SC Infliximab Superior to IV Dosage in Patients With Crohn Disease, Ulcerative Colitis

New data from Celltrion Healthcare show the subcutaneous (SC) form of infliximab, Remsima (CT-P13), yielded superior benefits in patients with inflammatory bowel disease (IBD) compared with intravenous (IV) dosing.

Findings presented at the European Crohn’s and Colitis Organization (ECCO) virtual congress 2022 also showed maintenance therapy with Remsima SC resulted in stable drug levels across a 14-day treatment cycle in a remitted patient with Crohn disease (CD), meaning drug monitoring could be performed at any time between the 2 injections, increasing patient convenience.

Celltrion’s infliximab was the first monoclonal antibody biosimilar to receive approval from the European Commission and is currently indicated for 8 autoimmune diseases, including IBD and rheumatoid arthritis.

Whereas infliximab IV must be given as an infusion over the course of 2 hours while patients are monitored for 1 to 2 hours afterward, the SC dose can be administered via a pre-filled pen, pre-filled syringe, or pre-filled syringe with needle safeguard. In the European Union, a 120 mg fixed dose of SC infliximab has been granted marketing authorization for adults regardless of body weight.

In the REMSWITCH study, 130 patients in remission (73% with CD and 26.9% with ulcerative colitis [UC]) were switched from 3 different IV dose regimens to SC infliximab at 120mg every 2 weeks.

After switching, analyses showed average Infliximab trough levels were significantly higher (9.8 [6.4] µg/ml vs 14.4 [5.7] µg/ml; P<.0001), with levels increased among patients who underwent 5mg/kg/8weeks or 10mg/kg/8weeks IV regimen. Levels remained stable in those who were treated with 10mg/kg/6weeks or 10mg/kg/4weeks of IV Remsima.

Data also revealed:

• Infliximab trough levels remained stable (variation V1-V0 (Visit 0 = V0) < [1]) in 4.3%, 15.0 %, 33.3 % and 50.0 % of the patients switched from the following IV doses respectively: 5mg/kg/8weeks, 10mg/kg/8weeks, 10mg/kg/6 weeks and 10mg/kg/4 weeks (P = .003)
• Clinical relapse after switching, which leads to therapeutic escalation, was observed in 11.1% and dose increase (240mg/2weeks) induced clinical remission in 93.3% of relapsed patients
• The risk of relapse was higher in patients with stable or decreasing trough levels after the switch, compared to those with increased trough levels (31.8% vs 7.1%; P = .024)

Patients reported greater acceptability of the SC injection compared with IV infusions.

Additional research was presented from the RDTM study evaluating intra-individual variations of the drug levels at different time points throughout 2 consecutive cycles of maintenance therapy.

“This is the first real-world study analyzing serum levels of infliximab at different time-points between 2 SC injections of infliximab and during 2 cycles at steady state during maintenance regimen in remitted CD patient,” said Xavier Roblin, MD, of the department of gastroenterology at the University Hospital of Saint-Etienne in France. “Our results clearly demonstrated stable levels of infliximab all over this period.”

Approximately 5 million individuals worldwide suffer from IBD.