From Intravenous to Subcutaneous Infliximab: the Same but Different? Real-World Evidence from a Tertiary Center

Area of Science:

• Gastroenterology
• Immunology
• Pharmacology

Background:

• A subcutaneous formulation of infliximab has been approved, offering potential convenience over the intravenous route.
• Limited data exist on the pharmacokinetics and immunogenicity of subcutaneous infliximab compared to its intravenous counterpart.

Purpose of the Study:

• To compare the efficacy and tolerability of subcutaneous infliximab versus intravenous infliximab.
• To assess if the subcutaneous formulation leads to higher plasma infliximab levels.

Main Methods:

• A retrospective, single-center cohort study involving 41 patients with Crohn's disease or ulcerative colitis.
• Patients stable on intravenous infliximab were switched to subcutaneous infliximab (120 mg every 2 weeks).
• Clinical evaluations, plasma infliximab levels, and anti-drug antibodies were measured at baseline and at weeks 2, 8, and 16.

Main Results:

• All 41 patients maintained clinical remission, with 95.1% treatment persistence.
• Median infliximab plasma levels increased significantly from week 0 to week 16 (4.89 to 21.55 ug/mL).
• No anti-drug antibodies were detected; mild adverse events included injection site reactions and arthralgia.

Conclusions:

• Switching to subcutaneous infliximab effectively maintains clinical response in IBD patients.
• The subcutaneous formulation leads to increased infliximab plasma levels and demonstrates good tolerability.
• Subcutaneous infliximab may potentially reduce the need for concomitant immunomodulators.