Long-term persistence and other treatment patterns among bio-naïve patients with Crohn’s disease treated with ustekinumab or adalimumab

Abstract

Objective

To estimate long-term persistence among bio-naïve patients with CD initiated on ustekinumab or adalimumab.

Methods

Adults with CD initiating ustekinumab or adalimumab (index date, between September 23, 2016 and August 1, 2019) were sampled from the IBM MarketScan Commercial Database. Patients without CD-indicated biologics (bio-naïve) and with no diagnoses for other autoimmune diseases 12 months pre-index date (baseline) were included. Cohorts were balanced on baseline characteristics with inverse probability of treatment weighting. Persistence was defined as the absence of therapy exposure gaps >120 days (ustekinumab) or >60 (adalimumab) between days of supply. Composite endpoints were persistence and being corticosteroid-free (no corticosteroids >14 days of supply after day 90 post-index) and persistence while on monotherapy (no immunomodulators/non-index biologics). Persistence was analyzed using Kaplan-Meier and Cox’s models.

Results

Ustekinumab and adalimumab cohorts included 671 and 2,975 patients. At 12 months post-index, ustekinumab patients were significantly more persistent (hazard ratio [HR] = 1.60; 95% confidence interval [CI] = 1.33–1.93), persistent while on monotherapy (HR = 1.43; 95% CI = 1.24–1.65), and trended toward being more persistent and corticosteroid-free (HR = 1.14; 95% CI = 0.99–1.30) vs adalimumab. At 24 months post-index, ustekinumab patients were significantly more persistent (HR = 1.66; 95% CI = 1.40–1.97), persistent while on monotherapy (HR = 1.44; 95% CI = 1.26–1.64), and persistent and corticosteroid-free (HR = 1.15; 95% CI = 1.01–1.31) vs adalimumab.

Conclusions

Bio-naïve patients with CD initiated on ustekinumab demonstrated significantly more persistence than patients initiated on adalimumab at 12 and 24 months of treatment. Long-term persistence is a measure of a drug’s real-world performance and findings may aid clinical decision-making.

PLAIN LANGUAGE SUMMARY

• Choosing a treatment on which a patient can stay over a long period of time is key for the successful management of chronic conditions such as Crohn’s disease. Information on whether and how long patients stay on treatment can help physicians make the right therapeutic choice. This study examined whether adults with Crohn’s disease, who have not previously taken biologics, stay on treatment longer when given the biologic ustekinumab or adalimumab. At 12 and 24 months after starting the treatment, a larger proportion of patients were still using ustekinumab compared with adalimumab. The proportion of patients using the biologic without immunomodulators or other biologics was also higher with ustekinumab. The results suggest that patients without previous biologic experience stay on treatment longer with ustekinumab than with adalimumab.

Keywords:

• Crohn’s disease
• inflammatory bowel disease
• biologics
• outcomes research
• long-term persistence
• clinical pharmacology

Transparency

Declaration of financial/other relationships

All authors declare competing interests. MZ, AMM, CH, and DP 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. ZD, RZ, and SK are employees of Janssen Scientific Affairs, LLC and stockholders of Johnson and Johnson, Inc. JI was an employee of Janssen Scientific Affairs, LLC, at the time this study was conducted. Peer reviewers on this manuscript have no relevant financial or other relationships to disclose.

Author contributions

All authors (MZ, ZD, AMM, RZ, CH, SK, JI, and DP) 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 read and approved the final manuscript.

Acknowledgements

Medical writing assistance was provided by Loraine Georgy, PhD, an employee of Analysis Group, Inc. which provided paid consultancy services to Janssen Scientific Affairs, LLC, for the conduct of this study.

Data availability statement

The data from IBM MarketScan Commercial Database that support the findings of this study are not publicly available. Restrictions apply to the availability of these data, which were used under license for this study. The data are available through request made directly to the data vendor, subject to the data vendor’s requirements for data access.

Ethics statement

This study used the IBM MarketScan Commercial Database, which contains retrospective de-identified data and complies with the patient confidentiality requirements of the HIPAA. Studies with retrospective de-identified claims data do not require a waiver of an ethics committee, per Title 45 of CFR, Part 46.101(b) (4) (www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.html#46.101). Therefore, this study is exempt from review by an ethics board for two reasons: (1) it is a retrospective analysis of existing administrative claims data (i.e. it did not involve the participation of any humans; hence, no patient intervention or interaction), and (2) no patient-identifiable information is included in the claims data.

Throughout the study, patient privacy was preserved, and researchers complied strictly with all applicable HIPAA data management rules and the 1964 Helsinki Declaration and its later amendments or comparable ethical standards. Patient consent was not required for this study.

Additional information

Funding

This study was funded by Janssen Scientific Affairs, LLC.