Effectiveness and Safety Data in Rheumatoid Arthritis Patients after Switching from Originator Rituximab to Biosimilar Rituximab (CT-P10)

Abstract

Backgorund Rituximab is an anti-CD20 monoclonal antibody used in the treatment of rheumatoid arthritis. The molecule CT -P10 is a biosimilar of rituximab used in rheumatoid arthritis and has the same safety and efficacy.

Material and methods The aim of our study was to investigate whether drug efficacy decreases after the mandatory switch from originator rituximab to biosimilar rituximab, whether there is an increase in disease activity indices in patients with rheumatoid arthritis receiving rituximab, that could indicate decreased efficacy, and whether the frequency of adverse events related to drug safety remains comparable. We analysed 131 patients with rheumatoid arthritis who received rituximab therapy between January 2010 and December 2022.These patients were switched from the originator rituximab to biosimilar rituximab and followed up.

Results After the switch, a statistically significant decrease in HAQ, DAS-28-CRP, and CDAI scores was observed, while there was no increase in disease activity in other scales. We found that the frequency of adverse events associated with originator rituximab treatment was correlated with anti-CCP positivity (OR=5.436; p=0.006), the presence of an infection requiring hospitalisation (OR=3.917; p=0.012), and the duration of first rituximab treatment (OR=1.032; p<0.001). Similarly, adverse events associated with the use of biosimilar rituximab were associated with a history of infection requiring hospitalisation (OR=50.762; p<0.001).There was not a statistically significant difference between the originator and biosimilar rituximab for total adverse events.

Conclusion Our results suggest that the use of biosimilar rituximab does not lead to an increase in disease activity indices, indicating comparable efficacy, and that the risk of adverse drug reactions is largely similar between the use of original rituximab and biosimilar rituximab.

Keywords

biosimilar - effectiveness - rheumatoid arthritis - rituximab - safety

Schlüsselwörter

Biosimilar - Wirksamkeit - Rheumatoide Arthritis - Rituximab - Sicherheit

Publication History

Article published online:
01 October 2024

• References

• 1 Scott DL, Wolfe F, Huizinga TW. Rheumatoid arthritis. Lancet 2010; 376: 1094-1098
• 2 Calabresi E, Monti S, Governato G. et al. One year in review 2018: psoriatic arthritis. Clin Exp Rheumatol 2019; 37: 167-178
• 3 van Gestel AM, Haagsma CJ, van Riel PL. Validation of rheumatoid arthritis improvement criteria that include simplified joint counts. Arthritis & Rheumatism: Official Journal of the American College of Rheumatology 1998; 41: 1845-1850
• 4 Lopez-Olivo MA, Urruela MA, McGahan L. et al. Rituximab for rheumatoid arthritis. Cochrane Database of Systematic Reviews. 2015
• 5 Ishii-Watabe A, Kuwabara T. Biosimilarity assessment of biosimilar therapeutic monoclonal antibodies. Drug Metabolism and Pharmacokinetics 2019; 34: 64-70
• 6 Yoo DH, Suh CH, Shim SC. et al. A multicentre randomised controlled trial to compare the pharmacokinetics, efficacy and safety of CT-P10 and innovator rituximab in patients with rheumatoid arthritis. Annals of the rheumatic diseases 2017; 76: 566-570
• 7 Yoo DH, Suh CH, Shim SC. et al. Efficacy, Safety and Pharmacokinetics of Up to Two Courses of the Rituximab Biosimilar CT-P10 Versus Innovator Rituximab in Patients with Rheumatoid Arthritis: Results up to Week 72 of a Phase I Randomized Controlled Trial. BioDrugs 2017; 31: 357-367
• 8 Generics and Biosimilars Initiative (GaBI). EMA approval for rituximab biosimilar Truxima. 2017 http://www.gabionline.net/Biosimilars/News/EMA-approval-for-rituximab-biosimilar-Truxima Accessed 14 Feb 2017.
• 9 Melville AR, Md Yusof MY, Fitton J. et al. Real-world experience of effectiveness of non-medical switch from originator to biosimilar rituximab in rheumatoid arthritis. Rheumatology 2021; 60: 3679-3688
• 10 Perneger TV. What's wrong with Bonferroni adjustments. BMJ (Clinical research ed.) 1998; 316: 1236-1238
• 11 van der Heijde D, Aletaha D, Carmona L. et al. EULAR definition of erosive disease in light of the 2010 ACR/EULAR rheumatoid arthritis classification criteria. Annals of the Rheumatic Diseases 2013; 72: 479-481
• 12 Park W, Suh CH, Shim SC. et al. Efficacy and safety of switching from innovator rituximab to biosimilar CT-P10 compared with continued treatment with CT-P10: results of a 56-week open-label study in patients with rheumatoid arthritis. BioDrugs 2017; 31: 369-377
• 13 Burmester G, Drescher E, Hrycaj P. et al. Efficacy and safety results from a randomized double-blind study comparing proposed biosimilar ABP 798 with rituximab reference product in subjects with moderate-to-severe rheumatoid arthritis. Clinical rheumatology 2020; 39: 3341-3352
• 14 Park W, Božić-Majstorović L, Milakovic D. et al. Comparison of biosimilar CT-P10 and innovator rituximab in patients with rheumatoid arthritis: a randomized controlled Phase 3 trial. In MAbs. 2018. Vol. 10. 934-943 Taylor & Francis;
• 15 Suh CH, Yoo DH, Berrocal Kasay A. et al. Long-term efficacy and safety of biosimilar CT-P10 versus innovator rituximab in rheumatoid arthritis: 48-week results from a randomized phase III trial. BioDrugs 2019; 33: 79-91
• 16 Cohen SB, Emery P, Greenwald MW. et al. Rituximab for rheumatoid arthritis refractory to anti-tumor necrosis factor therapy: results of a multicenter, randomized, double-blind, placebo-controlled, phase III trial evaluating primary efficacy and safety at twenty-four weeks. Arthritis & Rheumatism 2006; 54: 2793-2806
• 17 Kwak LW, Sancho JM, Cho SG. et al. Efficacy and Safety of CT-P10 Versus Rituximab in Untreated Low-Tumor-Burden Follicular Lymphoma: Final Results of a Randomized Phase III Study. Clinical Lymphoma Myeloma and Leukemia 2022; 22: 89-97
• 18 Della-Torre E, Lanzillotta M, Campochiaro C. et al. Efficacy and safety of rituximab biosimilar (CT-P10) in IgG4-related disease: an observational prospective open-label cohort study. European Journal of Internal Medicine 2021; 84: 63-67
• 19 Vacchi C, Visentini M, Gragnani L. et al. Safety and effectiveness of biosimilar of Rituximab CT-P10 in the treatment of cryoglobulinemic vasculitis: the MARBLe study (Mixed cryoglobulinemiA Rituximab BiosimiLar). Internal and Emergency Medicine 2021; 16: 149-156
• 20 Ekin A, Coskun BN, Dalkilic E. et al. The effects of COVID-19 infection on the mortality of patients receiving rituximab therapy. Ir J Med Sci 2023; 192: 1959-1973