Subcutaneous vedolizumab dose intensification in inflammatory bowel disease patients: the OPTI-VEDO multicenter study from the GETAID.

Abstract

Background and aims: While this strategy is frequently used for other biologics, real-world evidence on subcutaneous (SC) vedolizumab (VDZ) dose intensification in inflammatory bowel disease (IBD) is lacking. This study aimed to assess the effectiveness and safety of SC VDZ intensification.

Methods: We conducted a retrospective study in 25 centers including all patients with active ulcerative colitis (UC) or Crohn's disease (CD) (defined by PRO2), and incomplete or loss of response to SC VDZ 108mg EOW when the drug was intensified. The primary outcome was steroid-free clinical response (SFCr) defined by at least 50% of PRO2 improvement, no treatment change, no surgery, and SC VDZ persistence at 3 months.

Results: Out the 154 included patients (66% UC, 34% CD), prior anti-TNF exposure was reported in 85% of CD and 50% of UC patients. SC VDZ was intensified for an incomplete response in 73% of CD and 53% of UC patients, mostly at 108mg weekly (95%). At 3 months, SFCr was achieved in 35% of CD and 43% of UC patients. In multivariate analysis, factors associated with response were secondary loss of response in CD, and prior anti-TNF exposure in UC. At 12 months, 51% of CD and 37% of UC patients maintained SC VDZ. Adverse events occurred in 10 patients including one severe pneumonia and one angioedema.

Conclusions: In this real-world study evaluating SC VDZ intensification, a SFCr was observed in at least one third of IBD patients at 3 months, suggesting the benefit of this strategy in clinical practice.