Characterizing unmet medical need and the potential role of new biologic treatment options in patients with ulcerative colitis and Crohn's disease: a systematic review and clinician surveys.
OBJECTIVE
Comparative outcomes of patients with ulcerative colitis (UC) and Crohn's disease (CD) prescribed a biologic therapy are inconclusive. The aim of this research was to characterize the degree of unmet medical need in patients with UC or CD and to identify the potential role for new therapies.


METHODS
A systematic literature review was undertaken of studies reporting outcomes associated with the use of existing biologic therapies in patients with UC or CD, focusing on the nature and rate of treatment failure. To complement the systematic review, contemporaneous data were obtained from a survey of practising gastroenterologists in the UK and France. Data were qualitatively combined in a narrative framework to evaluate the degree of unmet medical need among patients with UC or CD.


RESULTS
Studies identified in the systematic review (n = 120) were heterogeneous, particularly with respect to the definitions of treatment failure; estimates of treatment failure were high but uncertain. On the basis of standardized definitions, estimates of treatment failure provided by clinicians (n = 102) were high, and they were higher for second-line treatment failure (primary: ≤ 37%; secondary: ≤ 41%) compared with first-line treatment failure (primary: ≤ 26%; secondary: ≤ 28%). The majority of the systematic review and survey data were reflective of outcomes with infliximab and adalimumab.


CONCLUSIONS
High treatment failure rates associated with existing biologics, identified by the review and clinician surveys, indicate a need for other biologic treatment options to improve the management and outcomes for people with UC and CD. Outcomes associated with existing and new biologic treatments should be investigated in head-to-head randomized trials in the context of their likely uses in clinical practice.
aHealth Economics and Outcomes Research Ltd, Monmouth bSwansea Centre for Health Economics, Swansea University, Wales cOxon Epidemiology dTakeda Pharmaceuticals, Takeda Development Centre, London, UK eUniversity of Adelaide, Department of Public Health, Adelaide, Australia.
Jason P
JP
Gordon
Phil C
PC
McEwan
Andy
A
Maguire
Daniel M
DM
Sugrue
Jorge
J
Puelles
D000068879:Adalimumab / Q000009:adverse effects / Q000627:therapeutic use*; D003093:Colitis, Ulcerative / Q000188:drug therapy*; D003424:Crohn Disease / Q000188:drug therapy*; D019317:Evidence-Based Medicine; D005765:Gastrointestinal Agents / Q000009:adverse effects / Q000627:therapeutic use*; D006801:Humans; D000069285:Infliximab / Q000009:adverse effects / Q000627:therapeutic use*; D017211:Treatment Failure; D016896:Treatment Outcome
D005765:Gastrointestinal Agents; D000069285:Infliximab; D000068879:Adalimumab