P477 Assessment of treatment sequence and real-world outcomes in patients with Ulcerative Colitis

Chen, J.(1);Zhao, Y.(1);Liu, T.(1);Candela, N.(2);Lasch, K.(2);

(1)Takeda Development Center Americas Inc., Biostatistics, Cambridge, United States;(2)Takeda Pharmaceuticals USA Inc., US Medical, Lexington, United States


Several therapies are available to manage moderately to severely active ulcerative colitis (UC); however, little is known about the impact of treatment sequence on patient outcomes. Using real-world data, we assessed the outcomes of patients treated with different UC treatment sequences in routine clinical practice in the USA with the aim of determining the optimal position of vedolizumab within the current UC treatment paradigm.


This analysis used deidentified claims and clinical data from the Optum Research Database between 2016 and 2019. Patients diagnosed with UC were identified using International Classification of Diseases, Tenth Revision codes, and UC treatments were identified using National Drug Codes. Two scenarios of treatment sequences were analysed: with (S1) or without (S2) the inclusion of immunomodulator (IM) therapy (Table).

Patients were matched on baseline age, sex and race using nearest neighbour propensity score matching. Outcomes, including colectomy-related procedure, disease flare defined as a relevant diagnostic/imaging procedure, UC-related hospitalization, UC-related laboratory test abnormality and all-cause death, were described for each of the treatment sequences (Figure 1).


Of a total of 143 678 patients diagnosed with UC, 3291 were treated with vedolizumab and an IM and/or an anti-tumour necrosis factor (TNF) therapy. Patients who received vedolizumab before an IM and/or anti-TNF therapy (S1a and S2a) had better outcomes than those who received vedolizumab after one or both of these therapies, including a numerically lower rate of UC-related hospitalizations, colectomies, disease flares, UC-related laboratory test abnormalities and all-cause death (Figures 2 and 3).


Given the increasing number of therapies available for the management of UC, it is important to understand the impact of treatment sequence on outcomes. Clinical trial evidence suggests that patients with UC may experience better outcomes when vedolizumab is used prior to anti-TNF therapy. This observation is consistent with the findings of this analysis of real-world outcomes in patients with UC who received treatments in different sequences.

Owing to the nature of the data, the population could not be stratified by disease activity. Future work will aim to further characterize outcomes associated with different treatment sequences in patients with moderately to severely active UC and include newly available therapies.

Table. Scenarios

ScenarioTreatment sequenceDescription
1a1: VDZ, 2: either IM or anti-TNF therapy
b1: IM, 2: VDZ, 3: anti-TNF therapy
c1: IM, 2: anti-TNF therapy, 3: VDZ
2a1: VDZ, 2: anti-TNF therapy
b1: anti-TNF therapy, 2: VDZ

IM, immunomodulator; TNF, tumour necrosis factor; VDZ, vedolizumab.