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.
References
1. Griffiths CEM, Armstrong AW, Gudjonsson JE, Barker JNWN. Psoriasis. Lancet. 2021;397(10281):1301-1315. doi:10.1016/S0140-6736(20)32549-6
2. Michalek IM, Loring B, John SM. A systematic review of worldwide epidemiology of psoriasis. J Eur Acad Dermatol Venereol. 2017;31(2):205-212. doi:10.1111/jdv.13854
3. Rachakonda TD, Schupp CW, Armstrong AW. Psoriasis prevalence among adults in the United States. J Am Acad Dermatol. 2014;70(3):512-516. doi:10.1016/j.jaad.2013.11.013
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
5. Augustin M, Reich K, Blome C, Schäfer I, Laass A, Radtke MA. Nail psoriasis in Germany: epidemiology and burden of disease. Br J Dermatol. 2010;163(3):580-585. doi:10.1111/j.1365-2133.2010.09831.x
6. Schmid-Ott G, Künsebeck HW, Jäger B, et al. Significance of the stigmatization experience of psoriasis patients: a 1-year follow-up of the illness and its psychosocial consequences in men and women. Acta Derm Venereol. 2005;85(1):27-32. doi:10.1080/000155550410021583
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
13. BIMZELX[®] Approved by the U.S. FDA for the Treatment of Adults with Moderate to Severe Plaque Psoriasis | UCB. www.ucb.com. https://www.ucb.com/stories-media/Press-Releases/article/BIMZELXR-Approved-by-the-US-FDA-for-the-Treatment-of-Adults-with-Moderate-to-Severe-Plaque-Psoriasis
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
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. doi:10.1016/j.jaad.2018.03.037
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
22. Reich K, Warren RB, Lebwohl M, et al. Bimekizumab versus Secukinumab in Plaque Psoriasis. N Engl J Med. 2021;385(2):142-152. doi:10.1056/NEJMoa2102383
23. 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):749-759. doi:10.1093/bjd/ljad035
24. 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):486-495. doi:10.1016/j.jaad.2023.04.063
25. 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. doi:10.1093/bjd/ljac021
26. Warren RB, Blauvelt A, Bagel J, et al. Bimekizumab versus Adalimumab in Plaque Psoriasis. N Engl J Med. 2021;385(2):130-141. doi:10.1056/NEJMoa2102388
27. Gordon KB, Langley RG, Warren RB, et al. Bimekizumab safety in patients with moderate to severe plaque psoriasis: Pooled data from up to three years of treatment in randomized phase 3 trials. Br J Dermatol. Published online November 10, 2023. doi:10.1093/bjd/ljad429
28. 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. doi:10.1016/S0140-6736(22)02302-9
29. 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. doi:10.1016/S0140-6736(22)02303-0
30. Ebell MH, Siwek J, Weiss BD, et al. Strength of recommendation taxonomy (SORT): a patient-centered approach to grading evidence in the medical literature. Am Fam Physician. 2004;69(3):548-556.
