P0822 Comparative Effectiveness and Safety of Upadacitinib and Vedolizumab in Anti-TNF Experienced Patients with Ulcerative Colitis: A Retrospective Study
N Sror, H Leibovitzh, A Hirsch, T Thurm, Y Ron, N Maharshak, N A CohenAbstract
Background
Upadacitinib (UPA) and vedolizumab (vedo) are approved for use in patients with moderate to severe ulcerative colitis (UC). Data comparing these therapies as second line in Anti-TNF experienced patients are limited yet important to aid in determining therapeutic positioning.
Methods
This was a retrospective study conducted between 2015-2024. Patients receiving vedo or UPA for at least 14 weeks following anti-TNF failure were included. Clinical response was defined as a decrease in the Partial Mayo Score by two or more points from baseline, and remission as a score less than two. Clinical response and remission rates at weeks 14 and 52 were compared between the two groups.
Results
Eighty-eight patients, 66 treated with vedo and 22 with UPA were included in this study. The mean ages of the vedo and UPA cohorts were 45.7 ±19 years, and 39.4 ± 12.8, respectively. Thirty-one males (46.9%) were treated with vedo, and nine (40.9%) with UPA. Patients treated with vedo had significantly higher rates of cardiovascular comorbidities (30.3% vs 0%, p<0.001), a higher rate of never smokers (86.8% Vs 63.6%, p=0.018), and shorter disease duration (8.9 years Vs 13.2, p = 0.03). (Table 1). There was no significant difference in terms of clinical response or remission although there was a trend towards a higher likelihood of both in patients receiving UPA (clinical response: adjusted odds-ratio (aOR)=6.85, P=0.09, 95% confidence interval (CI):0.74-62; clinical remission: aOR=3.7, P=0.14, 95% CI: 0.6-21.6). There was a greater decrease in fecal calprotectin in patients receiving UPA during follow-up although this was not significant (mean change of 1,750 ± 2,284 Vs 771 ± 1,727, P=0.13). Patients treated with UPA were significantly more likely to experience adverse events (AE) (aOR 8.72, CI: 1-65, P=0.04) (Table 2). Two patients treated with vedo had treatment discontinuation, one due to pulmonary embolism, and the other by the patient’s request with no objective AE. In the UPA cohort, there were no major AE resulting in treatment discontinuation. One patient in the UPA cohort had mild cutaneous herpes which required a temporary pause in therapy. No patients were hospitalized during the treatment period.
Conclusion
Clinical effectiveness of UPA and vedo were comparable in anti-TNF experienced patients with UC although there was a trend towards greater clinical response, remission and biochemical improvement in patients receiving UPA. Patients receiving UPA experienced a significantly higher incidence of AE. These data suggest that decision making based on disease severity and co-morbidities can help guide positioning of these therapies.