Abstract Background 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 two weeks) versus intensified IV VDZ (300 mg every four 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: (i) clinical remission with faecal calprotectin 250 µg/g and/or steroid use, or (ii) 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 faecal 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; 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 two 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.
Macaluso et al. (Mon,) studied this question.