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Open Access 10-02-2024 | Vulgar Psoriasis | Review

The Efficacy and Safety of Bimekizumab for Plaque Psoriasis: An Expert Consensus Panel

Authors: Joshua Burshtein, Milaan Shah, Danny Zakria, Benjamin Lockshin, Jeff Crowley, Joseph F. Merola, Ken Gordon, Mona Shahriari, Neil J. Korman, Raj Chovatiya, Robert Kalb, Mark Lebwohl

Published in: Dermatology and Therapy | Issue 2/2024

Abstract

Introduction

Psoriasis is a chronic inflammatory condition affecting the skin, joints, and several other organ systems with significant disease burden. Bimekizumab is the first monoclonal antibody targeting both interleukin (IL)-17A and interleukin-17F and has demonstrated efficacy for treating moderate to severe psoriasis. Limited guidelines exist for incorporating this drug into clinical practice. The purpose of this study was for a panel of experts in psoriasis management to synthesize current literature and provide consensus statements with guidance on use of bimekizumab.

Methods

A comprehensive literature search of PubMed, Scopus, and Google Scholar was completed for English-language original research articles on the use of bimekizumab for moderate to severe psoriasis and psoriatic arthritis. A panel of nine dermatologists with significant expertise in treatment of psoriasis gathered to review the articles and create consensus statements on this new medication. A modified Delphi process was used to approve each statement and a strength of recommendation was assigned using Strength of Recommendation Taxonomy criteria.

Results

The literature search produced 102 articles that met criteria. A thorough screening of the studies for relevance to the research question resulted in 19 articles. These were distributed to all panelists for review prior to a roundtable discussion. The panel unanimously voted to adopt 14 consensus statements and recommendations, 12 of which were given a strength of “A”, one of which was given a strength of “B”, and one of which was given a strength of “C”.

Conclusion

Bimekizumab results in rapid and long-lasting clinical improvement for patients with moderate to severe plaque psoriasis and psoriatic arthritis. It has demonstrated superior efficacy when compared to several other biologics. The safety profile is consistent with other biologics, except for an increased incidence of oropharyngeal candidiasis.

Gisondi P, Del Giglio M, Girolomoni G. Treatment approaches to moderate to severe psoriasis. Int J Mol Sci. 2017;18(11):2427. https://doi.org/10.3390/ijms18112427.CrossRefPubMedPubMedCentral

Kimball AB, Jacobson C, Weiss S, Vreeland MG, Wu Y. The psychosocial burden of psoriasis. Am J Clin Dermatol. 2005;6(6):383–92. https://doi.org/10.2165/00128071-200506060-00005.CrossRefPubMed

Raho G, Koleva DM, Garattini L, Naldi L. The burden of moderate to severe psoriasis: an overview. Pharmacoeconomics. 2012;30(11):1005–13. https://doi.org/10.2165/11591580-000000000-00000.CrossRefPubMed

Burshtein J, Strunk A, Garg A. Incidence of psoriasis among adults in the United States: a sex- and age-adjusted population analysis. J Am Acad Dermatol. 2021;84(4):1023–9. https://doi.org/10.1016/j.jaad.2020.11.039.CrossRefPubMed

Sbidian E, Chaimani A, Garcia-Doval I, et al. Systemic pharmacological treatments for chronic plaque psoriasis: a network meta-analysis. Cochrane Database Syst Rev. 2017. https://doi.org/10.1002/14651858.CD011535.pub2.CrossRefPubMedPubMedCentral

Brembilla NC, Senra L, Boehncke WH. The IL-17 family of cytokines in psoriasis: IL-17A and beyond. Front Immunol. 2018;9:1682. https://doi.org/10.3389/fimmu.2018.01682.CrossRefPubMedPubMedCentral

Soderstrom C, Berstein G, Zhang W, et al. Ultra-sensitive measurement of IL-17A and IL-17F in psoriasis patient serum and skin. AAPS J. 2017;19(4):1218–22. https://doi.org/10.1208/s12248-017-0094-4.CrossRefPubMed

Pariser D, Frankel E, Schlessinger J, et al. Efficacy of secukinumab in the treatment of moderate to severe plaque psoriasis in the North American subgroup of patients: pooled analysis of four phase 3 studies. Dermatol Ther. 2018;8(1):17–32. https://doi.org/10.1007/s13555-017-0211-4.CrossRef

Mease PJ, Smolen JS, Behrens F, et al. A head-to-head comparison of the efficacy and safety of ixekizumab and adalimumab in biological-naïve patients with active psoriatic arthritis: 24-week results of a randomised, open-label, blinded-assessor trial. Ann Rheum Dis. 2020;79(1):123–31. https://doi.org/10.1136/annrheumdis-2019-215386.CrossRefPubMed

10.

