Randomized Controlled Trial: Subcutaneous vs Intravenous Infliximab CT-P13 Maintenance in Inflammatory Bowel Disease

Gastroenterology. 2021 Jun;160(7):2340-2353. doi: 10.1053/j.gastro.2021.02.068. Epub 2021 Mar 5.


Background & aims: This study compared pharmacokinetics, symptomatic and endoscopic efficacy, safety, and immunogenicity of a subcutaneous formulation of the infliximab biosimilar CT-P13 (CT-P13 SC) vs intravenous CT-P13 (CT-P13 IV) in patients with inflammatory bowel disease (IBD).

Methods: This randomized, multicenter, open-label, parallel-group, phase 1 study enrolled tumor necrosis factor inhibitor-naïve patients with active ulcerative colitis (total Mayo score 6-12 points with endoscopic subscore ≥2) or Crohn's disease (Crohn's Disease Activity Index 220-450 points) at 50 centers. After CT-P13 IV induction at Week (W) 0/W2, patients were randomized (1:1) to receive CT-P13 SC every 2 weeks (q2w) from W6 to W54 or CT-P13 IV every 8 weeks from W6 to W22. At W30, all patients receiving CT-P13 IV switched to CT-P13 SC q2w until W54. The primary endpoint was noninferiority of CT-P13 SC to CT-P13 IV for observed predose CT-P13 concentration at W22 (Ctrough,W22), concluded if the lower bound of the 2-sided 90% confidence interval (CI) for the ratio of geometric least-squares means exceeded 80%.

Results: Overall, 66 and 65 patients were randomized to CT-P13 SC and CT-P13 IV, respectively. The primary endpoint of noninferiority was met with a geometric least-squares means ratio for Ctrough,W22 of 1154.17% (90% CI 786.37-1694.00; n = 59 [CT-P13 SC]; n = 57 [CT-P13 IV]). W30/W54 clinical remission rates were comparable between arms. Other efficacy, safety, and immunogenicity assessments were also broadly comparable between arms, including after switching.

Conclusions: The pharmacokinetic noninferiority of CT-P13 SC to CT-P13 IV, and the comparable efficacy, safety, and immunogenicity profiles, support the potential suitability of CT-P13 SC treatment in IBD. ClinicalTrials.gov ID: NCT02883452.

Keywords: CT-P13; Crohn’s disease; Infliximab; Subcutaneous; Ulcerative Colitis.

Publication types

  • Clinical Trial, Phase I
  • Equivalence Trial
  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Administration, Intravenous
  • Adolescent
  • Adult
  • Aged
  • Antibodies, Monoclonal / administration & dosage*
  • Biosimilar Pharmaceuticals / administration & dosage*
  • C-Reactive Protein / drug effects
  • Colitis, Ulcerative / drug therapy*
  • Colitis, Ulcerative / metabolism
  • Crohn Disease / drug therapy*
  • Crohn Disease / metabolism
  • Drug Substitution
  • Feces / chemistry
  • Female
  • Gastrointestinal Agents / administration & dosage*
  • Humans
  • Infliximab / administration & dosage
  • Infliximab / blood
  • Injections, Subcutaneous
  • Leukocyte L1 Antigen Complex / drug effects
  • Maintenance Chemotherapy
  • Male
  • Middle Aged
  • Severity of Illness Index
  • Treatment Outcome
  • Young Adult


  • Antibodies, Monoclonal
  • Biosimilar Pharmaceuticals
  • CT-P13
  • Gastrointestinal Agents
  • Leukocyte L1 Antigen Complex
  • C-Reactive Protein
  • Infliximab

Associated data

  • ClinicalTrials.gov/NCT02883452