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

Annals of the Rheumatic Diseases

Volumn 76, Issue 1, 2017, Pages 65-71

  Bae, Sang Cheol ^a   Kim, Jinseok ^b   Choe, Jung Yoon ^c   Park, Won ^d   Lee, Sang Heon ^e   Park, Yong Beom ^f   Shim, Seung Cheol ^g   Lee, Shin Seok ^h   Sung, Yoon Kyoung ^a   Choi, Chan Bum ^a   Lee, So Ra ⁱ   Park, Hanyu ⁱ   Ahn, Yongho ⁱ  

^a Hanyang University Hospital for Rheumatic Diseases   (South Korea)

^b Jeju National University College of Medicine   (South Korea)

^c Daegu University   (South Korea)

^d Inha University Hospital   (South Korea)

^e Konkuk University School of Medicine   (South Korea)

^f Yonsei University College of Medicine   (South Korea)

^g Chungnam National University College of Medicine   (South Korea)

^h Chonnam National University Medical School   (South Korea)

ⁱ Hanwha Corporation   (South Korea)

Author keywords

[No Author keywords available]

Indexed keywords

BIOSIMILAR AGENT; ETANERCEPT; HD 203; METHOTREXATE; UNCLASSIFIED DRUG; ANTIBODY; ANTIRHEUMATIC AGENT;

ADULT; ANEMIA; ARTHRALGIA; ARTICLE; CONTROLLED STUDY; COUGHING; DAS28; DIZZINESS; DOUBLE BLIND PROCEDURE; DRUG EFFICACY; DRUG FATALITY; DRUG SAFETY; DRUG TOLERABILITY; DRUG WITHDRAWAL; FEMALE; HUMAN; IMMUNOGENICITY; INJECTION SITE REACTION; LATENT TUBERCULOSIS; MAJOR CLINICAL STUDY; MALE; MORBIDITY; MULTICENTER STUDY; OUTCOME ASSESSMENT; PARALLEL DESIGN; PHASE 3 CLINICAL TRIAL; PNEUMONIA; PRIORITY JOURNAL; PRURITUS; PYELONEPHRITIS; RANDOMIZED CONTROLLED TRIAL; RASH; RHEUMATOID ARTHRITIS; RHINOPHARYNGITIS; SPINE FRACTURE; UPPER ABDOMINAL PAIN; UPPER RESPIRATORY TRACT INFECTION; AGED; ARTHRITIS, RHEUMATOID; BLOOD; CLINICAL TRIAL; COMBINATION DRUG THERAPY; COMPARATIVE STUDY; IMMUNOLOGY; MIDDLE AGED; THERAPEUTIC EQUIVALENCE; TREATMENT OUTCOME;

ADULT; AGED; ANTIBODIES; ANTIRHEUMATIC AGENTS; ARTHRITIS, RHEUMATOID; BIOSIMILAR PHARMACEUTICALS; DOUBLE-BLIND METHOD; DRUG THERAPY, COMBINATION; ETANERCEPT; FEMALE; HUMANS; MALE; METHOTREXATE; MIDDLE AGED; THERAPEUTIC EQUIVALENCY; TREATMENT OUTCOME;

EID: 84960192211     PISSN: 00034967     EISSN: 14682060     Source Type: Journal    
DOI: 10.1136/annrheumdis-2015-207613     Document Type: Article

References (44)

