Response to Initial Biologic Therapy in IBD

Tampa—Biologics are regularly used to treat different forms of inflammatory bowel disease (IBD). The most common types of IBD are Crohn’s disease and ulcerative colitis. However, biologic therapies used for IBD cost an estimated $15,000 to $25,000 per patient annually and often do not yield adequate responses in initial treatment.

Keith L. Davis and colleagues presented results of a study at the AMCP meeting during a poster session titled Association Between Inadequate Response to Initial Treatment with Biologics and Health Care Costs in Patients with Inflammatory Bowel Disease.

A total of 7493 patients with Crohn’s disease and 1183 patients with ulcerative colitis participated in the study. Of the 7493 Crohn’s disease patients, 54% had at least 1 indicator of inadequate response, and 55% of the 1183 ulcerative colitis patients had at least 1 indicator of inadequate response. This demonstrates that more than half of the Crohn’s disease and ulcerative colitis patients possessed at least 1 indicator of inadequate response to biologic therapy. To correct the inadequate responses, physicians either initiated dose escalation or changed the therapy type.

The most prevalent and costly indicator of inadequate response was dose escalation, which occurred in 31.9% of patients with Crohn’s disease and 34.2% of patients with ulcerative colitis. The mean total cost per Crohn’s disease patient with biologic dose escalation was $60,788 ($39,061) compared to a mean total cost of $49,199 ($35,317) for Crohn’s disease patients without biologic dose escalation (P<.0001). The mean total cost per ulcerative colitis patient with biologic dose escalation was $60,332 ($39,317), while ulcerative colitis patients without biologic dose escalation had a mean total cost of $47,342 ($34,701; P<.0001).

Another significant indicator of inadequate response to biologic therapy, which is generally associated with significantly increased cost, involved patients who augmented the biologic with another pharmacotherapy. The other pharamcotherapies included supplementing with corticosteroids (13.3% of Crohn’s disease patients and 11.6% of ulcerative colitis patients), immunomodulators (10.7% of Crohn’s disease patients and 7.7% of ulcerative colitis patients), or 5-aminosalicylic acid (7.1% of Crohn’s disease patients and 13.5% of ulcerative colitis patients).

Indicators of inadequate response associated with significantly reduced costs involved discontinuation or interruption of the biologic therapy, such as IBD-related hospitalization, surgery, or switching to a nonbiologic therapy. The reduced cost can be attributed to the decreased use of the expensive therapy.

The mean total costs for Crohn’s disease patients with and without indicators of inadequate response were $57,543 ($37,902) and $47,475 ($37,902), respectively (P<.0001). The mean total costs for ulcerative colitis patients with and without indicators of inadequate response were $56,403 ($37,869) and $46,281 ($34,866), respectively (P<.0001). Thus, both Crohn’s disease and ulcerative colitis patients with indicators of inadequate response experienced increased cost compared to Crohn’s disease and ulcerative colitis patients without indicators of inadequate response.

The researchers indicated study limitations. Factors such as disease severity and symptoms were not assessed, although they could affect the response of biologic therapy. Some changes in treatment could be attributed to adverse effects rather than lack of response, but because the researchers were unable to assess this through the given administrative data, the 2 factors could not be differentiated.

This study was sponsored and funded by Takeda Pharmaceuticals International, Inc.