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Review Article

Efficacy and safety evaluations of adalimumab biosimilars in the treatment of psoriasis

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Article: 2249145 | Received 10 Apr 2023, Accepted 17 May 2023, Published online: 22 Aug 2023

References

  • Torales J, Echeverría C, Barrios I, et al. Psychodermatological mechanisms of psoriasis. Dermatol Ther. 2020;33(6):1.
  • Griffiths CEM, Armstrong AW, Gudjonsson JE, et al. Psoriasis. Lancet. 2021;397(10281):1301–14. doi: 10.1016/S0140-6736(20)32549-6.
  • Takeshita J, Gelfand JM, Li P, et al. Psoriasis in the US medicare population: prevalence, treatment, and factors associated with biologic use. J Invest. 2015;135(12):2955–2963. doi: 10.1038/jid.2015.296.
  • Parisi R, Iskandar IYK, Kontopantelis E, et al. National, regional, and worldwide epidemiology of psoriasis: systematic analysis and modelling study. BMJ. 2020;369:m1590. doi: 10.1136/bmj.m1590.
  • Committee on Psoriasis CSoD. Guideline for the diagnosis and treatment of psoriasis in China (2018 simplified edition). Chin J Dermatol. 2019;52(4):223–230.
  • Nast A, Amelunxen L, Augustin M, et al. S3 guideline for the treatment of psoriasis vulgaris, update - Short version part 1 - Systemic treatment. J Dtsch Dermatol Ges. 2018;16(5):645–669. doi: 10.1111/ddg.13516.
  • Singh JA, Guyatt G, Ogdie A, et al. Special article: 2018 American college of rheumatology/national psoriasis foundation guideline for the treatment of psoriatic arthritis. Arthritis Rheumatol. 2019;71(1):5–32. doi: 10.1002/art.40726.
  • Zweegers J, de Jong EM, Nijsten TE, et al. Summary of the Dutch S3-guidelines on the treatment of psoriasis 2011. IJIJDVL. 2014;20(3):21769.
  • Nast A, Gisondi P, Ormerod AD, et al. European S3-guidelines on the systemic treatment of psoriasis vulgaris – update 2015 – short version – EDF in cooperation with EADV and IPC. J Eur Acad Dermatol Venereol. 2015;29(12):2277–2294. doi: 10.1111/jdv.13354.
  • Christophers E, Griffiths CEM, Gaitanis G, et al. The unmet treatment need for moderate to severe psoriasis: results of a survey and chart review. J Eur Acad Dermatol Venereol. 2006;20(8):921–925.
  • Feldmann M, Maini RN. Anti-TNF therapy, from rationale to standard of care: what lessons has it taught us? J Immunol. 2010;185(2):791–794. doi: 10.4049/jimmunol.1090051.
  • Kaymakcalan Z, Sakorafas P, Bose S, et al. Comparisons of affinities, avidities, and complement activation of adalimumab, infliximab, and etanercept in binding to soluble and membrane tumor necrosis factor. Clin Immunol. 2009;131(2):308–316. doi: 10.1016/j.clim.2009.01.002.
  • Gladman DD, Mease PJ, Ritchlin CT, et al. Adalimumab for long-term treatment of psoriatic arthritis: forty-eight week data from the adalimumab effectiveness in psoriatic arthritis trial. Arthritis Rheum. 2007;56(2):476–488. doi: 10.1002/art.22379.
  • Mease PJ, Gladman DD, Ritchlin CT, et al. Adalimumab for the treatment of patients with moderately to severely active psoriatic arthritis: results of a double-blind, randomized, placebo-controlled trial. Arthritis Rheum. 2005;52(10):3279–3289. doi: 10.1002/art.21306.
  • Gordon K, Papp K, Poulin Y, et al. Long-term efficacy and safety of adalimumab in patients with moderate to severe psoriasis treated continuously over 3 years: results from an open-label extension study for patients from REVEAL. J Am Acad Dermatol. 2012;66(2):241–251. doi: 10.1016/j.jaad.2010.12.005.
