High infliximab trough levels are associated with low risk of relapse when switching to subcutaneous infliximab in patients with inflammatory bowel disease, suggests new REMSWITCH study data presented at ECCO 2022 virtual congress
Celltrion Healthcare have announced two new data sets on the SC formulation of infliximab, Remsima® (CT-P13) in IBD, at the European Crohn’s and Colitis Organisation (ECCO) virtual congress 2022.
- New data from the REMSWITCH study shows switching from intravenous (IV) to subcutaneous (SC) infliximab leads to higher infliximab trough levels and a low risk of relapse in patients with inflammatory bowel disease (IBD).
- Data from the RTDM study show infliximab drug levels are stable across a 14-day treatment cycle for Crohn’s disease (CD) patients in remission, under maintenance therapy with Remsima® SC, enabling therapeutic drug monitoring to be performed at any time between the two SC injections.
The REMSWITCH Study
REMSWITCH, investigated the clinical and pharmacological impact of switching from IV to SC formulation of infliximab in patients with IBD, to evaluate the feasibility of switching and to determine the equivalence between IV and SC doses. In the study, 130 patients (73.1% CD patients, 26.9% ulcerative colitis [UC] patients) in clinical remission, each on an IV dose regimen of 5mg/kg/8weeks, 10mg/kg/8weeks, 10mg/kg/6weeks and 10mg/kg/4weeks, were switched to SC infliximab 120mg/ 2weeks, regardless of IV doses.
Results showed switching patients from IV to SC infliximab is feasible, well-accepted and leads to a low risk of relapse in patients with IBD:
- Infliximab trough levels were significantly higher after switching from IV to SC (9.8 ± 6.4 µg/ml vs 14.4 ± 5.7 µg/ml; p<0.0001)
- Trough levels increased in patients receiving 5mg/kg/8weeks (6.3 ± 3.4 µg/ml vs 14.7 ± 5.7 µg/ml; p<0.0001) or 10mg/kg/8weeks (8.4 ±5.6 µg/ml vs 13.7 µg/ml ±6.6; p=0.001)
- Trough levels remained stable in those treated with 10mg/kg/6weeks (11.1 ±7.6 µg/ml vs 13.1 ±5.1 µg/ml; p=0.31) or 10mg/kg/4weeks (17.8 ±4.2 µg/ml vs 15.8 ±4.6 µg/ml; p=0.12)
- 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: 5 mg/kg/8weeks, 10 mg/kg/8weeks, 10 mg/kg/6 weeks and 10 mg/kg/4 weeks (p=0.003).
- Clinical relapse after switching which leads to therapeutic escalation was observed in 11.1% and dose increase (240 mg/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=0.024)
- Patient’s acceptability was better with SC injections compared to IV infusions (10-point acceptability numerical scale = 8.7 ±1.6 µg/ml vs 6.8 ±0.9 µg/ml; p<0.0001)
Professor Anthony Buisson, MD, PhD, IBD Unit, CHU Clermont-Ferrand, France and Principal Investigator of the trial said, “The study results show that switching from intravenous to subcutaneous infliximab (120 mg/2weeks) is feasible and well-accepted leading to a low risk of relapse in patients with IBD including those with escalated intravenous doses. In addition, dose increase (240 mg/2weeks) induced clinical remission in 93.3% of relapsing patients.”
The RDTM Study
The second study investigated the intra-individual variations of infliximab drug levels at multiple time points during two consecutive cycles of maintenance therapy with Remsima® SC. Study results show that infliximab drug levels are stable across a 14-day treatment cycle. For CD patients in remission under maintenance therapy with Remsima® SC, therapeutic drug monitoring of infliximab can therefore be performed at any time between the two SC injections.
“This is the first real-world study analysing serum levels of infliximab at different time-points between two SC injections of infliximab and during two cycles at steady state during maintenance regimen in remitted CD patient,” said Professor Xavier Roblin, Department of Gastroenterology, University Hospital of Saint-Etienne, Saint-Etienne, France. “Our results clearly demonstrated stable levels of infliximab all over this period.”
Read the REMSWITCH study here
Read the RDTM study here