31. Hsu CC, Sandford B. The Delphi technique: making sense of consensus. Published online 1-8 2007.
32. 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. doi:10.25251/skin.3.5.1
33. 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):556-569. doi:10.25251/skin.7.1.1
34. 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. doi:10.1111/jdv.12560
35. 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-S23.e1. doi:10.1016/j.jaad.2017.09.078
36. 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. Published online May 2023:S0091674923006644. doi:10.1016/j.jaci.2023.03.035
37. Iznardo H, Puig L. Dual inhibition of IL-17A and IL-17F in psoriatic disease. Ther Adv Chronic Dis. 2021;12:20406223211037846. Published 2021 Aug 12. doi:10.1177/20406223211037846
38. 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):326-338. doi:10.1056/NEJMoa1314258
39. 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. Published 2023 Aug 8. doi:10.3389/fmed.2023.1243843
40. Menter A, Gordon KB, Leonardi CL, Gu Y, Goldblum OM. Efficacy and safety of adalimumab across subgroups of patients with moderate to severe psoriasis. J Am Acad Dermatol. 2010;63(3):448-456. doi:10.1016/j.jaad.2009.09.040
41. Leonardi CL, Kimball AB, Papp KA, et al. Efficacy and safety of ustekinumab, a human interleukin-12/23 monoclonal antibody, in patients with psoriasis: 76-week results from a randomised, double-blind, placebo-controlled trial (PHOENIX 1) [published correction appears in Lancet. 2008 May 31;371(9627):1838]. Lancet. 2008;371(9625):1665-1674. doi:10.1016/S0140-6736(08)60725-4
42. 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 (Heidelb). 2022;12(8):1777-1792. doi:10.1007/s13555-022-00760-8
43. 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. The Lancet. 2020;395(10222):427-440. doi:10.1016/S0140-6736(19)33161-7
44. Chew E, Perin J, Grader-Beck T, Orbai AM. Measurement of Minimal Disease Activity in Psoriatic Arthritis Using the Patient-Reported Outcomes Measurement Information System-Physical Function or the Health Assessment Questionnaire Disability Index. Arthritis Care Res (Hoboken). 2022;74(1):151-160. doi:10.1002/acr.24433
45. 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. Published online January 17, 2023:ard-2022-223595. doi:10.1136/ard-2022-223595
46. Egeberg A, Kristensen LE, Puig L, et al. Network meta-analyses comparing the efficacy of biologic treatments for achieving complete resolution of nail psoriasis at 24-28 and 48-52 weeks. J Dermatolog Treat. 2023;34(1):2263108. doi:10.1080/09546634.2023.2263108
47. Fu Y, Lee CH, Chi CC. Association of Psoriasis With Inflammatory Bowel Disease: A Systematic Review and Meta-analysis. JAMA Dermatol. 2018;154(12):1417-1423. doi:10.1001/jamadermatol.2018.3631
48. Li Y, Guo J, Cao Z, Wu J. Causal Association Between Inflammatory Bowel Disease and Psoriasis: A Two-Sample Bidirectional Mendelian Randomization Study. Front Immunol. 2022;13:916645. Published 2022 Jun 10. doi:10.3389/fimmu.2022.916645
49. 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):1693-1700. doi:10.1136/gutjnl-2011-301668
50. Blauvelt A, Gooderham M, Iversen L, et al. Efficacy and safety of ixekizumab for the treatment of moderate-to-severe plaque psoriasis: Results through 108 weeks of a randomized, controlled phase 3 clinical trial (UNCOVER-3) [published correction appears in J Am Acad Dermatol. 2019 Jan;80(1):301]. J Am Acad Dermatol. 2017;77(5):855-862. doi:10.1016/j.jaad.2017.06.153
51. Reich K, Thaçi D, Stingl G, et al. Safety of Brodalumab in Plaque Psoriasis: Integrated Pooled Data from Five Clinical Trials. Acta Derm Venereol. 2022;102:adv00683. doi:10.2340/actadv.v102.1993
