PGI46 - Systematic Literature Review in Moderate to Severe Ulcerative Colitis

Abstract

Ulcerative colitis (UC) is a chronic inflammatory bowel disease. The objective of this systematic literature review (SLR) was to examine the evidence on the efficacy and safety of all available pharmacological interventions for moderate to severe UC. A systematic literature search using a predefined strategy was performed in Medline®, EMBASE®, Medline-In-Process, Cochrane Library and BIOSIS from 1966 to 2013, to identify randomized controlled trials (RCTs) concerning the efficacy and safety of available treatments in adult patients with moderate to severe UC. Studies reporting on mild-moderate UC patients were included if they reported results for the moderate subgroup separately. No language restrictions were applied to the search. A total of 4344 abstracts were screened based on the predefined selection criteria, of which 4279 were excluded. In total, 65 publications, reporting results from 65 RCTs were included (49 double blind), examining aminosalicylates (n=23), corticosteroids (n=10), immunosuppressants (n=15), biologics (n=16) and kinase inhibitors (n=1). Baseline patient characteristics, study design and outcomes were extracted, including: adverse events (AE) (reported in n=24 studies), serious AE (n=25), deaths (n=23), clinical remission (n=49), clinical response (n=33) and mucosal healing (n=11). Eleven different disease activity scales and four different endoscopic scales were used. The mean age of included patients ranged from 27 to 51, and the percentage of males from 28.6% to 87.5%. Due to large differences and different scales used for reporting efficacy it is not feasible to report the range across different scales. Safety endpoints were also reported inconsistently. The results per outcome are presented in a narrative way per treatment class. A comprehensive SLR performed which identified 65 RCT reporting on the efficacy and safety of pharmacological treatments in moderate to severe UC patients. Differences in patient population, disease severity, disease activity scales and trial duration are explored and presented.