DOP085 Higher clinical remission and endoscopic response with vedolizumab in early versus late Crohn’s disease: data from the LOVE-CD trial

Abstract Background In clinical practice, vedolizumab (VDZ) is often considered a slow acting agent in Crohn’s disease (CD). However, a post-hoc analysis of the GEMINI trials revealed, that patients previously exposed to anti-TNF therapy already experienced less diarrhoea and abdominal pain already after respectively 2 and 4 weeks of VDZ treatment.1,2 We evaluated the rapidity of clinical and endoscopic benefit of VDZ treatment in the prospective, open-label LOVE-CD trial conducted in Belgium, the Netherlands and Hungary.3 Methods In the LOVE-CD trial, early and late CD patients with moderate-severe active CD (Crohn’s Disease Activity Index [CDAI] 220-450 and presence of ulcers at baseline endoscopy) received intravenous VDZ over a 52-week period. Early CD was defined as a diagnosis <24 months (treatment-naïve or prior corticosteroid and/or immunomodulator use), and late CD >24 months with prior anti-TNF exposure (and corticosteroids and/or immunomodulator use). Corticosteroids were tapered mandatorily and had to be discontinued by week 26. At every study visit, clinical remission (defined as a CDAI ≤150) and steroid-free clinical remission (no corticosteroids and CDAI ≤150) were calculated. At baseline, week 26 and week 52 an endoscopy was performed with independent scoring. Endoscopic response was defined as a reduction in SES-CD score of ≥50% compared to baseline. Missing data were imputed as non-responders. Results In total, 86 early CD patients and 174 late CD patients were included in the LOVE-CD trial. Baseline median CDAI and SES-CD were similar between the early and late group (255 [IQR 236-287] vs. 259 [235-315] and 9 [6-17] vs. 12 [7-17], resp.). Patients in the early group were younger and had evidently shorter disease duration compared to the late CD group (median age 30 [24-45] vs 36 [28-48] years old, median disease duration 0 [IQR 0-1] vs 11 [6-16] years, resp.). From week 6 onward, clinical remission was reached in a significantly higher proportion of early CD than late CD patients. At week 14, more than half of patients with early CD were in clinical remission, compared to 31% in the late CD group (p<0.001) (Table 1). Week 14 corticosteroid free clinical remission results were comparable (47.7% vs 27.6%, p=0.001) (Figure 1A). The proportion of patients with an endoscopic response was significantly higher in the early CD group compared to the late CD group at week 26 (64% vs 34.5%, p<0.001) and at week 52 (57% vs 35.6%, p=0.001) (Figure 1B). No new safety signals were observed. Conclusion Vedolizumab induced (steroid-free) clinical remission and endoscopic response more often in early than in late CD. Based on these observations, vedolizumab may be considered as a potential first line treatment for CD patients. References 1.Sandborn, et al. (2013). Vedolizumab as induction and maintenance therapy for Crohn's disease. The New England journal of medicine, 369(8), 711–721. https://doi.org/10.1056/NEJMoa1215739 2.Feagan, et al. (2019). Rapid Response to Vedolizumab Therapy in Biologic-Naive Patients With Inflammatory Bowel Diseases. Clinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association, 17(1), 130–138.e7. https://doi.org/10.1016/j.cgh.2018.05.026 3.D’Haens et al (2024). Vedolizumab treatment is more effective and safer in early versus late Crohn’s Disease: final results of the LOVE-CD trial. United European Gastroenterology Week, OP 2677.

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