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P366 The efficacy of vedolizumab for induction of clinical response and remission in anti-TNF naïve patients with inflammatory bowel disease – a multicenter European real world experience

Kopylov U.*1, Sebastian S.2, Ron Y.3, Steinhagen P.R.4, Roblin X.5, Pugliese D.6, Bar-Gil Shitrit A.7, Katsanos K.8, Fiorino G.9, Allocca M.10, Sipponen T.11, Ungar B.12, Armuzzi A.6, Eliakim R.12, Christodoulou D.8, Baumgart D.C.4, Ben-Horin S.12, Dotan I.3

1Sheba Medical Center, Gastroenterology, Tel Hashomer, Israel 2Hull Royal Infirmary, Hull & East Yorkshire Hospitals NHS Trust, Department of Gastroenterology and Hepatology, Hull, United Kingdom 3Tel Aviv Medical Ceter, IBD Center, Department of Gastroenterology and Liver Diseases, Tel Aviv, Israel 4Charité - University Hospital Berlin, Campus Benjamin Franklin, Department of Gastroenterology and Medicine I, Berlin, Germany 5CHU de Saint-Etienne, Gastroenterology, Saint-Etiennne, France 6IBD Unit, Complesso Integrato Columbus, Fondazione Policlinico Gemelli, Università Cattolica, internal Medicine, Gastroenterology Division, Rome, Italy 7Shaare Zedek Medical Center, Digestive diseases Institute, Jerusalem, Israel 8University of Ioannina, Gastroenterology, Ioannina, Greece 9Humanitas Research Hospital, Department of Gastroenterology, IBD Center, Rozzano, Italy 10Humanitas Gradenigo, Gastroenterology, Turin, Italy 11Helsinki University Central Hospital - Meilahti Hospital, Department of Gastroenterology, Helsinki, Finland 12Chaim Sheba Medical Center, Gastroenterology, Ramat Gan, Israel

Background

Vedolizumab (VDZ) is a humanized anti-α4β7 integrin monoclonal antibody that is effective and approved for treatment of ulcerative colitis (UC) and Crohn's disease (CD). In the GEMINI trials, anti-TNF naïve patients had a superior response compared to previously anti-TNF exposed patients. Several real world experience (RWE) series were published so far, with response rates ranging between 40–60%; however very few patients in those series were anti-TNF naïve. The aim of our study was to describe the outcome of VDZ treatment in anti-TNF naïve patients in a real-world setting.

Methods

This was a retrospective multicenter European pooled cohort analysis that focused on anti-TNF naïve patients who received VDZ and were prospectively followed for 14 weeks. Patients who completed the induction protocol or discontinued the treatment before week 14 for adverse events or primary non-response were included. Clinical, laboratory and endoscopic data were collected. The primary endpoint was induction of clinical remission at week 14; secondary endpoints included clinical response and CRP decrease.

Results

Fifty seven anti-TNF naïve patients treated with VDZ from 10 centers (3 – Italy, 3 – Israel, 1 – Germany, 1 – France, 1 – UK, 1 – Finland) were included in the study (26 (45.6%) male).

Forty seven (82.4%) patients received VDZ 300 mg at week 0, 2, 6 and 14; 10 (20%) received and additional dose at week 10. Thirteen (22.8%) patients had CD and 44 (77.2%)- UC. For CD patients: 8/13 (61.5%) had elevated CRP, 2 (15.4%) received concomitant methotrexate and 2 (15.4%) received systemic corticosteroids at treatment onset. At week 14, 11 (84.6%) responded to treatment, of them 5 (38.5%) achieved clinical remission; CRP levels decreased in 7/8 (87.5%) of the patients. For UC, 25 (56.8%) patients had elevated CRP, 11 (25%) received concomitant immunomodulators and 17 (38.6%) received systemic corticosteroids at treatment onset. At week 14, 38 (86.4%) responded to treatment, of them 25 (56.8%) achieved clinical remission. CRP levels decreased in 23/25 (92%) patients with elevated baseline CRP.

At week 14, VDZ was continued in 50 (87.7%) of the patients; in 6 patients (5 – UC, 1 – CD) VDZ was discontinued for primary non-response and in 1 patient (UC) for an adverse effect (tinnitus). Three patients required hospitalization during the induction, of them 2 were referred to colectomy and one was treated for Clostridium difficile infection

Conclusion

VDZ was effective for induction of clinical response in anti-TNF naïve patients with both UC and CD. CRP was reduced by week 14 in a vast majority of patients. Response and remission rate in anti-TNF naïve patients were substantially higher than the rates reported for anti-TNF experienced patients in current RWE series.