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Infliximab subcutaneous outcomes remain stable despite prior anti-drug antibodies
A post hoc analysis of the phase 3 LIBERTY-CD and LIBERTY-UC trials suggests that prior anti-drug antibodies (ADAs) do not significantly impact clinical outcomes for patients restarting subcutaneous (SC) infliximab 240 mg after a drug holiday.
Presented at the American College of Gastroenterology 2026 Annual Scientific Meeting, the study found that most patients with Crohn disease (72.5%) or ulcerative colitis (92.2%) who restarted SC infliximab after an interruption in intravenous (IV) therapy had detectable ADAs. Despite the presence of these antibodies, clinical outcomes remained generally similar regardless of prior ADA status.
While ADAs can compromise the reinitiation of IV infliximab, investigators led by Dr. Marla Dubinsky of the Icahn School of Medicine at Mount Sinai noted that data on SC infliximab initiation following a drug holiday remains limited. The subcutaneous formulation, infliximab-dyyb (Zymfentra), received FDA approval in October 2023 for the maintenance treatment of these conditions following IV induction.
Entities
American College of Gastroenterology · Icahn School of Medicine at Mount Sinai · Marla Dubinsky · U.S. Food and Drug Administration