52. Truong SL, Chin J, Liew DFL, et al. Systematic Review and Meta-Analysis of Inflammatory Bowel Disease Adverse Events with Anti-Interleukin 17A Agents and Tumor Necrosis Factor Inhibitors in Rheumatic Disease and Skin Psoriasis. Rheumatol Ther. 2021;8(4):1603-1616. doi:10.1007/s40744-021-00360-6
53. Kalb RE, Strober B, Weinstein G, Lebwohl M. Methotrexate and psoriasis: 2009 National Psoriasis Foundation Consensus Conference. J Am Acad Dermatol. 2009;60(5):824-837. doi:10.1016/j.jaad.2008.11.906
54. Rosmarin DM, Lebwohl M, Elewski BE, Gottlieb AB; National Psoriasis Foundation. Cyclosporine and psoriasis: 2008 National Psoriasis Foundation Consensus Conference. J Am Acad Dermatol. 2010;62(5):838-853. doi:10.1016/j.jaad.2009.05.017
55. Menter A, Gelfand JM, Connor C, et al. Joint American Academy of Dermatology-National Psoriasis Foundation guidelines of care for the management of psoriasis with systemic nonbiologic therapies. J Am Acad Dermatol. 2020;82(6):1445-1486. doi:10.1016/j.jaad.2020.02.044
56. Zachariae H. Methotrexate side-effects. Br J Dermatol. 1990;122 Suppl 36:127-133. doi:10.1111/j.1365-2133.1990.tb02890.x
57. Silva FS, Ribeiro MP, Santos MS, Rocha-Pereira P, Santos-Silva A, Custódio JB. Acitretin affects bioenergetics of liver mitochondria and promotes mitochondrial permeability transition: potential mechanisms of hepatotoxicity. Toxicology. 2013;306:93-100. doi:10.1016/j.tox.2013.01.020
58. Patocka J, Nepovimova E, Kuca K, Wu W. Cyclosporine A: Chemistry and Toxicity - A Review. Curr Med Chem. 2021;28(20):3925-3934. doi:10.2174/0929867327666201006153202
59. Langan SM, Seminara NM, Shin DB, et al. Prevalence of Metabolic Syndrome in Patients with Psoriasis: A Population-Based Study in the United Kingdom. J Invest Dermatol. 2012;132(3):556-562. doi:10.1038/jid.2011.365
60. Svanström C, Lonne-Rahm SB, Nordlind K. Psoriasis and alcohol. Psoriasis Targets Ther. 2019;Volume 9:75-79. doi:10.2147/PTT.S164104
61. UCB, Inc. BIMZELX (bimekizumab-bkzx) [package insert]. US Food Drug Adm. Published online 2023. Accessed February 23, 2024. https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761151s000lbl.pdf
62. Emer JJ, Frankel A, Zeichner JA. A practical approach to monitoring patients on biological agents for the treatment of psoriasis. J Clin Aesthetic Dermatol. 2010;3(8):20-26.
63. Ahn CS, Dothard EH, Garner ML, Feldman SR, Huang WW. To test or not to test? An updated evidence-based assessment of the value of screening and monitoring tests when using systemic biologic agents to treat psoriasis and psoriatic arthritis. J Am Acad Dermatol. 2015;73(3):420-428.e1. doi:10.1016/j.jaad.2015.06.004
64. Kurd S.K., Troxel A.B., Crits-Christoph P., Gelfand J.M. The risk of depression, anxiety, and suicidality in patients with psoriasis: A population-based cohort study. Arch. Dermatol. 2010;146:891–895. doi: 10.1001/archdermatol.2010.186
65. Dalgard F.J., Gieler U., Tomas-Aragones L., Lien L., Poot F.M., Jemec G.B.E., Misery L., Szabo C., Linder D., Sampogna F., et al. The psychological burden of skin diseases: A cross-sectional multicenter study among dermatological out-patients in 13 European countries. J. Investig. Dermatol. 2015;135:984–991. doi: 10.1038/jid.2014.530
66. Wu J.J., Feldman S.R., Koo J., Marangell L.B. Epidemiology of mental health comorbidity in psoriasis. J. Dermatol. Treat. 2018;29:487–495. doi: 10.1080/09546634.2017.1395800
67. Bewley A, Burrage DM, Ersser SJ, Hansen M, Ward C. Identifying individual psychosocial and adherence support needs in patients with psoriasis: a multinational two-stage qualitative and quantitative study. J Eur Acad Dermatol Venereol. 2014;28(6):763-770. doi:10.1111/jdv.12174
68. Ring L, Kettis-Lindblad A, Kjellgren KI, Kindell Y, Maroti M, Serup J. Living with skin diseases and topical treatment: patients' and providers' perspectives and priorities. J Dermatolog Treat. 2007;18(4):209-218. doi:10.1080/09546630701278224
