Safety, efficacy, and drug survival of the infliximab biosimilar CT-P13 in post-marketing surveillance of Japanese patients with psoriasis

J Dermatol. 2022 Oct;49(10):957-969. doi: 10.1111/1346-8138.16508. Epub 2022 Jul 7.


Based on extrapolation of similar clinical outcomes in rheumatoid arthritis to the originator infliximab (IFX) in randomized clinical trials, the first biosimilar antibody CT-P13 was approved for the treatment of psoriasis. To evaluate the safety, efficacy, and drug survival of CT-P13 for psoriasis in real-world clinical practice, prospective post-marketing surveillance was conducted in 165 Japanese psoriasis patients. During a 1-year follow-up period, adverse drug reactions (ADRs) occurred in 29 patients (17.6%). Infusion reaction was the most frequent ADR (6.7%), and mild pneumonia was reported as the only case of infection. Serious ADRs were reported in two patients (1.2%): acute cholecystitis and interstitial pneumonia. The interstitial pneumonia developed after a single infusion of CT-P13 and the patient died of respiratory failure. In naive patients to biologic therapy (n = 44), the Psoriasis Area Severity Index (PASI) decreased rapidly after the start of CT-P13 treatment, and response rate achieving an absolute PASI score <1 was 55% at 30 weeks. The response rate was high (78%) in patients with psoriatic arthritis, and 40% and 20% in those in plaque psoriasis and pustular psoriasis, respectively. Of patients switched from IFX to CT-P13 mainly for nonmedical reasons (n = 105), 57% had already reached PASI <1 by pretreatment with IFX and CT-P13 maintained this status. The incidence of ADRs in this patient group was low and the drug survival rate was as high as 74%, even at 1 year, which was significantly higher than that in the naïve patient group (47%). Patients switched from other biologics for medical reasons (n = 16) responded similarly to biologic-naïve patients, but drug survival was lower (24%). In conclusion, CT-P13 showed excellent effectiveness as a first-line therapy, no clinical difficulties in switching from IFX, and usefulness in patients who failed other biologics. CT-P13 could be a cost-effective alternative to IFX for the treatment of psoriasis.

Keywords: CT-P13; biosimilar; infliximab; post-marketing surveillance; psoriasis.

Publication types

  • Evaluation Study

MeSH terms

  • Antibodies, Monoclonal
  • Biosimilar Pharmaceuticals* / adverse effects
  • Drug Substitution
  • Humans
  • Infliximab / adverse effects
  • Japan / epidemiology
  • Product Surveillance, Postmarketing
  • Prospective Studies
  • Psoriasis* / chemically induced
  • Psoriasis* / drug therapy
  • Treatment Outcome


  • Antibodies, Monoclonal
  • Biosimilar Pharmaceuticals
  • CT-P13
  • Infliximab