1. Murray KM, Dahl SL. Recombinant human tumor necrosis factor receptor ( p75) Fc fusion protein (TNFR:Fc) in rheumatoid arthritis. Ann Pharmacother 1997;31:1335-8.
2. Haraoui B, Bykerk V. Etanercept in the treatment of rheumatoid arthritis. Ther Clin Risk Manag 2007;3:99-105.
3. Miossec P. Rheumatoid arthritis: still a chronic disease. Lancet 2013;381:884-6.
4. Kivelevitch D, Mansouri B, Menter A. Long term efficacy and safety of etanercept in the treatment of psoriasis and psoriatic arthritis. Biologics 2014;8:169-82.
5. Moreland LW, Schiff MH, Baumgartner SW, et al. Etanercept therapy in rheumatoid arthritis. A randomized, controlled trial. Ann Intern Med 1999;130:478-86.
6. 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.
7. 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.
8. Klareskog L, van der Heijde D, de Jager JP, et al, on behalf of the TEMPO (Trial of Etanercept and Methotrexate with Radiographic Patient Outcomes) study investigators. Therapeutic effect of the combination of etanercept and methotrexate compared with each treatment alone in patients with rheumatoid arthritis: double-blind randomised controlled trial. Lancet 2004;363:675-81.
9. Emery P, Szumski A, Bukowski J, et al. Early initiated etanercept plus methotrexate treatment induces remission in patients with either moderate or severe rheumatoid arthritis. Ann Rheum Dis 2014;72(Suppl. 3):A603-4.
10. Fleischmann R, Koenig AS, Szumski A, et al. Short term efficacy of etanercept plus methotrexate vs combinations of disease-modifying anti-rheumatic drugs with methotrexate in established rheumatoid arthritis. Rheumatology (Oxford) 2014;53:1984-93.
11. Enbrel PI. Immunex Corporation, Thousand Oaks, CA, USA (September 2013). 12 European Medicines Agency (EMA). Enbrel® (etanercept) authorisation details. EMA, 2014. http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/000262/human-med-000764.jsp&mid=WC0b01ac058001d124 (accessed 24 Feb 2015). 13 Kay J, Smolen JS. Biosimilars to treat inflammatory arthritis: The challenge of proving identity. Ann Rheum Dis 2013;72:1589-93.
12. Schneider CK. Biosimilars in rheumatology: The wind of change. Ann Rheum Dis 2013;72:315-8.
13. European Medicines Agency. Guideline on similar biological medicinal products containing biotechnology-derived proteins as active substance: quality issues (revision 1). 2014. http://www.ema.europa.eu/docs/en-GB/document-library/Scientific-guideline/2014/06/WC500167838.pdf (accessed 27 May 2015).
14. European Medicines Agency. Guideline on similar biological medicinal products containing biotechnology-derived proteins as active substance: non-clinical and clinical issues. 2014. http://www.ema.europa.eu/docs/en-GB/document-library/Scientific-guideline/2015/01/WC500180219.pdf (accessed 27 May 2015).
15. US Food and Drug Administration. Quality considerations in demonstrating biosimilarity to a reference product, April 2015. http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM291134.pdf (accessed 8 Oct 2015)
16. US Food and Drug Administration. Scientific considerations in demonstrating biosimilarity to a reference product, April 2015. http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM291128.pdf (accessed 8 Oct 2015)
17. World Health Organization. Expert committee on biological standardization. Geneva, 19 to 23 October 2009. Guidelines on evaluation of similar biotherapeutic products (SBPs). http://www.who.int/biologicals/areas/biological-therapeutics/BIOTHERAPEUTICS-0FOR-WEB-22APRIL2010.pdf (accessed 27 May 2015).
18. Expert Committee on Biological Standardization. Guidelines on evaluation on similar biotherapeutic products (SBPs). Geneva: World Health Organization, 2009.
19. Dörner T, Strand V, Castañeda-Hernández G, et al. The role of biosimilars in the treatment of rheumatic diseases. Ann Rheum Dis 2013;72:322-8.
20. McCamish M, Woollett G. The state of the art in the development of biosimilars. Clin Pharmacol Ther 2012;91:405-17.
21. Rak Tkaczuk KH, Jacobs IA. Biosimilars in oncology: from development to clinical practice. Semin Oncol 2014;41(Suppl 3):S3-S12.
