Indicators of suboptimal biologic therapy over time in patients with ulcerative colitis and Crohn's disease in the United States

Abstract

This study assessed the occurrence of indicators for suboptimal biologic therapy among ulcerative colitis (UC) and Crohn’s disease (CD) patients over time in the United States (US). Data from a large US claims database (2005–2013) were used to retrospectively identify patients with diagnosed with either UC or CD who were new biologic users. Indicators of suboptimal biologic therapy included: dose escalation during the maintenance phase, discontinuation of the initial biologic, switch to another biologic within 90 days following the last day of supply of the initial biologic, augmentation with a non-biologic systemic therapy, UC- or CD-related surgery, UC- or CD-related urgent care, and development of fistula (for CD only). Kaplan-Meier analyses were used. A total of 1,699 UC and 4,569 CD patients were included. Among UC patients, 51.1% and 90.9% experienced ≥1 indicator of suboptimal biologic therapy within 6 months and 36 months of biologic therapy initiation, respectively. Among CD patients, 54.3% and 91.4% experienced ≥1 indicator of suboptimal biologic therapy within 6 and 36 months of biologic therapy initiation, respectively. For both UC and CD patients, the most frequent indicators of suboptimal biologic therapy were discontinuation, dose escalation and augmentation. In conclusion, this study found that the occurrence of suboptimal biologic therapy is common among patients with UC and CD, with approximately 90% of patients experiencing at least one indicator of suboptimal biologic therapy within 36 months of biologic treatment initiation.

Real‐world evidence on adherence, persistence, switching and dose escalation with biologics in adult inflammatory bowel disease in the United States: A systematic review

“…However, in several studies reporting discontinuation rates for both CD and UC populations, there appeared to be no consistent differences between the two indications. It is important to note that no formal statistical comparison was conducted in any of these studies . Also, in a study conducted by Desai et al, IBD type was not a significant predictor of discontinuation in univariate analysis.…”

“…Six studies reported on rates of switching to another biologic agent, but they varied greatly in terms of study methods and reported switch rates (Table ). The switch rate among all patients who initiated the index biologic ranged from 4.5% to 20% in most studies . Chen et al reported time to switching with biologics in IBD (Table ).…”

“…We did not consider other potential indicators of unsuccessful or suboptimal therapy, such as frequency of IBD‐related surgery, hospitalization and urgent care, as well as augmentation (additional use of non‐biologic systemic therapy for IBD), prolonged corticosteroid use or development of fistulas in patients with CD …”

“…Thus, increasing adherence to IBD therapies may lead to better health outcomes . In turn, medication persistence, switching and dose escalations have been shown to be indicators of effectiveness and safety in the real‐world setting …”

“…6 In turn, medication persistence, switching and dose escalations have been shown to be indicators of effectiveness and safety in the real-world setting. 7 Medication adherence/compliance has been defined as the "extent to which a patient acts in accordance with the prescribed interval, and dose of a dosing regimen." 3 It is measured over a period of time and reported as a percentage.…”