Factors influencing the outcome of vedolizumab treatment: Real-life data with objective outcome measurements.

Mader, Orla; Juillerat, Pascal; Biedermann, Luc; Michetti, Pierre; Hruz, Petr; Pittet, Valerie; Rogler, Gerhard; Zahnd-Straumann, Nadine; Seibold, Frank (2021). Factors influencing the outcome of vedolizumab treatment: Real-life data with objective outcome measurements. United european gastroenterology journal, 9(3), pp. 398-406. Sage 10.1177/2050640620965106

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BACKGROUND

Vedolizumab (VDZ), a humanized monoclonal antibody against α4β7-integrin, has shown efficacy in inflammatory bowel disease (IBD). It is of importance to assess the mid- to long-term efficacy of VDZ using real-life data.

OBJECTIVE

Our study aimed to determine the efficacy of VDZ in patients with IBD with and without prior exposure to anti-tumour necrosis factor (TNF) treatments in a real-life setting. Furthermore, we investigated confounding factors influencing the remission to VDZ.

METHODS

Patients participating in the Swiss IBD Cohort Study were included in this study. Remission was defined as calprotectin <200 mg/kg stool and/or mucosal healing determined by endoscopy. End points were determined between months 4 and 8 (T1) and between months 12 and 16 (T2) after VDZ induction.

RESULTS

Remission was reported in 50.5% (110/218) of patients in T1 (48.7% Crohn's disease (CD) and 52.5% ulcerative colitis (UC)) and 46.8% (102/218) in T2 (47% CD and 46.5% UC). In UC patients, a significantly higher remission rate was achieved in T2 among anti-TNF-naive patients (57.7%) compared to anti-TNF-experienced patients (34.7%; p = 0.02; odds ratio=0.39, 95% confidence interval 0.17-0.87). In patients with CD, no difference could be seen in either evaluation intervals. Multivariable analysis showed that disease duration significantly influenced remission rates among UC patients. A late response to VDZ therapy with an achievement of remission in T2 was seen in a fifth of all patients (CD 21.7%, UC 20.8%). VDZ treatment was stopped in a third of all patients (31.8%) due to non-response, adverse events or aggravation of extra-intestinal manifestations.

CONCLUSION

In a real-life national cohort setting, VDZ induced remission in more than half of IBD patients. Previous treatment with anti-TNF agents was associated with a significant lower efficacy of VDZ in UC but not in CD patients.

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