Real-world Drug Survival of Biosimilar SB5 vs GP2017 Following a Mandatory Non-medical Switch from Adalimumab Originator for Psoriasis: A Nationwide Cohort Study

Authors

DOI:

https://doi.org/10.2340/actadv.v105.42572

Keywords:

Psoriasis, biologics, biosimilar, GP2017, SB5, drug switching

Abstract

Biosimilars are designed to be analogous to the biologic originators. However, comprehensive comparisons between biosimilars are limited and lacking for patients with psoriasis. This study’s objective was to compare 1-year drug survival of the 2 adalimumab biosimilars, GP2017 with SB5, following a non-medical mandatory switch from the adalimumab originator. Based on the national clinical database DERMBIO, this nationwide cohort study included all patients with psoriasis treated with the adalimumab originator who underwent a non-medical mandatory switch to GP2017 or SB5. The study included 525 patients switching from adalimumab originator to 1 of 2 biosimilars: GP2017 (n=267 patients) or SB5 (n=258 patients). When comparing the drug survival of the biosimilars, the hazard ratio was 1.11 (95% confidence interval, 0.58–2.12) for SB5 with GP2017 as reference. In the sensitivity analysis investigating changes in PASI, no differences were found when comparing the GP2017 group and the SB5 group at 120 days of follow-up (1.9% vs 1.6% improved, 1.9% vs 2.0% worsened, and 43.1% vs 40.9% remained unchanged). When comparing GP2017 and SB5, no discernible differences were found in drug survival or effectiveness based on PASI. Determining drug survival and effectiveness could benefit patients and clinicians in treatment decisions.

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Author Biographies

Julia-Tatjana Maul, Department of Dermatology, University Hospital of Zürich, Zürich, Switzerland; Faculty of Medicine, University of Zürich, Zürich, Switzerland

Department of Dermatology

Jashin J. Wu, Department of Dermatology, University of Miami Miller School of Medicine, Miami, USA

Department of Dermatology

Nikolai Nguyen Loft, Department of Dermatology and Allergy, Copenhagen University Hospital - Herlev and Gentofte, Copenhagen, Denmark

Department of Dermatology

Lone Skov, Department of Dermatology and Allergy, Copenhagen University Hospital - Herlev and Gentofte, Copenhagen, Denmark; DERMBIO registry; Department of Clinical Medicine, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark

Department of Dermatology and Allergy

Lars Erik Bryld, DERMBIO registry; Department of Dermatology, Zealand University Hospital, Roskilde, Denmark

Department of Dermatology

Mads Kirchheiner Rasmussen, DERMBIO registry; Department of Dermatology, Aarhus University Hospital, Aarhus, Denmark

Department of Dermatology

Trine Bertelsen, DERMBIO registry; Department of Dermatology, Aarhus University Hospital, Aarhus, Denmark

Department of Dermatology

Kawa Khaled Ajgeiy, Department of Dermatology, Odense University Hospital, Odense, Denmark

Department of Dermatology

Simon Francis Thomsen, Department of Dermatology, Bispebjerg Hospital, University of Copenhagen, Copenhagen, Denmark

Department of Dermatology

Jacob P. Thyssen, Department of Dermatology, Bispebjerg Hospital, University of Copenhagen, Copenhagen, Denmark

Department of Dermatology

Alexander Egeberg, Department of Dermatology, Bispebjerg Hospital, University of Copenhagen, Copenhagen, Denmark; DERMBIO registry; Department of Clinical Medicine, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark

Department of Dermatology

David Thein, Department of Dermatology, Bispebjerg Hospital, University of Copenhagen, Copenhagen, Denmark

Department of Dermatology

References

Parisi R, Iskandar IYK, Kontopantelis E, Augustin M, Griffiths CEM, Ashcroft DM. National, regional, and worldwide epidemiology of psoriasis: systematic analysis and modelling study. BMJ 2020; 369: m1590.

