Intest Res.  2019 Oct;17(4):504-515. 10.5217/ir.2019.00030.

Infliximab biosimilar CT-P13 is interchangeable with its originator for patients with inflammatory bowel disease in real world practice

• Nakagawa T
• Kobayashi
• Nishikawa
• Yamada F
• Asai S
• Sameshima
• Suzuki Y
• Watanabe M
• Hibi T

• KMID: 2465816
• DOI: http://doi.org/10.5217/ir.2019.00030

Abstract

BACKGROUND/AIMS
An interim analysis of post-marketing surveillance of CT-P13, an infliximab biosimilar, was performed to evaluate its safety and efficacy in Japanese patients with inflammatory bowel disease.
METHODS
Patients were prospectively enrolled between November 2014 and March 2017, after the launch of CT-P13 in Japan, and case report forms of patients followed for at least 4 months were analyzed as of July 2018.
RESULTS
Of 523 patients in the analysis set, 372 remained on CT-P13 therapy, while 54 (20.2%) of 267 patients with Crohn's disease, and 97 (37.9%) of 256 patients with ulcerative colitis were withdrawn during follow-up. A total of 144 adverse drug reactions (ADRs) were reported in 106 patients (20.3%). Infusion reaction was the most frequent ADR observed in 49 patients (9.4%). Efficacy parameters decreased immediately after the start of treatment in naïve patients to anti-tumor necrosis factor-α antibody. In the patients switched from originator infliximab for nonmedical reasons, the decreased parameters due to proceeded treatment with the originator were maintained in low ranges, and the treatment continuation rate was high with low ADR incidence. In contrast, in patients switched for medical reasons such as adverse event or loss of response, the incidence of ADRs was high. However, the efficacy parameters were improved, and the treatment continuation rate was not significantly different from that of the naïve patient group.
CONCLUSIONS
In this interim analysis, CT-P13 was comparable to the originator infliximab with respect to ADRs and efficacy, and is therefore considered to be a cost-efficient interchangeable biosimilar for Japanese patients with inflammatory bowel disease.

Keyword

Infliximab; Biosimilar; CT-P13; Post-marketing surveillance; Inflammatory bowel disease

MeSH Terms

Asian Continental Ancestry Group
Colitis, Ulcerative
Drug-Related Side Effects and Adverse Reactions
Follow-Up Studies
Humans
Incidence
Inflammatory Bowel Diseases*
Infliximab*
Japan
Necrosis
Prospective Studies
Infliximab

Figure

• 

  Fig. 1. Patient demography (A) and patient classification based on prior biologic therapy and reasons for switching to CT-P13 (B). Patients were classified into 3 groups: naïve patients who had no previous anti-TNF-α antibody treatment, patients switched for nonmedical reasons such as institutional policy or economic reason (nonmedical switch), and patients switched for medical reasons (medical switch). The medical switch group was further devided into 3 subgroups. aSwitching to CT-P13 from infliximab (IFX) due to adverse events or insufficient efficacy; bSwitching from adalimumab; cRetreatment with CT-P13 for relapse after discontinuation of IFX due to remission of disease.

• 

  Fig. 2. Kaplan-Meier plot of treatment period of CT-P13 in CD (A) and UC patients (B). Patients who ceased further treatment with CT-P13 earlier than 7 days from the initial administration were excluded from the plot. Statistically significant differences were analyzed by the generalized Wilcoxon test. aP<0.05, bP<0.01, cP<0.001.

• 

  Fig. 3. Changes in 3 efficacy variables in CD (A-C) and UC patients (D-F). Evaluated CDAI (A), partial Mayo score (D), and measured CRP (B, E) are expressed as mean±SD. Effective rate of clinician-reported efficacy (C, F) is based on assessment of the response to CT-P13 as effective or partially effective by primary care physicians.

• 

  Fig. 4. Efficacy of CT-P13 based on CDAI in CD (A) and partial Mayo score in UC patients (B). Efficacy of treatment with CT-P13 in each patient was assessed based on CDAI or partial Mayo score estimated at week 14/16 in comparison with baseline scores (see methodological details described in the text).

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