Skip to main content
SpringerLink
Log in

Brodalumab: A Review in Moderate to Severe Plaque Psoriasis

  • Adis Drug Evaluation
  • Published:
Drugs Aims and scope Submit manuscript

Abstract

Brodalumab (Kyntheum®) is a human anti-interleukin-17 receptor A (IL-17RA) monoclonal antibody available for use in patients with moderate to severe plaque psoriasis. In the phase III AMAGINE trials in this patient population, 12 weeks of induction therapy with subcutaneous brodalumab was superior to placebo in terms of the proportion of patients with ≥ 75% improvement in the Psoriasis Area and Severity Index score (PASI 75) and the proportion of patients with a static Physician Global Assessment score of 0 or 1. Brodalumab was also superior to ustekinumab for PASI 100 (i.e. complete skin clearance) at week 12. Health-related quality of life (HR-QOL) outcomes improved to a significantly greater extent with brodalumab than with placebo. Moreover, brodalumab was more effective than placebo in patients with difficult-to-treat nail or scalp psoriasis. Brodalumab was generally well tolerated, with low rates of immunogenicity. Efficacy was sustained and brodalumab remained well tolerated during up to 52 weeks of maintenance therapy. Thus, subcutaneous brodalumab is a useful addition to the treatment options currently available for patients with moderate to severe plaque psoriasis.

This is a preview of subscription content, log in via an institution to check access.

Access this article

Log in via an institution

Price excludes VAT (USA)
Tax calculation will be finalised during checkout.

Instant access to the full article PDF.

Institutional subscriptions

Similar content being viewed by others

References

  1. Campa M, Mansouri B, Warren R, et al. A review of biologic therapies targeting IL-23 and IL-17 for use in moderate-to-severe plaque psoriasis. Dermatol Ther. 2016;6(1):1–12.

    Article  Google Scholar 

  2. Canavan TN, Elmets CA, Cantrell WL, et al. Anti-IL-17 medications used in the treatment of plaque psoriasis and psoriatic arthritis: a comprehensive review. Am J Clin Dermatol. 2016;17(1):33–47.

    Article  PubMed  Google Scholar 

  3. World Health Organization. Global report on psoriasis. 2016. http://www.who.int. Accessed 27 Feb 2018.

  4. Menter A, Korman NJ, Elmets CA, et al. Guidelines of care for the management of psoriasis and psoriatic arthritis: section 6. Guidelines of care for the treatment of psoriasis and psoriatic arthritis: case-based presentations and evidence-based conclusions. J Am Acad Dermatol. 2011;65(1):137–74.

    Article  PubMed  Google Scholar 

  5. European Medicines Agency. Summary of product characteristics: Kyntheum 210 mg solution for injection in pre-filled syringe. 2017. http://www.ema.europa.eu. Accessed 27 Feb 2018.

  6. Papp KA, Reid C, Foley P, et al. Anti-IL-17 receptor antibody AMG 827 leads to rapid clinical response in subjects with moderate to severe psoriasis: results from a phase I, randomized, placebo-controlled trial. J Invest Dermatol. 2012;132(10):2466–9.

    Article  CAS  PubMed  Google Scholar 

  7. Salinger DH, Endres CJ, Martin DA, et al. A semi-mechanistic model to characterize the pharmacokinetics and pharmacodynamics of brodalumab in healthy volunteers and subjects with psoriasis in a first-in-human single ascending dose study. Clin Pharmacol Drug Dev. 2014;3(4):276–83.

    Article  CAS  PubMed  Google Scholar 

  8. Russell CB, Rand H, Bigler J, et al. Gene expression profiles normalized in psoriatic skin by treatment with brodalumab, a human anti-IL-17 receptor monoclonal antibody. J Immunol. 2014;192(8):3828–36.

    Article  CAS  PubMed  Google Scholar 

  9. Endres CJ, Salinger DH, Kock K, et al. Population pharmacokinetics of brodalumab in healthy adults and adults with psoriasis from single and multiple dose studies. J Clin Pharmacol. 2014;54(11):1230–8.

    Article  CAS  PubMed  Google Scholar 

  10. Papp KA, Reich K, Paul C, et al. A prospective phase III, randomized, double-blind, placebo-controlled study of brodalumab in patients with moderate-to-severe plaque psoriasis. Br J Dermatol. 2016;175(2):273–86.

    Article  CAS  PubMed  Google Scholar 

  11. Lebwohl M, Strober B, Menter A, et al. Phase 3 studies comparing brodalumab with ustekinumab in psoriasis. N Engl J Med. 2015;373(14):1318–28.

    Article  PubMed  Google Scholar 

  12. Blauvelt A, Bhatt V, Green L, et al. Median time to treatment response in patients with moderate-to-severe plaque psoriasis treated with brodalumab 210 mg or ustekinumab: a pooled analysis of data from two phase 3 randomized clinical trials (AMAGINE-2 and AMAGINE-3) [abstract no. 5092]. J Am Acad Dermatol. 2017;76(6):AB167.

