Effectiveness and Safety of Vedolizumab in Anti-TNF-Naïve Patients With Inflammatory Bowel Disease-A Multicenter Retrospective European Study.

Abstract

Background:

Vedolizumab (VDZ) is effective for treatment of ulcerative colitis (UC) and Crohn's disease (CD). In GEMINI trials, anti-tumor necrosis factor (anti-TNF)-naïve patients had a superior response compared with anti-TNF-exposed patients. In real-world experience (RWE), the number of included anti-TNF-naïve patients was low. We aimed to evaluate the effectiveness and safety of VDZ in anti-TNF-naïve patients in an RWE setting.

Methods:

This retrospective multicenter European pooled cohort study included consecutive active anti-TNF-naïve IBD patients treated with VDZ. The primary end point was clinical response at week 14. Patients with follow-up beyond week 14 and those discontinuing VDZ at any time were included for maintenance outcomes analysis.

Results:

Since January 2015, 184 anti-TNF-naïve patients from 23 centers initiated VDZ treatment (Crohn's disease [CD], 50; ulcerative colitis [UC], 134). In CD, 42/50 (82%) patients responded by week 14 and 32 (64%) were in clinical remission; 26/50 (52%) achieved corticosteroid-free remission (CSFR). At last follow-up (44 weeks; interquartile range [IQR], 30-52 weeks), 27/35 (77.1%) patients with available data responded to treatment; 24/35 (68.6%) were in clinical remission, 21/35 (60%) were in CSFR. For UC, 116/134 (79.1%) responded to treatment by week 14, including 53 (39.5%) in clinical remission; 49/134 (36.6%) achieved CSFR. At last follow-up (42.5 weeks; IQR, 30-52 weeks), 79/103 (76.7%) patients responded to treatment, 69/103 (67.0%) were in remission, and 61/103 (59.2%) were in CSFR. Adverse effects were reported in 20 (11%) of the patients, leading to treatment discontinuation in 6 (3.3%).

Conclusions:

VDZ is similarly effective in ant-TNF-naïve CD and UC patients. The efficacy is higher than reported in anti-TNF-experienced patients and is comparable to that of anti-TNF biologics in this population.

• Authors: Uri Kopylov, Bram Verstockt, Luc Biedermann, Shaji Sebastian, Daniela Pugliese, Elena Sonnenberg, Peter Steinhagen, Naila Arebi, Yulia Ron, Torsten Kucharzik, Xavier Roblin, Bella Ungar, Ariella Bar-Gil Shitrit, Sandro Ardizzone, Pauliina Molander, Marina Coletta, Laurent Peyrin-Biroulet, Peter Bossuyt, Irit Avni-Biron, Emmanouela Tsoukali, Mariangela Allocca, Konstantinos Katsanos, Tim Raine, Taina Sipponen, Gionata Fiorino, Shomron Ben-Horin, Rami Eliakim, Alessandro Armuzzi, Britta Siegmund, Daniel C Baumgart, Nikolaos Kamperidis, Nitsan Maharshak, Christian Maaser, Gerassimos Mantzaris, Henit Yanai, Dimitrious K Christodoulou, Iris Dotan, Marc Ferrante
• Journal: Inflammatory bowel diseases (Inflamm Bowel Dis) Vol. 24 Issue 11 Pg. 2442-2451 (10 12 2018) ISSN: 1536-4844 [Electronic] England
• PMID: 29788318 (Publication Type: Journal Article, Multicenter Study, Observational Study)

Chemical References

• Antibodies, Monoclonal, Humanized
• Gastrointestinal Agents
• Tumor Necrosis Factor-alpha
• vedolizumab

Topics

• Adult
• Aged
• Antibodies, Monoclonal, Humanized (therapeutic use)
• Colitis, Ulcerative (drug therapy)
• Crohn Disease (drug therapy)
• Female
• Follow-Up Studies
• Gastrointestinal Agents (therapeutic use)
• Humans
• Male
• Middle Aged
• Patient Safety
• Prognosis
• Remission Induction
• Retrospective Studies
• Tumor Necrosis Factor-alpha (antagonists & inhibitors)
• Young Adult