https://doi.org/10.1136/bmj.m1590 DOI: https://doi.org/10.1136/bmj.m1590

Nast A, Smith C, Spuls PI, Avila Valle G, Bata-Csörgö Z, Boonen H, et al. EuroGuiDerm Guideline on the systemic treatment of Psoriasis vulgaris - Part 1: treatment and monitoring recommendations. J Eur Acad Dermatol Venereol 2020; 34: 2461-2498.

https://doi.org/10.1111/jdv.16915 DOI: https://doi.org/10.1111/jdv.16915

Loft N, Egeberg A, Rasmussen MK, Bryld LE, Nissen CV, Dam TN, et al. Outcomes following a mandatory nonmedical switch from adalimumab originator to adalimumab biosimilars in patients with psoriasis. JAMA dermatology 2021; 157: 676-683.

https://doi.org/10.1001/jamadermatol.2021.0221 DOI: https://doi.org/10.1001/jamadermatol.2021.0221

Thatiparthi A, Martin A, Liu J, Egeberg A, Wu JJ. Biologic treatment algorithms for moderate-to-severe psoriasis with comorbid conditions and special populations: a review. Am J Clin Dermatol 2021; 22: 425-442.

https://doi.org/10.1007/s40257-021-00603-w DOI: https://doi.org/10.1007/s40257-021-00603-w

Brownstone ND, Hong J, Mosca M, Hadeler E, Liao W, Bhutani T, et al. Biologic treatments of psoriasis: an update for the clinician. Biologics 2021; 15: 39-51.

https://doi.org/10.2147/BTT.S252578 DOI: https://doi.org/10.2147/BTT.S252578

Constantin MM, Cristea CM, Taranu T, Bucur S, Constantin T, Dinu A, et al. Biosimilars in dermatology: The wind of change. Exp Ther Med 2019; 18: 911-915.

https://doi.org/10.3892/etm.2019.7505 DOI: https://doi.org/10.3892/etm.2019.7505

Annex 3 Guidelines on evaluation of biosimilars. WHO. 2022. [accessed 12 Apr2023] Available from https://cdn.who.int/media/docs/default-source/biologicals/who_trs_1043_annex-3_biosimilars_tk.pdf?sfvrsn=998a85d_1&download=true.

García-Beloso N, Altabás-González I, Samartín-Ucha M, Gayoso-Rey M, De Castro-Parga ML, Salgado-Barreira Á, et al. Switching between reference adalimumab and biosimilars in chronic immune-mediated inflammatory diseases: A systematic literature review. Br J Clin Pharmacol 2022; 88: 1529-1550.

https://doi.org/10.1111/bcp.15101 DOI: https://doi.org/10.1111/bcp.15101

Barbier L, Ebbers HC, Declerck P, Simoens S, Vulto AG, Huys I. The efficacy, safety, and immunogenicity of switching between reference biopharmaceuticals and biosimilars: a systematic review. Clin Pharmacol Ther 2020; 108: 734-755.

https://doi.org/10.1002/cpt.1836 DOI: https://doi.org/10.1002/cpt.1836

Biosimilars in the EU (Information guide for healthcare professionals). Eur Med Agency [accessed 12 Apr2023] Available from https://www.ema.europa.eu/en/documents/leaflet/biosimilars-eu-information-guide-healthcare-professionals_en.pdf.

Colaci M, Aprile ML, Rosa A La, Maggio ADI, Malatino L. AB0218 Non medical switch from adalimumab originator to the biosimilar GP2017 in patients affected by chronic arthritis. Ann Rheum Dis 2021; 80: 1135.

https://doi.org/10.1136/annrheumdis-2021-eular.1563 DOI: https://doi.org/10.1136/annrheumdis-2021-eular.1563

Nabi H, Georgiadis S, Loft AG, Hendricks O, Jensen DV, Andersen M, et al. Comparative effectiveness of two adalimumab biosimilars in 1318 real-world patients with inflammatory rheumatic disease mandated to switch from originator adalimumab: nationwide observational study emulating a randomised clinical trial. Ann Rheum Dis 2021; 80: 1400-1409.

