SC infliximab retreatment

SC infliximab retreatment has demonstrated the ability to restore and maintain disease control in patients with inflammatory bowel disease after a treatment interruption. New findings from Celltrion, Inc. show sustained efficacy, safety, and persistence through Week 102 in Crohn’s disease and ulcerative colitis. The results will be presented at the 21st Congress of the European Crohn’s and Colitis Organisation in Stockholm.

Managing Treatment Interruption in IBD

Interruptions in biologic therapy can occur for clinical or personal reasons. However, restarting infliximab may raise concerns about immunogenicity and reduced response. Therefore, evidence supporting effective retreatment strategies is essential.

According to Dr. Marla Dubinsky of the Icahn School of Medicine at Mount Sinai, patients were able to regain disease control early after restarting therapy. Moreover, clinical response was maintained through Week 102, even in some patients with immunogenicity.

Professor Stefan Schreiber of University Hospital Schleswig-Holstein highlighted that the data provide reassurance for clinicians considering reinitiating therapy after a drug holiday.

LIBERTY Study Results

The post-hoc analysis included Crohn’s disease (CD) and ulcerative colitis (UC) patients from the Phase 3 LIBERTY-CD and LIBERTY-UC trials. After completing intravenous induction, participants assigned to placebo maintenance experienced a drug holiday of at least 16 weeks before starting subcutaneous infliximab 240 mg.

Among 51 CD and 77 UC patients, clinical response was observed within 8±2 weeks. Importantly, improvements were sustained through Week 102.

By the end of treatment:

  • 61.1% of CD and 65.2% of UC patients achieved faecal calprotectin remission.

  • 64.0% of CD and 68.8% of UC patients achieved endoscopic response or improvement.

  • Treatment persistence reached 72.3% in CD and 61.9% in UC patients.

In addition, serum infliximab levels increased after restarting therapy and remained stable. No new safety concerns were identified during follow-up.

Implications for Clinical Practice

These findings suggest that restarting subcutaneous infliximab can effectively recapture and maintain disease control after a planned or unplanned interruption. Furthermore, the subcutaneous formulation offers a convenient option that may support long-term management.

Overall, the ECCO 2026 data strengthen the evidence base for retreatment strategies in inflammatory bowel disease and provide reassurance for both clinicians and patients navigating therapy interruptions.

Read Also: HanchorBio FDA Orphan Drug Designation Boosts HCB101 for Gastric Cancer