Evaluating the Efficacy and Safety of Bimekizumab for Plaque Psoriasis and Psoriatic Arthritis: An Expert Consensus Panel Report
Main Article Content
Keywords
plaque psoriasis, psoriatic arthritis, bimekizumab, interleukin-17, IL-17, biologic, treatment, efficacy, safety
Abstract
Background: While there are numerous effective therapies for psoriasis, there remains an unmet need as some patients still suffer from inadequate response with available medications. Bimekizumab is a first-in-class monoclonal antibody that inhibits both interleukin (IL)-17A and IL-17F and was recently approved by the Food and Drug Administration. The aim of this study was for a panel of experts in psoriasis management to review the available data on bimekizumab and create consensus statements on its use in clinical practice.
Methods: A comprehensive literature search of PubMed, Scopus, and Google Scholar was conducted for English-language original research articles, systematic reviews, and meta-analyses discussing the safety and efficacy of bimekizumab for moderate to severe plaque psoriasis and psoriatic arthritis. A panel of nine dermatology physician assistants and one dermatology nurse practitioner with significant expertise in the management of psoriasis convened virtually on December 16, 2023, to review the studies and create recommendations for their peers on the use of bimekizumab. A modified Delphi process was implemented to reach a consensus on these statements and the Strength of Recommendation Taxonomy was used to assign each one a strength of recommendation.
Results: The literature search resulted in 92 articles that met search criteria. After a thorough screening of these studies for relevance to the discussion questions, 20 articles remained and were distributed to each panelist prior to the meeting. The panel unanimously voted to adopt 10 consensus recommendations and assigned all 10 statements a strength of recommendation of “A.”
Conclusion: Bimekizumab has a very high efficacy in the treatment of moderate to severe psoriasis and psoriatic arthritis. It also has a favorable safety profile that is consistent with that of other biologics, except for an increased risk of oral candidiasis.
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4. Parisi R, Symmons DPM, Griffiths CEM, Ashcroft DM; Identification and Management of Psoriasis and Associated ComorbidiTy (IMPACT) project team. Global epidemiology of psoriasis: a systematic review of incidence and prevalence. J Invest Dermatol. 2013;133(2):377-385. doi:10.1038/jid.2012.339
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7. Fortune DG, Richards HL, Griffiths CE, Main CJ. Psychological stress, distress and disability in patients with psoriasis: consensus and variation in the contribution of illness perceptions, coping and alexithymia. Br J Clin Psychol. 2002;41(Pt 2):157-174. doi:10.1348/014466502163949
8. Gisondi P, Del Giglio M, Girolomoni G. Treatment Approaches to Moderate to Severe Psoriasis. Int J Mol Sci. 2017;18(11):2427. doi:10.3390/ijms18112427
9. Sbidian E, Chaimani A, Garcia-Doval I, et al. Systemic pharmacological treatments for chronic plaque psoriasis: a network meta-analysis. Cochrane Skin Group, ed. Cochrane Database Syst Rev. Published online December 22, 2017. doi:10.1002/14651858.CD011535.pub2
10. Blauvelt A, Chiricozzi A. The Immunologic Role of IL-17 in Psoriasis and Psoriatic Arthritis Pathogenesis. Clin Rev Allergy Immunol. 2018;55(3):379-390. doi:10.1007/s12016-018-8702-3
11. Brembilla NC, Senra L, Boehncke WH. The IL-17 Family of Cytokines in Psoriasis: IL-17A and Beyond. Front Immunol. 2018;9:1682. Published 2018 Aug 2. doi:10.3389/fimmu.2018.01682
12. Ghoreschi K, Balato A, Enerbäck C, Sabat R. Therapeutics targeting the IL-23 and IL-17 pathway in psoriasis. Lancet. 2021;397(10275):754-766. doi:10.1016/S0140-6736(21)00184-7
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14. Glatt S, Helmer E, Haier B, et al. First-in-human randomized study of bimekizumab, a humanized monoclonal antibody and selective dual inhibitor of IL-17A and IL-17F, in mild psoriasis. Br J Clin Pharmacol. 2017;83(5):991-1001. doi:10.1111/bcp.13185
15. Blauvelt A, Papp KA, Merola JF, et al. Bimekizumab for patients with moderate to severe plaque psoriasis: 60-week results from BE ABLE 2, a randomized, double-blinded, placebo-controlled, phase 2b extension study. J Am Acad Dermatol. 2020;83(5):1367-1374. doi:10.1016/j.jaad.2020.05.105
16. Gordon KB, Foley P, Krueger JG, et al. Bimekizumab efficacy and safety in moderate to severe plaque psoriasis (BE READY): a multicentre, double-blind, placebo-controlled, randomised withdrawal phase 3 trial. Lancet. 2021;397(10273):475-486. doi:10.1016/S0140-6736(21)00126-4
17. Gordon KB, Langley RG, Warren RB, et al. Bimekizumab Safety in Patients With Moderate to Severe Plaque Psoriasis: Pooled Results From Phase 2 and Phase 3 Randomized Clinical Trials. JAMA Dermatol. 2022;158(7):735-744. doi:10.1001/jamadermatol.2022.1185
18. Kokolakis G, Warren RB, Strober B, et al. Bimekizumab efficacy and safety in patients with moderate-to-severe plaque psoriasis who switched from adalimumab, ustekinumab or secukinumab: results from phase III/IIIb trials. Br J Dermatol. 2023;188(3):330-340. doi:10.1093/bjd/ljac089
19. Oliver R, Krueger JG, Glatt S, et al. Bimekizumab for the treatment of moderate-to-severe plaque psoriasis: efficacy, safety, pharmacokinetics, pharmacodynamics and transcriptomics from a phase IIa, randomized, double-blind multicentre study. Br J Dermatol. 2022;186(4):652-663. doi:10.1111/bjd.20827
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21. Reich K, Papp KA, Blauvelt A, et al. Bimekizumab versus ustekinumab for the treatment of moderate to severe plaque psoriasis (BE VIVID): efficacy and safety from a 52-week, multicentre, double-blind, active comparator and placebo controlled phase 3 trial [published correction appears in Lancet. 2021 Feb 20;397(10275):670]. Lancet. 2021;397(10273):487-498. doi:10.1016/S0140-6736(21)00125-2
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Zakria, D., Miller, L., Chao, T., Gautier, K., Glover, H., Kucera, K., Nguyen, A., Pansch, L.A., Printy, R., Trickett, C., Volz, J., Shah, M. and Burshtein, J. 2024. Evaluating the Efficacy and Safety of Bimekizumab for Plaque Psoriasis and Psoriatic Arthritis: An Expert Consensus Panel Report. SKIN The Journal of Cutaneous Medicine. 8, 2 (Mar. 2024), 1348–1364. DOI:https://doi.org/10.25251/skin.8.2.1.
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Clinical Management Recommendations
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