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Comparing biosimilar SB2 with reference infliximab after 54 weeks of a double-blind trial: clinical, structural and safety results

. 2017 Oct 01 ; 56 (10) : 1771-1779.

Language English Country Great Britain, England Media print

Document type Clinical Trial, Phase III, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't

Persistent link   https://www.medvik.cz/link/pmid28957563

OBJECTIVES: SB2 is a biosimilar to the reference infliximab (INF). Similar efficacy, safety and immunogenicity between SB2 and INF up to 30 weeks were previously reported. This report investigates such clinical similarity up to 54 weeks, including structural joint damage. METHODS: In this phase III, double-blind, parallel-group, multicentre study, patients with moderate to severe RA despite MTX were randomized (1:1) to receive 3 mg/kg of either SB2 or INF at 0, 2, 6 and every 8 weeks thereafter. Dose escalation by 1.5 mg/kg up to a maximum dose of 7.5 mg/kg was allowed after week 30. Efficacy, safety and immunogenicity were measured at each visit up to week 54. Radiographic damage evaluated by modified total Sharp score was measured at baseline and week 54. RESULTS: A total of 584 patients were randomized to receive SB2 (n = 291) or INF (n = 293). The rate of radiographic progression was comparable between SB2 and INF (mean modified total Sharp score difference: SB2, 0.38; INF, 0.37) at 1 year. ACR responses, 28-joint DAS, Clinical Disease Activity Index and Simplified Disease Activity Index were comparable between SB2 and INF up to week 54. The incidence of treatment-emergent adverse events and anti-drug antibodies were comparable between treatment groups. Such comparable trends of efficacy, safety and immunogenicity were consistent from baseline up to 54 weeks. The pattern of dose increment was also comparable between SB2 and INF. CONCLUSION: SB2 maintained similar efficacy, safety and immunogenicity with INF up to 54 weeks in patients with moderate to severe RA. Radiographic progression was comparable at 1 year. TRIAL REGISTRATION: ClinicalTrials.gov (http://clinicaltrials.gov; NCT01936181) and EudraCT (https://www.clinicaltrialsregister.eu; 2012-005733-37).

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Smolen JS, Landewe R, Breedveld FC. et al. EULAR recommendations for the management of rheumatoid arthritis with synthetic and biological disease-modifying antirheumatic drugs: 2013 update. Ann Rheum Dis 2014;73:492–509. PubMed PMC

Braun J, van den Berg R, Baraliakos X. et al. 2010 update of the ASAS/EULAR recommendations for the management of ankylosing spondylitis. Ann Rheum Dis 2011;70:896–904. PubMed PMC

Gossec L, Smolen JS, Ramiro S. et al. European League Against Rheumatism (EULAR) recommendations for the management of psoriatic arthritis with pharmacological therapies: 2015 update. Ann Rheum Dis 2016;75:499–510. PubMed

Maini R, St Clair EW, Breedveld F. et al. Infliximab (chimeric anti-tumour necrosis factor alpha monoclonal antibody) versus placebo in rheumatoid arthritis patients receiving concomitant methotrexate: a randomised phase III trial. Lancet 1999;354:1932–9. PubMed

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. PubMed

Putrik P, Ramiro S, Kvien TK. et al. Inequities in access to biologic and synthetic DMARDs across 46 European countries. Ann Rheum Dis 2014;73:198–206. PubMed

Dörner T, Strand V, Cornes P. et al. The changing landscape of biosimilars in rheumatology. Ann Rheum Dis 2016;75:974–82. PubMed PMC

Modena V, Bianchi G, Roccatello D.. Cost-effectiveness of biologic treatment for rheumatoid arthritis in clinical practice: an achievable target? Autoimmun Rev 2013;12:835–8. PubMed

Curtis JR, Singh JA.. Use of biologics in rheumatoid arthritis: current and emerging paradigms of care. Clin Ther 2011;33:679–707. PubMed PMC

European Medicines Agency. Guideline on similar biological medicinal products. CHMP/437/04Rev1. 2014. http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2014/10/WC500176768.pdf (2 October 2016, date last accessed).

US Food and Drug Administration. Biologics price competition and innovation. http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/ucm216146.pdf. (2 October 2016, date last accessed).

European Medicines Agency. Guideline on similar biological medicinal products containing monoclonal antibodies: non-clinical and clinical issues. EMA/CHMP/BMWP/403543/2010. 2012. http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2012/06/WC500128686.pdf. (7 November 2016, date last accessed).

US Food and Drug Administration. Scientific considerations in demonstrating biosimilarity to a reference product: guidance for industry. http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM291128.pdf. (2 October 2016, date last accessed).

