Two studies of Remsima SC shows switching to subcutaneous therapy has no impact on treatment for inflammatory bowel disease – Celltrion Healthcare

Celltrion Healthcare announced two data sets relating to the use of the subcutaneous formulation of infliximab, Remsima SC (CT-P13 SC), in inflammatory bowel disease (IBD).

The first study investigated clinical impact of switching from intravenous (IV) to subcutaneous (SC) treatment of infliximab in patients with Crohn’s disease (CD) or ulcerative colitis (UC) from the pivotal randomised controlled trial of CT-P13 SC.3 65 patients (25 CD patients, 40 UC patients) were included in the CT-P13 IV arm in which patients received CT-P13 5 mg/kg IV every 8 weeks from week 6 until week 22. At week 30, patients switched to receive CT-P13 SC every 2 weeks up to week 54 (dose 120 mg or 240 mg for patients < 80 kg or at least 80 kg, respectively).

Results showed switching from IV to SC infliximab conferred more favourable clinical outcomes in terms of pharmacokinetics, efficacy, and possibly, immunogenicity. There was a significant difference in Ctrough pre- and post-switch (median Ctrough Levels at 2.05 microg/mL (interquartile range [IQR], 0.10-3.61) and 21.10 microg/mL (IQR, 11.30-26.50) pre- and post-switch, respectively; p<0.0001). The proportion of patients with Ctrough exceeding target exposure (5 microg/mL) was significantly higher post-switch (36/41, 87.80%) than pre-switch (8/41, 19.51%; p<0.00001). In terms of efficacy, clinical response rates were comparable at both pre- and post-switch timepoints (40/49 [81.63%] vs 44/49 [89.80%], respectively; p=0.3873). However, faecal calprotectin (FC) levels were significantly lower post-switch compared with pre-switch. Anti-drug antibody (ADA) and neutralising antibody (NAb) positivity were also numerically lower post-switch although statistical significance was not reached.

The second study presented investigated comparable efficacy of subcutaneous (SC) infliximab monotherapy versus combination therapy with immunomodulators using data from the pivotal randomised controlled trial of CT-P13 SC in active CD or UC. Patients with active CD or UC who were tumour necrosis factor (TNF) inhibitor treatment–naïve were enrolled and received induction therapy with CT-P13 5 mg/kg intravenously (IV) at week 0 and week 2, after which they were randomised to continue therapy with CT-P13 IV or receive CT-P13 SC 120 mg (patients<80 kg) or 240 mg (patients of at least 80 kg) every 2 weeks from week 6 to week 54. Of 66 patients, 37 and 29 received monotherapy and combination therapy, respectively.

The results show there was no significant difference between groups in the number of patients with Ctrough level exceeding target exposure with both groups exceeding target exposure throughout the study period (target exposure: 5 microg/mL; monotherapy: 28/29, 96.55%; combination therapy: 23/24, 95.83%; p>0.9999). Clinical response rates in terms of CDAI-100 and partial Mayo response were comparable between arms and there was no difference in immunogenicity between the groups despite the concomitant use of immunomodulators in the combination therapy group.

Data were presented at a poster presentation at United European Gastroenterology (UEG) Week 2021, held virtually from October 3- 5.