Abstract
Objectives: We aimed to quantify the safety and effectiveness of vedolizumab (VDZ) when used for UC, and to identify predictors of response to treatment. Methods: Retrospective review (May 2014–December 2016) of VICTORY Consortium data. Adults with follow-up after starting VDZ for clinically active UC were included. Primary effectiveness outcomes were cumulative rates of clinical remission (resolution of all UC-related symptoms) and endoscopic remission (Mayo endoscopic sub-score 0). Key secondary effectiveness outcomes included cumulative rates of corticosteroid-free remission and deep remission (clinical remission and endoscopic remission). Cox proportional hazard analyses were used to identify independent predictors of treatment effectiveness. Non-response imputation (NRI) sensitivity analyses were performed for effectiveness outcomes. Key safety outcomes were rates of serious infection, serious adverse events, and colectomy. Results: We included 321 UC patients (71% prior TNFα antagonist exposure, median follow-up 10 months). The 12-month cumulative rates of clinical remission and endoscopic remission were 51% and 41%, respectively. Corresponding rates for corticosteroid-free remission and deep remission were 37% and 30%, respectively. Using NRI, 12-month rates were 20% (n = 64/321) for clinical remission, 17% (n = 35/203) for endoscopic remission, 15% (n = 30/195) for corticosteroid-free remission, and 14% (n = 28/203) for deep remission. A majority of the patients without adequate follow-up at 12 months who were deemed non-responders using NRI had already achieved clinical remission (n = 70) or a significant clinical response (n = 36) prior to 12 months. VDZ discontinuation prior to 12 months was observed in 91 patients, for lack of response (n = 56), need for surgery (n = 29), or adverse event (n = 6). On multivariable analyses, prior exposure to a TNFα antagonist was associated with a reduced probability of achieving clinical remission (HR 0.53, 95% CI 0.38–0.75) and endoscopic remission (HR 0.51, 95% CI 0.29–0.88). Serious adverse events and serious infections were reported in 6% and 4% of patients, respectively. Overall cumulative rates of colectomy over 12 months were 13%, with lower rates observed in patients naive to TNFα antagonist therapy (2%) than those who had been exposed to TNFα antagonists (19%). Conclusion: In this large real-world cohort we observed that VDZ was well tolerated and effective in achieving key clinical outcomes.
| Original language | English (US) |
|---|---|
| Pages (from-to) | 1345-1354 |
| Number of pages | 10 |
| Journal | American Journal of Gastroenterology |
| Volume | 113 |
| Issue number | 9 |
| DOIs | |
| State | Published - Sep 1 2018 |
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ASJC Scopus subject areas
- Hepatology
- Gastroenterology
Cite this
Vedolizumab for Ulcerative Colitis : Treatment Outcomes from the VICTORY Consortium. / Narula, Neeraj; Peerani, Farhad; Meserve, Joseph; Kochhar, Gursimran; Chaudrey, Khadija; Hartke, Justin; Chilukuri, Prianka; Koliani-Pace, Jenna; Winters, Adam; Katta, Leah; Shmidt, Eugenia; Hirten, Robert; Faleck, David; Parikh, Malav P.; Whitehead, Diana; Boland, Brigid S.; Singh, Siddharth; Sagi, Sashidhar Varma; Fischer, Monika; Chang, Shannon; Barocas, Morris; Luo, Michelle; Lasch, Karen; Bohm, Matthew; Lukin, Dana; Sultan, Keith; Swaminath, Arun; Hudesman, David; Gupta, Nitin; Shen, Bo; Kane, Sunanda; Loftus, Jr, Edward Vincent; Siegel, Corey A.; Sands, Bruce E.; Colombel, Jean Frederic; Sandborn, William J.; Dulai, Parambir S.
In: American Journal of Gastroenterology, Vol. 113, No. 9, 01.09.2018, p. 1345-1354.Research output: Contribution to journal › Article
}
TY - JOUR
T1 - Vedolizumab for Ulcerative Colitis
T2 - Treatment Outcomes from the VICTORY Consortium
AU - Narula, Neeraj
AU - Peerani, Farhad
AU - Meserve, Joseph
AU - Kochhar, Gursimran
AU - Chaudrey, Khadija
AU - Hartke, Justin
AU - Chilukuri, Prianka
AU - Koliani-Pace, Jenna
AU - Winters, Adam
AU - Katta, Leah
AU - Shmidt, Eugenia
AU - Hirten, Robert
AU - Faleck, David
AU - Parikh, Malav P.
AU - Whitehead, Diana
AU - Boland, Brigid S.
AU - Singh, Siddharth
AU - Sagi, Sashidhar Varma
AU - Fischer, Monika
AU - Chang, Shannon
AU - Barocas, Morris
AU - Luo, Michelle
AU - Lasch, Karen
AU - Bohm, Matthew
AU - Lukin, Dana
AU - Sultan, Keith
AU - Swaminath, Arun
AU - Hudesman, David
AU - Gupta, Nitin
AU - Shen, Bo
AU - Kane, Sunanda
AU - Loftus, Jr, Edward Vincent
AU - Siegel, Corey A.
AU - Sands, Bruce E.
