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TOPLINE:

Among patients with inflammatory bowel disease (IBD), overlapping biologic therapy was common during medication switches and was not associated with a higher risk for infection than nonoverlapping biologic therapy, indicating that shorter washout periods could improve therapeutic management of IBD (ulcerative colitis or Crohn’s disease) without compromising safety.

METHODOLOGY:

• The US Food and Drug Administration advises a medication washout period of five half-lives when switching patients to a different biologic in trials for ulcerative colitis or Crohn’s disease, but in clinical practice physicians often favor a faster process, which leads to some overlap in biologics.
• Researchers conducted a retrospective observational study using US health insurance claims data to assess the frequency of biologic switches in clinical practice and the infection risk in patients with IBD whose biologics overlapped during the switching process and those whose biologics didn’t overlap.
• The study population consisted of adult patients with IBD with new initiated biologic therapy (infliximab or a biosimilar, golimumab, adalimumab, natalizumab, vedolizumab, certolizumab, or Ustekinumab) between September 2017 and August 2022.
• Switch events were defined as the move to a different biologic 1 day or more after initiation of the first biologic. A switch was considered overlapping if it was initiated within five half-lives after discontinuation of the initial biologic and nonoverlapping if it was initiated more than five half-lives after discontinuation of the initial biologic.

TAKEAWAY:

• Among 11,992 adult patients newly initiating biologic therapy (median age, 47 years; 52.7% women), 1293 (10.8%) underwent a biologic switch during a minimum follow-up of 90 days.
• Among the switches, 64.2% were overlapping, and the median time between the last administration of the initial biologic and the first dose of the subsequent biologic was 47 days, or 3.26 half-lives.
• The most common overlapping switch was from vedolizumab (82.7%), whereas the most common nonoverlapping switch was from infliximab (60.3%).
• No significant differences were observed in the adjusted hazard ratios or incidence rates per 1000 person-years for any infection or serious infection between patients with overlapping switches and those with nonoverlapping switches.

IN PRACTICE:

“In clinical practice, shortening washout periods could improve persistence on therapy by avoiding prolonged gaps in treatment and also prevent UC/CD [ulcerative colitis/Crohn’s disease] symptoms worsening during washout periods, with minimal additional risk of serious infection from overlapping therapies. Clarifying guidance may alleviate confusion in UC/CD biologic switching and prevent adverse outcomes due to preventable therapy lapses or discontinuations,” the authors wrote.

SOURCE:

This study, led by Annie J. Kruger, MD, PhD, clinical lead, Immunology and Inflammation, Sanofi, Cambridge, Massachusetts, was published online in Clinical Gastroenterology and Hepatology.

LIMITATIONS:

Findings of this study may not be generalized and applicable to uninsured or non-US populations. Exposures, covariates, and outcomes may have been misclassified owing to inaccurate or incomplete coding of claims. Additionally, the overlapping and nonoverlapping switch periods varied by therapeutic half-life, and therapies with longer half-lives required longer enrollment periods.

DISCLOSURES:

This study was funded by Sanofi. Six authors reported being current or former employees of Sanofi and may have held stock options or equity in the company. Many other authors reported receiving research funding, honorarium, grants, payments for lectures, and consulting fees and having other ties with various pharmaceutical, healthcare, and biotechnology companies. 

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.