Top

Published in:

Open Access 31-01-2024 | Etanercept | Original Research Article

Forty-Eight-Month Monitoring of Disease Activity in Patients with Long-Standing Rheumatoid Arthritis Treated with TNF-α Inhibitors: Time for Clinical Outcome Prediction and Biosimilar vs Biologic Originator Performance

Authors: Matteo Colina, Micheline Khodeir, Roberto Rimondini, Marco Valentini, Federica Campomori, Stefania Corvaglia, Gabriele Campana

Published in: Clinical Drug Investigation | Issue 3/2024

Abstract

Background and Objectives

Long-term treatment of patients with rheumatoid arthritis with tumor necrosis factor-α inhibitors leads to initial changes in disease activity that can predict a late treatment response. This observational and retrospective study aimed to determine when it is possible to foresee the response to therapy in the case of long-standing rheumatoid arthritis comparing also the efficacy of the original biologics with their biosimilars.

Methods

A total of 1598 patients were recruited and treated with the original biologics, adalimumab and etanercept, or with biosimilars. Patients were monitored over a period of 48 months and disease activity scores (28-Joint Disease Activity Score, Simplified Disease Activity Index, and Clinical Disease Activity Index) were measured every 6 months.

Results

No differences in disease activity levels were observed in etanercept versus biosimilars (GP2015/SB4) and adalimumab versus biosimilar (GP2017) patient groups. All scores significantly decreased in all treatments during the first 18 months of therapy, and after 24 months reached a minimum that lasted up to 48 months.

Conclusions

We conclude that biosimilars of adalimumab and etanercept have equivalent effectiveness over a long period of time compared to their originator drugs, and also that the levels of disease activity after 6 months of tumor necrosis factor-α inhibitors (originator drugs and biosimilars) might predict the response to therapy at 4 years in patients with long-standing rheumatoid arthritis.

Leone GM, Mangano K, Petralia MC, Nicoletti F, Fagone P. Past, present and (foreseeable) future of biological anti-TNF alpha therapy. J Clin Med. 2023;12(4):1630. https://doi.org/10.3390/jcm12041630.CrossRefPubMedPubMedCentral

Jang S, Kwon EJ, Lee JJ. Rheumatoid arthritis: pathogenic roles of diverse immune cells. Int J Mol Sci. 2022;23(2):905. https://doi.org/10.3390/ijms23020905.CrossRefPubMedPubMedCentral

Taylor P, Gartemann J, Hsieh J, Creeden J. A systematic review of serum biomarkers anti-cyclic citrullinated peptide and rheumatoid factor as tests for rheumatoid arthritis. Autoimmune Dis. 2011;2011: 815038. https://doi.org/10.4061/2011/815038.CrossRefPubMedPubMedCentral

Smolen JS, Landewé RBM, Bijlsma JWJ, Burmester GR, Dougados M, Kerschbaumer A, et al. EULAR recommendations for the management of rheumatoid arthritis with synthetic and biological disease-modifying antirheumatic drugs: 2019 update. Ann Rheum Dis. 2020;79(6):685–99. https://doi.org/10.1136/annrheumdis-2019-216655.CrossRefPubMed

Singer O, Gibofsky A. Methotrexate versus leflunomide in rheumatoid arthritis: what is new in 2011? Curr Opin Rheumatol. 2011;23(3):288–92. https://doi.org/10.1097/BOR.0b013e328344f2e4.CrossRefPubMed

Huang R, Pan H, Wu J, Zhou H, Li Z, Qiu P, et al. Comparison of combination therapy with methotrexate and sinomenine or leflunomide for active rheumatoid arthritis: a randomized controlled clinical trial. Phytomedicine. 2019;57:403–10. https://doi.org/10.1016/j.phymed.2018.12.030.CrossRefPubMed

Nakafero G, Grainge MJ, Card T, Mallen CD, Zhang W, Doherty M, et al. What is the incidence of methotrexate or leflunomide discontinuation related to cytopenia, liver enzyme elevation or kidney function decline? Rheumatol. 2021;60(12):5785–94. https://doi.org/10.1093/rheumatology/keab254.CrossRef

Hernández MV, Meineri M, Sanmartí R. Skin lesions and treatment with tumor necrosis factor alpha antagonists. Rheumatol Clin. 2013;9(1):53–61. https://doi.org/10.1016/j.reuma.2012.04.007.CrossRef

Ma X, Xu S. TNF inhibitor therapy for rheumatoid arthritis. Biomed Rep. 2013;1(2):177–84. https://doi.org/10.3892/br.2012.42.1:177-84.MathSciNetCrossRefPubMed

10.

Aaltonen KJ, Virkki LM, Malmivaara A, Konttinen YT, Nordström DC, Blom M. Systematic review and meta-analysis of the efficacy and safety of existing TNF blocking agents in treatment of rheumatoid arthritis. PLoS ONE. 2012;7(1): e30275. https://doi.org/10.1371/journal.pone.0030275.ADSCrossRefPubMedPubMedCentral

11.