69. Fabrazzo M, Romano F, Arrigo M, et al. A Multivariate Analysis of Depression Prevalence in Psoriasis Patients: A Cohort Study. Int J Environ Res Public Health. 2022;19(4):2060. Published 2022 Feb 12. doi:10.3390/ijerph19042060
70. Patel N, Nadkarni A, Cardwell LA, et al. Psoriasis, Depression, and Inflammatory Overlap: A Review. Am J Clin Dermatol. 2017;18(5):613-620. doi:10.1007/s40257-017-0279-8
71. Koo J, Marangell LB, Nakamura M, et al. Depression and suicidality in psoriasis: review of the literature including the cytokine theory of depression. J Eur Acad Dermatol Venereol. 2017;31(12):1999-2009. doi:10.1111/jdv.14460
72. Pompili M, Innamorati M, Trovarelli S, et al. Suicide risk and psychiatric comorbidity in patients with psoriasis. J Int Med Res. 2016;44(1 suppl):61-66. doi:10.1177/0300060515593253
73. Blauvelt A, Armstrong A, Merola JF, et al. Bimekizumab in Patients with Moderate to Severe Plaque Psoriasis: Analysis of Mental Health and Associated Disorders. SKIN J Cutan Med. 2023;7(6):s300. doi:10.25251/skin.7.supp.300
2. Michalek IM, Loring B, John SM. A systematic review of worldwide epidemiology of psoriasis. J Eur Acad Dermatol Venereol. 2017;31(2):205-212. doi:10.1111/jdv.13854
3. Rachakonda TD, Schupp CW, Armstrong AW. Psoriasis prevalence among adults in the United States. J Am Acad Dermatol. 2014;70(3):512-516. doi:10.1016/j.jaad.2013.11.013
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
5. Augustin M, Reich K, Blome C, Schäfer I, Laass A, Radtke MA. Nail psoriasis in Germany: epidemiology and burden of disease. Br J Dermatol. 2010;163(3):580-585. doi:10.1111/j.1365-2133.2010.09831.x
6. Schmid-Ott G, Künsebeck HW, Jäger B, et al. Significance of the stigmatization experience of psoriasis patients: a 1-year follow-up of the illness and its psychosocial consequences in men and women. Acta Derm Venereol. 2005;85(1):27-32. doi:10.1080/000155550410021583
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
13. BIMZELX[®] Approved by the U.S. FDA for the Treatment of Adults with Moderate to Severe Plaque Psoriasis | UCB. www.ucb.com. https://www.ucb.com/stories-media/Press-Releases/article/BIMZELXR-Approved-by-the-US-FDA-for-the-Treatment-of-Adults-with-Moderate-to-Severe-Plaque-Psoriasis
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
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. doi:10.1016/j.jaad.2018.03.037
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
22. Reich K, Warren RB, Lebwohl M, et al. Bimekizumab versus Secukinumab in Plaque Psoriasis. N Engl J Med. 2021;385(2):142-152. doi:10.1056/NEJMoa2102383
23. 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):749-759. doi:10.1093/bjd/ljad035
24. 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):486-495. doi:10.1016/j.jaad.2023.04.063
25. 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. doi:10.1093/bjd/ljac021
26. Warren RB, Blauvelt A, Bagel J, et al. Bimekizumab versus Adalimumab in Plaque Psoriasis. N Engl J Med. 2021;385(2):130-141. doi:10.1056/NEJMoa2102388
27. Gordon KB, Langley RG, Warren RB, et al. Bimekizumab safety in patients with moderate to severe plaque psoriasis: Pooled data from up to three years of treatment in randomized phase 3 trials. Br J Dermatol. Published online November 10, 2023. doi:10.1093/bjd/ljad429
28. 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. doi:10.1016/S0140-6736(22)02302-9
29. 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. doi:10.1016/S0140-6736(22)02303-0
30. Ebell MH, Siwek J, Weiss BD, et al. Strength of recommendation taxonomy (SORT): a patient-centered approach to grading evidence in the medical literature. Am Fam Physician. 2004;69(3):548-556.
