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Real-World Evidence

Real-world clinical outcomes and healthcare costs in patients with Crohn’s disease treated with vedolizumab versus ustekinumab in the United States

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Pages 877-885 | Received 13 Jul 2023, Accepted 29 Feb 2024, Published online: 08 Apr 2024

Figures & data

Figure 1. Patient disposition. aThe first claim for VDZ or UST was defined as the index date. The first treatment initiated (VDZ or UST) was defined as the index treatment. bFor VDZ, no UC diagnosis and for UST, no diagnosis for psoriatic arthritis or psoriasis, between the latest CD diagnosis pre-index and the index date, and within the 30 days before the index date, inclusively. Abbreviations: CD, Crohn’s disease; UC, ulcerative colitis; UST, ustekinumab; VDZ, vedolizumab.

Figure 1. Patient disposition. aThe first claim for VDZ or UST was defined as the index date. The first treatment initiated (VDZ or UST) was defined as the index treatment. bFor VDZ, no UC diagnosis and for UST, no diagnosis for psoriatic arthritis or psoriasis, between the latest CD diagnosis pre-index and the index date, and within the 30 days before the index date, inclusively. Abbreviations: CD, Crohn’s disease; UC, ulcerative colitis; UST, ustekinumab; VDZ, vedolizumab.

Table 1. Patient characteristics.

Figure 2. Post-index treatment persistence in VDZ and UST cohorts. Treatment persistence was defined as time from index date to treatment discontinuation date (event) or end of follow-up (censor). Treatment discontinuation was defined as a treatment gap of ≥146 d (90 d following the recommended 56-day dosing interval), or a switch to or add-on of another biologic or biosimilar therapy indicated for CD. Date of discontinuation was set at 56 d after the patient received the last dose of index treatment, or the date before receiving the switch/add-on. Abbreviations: UST, ustekinumab; VDZ, vedolizumab; WKM, weighted Kaplan–Meier.

Figure 2. Post-index treatment persistence in VDZ and UST cohorts. Treatment persistence was defined as time from index date to treatment discontinuation date (event) or end of follow-up (censor). Treatment discontinuation was defined as a treatment gap of ≥146 d (90 d following the recommended 56-day dosing interval), or a switch to or add-on of another biologic or biosimilar therapy indicated for CD. Date of discontinuation was set at 56 d after the patient received the last dose of index treatment, or the date before receiving the switch/add-on. Abbreviations: UST, ustekinumab; VDZ, vedolizumab; WKM, weighted Kaplan–Meier.

Figure 3. Dose escalation in the VDZ and UST cohorts. Dose escalation was measured based on intensification of dosing frequency defined as two consecutive intervals between dosing of ≤49 d (i.e. at least 7 d shorter than the recommended 56-day interval); one dosing interval of ≤49 d followed by treatment discontinuation; or IV administration of UST during the maintenance phase. Time from maintenance phase initiation to first observed dose intensification (event), treatment discontinuation (censor), or end of follow-up period (censor) was assessed. Abbreviations: IV, intravenous; UST, ustekinumab; VDZ, vedolizumab; WKM, weighted Kaplan–Meier.

Figure 3. Dose escalation in the VDZ and UST cohorts. Dose escalation was measured based on intensification of dosing frequency defined as two consecutive intervals between dosing of ≤49 d (i.e. at least 7 d shorter than the recommended 56-day interval); one dosing interval of ≤49 d followed by treatment discontinuation; or IV administration of UST during the maintenance phase. Time from maintenance phase initiation to first observed dose intensification (event), treatment discontinuation (censor), or end of follow-up period (censor) was assessed. Abbreviations: IV, intravenous; UST, ustekinumab; VDZ, vedolizumab; WKM, weighted Kaplan–Meier.

Figure 4. Time to (a) opportunistic and (b) serious infection–related encounters post index date in VDZ and UST cohorts. Time to opportunistic infection–related encounters was measured as the time from index date to the first medical claim with a diagnosis code for an opportunistic infection (event) or end of the patient’s continuous health plan enrollment (censored). Time to serious infection–related encounters was measured as the time from index date to the first IP medical claim with a diagnosis code for a serious infection (event) or end of the patient’s continuous health plan enrollment (censored). Abbreviations: IP, inpatient; UST, ustekinumab; VDZ, vedolizumab; WKM, weighted Kaplan-Meier.

Figure 4. Time to (a) opportunistic and (b) serious infection–related encounters post index date in VDZ and UST cohorts. Time to opportunistic infection–related encounters was measured as the time from index date to the first medical claim with a diagnosis code for an opportunistic infection (event) or end of the patient’s continuous health plan enrollment (censored). Time to serious infection–related encounters was measured as the time from index date to the first IP medical claim with a diagnosis code for a serious infection (event) or end of the patient’s continuous health plan enrollment (censored). Abbreviations: IP, inpatient; UST, ustekinumab; VDZ, vedolizumab; WKM, weighted Kaplan-Meier.

Figure 5. Mean healthcare costs PPPM in VDZ and UST cohorts. Note: Full details, including 95% CI, provided in Supplementary Table 3. *P value for mean cost difference < 0.01. Abbreviations: PPPM, per patient per month; UST, ustekinumab; VDZ, vedolizumab.

Figure 5. Mean healthcare costs PPPM in VDZ and UST cohorts. Note: Full details, including 95% CI, provided in Supplementary Table 3. *P value for mean cost difference < 0.01. Abbreviations: PPPM, per patient per month; UST, ustekinumab; VDZ, vedolizumab.
Supplemental material

CMRO-2023-ST-0473 Supplement clean_30Nov23.pdf

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Data availability statement

Due to the nature of the research in this study, the supporting data are not available.