Switch from original to biosimilar adalimumab SB-5 in patients with Crohn‘s disease – long-term results

Česká verzia

Authors: Lukáš M.; Kolář M.; Reissigová J.; Černá K.; Machková N.; Hrubá V.; Vašátko M.; Ďuricová D.
Authors place of work: Klinické a výzkumné centrum pro střevní záněty, Klinické centrum ISCARE a. s. a 1. LF UK v Praze
Published in the journal: Gastroent Hepatol 2021; 75(3): 242-251
Category: Original Article
doi: https://doi.org/10.48095/ccgh2021242

Summary

Background and aims: Originator-adalimumab, an established treatment for patients with Crohn‘s disease (CD) showed no difference in efficacy or adverse events vs the adalimumab biosimilar SB5 (SB5-adalimumab) over 10 weeks of treatment. To understand the long-term efficacy of SB5-adalimumab in CD, patients who switched from originator-adalimumab to SB5-adalimumab were compared to a cohort who remained on originator-adalimumab over a follow up of 104 weeks. Methods: In this analysis, data on patients ≥18 years and diagnosed with CD treated at the IBD ISCARE centre were collected prospectively between July 2018 and January 2021. Clinical disease activity as measured by Harvey-Bradshaw index (HBI) at Week 52 was the primary outcome, while C-reactive protein (CRP), faecal calprotectin (FC), adalimumab trough levels in Weeks 10, 26, 52, 78, and 104, adverse events leading to therapy withdrawal, and persistence on treatment were secondary outcomes. To ensure comparable treatment cohorts, patients were propensity score matched (PSM) for age, gender, diagnosis, and disease activity. Results: A total of 54 patients were matched according to the given criteria in each group. At Week 52, the mean [SD] HBI score was 3.2 (2.5) in the originator-adalimumab group and 4.0 (3.6) in SB5-adalimumab patients (difference [95% CI] –0.78 [–2.8, 1.3]). Similarly, no clinically significant differences in CRP, FC, or trough levels were noted between originator-adalimumab and SB5-adalimumab cohorts through Week 52. The Kaplan-Meier estimates (95% CI) of patients remaining on treatment for the originator-adalimumab vs SB5-adalimumab cohorts were 0.870 (0.785–0.965) vs 0.648 (0.533–0.789) at Week 52. Conclusions: These long-term study results in CD patients after a non-medical switch from originator-adalimumab to SB5-adalimumab showed that the biosimilar SB5 had similar therapeutic effects as originator-adalimumab in terms of clinical disease activity, biological parameters, and pharmacokinetics profile at the primary endpoint of 52 weeks, as well as 104 weeks. Differences in persistence were not clinically driven. Persistence on treatment was lower in patients treated with biosimilar adalimumab SB-5.

Keywords:

biosimilar adalimumab SB-5 – inflammatory bowel disease – Crohn‘s disease– biological therapy

Zdroje

1. Bioepis S. Imraldi summary of product characteritics. 2020 [online]. Available from: https:/ / www.ema.europa.eu/ en/ documents/ product-information/ imraldi-epar-product-information_en.pdf.

2. Bioepis S. HADLIMA product information. 2020 [online]. Available from: https:/ / www.accessdata.fda.gov/ drugsatfda_docs/ label/ 2019/ 761059s000lbl.pdf.

3. Argollo M, Fiorino G, Gilardi D et al. Biosimilars of adalimumab in inflammatory bowel disease: are we ready for that? Curr Pharm Des 2019; 25(1): 7–12. doi: 10.2174/ 1381612825666312113610.

4. European Medicines Agency. Guideline on similar biological medicinal products. 2014 [online]. Available from: https:/ / www.ema.europa.eu/ en/ documents/ scientific-guideline/ guide-line-similar-biological-medicinal-products-rev1_en.pdf.

5. (FDA) UFaDA. Scientific considerations in demonstrating biosimilarity to a reference product. 2015 [online]. Available from: https:/ / www.fda.gov/ regulatory-information/ search-fda-guidance-documents/ scientific-considerations-demonstrating-biosimilarity-reference-productDemonstrating Biosimilarity to a Reference Product | FDA.

6. Lee JJ, Yang J, Lee C et al. Demonstration of functional similarity of a biosimilar adalimumab SB5 to Humira®. Biologicals 2019; 58: 7–15. doi: 10.1016/ j.biologicals.2018.12.002.

7. Lee N, Lee JJ, Yang H et al. Evaluation of similar quality attribute characteristics in SB5 and reference product of adalimumab. MAbs 2019; 11(1): 129–144. doi: 10.1080/ 19420862.2018.1530920.