31. Hsu CC, Sandford B. The Delphi technique: making sense of consensus. Published online 1-8 2007.
32. 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. doi:10.25251/skin.3.5.1
33. 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):556-569. doi:10.25251/skin.7.1.1
34. 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. doi:10.1111/jdv.12560
35. 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-S23.e1. doi:10.1016/j.jaad.2017.09.078
36. 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. Published online May 2023:S0091674923006644. doi:10.1016/j.jaci.2023.03.035
37. Iznardo H, Puig L. Dual inhibition of IL-17A and IL-17F in psoriatic disease. Ther Adv Chronic Dis. 2021;12:20406223211037846. Published 2021 Aug 12. doi:10.1177/20406223211037846
38. 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):326-338. doi:10.1056/NEJMoa1314258
39. 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. Published 2023 Aug 8. doi:10.3389/fmed.2023.1243843
40. Menter A, Gordon KB, Leonardi CL, Gu Y, Goldblum OM. Efficacy and safety of adalimumab across subgroups of patients with moderate to severe psoriasis. J Am Acad Dermatol. 2010;63(3):448-456. doi:10.1016/j.jaad.2009.09.040
41. Leonardi CL, Kimball AB, Papp KA, et al. Efficacy and safety of ustekinumab, a human interleukin-12/23 monoclonal antibody, in patients with psoriasis: 76-week results from a randomised, double-blind, placebo-controlled trial (PHOENIX 1) [published correction appears in Lancet. 2008 May 31;371(9627):1838]. Lancet. 2008;371(9625):1665-1674. doi:10.1016/S0140-6736(08)60725-4
42. 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 (Heidelb). 2022;12(8):1777-1792. doi:10.1007/s13555-022-00760-8
43. 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. The Lancet. 2020;395(10222):427-440. doi:10.1016/S0140-6736(19)33161-7
44. Chew E, Perin J, Grader-Beck T, Orbai AM. Measurement of Minimal Disease Activity in Psoriatic Arthritis Using the Patient-Reported Outcomes Measurement Information System-Physical Function or the Health Assessment Questionnaire Disability Index. Arthritis Care Res (Hoboken). 2022;74(1):151-160. doi:10.1002/acr.24433
45. 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. Published online January 17, 2023:ard-2022-223595. doi:10.1136/ard-2022-223595
46. Egeberg A, Kristensen LE, Puig L, et al. Network meta-analyses comparing the efficacy of biologic treatments for achieving complete resolution of nail psoriasis at 24-28 and 48-52 weeks. J Dermatolog Treat. 2023;34(1):2263108. doi:10.1080/09546634.2023.2263108
47. Fu Y, Lee CH, Chi CC. Association of Psoriasis With Inflammatory Bowel Disease: A Systematic Review and Meta-analysis. JAMA Dermatol. 2018;154(12):1417-1423. doi:10.1001/jamadermatol.2018.3631
48. Li Y, Guo J, Cao Z, Wu J. Causal Association Between Inflammatory Bowel Disease and Psoriasis: A Two-Sample Bidirectional Mendelian Randomization Study. Front Immunol. 2022;13:916645. Published 2022 Jun 10. doi:10.3389/fimmu.2022.916645
