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On the question of the interchangeability of monoclonal bio similar antibodies in the treatment of immune-mediated infl ammatory diseases


Authors: M. Lukáš 1;  L. Šenolt 2;  S. Gkalpakiotis 3
Authors‘ workplace: Klinické a výzkumné centrum pro střevní záněty, Klinické centrum ISCARE a. s. a 1. LF UK v Praze 1;  Revmatologický ústav 1. LF UK a VFN v Praze 2;  Dermatovenerologická klinika 3. LF UK a FNKV, Praha 3
Published in: Gastroent Hepatol 2023; 77(1): 34-37
Category:
doi: https://doi.org/10.48095/ccgh202334


Sources

1. Statement on the scientific rationale supporting interchangeability of bio­similar medicines in the EU. 2022 [online]. Dostupné z: https: //www.ema.europa.eu/en/documents/public-state- ment/statement-scientific-rationale-support- ing-interchangeability-bio­similar-medicines- eu_en.pdf.

2. Lukáš M. Zkušenosti s bio­logickou léčbou v Klinickém centru ISCARE. In: Idiopatické střevní záněty II. Nové trendy a mezioborové zkušenosti. Praha: Grada Publishing 2021; 177–202.

3. Rubbert-Roth A, Szabó MZ, Kedves M et al. 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. doi: 10.1016/ j.autrev.2019.102398.

4. Smolen JS, Landewé RB, Bergstra S 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. doi: 10.1136/ard-2022-223356.

5. Ramiro S, Nikiphorou E, Sepriano A et al. ASAS-EULAR recommendations for the management of axial spondyloarthritis: 2022 update. Ann Rheum Dis 2023; 82 (1): 19–34. doi: 10.1136/ard-2022-223296.

6. Coates LC, Soriano ER, Corp N et al. GRAPPA Treatment Recommendations domain subcommittees. Group for Research and Assessment of Psoriasis and Psoriatic Arthritis (GRAPPA): updated treatment recommendations for psoriatic arthritis 2021. Nat Rev Rheumatol 2022; 18 (8): 465–479. doi: 10.1038/s41584-022-007 98-0.

7. Nast A, Smith C, Spuls PI et al. EuroGuiDerm Guideline on the systemic treatment of Psoriasis vulgaris – Part 1: treatment and monitoring recommendations. J Eur Acad Dermatol Venerol 2020; 34 (11): 2461–2498. doi: 10.1111/jdv.16915.

8. Lukáš M et al. Pokroky v dia­gnostice a léčbě idiopatických střevních zánětů. Praha: Galén 2019.

9. Lukáš M. Přínos bio­similárních monoklonálních protilátek v terapii idiopatických střevních zánětů. Gastro Hepatol 2022; 76 (5): 447–452. doi: 10.48095/ccgh2022447.

10. Fleischmann R, Lakhanpal S, Saikali W et al. Multiple Switching Between the Biosimilar Adalimumab PF-06410293 (Abrilada™) and Reference Adalimumab (Humira®) in Combination with Methotrexate in Patients with Moderately to Severely Active Rheumatoid Arthritis. Arthritis Rheumatol 2022; 74 (9).

11. Feldman S, Stroissnig H, Kay R et al. A Clinical Study Designed to Support a Demonstration of Interchangeability Between AVT02 and Reference Adalimumab (Humira®). Arthritis Rheumatol 2022; 74 (9).

12. Ruda RC, Kelly KA, Feldman SR. Real-world outcomes following switching from anti-TNF reference products to bio­similars for the treatment of psoriasis. J Dermatolog Treat 2023; 34 (1): 2140569. doi: 10.1080/09546634.2022.2140569.

13. Roccuzzo G, Rozzo G, Burzi L et al. Switching from adalimumab originator to bio­similars in hidradenitis suppurativa: What‘s beyond cost-effectiveness? Dermatol Ther 2022; 35 (11): e15803. doi: 10.1111/dth.15803.

14. Jørgensen KK, Olsen IC, Goll GL et al. Switching from originator infliximab to bio­similar CT-P13 compared with maintained treatment with originator infliximab (NOR-SWITCH): a 52-week, randomised, double-blind, non-inferiority trial. Lancet 2017; 389 (10086): 2304–2316. doi: 10.1016/S0140-6736 (17) 30068-5.

15. Lukas M, Kolar M, Reisigova J et al. A switch from originator adalimumab to the bio­similar SB5 in patients with Crohn’s disease: an analysis of two propensity score-matched cohorts. Scand J Gastroenterol. 2022; 57 (7): 814–824. doi: 10.1080/00365521.2022.2041082.

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Paediatric gastroenterology Gastroenterology and hepatology Surgery

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Gastroenterology and Hepatology

Issue 1

2023 Issue 1

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