Factors Associated with Biologic Treatment De-Escalation in Patients with Crohn’s Disease

OBJECTIVES: Long-term biologic treatment in Crohn’s disease (CD) can pose important economic and safety concerns. One treatment strategy that has been proposed is biologic de-escalation. The aim of this study was to identify factors associated with biologic de-escalation among patients with CD in remission.

METHODS: We identified adult CD patients in remission (no/low-dose steroid use for ≥6 months) continuously treated with biologics for ≥8 months from the Merative Marketscan Research Databases during the period from 2010-2021. We identified individuals with a biologic treatment gap (>30 days) as those with therapy de-escalation. We compared those with de-escalation to individuals that continued treatment and identified factors associated with de-escalation using logistic regression.

RESULTS: In the cohort (n=12,606; mean age: 40 [SD: 16] years; female: 50%), 38% (4,827) were identified as having a period of de-escalation. Individuals in the de-escalation group had a median of one de-escalation period (IQR: 1-2) during the follow-up period. The median duration of the de-escalation period was 4.5 months (IQR: 3.0-12.2). When contrasting the de-escalation group with the continuous treatment group, predictors of de-escalation included renal disease (OR: 1.29; 95% CI: 1.03-1.61), unspecified disease location vs. ilium colonic disease location (OR: 1.19; 95% CI: 1.08-1.32), ilium disease location (OR: 1.12; 95% CI: 1.01-1.25), and prior CD-related emergency visits (OR: 1.16; 95% CI: 1.04-1.30). Factors associated with being in the continuous treatment group were male gender (OR: 0.89; 95% CI: 0.83-0.96), recent cohort entrance (OR: 0.52; 95% CI: 0.49-0.57), and use of intravenous biologics (OR: 0.56; 95% CI: 0.52-0.61). Other factors including prior CD-related hospitalizations, prior surgeries, stricture, fistula, and anemia were not significantly associated with either group.

CONCLUSIONS: Biologic de-escalation post remission was not uncommon in CD patients and factors beyond disease severity were associated with de-escalation. Future studies should investigate the real-world effectiveness of biologic de-escalation post remission on patient outcomes.