49. 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):1693-1700. doi:10.1136/gutjnl-2011-301668
50. Blauvelt A, Gooderham M, Iversen L, et al. Efficacy and safety of ixekizumab for the treatment of moderate-to-severe plaque psoriasis: Results through 108 weeks of a randomized, controlled phase 3 clinical trial (UNCOVER-3) [published correction appears in J Am Acad Dermatol. 2019 Jan;80(1):301]. J Am Acad Dermatol. 2017;77(5):855-862. doi:10.1016/j.jaad.2017.06.153
51. Reich K, Thaçi D, Stingl G, et al. Safety of Brodalumab in Plaque Psoriasis: Integrated Pooled Data from Five Clinical Trials. Acta Derm Venereol. 2022;102:adv00683. doi:10.2340/actadv.v102.1993
52. Truong SL, Chin J, Liew DFL, et al. Systematic Review and Meta-Analysis of Inflammatory Bowel Disease Adverse Events with Anti-Interleukin 17A Agents and Tumor Necrosis Factor Inhibitors in Rheumatic Disease and Skin Psoriasis. Rheumatol Ther. 2021;8(4):1603-1616. doi:10.1007/s40744-021-00360-6
53. Kalb RE, Strober B, Weinstein G, Lebwohl M. Methotrexate and psoriasis: 2009 National Psoriasis Foundation Consensus Conference. J Am Acad Dermatol. 2009;60(5):824-837. doi:10.1016/j.jaad.2008.11.906
54. Rosmarin DM, Lebwohl M, Elewski BE, Gottlieb AB; National Psoriasis Foundation. Cyclosporine and psoriasis: 2008 National Psoriasis Foundation Consensus Conference. J Am Acad Dermatol. 2010;62(5):838-853. doi:10.1016/j.jaad.2009.05.017
55. Menter A, Gelfand JM, Connor C, et al. Joint American Academy of Dermatology-National Psoriasis Foundation guidelines of care for the management of psoriasis with systemic nonbiologic therapies. J Am Acad Dermatol. 2020;82(6):1445-1486. doi:10.1016/j.jaad.2020.02.044
56. Zachariae H. Methotrexate side-effects. Br J Dermatol. 1990;122 Suppl 36:127-133. doi:10.1111/j.1365-2133.1990.tb02890.x
57. Silva FS, Ribeiro MP, Santos MS, Rocha-Pereira P, Santos-Silva A, Custódio JB. Acitretin affects bioenergetics of liver mitochondria and promotes mitochondrial permeability transition: potential mechanisms of hepatotoxicity. Toxicology. 2013;306:93-100. doi:10.1016/j.tox.2013.01.020
58. Patocka J, Nepovimova E, Kuca K, Wu W. Cyclosporine A: Chemistry and Toxicity - A Review. Curr Med Chem. 2021;28(20):3925-3934. doi:10.2174/0929867327666201006153202
59. Langan SM, Seminara NM, Shin DB, et al. Prevalence of Metabolic Syndrome in Patients with Psoriasis: A Population-Based Study in the United Kingdom. J Invest Dermatol. 2012;132(3):556-562. doi:10.1038/jid.2011.365
60. Svanström C, Lonne-Rahm SB, Nordlind K. Psoriasis and alcohol. Psoriasis Targets Ther. 2019;Volume 9:75-79. doi:10.2147/PTT.S164104
61. UCB, Inc. BIMZELX (bimekizumab-bkzx) [package insert]. US Food Drug Adm. Published online 2023. Accessed February 23, 2024. https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761151s000lbl.pdf
62. Emer JJ, Frankel A, Zeichner JA. A practical approach to monitoring patients on biological agents for the treatment of psoriasis. J Clin Aesthetic Dermatol. 2010;3(8):20-26.
