Dose–escalation of adalimumab, golimumab or ustekinumab in inflammatory bowel diseases: characterization and implications in real-life clinical practice

Abstract

Objectives

Dose–escalation is a common practice to optimize treatment with subcutaneously administered biologicals in Crohn’s disease (CD) and ulcerative colitis (UC). However, limited data is available on the extent of dose-escalation in real-life. Here, we analyzed treatment persistence, dose–escalation, concomitant corticosteroid use, and costs of adalimumab, golimumab, and ustekinumab in inflammatory bowel diseases (IBD).

Methods

This was a nationwide, retrospective, non-interventional registry study. All adult patients who were diagnosed with CD or UC and had purchased adalimumab, golimumab, or ustekinumab from Finnish pharmacies between 2008 and 2018 were included in the study and followed up for 24 months after treatment initiation.

Results

A total of 2884 patients were included in the analyses. For adalimumab, treatment persistence was higher for CD patients compared to UC patients both at months 12 (46.2% versus 37.1%; p < .0001) and 24 (26.1% versus 19.7%; p < 0.0001). For golimumab (UC), treatment persistence was 48.3% at month 12 and 28.1% at month 24. The 12-month treatment persistence rate for patients on ustekinumab (CD) was 47.1%. Cumulative doses exceeding the regular dosing according to the summary of product characteristics (SPC), was observed for adalimumab in CD during the first 6 months of treatment (62.9% of the treatment periods), golimumab in the later stages of the UC treatment (52–54% of treatment periods at months 7–24), and ustekinumab during the first 6 months (70.7%).

Conclusions

Based on this study, dose–escalation of subcutaneously administered biologicals is a common clinical practice in IBD. This has implications for treatment costs, use of concomitant medications, and treatment outcomes.

Keywords:

• Subcutaneous IBD therapy
• adalimumab
• golimumab
• ustekinumab
• treatment persistence
• treatment cost
• dosing
• corticosteroid

Acknowledgments

Harlan Barker from MedEngine Oy is acknowledged for language review.

Disclosure statement

T. Y. is owner of MedEngine Oy and J. J. and M. K. are employees of MedEngine Oy. MedEngine Oy has been paid by Takeda Oy to perform the analyses described in this study. M. P. and K. T. are employees of Takeda Oy. S. T. is a former employee of Takeda Oy. M. V. has been reimbursed by Biocodex (Finland), Ferring (Finland), Pfizer (Finland), and Olympus (Finland) for attending conferences, and by Finnish Medical Society Duodecim for writing articles.

Additional information

Funding

This work was supported by Takeda Oy.