The Long-Term Safety and Durability of Response of Chs-0214, a Proposed Biosimilar to Etanercept: An Open-Label Safety Extension Study

Ingrid Louw¹, Alan J. Kivitz², Tsutomu Takeuchi³, Yoshiya Tanaka⁴, Satoshi Nakashima⁵, Jennifer Hodge⁶, Hong Tang⁶, Paula O'Connor⁶ and Barbara Finck⁶, ¹Panorama Medical Centre, Cape Town, South Africa, ²Department of Rheumatology, Altoona Center for Clinical Research, Duncansville, PA, ³Keio University School of Medicine, Tokyo, Japan, ⁴School of Medicine, University of Occupational and Environmental Health, Kitakyushu, Japan, ⁵Daiichi Sankyo, Tokyo, Japan, ⁶Coherus BioSciences, Inc., Redwood City, CA

Meeting: 2017 ACR/ARHP Annual Meeting

Date of first publication: September 18, 2017

Keywords: Biologics, biosimilars, etanercept, psoriasis and rheumatoid arthritis, treatment

Session Information

Date: Tuesday, November 7, 2017

Title: Rheumatoid Arthritis – Small Molecules, Biologics and Gene Therapy Poster III: Efficacy and Safety of Originator Biologics and Biosimilars

Session Type: ACR Poster Session C

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

Background/Purpose: CHS-0214 is a proposed biosimilar to etanercept for the treatment of rheumatoid arthritis and other auto-immune diseases. Two randomized, double-blind studies demonstrated equivalence of CHS-0214 to etanercept in patients with rheumatoid arthritis (RA) and chronic plaque psoriasis (PsO). This ongoing, open-label, safety extension study evaluates the long-term safety of and durability of response to CHS-0214 in patients who completed Week 48 of a prior trial.

Methods: All patients are to receive open-label CHS-0214 50 mg weekly for at least 48 weeks. Patients are evaluated at 1 and 3 months post enrollment and every 3 months thereafter. Patients had to have achieved an ACR20 or a PASI50 at Week 48 in the prior trial. The primary endpoints are maintenance of response (ACR20 or PASI50) at Week 4, Week 12 and every 3 months thereafter during the study.

Results: This interim analysis included 359 patients with a mean duration of treatment of 31.45 weeks of open-label CHS-0214 in addition to 48 weeks of treatment in the prior study. Of those, 56.5% were female, 49.6% were Asian, and 44.3% were white. Mean age was 49.9 years, and mean body mass index was 27.1. Of the 359 (225 with RA and 134 with PsO), 357 received ≥1 dose of study drug.

Overall, 197 (87.9%) patients with RA had achieved a durable response (maintenance of ACR20), and 118 (90.1%) of patients with PsO had achieved a durable response (maintenance of PASI50) as of the data cut-off date. Loss of efficacy was a factor in study discontinuation for 5 patients. Treatment-emergent adverse events were reported in 216 (60.5%) patients, and serious TEAE were reported in 14 (3.9%) patients. Four (1.1%) patients had a TEAE that led to study drug discontinuation. The most common (>5%) TEAEs were nasopharyngitis and upper respiratory tract infection.

Conclusion: The majority of patients maintained an efficacious response to treatment with CHS-0214. Treatment was well tolerated and the incidence of TEAEs did not increase with ongoing drug exposure. No new safety signals were identified in these patients with an average of 80 weeks of treatment.

Disclosure: I. Louw, None; A. J. Kivitz, Sanofi, Pfizer, Roche, and UCB, 5; T. Takeuchi, AbbVie, Asahi Kasei Pharma, Astellas, Astra Zeneca, BMS, Celltrion, Chugai, Daiichi-Sankyo, Eisai, Eli-Lilly Japan, Janssen, Mitsubishi Tanabe, Nippon Kayaku, Novartis, Pfizer, Sanofi-Aventis, Santen, Taisho Toyama, Takeda, Teijin Pharma;, 2; Y. Tanaka, Abbvie, Astellas, BMS, Chugai, Daiichi-Sankyo, Eisai, GSK, Janssen, Mitsubishi-Tanabe, MSD, Novartis, Pfizer, Santen, Takeda, UCB, 2; S. Nakashima, Daiichi-Sankyo, 3; J. Hodge, Coherus BioSciences, Inc., 1,Coherus BioSciences, Inc., 3; H. Tang, Coherus BioSciences, Inc., 1,Coherus BioSciences, Inc., 3; P. O'Connor, Coherus BioSciences, Inc., 1,Coherus BioSciences, Inc., 3; B. Finck, Coherus BioSciences, Inc., 1,Coherus BioSciences, Inc., 3.

To cite this abstract in AMA style:

Louw I, Kivitz AJ, Takeuchi T, Tanaka Y, Nakashima S, Hodge J, Tang H, O'Connor P, Finck B. The Long-Term Safety and Durability of Response of Chs-0214, a Proposed Biosimilar to Etanercept: An Open-Label Safety Extension Study [abstract]. Arthritis Rheumatol. 2017; 69 (suppl 10). https://acrabstracts.org/abstract/the-long-term-safety-and-durability-of-response-of-chs-0214-a-proposed-biosimilar-to-etanercept-an-open-label-safety-extension-study/. Accessed .

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