Treatment persistence among bio-naïve patients with Crohn’s disease initiated on ustekinumab or adalimumab

Abstract

Objectives

To compare persistence and describe dose titration among bio-naïve patients with Crohn’s disease (CD) initiated on ustekinumab or adalimumab.

Methods

Bio-naïve adults with CD who initiated ustekinumab or adalimumab (index date) from 23 September 2016 (ustekinumab US approval for CD) to 1 August 2019 were selected from IQVIA PharMetrics Plus. Cohorts were balanced on baseline characteristics measured over 12 months pre-index using inverse probability of treatment weights. Persistence was defined as no gaps (ustekinumab: >120 days; adalimumab: >60 days) between days of supply. Dose escalation was defined as ≥2 consecutive sub-cutaneous claims 100% above the US label daily dose in the maintenance phase; de-escalation was a return to the daily dose for ≥2 consecutive claims. Outcomes were described using weighted Kaplan-Meier models; persistence outcomes were compared using Cox’s proportional hazards models.

Results

At 12 months post-index, patients in the ustekinumab (n = 948) versus adalimumab (n = 4143) cohort had a significantly higher rate of persistence on index biologic (hazard ratio [HR] 1.50; 95% confidence interval [CI]: 1.29–1.74). A total of 830 (87.6%) patients in the ustekinumab cohort and 3713 (89.6%) in the adalimumab cohort began the maintenance phase; within 12 months, 11.2% and 16.9%, underwent a dose escalation, and 26.6% and 6.3%, respectively, subsequently de-escalated to the per US label daily exposure.

Conclusions

Bio-naïve patients with CD initiated on ustekinumab were more persistent than patients initiated on adalimumab; moreover, these patients had numerically lower dose escalation and higher de-escalation rates than patients initiated on adalimumab. Findings support the use of ustekinumab as a first-line treatment for bio-naïve patients with CD.

Keywords:

• Crohn’s disease
• inflammatory bowel disease
• biologics
• outcomes research
• compliance/adherence
• clinical pharmacology

Transparency

Declaration of financial/other relationships

Maryia Zhdanava, Ameur M. Manceur, Patrick Lefebvre, Christopher Holiday, Marie-Hélène Lafeuille, and Dominic Pilon are employees of Analysis Group, Inc., a consulting company that provided paid consulting services to Janssen Scientific Affairs, LLC, for the conduct of this study. Zhijie Ding and Erik Muser are employees of Janssen Scientific Affairs, LLC and stockholders of Johnson and Johnson, Inc.

A reviewer on this manuscript has disclosed that they received have fees for serving as a speaker for UCB, Janssen, Takeda, AbbVie and research funding from AbbVie, Takeda and Janssen. Peer reviewers on this manuscript have no other relevant financial relationships or otherwise to disclose.

Author contributions

All authors (Maryia Zhdanava, Zhijie Ding, Ameur M. Manceur, Erik Muser, Patrick Lefebvre, Christopher Holiday, Marie-Hélène Lafeuille, and Dominic Pilon) have made substantial contributions to the conception and design of the study, or analysis and interpretation of the data, and drafting of the paper and revising it critically for important intellectual content. All authors have given their approval to submit this version of the manuscript for publication and agree to be accountable for all aspects of the work.

Acknowledgements

The authoyee of Analysis Group, Inc., a consulting company that provided paid consulting services to Janssen Scientific Affairs, LLC., which funded the development and conduct of this study and manuscript.

Data availability statement

The data that support the findings of this study are available from IQVIA PharMetrics Plus. Restrictions apply to the availability of these data, which were used under license for this study.

Previous presentations

Results were presented as a poster at the American College of Gastroenterology Annual Scientific Meeting 2021, 22–27 October 2021.

Additional information

Funding

This study was funded by Janssen Scientific Affairs, LLC.