AU - Colombel, Jean Frederic
AU - Sandborn, William J.
AU - Dulai, Parambir S.
PY - 2018/9/1
Y1 - 2018/9/1
N2 - Objectives: We aimed to quantify the safety and effectiveness of vedolizumab (VDZ) when used for UC, and to identify predictors of response to treatment. Methods: Retrospective review (May 2014–December 2016) of VICTORY Consortium data. Adults with follow-up after starting VDZ for clinically active UC were included. Primary effectiveness outcomes were cumulative rates of clinical remission (resolution of all UC-related symptoms) and endoscopic remission (Mayo endoscopic sub-score 0). Key secondary effectiveness outcomes included cumulative rates of corticosteroid-free remission and deep remission (clinical remission and endoscopic remission). Cox proportional hazard analyses were used to identify independent predictors of treatment effectiveness. Non-response imputation (NRI) sensitivity analyses were performed for effectiveness outcomes. Key safety outcomes were rates of serious infection, serious adverse events, and colectomy. Results: We included 321 UC patients (71% prior TNFα antagonist exposure, median follow-up 10 months). The 12-month cumulative rates of clinical remission and endoscopic remission were 51% and 41%, respectively. Corresponding rates for corticosteroid-free remission and deep remission were 37% and 30%, respectively. Using NRI, 12-month rates were 20% (n = 64/321) for clinical remission, 17% (n = 35/203) for endoscopic remission, 15% (n = 30/195) for corticosteroid-free remission, and 14% (n = 28/203) for deep remission. A majority of the patients without adequate follow-up at 12 months who were deemed non-responders using NRI had already achieved clinical remission (n = 70) or a significant clinical response (n = 36) prior to 12 months. VDZ discontinuation prior to 12 months was observed in 91 patients, for lack of response (n = 56), need for surgery (n = 29), or adverse event (n = 6). On multivariable analyses, prior exposure to a TNFα antagonist was associated with a reduced probability of achieving clinical remission (HR 0.53, 95% CI 0.38–0.75) and endoscopic remission (HR 0.51, 95% CI 0.29–0.88). Serious adverse events and serious infections were reported in 6% and 4% of patients, respectively. Overall cumulative rates of colectomy over 12 months were 13%, with lower rates observed in patients naive to TNFα antagonist therapy (2%) than those who had been exposed to TNFα antagonists (19%). Conclusion: In this large real-world cohort we observed that VDZ was well tolerated and effective in achieving key clinical outcomes.
AB - Objectives: We aimed to quantify the safety and effectiveness of vedolizumab (VDZ) when used for UC, and to identify predictors of response to treatment. Methods: Retrospective review (May 2014–December 2016) of VICTORY Consortium data. Adults with follow-up after starting VDZ for clinically active UC were included. Primary effectiveness outcomes were cumulative rates of clinical remission (resolution of all UC-related symptoms) and endoscopic remission (Mayo endoscopic sub-score 0). Key secondary effectiveness outcomes included cumulative rates of corticosteroid-free remission and deep remission (clinical remission and endoscopic remission). Cox proportional hazard analyses were used to identify independent predictors of treatment effectiveness. Non-response imputation (NRI) sensitivity analyses were performed for effectiveness outcomes. Key safety outcomes were rates of serious infection, serious adverse events, and colectomy. Results: We included 321 UC patients (71% prior TNFα antagonist exposure, median follow-up 10 months). The 12-month cumulative rates of clinical remission and endoscopic remission were 51% and 41%, respectively. Corresponding rates for corticosteroid-free remission and deep remission were 37% and 30%, respectively. Using NRI, 12-month rates were 20% (n = 64/321) for clinical remission, 17% (n = 35/203) for endoscopic remission, 15% (n = 30/195) for corticosteroid-free remission, and 14% (n = 28/203) for deep remission. A majority of the patients without adequate follow-up at 12 months who were deemed non-responders using NRI had already achieved clinical remission (n = 70) or a significant clinical response (n = 36) prior to 12 months. VDZ discontinuation prior to 12 months was observed in 91 patients, for lack of response (n = 56), need for surgery (n = 29), or adverse event (n = 6). On multivariable analyses, prior exposure to a TNFα antagonist was associated with a reduced probability of achieving clinical remission (HR 0.53, 95% CI 0.38–0.75) and endoscopic remission (HR 0.51, 95% CI 0.29–0.88). Serious adverse events and serious infections were reported in 6% and 4% of patients, respectively. Overall cumulative rates of colectomy over 12 months were 13%, with lower rates observed in patients naive to TNFα antagonist therapy (2%) than those who had been exposed to TNFα antagonists (19%). Conclusion: In this large real-world cohort we observed that VDZ was well tolerated and effective in achieving key clinical outcomes.
UR - http://www.scopus.com/inward/record.url?scp=85049104634&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85049104634&partnerID=8YFLogxK
U2 - 10.1038/s41395-018-0162-0
DO - 10.1038/s41395-018-0162-0
M3 - Article
C2 - 29946178
AN - SCOPUS:85049104634
VL - 113
SP - 1345
EP - 1354
JO - American Journal of Gastroenterology
JF - American Journal of Gastroenterology
SN - 0002-9270
IS - 9
ER -