Abstract
Abstract Background Subcutaneous (SC) vedolizumab (VDZ) has demonstrated its efficacy and safety in patients with moderate-to-severe ulcerative colitis (UC) and Crohn’s disease (CD). This study aimed to evaluate the effectiveness and safety of SC VDZ dose intensification in IBD patients with an incomplete clinical response or loss of response. Methods We conducted a retrospective international study in 25 IBD centers from August 2023 to April 2024. All patients with active CD or UC, as defined by patient-reported outcomes (PRO2), who had incomplete response or lost response and required intensified SC VDZ at 108 mg weekly or 216 mg every other week, were included. The endpoints at 3 months post-intensification were steroid-free (SF) clinical response (defined as at least a 50% PRO2 improvement, no treatment change, no surgery, and SC VDZ persistence) and SF clinical remission (CD: abdominal pain≤1 and liquid stool frequency≤3; UC: rectal bleeding=0 and stool frequency=0). Results 154 patients (66% UC, 34% CD) were included. Among the 52 CD patients (median age 36 years, disease duration 14 years), 85% had already been exposed to anti-TNF; among the 102 UC patients (median age 40 years, disease duration 7 years), 50% had prior anti-TNF exposure. The reason for SC VDZ intensification was an incomplete response in 73% of CD and 53% of UC patients, and a secondary loss of response in 27% of CD and 47% of UC patients. Intensification had been done at 108 mg weekly in 95% of patients. At 3 months, SF clinical response was observed in 18/52 (35%) CD and 44/102 (43%) UC patients. Clinical response occurred in 9/14 (64%) of CD patients and 23/48 (48%) of UC patients who had been intensified due to loss of response, and in 9/38 (24%) of CD patients and 21/54 (39%) of UC patients who were in incomplete clinical response. Among responders, all CD patients and 72% of UC patients achieved SF clinical remission. In multivariate analysis, factors associated with SC VDZ response after dose escalation were secondary loss of response (vs incomplete response) (OR=5.8(95%CI: 1.54-21.8);p=0.01) in CD patients, and prior anti-TNF exposure (OR=2.66(95%CI: 1.19-5.98);p=0.02) in UC patients. In survival analysis, 50% of patients had discontinued SC VDZ within 12 months for CD and within 8 months for UC following dose intensification. Adverse effects were reported in 11 patients (7%), including one severe case (pneumonia) and one systemic allergic reaction. Four patients underwent surgery (1 UC and 3 CD patients). Conclusion This first real-world study evaluating SC VDZ intensification demonstrated a SF clinical response at 3 months in more than one third of IBD patients, suggesting the interest of this strategy in clinical practice. Acknowledgment Takeda
Published Version
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