A large real-world study has demonstrated that switching from intravenous to subcutaneous infliximab maintenance therapy may be effective, safe, and patient-friendly in patients with inflammatory bowel disease.
In the study, published in Digestive Diseases and Sciences, researchers consolidated key findings, reporting high treatment persistence rates, stable clinical outcomes, and increased infliximab concentrations without significant safety concerns.
The study analyzed 274 patients (104 with Crohn's disease [CD] and 170 with ulcerative colitis [UC]). Treatment persistence at 12 months postswitch was 94.8% for CD and 88.8% for UC, with only 11.3% discontinuing subcutaneous therapy over a median follow-up of 79 weeks. Infliximab concentrations were significantly higher during subcutaneous administration (median = 16.75 µg/ml) compared with intravenous (IV) trough levels (6.71 µg/ml, P < .0001). Clinical disease activity and fecal calprotectin levels remained stable at 3, 6, and 12 months, reflecting sustained disease control without redundant mentions.
"Switching to subcutaneous infliximab maintenance therapy was associated with high treatment persistence, a stable disease course, increased infliximab concentrations, and an acceptable safety profile," said lead study author Jaakko Rautakorpi, of the Abdominal Center–Department of Gastroenterology at the University of Turku and Turku University Hospital in Turku, Finland, and colleagues.
Adverse events occurred in 15% of patients, mainly mild reactions such as local injection site irritation and rashes. Serious adverse events were rare (1.5%) and included infections requiring hospitalization. Six patients discontinued subcutaneous therapy as a result of adverse effects. The streamlined presentation of safety information reduces previous overlaps.
Subcutaneous infliximab’s higher and more stable concentrations may better support long-term remission, reducing the risk of immunogenicity associated with fluctuating drug levels. The subcutaneous formulation also improved patient convenience by eliminating the need for regular hospital visits required for IV infusions, potentially enhancing adherence and quality of life. These clinical advantages have been combined into a single cohesive section to eliminate repetition.
The researchers indicated that future studies should explore dose adjustment strategies and patient-reported outcomes to provide a more comprehensive understanding of the therapy’s impact. They emphasized that randomized multicenter studies with longer follow-up periods are needed to confirm these findings and further evaluate subcutaneous infliximab in broader inflammatory bowel disease management.
Full disclosures can be found in the study.
