Immunogenicity of the biosimilar CT-P13 infliximab or the original infliximab in Iraqi patients with Ankylosing spondylitis does not correlate with their demographic characteristics

Mohammed M. Kamil; Mohammed Abdul- Hassan Jabarah; Nizar A.l. Jasim

doi:10.32007/jfacmedbagdad.6441969

Authors

Mohammed M. Kamil
Mohammed Abdul- Hassan Jabarah Dept. of pharmacology, College of Medicine, Baghdad University
Nizar A.l. Jasim Dept. of Medicine/ College of Medicine/ University of Baghdad

DOI:

https://doi.org/10.32007/jfacmedbagdad.6441969

Abstract

Background: Ankylosing spondylitis is a rare disease affecting people with hereditary factors. Its treatment includes life style modification and use of drugs such as the biologic agent infliximab or its biosimilar, CT-P13 infliximab. Despite their therapeutic usefulness, these agents are associated with a number of serious adverse effects such as immunogenicity.

Objectives: The aim of current study was to investigate if immunogenicity of the biosimilar CT-P13 infliximab or the original infliximab, in Iraqi patients with Ankylosing spondylitis, is affected by any of the patients’ demographic characteristics.

Methods: A retrospective open-label study was conducted from December 2021 to March 2022 at the Rheumatology Unit, Baghdad Teaching Hospital/Medical City, Baghdad. Forty-four patients were taking Infliximab, and another 50 patients were taking CT-P13, both at a dose of 5mg/kg for 3 months prior to recruitment in current study. Disease activity was assessed by ASDAS-CRP score while antibodies and C-reactive protein were tested by Enzyme-Linked Immunosorbent Assay technique. Statistical analyses were performed using SPSS statistical package for Social Sciences version 20.0. The level of significance was considered at P<0.05.

Results: There was non-significant correlation between anti-infliximab antibodies and demographic data of patients (P>0.05). Similar data were reported regarding the biosimilar CT-P13 infliximab except for smoking and disease activity which exhibited significant correlation with development of anti-CT-P13 antibodies (P<0.05).

Conclusion: Immunogenicity of the biosimilar CT-P13 infliximab, but not that of the original Infliximab, may be influenced by demographic characteristics or disease activity in patients with ankylosing spondylitis.

Downloads

Download data is not yet available.

Author Biography

Mohammed Abdul- Hassan Jabarah, Dept. of pharmacology, College of Medicine, Baghdad University

Assisstant prof.

References

Hwang MC, Ridley L, Reveille JD. Ankylosing spondylitis risk factors: a systematic literature review. Clin Rheumatol 2021;40:3079–93. https://doi.org/10.1007/s10067-021-05679-7.

Al-Bedri KZM. Prevalence, Clinical Features, and Radiological Features of Iraqi Patients with Ankylosing Spondylitis. vol. 4. Online; 2014.

Dundar U, Solak O, Toktas H, Demirdal US, Subasi V, Kavuncu V, et al. Effect of aquatic exercise on ankylosing spondylitis: a randomized controlled trial. Rheumatol Int 2014;34:1505–11. https://doi.org/10.1007/s00296-014-2980-8.

Zhao S, Duffield SJ, Moots RJ, Goodson NJ. Systematic review of association between vitamin D levels and susceptibility and disease activity of ankylosing spondylitis. Rheumatology (United Kingdom) 2014;53:1595–603. https://doi.org/10.1093/rheumatology/keu042.

Zhu W, He X, Cheng K, Zhang L, Chen D, Wang X, et al. Ankylosing spondylitis: etiology, pathogenesis, and treatments. Bone Res 2019;7. https://doi.org/10.1038/s41413-019-0057-8.

Chen CH, Chen HA, Liu CH, Liao HT, Chou CT, Chen CH. Association of obesity with inflammation, disease severity and cardiovascular risk factors among patients with ankylosing spondylitis. Int J Rheum Dis 2020;23:1165–74. https://doi.org/10.1111/1756-185X.13912.

Murdaca G, Spanò F, Contatore M, Guastalla A, Penza E, Magnani O, et al. Immunogenicity of infliximab and adalimumab: What is its role in hypersensitivity and modulation of therapeutic efficacy and safety? Expert Opin Drug Saf 2016;15:43–52. https://doi.org/10.1517/14740338.2016.1112375.

Yoo DH. Comparative effectiveness of the biosimilar CT-P13. J Comp Eff Res 2017;6:693–712. https://doi.org/10.2217/cer-2017-0033.

Strand V, Balsa A, Al-Saleh J, Barile-Fabris L, Horiuchi T, Takeuchi T, et al. Immunogenicity of Biologics in Chronic Inflammatory Diseases: A Systematic Review. BioDrugs 2017;31:299–316. https://doi.org/10.1007/s40259-017-0231-8.

