TY - JOUR
T1 - Vedolizumab Dose Escalation Improves Therapeutic Response in a Subset of Patients with Ulcerative Colitis
AU - Perry, Courtney
AU - Fischer, Kyle
AU - Elmoursi, Ahmed
AU - Kern, Cody
AU - Currier, Alden
AU - Kudaravalli, Praneeth
AU - Akanbi, Olalekan
AU - Tripathi, Nishant
AU - Yarra, Pradeep
AU - Su, Leon
AU - Flomenhoft, Deborah
AU - Stromberg, Arnold
AU - Barrett, Terrence A.
N1 - Publisher Copyright:
© 2020, Springer Science+Business Media, LLC, part of Springer Nature.
PY - 2021/6
Y1 - 2021/6
N2 - Background: The Gemini trial failed to detect a significant difference in response rate for patients with ulcerative colitis (UC) randomized to standard (every 8 week) vedolizumab dosing vs escalated (every 4 week) dosing. Subsequent real-world data imply the Gemini trial design may have obscured a benefit of escalated dosing. Aims: We investigated outcomes after vedolizumab dose escalation for patients with UC. We also explored potential clinical predictors of dose escalation requirement. Methods: In this retrospective study, we included patients with UC who received vedolizumab between 1/2017-1/2019. We compared rates of clinical response (decrease in partial Mayo score by ≥ 2) and remission (partial Mayo < 2) for standard vs escalated dosing. Results: Among the 90 patients reviewed, 52 achieved and maintained remission on standard dosing. The average time to remission with standard dosing was 33.3 ± 6.6 weeks. After an average of 56.3 ± 7.4 weeks standard dosing, 24 patients (22 “partial responders” and 2 “non-responders”) were dose-escalated. Of the 22 “partial responders” dose-escalated, 10 (45%) achieved remission, 10 (45%) achieved further improvement. Neither “non-responder” demonstrated further clinical benefit. Prior anti-tumor necrosis factor (anti-TNF) biologic exposure predicted dose escalation requirement (p = 0.008). Patients requiring dose escalation had more severe disease at baseline as measured by both full Mayo (p = 0.009) and partial Mayo scores (p = 0.01). Conclusions: We show dose escalation benefited patients with UC who exhibit a “partial response” to standard dosing. Early vedolizumab dose escalation should be considered in both patients with severe disease and those with prior anti-TNF experience.
AB - Background: The Gemini trial failed to detect a significant difference in response rate for patients with ulcerative colitis (UC) randomized to standard (every 8 week) vedolizumab dosing vs escalated (every 4 week) dosing. Subsequent real-world data imply the Gemini trial design may have obscured a benefit of escalated dosing. Aims: We investigated outcomes after vedolizumab dose escalation for patients with UC. We also explored potential clinical predictors of dose escalation requirement. Methods: In this retrospective study, we included patients with UC who received vedolizumab between 1/2017-1/2019. We compared rates of clinical response (decrease in partial Mayo score by ≥ 2) and remission (partial Mayo < 2) for standard vs escalated dosing. Results: Among the 90 patients reviewed, 52 achieved and maintained remission on standard dosing. The average time to remission with standard dosing was 33.3 ± 6.6 weeks. After an average of 56.3 ± 7.4 weeks standard dosing, 24 patients (22 “partial responders” and 2 “non-responders”) were dose-escalated. Of the 22 “partial responders” dose-escalated, 10 (45%) achieved remission, 10 (45%) achieved further improvement. Neither “non-responder” demonstrated further clinical benefit. Prior anti-tumor necrosis factor (anti-TNF) biologic exposure predicted dose escalation requirement (p = 0.008). Patients requiring dose escalation had more severe disease at baseline as measured by both full Mayo (p = 0.009) and partial Mayo scores (p = 0.01). Conclusions: We show dose escalation benefited patients with UC who exhibit a “partial response” to standard dosing. Early vedolizumab dose escalation should be considered in both patients with severe disease and those with prior anti-TNF experience.
KW - Symptoms
KW - Therapeutic index
KW - Ulcerative colitis
KW - Vedolizumab
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U2 - 10.1007/s10620-020-06486-x
DO - 10.1007/s10620-020-06486-x
M3 - Article
C2 - 32710192
AN - SCOPUS:85088402051
SN - 0163-2116
VL - 66
SP - 2051
EP - 2058
JO - Digestive Diseases and Sciences
JF - Digestive Diseases and Sciences
IS - 6
ER -