    Google Scholar 

  13. Papp K, Reich K, Paul C, et al. Improvements in depression and anxiety with brodalumab therapy in AMAGINE-1, a phase 3 study for moderate to severe plaque psoriasis [abstract no. 2863]. J Am Acad Dermatol. 2016;74(5 Suppl 1):AB254.

    Google Scholar 

  14. Mrowietz U, Moller AH, Hansen JB, et al. Treatment with brodalumab leads to significant improvements in patients’ daily lives compared with placebo [abstract no. P1792 plus poster]. In: 26th European Academy of Dermatology and Venerology Congress. 2017.

  15. Paul C, Barker J, Klekotka P, et al. Improvements in health-related quality of life measured by SF-36 and EQ-5D in patients with moderate to severe plaque psoriasis treated with brodalumab. J Am Acad Dermatol [abstract no. 3172]. 2016;74(5 Suppl 1):AB256.

    Google Scholar 

  16. Lebwohl MG, Green L, Hsu S, et al. Improvement of nail psoriasis with brodalumab in phase 3 trials [abstract no. 5296]. J Am Acad Dermatol. 2017;76(6 Suppl 1):AB410.

    Google Scholar 

  17. Yamauchi P, Gottlieb A, Hsu S, et al. Improvement in scalp psoriasis with brodalumab in a randomized placebo-controlled phase 3 study (AMAGINE-1) [abstract no. 5247]. J Am Acad Dermatol. 2017;76(6):AB408.

    Google Scholar 

  18. Lebwohl M, Rosen M, Hansen JB, et al. Patients with inadequate response to ustekinumab achieve high levels of clearance after switching to brodalumab [abstract no. P1800 plus poster]. In: 26th European Academy of Dermatology and Venerology Congress. 2017.

  19. Lebwohl M, Puig L, Langley RG, et al. Brodalumab provides robust and sustained levels of efficacy in moderate-to-severe psoriasis: 120 weeks of treatment in the AMAGINE-2 study [abstract no. P1790 plus poster]. In: 26th European Academy of Dermatology and Venerology Congress. 2017.

  20. Armstrong A, Blauvelt A, Wu JJ, et al. Retreatment with brodalumab results in high response rates in patients with psoriasis after treatment interruption [abstract no. 6841 plus poster]. In: 76th Annual Meeting of the American Academy of Dermatology. 2018.

  21. Armstrong A, Elewski B, Rastogi S, et al. Impact of brodalumab on work productivity in patients with moderate-to-severe plaque psoriasis: analysis of two phase 3 studies [abstract no. 6897 plus poster]. In: 76th Annual Meeting of the American Academy of Dermatology. 2018.

  22. Blauvelt A, Tyring S, Langley R, et al. Efficacy and safety of brodalumab in patients with inadequate response to ustekinumab: analysis of two phase 3 psoriasis studies [abstract no. 6027 plus poster]. In: 76th Annual Meeting of the American Academy of Dermatology. 2018.

  23. Green L, Hsu S, Papp KA, et al. Long-term efficacy of brodalumab in ustekinumab-responsive patients with moderate-to-severe psoriasis [abstract no. 6832 plus poster]. In: 76th Annual Meeting of the American Academy of Dermatology. 2018.

  24. Lebwohl M, Papp K, Tyring S, et al. Long-term efficacy of brodalumab for the treatment of moderate-to-severe psoriasis in 2 pivotal phase 3 clinical trials [abstract no. 6616 plus poster]. In: 76th Annual Meeting of the American Academy of Dermatology. 2018.

  25. Strober B, Armstrong A, Tyring S, et al. Maintenance of response to brodalumab at 52 weeks among patients with moderate-to-severe psoriasis: post hoc analysis of two phase 3 studies [abstract no. 6487 plus poster]. In: 76th Annual Meeting of the American Academy of Dermatology. 2018.

  26. Papp KA, Leonardi C, Menter A, et al. Brodalumab, an anti-interleukin-17-receptor antibody for psoriasis. N Engl J Med. 2012;366(13):1181–9.

    Article  CAS  PubMed  Google Scholar 

  27. Papp KA, Sobell JM, Tyring S, et al. Long-term safety of brodalumab for the treatment of moderate-to-severe psoriasis: 2-year data from 3 pivotal phase 3 clinical trials [abstract no. 6402 plus poster]. In: 76th Annual Meeting of the American Academy of Dermatology. 2018.

  28. Green L, Hsu S, Papp K, et al. Fungal infections in patients with psoriasis during treatment with brodalumab: analysis of clinical trials [abstract no. 6839 plus poster]. In: 76th Annual Meeting of the American Academy of Dermatology. 2018.

  29. Lebwohl MG, Papp KA, Marangell LB, et al. Psychiatric adverse events during treatment with brodalumab: analysis of psoriasis clinical trials. J Am Acad Dermatol. 2018;78(1):81–9.