22. Liu Y, Wu EQ, Bensimon AG, et al. Cost per responder associated with biologic therapies for Crohn's disease, psoriasis, and rheumatoid arthritis. Adv Ther 2012;29:620-34.
23. Yoo DH. The rise of biosimilars: potential benefits and drawbacks in rheumatoid arthritis. Expert Rev Clin Immunol 2014;10:981-3.
24. Putrik P, Ramiro S, Kvien TK, et al Working Group Equity in access to treatment of rheumatoid arthritis in Europe. Inequalities in access to biologic and synthetic DMARDs across 46 European countries. Ann Rheum Dis 2014;73:198-206.
25. Yi S, Kim SE, Park MK, et al. Comparative pharmacokinetics of HD203, a biosimilar of etanercept, with marketed etanercept (Enbrel®): A double-blind, single-dose, crossover study in healthy volunteers. BioDrugs 2012;26:177-84.
26. Arnett FC, Edworthy SM, Bloch DA, et al. The American Rheumatism Association 1987 revised criteria for the classification of rheumatoid arthritis. Arthritis Rheum 1988;31:315-24.
27. 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.
28. Bae SC, Cook FE, Kim SY. Psychometric evaluation of a Korean Health Assessment Questionnaire (KHAQ) for clinical research. J Rheumatol 1998;25:1975-9.
29. Kim MH, Cho YS, Uhm WS, et al. Cross-cultural adaptation and validation of the Korean version of the EQ-5D in patients with reumatic disease. Qual Life Res 2005;14:1401-6.
30. 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.
31. Moreland LW, Baumgartner SW, Schiff MH, et al. Treatment of rheumatoid arthritis with a recombinant human tumor necrosis factor receptor ( p75)-FC fusion protein. N Engl J Med 1997;337:141-7.
32. Wajdula J. A double-blind, placebo controlled study of the efficacy and safety of four different doses of etanercept in patients with rheumatoid arthritis. Ann Rheum Dis 2000;59(Suppl):163.
33. Codreanu C, Combe B, Fiocco U, et al. Double-blind comparison of etanercept and sulfasalazine, alone and combined in active RA patients. Presentation at the 2003 EULAR Annual Meeting (Abstract THU0120).
34. 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, double-blind, placebo-controlled trial. Arthritis Rheum 2004;50:353-63.
35. Lan JL, Chou SJ, Chen DY, et al. A comparative study of etanercept plus methotrexate and methotrexate alone in Taiwanese patients with active rheumatoid arthritis: A 12-week, double-blind, randomized, placebo-controlled study. J Formos Med Assoc 2004;103:618-23.
36. Felson DT, Smolen JS, Wells G, et al. American College of Rheumatology/European League against Rheumatism provisional definition of remission in rheumatoid arthritis for clinical trials. Ann Rheum Dis 2011;70:404-13.
37. Boers M, Kostense PJ. Non-overlapping American College of Rheumatology response rates: A better way to report response in rheumatoid arthritis clinical trials. Arthritis Rheum 2010;62:3524-7.
38. Schellekens GA, Visser H, de Jong BA, et al. The diagnostic properties of rheumatoid arthritis antibodies recognizing a cyclic citrullinated peptide. Arthritis Rheum 2000;43:155-63.
39. Bizzaro N, Mazzanti G, Tonutti E, et al. Diagnostic accuracy of the anti-citrulline antibody assay for rheumatoid arthritis. Clin Chem 2001;47:1089-93.
40. Vasishta A. Diagnosing early-onset rheumatoid arthritis: The role of anti-CCP antibodies. Am Clin Lab 2002;21:34-6.
41. Pinheiro GC, Scheinberg MA, Aparecida DS, et al. Anti-cyclic citrullinated peptide antibodies in advanced rheumatoid arthritis. Ann Intern Med 2003;139:234-5.
42. van Venrooij WJ, Hazes JM, Visser H. Anticitrullinated protein/peptide antibody and its role in the diagnosis and prognosis of early rheumatoid arthritis. Neth J Med 2002;60:383-8.
43. Garces S, Demengeot J, Benito-Garcia E. The immunogenicity of anti-TNF therapy in immune-mediated inflammatory diseases: A systematic review of the literature with a meta-Analysis. Ann Rheum Dis 2013;72:1947-55.
44. Jung SM, Kim HS, Kim HR, et al. Immunogenicity of anti-Tumour necrosis factor therapy in Korean patients with rheumatoid arthritis and ankylosing spondylitis. Int Immunopharmacol 2014;21:20-5.