US FDA. Scientific considerations in demonstrating biosimilarity to a reference product: guidance for industry. 2015; 80 FR 24258. Available from: https://www.fda.gov/media/82647/download. Accessed 25 Jan 2024.

12.

IQVIA. The impact of biosimilar competition in Europe. IQVIA Inst Hum Data Sci. 2022. Available from: https://www.iqvia.com/library/white-papers/the-impact-of-biosimilar-competition-in-europe-2022. Accessed 25 Jan 2024.

13.

Rubbert-Roth A, Szabó MZ, Kedves M, Nagy G, Atzeni F, Sarzi-Puttini P. Failure of anti-TNF treatment in patients with rheumatoid arthritis: the pros and cons of the early use of alternative biological agents. Autoimmun Rev. 2019;18(12): 102398. https://doi.org/10.1016/j.autrev.2019.102398.CrossRefPubMed

14.

Berenbaum F, Pham T, Claudepierre P, de Chalus T, Joubert JM, Saadoun C, et al. Early non-response to certolizumab pegol in rheumatoid arthritis predicts treatment failure at one year: data from a randomised phase III clinical trial. Jt Bone Spine. 2018;85(1):59–64. https://doi.org/10.1016/j.jbspin.2017.01.011.CrossRef

15.

Wijbrandts CA, Tak PP. Prediction of response to targeted treatment in rheumatoid arthritis. Mayo Clin . 2017;92(7): 1129–43. doi: https://doi.org/10.1016/j.mayocp.2017.05.009.

16.

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(3):315–24. https://doi.org/10.1002/art.1780310302.CrossRefPubMed

17.

Jamovi. The Jamovi Project. (Version 1.6) [computer software]. 2023. Available from: https://www.jamovi.org. [Accessed 25 Jan 2024].

18.

Wan JL, Sparfel A, Derolez S, Azzopardi N, Goupille P, Detert J, et al. Predictors of response to TNF inhibitors in rheumatoid arthritis: an individual patient data pooled analysis of randomised controlled trials. RMD Open. 2021;7(3): e001882. https://doi.org/10.1136/rmdopen-2021-001882.CrossRef

19.

Lau CS, Gibofsky A, Damjanov N, Lula S, Marshall L, Jones H, et al. Down-titration of biologics for the treatment of rheumatoid arthritis: a systematic literature review. Rheumatol Int. 2017;37:1789–98. https://doi.org/10.1007/s00296-017-3780-8.CrossRefPubMedPubMedCentral

20.

Smolen JS, Landewé RBM, Bijlsma JWJ, Burmester GR, Chatzidionysiou K, Dougados M, Name J, et al. EULAR recommendations for the management of rheumatoid arthritis with synthetic and biological disease-modifying antirheumatic drugs: 2016 update. Ann Rheum Dis. 2017;76(6):960–77. https://doi.org/10.1136/annrheumdis-2016-210715.CrossRefPubMed

21.

Smolen JS, Landewé RBM, Bergstra SA, Kerschbaumer A, Sepriano A, Aletaha D, Caporali R, et al. EULAR recommendations for the management of rheumatoid arthritis with synthetic and biological disease-modifying antirheumatic drugs: 2022 update. Ann Rheum Dis. 2023;82(1):3–18. https://doi.org/10.1136/ard-2022-223356.CrossRefPubMed

22.

de Castro CT, de Queiroz MJ, Albuquerque FC, Brandão CC, Gerlack LF, Pereira DCR, et al. Real-world effectiveness of biological therapy in patients with rheumatoid arthritis: systematic review and meta-analysis. Front Pharmacol. 2022;11(13): 927179. https://doi.org/10.3389/fphar.2022.927179.CrossRef

23.

Schmitz S, Adams R, Walsh CD, Barry M, FitzGerald O. A mixed treatment comparison of the efficacy of anti-TNF agents in rheumatoid arthritis for methotrexate non-responders demonstrates differences between treatments: a Bayesian approach. Ann Rheum Dis. 2012;71(2):225–30. https://doi.org/10.1136/annrheumdis-2011-200228.CrossRefPubMed

24.

Popescu CC, Mogoșan CD, Enache L, Codreanu C. Comparison of efficacy and safety of original and biosimilar adalimumab in active rheumatoid arthritis in a real-world national cohort. Medicina (Kaunas). 2022;58(12):1851. https://doi.org/10.3390/medicina58121851.CrossRefPubMed

25.

Codreanu C, Popescu CC, Mogoșan C, Enache L, Daia S, Ionescu R, et al. Efficacy and safety of original and biosimilar etanercept (SB4) in active rheumatoid arthritis: a comparison in a real-world national cohort: original and biosimilar etanercept in RA. Biologicals. 2019;62:27–32. https://doi.org/10.1016/j.biologicals.2019.10.009.CrossRefPubMed

26.

