Chronic Corticosteroid Use in Ulcerative Colitis Patients Associated with Increased Clinical and Economic Burden

Ulcerative colitis (UC) is a type of inflammatory bowel disease (IBD) characterized by periods of symptomatic disease alternating with periods of remission. Current treatment for UC focuses on inducing and maintaining remission. Clinical guidelines recommend using 5-aminosalicylic acid (5-ASA) corticosteroids, tumor necrosis factor (TNF) inhibitors, and other advanced therapies to induce remission.

To maintain remission, the American College of Gastroenterology recommends using 5-ASA, thiopurines, and targeted treatments such as biologics and other advanced therapies. The ultimate goal is achieving sustained, corticosteroid-free remission.

Studies have shown that the use of oral corticosteroids in patients with UC is associated with higher rates of adverse effects and use of healthcare resources compared with biologics or immunosuppressants. However, there is little research focusing on the economic and clinical burden of chronic corticosteroid use among people living with UC.

To gain more understanding, Maryia Zhdanava, M.A., and researchers from Analysis Group in Montreal and Janssen Scientific Affairs in Horsham, PA, conducted a retrospective longitudinal cohort study investigating the clinical and economic burden related to chronic oral corticosteroid use among adults with UC who had begun either targeted treatments or conventional therapies. The study results were published in the Journal of Managed Care and Specialty Pharmacy earlier this month.

Zhdanava and her colleagues used insurance claims data from Optum’s de-identified Clinformatics Data Mart Database between January 1, 2004, and September 30, 2021, to analyze populations of patients with UC who had been initiated on targeted treatments and those who had been initiated on conventional therapies. Targeted treatments included biologics or advanced and small molecule therapies. Conventional therapies consisted of 5-ASA and immunomodulators.

Each study population was further divided into two cohorts: patients with chronic corticosteroid use and those with nonchronic use. Chronic use was defined as more than 90 cumulative nonoverlapping corticosteroid days of supply.

After weighing the cohorts to ensure equal distribution of characteristics, 1,886 patients in the target treatment initiator group were considered chronic corticosteroid users, and 1,911 were nonchronic users. In the conventional therapy initiator group, there were 4,980 chronic corticosteroid users and 5,199 nonchronic users. The majority of patients in the target treatment group were initiated on TNF inhibitors. In the conventional therapy group, the most common class of treatment initiated was 5-ASA. Prednisone was the most used corticosteroid in all groups.

Study results showed that mean total healthcare costs per patient per year were significantly higher among chronic corticosteroid users compared with nonchronic users among both targeted treatment and conventional therapy initiators. In the targeted treatment group, these numbers were $73,491 and $58,884 for chronic and nonchronic users, respectively. In the conventional therapy group, the numbers were $39,335 for chronic corticosteroid users and $21,271 for nonchronic users.

The rates of inpatient admissions, inpatient days, and IBD-related surgery visits were also significantly higher in patients with chronic corticosteroid use versus those with nonchronic use. This was true for both the targeted treatment and the conventional therapy populations. Corticosteroid-related complications, such as infection and bone loss, were significantly higher in chronic corticosteroid users compared with nonchronic users in both populations.

Based on these results, the researchers emphasized the need for treatments that induce and maintain corticosteroid-free remission in patients with UC. They wrote, “Notably, newer targeted treatments that have different mechanisms of action or dual targeted therapy may be promising new approaches to improve care in patients with nonresponse or loss of response to prior lines of therapy.”

Zhdanava and her colleagues concluded that chronic corticosteroid use in patients with UC is associated with a significantly higher clinical and economic burden, particularly in inpatient and outpatient healthcare resource utilization and corticosteroid-related complications. The authors recommend continued research to develop treatment options that effectively reduce the need for corticosteroid use.