ACR Meeting Abstracts

ACR Meeting Abstracts

Abstract Number: 1709

Randomized, Double-Blind Study Comparing Chs-0214 with Etanercept (Enbrel) in Patients with Psoriasis and Psoriatic Arthritis

Alan J. Kivitz1, Kim Papp2, Alim Devani3, Andreas Pinter4, Rodney Sinclair5,6,7, Michael Ziv8, John Caminis9, Cass Kelleher10, Helen Tang11, Barbara Finck10 and RaPsOdy study group , 1Altoona Center for Clinical Research, Duncansville, PA, 2K Papp Clinical Research, Inc. and Probity Medical Research, Waterloo, ON, Canada, 3Institute for Skin Advancement, Surgical and Cosmetic Dermatology, Calgary, AB, Canada, 4Dept. of Dermatology, Venereology and Allergology, Theodor-Stern-Kai 7, Frankfurt, Germany, 5University of Melbourne, E. Melbourne, Australia, 6Epworth Healthcare, E. Melbourne, Australia, 7Sinclair Dermatology Investigational Research, Education and Clinical Trials, E. Melbourne, Australia, 8Dept of Dermatology, Emek Medical Center, Afula, Israel, 9Shire, cambridge, MA, 10Clinical Science, Coherus BioSciences, Redwood City, CA, 11Coherus BioSciences, Redwood City, CA

Meeting: 2016 ACR/ARHP Annual Meeting

Date of first publication: September 28, 2016

Keywords: , , ,

Session Information

Date: Monday, November 14, 2016

Title: Spondylarthropathies and Psoriatic Arthritis – Clinical Aspects and Treatment - Poster II: Psoriatic Arthritis

Session Type: ACR Poster Session B

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

Background/Purpose:  CHS-0214 is a proposed biosimilar of etanercept, a fusion protein inhibiting tumor necrosis factor. This Phase III multi-center study compared the efficacy and safety of CHS-0214 with commercial, European-sourced etanercept in patients with moderate/severe chronic plaque psoriasis (PsO), including patients with psoriatric arthritis (PsA).

Methods:  Patients were randomized to CHS-0214 or etanercept 50 mg SC BIW for 12 weeks (Part 1) and then QW for 36 weeks (Part 2). The percent change in Psoriasis Area and Severity Index (PASI) and the PASI75 at Week 12 were the primary endpoints. The 95% confidence interval (CI) of the treatment difference had to be within the prespecified margin to establish equivalence of CHS-0214 to etanercept. The changes in Health Assessment Questionnaire – Disability Index (HAQ-DI) and hs-CRP were evaluated in patients with PsA.

Results:  In 7 countries, 521 patients (102 [19.6%] with PsA) were randomized, and 456 patients (84 [18.4%] with PsA) were evaluable for efficacy at 12 weeks. The PASI75 response rate at 12 weeks was similar for CHS-0214 (64.5%) and etanercept (62.3%). The 95% CI of the treatment difference (-6.36, 11.21) was within the pre-defined equivalence range (-18.0, 18.0). In patients with PsA, the PASI75 response rate was 67.4% for CHS-0214 and 61.0% for etanercept. The mean percent change in PASI at 12 weeks was similar for CHS-0214 (-76.7) and etanercept (-73.4). The 95% CI (-7.63, 0.80) was within the pre-defined equivalence range (-12.5, 12.5). In PsA patients with body surface area (BSA) <2.0 m2, the mean percent change in PASI was -80.0 for CHS-0214 and -72.0 for etanercept; in PsA patients with BSA ≥2.0 m2, the results were -76.4 for CHS-0214 and -69.9 for etanercept. Mean HAQ-DI scores in patients with PsA were 0.8 and 0.9 at Baseline and decreased to 0.6 and 0.7 at Week 12 for CHS-0214 and etanercept, respectively. Mean hs-CRP scores in patients with PsA were 6.5 and 11.7 at Baseline and decreased to 3.4 and 3.8 at Week 12 for CHS-0214 and etanercept, respectively. Overall, 73.2% of the 261 subjects in the CHS-0214 arm and 76.5% of the 260 subjects in the etanercept arm experienced a treatment emergent adverse event. The majority of the treament emergent adverse events were mild or moderate in severity. No deaths were reported.

Conclusion:  This study demonstrated equivalence of CHS-0214 to etanercept with respect to the primary efficacy endpoints. PASI results were similar in patients with PsA as compared with the full study group. Improvement in HAQ-DI and hs-CRP were seen in patients with PsA. Overall both treatments were well tolerated.

Disclosure: A. J. Kivitz, Coherus, 9; K. Papp, Abbott / AbbVie, Allergan, Amgen, Anacor, Applied Molecular Evoluation, Astellas, Boehringer Ingelheim, Celgene, Celtic, Cipher, Coherus, Dermira, Dow Pharma, Eli Lilly, Galderma, GSK, Isotechnika, Janssen, Janssen Biotech (Centovor), Kyowa Hakko Kirin, L, 2,3M, Abbott, AbbVie, Amgen, Astellas, Celgene, Genentech, Janssen Biotech (Centocor), Merck, Novartis, Pfizer, Merck-Serono, 8,3M, Abbott/AbbVie, Akesis, Akros, Alza, Amgen, Anacor, Applied Molecular Evoluation, Astellas, Baxter, Bayer, Boehringer Ingelheim, Celgene, Centocor, Cipher, Coherus, Dermira, Dow Pharma, Eli Lilly, Forward Pharma, Funxional Therapeutics, Galderma, Genet, 5; A. Devani, Coherus, 2; A. Pinter, AbbVie, Biogen, Boehringer-Ingelheim, Celgene, GSK, Janssen, LEO-Pharma, Lilly, MSD, Novartis, Tigerkat Pharma, Pfizer, Regeneron, Roche, USB, 5,AbbVie, Biogen,Celgene, GSK, Janssen, LEO-Pharma, Lilly, Novartis, Pfizer, Roche, 6; R. Sinclair, Samson Pharmaceutical, 1,Ascend, Leo, 5; M. Ziv, None; J. Caminis, Shire, 3; C. Kelleher, Coherus BioSciences, 3; H. Tang, Coherus BioSciences, 1,Coherus BioSciences, 3; B. Finck, Coherus Biosciences, 1,Coherus Biosciences, 3.

To cite this abstract in AMA style:

Kivitz AJ, Papp K, Devani A, Pinter A, Sinclair R, Ziv M, Caminis J, Kelleher C, Tang H, Finck B. Randomized, Double-Blind Study Comparing Chs-0214 with Etanercept (Enbrel) in Patients with Psoriasis and Psoriatic Arthritis [abstract]. Arthritis Rheumatol. 2016; 68 (suppl 10). https://acrabstracts.org/abstract/randomized-double-blind-study-comparing-chs-0214-with-etanercept-enbrel-in-patients-with-psoriasis-and-psoriatic-arthritis/. Accessed .

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