TY - JOUR
T1 - Effectiveness and safety of vedolizumab in anti-TNF-naïve patients with inflammatory bowel disease-a multicenter retrospective European study
AU - Kopylov, Uri
AU - Verstockt, Bram
AU - Biedermann, Luc
AU - Sebastian, Shaji
AU - Pugliese, Daniela
AU - Sonnenberg, Elena
AU - Steinhagen, Peter
AU - Arebi, Naila
AU - Ron, Yulia
AU - Kucharzik, Torsten
AU - Roblin, Xavier
AU - Ungar, Bella
AU - Shitrit, Ariella Bar Gil
AU - Ardizzone, Sandro
AU - Molander, Pauliina
AU - Coletta, Marina
AU - Peyrin-Biroulet, Laurent
AU - Bossuyt, Peter
AU - Avni-Biron, Irit
AU - Tsoukali, Emmanouela
AU - Allocca, Mariangela
AU - Katsanos, Konstantinos
AU - Raine, Tim
AU - Sipponen, Taina
AU - Fiorino, Gionata
AU - Ben-Horin, Shomron
AU - Eliakim, Rami
AU - Armuzzi, Alessandro
AU - Siegmund, Britta
AU - Baumgart, Daniel C.
AU - Kamperidis, Nikolaos
AU - Maharshak, Nitsan
AU - Maaser, Christian
AU - Mantzaris, Gerassimos
AU - Yanai, Henit
AU - Christodoulou, Dimitrious K.
AU - Dotan, Iris
AU - Ferrante, Marc
N1 - Publisher Copyright:
© 2018 Crohn's & Colitis Foundation. Published by Oxford University Press.
PY - 2018/11
Y1 - 2018/11
N2 - 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.
AB - 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.
KW - Anti-TNF-naïve
KW - Crohn's disease
KW - Ulcerative colitis
KW - Vedolizumab
UR - http://www.scopus.com/inward/record.url?scp=85054889893&partnerID=8YFLogxK
U2 - 10.1093/ibd/izy155
DO - 10.1093/ibd/izy155
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AN - SCOPUS:85054889893
SN - 1078-0998
VL - 24
SP - 2442
EP - 2451
JO - Inflammatory Bowel Diseases
JF - Inflammatory Bowel Diseases
IS - 11
ER -