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Abstract Number: 1509

A Randomized, Double-Blind, Three-Arm, Parallel Group, Single-Dose Study to Compare the Pharmacokinetics, Safety, and Tolerability of Three Formulations of Infliximab (CT-P13, EU-sourced Infliximab and US-sourced Infliximab) in Healthy Volunteers

Dae-Hyun Yoo1, Won Park2, Seung-Cheol Shim3, Chang-Hee Suh4, Jihye Yun5 and Tina Pyo5, 1Department of Rheumatology, Hanyang University Hospital for Rheumatic Diseases, Seoul, South Korea, 2Division of Rheumatology, Department of Internal Medicine, Inha University Hospital, Incheon, South Korea, 3Chungnam National University Hospital, Daejeon, South Korea, 4Allergy-Rheumatology, Ajou University Hospital, Suwon, South Korea, 5CELLTRION, Inc, Incheon, South Korea

Meeting: 2014 ACR/ARHP Annual Meeting

Keywords: biosimilars, clinical trials, infliximab and pharmacokinetics

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Session Information

Session Title: Rheumatoid Arthritis - Small Molecules, Biologics and Gene Therapy: Novel therapies, Biosimilars, Strategies and Mechanisms in Rheumatoid Arthritis

Session Type: Abstract Submissions (ACR)

Background/Purpose CT-P13 has been approved as the first biosimilar to innovator infliximab sourced from European Union (EU‑INX) in Sep 2013. Even if it has been concluded as equivalent or comparable to EU‑INX through pivotal studies and switching studies, it was questioned about the comparability between reference products with different origins1,2,3,4.

This study was designed to demonstrate comparability among CT‑P13, EU-INX and US-sourced infliximab (US-INX) in healthy volunteers and to examine whether three-biologic infliximab from the different manufacturing sources are comparable to each other primarily in pharmacokinetics (PK).

Methods In this double blind, randomized, parallel group, single-dose study, a total of 213 healthy volunteers were randomized 1:1:1 to receive a single dose (5 mg/kg) of CT‑P13, EU-INX or US-INX by intravenous infusion on Day 1 followed for 8 weeks. The primary endpoints were maximum serum concentration (Cmax), area under the concentration-time curve from time zero to the last quantifiable concentration (AUClast) and area under the concentration-time curve from time zero to infinity (AUCinf) of CT-P13, EU-INX and US-INX. A total of 11 serum blood samples were obtained for the primary PK analysis, and safety and tolerability were also evaluated up to 8 weeks. Similarity of systemic exposure (Cmax, AUClast and AUCinf) was considered to be demonstrated if the 90% confidence interval (CI) for the ratio of geometric means was within the acceptance interval of 0.8 to 1.25 for the following comparisons: CT-P13 vs EU-INX, CT-P13 vs US-INX, and EU-INX vs US-INX.

Results The baseline demographics for 213 subjects among 3 study groups were highly similar. The PK parameters in the study groups were highly similar (Table 1). The 90% CI for the ratios of Cmax, AUClast and AUCinf were within the acceptance interval of 0.8 to 1.25 for the comparisons of CT-P13 to EU-INX, CT-P13 to US-INX and EU-INX to US-INX.

Adverse events (AEs) were similar between 3 study groups with AEs related to the study drug reported by 39.4%, 23.9%, and 42.3% of subjects in CT-P13, EU-INX and US-INX groups, respectively. The majority of AEs related to the study drug reported in the study groups was Grade 1, and there was only 1 AE reported as Grade 3 in US-INX group based on Common Terminology Criteria for Adverse Events. No serious AE related to the study drug was reported, and no AEs led to the withdrawal of a subject from the study. All AEs related to study drug were resolved by the end of the study.

Table 1. Pharmacokinetic Exposure Estimates (Mean ± SD)

Parameters (units)

CT-P13

(N=71)

EU-INX

(N=71)

US-INX

(N=71)

Cmax (ug/mL)

127.6 ± 21.6

121.3 ± 19.7

119.9 ± 19.5

AUClast (h*ug/mL)

31343.2 ± 7107.3

30669.0 ± 6020.5

31629.6 ± 5886.8

AUCinf (h*ug/mL)

33212.3 ± 8326.1

32986.6 ± 7806.8

34363.6 ± 8004.2

Conclusion Equivalence of PK in terms of Cmax, AUClast and AUCinfwas demonstrated and comparable safety profiles were observed in the comparisons of CT-P13 to EU-INX, CT-P13 to US-INX and EU-INX to US-INX in healthy volunteers.

 References

  1. Park W, et al. Ann Rheum Dis 2013;72:1605-12
  2. Yoo DH, et al. Ann Rheum Dis 2013;72:1613-20
  3. Yoo DH, et al. Arthritis Rheum 2013;65(12): 3319
  4. Park W, et al. Arthritis Rheum 2013;65(12): 3323

Disclosure:

D. H. Yoo,

CELLTRION, Inc.,

5;

W. Park,

CELLTRION, Inc.,

5;

S. C. Shim,
None;

C. H. Suh,
None;

J. Yun,

CELLTRION, Inc.,

3;

T. Pyo,

CELLTRION, Inc.,

3.

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