63. Ahn CS, Dothard EH, Garner ML, Feldman SR, Huang WW. To test or not to test? An updated evidence-based assessment of the value of screening and monitoring tests when using systemic biologic agents to treat psoriasis and psoriatic arthritis. J Am Acad Dermatol. 2015;73(3):420-428.e1. doi:10.1016/j.jaad.2015.06.004
64. Kurd S.K., Troxel A.B., Crits-Christoph P., Gelfand J.M. The risk of depression, anxiety, and suicidality in patients with psoriasis: A population-based cohort study. Arch. Dermatol. 2010;146:891–895. doi: 10.1001/archdermatol.2010.186
65. Dalgard F.J., Gieler U., Tomas-Aragones L., Lien L., Poot F.M., Jemec G.B.E., Misery L., Szabo C., Linder D., Sampogna F., et al. The psychological burden of skin diseases: A cross-sectional multicenter study among dermatological out-patients in 13 European countries. J. Investig. Dermatol. 2015;135:984–991. doi: 10.1038/jid.2014.530
66. Wu J.J., Feldman S.R., Koo J., Marangell L.B. Epidemiology of mental health comorbidity in psoriasis. J. Dermatol. Treat. 2018;29:487–495. doi: 10.1080/09546634.2017.1395800
67. Bewley A, Burrage DM, Ersser SJ, Hansen M, Ward C. Identifying individual psychosocial and adherence support needs in patients with psoriasis: a multinational two-stage qualitative and quantitative study. J Eur Acad Dermatol Venereol. 2014;28(6):763-770. doi:10.1111/jdv.12174
68. Ring L, Kettis-Lindblad A, Kjellgren KI, Kindell Y, Maroti M, Serup J. Living with skin diseases and topical treatment: patients' and providers' perspectives and priorities. J Dermatolog Treat. 2007;18(4):209-218. doi:10.1080/09546630701278224
69. Fabrazzo M, Romano F, Arrigo M, et al. A Multivariate Analysis of Depression Prevalence in Psoriasis Patients: A Cohort Study. Int J Environ Res Public Health. 2022;19(4):2060. Published 2022 Feb 12. doi:10.3390/ijerph19042060
70. Patel N, Nadkarni A, Cardwell LA, et al. Psoriasis, Depression, and Inflammatory Overlap: A Review. Am J Clin Dermatol. 2017;18(5):613-620. doi:10.1007/s40257-017-0279-8
71. Koo J, Marangell LB, Nakamura M, et al. Depression and suicidality in psoriasis: review of the literature including the cytokine theory of depression. J Eur Acad Dermatol Venereol. 2017;31(12):1999-2009. doi:10.1111/jdv.14460
72. Pompili M, Innamorati M, Trovarelli S, et al. Suicide risk and psychiatric comorbidity in patients with psoriasis. J Int Med Res. 2016;44(1 suppl):61-66. doi:10.1177/0300060515593253
73. Blauvelt A, Armstrong A, Merola JF, et al. Bimekizumab in Patients with Moderate to Severe Plaque Psoriasis: Analysis of Mental Health and Associated Disorders. SKIN J Cutan Med. 2023;7(6):s300. doi:10.25251/skin.7.supp.300
Article Sidebar
Published
Mar 18, 2024
Article Details
How to Cite
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., & 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), 1348–1364. https://doi.org/10.25251/skin.8.2.1
Section
Clinical Management Recommendations
This work is licensed under a Creative Commons Attribution 4.0 International License.
All authors retain copyright in their articles. All articles published open access allowing for immediate free access to the work and permitting any user to read, download, copy, distribute, print, search, or link to the full texts of articles, crawl them for indexing, pass them as data to software or use them for any other lawful purpose. Permitted reuse is defined by the following user license:
Creative Commons Attribution (CC BY): lets others distribute and copy the article, to create extracts, abstracts, and other revised versions, adaptations or derivative works of or from an article (such as a translation), to include in a collective work (such as an anthology), to text or data mine the article, even for commercial purposes, as long as they credit the author(s), do not represent the author as endorsing their adaptation of the article, and do not modify the article in such a way as to damage the author's honor or reputation.
Authors retain copyright in their work and license the publisher to publish the content. The publisher is the National Society for Cutaneous Medicine, with production and publishing support provided by OJS, Open Journal Systems,see https://pkp.sfu.
Prior to January 2022, authors transferred copyright to the National Society for Cutaneous Medicine. However, all articles are freely available to anyone in the world. There are no subscription fees, page charges, or article processing charges.