Colon to Rectum
J Crohns Colitis. 2025;19(10):jjaf175
Switching to subcutaneous administration may offer more profound remission compared to intensified intravenous therapy in patients with inflammatory bowel disease and partial response following induction with intravenous vedolizumab: The PRIVEDO study
Background and aims: The optimal management of inflammatory bowel disease (IBD) patients with a partial response after intravenous (IV) vedolizumab (VDZ) induction remains unclear.
Methods: PRIVEDO was an observational, non-randomized, open-label, prospective cohort study conducted within the Sicilian Network for IBD. It compared subcutaneous (SC) VDZ (108 mg every 2 weeks) versus intensified IV VDZ (300 mg every 4 weeks) in Crohn’s disease (CD) or ulcerative colitis (UC) patients with a partial response at Week 14 post-induction. Partial response was defined as: (1) clinical remission with fecal calprotectin > 250 µg/g and/or steroid use, or (2) a reduction in the Harvey-Bradshaw Index by ≥ 3 points (for CD) or in the Partial Mayo Score by ≥ 2 points (for UC) from baseline, without fulfilling clinical remission criteria. The primary endpoint was steroid-free clinical remission with fecal calprotectin < 250 µg/g at Weeks 26 and 52. The secondary endpoints were clinical benefit (remission or partial response), regardless of calprotectin values, and treatment persistence.
Results: 107 patients were enrolled (CD: 58/107, 54.2%; UC: 49/107, 45.8%), allocated to SC (n = 52) or IV (n = 55) groups. The primary endpoint was met more often with SC VDZ at Week 26 (30/52, 57.7% vs. 14/55, 25.5%; p < 0.001; odds ratio [OR] = 3.57, p = 0.004 at multivariable analysis) and at Week 52 (25/52, 48.1% vs. 14/55, 25.5%; p = 0.016; OR = 3.05, p = 0.029 at multivariable analysis). Clinical benefit was also higher in the SC group at both timepoints, though not statistically significant. Treatment persistence was comparable between the 2 groups (log-rank test, p = 0.225).
Conclusions: In IBD patients with partial response to IV VDZ induction, switching to SC VDZ may lead to more profound remission than continuing IV optimization.