An Australian Real-World Study of Treatment Persistence of Ustekinumab in Crohn’s Disease

Abstract

Introduction

Real-world treatment persistence to ustekinumab for Crohn’s disease (CD) was studied using Australian Pharmaceutical Benefits Scheme (PBS) data. Demographic and treatment pattern characteristics were also investigated.

Methods

Our retrospective cohort analysis included PBS 10% sample data for ustekinumab from September 2017 to March 2020, and for other biologics from October 2007 to capture earlier line(s) of therapy. Included patients received ustekinumab for CD prescribed by a gastroenterologist. Treatment persistence overall and by prior biologic experience, mono- or combination therapy, sex and age were estimated using Kaplan–Meier methods. A Cox proportional hazards regression analysis was performed to assess the effect of age, sex and line of therapy on persistence.

Results

Data were available for 301 patients. Of these, 58.8% were female and 76.7% were aged 26–65 years. Median follow-up from first ustekinumab dispense was 16 months. Median persistence to ustekinumab had not been reached. Twelve-month persistence to ustekinumab was 82.6% (95% CI 78.1–87.5%). Patients receiving ustekinumab as their first biologic therapy had 12-month persistence of 88.0% (80.8–95.9%) compared to 80.6% (75.0–86.6%) for patients who had previously received other biologic therapies (p=0.059). The adjusted analysis showed a trend to longer persistence for patients receiving ustekinumab as their first biologic therapy compared to biologic experienced patients (HR 1.86 (95% CI 0.95–3.63), p=0.070). Males had higher persistence to ustekinumab than females (HR 0.36 (0.20–0.66), p<0.001). Receiving ustekinumab as a monotherapy or in combination with azathioprine, mercaptopurine, 5ASAs, methotrexate, or corticosteroids had no effect on persistence (p=0.22).

Conclusion

In an Australian real-world setting, persistence to ustekinumab was demonstrated to be over 80% at 12 months. Use as monotherapy or in combination with other therapy for CD did not affect persistence. Differences in treatment persistence by gender and previous biologic use warrant further investigation as further long-term data becomes available.

Graphical abstract

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Keywords:

• persistence
• durability
• real-world data
• Crohn’s disease
• ustekinumab

Acknowledgments

The authors thank Caroline Pile of WriteSource Medical Pty Ltd, Sydney, Australia, for providing medical writing support, which was funded by Janssen-Cilag Pty Ltd in accordance with Good Publication Practice (GPP3) guidelines (http://www.ismpp.org/gpp3).

Disclosure

AP, THC and THWH are employees of Janssen-Cilag Australia Pty Ltd. TK, MK and SC are employees of Prospection who were contracted by Janssen-Cilag to conduct this analysis. The authors report no other conflicts of interest in this work.

Additional information

Funding

This study was funded by Janssen-Cilag Pty Ltd, the manufacturer of ustekinumab.