Efficacy of Vedolizumab as Induction Therapy in Refractory IBD Patients: A Multicenter Cohort.
BACKGROUND
Vedolizumab (VDZ) demonstrated efficacy in Crohn's disease (CD) and ulcerative colitis (UC) in the GEMINI trials. Our aim was to evaluate the efficacy of VDZ at week 14 in inflammatory bowel disease in a multicenter cohort of patients.


METHODS
Patients at Massachusetts General Hospital and Brigham and Women's Hospital were considered for inclusion. VDZ (300 mg) was administered at weeks 0, 2, 6, and 14. Efficacy was assessed using the Harvey-Bradshaw index for CD, the simple clinical colitis activity index for UC and physician assessment, along with C-reactive protein and decrease of corticosteroid therapy. Clinical response was defined as decrease in Harvey-Bradshaw index ≥3 and simple clinical colitis activity index ≥3 and remission as Harvey-Bradshaw index ≤4, simple clinical colitis activity index ≤2 and physician assessment of response and remission.


RESULTS
Our study included 172 patients (107 CD, 59 UC, 6 inflammatory bowel disease-unclassified, men 48.3%, mean age 40 years and disease duration 14 years). Fourteen patients had ostomy and 9 ileoanal pouch, and only 35.5% fulfilled eligibility for the GEMINI trials. Previous treatment failures with ≥ 2 anti-TNFs occurred in 70.9%, one-third were on an immunomodulator and 46% systemic steroids at baseline. In CD, 48.9% and 23.9% and in UC, 53.9% and 29.3% had clinical response and clinical remission at week 14, respectively. Adverse events occurred in 10.5%.


CONCLUSIONS
VDZ is safe and well tolerated in refractory inflammatory bowel disease patients in a clinical practice with efficacy in UC and CD with responses similar to what was seen in clinical trials.
*Division of Gastroenterology, Massachusetts General Hospital, Boston, Massachusetts; †Harvard Medical School, Boston, Massachusetts; and ‡Division of Gastroenterology, Brigham and Women's Hospital, Boston, Massachusetts.
Edward
E
Shelton
Jessica R
JR
Allegretti
Betsy
B
Stevens
Matthew
M
Lucci
Hamed
H
Khalili
Deanna D
DD
Nguyen
Jenny
J
Sauk
Cosmas
C
Giallourakis
John
J
Garber
Matthew J
MJ
Hamilton
Michal
M
Tomczak
Fredrick
F
Makrauer
Robert B
RB
Burakoff
Jonathan
J
Levine
Punyaganie
P
de Silva
Sonia
S
Friedman
Ashwin
A
Ananthakrishnan
Joshua R
JR
Korzenik
Vijay
V
Yajnik
D000305:Adrenal Cortex Hormones / Q000627:therapeutic use; D000328:Adult; D061067:Antibodies, Monoclonal, Humanized / Q000008:administration & dosage*; D002097:C-Reactive Protein / Q000032:analysis; D015331:Cohort Studies; D003093:Colitis, Ulcerative / Q000097:blood / Q000188:drug therapy*; D003424:Crohn Disease / Q000097:blood / Q000188:drug therapy*; D005260:Female; D005765:Gastrointestinal Agents / Q000008:administration & dosage*; D006801:Humans; D007155:Immunologic Factors / Q000627:therapeutic use; D060828:Induction Chemotherapy / Q000379:methods*; D008297:Male; D008875:Middle Aged; D012720:Severity of Illness Index; D017211:Treatment Failure; D014409:Tumor Necrosis Factor-alpha / Q000037:antagonists & inhibitors / Q000627:therapeutic use
D000305:Adrenal Cortex Hormones; D061067:Antibodies, Monoclonal, Humanized; D005765:Gastrointestinal Agents; D007155:Immunologic Factors; C439524:TNF protein, human; D014409:Tumor Necrosis Factor-alpha; D002097:C-Reactive Protein; C543529:vedolizumab