NOVEL FORMULATION OF CT-P13 FOR SUBCUTANEOUS ADMINISTRATION IN PATIENTS WITH RHEUMATOID ARTHRITIS: INITIAL RESULTS FROM A PHASE I/III RANDOMISED CONTROLLED TRIAL
- Authors
- Westhovens, Rene; Yoo, Dae Hyun; Jaworski, Janusz; Matyska-Piekarska, Ewa; Smiyan, Svitlana; Ivanova, Delina; Zielinska, Agnieszka K; Raussi, Eve Kai; Batalov, Anastas Zgurov; Lee, SJ; Lee, SY; Suh, Hyon Sook
- Issue Date
- Jun-2018
- Publisher
- BMJ PUBLISHING GROUP
- Citation
- ANNALS OF THE RHEUMATIC DISEASES, v.77, pp.315 - 315
- Indexed
- SCIE
SCOPUS
- Journal Title
- ANNALS OF THE RHEUMATIC DISEASES
- Volume
- 77
- Start Page
- 315
- End Page
- 315
- URI
- https://scholarworks.bwise.kr/hanyang/handle/2021.sw.hanyang/3110
- DOI
- 10.1136/annrheumdis-2018-eular.1810
- ISSN
- 0003-4967
- Abstract
- Background
While the treatment with intravenous (IV) CT-P13, an infliximab biosimilar, is effective and well tolerated, a new subcutaneous (SC) CT-P13 formulation (CT-P13 SC) is developed to provide additional, more convenient treatment options and opportunity for self-injection.
Objectives
To find the optimal dose of CT-P13 SC and to evaluate efficacy, PK and safety over the first 30 weeks in patients with rheumatoid arthritis.
Methods
This study consists of 1 cohort with CT-P13 IV, and 3 cohorts with 3 different doses of CT-P13 SC injected biweekly. All enrolled patients initially received CT-P13 IV at Weeks 0 and 2 and patients who received 2 full doses and displayed no safety concerns were randomly assigned to receive either CT-P13 SC or IV at Week 6. Using part 1 result, PK-PD modelling was conducted for the 3 regimens.
Results
A total of 50 patients were enrolled, of whom 48 patients were randomly assigned into 4 cohorts.
Overall, the efficacy results of CT-P13 SC up to Week 30 were comparable to those of CT-P13 IV. Disease improvement by DAS28 and ACR20 were comparable across all 4 cohorts, regardless of the route of administration or dosage of CT-P13 (table 1).
The safety profiles in CT-P13 SC cohorts were generally comparable to CT-P13 IV. One of the 2 patients who experienced a hypersensitivity reaction became anti-drug antibody (ADA) positive at Week 6 and experienced hypersensitivity from Week 2 to 8. All injection site reactions were grade 1 or 2. The proportion of ADA (positive) was lower in the SC cohorts.
In PK-PD modelling, bioavailability was 59% (95% CI, 52%–67%). The dose linearity in SC regimens was confirmed based on Weeks 22 to 30 Ctrough, AUCτ and Cmax, ss (figure 1). Ctrough were greater (above 4 µg/mL) than the target exposure (1 µg/mL)[1][2] in all SC regimens. There was a trend towards slightly lower DAS28 score in all SC regimens, which was consistent with the higher Ctrough comparing with CT-P13 IV. Based on the exposure-response safety analyses, there was no correlation between PK (AUCτ or Cmax) and safety (IRRs or infections).
- Files in This Item
-
Go to Link
- Appears in
Collections - 서울 의과대학 > 서울 내과학교실 > 1. Journal Articles
![qrcode](https://api.qrserver.com/v1/create-qr-code/?size=55x55&data=https://scholarworks.bwise.kr/hanyang/handle/2021.sw.hanyang/3110)
Items in ScholarWorks are protected by copyright, with all rights reserved, unless otherwise indicated.