Influence of drug exposure on vedolizumab-induced endoscopic remission in anti-TNF naïve and anti-TNF exposed IBD patients.
J Crohns Colitis. 2019 Aug 29;:
Authors: Verstockt B, Mertens E, Dreesen E, Outtier A, Noman M, Tops S, Schops G, Van Assche G, Vermeire S, Gils A, Ferrante M
BACKGROUND AND OBJECTIVES: Vedolizumab has demonstrated efficacy and safety in patients with Crohn’s disease (CD) and ulcerative colitis (UC). Endoscopic outcome data are limited, especially in anti-TNF naïve patients. The present study compared endoscopic outcome in anti-TNF naïve and exposed patients, and explored if this was affected by drug exposure.
METHODS: We retrospectively analysed all patients initiating vedolizumab at our tertiary referral centre since 2015. For UC, endoscopic improvement was defined as a Mayo endoscopic subscore ≤1 at week 14. For CD, endoscopic remission was defined as absence of ulcerations at week 22. Vedolizumab trough concentrations were measured at week 6, week 14 and during maintenance.
RESULTS: A total of 336 patients were identified (53.3% CD), 20% of them were anti-TNF naïve. Endoscopic improvement was achieved by 56.1% of UC patients and endoscopic remission by 39.1% of CD patients. Endoscopic outcomes were significantly better in anti-TNF naïve vs exposed patients (all 67.2% vs 42.0%, p=0.0002; UC 74.4% vs 50.0%, p=0.02; CD: 57.1% vs 35.8%, p=0.03). Achievement of endoscopic endpoints significantly impacted long-term treatment continuation (p=9.7×10-13). A better endoscopic outcome was associated with significant higher drug exposure in both CD and UC.
CONCLUSION: The results of this observational, single-centre real-life study suggest that vedolizumab may induce endoscopic remission in both CD and UC. Although anti-TNF naïve patients had a significantly better outcome, 42% of anti-TNF exposed patients still benefited endoscopically. A clear exposure-endoscopic response relationship exists, however not all patients will benefit from treatment intensification. Hence, predictive biomarkers will remain necessary.
PMID: 31504343 [PubMed – as supplied by publisher]