Subcutaneous CT-P13 performs similarly to intravenous administration

Subcutaneous (SC) administration of the infliximab biosimilar CT-P13 yields similar safety, efficacy, and immunogenicity profiles compared with the intravenous (IV) route, a recent study has found.

Researchers conducted a randomized, multicentre, open-label, parallel-group study, including 66 and 65 patients with inflammatory bowel diseases, given CT-P13 SC and CT-P13 IV, respectively, following a 6-week induction phase with CT-P13 IV. All participants had never received tumour necrosis factor inhibitors before and had active ulcerative colitis or Crohn’s disease.

CT-P13 SC was given every 2 weeks from week 6–54, while IV administration was performed every 8 weeks from weeks 6–22. At week 30, those in the CT-P13 IV arm were switched to SC administration until the end of study. The primary endpoint was the pharmacokinetic noninferiority of the observed predose concentration of CT-P13 at week 22 (C_trough,W22) in the SC vs IV arms.

The mean C_trough,W22 in the SC and IV arms were 21.45 and 2.93 µg/mL, respectively. The resulting ratio of geometric least-squares mean was 1,154.17 percent (90 percent confidence interval [CI], 786.37–1,694.00). Since the lower CI bound exceeded 80 percent, SC was deemed pharmacokinetically noninferior to IV.

In addition, treatment response rate was comparable between arms at week 30 (p=0.2501), as was the clinical remission rate (p=0.0694). Safety and immunogenicity endpoints were also generally comparable between the SC and IV arms, even after treatment switching at week 30.

“CT-P13 SC could provide efficacious maintenance therapy for patients with active Crohn’s disease or ulcerative colitis who are in need of infliximab treatment, with a tolerable safety profile,” the researchers said.