Post-marketing study of biosimilar infliximab (CT-P13) to evaluate its safety and efficacy in Korea

Expert Rev Gastroenterol Hepatol. 2015;9 Suppl 1:35-44. doi: 10.1586/17474124.2015.1091309.

Abstract

Objective: To evaluate the safety and efficacy of CT-P13 (Remsima(®)) in patients with inflammatory bowel disease (IBD) in South Korea.

Methods: This post-marketing study included patients with active moderate-to-severe Crohn's disease (CD), fistulizing CD (FCD), or moderate-to-severe ulcerative colitis (UC) treated with CT-P13 and followed for 30 weeks. Assessments included treatment-emergent adverse events (TEAEs) and disease-specific clinical response and remission.

Results: No unexpected TEAEs were observed in the 173 patients recruited to date. TEAEs occurred in 18.1, 16.7, and 26.9% of CD, FCD, and UC patients, respectively. Treatment-related TEAEs occurred in 10% of patients and were mostly mild-moderate in severity. There were five serious TEAEs (two infusion-related reactions, two infections, one abdominal pain) and no cases of malignancy, pneumonia, or death. Positive outcomes for response/remission were reported regardless of whether patients had received prior infliximab or not.

Conclusion: CT-P13 was well tolerated and efficacious in patients with IBD.

Keywords: CT-P13; Crohn’s disease; South Korea; biosimilar; efficacy; inflammatory bowel disease; infliximab; post-marketing study; safety; switching; ulcerative colitis.

Publication types

  • Clinical Trial, Phase IV
  • Multicenter Study

MeSH terms

  • Adolescent
  • Adult
  • Aged
  • Anti-Inflammatory Agents / adverse effects
  • Anti-Inflammatory Agents / therapeutic use*
  • Antibodies, Monoclonal / adverse effects
  • Antibodies, Monoclonal / therapeutic use*
  • Biosimilar Pharmaceuticals / adverse effects
  • Biosimilar Pharmaceuticals / therapeutic use*
  • Colitis, Ulcerative / diagnosis
  • Colitis, Ulcerative / drug therapy*
  • Colitis, Ulcerative / immunology
  • Crohn Disease / diagnosis
  • Crohn Disease / drug therapy*
  • Crohn Disease / immunology
  • Female
  • Gastrointestinal Agents / adverse effects
  • Gastrointestinal Agents / therapeutic use*
  • Humans
  • Infliximab / adverse effects
  • Infliximab / therapeutic use*
  • Male
  • Middle Aged
  • Product Surveillance, Postmarketing
  • Remission Induction
  • Republic of Korea
  • Severity of Illness Index
  • Time Factors
  • Treatment Outcome
  • Tumor Necrosis Factor-alpha / antagonists & inhibitors*
  • Tumor Necrosis Factor-alpha / immunology
  • Young Adult

Substances

  • Anti-Inflammatory Agents
  • Antibodies, Monoclonal
  • Biosimilar Pharmaceuticals
  • CT-P13
  • Gastrointestinal Agents
  • Tumor Necrosis Factor-alpha
  • Infliximab