Kusner LL, Fernandez C, Atzeni F, Lu X, Hu R, Peng L, et al. Efficacy and safety of adalimumab biosimilars: current critical clinical data in rheumatoid arthritis. Front Immunol. 2021;6(12): 638444. https://doi.org/10.3389/fimmu.2021.638444.CrossRef

27.

Huizinga TWJ, Torii Y, Muniz R. Adalimumab biosimilars in the treatment of rheumatoid arthritis: a systematic review of the evidence for biosimilarity. Rheumatol Ther. 2021;8(1):41–61. https://doi.org/10.1007/s40744-020-00259-8.CrossRefPubMed

28.

Glintborg B, Loft AG, Omerovic E, et al. Response to: ‘Mandatory, cost-driven switching from originator etanercept to its biosimilar SB4: possible fallout on non-medical switching’ by Cantini and Benucci. Ann Rheum Dis. 2020;79(2): e14. https://doi.org/10.1136/annrheumdis-2018-214788.CrossRefPubMed

29.

Glintborg B, Loft AG, Omerovic E, Hendricks O, Linauskas A, Espesen J, et al. To switch or not to switch: results of a nationwide guideline of mandatory switching from originator to biosimilar etanercept. One-year treatment outcomes in 2061 patients with inflammatory arthritis from the DANBIO registry. Ann Rheum Dis. 2019;78(2):192–200. https://doi.org/10.1136/annrheumdis-2018-213474.CrossRefPubMed

30.

Glintborg B, Loft AG, Omerovic E, Hendricks O, Linauskas A, Espesen J, et al. Response to: ‘Mandatory, cost-driven switching from originator etanercept to its biosimilar SB4: possible fallout on non-medical switching’ by Cantini and Benucci. Ann Rheum Dis. 2020;79:1–2. https://doi.org/10.1136/annrheumdis-2018-213474.CrossRef

31.

Michelsen B, Berget KT, Loge JH, Kavanaugh A, Haugeberg G. Sex difference in disease burden of inflammatory arthritis patients treated with tumor necrosis factor inhibitors as part of standard care. PLoS ONE. 2022;17(5): e0266816. https://doi.org/10.1371/journal.pone.0266816.CrossRefPubMedPubMedCentral

32.

Santos-Moreno P, Sánchez G, Castro C. Rheumatoid factor as predictor of response to treatment with anti-TNF alpha drugs in patients with rheumatoid arthritis. Med (United States). 2019;98(5): e14181. https://doi.org/10.1097/MD.0000000000014181.2019;98:1-8.CrossRef

Title: Forty-Eight-Month Monitoring of Disease Activity in Patients with Long-Standing Rheumatoid Arthritis Treated with TNF-α Inhibitors: Time for Clinical Outcome Prediction and Biosimilar vs Biologic Originator Performance
Authors: Matteo Colina
Micheline Khodeir
Roberto Rimondini
Marco Valentini
Federica Campomori
Stefania Corvaglia
Gabriele Campana
Publication date: 31-01-2024
Publisher: Springer International Publishing
Keywords: Etanercept
Adalimumab
Rheumatoid Arthritis
Published in: Clinical Drug Investigation / Issue 3/2024
Print ISSN: 1173-2563
Electronic ISSN: 1179-1918
DOI: https://doi.org/10.1007/s40261-024-01341-7

Keynote webinar | Spotlight on medication adherence

Springer Medicine

Forty-Eight-Month Monitoring of Disease Activity in Patients with Long-Standing Rheumatoid Arthritis Treated with TNF-α Inhibitors: Time for Clinical Outcome Prediction and Biosimilar vs Biologic Originator Performance

Abstract

Background and Objectives

Methods

Results

Conclusions

Keynote webinar | Spotlight on medication adherence

Springer Medicine

Abstract

Background and Objectives

Methods

Results

Conclusions

Please log in to get access to this content

Other articles of this Issue 3/2024

Effect of Ticagrelor versus Clopidogrel on All-Cause and Cardiovascular Mortality in Acute Coronary Syndrome Patients with Hyperuricemia

Real-World Effectiveness of Sotrovimab for the Early Treatment of COVID-19: Evidence from the US National COVID Cohort Collaborative (N3C)

Thromboembolic Events Associated with Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitors: A Pharmacovigilance Analysis of the US FDA Adverse Event Reporting System (FAERS) Database

Safety and Efficacy of Biologic Medications and Janus Kinase Inhibitors in Patients with Down Syndrome: A Retrospective Cohort Study

Cost-Effectiveness Evaluation of Oral CGRP Antagonists, Atogepant and Rimegepant, for the Preventative Treatment of Episodic Migraine: Results from a US Societal Perspective Model

Safety of Intravenous Push Valproate Compared with Intravenous Piggyback at a Tertiary Academic Medical Center