EFFICACY AND SAFETY OF VEDOLIZUMAB IN THE TREATMENT OF ULCERATIVE COLITIS- A SYSTEMATIC REVIEW AND META-ANALYSIS
Author(s)
Thode R1, Veeranki P1, Inuganti A1, Paladugu G1, Hyderboini RK1, Kolapalli N1, Vsn M1, Dang D1, Dang A2
1MarksMan Healthcare Solutions LLP, Health Economics and Outcomes Research (HEOR) and RWE (Real World Evidence), Navi Mumbai, India, 2MarksMan Healthcare Solutions LLP, Health Economics and Outcomes Research (HEOR) and RWE (Real World Evidence), Navi Mumbai, MA, India
OBJECTIVES : Ulcerative Colitis (UC) is a chronic, inflammatory bowel disease that affects only the colon and rectum. The disease can affect people of any age. The incidence of UC is 1.2 to 20.3 cases per 100,000 persons per year. The objective of this review is to evaluate the efficacy and safety of vedolizumab versus placebo for the treatment of ulcerative colitis (UC) METHODS : Literature searches were conducted in MEDLINE and the Cochrane Library. In addition, references of included studies and clinicaltrials.gov were searched for relevant studies. No language or date restrictions were imposed. Study quality of included trials were assessed using the Cochrane Risk of Bias Tool. Two authors independently selected, extracted and assessed the quality of included studies. The pooled odds ratio (OR) and the corresponding 95% confidence interval (95% CI) were calculated and analyzed. All randomized controlled trials (RCTs) examining the efficacy and safety of vedolizumab versus placebo in patients with UC. The included outcomes were clinical remission, corticosteroid-free remission, healing rate, durable clinical remission, durable clinical response and adverse events. RESULTS : A total of 5 RCTs involving a total of 1189 patients were included in this meta-analysis. Compared to placebo, the vedolizumab showed improved clinical remission (OR=4.35, 95% CI 3.19 to 5.93), corticosteroid-free remission (OR=3.99, 95% CI 2.61 to 6.11) and healing rate (OR=5.12, 95% CI 3.82 to 6.86), durable clinical remission (OR=2.96, 95% CI 2.02 to 4.33) and durable clinical response (OR=4.01, 95% CI 3.04 to 5.31). However; the adverse events and serious adverse events were higher with vedolizumab. CONCLUSIONS : Vedolizumab associated with significant improvement in clinical remission, corticosteroid-free remission and healing rate compared to placebo among patients with UC.
Conference/Value in Health Info
2018-05, ISPOR 2018, Baltimore, MD, USA
Value in Health, Vol. 21, S1 (May 2018)
Code
PGI2
Topic
Clinical Outcomes
Topic Subcategory
Comparative Effectiveness or Efficacy
Disease
Gastrointestinal Disorders