Cindy Kin1, M Kate Bundorf2. 1. Department of Surgery, Stanford University School of Medicine, 300 Pasteur Drive, H3680, Stanford, CA, 94305, USA. cindykin@stanford.edu. 2. Department of Health Research & Policy, Stanford University School of Medicine, Stanford, CA, USA.
Abstract
BACKGROUND: Infliximab was approved for ulcerative colitis in 2005 after randomized trials showed it reduced the risk of colectomy. Its effect on population-level surgery rates is unknown. Our aim is to assess the impact of infliximab approval for ulcerative colitis on surgical intervention. METHODS: Retrospective review of a private insurance claims database (2002 to 2013) was performed of patients aged 18-64 diagnosed with ulcerative colitis and with 2 years of follow-up. Outcome measures were infliximab treatment and surgical resection. Multivariable logistic regression used independent variables of time period of diagnosis, age, gender, comorbidities, and insurance type. RESULTS: The cohort included 58,681 patients. Age, gender, and comorbidities were comparable across time periods. Patients diagnosed in the post-infliximab period had greater odds of undergoing infliximab treatment within the first year of diagnosis than those in the pre-infliximab era (OR = 2.88, p < 0.001). However, the odds of undergoing total colectomy or total proctocolectomy were also higher in patients diagnosed in the post-infliximab period (OR 1.5, p < 0.001). CONCLUSIONS: The use of infliximab for ulcerative colitis has, as expected, increased since its approval, but so has the risk of surgery. Thus, the introduction of biologic therapy has not decreased the risk for surgery for this patient population.
BACKGROUND: Infliximab was approved for ulcerative colitis in 2005 after randomized trials showed it reduced the risk of colectomy. Its effect on population-level surgery rates is unknown. Our aim is to assess the impact of infliximab approval for ulcerative colitis on surgical intervention. METHODS: Retrospective review of a private insurance claims database (2002 to 2013) was performed of patients aged 18-64 diagnosed with ulcerative colitis and with 2 years of follow-up. Outcome measures were infliximab treatment and surgical resection. Multivariable logistic regression used independent variables of time period of diagnosis, age, gender, comorbidities, and insurance type. RESULTS: The cohort included 58,681 patients. Age, gender, and comorbidities were comparable across time periods. Patients diagnosed in the post-infliximab period had greater odds of undergoing infliximab treatment within the first year of diagnosis than those in the pre-infliximab era (OR = 2.88, p < 0.001). However, the odds of undergoing total colectomy or total proctocolectomy were also higher in patients diagnosed in the post-infliximab period (OR 1.5, p < 0.001). CONCLUSIONS: The use of infliximab for ulcerative colitis has, as expected, increased since its approval, but so has the risk of surgery. Thus, the introduction of biologic therapy has not decreased the risk for surgery for this patient population.
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