PMID- 28178003
OWN - NLM
STAT- MEDLINE
DCOM- 20180215
LR  - 20180913
IS  - 1536-4844 (Electronic)
IS  - 1078-0998 (Linking)
VI  - 23
IP  - 3
DP  - 2017 Mar
TI  - Efficacy and Safety of Vedolizumab for Induction of Remission in Inflammatory 
      Bowel Disease-the Israeli Real-World Experience.
PG  - 404-408
LID - 10.1097/MIB.0000000000001039 [doi]
AB  - BACKGROUND: Vedolizumab (VDZ) is an anti-integrin monoclonal antibody effective 
      in ulcerative colitis (UC) and Crohn's disease (CD). The aim of this study was to 
      examine the "real world" efficacy and safety of VDZ in a large national patient 
      cohort. METHODS: Patients with inflammatory bowel disease treated with VDZ were 
      prospectively followed for 14 weeks. Patients who completed the induction 
      protocol (week 0/2/6/14) or discontinued the treatment before week 14 for adverse 
      events (AEs) or primary nonresponse were included. The primary outcome was 
      induction of clinical remission at week 14; secondary outcomes included clinical 
      response and corticosteroid-free clinical remission. RESULTS: A total of 204 
      patients (CD-130, UC-69, inflammatory bowel disease-unclassified-5) from 8 
      centers in Israel were included. Fifteen (7.4%) of the patients were anti-tumor 
      necrosis factor naive and 46 (35.4%) had a previous surgery. For patients with 
      CD, 69/130 (53.1%) responded to treatment; 45 (34.6%) achieved clinical 
      remission; and 38 (29.2%) achieved corticosteroid-free remission at week 14. 
      Fourteen (10.7%) patients discontinued VDZ before week 14 due to primary 
      nonresponse or AEs. For UC, 32/74 (43.2%) responded to treatment; 20 (28.4%) 
      achieved clinical remission, and 18 (24.3%) achieved corticosteroid-free 
      remission at week 14. Fifteen (20.3%) patients with UC did not complete the 
      induction due to primary nonresponse or AEs. AEs were reported by 29 (14.2%) 
      patients (CD and UC combined), most common being nasopharyngitis and skin 
      eruptions. CONCLUSIONS: In a large real-world Israeli cohort of anti-tumor 
      necrosis factor-experienced patients with inflammatory bowel disease, VDZ was 
      effective and safe in induction of clinical remission and steroid-free clinical 
      remission.
FAU - Kopylov, Uri
AU  - Kopylov U
AD  - *Department of Gastroenterology, Sheba Medical Center, Tel Hashomer, Ramat Gan, 
      Israel; daggerIBD Center, Department of Gastroenterology and Liver Diseases, Tel Aviv 
      Sourasky Medical Center, Tel Aviv, Israel; double daggerDepartment of Gastroenterology, Rabin 
      Medical Center, Petach Tikva, Israel;  section signDigestive Diseases Institute, Shaare Zedek 
      Medical Center, Jerusalem, Israel;  ||Department of Gastroenterology, Rambam 
      Healthcare Campus, Haifa, Israel;  paragraph signDepartment of Gastroenterology, Hadassah 
      Medical Center, Jerusalem, Israel; **Department of Gastroenterology, Soroka 
      Medical Center, Beer Sheva, Israel; daggerdaggerDepartment of Gastroenterology, Haemek 
      Medical Center, Afula, Israel; double daggerdouble daggerSackler Faculty of Medicine, Tel Aviv 
      University, Tel Aviv, Israel;  section sign section signFaculty of Medicine, Hebrew University, 
      Jerusalem, Israel;  || ||Bruce Rappoport Faculty of Medicine, Technion, Haifa, 
      Israel; and  paragraph sign paragraph signFaculty of Medicine, Beer Sheba University, Beer Sheba, Israel.
FAU - Ron, Yulia
AU  - Ron Y
FAU - Avni-Biron, Irit
AU  - Avni-Biron I
FAU - Koslowsky, Benjamin
AU  - Koslowsky B
FAU - Waterman, Matti
AU  - Waterman M
FAU - Daher, Saleh
AU  - Daher S
FAU - Ungar, Bella
AU  - Ungar B
FAU - Yanai, Henit
AU  - Yanai H
FAU - Maharshak, Nitsan
AU  - Maharshak N
FAU - Ben-Bassat, Ofer
AU  - Ben-Bassat O
FAU - Lichtenstein, Lev
AU  - Lichtenstein L
FAU - Bar-Gil Shitrit, Ariella
AU  - Bar-Gil Shitrit A
FAU - Israeli, Eran
AU  - Israeli E
FAU - Schwartz, Doron
AU  - Schwartz D
FAU - Zittan, Eran
AU  - Zittan E
FAU - Eliakim, Rami
AU  - Eliakim R
FAU - Chowers, Yehuda
AU  - Chowers Y
FAU - Ben-Horin, Shomron
AU  - Ben-Horin S
FAU - Dotan, Iris
AU  - Dotan I
LA  - eng
PT  - Journal Article
PT  - Multicenter Study
PT  - Observational Study
PL  - England
TA  - Inflamm Bowel Dis
JT  - Inflammatory bowel diseases
JID - 9508162
RN  - 0 (Antibodies, Monoclonal, Humanized)
RN  - 0 (Gastrointestinal Agents)
RN  - 0 (Tumor Necrosis Factor-alpha)
RN  - 9RV78Q2002 (vedolizumab)
SB  - IM
MH  - Adult
MH  - Antibodies, Monoclonal, Humanized/*administration & dosage
MH  - Cohort Studies
MH  - Colitis, Ulcerative/*drug therapy
MH  - Crohn Disease/*drug therapy
MH  - Female
MH  - Gastrointestinal Agents/*administration & dosage
MH  - Humans
MH  - Induction Chemotherapy/methods
MH  - Inflammatory Bowel Diseases/*drug therapy
MH  - Israel
MH  - Male
MH  - Middle Aged
MH  - Prospective Studies
MH  - Treatment Outcome
MH  - Tumor Necrosis Factor-alpha/antagonists & inhibitors
EDAT- 2017/02/09 06:00
MHDA- 2018/02/16 06:00
CRDT- 2017/02/09 06:00
PHST- 2017/02/09 06:00 [pubmed]
PHST- 2018/02/16 06:00 [medline]
PHST- 2017/02/09 06:00 [entrez]
AID - 10.1097/MIB.0000000000001039 [doi]
PST - ppublish
SO  - Inflamm Bowel Dis. 2017 Mar;23(3):404-408. doi: 10.1097/MIB.0000000000001039.