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INTRODUCTION Inadequate response, loss of response, or intolerance to a first-line biologic typically requires patients with ulcerative colitis (UC) to switch treatment to a second-line biologic therapy. However, the clinical outcomes of patients receiving different sequences of biologic treatment are poorly understood. We assessed the adverse clinical outcomes of different treatment sequences. METHODS ROTARY (Real wOrld ouTcomes Across tReatment sequences in inflammatorY bowel disease patients) part B used data from the Optum Clinical Database and included adult patients diagnosed with UC who received at least two biologics successively between January 1, 2013 and February 29, 2020. This retrospective cohort study measured adverse clinical outcomes, including the incidences of inflammatory bowel disease (IBD)-related hospitalization, IBD-related surgery, dysplasia, colorectal cancer (CRC), and infection during each line of therapy individually and for both lines of treatment overall. The start of the first line of therapy (LOT1) was defined as the date of first prescription or infusion of a biologic therapy. The start of the second line of therapy (LOT2) was defined as the first date of prescription or infusion of a second-line biologic therapy. LOT1 biologics included in the analysis were adalimumab (ADA), infliximab (IFX), and vedolizumab (VDZ). LOT2 biologics included were IFX and ADA. RESULTS Among all treatment sequences the overall incidences of hospitalization, surgery, CRC, dysplasia, and infection were lowest for the VDZ to ADA treatment sequence (Figure 1). Patients who received VDZ to IFX had similar overall incidences of adverse outcomes as patients who received two sequential anti-tumor necrosis factor (TNF) therapies (either ADA to IFX or IFX to ADA) (Figure 1). When comparing adverse outcomes during LOT2 there were lower incidences of hospitalization and surgery for the IFX to ADA sequence compared with the ADA to IFX sequence (19.17% vs 23.64% and 7.14% vs 14.24%, respectively) (Table 1). When comparing adverse outcomes on LOT2 for the VDZ to ADA and VDZ to IFX sequences, there were lower incidences of hospitalization and surgery with VDZ to ADA compared with VDZ to IFX (12.50% vs 26.89% and 3.13% vs 22.69%, respectively) (Table 1). DISCUSSION In this real-world assessment of biologic treatment sequences in UC, we identified the VDZ to ADA treatment sequence to be associated with the lowest incidence of adverse clinical outcomes. In patients who were unsuccessfully treated with VDZ, ADA as a second-line biologic therapy was associated with lower incidences of adverse clinical outcomes compared with IFX. Although our results could be influenced by selection bias, these data provide potential guidance to clinicians in sequencing biologic therapies in patients with UC. |