Farahnik B, Beroukhim K, Abrouk M, et al. Brodalumab for the treatment of psoriasis: a review of phase III trials. Dermatol Ther. 2016;6(2):111–24. https://doi.org/10.1007/s13555-016-0121-x.CrossRef

11.

Reis J, Vender R, Torres T. Bimekizumab: the first dual inhibitor of interleukin (IL)-17A and IL-17F for the treatment of psoriatic disease and ankylosing spondylitis. BioDrugs. 2019;33(4):391–9. https://doi.org/10.1007/s40259-019-00361-6.CrossRefPubMed

12.

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. https://doi.org/10.1111/bcp.13185.CrossRefPubMedPubMedCentral

13.

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):1367–74. https://doi.org/10.1016/j.jaad.2020.05.105.CrossRefPubMed

14.

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):475–86. https://doi.org/10.1016/S0140-6736(21)00126-4.CrossRefPubMed

15.

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):652–63. https://doi.org/10.1111/bjd.20827.CrossRefPubMed

16.

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):330–40. https://doi.org/10.1093/bjd/ljac089.CrossRefPubMed

17.

McInnes IB, Asahina A, Coates LC, et al. Bimekizumab in patients with psoriatic arthritis, naive to biologic treatment: a randomised, double-blind, placebo-controlled, phase 3 trial (BE OPTIMAL). Lancet. 2023;401(10370):25–37. https://doi.org/10.1016/S0140-6736(22)02302-9.CrossRefPubMed

18.

Merola JF, Landewé R, McInnes IB, et al. Bimekizumab in patients with active psoriatic arthritis and previous inadequate response or intolerance to tumour necrosis factor-α inhibitors: a randomised, double-blind, placebo-controlled, phase 3 trial (BE COMPLETE). Lancet. 2023;401(10370):38–48. https://doi.org/10.1016/S0140-6736(22)02303-0.CrossRefPubMed

19.

Ritchlin CT, Kavanaugh A, Merola JF, et al. Bimekizumab in patients with active psoriatic arthritis: results from a 48-week, randomised, double-blind, placebo-controlled, dose-ranging phase 2b trial. Lancet. 2020;395(10222):427–40. https://doi.org/10.1016/S0140-6736(19)33161-7.CrossRefPubMed

20.

Papp KA, Merola JF, Gottlieb AB, et al. Dual neutralization of both interleukin 17A and interleukin 17F with bimekizumab in patients with psoriasis: results from BE ABLE 1, a 12-week randomized, double-blinded, placebo-controlled phase 2b trial. J Am Acad Dermatol. 2018;79(2):277-286.e10. https://doi.org/10.1016/j.jaad.2018.03.037.CrossRefPubMed

21.

Strober B, Paul C, Blauvelt A, et al. Bimekizumab efficacy and safety in patients with moderate to severe plaque psoriasis: two-year interim results from the open-label extension of the randomized BE RADIANT phase 3b trial. J Am Acad Dermatol. 2023;89(3):486–95. https://doi.org/10.1016/j.jaad.2023.04.063.CrossRefPubMed

22.

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. https://doi.org/10.1001/jamadermatol.2022.1185.CrossRefPubMedPubMedCentral

23.

Gargiulo L, Narcisi A, Ibba L, et al. Effectiveness and safety of bimekizumab for the treatment of plaque psoriasis: a real-life multicenter study-IL PSO (Italian landscape psoriasis). Front Med (Lausanne). 2023;10:1243843. https://doi.org/10.3389/fmed.2023.1243843.CrossRefPubMed

24.

Megna M, Battista T, Potestio L, et al. A case of erythrodermic psoriasis rapidly and successfully treated with bimekizumab. J Cosmet Dermatol. 2023;22(3):1146–8. https://doi.org/10.1111/jocd.15543.CrossRefPubMed

25.

Warren RB, Smith CH, Yiu ZZN, et al. Differential drug survival of biologic therapies for the treatment of psoriasis: a prospective observational cohort study from the British Association of Dermatologists Biologic Interventions Register (BADBIR). J Invest Dermatol. 2015;135(11):2632–40. https://doi.org/10.1038/jid.2015.208.CrossRefPubMed

26.

Ebell MH, Siwek J, Weiss BD, et al. Strength of recommendation taxonomy (SORT): a patient-centered approach to grading evidence in the medical literature. J Am Board Fam Med. 2004;17(1):59–67. https://doi.org/10.3122/jabfm.17.1.59.CrossRef

27.

