Biologic Dose Adjustments May Benefit Patients With IBD

TOPLINE:

The dose escalation of biologic therapy was effective in achieving remission in up to approximately half of patients with inflammatory bowel disease (IBD), with a probability of sustaining the escalated dose ranging from 71% to 88% at 24 months across different biologics. Dose de-escalation was proved to be feasible in selected patients, with 89%-100% maintaining clinical remission at 12 months.

METHODOLOGY:

• In this cross-sectional study, researchers analysed patients with IBD enrolled in a Spanish registry (January 2012 to December 2022) from 72 Spanish centres to assess the frequency, persistence, and effectiveness of the dose escalation of biologics or their discontinuation.
• Adult patients with a diagnosis of Crohn’s disease or ulcerative colitis (UC) who received standard maintenance doses of infliximab (5 mg/kg every 8 weeks), adalimumab (40 mg every other week), golimumab (50 and 100 mg monthly for those with weight ≤ 80 kg and > 80 kg, respectively), vedolizumab (300 mg every 8 weeks), or ustekinumab (90 mg every 8 or 12 weeks) were identified.
• Overall, 5096 patients underwent dose escalation, defined as any increase in the dose and/or shortening of the dosing interval from the standard schedule’s doses. Conversely, dose de-escalation was defined as the reduction in the dose and/or lengthening of the dosing interval following an escalation regimen, occurring in 669 patients.
• The effectiveness of dose escalation or de-escalation was assessed on the basis of clinical remission with or without corticosteroids, response, and non-response.
• Factors associated with drug discontinuation after dose escalation were also assessed, with a median follow-up duration ranging from 9 to 24 months across different biologics.

TAKEAWAY:

• Among patients on various biologics, the incidence rate of dose escalation per patient-year of follow-up was 5% for those on infliximab, 7% for those on adalimumab, 7% for those on golimumab, 10% for those on vedolizumab, and 12% for those on ustekinumab.
• Remission was achieved in 32%-49% of patients after dose escalation, with a probability of maintaining the escalated dose ranging from 71% to 88% at 24 months across different biologics.
• Incidence rates of dose de-escalation per patient-year of follow-up ranged from 3% to 9% across various biologics. Factors associated with drug discontinuation after dose escalation were previous biologic exposure and the duration of IBD (for infliximab), monotherapy (for adalimumab), and the presence of UC (for ustekinumab).
• Clinical remission was observed in 89%-100% of patients who underwent dose de-escalation, with a probability of maintaining the de-escalated dose ranging from 82% to 90% at 12 months across different biologics. Factors linked to relapses after dose de-escalation were previous biologic exposure (for infliximab) and age at dose de-escalation (for adalimumab).

IN PRACTICE:

“While dose escalation offers a clear benefit in cases of LOR [loss of response], with a high proportion of patients achieving response (and remission) over time, dose de-escalation seems feasible for long-term management in selected patients, although it must be approached with caution,” the authors of the study wrote.

SOURCE:

This study was led by Cristina Rubín de Célix, MD, PhD, Department of Gastroenterology, Hospital Universitario de Fuenlabrada, Madrid, Spain. It was published online on August 08, 2025, in Alimentary Pharmacology and Therapeutics.

LIMITATIONS:

Drug trough levels and antidrug antibodies were not routinely measured prior to dose escalation and de-escalation. The small number of patients undergoing vedolizumab or ustekinumab dose de-escalation precluded definitive conclusions about these regimens. Response after dose escalation and outcomes following dose de-escalation were determined solely by clinician judgement as endoscopic confirmation was unavailable.

DISCLOSURES:

This study received support from Eli Lilly and Company for the statistical analysis, medical writing, and publication fees alone. Several authors reported receiving education funding, support for congress and conference attendance or travelling, speaker fees, research support, and consulting fees and serving as speakers, consultants, and advisory members for various pharmaceutical companies.

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