TY - JOUR
T1 - Vedolizumab as Induction and Maintenance for Inflammatory Bowel Disease
T2 - 12-month Effectiveness and Safety
AU - Christensen, Britt
AU - Colman, Ruben J.
AU - Micic, Dejan
AU - Gibson, Peter R.
AU - Goeppinger, Sarah R.
AU - Yarur, Andres
AU - Weber, Christopher R.
AU - Cohen, Russell D.
AU - Rubin, David T.
N1 - Funding Information: Conflicts of interest: David T. Rubin has received institutional grant support from Abbvie, Janssen, and Takeda and served as a consultant for Abbvie, Janssen, Takeda, Amgen, Pfizer, and UCB. Russell D. Cohen has received institutional grant support from Abbvie, Janssen, and Takeda and served as a consultant for Abbvie, Janssen, Takeda, and UCB. Peter R. Gibson has served as consultant or advisory board member for AbbVie, Ferring, Janssen, Merck, Nestle Health Science, Danone, Allergan, Celgene, and Takeda. His institution has received speaking honoraria from AbbVie, Janssen, Ferring, Takeda, Fresenius Kabi, Mylan, and Pfizer. He has received research grants for investigator-driven studies from AbbVie, Janssen, Falk Pharma, Danone, and A2 Milk Company. Britt Christensen has received travel grants from Takeda. Funding Information: Supported by: This work was funded in part by the Digestive Diseases Research Core Center and a National Institute of Health Grant (grant number P30DK42086). Britt Christensen receives support through an “Australian Government Research Training Program Scholarship.” This is an investigator-initiated study, and has no industry funding. Publisher Copyright: © 2018 Crohn's & Colitis Foundation. Published by Oxford University Press on behalf of Crohn's & Colitis Foundation.
PY - 2018/3/19
Y1 - 2018/3/19
N2 - Background Vedolizumab is approved for moderate to severe Crohn's disease (CD) and ulcerative colitis (UC). We present prospective, 1-year data of the real-world effectiveness and safety of vedolizumab in inflammatory bowel disease. Methods Consecutive patients receiving vedolizumab for treatment of UC or CD with at least 14 weeks of follow-up, regardless of outcome, were included. Patients had clinical activity scores (Harvey-Bradshaw Index [HBI] or Simple Clinical Colitis Activity Index [SCCAI]) and inflammatory markers prospectively measured at baseline and weeks 14, 30, and 52. Clinical response was defined as a reduction ≥3 in HBI or SCCAI, clinical remission as HBI ≤4 or SCCAI ≤2, steroid-free remission as clinical remission without the need for corticosteroids, and mucosal healing (assessed at 6 months) as a Mayo endoscopic subscore of 0 or 1 or CD-SES <3. Results A total of 132 patients were included: 61 (45%) male, 94 (71%) with CD, 42 (29%) with UC; 22% and 34% of CD and UC patients, respectively, achieved steroid-free remission by week 14. This increased to 31% in CD patients and plateaued at 35% in UC patients at 12 months. Increasing remission rates to 6 months were seen in patients with CD, but minimal improvements after 3 months of therapy occurred in those with UC. Mucosal healing was achieved in 52% of UC and 30% of CD patients. Most adverse events were minor; 74% remained on vedolizumab at 12 months. Conclusions In this real-world study, vedolizumab demonstrated similar efficacy and safety seen in pivotal trials, with sustained clinical response in the majority of patients. Similar rates of response were seen in UC and CD patients. 10.1093/ibd/izx067-video1 izx067-Video 5754037470001
AB - Background Vedolizumab is approved for moderate to severe Crohn's disease (CD) and ulcerative colitis (UC). We present prospective, 1-year data of the real-world effectiveness and safety of vedolizumab in inflammatory bowel disease. Methods Consecutive patients receiving vedolizumab for treatment of UC or CD with at least 14 weeks of follow-up, regardless of outcome, were included. Patients had clinical activity scores (Harvey-Bradshaw Index [HBI] or Simple Clinical Colitis Activity Index [SCCAI]) and inflammatory markers prospectively measured at baseline and weeks 14, 30, and 52. Clinical response was defined as a reduction ≥3 in HBI or SCCAI, clinical remission as HBI ≤4 or SCCAI ≤2, steroid-free remission as clinical remission without the need for corticosteroids, and mucosal healing (assessed at 6 months) as a Mayo endoscopic subscore of 0 or 1 or CD-SES <3. Results A total of 132 patients were included: 61 (45%) male, 94 (71%) with CD, 42 (29%) with UC; 22% and 34% of CD and UC patients, respectively, achieved steroid-free remission by week 14. This increased to 31% in CD patients and plateaued at 35% in UC patients at 12 months. Increasing remission rates to 6 months were seen in patients with CD, but minimal improvements after 3 months of therapy occurred in those with UC. Mucosal healing was achieved in 52% of UC and 30% of CD patients. Most adverse events were minor; 74% remained on vedolizumab at 12 months. Conclusions In this real-world study, vedolizumab demonstrated similar efficacy and safety seen in pivotal trials, with sustained clinical response in the majority of patients. Similar rates of response were seen in UC and CD patients. 10.1093/ibd/izx067-video1 izx067-Video 5754037470001
KW - alpha-4 integrin inhibitors
KW - biological therapy
KW - inflammatory bowel disease
KW - response to therapy
KW - vedolizumab
UR - http://www.scopus.com/inward/record.url?scp=85044472969&partnerID=8YFLogxK
U2 - https://doi.org/10.1093/ibd/izx067
DO - https://doi.org/10.1093/ibd/izx067
M3 - Article
C2 - 29562271
SN - 1078-0998
VL - 24
SP - 849
EP - 860
JO - Inflammatory Bowel Diseases
JF - Inflammatory Bowel Diseases
IS - 4
ER -