In patients with Crohn Disease (CD) who are biologic therapy-naïve, certain clinical characteristics, such as disease behavior type and extraintestinal manifestations (EIMs), may predict clinical remission with vedolizumab (VDZ) use. These data were reported at the Digestive Disease Week 2021 Annual Meeting, held virtually from May 21-23, 2021.
Data were extracted from the EVOLVE retrospective cohort study for analysis (ClinicalTrials.gov identifier: NCT03710486). Patients diagnosed with CD receiving first-line biologic treatment with either VDZ or anti-tumor necrosis factor-α (anti-TNFα) therapies were included in the original study. Separate prediction models compared the effects of VDZ vs anti-TNFα therapies based on the outcome of clinical remission (CR). Effect scores were then used to predict differences in 1-year probability of CR between groups.
In this subanalysis, 195 patients who received VDZ and 245 patients who received anti-TNFα therapies were included. Location of intestinal involvement, prior treatment with non-biologic therapies, use of immune modulators at start of treatment, and retaining ≥1 pre-existing EIM at treatment initiation were identified as predictors of CR in patients receiving VDZ therapy. Only age was identified as a predictor of CR in the anti-TNFα model.
The unadjusted mean time to CR was 9.0 months in the VDZ group vs 10.1 months in the anti-TNFα group (log-rank P =.35). The weighted median time to CR was 4.8 months for patients in the top 40% of the effect score distribution receiving VDZ vs 18.1 months for those receiving anti-TNFα (weighted log-rank P <.001). Additionally, 82.8% vs 42.8% of patients in these VDZ and anti-TNFα subpopulations achieved CR within the first year, respectively. Similar results were reported across other subpopulations.
These analyses identified specific patient and clinical characteristics to be used as predictors of CR, while also discerning subpopulations in which VDF proved more effective than anti-TNFα at achieving CR. Further research to support the validity of these subpopulations is needed.
Yarur A, Bressler B, Wang S, et al. Real-world effectiveness of first-line biologic vedolizumab in Crohn’s disease: analysis of higher treatment effect subpopulation from the EVOLVE study. Presented at: Digestive Disease Week 2021 Annual Meeting; May 21-23, 2021. Abstract 22.