S862 Real-World Clinical Effectiveness and Safety of Vedolizumab and Ustekinumab in Bio-Naïve Patients With Early Crohn’s Disease: Results From the EVOLVE Expansion Study

Introduction: There is limited data comparing real-world clinical effectiveness and safety of vedolizumab (VDZ) and ustekinumab (UST) in patients (pts) with early Crohn’s Disease (CD, with a disease duration ≤2 years). Methods: EVOLVE Expansion (NCT05056441) was a multicenter, observational, retrospective medical chart review study in biologic-naïve pts with CD (≥18 years old) who initiated VDZ or UST treatment in Australia, Belgium, or Switzerland from 2016 to 2021. This analysis looked at treatment outcomes in patients with early treatment (disease duration ≤2 years) who initiated VDZ or UST as first-line biologic. Data were collected from treatment initiation to chart abstraction, treatment discontinuation, death, or loss to follow-up. Cumulative rates of clinical response, remission, mucosal healing, and treatment persistence were estimated using the Kaplan Meier method over 12, 24 and 36 months. Serious adverse events (SAEs), serious infections (SIs), CD exacerbations, and CD-related hospitalization and surgeries were also evaluated. Baseline demographic and clinical characteristics across treatment groups were balanced using inverse probability weighting (IPW). Results: There were 141 VDZ and 108 UST pts with early treatment. After IPW, both groups had similar baseline characteristics (Table 1). Over 36 months, cumulative rates were similar between VDZ- and UST-treated pts for clinical response (VDZ 80.8%, UST 79.0%; P=0.52) and clinical remission (VDZ 85.3%, UST 82.8%; P=0.52). Mucosal healing rates were significantly higher in VDZ- vs UST-treated pts (VDZ 92.5%, UST 87.0%, P=0.02). Treatment persistence (VDZ 64.6%, UST 76.7%; P=0.57) was not significantly different over 36 months. There were no significant differences in the risk of safety outcomes: SAEs (hazard ratio [HR]=1.23; CI 0.56-2.72; P=0.60), SIs (HR=6.57; CI 0.44-98.04; P=0.17), CD exacerbations (HR=1.07; CI 0.65-1.75; P=0.79), CD-related surgeries (HR=0.82; CI 0.38-1.76; P=0.61) or CD-related hospitalizations (HR=0.83; CI 0.35-1.95; P=0.67). Conclusion: In CD pts with early initiation of biologic treatment, rates of mucosal healing were significantly greater with VDZ vs UST. There were no significant differences between the VDZ and UST cohorts in clinical remission, clinical response, or treatment persistence. The probability of mucosal healing was significantly greater in pts treated with VDZ. The risk of CD-related hospitalization, surgeries, SAEs and SIs was similar between cohorts. Table 1. - Baseline Characteristics Unweighted Weighted Baseline Characteristics VDZN=141 USTN=108 P-value VDZN=126 USTN=123 Std Diff after IPW Age (years), mean ± SD 44.5±19.1 39.9±18.5 0.0567 42.9±18.5 43.0±19.0 0.0035 Male, n (%) 72 (51.1) 54 (50.0) 0.8678 66 (52.3) 61 (49.4) 0.0595 Disease duration (years), median (min, max) 0.5 (0.0, 2.0) 0.5 (0.0, 1.9) 0.7667 0.5 (0, 2.0) 0.4 (0, 1.9) 0.0501 CD location 0.0152 Colonic with/without upper GI disease, n (%) 28 (19.9) 11 (10.2) 21 (17.0) 13 (10.9) 0.0807 Ileal with/without upper GI disease, n (%) 71 (50.4) 60 (55.6) 69 (55.2) 64 (52.1) 0.0585 Ileocolonic with/without upper GI disease, n (%) 34 (24.1) 37 (34.3) 33 (26.3) 44 (35.6) 0.1115 Disease behavior 0.3313 0.0976 Non-stricturing, non-penetrating, n (%) 104 (73.8) 70 (64.8) 99 (78.7) 88 (71.7) Penetrating, n (%) 10 (7.1) 8 (7.4) 9 (7.0) 7 (6.0) Stricturing, n (%) 19 (13.5) 24 (22.2) 15 (11.8) 22 (17.7) Disease severity 0.0384 Normal, n (%) 10 (7.1) 10 (9.3) 9 (7.3) 13 (10.5) Mild, n (%) 40 (28.4) 13 (12.0) 40 (31.4) 17 (13.4) 0.1347 Moderate, n (%) 64 (45.4) 62 (57.4) 54 (43.0) 66 (53.2) 0.0885 Severe, n (%) 17 (12.1) 13 (12.0) 16 (12.4) 16 (12.7) 0.0914 Active fistula* at index Yes, n (%) 11 (7.8) 5 (4.6) 0.3118 8 (6.2) 6 (5.0) 0.0109 Prior CD-related surgeries before treatment initiation Yes, n (%) 18 (12.8) 11 (10.2) 0.5292 13 (10.3) 12 (9.9) 0.0525 CD-related hospitalizations in previous 12 months Yes, n (%) 30 (21.3) 24 (22.2) 0.8576 27 (21.3) 25 (20.1) 0.0120 *Includes enterocutaneous, perianal, rectovaginal, other, and unknown. CD, Crohn’s disease; GI, gastrointestinal; IPW, inverse probability weighting; NA, not available; Std Diff, standardized difference; UST, ustekinumab, VDZ, vedolizumab.

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