Hsu C-C, Sandford BA. The Delphi technique: making sense of consensus. In: Practical assessment, research, and evaluation, vol. 12, Article 10. 2019. https://doi.org/10.7275/pdz9-th90.

28.

Berman B, Ceilley R, Cockerell C, et al. Appropriate use criteria for the integration of diagnostic and prognostic gene expression profile assays into the management of cutaneous malignant melanoma: an expert panel consensus-based modified delphi process assessment. SKIN J Cutan Med. 2019;3(5):291–306. https://doi.org/10.25251/skin.3.5.1.CrossRef

29.

Thiboutot DM, Dréno B, Abanmi A, et al. Practical management of acne for clinicians: an international consensus from the global alliance to improve outcomes in acne. J Am Acad Dermatol. 2018;78(2):S1–23. https://doi.org/10.1016/j.jaad.2017.09.078.CrossRefPubMed

30.

Richard MA, Barnetche T, Rouzaud M, et al. Evidence-based recommendations on the role of dermatologists in the diagnosis and management of psoriatic arthritis: systematic review and expert opinion. J Eur Acad Dermatol Venereol. 2014;28:3–12. https://doi.org/10.1111/jdv.12560.CrossRefPubMed

31.

Zakria D, Brownstone N, Berman B, et al. Incorporating prognostic gene expression profile assays into the management of cutaneous melanoma: an expert consensus panel. SKIN J Cutan Med. 2023;7(1):556–69. https://doi.org/10.25251/skin.7.1.1.CrossRef

32.

Bayaraa B, Imafuku S. Sustainability and switching of biologics for psoriasis and psoriatic arthritis at Fukuoka University Psoriasis Registry. J Dermatol. 2019;46(5):389–98. https://doi.org/10.1111/1346-8138.14834.CrossRefPubMed

33.

Özkur E, Kıvanç Altunay İ, Oğuz Topal İ, et al. Switching biologics in the treatment of psoriasis: a multicenter experience. Dermatology. 2021;237(1):22–30. https://doi.org/10.1159/000504839.CrossRefPubMed

34.

Armstrong A, Fahrbach K, Leonardi C, et al. Efficacy of bimekizumab and other biologics in moderate to severe plaque psoriasis: a systematic literature review and a network meta-analysis. Dermatol Ther. 2022;12(8):1777–92. https://doi.org/10.1007/s13555-022-00760-8.CrossRef

35.

Gottlieb A, Gratacos J, Dikranian A, et al. Treatment patterns, unmet need, and impact on patient-reported outcomes of psoriatic arthritis in the United States and Europe. Rheumatol Int. 2019;39(1):121–30. https://doi.org/10.1007/s00296-018-4195-x.CrossRefPubMed

36.

Michelsen B, Diamantopoulos AP, Høiberg HK, Soldal DM, Kavanaugh A, Haugeberg G. Need for improvement in current treatment of psoriatic arthritis: study of an outpatient clinic population. J Rheumatol. 2017;44(4):431–6. https://doi.org/10.3899/jrheum.160973.CrossRefPubMed

37.

Kamata M, Tada Y. Efficacy and safety of biologics for psoriasis and psoriatic arthritis and their impact on comorbidities: a literature review. Int J Mol Sci. 2020;21(5):1690. https://doi.org/10.3390/ijms21051690.CrossRefPubMedPubMedCentral

38.

Cole S, Manghera A, Burns L, et al. Differential regulation of IL-17A and IL-17F via STAT5 contributes to psoriatic disease. J Allergy Clin Immunol. 2023. https://doi.org/10.1016/j.jaci.2023.03.035.CrossRefPubMed

39.

Reich K, Warren RB, Lebwohl M, et al. Bimekizumab versus secukinumab in plaque psoriasis. N Engl J Med. 2021;385(2):142–52. https://doi.org/10.1056/NEJMoa2102383.CrossRefPubMed

40.

Warren RB, Blauvelt A, Bagel J, et al. Bimekizumab versus adalimumab in plaque psoriasis. N Engl J Med. 2021;385(2):130–41. https://doi.org/10.1056/NEJMoa2102388.CrossRefPubMed

41.

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. Lancet. 2021;397(10273):487–98. https://doi.org/10.1016/S0140-6736(21)00125-2.CrossRefPubMed

42.

Langley RG, Elewski BE, Lebwohl M, et al. Secukinumab in plaque psoriasis — results of two phase 3 trials. N Engl J Med. 2014;371(4):326–38. https://doi.org/10.1056/NEJMoa1314258.CrossRefPubMed

43.

