Efficacy, safety and immunogenicity of GP2015, an etanercept biosimilar, compared with the reference etanercept in patients with moderate-To-severe rheumatoid arthritis: 24-week results from the comparative phase III, randomised, double-blind EQUIRA study

RMD Open

Volumn 4, Issue 2, 2018, Pages

  Matucci Cerinic, Marco ^a   Allanore, Yannick ^b   Kavanaugh, Arthur ^c   Buch, Maya H ^d   Schulze Koops, Hendrik ^e   Kucharz, Eugeniusz J ^f   Woehling, Heike ^g   Babic, Goran ^g   Poetzl, Johann ^g   Davis, Adanna ^h   Schwebig, Arnd ^g  

^a UNIVERSITY OF FLORENCE   (Italy)

^b Institut Cochin   (France)

^c UNIVERSITY OF CALIFORNIA   (United States)

^d Chapel Allerton Hospital   (United Kingdom)

^e UNIVERSITY OF MUNICH   (Germany)

^f MEDICAL UNIVERSITY OF SILESIA   (Poland)

^g Sandoz Biopharmaceuticals   (Germany)

^h Sandoz Pharma Ltd   (Switzerland)

Author keywords

bioequivalence; biosimilar; etanercept; GP2015; rheumatoid arthritis

Indexed keywords

ALANINE AMINOTRANSFERASE; C REACTIVE PROTEIN; ETANERCEPT; FOLIC ACID; GP 2015; METHOTREXATE; PARACETAMOL; PREDNISONE;

ADULT; ALANINE AMINOTRANSFERASE BLOOD LEVEL; ARTICLE; ATRIAL FIBRILLATION; BACKACHE; BRONCHITIS; CHOLELITHIASIS; CONTROLLED STUDY; CYSTITIS; DAS28; DIARRHEA; DRUG DOSE ESCALATION; DRUG EFFICACY; DRUG SAFETY; DRUG TOLERABILITY; ERYTHROCYTE SEDIMENTATION RATE; FEMALE; HUMAN; IMMUNOGENICITY; INCIDENCE; INJECTION SITE REACTION; LUNG CANCER; MAJOR CLINICAL STUDY; MALE; PHASE 3 CLINICAL TRIAL; POPULATION RESEARCH; RANDOMIZED CONTROLLED TRIAL; RHEUMATOID ARTHRITIS; RHINOPHARYNGITIS; SIDE EFFECT; SPINE FRACTURE; THROMBOCYTOPENIA; TREATMENT RESPONSE; UPPER RESPIRATORY TRACT INFECTION; URINARY TRACT INFECTION; URTICARIA;

EID: 85057737917     PISSN: None     EISSN: 20565933     Source Type: Journal    
DOI: 10.1136/rmdopen-2018-000757     Document Type: Article

References (33)