Raychaudhuri SP, Deodhar A. The classification and diagnostic criteria of ankylosing spondylitis. J Autoimmun 2014;48–49:128–33. https://doi.org/10.1016/j.jaut.2014.01.015.

van der Heijde D, Lie E, Kvien TK, Sieper J, van den Bosch F, Listing J, et al. ASDAS, a highly discriminatory ASAS-endorsed disease activity score in patients with ankylosing spondylitis. Ann Rheum Dis 2009;68:1811–8. https://doi.org/10.1136/ard.2008.100826.

Sommerfleck FA, Schneeberger EE, Buschiazzo EE, Maldonado Cocco JA, Citera G. A simplified version of Ankylosing Spondylitis Disease Activity Score (ASDAS) in patients with ankylosing spondylitis. Clin Rheumatol 2012;31:1599–603. https://doi.org/10.1007/s10067-012-2056-7.

Lukas C, Landewé R, Sieper J, Dougados M, Davis J, Braun J, et al. Development of an ASAS-endorsed disease activity score (ASDAS) in patients with ankylosing spondylitis. Ann Rheum Dis 2009;68:18–24. https://doi.org/10.1136/ard.2008.094870.

Smith JA. Update on Ankylosing Spondylitis: Current Concepts in Pathogenesis. Curr Allergy Asthma Rep 2015;15. https://doi.org/10.1007/s11882-014-0489-6.

Dean LE, Jones GT, Macdonald AG, Downham C, Sturrock RD, Macfarlane GJ. Global prevalence of ankylosing spondylitis. Rheumatology (United Kingdom) 2014;53:650–7. https://doi.org/10.1093/rheumatology/ket387.

Hu L, Ji X, Wang Y, Man S, Liu X, Wang L, et al. Underweight and obesity are strong predictors of clinical outcomes in patients with ankylosing spondylitis: data from the Smart-phone SpondyloArthritis Management System. Ther Adv Musculoskelet Dis 2021;13. https://doi.org/10.1177/1759720X211030792.

Dülger S, Aykurt Karlibel I, Kasapoǧlu Aksoy M, Altan L, Şengören Dikiş Ö, Yildiz T. How Does Smoking Cessation Affect Disease Activity, Function Loss, and Quality of Life in

Smokers with Ankylosing Spondylitis? Journal of Clinical Rheumatology 2019;25:288–96. https://doi.org/10.1097/RHU.0000000000000851.

Zhang L, Zhang YJ, Chen J, Huang XL, Fang GS, Yang LJ, et al. The association of HLA-B27 and Klebsiella pneumoniae in ankylosing spondylitis: A systematic review. Microb Pathog 2018;117:49–54. https://doi.org/10.1016/j.micpath.2018.02.020.

Hashim NA, Jassim NA. Effect of Smoking on Disease Activity and Functional Impairment in a Sample of Iraqi Patients with Ankylosing Spondylitis. Indian J Public Health Res Dev 2020;11:2619. https://doi.org/10.37506/v11/i2/2020/ijphrd/195226.

Ibn Yacoub Y, Amine B, Laatiris A, Abouqal R, Hajjaj-Hassouni N. Health-related quality of life in Moroccan patients with ankylosing spondylitis. Clin Rheumatol 2011;30:673–7. https://doi.org/10.1007/s10067-010-1613-1.

Shimabuco AY, Gonçalves CR, Moraes JCB, Waisberg MG, Ribeiro AC de M, Sampaio-Barros PD, et al. Factors associated with ASDAS remission in a long-term study of ankylosing spondylitis patients under tumor necrosis factor inhibitors. Adv Rheumatol 2018;58:40. https://doi.org/10.1186/s42358-018-0040-x.

Aydin SZ, Karadag O, Filippucci E, Atagunduz P, Akdogan A, Kalyoncu U, et al. Monitoring Achilles enthesitis in ankylosing spondylitis during TNF-α antagonist therapy: An ultrasound study. Rheumatology 2009;49:578–82. https://doi.org/10.1093/rheumatology/kep410.

Benjamin M, Toumi H, Ralphs JR, Bydder G, Best TM, Milz S. Where tendons and ligaments meet bone: attachment sites ('entheses’) in relation to exercise and/or mechanical load. 2006; vol. 208.

Moss AC, Brinks V, Carpenter JF. Review article: Immunogenicity of anti-TNF biologics in IBD - The role of patient, product and prescriber factors. Aliment Pharmacol Ther 2013;38:1188–97. https://doi.org/10.1111/apt.12507.

Mahmoud I, Rouached L, ben Tekaya A, Saidane O, Bouden S, Jradi S, et al. Immunogenicity of antitumor necrosis factor therapy in patients with spondyloarthritis. Drug Metab Pers Ther 2021;36:25–32. https://doi.org/10.1515/dmpt-2020-0139.

Hwang J, Kim H-M, Jeong H, Lee J, Ahn JK, Koh E-M, et al. Higher body mass index and anti-drug antibodies predict the discontinuation of anti-TNF agents in Korean patients with axial spondyloarthritis. Revista Brasileira de Reumatologia (English Edition) 2017;57:311–9. https://doi.org/10.1016/j.rbre.2016.11.009.

