Real-World Persistence, Maintenance Dosing, and Pre-Post Corticosteroid and Opioid Use Among Crohn's Disease Patients with Prescription Claims for Ustekinumab in the USA

Zhijie Ding; Camilo Obando; Erik Muser; Chris Kozma; Terra Slaton

doi:10.1007/s40801-021-00264-5

Real-World Persistence, Maintenance Dosing, and Pre-Post Corticosteroid and Opioid Use Among Crohn's Disease Patients with Prescription Claims for Ustekinumab in the USA

Drugs Real World Outcomes. 2021 Dec;8(4):565-575. doi: 10.1007/s40801-021-00264-5. Epub 2021 Jun 16.

Authors

Zhijie Ding¹, Camilo Obando², Erik Muser², Chris Kozma³, Terra Slaton⁴

Affiliations

¹ Janssen Scientific Affairs, LLC, Horsham, PA, USA. zding17@ITS.JNJ.com.
² Janssen Scientific Affairs, LLC, Horsham, PA, USA.
³ Independent Consultant, St Helena Island, SC, USA.
⁴ Independent Consultant, West Columbia, SC, USA.

Abstract

Background: Real-world evidence for how US Crohn's disease (CD) patients use ustekinumab is limited.

Objectives: The aim of this study was to describe the persistence, maintenance dosing, and pre-post corticosteroid and opioid use for CD patients in the USA treated with ustekinumab and those treated with adalimumab as a commonly used descriptive reference product.

Methods: CD patients aged ≥ 18 years with ≥2 CD diagnoses between 1 October 2012 and 31 May 2018 and ≥ 1 new (i.e., no claim for at least 1 year) outpatient pharmacy claim for ustekinumab or adalimumab (first claim date = index date) on or after 26 September 2016 were selected from Symphony Health database. McNemar's tests were used to derive the p-values for pre-post changes in corticosteroid and opioid use within each treatment cohort.

Results: A total of 1073 ustekinumab and 2904 adalimumab patients met analysis criteria. Using a 90-day rule for discontinuation, persistence at 1 year post-index was 69.8% for ustekinumab and 65.1% for adalimumab. The majority received doses within ±30% of the approved labeling (ustekinumab 81.1%; adalimumab 78.8%). Doses higher than US package insert (PI) recommended maintenance dose were 7.0% for ustekinumab and 13.6% for adalimumab for 30% above PI, respectively; and 4.0% versus 9.4% for 50% above PI, respectively. Rates of pre-index biologic use suggest that patients treated with ustekinumab may have greater CD severity based on a greater percentage being biologic-experienced (ustekinumab 51.5% and adalimumab 8.4%). From pre- to post-index, the relative proportion of ustekinumab patients with ≥ 1 pharmacy claim for corticosteroids decreased by 25.5% (p < 0.0001) and opioids decreased by 8.4% (p = 0.0030). Results for adalimumab (a commonly used descriptive reference product in CD) showed generally similar trends.

Conclusions: In this real-world study, persistence for ustekinumab remained high at 1 year. The majority of the patients in the ustekinumab cohort followed US PI recommended dosing. The percentage of patients with average dose above PI recommendations over 1 year were low for ustekinumab. Reductions in the proportion of patients with claims for corticosteroids or opioids were observed in patients using ustekinumab.