Real-world Assessment of Therapy Changes, Suboptimal Treatment and Associated Costs in Patients with Ulcerative Colitis or Crohn's Disease

Background: Treatments for Crohn's disease (CD) and ulcerative colitis (UC) are not uniformly effective, thus necessitating dose changes, switching, and augmentation and carry adverse event risk, often requiring discontinuation, which reduces treatment benefits.

Aim: To assess continuity of and changes to initial CD and UC treatments, as well as costs associated with specific parameters defining suboptimal therapy.

Methods: Commercial US insurance claims (2006-2010) were retrospectively analysed. CD and UC patients receiving monotherapy with 5-aminosalicylates (5-ASAs), corticosteroids (CS), immunomodulators (IM) or biologics were included. Continuity of and changes to initial (index) therapy and associated costs (2011 US$) were assessed over 12 months following therapy initiation. Suboptimal therapy included discontinuation or switch (except for CS), dose escalation, augmentation, inadequate loading (biologics only), prolonged CS use (>3 months), surgery or hospitalisation.

Results: The study included 13,005 CD and 19,878 UC patients. Augmentation was a common index therapy change (~20% of 5-ASA initiators, ~40% of CS initiators, ≥40% of IM initiators and 26-55% of biologic initiators) in both CD and UC patients. Approximately 50% of CD and UC 5-ASA initiators discontinued/interrupted treatment. Approximately 80% of CD and UC patients had ≥1 suboptimal therapy marker. Mean all-cause total costs per CD patient were significantly higher in those with vs. without suboptimal therapy ($18,736 vs. $10,878; P < 0.001); in UC, the disparity was smaller ($12,679 vs. $9653; P < 0.001).

Conclusions: Frequent dose and treatment changes were observed in all classes of initial UC and CD treatments. The economic impact of suboptimal therapy among UC and CD patients is substantial.