OBJECTIVES: The Joint Canadian Ustekinumab Real World Effectiveness and Safety in Bio-naïve Patients with moderately-to-severely active Crohn’s Disease (JUSTify) study assessed healthcare resource utilization (HCRU) among bio-naïve Crohn’s disease (CD) patients treated with ustekinumab.

METHODS: JUSTify was a retrospective chart review study of adult patients with CD who received at least 1 induction dose of ustekinumab and had a minimum of 6 months follow-up data. HCRU included CD-related surgery, hospitalization, or emergency room (ER) visits. Cost inputs in 2021 Canadian dollars were obtained from the Ontario Case Costing Initiative. Complete case analysis was used to descriptively assess and summarize all study endpoints. A paired analysis was conducted to compare incurred HCRU and costs for the same patient whilst in remission versus not.

RESULTS:

The study included 158 patients with a mean age of 42.3 (SD:16.6) years. Females represented 53.8% (85/158). By 12 months, 93.5% of patients persisted on ustekinumab. Remission was achieved by 50.0%, 67.7%, and 73.7% of patients at 4, 6, and 12 months, respectively.

By 12 months, 11.1% of patients treated with ustekinumab had any CD-related HCRU, with the most common being ER visit (7.7%), followed by surgery (5.9%), and hospitalization (5.2%).

The average HCRU total annual cost per patient was $530.5 most of which was due to hospitalizations (82.2%, $436.1). Average annual costs for ER visits and outpatient surgeries were $59.6 and $31.0 per patient, respectively.

In the paired analysis (n=129), patients had fewer healthcare events whilst in remission versus when not (≤3.9% vs. 7%, p=0.289). Furthermore, numerically lower costs were incurred by a patient when in remission versus when not ($102.5 vs. $413.2, p=0.080).

CONCLUSIONS:

Most patients remained on ustekinumab therapy by 12 months. HCRU events and associated costs were incurred by few patients overall and were lower when patients were in remission.