TY - JOUR
T1 - Early Intervention with Vedolizumab and Longer-term Surgery Rates in Crohn's Disease
T2 - Post Hoc Analysis of the GEMINI Phase 3 and Long-term Safety Programmes
AU - Dulai, Parambir S.
AU - Peyrin-Biroulet, Laurent
AU - Demuth, Dirk
AU - Lasch, Karen
AU - Hahn, Kristen A.
AU - Lindner, Dirk
AU - Patel, Haridarshan
AU - Jairath, Vipul
N1 - Funding Information:
This work was supported by Takeda Pharmaceuticals, Inc. Takeda analysed the data, and together with all authors jointly interpreted the results. Medical writing support was provided by Rezan Sahinkaya, PhD, of ProEd Communications, Inc., and funded by Takeda. PSD is supported by an American Gastroenterology Association Research Scholar Award.
Publisher Copyright:
© 2020 The Author(s).
PY - 2021/2/1
Y1 - 2021/2/1
N2 - Background: Crohn's disease [CD] is a chronic inflammatory bowel disease that, with progression, may require surgical intervention. Aim: To determine whether vedolizumab treatment of CD earlier in the disease course [≤2 or ≤5 years of disease duration] influences risk of CD-related surgery after accounting for probability of response. Methods: Post hoc analyses of data from CD patients treated with vedolizumab in the GEMINI 2, GEMINI 3, and GEMINI LTS trials [N = 1253] evaluated CD-related surgery [bowel resection or colectomy] with stratification by probability of response to vedolizumab [low/intermediate or high]. Analyses used a previously validated clinical decision support tool and both logistic regression and Cox proportional hazard analyses. Results: In total, 113 [9.0%] vedolizumab-treated patients required CD-related surgery. Surgical rates were 6.1% and 9.8% for the high and low/intermediate probability of response groups, respectively. Risk of surgery was lower for patients with a high probability of response versus those with a low/intermediate probability of response (hazard ratio [HR] 0.50, 95% confidence interval [CI] 0.29 to 0.85). For patients with a low/intermediate probability of vedolizumab response, there was a consistent trend for association between earlier treatment [≤2 or ≤5 years since diagnosis] and a lower risk of surgery relative to later treatment (≤2 years versus >2 years: odds ratio [OR] 0.77, 95% CI 0.38 to 1.58; ≤5 years versus >5 years: OR 0.61, 95% CI 0.37 to 1.00]. Conclusions: Earlier intervention with vedolizumab may be associated with lower rates of surgery. Use of the clinical decision support tool may help identify patients most likely to benefit from earlier intervention with vedolizumab.
AB - Background: Crohn's disease [CD] is a chronic inflammatory bowel disease that, with progression, may require surgical intervention. Aim: To determine whether vedolizumab treatment of CD earlier in the disease course [≤2 or ≤5 years of disease duration] influences risk of CD-related surgery after accounting for probability of response. Methods: Post hoc analyses of data from CD patients treated with vedolizumab in the GEMINI 2, GEMINI 3, and GEMINI LTS trials [N = 1253] evaluated CD-related surgery [bowel resection or colectomy] with stratification by probability of response to vedolizumab [low/intermediate or high]. Analyses used a previously validated clinical decision support tool and both logistic regression and Cox proportional hazard analyses. Results: In total, 113 [9.0%] vedolizumab-treated patients required CD-related surgery. Surgical rates were 6.1% and 9.8% for the high and low/intermediate probability of response groups, respectively. Risk of surgery was lower for patients with a high probability of response versus those with a low/intermediate probability of response (hazard ratio [HR] 0.50, 95% confidence interval [CI] 0.29 to 0.85). For patients with a low/intermediate probability of vedolizumab response, there was a consistent trend for association between earlier treatment [≤2 or ≤5 years since diagnosis] and a lower risk of surgery relative to later treatment (≤2 years versus >2 years: odds ratio [OR] 0.77, 95% CI 0.38 to 1.58; ≤5 years versus >5 years: OR 0.61, 95% CI 0.37 to 1.00]. Conclusions: Earlier intervention with vedolizumab may be associated with lower rates of surgery. Use of the clinical decision support tool may help identify patients most likely to benefit from earlier intervention with vedolizumab.
KW - Crohn's disease
KW - therapy
KW - vedolizumab
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U2 - 10.1093/ecco-jcc/jjaa153
DO - 10.1093/ecco-jcc/jjaa153
M3 - Article
C2 - 32691844
AN - SCOPUS:85104634206
SN - 1873-9946
VL - 15
SP - 195
EP - 202
JO - Journal of Crohn's and Colitis
JF - Journal of Crohn's and Colitis
IS - 2
ER -