TY - JOUR
T1 - Entyvio lengthen dose-interval study
T2 - Lengthening vedolizumab dose interval and the risk of clinical relapse in inflammatory bowel disease
AU - Chan, Webber
AU - Lynch, Nicole
AU - Bampton, Peter
AU - Chang, Jeff
AU - Chung, Alvin
AU - Florin, Timothy
AU - Hetzel, David J.
AU - Jakobovits, Simon
AU - Moore, Gregory
AU - Pavli, Paul
AU - Radford-Smith, Graham
AU - Thin, Lena
AU - Baraty, Brandon
AU - Haifer, Craig
AU - Yau, Yunki
AU - Leong, Rupert W.L.
PY - 2018/7
Y1 - 2018/7
N2 - Background Vedolizumab (VDZ), an α4β7 anti-integrin antibody, is efficacious in the induction and maintenance of remission in ulcerative colitis (UC) and Crohn's disease (CD). In the GEMINI long-term safety study, enrolled patients received 4-weekly VDZ. Upon completion, patients were switched to 8-weekly VDZ in Australia. The clinical success rate of treatment de-escalation for patients in remission on VDZ has not been described previously. Aim To determine the proportion of patients who relapsed after switching from 4 to 8-weekly VDZ, the mean time to relapse, and the recapture rate when switching back to 8-weekly dosing. Materials and methods This was a retrospective, observational, multicenter study of patients previously recruited into GEMINI long-term safety in Australia. Data on the demographics and biochemical findings were collected. Results There were 34 patients [23 men, mean age 49.1 (±13.1) years] and their mean disease duration was 17.6 (±8.5) years. The mean 4-weekly VDZ infusion duration was 286.5 (±48.8) weeks. A total of five (15%) patients relapsed on dose-interval increase (4/17 UC, 1/17 CD) at a median duration from dose interval lengthening to flare of 14 weeks (interquartile range=6-25). Eighty percent (4/5) of patients re-entered remission following dose-interval decrease back to 4-weekly. No clinical predictors of relapse could be determined because of the small cohort size. Conclusion The risk of patients relapsing when switching from 4 to 8-weekly VDZ ∼15% and is similar between CD and UC. Dose-interval decrease recaptures 80% of patients who relapsed. Therapeutic drug monitoring of VDZ may be of clinical relevance.
AB - Background Vedolizumab (VDZ), an α4β7 anti-integrin antibody, is efficacious in the induction and maintenance of remission in ulcerative colitis (UC) and Crohn's disease (CD). In the GEMINI long-term safety study, enrolled patients received 4-weekly VDZ. Upon completion, patients were switched to 8-weekly VDZ in Australia. The clinical success rate of treatment de-escalation for patients in remission on VDZ has not been described previously. Aim To determine the proportion of patients who relapsed after switching from 4 to 8-weekly VDZ, the mean time to relapse, and the recapture rate when switching back to 8-weekly dosing. Materials and methods This was a retrospective, observational, multicenter study of patients previously recruited into GEMINI long-term safety in Australia. Data on the demographics and biochemical findings were collected. Results There were 34 patients [23 men, mean age 49.1 (±13.1) years] and their mean disease duration was 17.6 (±8.5) years. The mean 4-weekly VDZ infusion duration was 286.5 (±48.8) weeks. A total of five (15%) patients relapsed on dose-interval increase (4/17 UC, 1/17 CD) at a median duration from dose interval lengthening to flare of 14 weeks (interquartile range=6-25). Eighty percent (4/5) of patients re-entered remission following dose-interval decrease back to 4-weekly. No clinical predictors of relapse could be determined because of the small cohort size. Conclusion The risk of patients relapsing when switching from 4 to 8-weekly VDZ ∼15% and is similar between CD and UC. Dose-interval decrease recaptures 80% of patients who relapsed. Therapeutic drug monitoring of VDZ may be of clinical relevance.
KW - Crohn's disease
KW - inflammatory bowel disease
KW - relapse
KW - ulcerative colitis
KW - vedolizumab
UR - http://www.scopus.com/inward/record.url?scp=85048210017&partnerID=8YFLogxK
U2 - 10.1097/MEG.0000000000001150
DO - 10.1097/MEG.0000000000001150
M3 - Article
C2 - 29727386
AN - SCOPUS:85048210017
SN - 0954-691X
VL - 30
SP - 735
EP - 740
JO - European Journal of Gastroenterology and Hepatology
JF - European Journal of Gastroenterology and Hepatology
IS - 7
ER -