8. Shin D, Lee Y, Kim H et al. A randomized phase Icomparative pharmacokinetic study comparing SB5 with reference adalimumab in healthy volunteers. J Clin Pharm Ther 2017; 42(6): 672–678. doi: 10.1111/ jcpt.12583.

9. Weinblatt ME, Baranauskaite A, Niebrzydowski J et al. Phase III randomized study of SB5, an adalimumab biosimilar, versus reference adalimumab in patients with moderate-to-severe rheumatoid arthritis. Arthritis Rheumatol 2018; 70(1): 40–48. doi: 10.1002/ art.40336.

10. AbbVie. Humira summary of product characteristics. 2020 [online]. Available from: https:/ / www.ema.europa.eu/ en/ documents/ product-information/ humira-epar-product-information_en.pdf.

11. AbbVie. Humira prescribing information. 2020 [online]. Available from: https:/ / www.accessdata.fda.gov/ drugsatfda_docs/ label/ 2008/ 125057s0110lbl.pdf.

12. Lukas M, Malickova K, Kolar M et al. Switching from originator-adalimumab to the biosimilar SB5 in patients with inflammatory bowel disease: short-term experience from a single tertiary clinical centre. J Crohns Colitis 2020; 14(7): 915–919. doi: 10.1093/ ecco-jcc/ jjaa001.

13. European Medicines Agency. ENCePP guide on methodological standards in pharmacoepidemiology. 2020 [online]. Available from: http:/ / www.encepp.eu/ standards_and_guidances/ methodologicalGuide.shtml.

14. Parsons L. Reducing bias in a propensity score matched-pair sample using greedy matching techniques. 26th Annual SAS Users Group International Conference; 22–25 April 2001. USA: CA, Long Beach: 214–226.

15. Di Cesare A, Tronconi G, Fastame TM et al. SB5 adalimumab biosimilar in the treatment of psoriasis and psoriatic arthritis. Dermatol Ther 2020; 33(3): e13435. doi: 10.1111/ dth.13435.

16. Dragoni G, Pieraccini A, Bagnoli S et al. P620 Maintenance of clinical remission with SB5 biosimilar after switch from adalimumab originator: real-life experience of a tertiary referral centre. J Crohns Colitis 2020; 14(Suppl 1): S515. doi: 10.1093/ ecco-jcc/ jjz203.748.

17. Padilla Suarez C, Webb K, Persad N et al. P473 Long-term follow-up of switching from original adalimumab to adalimumab biosimilar: real-world data in IBD. J Crohns Colitis 2020; 14(Suppl 1): S416. doi: 10.1093/ ecco-jcc/ jjz203.602.

18. Young D, Freudensprung U, Harris C et al. P616 IBD reference and biosimilar adalimumab CroSS over study (iBaSS): design considerations and methodology. J Crohns Colitis 2020; 14(Suppl 1): S513. doi: 10.1093/ ecco-jcc/ jjz203.744.

19. Rosembert D, Malaviya A, How J et al. P505 Different failure rates after non-medical switching of 744 patients from adalimumab originator to 2 different adalimumab biosimilars at Cambridge University Hospitals, UK: real-world experience. J Crohns Colitis 2020; 14(Suppl 1): S438–S439. doi: 10.1093/ ecco-jcc/ jjz203.634.

20. Müller-Ladner U, Gaffney K, Jadon D et al. The PROPER study: results of the first interim analysis of a pan-EU real-world study of SB5 biosimilar following transition from reference adalimumab in patients with rheumatoid arthritis, axial spondyloarthritis or psoriatic arthritis. Ann Rheum Dis 2020; 79: 1454–1455. doi: 10.1136/ annrheumdis-2020-eular.5429.

21. Tapete G, Bertani L, Pieraccini A et al. Effectiveness and safety of nonmedical switch from adalimumab originator to SB5 biosimilar in patients with inflammatory bowel diseases: twelve-month follow-up from the TABLET registry. Inflamm Bowel Dis 2021; izab027. doi: 10.1093/ ibd/ izab027.

22. Pouillon L, Danese S, Hart A et al. Consensus report: clinical recommendations for the prevention and management of the nocebo effect in biosimilar-treated IBD patients. Aliment Pharmacol Ther 2019; 49(9): 1181–1187. doi: 10.1111/ apt.15223.

23. D‘Amico F, Pouillon L, Argollo M et al. Multidisciplinary management of the nocebo effect in biosimilar-treated IBD patients: results of a workshop from the NOCE-BIO consensus group. Dig Liver Dis 2020; 52(2): 138–142. doi: 10.1016/ j.dld.2019.11.004.