https://doi.org/10.1136/annrheumdis-2021-219951 DOI: https://doi.org/10.1136/annrheumdis-2021-219951

Thein D, Rosenø NAL, Maul J-T, Wu JJ, Skov L, Bryld LE, et al. Drug survival of adalimumab, secukinumab, and ustekinumab in psoriasis as determined by either dose escalation or drug discontinuation during the first 3 years of treatment - a nationwide cohort study. J Invest Dermatol 2023; 143: 2211-2218.e4.

https://doi.org/10.1016/j.jid.2023.04.009 DOI: https://doi.org/10.1016/j.jid.2023.04.009

Yiu ZZN, Mason KJ, Hampton PJ, Reynolds NJ, Smith CH, Lunt M, et al. Drug survival of adalimumab, ustekinumab and secukinumab in patients with psoriasis: a prospective cohort study from the British Association of Dermatologists Biologics and Immunomodulators Register (BADBIR). Br J Dermatol 2020; 183: 294-302.

https://doi.org/10.1111/bjd.18981 DOI: https://doi.org/10.1111/bjd.18981

Egeberg A, Rosenø NAL, Aagaard D, Lørup EH, Nielsen M-L, Nymand L, et al. Drug survival of biologics and novel immunomodulators for rheumatoid arthritis, axial spondyloarthritis, psoriatic arthritis, and psoriasis - A nationwide cohort study from the DANBIO and DERMBIO registries. Semin Arthritis Rheum 2022; 53: 151979.

https://doi.org/10.1016/j.semarthrit.2022.151979 DOI: https://doi.org/10.1016/j.semarthrit.2022.151979

Rupert DJ, Jordan AM, Ziemian MA, Brown RM, Fleming NS, Lefebvre RC. Understanding US physician and pharmacist attitudes toward biosimilar products: a qualitative study. BioDrugs 2022; 36: 645-655.

https://doi.org/10.1007/s40259-022-00545-7 DOI: https://doi.org/10.1007/s40259-022-00545-7

Blauvelt A, Lacour J-P, Fowler JFJ, Weinberg JM, Gospodinov D, Schuck E, et al. Phase III randomized study of the proposed adalimumab biosimilar GP2017 in psoriasis: impact of multiple switches. Br J Dermatol 2018; 179: 623-631.

https://doi.org/10.1111/bjd.16890 DOI: https://doi.org/10.1111/bjd.16890

Giunta A, Zangrilli A, Bavetta M, Manfreda V, Pensa C, Bianchi L. A single-centre, observational, retrospective, real-life study evaluating adalimumab biosimilar ABP 501 in the treatment of plaque-type psoriasis and psoriatic arthritis in originator-naïve patients and in patients undergoing non-medical switch from orig. Curr Med Res Opin 2021; 37: 1099-1102.

https://doi.org/10.1080/03007995.2021.1923467 DOI: https://doi.org/10.1080/03007995.2021.1923467

Hercogová J, Papp KA, Chyrok V, Ullmann M, Vlachos P, Edwards CJ. AURIEL-PsO: a randomized, double-blind phase III equivalence trial to demonstrate the clinical similarity of the proposed biosimilar MSB11022 to reference adalimumab in patients with moderate-to-severe chronic plaque-type psoriasis. Br J Dermatol 2020; 182: 316-326.

https://doi.org/10.1111/bjd.18220 DOI: https://doi.org/10.1111/bjd.18220

Published

2025-03-03

How to Cite

Sieborg, J., Maul, J.-T., Wu, J. J., Loft, N. N., Skov, L., Bryld, L. E., … Thein, D. (2025). Real-world Drug Survival of Biosimilar SB5 vs GP2017 Following a Mandatory Non-medical Switch from Adalimumab Originator for Psoriasis: A Nationwide Cohort Study. Acta Dermato-Venereologica, 105, adv42572. https://doi.org/10.2340/actadv.v105.42572

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