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ORLANDO – Higher vedolizumab levels during induction were associated with better responses to therapy at 22 weeks in patients with inflammatory bowel diseases in a prospective cohort study.
The findings suggest that therapeutic drug monitoring and early optimization could play an important role in improving outcomes in patients with Crohn’s disease or ulcerative colitis who are receiving treatment with the monoclonal antibody, Andres J. Yarur, MD, reported in a poster at the World Congress of Gastroenterology at ACG 2017.
Patients with a VTL of 24 mcg/mL or greater at week 2, and 10.6 mcg/mL or greater at week 6, were more likely to be in remission at week 22 (odds ratios, 5 and 13.5, respectively).
Of note, VTLs were numerically higher in patients receiving combination therapy, compared with those receiving vedolizumab monotherapy, but the difference was statistically significant only at week 2 (24.7 vs. 21.8 mcg/mL, respectively), he said.
Similar correlations between trough levels and response rates have been seen with other biologics, but data on such correlations has been lacking for vedolizumab. Since some patients develop primary or secondary nonresponse, Dr. Yarur and his colleagues assessed the relationship between serum VTLs during induction and disease remission after 22 weeks, he explained in an interview.
They also investigated the presence of antibodies to vedolizumab .
The primary outcome of deep remission at 22 weeks was defined as normal C-reactive protein levels and Simple Endoscopic Score for Crohn’s Disease of 2 or less in patients with Crohn’s disease, and Mayo Endoscopic score of 1 or less in patients with ulcerative colitis, plus clinical remission (Harvey-Bradshaw Index score of less than 5 in patients with Crohn’s disease and Mayo Clinical Score of less than 3 in ulcerative colitis).
Three patients developed antibodies to vedolizumab during induction, but the antibodies were undetectable by week 14 in all three, he said.
“The findings open the question of whether higher doses during induction will improve the rate of remission,” he said, noting that such early optimization is currently being evaluated in ongoing studies.
Dr. Yarur reported having no relevant disclosures.
ORLANDO – Higher vedolizumab levels during induction were associated with better responses to therapy at 22 weeks in patients with inflammatory bowel diseases in a prospective cohort study.
The findings suggest that therapeutic drug monitoring and early optimization could play an important role in improving outcomes in patients with Crohn’s disease or ulcerative colitis who are receiving treatment with the monoclonal antibody, Andres J. Yarur, MD, reported in a poster at the World Congress of Gastroenterology at ACG 2017.
Patients with a VTL of 24 mcg/mL or greater at week 2, and 10.6 mcg/mL or greater at week 6, were more likely to be in remission at week 22 (odds ratios, 5 and 13.5, respectively).
Of note, VTLs were numerically higher in patients receiving combination therapy, compared with those receiving vedolizumab monotherapy, but the difference was statistically significant only at week 2 (24.7 vs. 21.8 mcg/mL, respectively), he said.
Similar correlations between trough levels and response rates have been seen with other biologics, but data on such correlations has been lacking for vedolizumab. Since some patients develop primary or secondary nonresponse, Dr. Yarur and his colleagues assessed the relationship between serum VTLs during induction and disease remission after 22 weeks, he explained in an interview.
They also investigated the presence of antibodies to vedolizumab .
The primary outcome of deep remission at 22 weeks was defined as normal C-reactive protein levels and Simple Endoscopic Score for Crohn’s Disease of 2 or less in patients with Crohn’s disease, and Mayo Endoscopic score of 1 or less in patients with ulcerative colitis, plus clinical remission (Harvey-Bradshaw Index score of less than 5 in patients with Crohn’s disease and Mayo Clinical Score of less than 3 in ulcerative colitis).
Three patients developed antibodies to vedolizumab during induction, but the antibodies were undetectable by week 14 in all three, he said.
“The findings open the question of whether higher doses during induction will improve the rate of remission,” he said, noting that such early optimization is currently being evaluated in ongoing studies.
Dr. Yarur reported having no relevant disclosures.
ORLANDO – Higher vedolizumab levels during induction were associated with better responses to therapy at 22 weeks in patients with inflammatory bowel diseases in a prospective cohort study.
The findings suggest that therapeutic drug monitoring and early optimization could play an important role in improving outcomes in patients with Crohn’s disease or ulcerative colitis who are receiving treatment with the monoclonal antibody, Andres J. Yarur, MD, reported in a poster at the World Congress of Gastroenterology at ACG 2017.
Patients with a VTL of 24 mcg/mL or greater at week 2, and 10.6 mcg/mL or greater at week 6, were more likely to be in remission at week 22 (odds ratios, 5 and 13.5, respectively).
Of note, VTLs were numerically higher in patients receiving combination therapy, compared with those receiving vedolizumab monotherapy, but the difference was statistically significant only at week 2 (24.7 vs. 21.8 mcg/mL, respectively), he said.
Similar correlations between trough levels and response rates have been seen with other biologics, but data on such correlations has been lacking for vedolizumab. Since some patients develop primary or secondary nonresponse, Dr. Yarur and his colleagues assessed the relationship between serum VTLs during induction and disease remission after 22 weeks, he explained in an interview.
They also investigated the presence of antibodies to vedolizumab .
The primary outcome of deep remission at 22 weeks was defined as normal C-reactive protein levels and Simple Endoscopic Score for Crohn’s Disease of 2 or less in patients with Crohn’s disease, and Mayo Endoscopic score of 1 or less in patients with ulcerative colitis, plus clinical remission (Harvey-Bradshaw Index score of less than 5 in patients with Crohn’s disease and Mayo Clinical Score of less than 3 in ulcerative colitis).
Three patients developed antibodies to vedolizumab during induction, but the antibodies were undetectable by week 14 in all three, he said.
“The findings open the question of whether higher doses during induction will improve the rate of remission,” he said, noting that such early optimization is currently being evaluated in ongoing studies.
Dr. Yarur reported having no relevant disclosures.
AT THE WORLD CONGRESS OF GASTROENTEROLOGY
Key clinical point:
Major finding: Vedolizumab trough levels at weeks 2 and 6 were higher among those who achieved remission at week 22, compared with those who did not (25 vs. 21.8 mcg/mL and 26.1 vs. 12.7 mcg/mL, respectively).
Data source: A prospective cohort study of 45 patients.
Disclosures: Dr. Yarur reported having no relevant disclosures.