot	1	119	Risk Ratio (M‐H, Fixed, 95% CI)	0.92 [0.85, 1.00]

8.1 100 mg	1	59	Risk Ratio (M‐H, Fixed, 95% CI)	0.91 [0.80, 1.03]
8.2 300 mg	1	60	Risk Ratio (M‐H, Fixed, 95% CI)	0.93 [0.83, 1.05]
9 Adverse events Show forest plot	2		Risk Ratio (M‐H, Fixed, 95% CI)	Totals not selected

10 Serious adverse events Show forest plot	2	165	Risk Ratio (M‐H, Fixed, 95% CI)	0.92 [0.36, 2.34]

11 Withdrawal due to adverse events Show forest plot	2	165	Risk Ratio (M‐H, Fixed, 95% CI)	1.09 [0.26, 4.62]

Comparison 1. Etrolizumab versus placebo

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