P0595 Comparative effectiveness between ustekinumab and vedolizumab after anti-TNF failure in Ulcerative Colitis: Real-world experience
Authors: Jairath R , Zoughlami A , Mahmoud O , Pilote N , Solitano V , Mohammad D , Afif W , Bitton A , Wild G , Lakatos P L , Narula N , Jairath V , Bessissow T 
Published: January 2025

Abstract

Background
Ustekinumab (UST) and vedolizumab (VED) have proven to be effective therapies for ulcerative colitis (UC), with similar safety profiles. There are limited real-world studies comparing the effectiveness between UST and VED in UC, especially after anti-TNF failure1–4. Our aim was to evaluate the real-world efficacy and safety of UST and VED in UC patients previously exposed to anti-TNF therapies across multiple Canadian institutions.

Methods
This was a multicentre retrospective study looking at 12 months of clinical data for patients with UC who had previously been exposed to at least one anti-TNF. These patients were from McGill University Health Centre, Hamilton Health Sciences, and London Health Sciences Centre. The primary outcome was clinical remission at 6 months, defined by a partial Mayo score (pMS) ≤ 2, Mayo Endoscopic Score (MES) ≤ 1, or physician’s judgement of clinical remission. Secondary outcomes included clinical remission at 12 months, clinical response, biochemical remission and response, and drug persistence at 12 months. Clinical response was defined as a decrease in pMS ≥ 2 points or physician’s judgement of clinical response. Biochemical remission was defined as c-reactive protein (CRP) &lt; 5mg/L and/or fecal calprotectin (FCP) &lt; 250μg/g. Biochemical response was defined as a reduction of CRP or FCP by 50% from baseline. These parameters were all evaluated at 6 and 12 months. Adverse events were summarized for all patients after 12 months.

Results
One hundred and fifty patients were included: 28 in UST and 122 in VED. Mean age was 38.4 (SD 15.6) in UST and 43.8 (SD 16.8) in VED. Percentage of female patients was 67.9% in UST and 53.3% in VED. Mean baseline partial mayo score was 3.78 (SD 3.07) for UST and 4.48 (SD 2.43) for VED. Mean disease duration was 10.63 years (SD 8.44) for UST and 11.80 years (SD 8.25) for VED. There was no significant difference in clinical remission between UST or VED, for data that was available at each time point (UST 65.0% vs. VED 72.6%, p=0.49 at 6 months; UST 68.4% vs. VED 82.3%, p=0.17 at 12 months). There was no significant difference between UST and VED for biochemical remission at 6 and 12 months. Higher MES at baseline was negatively associated with clinical remission in UST and VED with univariate analysis, though only significant in VED when adjusted for sex, age, and disease duration (OR 0.07, 95% CI [0-0.26], p=0.0006). There was no significant difference between drug persistence at 12 months (95.0% UST vs. 91.5% VED, p=0.41). Infectious adverse events were similar between groups (17.9% UST vs. 4.1% VED, p=0.07), with no serious adverse events.

Conclusion
This real-world multicentre Canadian study shows similar efficacy and safety profiles for UST and VED in UC over 1 year.

References
1.Holvoet T, Truyens M, De Galan C, et al. Safety and Effectiveness of Vedolizumab and Ustekinumab in Elderly Patients with Inflammatory Bowel Disease: A Real-Life Multicentric Cohort Study. J Clin Med. 2024;13(2). doi:10.3390/JCM13020365
2.Nomura K, Shibuya T, Odakura R, et al. Comparison of the Effectiveness of Vedolizumab and Ustekinumab in Patients with Ulcerative Colitis: A Real-World Retrospective Study. Biomedicines. 2024;12(9):1991. doi:10.3390/BIOMEDICINES12091991
3.Fumery M, Serrero M, Bouguen G, et al. Real-World Comparison of the Effectiveness between Ustekinumab and Vedolizumab in Patients with Ulcerative Colitis Exposed to at least One Anti-TNF Agent. J Crohns Colitis. 2024;18(10):1615-1621. doi:10.1093/ECCO-JCC/JJAE063
4.Meyer A, Fumery M, Peyrin-Biroulet L, et al. Comparative real-world effectiveness of vedolizumab and ustekinumab for patients with ulcerative colitis: a GETAID multicentre cohort study. Scand J Gastroenterol. 2022;57(12):1454-1462. doi:10.1080/00365521.2022.2095668