1. Goffe B, Cather JC. Etanercept: An overview. J Am Acad Dermatol 2003;49:105-11.
2. Amgen, 1998. Enbrel US prescribing information. Available from:http://pi. amgen. com/united- states/enbrel/derm/enbrel- pi. pdf [Accessed16 Oct 2017].
3. European Medicines Agency, 2017. Enbrel, summary of product characteristics. Available from:http://www.ema.europa. eu/docs/en-GB/document-library/EPAR-Product_Information/human/000262/WC500027361.pdf[Accessed16 Oct 2017].
4. World Health Organization, Guidelines on evaluation of similar biotherapeutic products (SBPs). 2009. Available from:http://www.who.int/biologicals/areas/biological-therapeutics/BIOTHERAPEUTICS-FOR-WEB-22APRIL2010. pdf [accessed6 Jan 2018].
5. Weise M, Bielsky MC, De Smet K, et al. Biosimilars-why terminology matters. Nat Biotechnol 2011;29:690-3.
6. European Medicines Agency, Guideline on similar biological medicinal products containing biotechnology-derived proteins as active substance: non-clinical and clinical issues. 2017. Available from:http://www. ema. europa. eu/docs/en-GB/document-library/Scientific-guideline/2015/01/WC500180219.pdf [Accessed18 Dec 2017].
7. von Richter O, Skerjanec A, Afonso M, et al. GP2015, a proposed etanercept biosimilar: pharmacokinetic similarity to its reference product and comparison of its autoinjector device with prefilled syringes. Br J Clin Pharmacol 2017;83:732-41.
8. Griffiths CEM, Tha D, Gerdes S, et al. The EGALITY study: A confirmatory, randomized, double-blind study comparing the efficacy, safety and immunogenicity of GP2015, a proposed etanercept biosimilar, vs.The originator product in patients with moderate-Tosevere chronic plaque-Type psoriasis. Br J Dermatol 2017;176:928-38.
9. European Medicines Agency, 2018. Assessment report Erelzi. Availablefrom:http://www.ema.europa.eu/docs/en-GB/document-library/EPARPublic-Assessment-report/human/004192/WC500230144.pdf [accessedon 11 Sep].
10. Accessdata, 2018. Erelzi Prescribing information. Available from:https://www.accessdata.fda.gov/drugsatfdadocs/label/2016/761042lbl.pdf [Accessed11 Sep].
11. Prevoo ML, van Hof MA, Kuper HH, et al. Modified disease activity scores that include twenty-eight-joint counts. Development and validation in a prospective longitudinal study of patients with rheumatoid arthritis. Arthritis Rheum 1995;38:44-8.
12. Van Gestel AM, Prevoo MLL, Van 't Hof MA. Development and validation of the European League Against Rheumatism response criteria for rheumatoid arthritis. Arthritis Rheum 1996;39:34-40.
13. Fries JF, Spitz P, Kraines RG, et al. Measurement of patient outcome in arthritis. Arthritis Rheum 1980;23:137-45.
14. Bruce B, Fries JF. The Health Assessment Questionnaire (HAQ). Clin Exp Rheumatol 2005;23(5 Suppl 39):S14-18.
15. Cella DF, Tulsky DS, Gray G, et al. The functional assessment of cancer therapy scale: development and validation of the general measure. J Clin Oncol 1993;11:570-9.
16. Yellen SB, Cella DF, Webster K, et al. Measuring fatigue and other anemia-related symptoms with the Functional Assessment of Cancer Therapy (FACT) measurement system. J Pain Symptom Manage 1997;13:63-74.
17. Poetzl J, Arlt I, von Richter O. State-of-The-Art immunogenicity evaluation in phase 3 confirmatory study (EGALITY) with etanercept biosimilar GP. J Eur Acad Dermatol Venereol 2015.
18. Kay J, Upchurch KS. ACR/EULAR 2010 rheumatoid arthritis classification criteria. Rheumatology 2012;51(suppl 6):vi5-vi9.
19. Hochberg MC, Chang RW, Dwosh I, et al. The American College of Rheumatology 1991 revised criteria for the classification of global functional status in rheumatoid arthritis. Arthritis Rheum 1992;35:498-502.
20. Wells G, Becker JC, Teng J, et al. Validation of the 28-joint Disease Activity Score (DAS28) and European League Against Rheumatism response criteria based on C-reactive protein against disease progression in patients with rheumatoid arthritis, and comparison with the DAS28 based on erythrocyte sedimentation rate. Ann Rheum Dis 2009;68:954-60.
21. Keystone EC, Schiff MH, Kremer JM, et al. Once-weekly administration of 50 mg etanercept in patients with active rheumatoid arthritis: results of a multicenter, randomized, doubleblind, placebo-controlled trial. Arthritis Rheum 2004;50:353-63.
22. Bathon JM, Martin RW, Fleischmann RM, et al. A comparison of etanercept and methotrexate in patients with early rheumatoid arthritis. N Engl J Med 2000;343:1586-93.
23. Genovese MC, Bathon JM, Fleischmann RM, et al. Longterm safety, efficacy, and radiographic outcome with etanercept treatment in patients with early rheumatoid arthritis. J Rheumatol 2005;32:1232-42.
24. Genovese MC, Bathon JM, Martin RW, et al. Etanercept versus methotrexate in patients with early rheumatoid arthritis: Twoyear radiographic and clinical outcomes. Arthritis Rheum 2002;46:1443-50.
25. Weinblatt ME, Kremer JM, Bankhurst AD, et al. A trial of etanercept, a recombinant tumor necrosis factor receptor:Fc fusion protein, in patients with rheumatoid arthritis receiving methotrexate. N Engl J Med 1999;340:253-9.
26. Combe B, Codreanu C, Fiocco U, et al. Etanercept and sulfasalazine, alone and combined, in patients with active rheumatoid arthritis despite receiving sulfasalazine: A double-blind comparison. Ann Rheum Dis 2006;65:1357-62.
27. Bae SC, Kim J, Choe JY, et al. A phase III, multicentre, randomised, double-blind, active-controlled, parallel-group trial comparing safety and efficacy of HD203, with innovator etanercept, in combination with methotrexate, in patients with rheumatoid arthritis: The HERA study. Ann Rheum Dis 2017;76:65-71.
28. Emery P, Vencovsk J, Sylwestrzak A, et al. A phase III randomised, double-blind, parallel-group study comparing SB4 with etanercept reference product in patients with active rheumatoid arthritis despite methotrexate therapy. Ann Rheum Dis 2017;76:51-7.
29. Yoo DH, Hrycaj P, Miranda P, et al. A randomised, double-blind, parallel-group study to demonstrate equivalence in efficacy and safety of CT-P13 compared with innovator infliximab when coadministered with methotrexate in patients with active rheumatoid arthritis: The PLANETRA study. Ann Rheum Dis 2013;72:1613-20.
30. Matsuno H, Tomomitsu M, Hagino A, et al. Phase III, multicentre, double-blind, randomised, parallel-group study to evaluate the similarities between LBEC0101 and etanercept reference product in terms of efficacy and safety in patients with active rheumatoid arthritis inadequately responding to methotrexate. Ann Rheum Dis 2018;77:488-94.
31. ODell J, Takeuchi T, Tanaka Y. Randomized, double-blind study comparing CHS-0214 with etanercept in patients with active rheumatoid arthritis (RA) despite methotrexate (MTX) therapy [abstract]. Ann Rheum Dis 2016;75(Suppl 2):P143.
32. FDA, 2018. Assay development and validation for immunogenicity testing of therapeutic protein products (draft guidance, 2016). Available from:https://www.fda.gov/downloads/Drugs/Guidances/UCM192750.pdf [Accessed31 Jan 2018].
33. Shankar G, Devanarayan V, Amaravadi L, et al. Recommendations for the validation of immunoassays used for detection of host antibodies against biotechnology products. J Pharm Biomed Anal 2008;48:1267-81.