Patil A, Upadhyaya S, Dawar R, Dadhaniya N, Sood I, Gupta SJ, et al. Anti-drug antibodies and low serum trough infliximab levels correlate with disease activity measures in spondyloarthritis patients on an as-needed infliximab treatment. Int J Rheum Dis 2019;22:1638–43. https://doi.org/10.1111/1756-185X.13636.

Vincent FB, Morand EF, Murphy K, Mackay F, Mariette X, Marcelli C. Antidrug antibodies (ADAb) to tumour necrosis factor (TNF)-specific neutralising agents in chronic

inflammatory diseases: A real issue, a clinical perspective. Ann Rheum Dis 2013;72:165–78. https://doi.org/10.1136/annrheumdis-2012-202545.

Thomas SS, Borazan N, Barroso N, Duan L, Taroumian S, Kretzmann B, et al. Comparative Immunogenicity of TNF Inhibitors: Impact on Clinical Efficacy and Tolerability in the Management of Autoimmune Diseases. A Systematic Review and Meta-Analysis. BioDrugs 2015;29:241–58. https://doi.org/10.1007/s40259-015-0134-5.

Park W, Hrycaj P, Jeka S, Kovalenko V, Lysenko G, Miranda P, et al. A randomised, double-blind, multicentre, parallel-group, prospective study comparing the pharmacokinetics, safety, and efficacy of CT-P13 and innovator infliximab in patients with ankylosing spondylitis: The PLANETAS study. Ann Rheum Dis 2013;72:1605–12. https://doi.org/10.1136/annrheumdis-2012-203091.

Ducourau E, Mulleman D, Paintaud G, Chu D, Lin M, Lauféron F, et al. Antibodies toward infliximab are associated with low infliximab concentration at treatment initiation and poor infliximab maintenance in rheumatic diseases. 2011.

Bornstein G, Lidar M, Langevitz P, Fardman A, Ben-Zvi I, Grossman C, et al. The prevalence and clinical effect of immunogenicity of TNF-α blockers in patients with axial spondyloarthritis Immunogenicity of TNF-α blockers in axial SpA patients / G. Bornstein et al.2018; vol. 36.

Li EK, Griffith JF, Lee VW, Wang YX, Li TK, Lee KK, et al. Short-term efficacy of combination methotrexate and infliximab in patients with ankylosing spondylitis: A clinical and magnetic resonance imaging correlation. Rheumatology 2008;47:1358–63. https://doi.org/10.1093/rheumatology/ken207.

Ben-Horin S, Heap GA, Ahmad T, Kim HU, Kwon TS, Chowers Y. The immunogenicity of biosimilar infliximab: Can we extrapolate the data across indications? Expert Rev Gastroenterol Hepatol 2015;9:27–34. https://doi.org/10.1586/17474124.2015.1091307.

Brun MK, Goll GL, Jørgensen KK, Sexton J, Gehin JE, Sandanger Ø, et al. Risk factors for anti‐drug antibody formation to infliximab: Secondary analyses of a randomised controlled trial. J Intern Med 2022. https://doi.org/10.1111/joim.13495.

Arnson Y, Shoenfeld Y, Amital H. Effects of tobacco smoke on immunity, inflammation and autoimmunity. J Autoimmun 2010;34. https://doi.org/10.1016/j.jaut.2009.12.003.

Quistrebert J, Hässler S, Bachelet D, Mbogning C, Musters A, Tak PP, et al. Incidence and risk factors for adalimumab and infliximab anti-drug antibodies in rheumatoid arthritis: A European retrospective multicohort analysis. Semin Arthritis Rheum 2019;48:967–75. https://doi.org/10.1016/j.semarthrit.2018.10.006.

Arends S, Lebbink HR, Spoorenberg A, Bungener LB, Roozendaal C, van der Veer E, et al. The formation of autoantibodies and antibodies to TNF-α blocking agents in relation to clinical response in patients with ankylosing spondylitis Autoantibodies and antibodies to TNF-α blocking agents in AS / S. Arends et al.2010; vol. 28.

Gratacós J, Díaz del Campo Fontecha P, Fernández-Carballido C, Juanola Roura X, Linares Ferrando LF, de Miguel Mendieta E, et al. Recommendations by the Spanish Society of Rheumatology on the Use of Biological Therapies in Axial Spondyloarthritis. Reumatología Clínica (English Edition) 2018;14:320–33. https://doi.org/10.1016/j.reumae.2017.08.004.

Ruiz-Argüello MB, Maguregui A, Ruiz Del Agua A, Pascual-Salcedo D, Martínez-Feito A, Jurado T, et al. Antibodies to infliximab in Remicade-treated rheumatic patients show identical reactivity towards biosimilars. Ann Rheum Dis 2016;75:1693–6. https://doi.org/10.1136/annrheumdis-2015-208684