  • Mease PJ, Ory P, Sharp JT, et al. Adalimumab for long-term treatment of psoriatic arthritis: 2-year data from the adalimumab effectiveness in psoriatic arthritis trial (ADEPT). Ann Rheum Dis. 2009;68(5):702–709. doi: 10.1136/ard.2008.092767.
  • Cai L, Gu J, Zheng J, et al. Efficacy and safety of adalimumab in Chinese patients with moderate-to-severe plaque psoriasis: results from a phase 3, randomized, placebo-controlled, double-blind study. J Eur Acad Dermatol Venereol. 2017;31(1):89–95. doi: 10.1111/jdv.13746.
  • Papp K, Thaçi D, Marcoux D, et al. Efficacy and safety of adalimumab every other week versus methotrexate once weekly in children and adolescents with severe chronic plaque ­psoriasis: a randomised, double-blind, phase 3 trial. Lancet. 2017;390(10089):40–49. doi: 10.1016/S0140-6736(17)31189-3.
  • Sanjeev K, Pankai S, Rajalaxmi N. Opportunities and challenges in biosimilar development Boston: BioProcess International; 2017 [cited 2018]. Available from: http://www.bioprocessintl.com/manufacturing/biosimilars/opportunities-challenges-biosimilar-development/.
  • Kim H, Alten R, Avedano L, et al. The future of biosimilars: maximizing benefits across immune-mediated inflammatory diseases. Drugs. 2020;80(2):99–113. doi: 10.1007/s40265-020-01256-5.
  • Jadad AR, Moore RA, Carroll D, et al. Assessing the quality of reports of randomized clinical trials: is blinding necessary? Control Clin Trials. 1996;17(1):1–12. doi: 10.1016/0197-2456(95)00134-4.
  • Cai L, Li LF, Cheng H, et al. Efficacy and safety of HLX03, an adalimumab biosimilar, in patients with moderate-to-severe plaque psoriasis: a randomized, double-blind, phase III study. Adv Ther. 2022;39(1):583–597. doi: 10.1007/s12325-021-01899-0.
  • Feldman SR, Reznichenko N, Pulka G, et al. Efficacy, safety and immunogenicity of AVT02 versus originator adalimumab in subjects with moderate to severe chronic plaque psoriasis: a multicentre, double-blind, randomised, parallel group, active control, phase III study.BioDrugs. 2021;35(6):735–748. doi: 10.1007/s40259-021-00502-w.
  • Menter A, Arenberger P, Balser S, et al. Similar efficacy, safety, and immunogenicity of the biosimilar BI 695501 and adalimumab reference product in patients with moderate-to-severe chronic plaque psoriasis: results from the randomized phase III VOLTAIRE-PSO study. Expert Opin Biol Ther. 2021;21(1):87–96. doi: 10.1080/14712598.2021.1851362.
  • Hercogova J, Papp KA, Chyrok V, et al. 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(2):316–326. doi: 10.1111/bjd.18220.
  • Papp K, Bachelez H, Costanzo A, et al. Clinical similarity of biosimilar ABP 501 to adalimumab in the treatment of patients with moderate to severe plaque psoriasis: a randomized, double-blind, multicenter, phase III study. J Am Acad Dermatol. 2017;76(6):1093–1102. doi: 10.1016/j.jaad.2016.12.014.
  • Papp K, Bachelez H, Costanzo A, et al. Clinical similarity of the biosimilar ABP 501 compared with adalimumab after single transition: long-term results from a randomized controlled, double-blind, 52-week, phase III trial in patients with moderate-to-severe plaque psoriasis. Br J Dermatol. 2017;177(6):1562–1574. doi: 10.1111/bjd.15857.
  • Samtsov AV, Bakulev AL, Khairutdinov VR, et al. Long-term data on the proposed adalimumab biosimilar BCD-057 in patients with moderate to severe psoriasis: a randomized controlled trial. PLoS One. 2022;17(2):e0263214. doi: 10.1371/journal.pone.0263214.
  • Blauvelt A, Lacour JP, Fowler JF, et al. Phase III randomized study of the proposed adalimumab biosimilar GP2017 in psoriasis: impact of multiple switches. Br J Dermatol. 2018;179(3):623–631. doi: 10.1111/bjd.16890.