ACR Meeting Abstracts

ACR Meeting Abstracts

Abstract Number: 642

Quality of Life Outcomes Following Therapy with Chs-0214 and Etanercept (Enbrel): Randomized, Double-Blind Study in Subjects with Rheumatoid Arthritis

Alan J. Kivitz1,2, James R. O'Dell3, Tsutomu Takeuchi4, Yoshiya Tanaka5, Satoshi Nakashima6, Cass Kelleher7, Jennifer Hodge8, Barbara Finck7 and RApsody Study Group, 1Altoona Center for Clinical Research, Duncansville, PA, 2Altoona Arthritis & Osteoporosis Center, Duncansville, PA, 3Department of Internal Medicine, University of Nebraska Medical Center, Omaha, NE, 4Division of Rheumatology, Department of Internal Medicine,, Keio University School of Medicine, Tokyo, Japan, 5The First Department of Internal Medicine,, School of Medicine, University of Occupational and Environmental Health, Kitakyushu, Japan, 6Daiishi Sankyo, Shinagawa-Ku Tokyo, Japan, 7Clinical Science, Coherus BioSciences, Redwood City, CA, 8Coherus BioSciences, Redwood City, CA

Meeting: 2016 ACR/ARHP Annual Meeting

Date of first publication: September 28, 2016

Keywords: , , ,

Session Information

Date: Sunday, November 13, 2016

Title: Rheumatoid Arthritis – Small Molecules, Biologics and Gene Therapy - Poster I

Session Type: ACR Poster Session A

Session Time: 9:00AM-11:00AM

Background/Purpose:   CHS-0214 is in development as a proposed biosimilar of etanercept. This Phase III confirmatory, safety and efficacy study randomized and dosed 644 subjects with rheumatoid arthritis (RA) in 13 countries. Health-related quality of life (QOL) outcomes were based on the Health Assessment Questionnaire – Disability Index (HAQ-DI), Subject Pain Assessment (SPA), Subject Global Assessment (SGA), and Physician Global Assessment (PGA).

Methods:   Subjects had moderate/severe RA and an inadequate response to methotrexate (MTX). Subjects were randomized 1:1 to CHS-0214 or etanercept (commercial European-sourced) at 50 mg SC QW for 24 weeks (Part 1) and then received CHS-0214 50 mg SC QW open-label for 24 weeks (Part 2). Subjects continued on their stable dose of MTX throughout the study.

Results:   The evaluable population for efficacy analysis in Part 1 included 512 subjects of mean age (50.6 vs 51.4 years), most of whom were female (81% vs 81%) and white (73% vs 71%) or Asian (25% vs 26%) for CHS-0214 vs etanercept, respectively. At baseline, subjects had a mean duration of RA of 6.9 vs 6.8 years and a mean DAS28-CRP(4) of 5.4 vs 5.4 for CHS-0214 vs etanercept, respectively. The primary endpoint of the study, ACR20 response at 24 weeks, was met in 91.0% vs 90.6% of subjects for CHS-0214 vs etanercept, respectively. The 95% CI of the treatment difference (0.41%) was [-4.55%, 5.37%], which fell within the predefined margin for equivalence of [-15%, 15%]. Mean scores on the HAQ-DI were 1.2 vs. 1.2 at Baseline with CHS-0214 and etanercept, respectively, and decreased 53% vs. 51% to 0.6 vs. 0.6 at Week 24. Mean scores on the SPA were 58.5 vs. 57.4 at Baseline with CHS-0214 and etanercept, respectively, and decreased 64% vs. 64% to 20.2 vs. 19.9 at Week 24. Mean scores on the SGA were 59.8 vs. 58.8 at Baseline with CHS-0214 and etanercept, respectively, and decreased 66% vs. 64% to 19.9 vs. 20.6 at Week 24. Mean scores on the PGA were 60.2 vs. 58.1 at Baseline with CHS-0214 and etanercept, respectively, and decreased 72% vs. 69% to 17.1 vs. 17.7 at Week 24. Overall, treatment emergent adverse events in Part 1 were reported in 60.8% of 324 subjects in the CHS-0214 treatment arm and 65.0% of 320 subjects in the etanercept treatment arm. The majority of adverse event were mild or moderate in severity. No deaths were reported.

Conclusion:  This randomized, double-blind, active-control, global study demonstrated equivalence of CHS-0214 to etanercept based on the primary endpoint. The levels of improvement in health-related QOL measures were similar in both treatment groups.

Disclosure: A. J. Kivitz, Coherus, 9; J. R. O'Dell, Coherus, Medac, Lilly, BMS, GSK, 9; T. Takeuchi, Astellas, BMS, Celtrion, Chugai, Daiichi-Sankyo, Eisai, Mitsubishi Tanabe,Nipponkayaku, Pfizer, Sanofi-Aventis, Santen, Takeda, Teijin Pharma, AbbVie, Asahi Kasei Pharma, Taisho Toyama, Janssen, Astra Zeneca, Eli-Lilly Japan, and Novartis, 5; Y. Tanaka, Abbvie, Chugai, Astellas, Takeda, Santen, Mitsubishi-Tanabe, Pfizer, Janssen, Eisai, Daiichi-Sankyo, UCB, GSK, BMS, MSD, and Novartis, 5; S. Nakashima, Daiichi Sankyo, 3; C. Kelleher, Coherus BioSciences, 3,Coherus BioSciences, 1; J. Hodge, Coherus BioSciences, 1,Coherus BioSciences, 3; B. Finck, Coherus Biosciences, 1.

To cite this abstract in AMA style:

Kivitz AJ, O'Dell JR, Takeuchi T, Tanaka Y, Nakashima S, Kelleher C, Hodge J, Finck B. Quality of Life Outcomes Following Therapy with Chs-0214 and Etanercept (Enbrel): Randomized, Double-Blind Study in Subjects with Rheumatoid Arthritis [abstract]. Arthritis Rheumatol. 2016; 68 (suppl 10). https://acrabstracts.org/abstract/quality-of-life-outcomes-following-therapy-with-chs-0214-and-etanercept-enbrel-randomized-double-blind-study-in-subjects-with-rheumatoid-arthritis/. Accessed .

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