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* = Presenting author

P301 Vedolizumab for induction of remission in Crohn's disease in adults, a systematic review and meta-analysis

M.C.W. Lam, N. Fu, B. Bressler, G. Rosenfeld*

ECCOJC jju027 P301 F0001

 

 

University of British Columbia, Gastroenterology, Vancouver, Canada

Background

Vedolizumab (VDZ) is a humanized monoclonal IgG1, specific to the alpha4beta7 integrin. Several studies have evaluated the efficacy of VDZ in Crohn's disease (CD). We systematically reviewed and analyzed published clinical trial data assessing the efficacy VDZ for the induction of remission and clinical response in moderate to severe CD in adults.

Methods

Electronic bibliographic databases of the Cochrane Central Register of Controlled Trials (CENTRAL)(1991 to October 2014), MEDLINE (1946 to 11/26/2014), EMBASE (1974 to 11/26/2014), International Pharmaceutical Abstracts (IPA)(1970 to 11/26/2014), BIOSIS Previews (1969 to 2008), PubMed, clinicaltrials.gov, and Drugs@FDA (http://www.accessdata.fda.gov) was searched. MeSH terms Entyvio, LDP 02, LDP-02, LDP02, MLN0002, MLN02, UNII-9RV78Q2002 were used for VDZ. Hand searches of abstracts from scientific proceedings and reference lists of primary articles were also performed.

Controlled trials of VDZ in treatment of moderate to severe CD were selected for review. Two independent reviewers (ML and NF) evaluated article titles and abstracts to determine the need for detailed review and eligibility for inclusion. Disagreements were resolved by consensus or majority vote with a third reviewer (GR). The review authors extracted data independently. Study bias was assessed using the Cochrane Risk of Bias tool.

The primary outcome was proportion of patients achieving induction of clinical remission within 8 weeks of therapy, defined as CDAI of < 150. The secondary outcome was proportion of patients achieving induction of clinical response within 8 weeks of therapy, defined as a drop of CDAI >100. Subgroup analysis based on anti-TNF-alpha exposure was performed to assess confounding. Adverse events (AE) and serious AE were also evaluated.

Results

A total of 668 studies were identified using the search strategy. Three studies involving 1716 participants were included in the final analysis. The risk ratio (RR) for induction of clinical remission and response was 1.75 (95% CI: 1.27, 2.42 ) and 1.42 (95%CI: 1.17, 1.73) respectively. Subgroup analysis of induction of remission and response in anti-TNF-alpha naïve was 2.03 (95% CI: 1.33, 3.08) and 1.36 (95%CI: 1.05, 1.76) respectively, and in anti-TNF-alpha experienced was 1.41 (95% CI: 0.84, 2.34) and 1.42 (95% CI: 0.85, 2.35) respectively. (Figure 1) The RRs of AE and serious AE were 1.01 and 1.06 respectively. Moderate heterogeneity among studies was due to different VDZ dosing and schedule.

Conclusion

Vedolizumab is effective for induction of remission and clinical response for patients with moderate to severe CD. Most benefit is seen in anti-TNF naïve patients.