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Efficacy and safety of biosimilar CT-P13 compared with originator infliximab in patients with active Crohn's disease: an international, randomised, double-blind, phase 3 non-inferiority study

 Byong Duk Ye  ;  Marina Pesegova  ;  Olga Alexeeva  ;  Marina Osipenko  ;  Adi Lahat  ;  Andriy Dorofeyev  ;  Sigal Fishman  ;  Olena Levchenko  ;  Jae Hee Cheon  ;  Maria Lia Scribano  ;  Radu-Bogdan Mateescu  ;  Kang-Moon Lee  ;  Chang Soo Eun  ;  Sang Joon Lee  ;  Sung Young Lee  ;  Ho Ung Kim  ;  Stefan Schreiber  ;  Heather Fowler  ;  Raymond Cheung  ;  Young-Ho Kim 
 LANCET, Vol.393(10182) : 1699-1707, 2019 
Journal Title
Issue Date
Adult ; Antibodies, Monoclonal/adverse effects ; Antibodies, Monoclonal/therapeutic use ; Biosimilar Pharmaceuticals/adverse effects ; Biosimilar Pharmaceuticals/therapeutic use ; Crohn Disease/drug therapy ; Double-Blind Method ; Drug Substitution ; Female ; Gastrointestinal Agents/adverse effects ; Gastrointestinal Agents/therapeutic use ; Humans ; Infliximab/adverse effects ; Infliximab/therapeutic use ; Male ; Middle Aged ; Severity of Illness Index ; Treatment Outcome ; Young Adult
The infliximab biosimilar CT-P13 was approved for use in Crohn's disease after clinical comparison with originator infliximab in ankylosing spondylitis and rheumatoid arthritis; however, concerns about such indication extrapolation have been expressed. This study investigated whether CT-P13 is non-inferior to infliximab in patients with Crohn's disease who were naive to biological therapy.

In this randomised, multicentre, double-blind, phase 3 non-inferiority study, we enrolled patients with active Crohn's disease who had not responded to, or were intolerant to, non-biological treatments. Patients were randomly assigned (1:1:1:1) to receive CT-P13 then CT-P13, CT-P13 then infliximab, infliximab then infliximab, or infliximab then CT-P13, with switching occurring at week 30. Patients received 5 mg/kg CT-P13 or infliximab at weeks 0, 2, 6, and then every 8 weeks up to week 54. The primary endpoint was the proportion of patients with a decrease of 70 points or more in Crohn's Disease Activity Index (CDAI) from baseline to week 6. A non-inferiority margin of -20% was set (CT-P13 was non-inferior to infliximab if the lower limit of the two-sided 95% CI for the treatment difference was greater than -20). This trial is registered with ClinicalTrials.gov, number NCT02096861, and is completed.

Between Aug 20, 2014, and Feb 15, 2017, 308 patients were assessed for eligibility, and 220 patients were enrolled: 111 were randomly assigned to initiate CT-P13 (56 to the CT-P13-CT-P13 group and 55 to the CT-P13-infliximab group) and 109 to initiate infliximab (54 to the infliximab-infliximab group and 55 to the infliximab-CT-P13 group). CDAI-70 response rates at week 6 were similar for CT-P13 (77 [69·4%, 95% CI 59·9 to 77·8] of 111) and infliximab (81 [74·3%, 95% CI 65·1 to 82·2] of 109; difference -4·9% [95% CI -16·9 to 7·3]), thereby establishing non-inferiority. Over the total study period, 147 (67%) patients experienced at least one treatment-emergent adverse event (36 [64%] in the CT-P13-CT-P13 group, 34 [62%] in the CT-P13-infliximab group, 37 [69%] in the infliximab-infliximab group, and 40 [73%] in the infliximab-CT-P13 group).

This study showed non-inferiority of CT-P13 to infliximab in patients with active Crohn's disease. Biosimilar CT-P13 could be a new option for the treatment of active Crohn's disease.

Celltrion, Pfizer.
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1. College of Medicine (의과대학) > Dept. of Internal Medicine (내과학교실) > 1. Journal Papers
Yonsei Authors
Cheon, Jae Hee(천재희) ORCID logo https://orcid.org/0000-0002-2282-8904
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