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Effectiveness and safety of vedolizumab for treatment of Crohn's disease: a systematic review and meta-analysis

View Article: PubMed Central - PubMed

ABSTRACT

Introduction: The aim of this systematic review (SR) and meta-analysis was to assess the efficacy and safety of vedolizumab in the treatment of Crohn's disease (CD).

Material and methods: A systematic literature search was conducted in Medline/PubMed, Embase and Cochrane Library until 25 January, 2015. Included studies were critically appraised according to the PRISMA protocol. Assessment in specified subgroups of CD patients and meta-analysis with Revman software were performed.

Results: Two randomized controlled trial (RCTs) were included in a meta-analysis for the induction phase of therapy: GEMINI II and GEMINI III. The clinical response was significantly higher for patients who received vedolizumab compared to placebo in the general population (risk benefit (RB) = 1.48; p = 0.0006) and in both analyzed subgroups: patients with previous failure of anti-TNFs treatment (RB = 1.51; p = 0.006) and patients naive to earlier anti-TNFs (RB = 1.41; p = 0.001). The clinical remission in the general population and subpopulation of TNF-antagonist naive patients was significantly higher for patients who received vedolizumab compared to placebo (RB = 1.77; p = 0.003; RB = 2.29; p = 0.0004; respectively). Meta-analysis for adverse events, serious adverse events (SAEs) and serious infections, revealed that vedolizumab was as safe as placebo in the induction phase of therapy.

Conclusions: The clinical response was significantly higher for patients who received vedolizumab in the general population and in both analyzed subgroups of patients. The clinical remission in the general population and subpopulation of TNF-antagonist naive patients was significantly higher for vedolizumab, but no significant differences were revealed in the subgroup of patients with previous TNF antagonist failure.

No MeSH data available.


Forest plot of meta-analysis for vedolizumab vs. placebo of response to treatment A) in the general population (ITT analysis) at week 6, B) in the subpopulation of patients who reported no response and/or poor tolerance of the prior treatment with TNF antagonists at week 6, and C) in the TNF antagonist-naive subgroup at week 6
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Figure 0004: Forest plot of meta-analysis for vedolizumab vs. placebo of response to treatment A) in the general population (ITT analysis) at week 6, B) in the subpopulation of patients who reported no response and/or poor tolerance of the prior treatment with TNF antagonists at week 6, and C) in the TNF antagonist-naive subgroup at week 6

Mentions: Clinical response was defined as a ≥ 100-point decrease in the CDAI score from output values in both analyzed studies. In the general population the clinical response to vedolizumab was higher than in the placebo groups (Figure 4). The fixed-effect model was used for analysis of the clinical response because there was no evidence of significant heterogeneity when data from the studies were pooled. Results of the meta-analysis showed that clinical remission was significantly higher for patients who received vedolizumab as compared to control patients (Figure 4 A). The meta-analysis in subpopulations of patients revealed that clinical response was significantly higher for patients who received vedolizumab as compared to control patients in both subgroups: patients with previous failure of TNF antagonist treatment (Figure 4 B) and patients naive to earlier TNF antagonist treatment (Figure 4 C).


Effectiveness and safety of vedolizumab for treatment of Crohn's disease: a systematic review and meta-analysis
Forest plot of meta-analysis for vedolizumab vs. placebo of response to treatment A) in the general population (ITT analysis) at week 6, B) in the subpopulation of patients who reported no response and/or poor tolerance of the prior treatment with TNF antagonists at week 6, and C) in the TNF antagonist-naive subgroup at week 6
© Copyright Policy - open-access
Related In: Results  -  Collection

License
Show All Figures
getmorefigures.php?uid=PMC5016590&req=5

Figure 0004: Forest plot of meta-analysis for vedolizumab vs. placebo of response to treatment A) in the general population (ITT analysis) at week 6, B) in the subpopulation of patients who reported no response and/or poor tolerance of the prior treatment with TNF antagonists at week 6, and C) in the TNF antagonist-naive subgroup at week 6
Mentions: Clinical response was defined as a ≥ 100-point decrease in the CDAI score from output values in both analyzed studies. In the general population the clinical response to vedolizumab was higher than in the placebo groups (Figure 4). The fixed-effect model was used for analysis of the clinical response because there was no evidence of significant heterogeneity when data from the studies were pooled. Results of the meta-analysis showed that clinical remission was significantly higher for patients who received vedolizumab as compared to control patients (Figure 4 A). The meta-analysis in subpopulations of patients revealed that clinical response was significantly higher for patients who received vedolizumab as compared to control patients in both subgroups: patients with previous failure of TNF antagonist treatment (Figure 4 B) and patients naive to earlier TNF antagonist treatment (Figure 4 C).

View Article: PubMed Central - PubMed

ABSTRACT

Introduction: The aim of this systematic review (SR) and meta-analysis was to assess the efficacy and safety of vedolizumab in the treatment of Crohn's disease (CD).

Material and methods: A systematic literature search was conducted in Medline/PubMed, Embase and Cochrane Library until 25 January, 2015. Included studies were critically appraised according to the PRISMA protocol. Assessment in specified subgroups of CD patients and meta-analysis with Revman software were performed.

Results: Two randomized controlled trial (RCTs) were included in a meta-analysis for the induction phase of therapy: GEMINI II and GEMINI III. The clinical response was significantly higher for patients who received vedolizumab compared to placebo in the general population (risk benefit (RB) = 1.48; p = 0.0006) and in both analyzed subgroups: patients with previous failure of anti-TNFs treatment (RB = 1.51; p = 0.006) and patients naive to earlier anti-TNFs (RB = 1.41; p = 0.001). The clinical remission in the general population and subpopulation of TNF-antagonist naive patients was significantly higher for patients who received vedolizumab compared to placebo (RB = 1.77; p = 0.003; RB = 2.29; p = 0.0004; respectively). Meta-analysis for adverse events, serious adverse events (SAEs) and serious infections, revealed that vedolizumab was as safe as placebo in the induction phase of therapy.

Conclusions: The clinical response was significantly higher for patients who received vedolizumab in the general population and in both analyzed subgroups of patients. The clinical remission in the general population and subpopulation of TNF-antagonist naive patients was significantly higher for vedolizumab, but no significant differences were revealed in the subgroup of patients with previous TNF antagonist failure.

No MeSH data available.