REFILE-Vedolizumab response at week 14 predicts long-term outcome in UC patients

Last Updated: 2018-11-22

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By Reuters Staff

NEW YORK (Reuters Health) - Ulcerative colitis (UC) patients in remission at week 14 of vedolizumab therapy are more likely to be in remission at one year, a new post-hoc analysis of data from the GEMINI 1 study shows.

"These findings support the guidance that the full standard 3-dose induction course of vedolizumab must be completed before a final decision on clinical benefit is assessed at week 10 or 14, dependent on EU or US label," Dr. Brian Feagan of Robarts Research Institute at the University of Western Ontario in London and colleagues conclude in in Inflammatory Bowel Diseases, online October 24.

Vedolizumab is a humanized immunoglobulin G1 monoclonal antibody that prevents inflammation by blocking leukocytes from migrating into gut tissue, Dr. Feagan and his team explain.

They analyzed the phase 3 GEMINI 1 trial, which included a three-dose induction phase and maintenance phase, as well as a long-term safety study (GEMINI LTS) including patients who stopped treatment during the maintenance phase or completed a year of treatment.

At 14 weeks, 32.7% of the 620 patients on vedolizumab were in remission based on partial Mayo score (pMS), versus 20.1% of the placebo group, a significant difference. Based on rectal bleeding subscore (RBS), 47.3% and 28.9% were in clinical remission, respectively.

Among the patients who were in remission at 14 weeks, 66.5% of those in the vedolizumab group had sustained clinical remission through week 52 of the study versus 26.7% of the placebo group, based on pMS. Based on RBS, 56.7% and 20.9%, respectively, had sustained clinical remission. Both findings were significant.

Results were similar in tumor necrosis factor (TNF)-antagonist-naive and TNF-antagonist-failure patients.

"Compared with placebo, 35%-40% more patients receiving a full induction course of vedolizumab had sustained clinical remission after 52 weeks of therapy. This result was observed irrespective of TNF antagonist treatment history," Dr. Feagan and colleagues write. "Clinical remission at week 14 may therefore be a predictor for sustained clinical remission with vedolizumab."

Takeda Pharmaceuticals International in Zurich, the maker of vedolizumab, funded the study and post-hoc analysis.

SOURCE: https://bit.ly/2znHHNQ

Inflamm Bowel Dis 2018.