Leonardi C, Papp K, Strober B, et al. The long-term safety of adalimumab treatment in moderate to severe psoriasis: a comprehensive analysis of all adalimumab exposure in all clinical trials. Am J Clin Dermatol. 2011;12(5):321–37. https://doi.org/10.2165/11587890-000000000-00000.CrossRefPubMed

44.

Zaghi D, Krueger GG, Callis DK. Ustekinumab: a review in the treatment of plaque psoriasis and psoriatic arthritis. J Drugs Dermatol JDD. 2012;11(2):160–7.PubMed

45.

Strober B, Tada Y, Mrowietz U, et al. Bimekizumab maintenance of response through 3 years in patients with moderate-to-severe plaque psoriasis: results from the BE BRIGHT open-label extension trial. Br J Dermatol. 2023;188(6):749–59. https://doi.org/10.1093/bjd/ljad035.CrossRefPubMed

46.

Thaçi D, Vender R, De Rie MA, et al. Safety and efficacy of bimekizumab through 2 years in patients with moderate-to-severe plaque psoriasis: longer-term results from the BE SURE randomized controlled trial and the open-label extension from the BE BRIGHT trial. Br J Dermatol. 2023;188(1):22–31. https://doi.org/10.1093/bjd/ljac021.CrossRefPubMed

47.

Rodríguez-Cerdeira C, González-Cespón JL, Martínez-Herrera E, et al. Candida infections in patients with psoriasis and psoriatic arthritis treated with interleukin-17 inhibitors and their practical management. Ital J Dermatol Venereol. 2021. https://doi.org/10.23736/S2784-8671.20.06580-3.CrossRef

48.

Armstrong AW, Bukhalo M, Blauvelt A. A clinician’s guide to the diagnosis and treatment of candidiasis in patients with psoriasis. Am J Clin Dermatol. 2016;17(4):329–36. https://doi.org/10.1007/s40257-016-0206-4.CrossRefPubMedPubMedCentral

49.

Armstrong AW, Blauvelt A, Mrowietz U, et al. A practical guide to the management of oral candidiasis in patients with plaque psoriasis receiving treatments that target interleukin-17. Dermatol Ther. 2022;12(3):787–800. https://doi.org/10.1007/s13555-022-00687-0.CrossRef

50.

Kessler SQS, Lang PM, Dal-Pizzol TS, Montagner F. Resistance profiles to antifungal agents in Candida albicans isolated from human oral cavities: systematic review and meta-analysis. Clin Oral Investig. 2022;26(11):6479–89. https://doi.org/10.1007/s00784-022-04716-2.CrossRefPubMedPubMedCentral

51.

Van Der Heijde D, Deodhar A, Baraliakos X, et al. Efficacy and safety of bimekizumab in axial spondyloarthritis: results of two parallel phase 3 randomised controlled trials. Ann Rheum Dis. 2023. https://doi.org/10.1136/ard-2022-223595.CrossRefPubMed

52.

Fu Y, Lee CH, Chi CC. Association of psoriasis with inflammatory bowel disease: a systematic review and meta-analysis. JAMA Dermatol. 2018;154(12):1417. https://doi.org/10.1001/jamadermatol.2018.3631.CrossRefPubMedPubMedCentral

53.

Hedin CRH, Sonkoly E, Eberhardson M, Ståhle M. Inflammatory bowel disease and psoriasis: modernizing the multidisciplinary approach. J Intern Med. 2021;290(2):257–78. https://doi.org/10.1111/joim.13282.CrossRefPubMed

54.

Hueber W, Sands BE, Lewitzky S, et al. Secukinumab, a human anti-IL-17A monoclonal antibody, for moderate to severe Crohn’s disease: unexpected results of a randomised, double-blind placebo-controlled trial. Gut. 2012;61(12):1693–700. https://doi.org/10.1136/gutjnl-2011-301668.CrossRefPubMed

Title: The Efficacy and Safety of Bimekizumab for Plaque Psoriasis: An Expert Consensus Panel
Authors: Joshua Burshtein
Milaan Shah
Danny Zakria
Benjamin Lockshin
Jeff Crowley
Joseph F. Merola
Ken Gordon
Mona Shahriari
Neil J. Korman
Raj Chovatiya
Robert Kalb
Mark Lebwohl
Publication date: 10-02-2024
Publisher: Springer Healthcare
Keywords: Vulgar Psoriasis
Psoriatic Arthritis
Plaque Psoriasis
Secukinumab
Candidiasis
Candidiasis
Ustekinumab
Adalimumab
Published in: Dermatology and Therapy / Issue 2/2024
Print ISSN: 2193-8210
Electronic ISSN: 2190-9172
DOI: https://doi.org/10.1007/s13555-024-01099-y

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Abstract

Introduction

Methods

Results

Conclusion

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