Remicade Prescribing Information. Janssen Biotech, Inc. April 2016. http://www.janssen.com/australia/sites/www_janssen_com_australia/files/product/pdf/remicade_pi.pdf. (27 February 2017, date last accessed)

Shin D, Kim Y, Kim YS, Körnicke T, Fuhr R.. A randomized, phase I pharmacokinetic study comparing SB2 and infliximab reference product (Remicade®) in healthy subjects. Biodrugs 2015;29:381–8. PubMed PMC

Choe J-Y, Prodanovic N, Niebrzydowski J. et al. A randomised, double-blind, phase III study comparing SB2, an infliximab biosimilar, to the infliximab reference product Remicade in patients with moderate to severe rheumatoid arthritis despite methotrexate therapy. Ann Rheum Dis 2015;76:58–64. PubMed PMC

Lipsky PE, van der Heijde D, St. Clair EW. et al. Infliximab and methotrexate in the treatment of rheumatoid arthritis. N Engl J Med 2000;343:1594–602. PubMed

Smolen JS, Han C, van der Heijde DM. et al. Radiographic changes in rheumatoid arthritis patients attaining different disease activity states with methotrexate monotherapy and infliximab plus methotrexate: the impacts of remission and tumour necrosis factor blockage. Ann Rheum Dis 2009;68:823–7. PubMed

European Medicines Agency. Remicade: EPAR—product information (SmPC). 2016. http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/000240/WC500050888.pdf (27 February 2017, date last accessed).

Fries JF, Spitz P, Kraines RG. et al. Measurement of patient outcome in arthritis. Arthritis Rheum 1980;23:137–45. PubMed

Anderson J, Caplan L, Yazdany J. et al. Rheumatoid arthritis disease activity measures: American College of Rheumatology recommendations for use in clinical practice. Arthritis Care Res 2012;64:640–7. PubMed PMC

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. PubMed

van der Heijde D. How to read radiographs according to the Sharp/van der Heijde method. J Rheumatol 1999;26:743–5. PubMed

Shankar G, Arkin S, Cocea L. et al. Assessment and reporting of the clinical immunogenicity of therapeutic proteins and peptides—harmonized terminology and tactical recommendations. AAPS J 2014;16:658–73. PubMed PMC

Souto A, Maneiro JR, Gómez-Reino JJ.. Rate of discontinuation and drug survival of biologic therapies in rheumatoid arthritis: a systemic review and meta-analysis of drug registries and health care databases. Rheumatology 2016;55:523–34. PubMed

Klareskog L, van der Heijde D, de Jager JP. et al. Therapeutic effect of the combination of etanercept and methotrexate compared with each treatment alone in patients with rheumatoid arthritis: double-blind randomized controlled trial. Lancet 2004;363:675–81. PubMed

Navarro-Compán V, Gherghe AM, Smolen JS. et al. Relationship between disease activity indices and their individual components and radiographic progression in RA: a systemic literature review. Rheumatology 2015;54:994–1007. PubMed

Smolen JS, Han C, Bala M. et al. Evidence of radiographic benefit of treatment with infliximab plus methotrexate in rheumatoid arthritis patients who had no clinical improvement: a detailed subanalysis of data from the anti-tumor necrosis factor trial in rheumatoid arthritis with concomitant therapy study. Arthritis Rheum 2005;52:1020–30. PubMed

Binder NB, Puchner A, Niederreiter B. et al. Tumor necrosis factor-inhibiting therapy preferentially targets bone destruction but not synovial inflammation in a tumor necrosis factor-driven model of rheumatoid arthritis. Arthritis Rheum 2013;65:608–17. PubMed

Rahman MU, Strusberg I, Geusens P. et al. Double-blinded infliximab dose escalation in patients with rheumatoid arthritis. Ann Rheum Dis 2007;66:1233–8. PubMed PMC

Yoo DH, Racewicz A, Brzezicki J. et al. A phase III randomized study to evaluate the efficacy and safety of CT-P13 compared with reference infliximab in patients with active rheumatoid arthritis: 54-week results from the PLANETRA study. Arthritis Res Ther 2016;18:82. PubMed PMC

Kay J, Smolen JS.. Biosimilars to treat inflammatory arthritis: the challenge of proving identity. Ann Rheum Dis 2013;72:1589–93. PubMed

Kay J, Isaacs JD.. Clinical trials of biosimilars should become more similar. Ann Rheum Dis 2017;76:4–6. PubMed

Obama B. United States Health Care Reform. JAMA 2016;316:525–32. PubMed PMC

Kay J. Editorial: biosimilars: new or déjà vu? Arthritis Rheum 2016;68:1049–52. PubMed

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