    Article  CAS  PubMed  Google Scholar 

  30. Strober B, Eichenfield LF, Armstrong A, et al. Overview of adverse cardiovascular events in the brodalumab psoriasis studies [abstract no. 6115]. In: 75th Annual Meeting of the American Academy of Dermatology. 2017.

  31. Reich K, Lebwohl M, Paul C, et al. Brodalumab, a human anti-interleukin-17 receptor A monoclonal antibody, shows low immunogenicity in patients with moderate-to-severe psoriasis [abstract no. P1802 plus poster]. In: 26th European Academy of Dermatology and Venerology Congress. 2017.

  32. 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):2277–94.

    Article  CAS  PubMed  Google Scholar 

  33. Nast A, Spuls PI, van der Kraaij G, et al. European S3-guideline on the systemic treatment of psoriasis vulgaris—update apremilast and secukinumab—EDF in cooperation with EADV and IPC. J Eur Acad Dermatol Venereol. 2017;31(12):1951–63.

    Article  CAS  PubMed  Google Scholar 

  34. National Institute for Health and Care Excellence. Brodalumab for treating moderate to severe plaque psoriasis. 2018. https://www.nice.org.uk. Accessed 27 Feb 2018.

  35. Masson Regnault M, Konstantinou MP, Khemis A, et al. Early relapse of psoriasis after stopping brodalumab: a retrospective cohort study in 77 patients. J Eur Acad Dermatol Venereol. 2017;31(9):1491–6.

    Article  CAS  PubMed  Google Scholar 

  36. Mrowietz U, Kragballe K, Reich K, et al. Definition of treatment goals for moderate to severe psoriasis: a European consensus. Arch Dermatol Res. 2011;303(1):1–10.

    Article  CAS  PubMed  Google Scholar 

  37. European Medicines Agency. Kyntheum® (brodalumab): assessment report. 2017. http://www.ema.europa.eu. Accessed 27 Feb 2018.

  38. Dalgard FJ, Gieler U, Tomas-Aragones L, et al. The psychological burden of skin diseases: a cross-sectional multicenter study among dermatological out-patients in 13 European countries. J Invest Dermatol. 2015;135(4):984–91.

    Article  CAS  PubMed  PubMed Central  Google Scholar 

  39. Loos AM, Liu S, Segel C, et al. Comparative effectiveness of targeted immunomodulators for the treatment of moderate-to-severe plaque psoriasis: a systematic review and network meta-analysis [abstract no. PSY13 plus poster]. Value Health. 2017;20(5):A210.

    Google Scholar 

  40. Sawyer L, Fotheringham I, Gibbons C, et al. Brodalumab versus secukinumab and other biologics in moderate-to-severe psoriasis: an indirect comparison of 52-week efficacy outcomes [abstract no. P1839 plus poster]. In: 26th European Academy of Dermatology and Venerology Congress. 2017.

  41. Sawyer L, Fotheringham I, Gibbons C, et al. Network meta-analysis to evaluate the efficacy of brodalumab in the treatment of moderate-severe psoriasis [abstract no. P1838 plus poster]. In: 26th European Academy of Dermatology and Venerology Congress. 2017.

  42. 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;12:CD011535.

    PubMed  Google Scholar 

  43. Cyr ME. The psychosocial, economic, and occupational impacts of psoriasis. J Dermatol Nurses Assoc. 2017;9(2):75–7.

    Article  Google Scholar 

  44. Moller AH, Gibbons C, Olsen J, et al. Cost per responder of brodalumab compared to other biologics in patients with moderate to severe psoriasis in Sweden [abstract no. P1939 plus poster]. In: 26th European Academy of Dermatology and Venerology Congress. 2017.

  45. Moller AH, Gibbons C, Oluwa F, et al. The cost per responder of brodalumab compared to other biologics in patients with moderate to severe psoriasis in the UK [abstract no. P1936 plus poster]. In: 26th European Academy of Dermatology and Venerology Congress. 2017.

Download references

Acknowledgements

During the peer review process, the manufacturer of brodalumab was also offered an opportunity to review this article. Changes resulting from comments received were made on the basis of scientific and editorial merit.

Author information

Authors and Affiliations

  1. Springer, Private Bag 65901, Mairangi Bay, Auckland, 0754, New Zealand

    Hannah A. Blair

Authors
  1. Hannah A. Blair
    View author publications

    You can also search for this author in PubMed Google Scholar

Corresponding author

Correspondence to Hannah A. Blair.

Ethics declarations

Funding

The preparation of this review was not supported by any external funding.

Conflicts of interest

Hannah Blair is a salaried employee of Adis/Springer, is responsible for the article content and declares no relevant conflicts of interest.

Additional information about this Adis Drug Review can be found at http://www.medengine.com/Redeem/C5FCF0605A157671.

Additional information

The manuscript was reviewed by: A. D. Ormerod, Department of Dermatology, University of Aberdeen, Aberdeen, Scotland; L. Puig, Department of Dermatology, Hospital de la Santa Creu I Sant Pau, Barcelona, Spain.

Rights and permissions

Reprints and permissions

About this article

Check for updates. Verify currency and authenticity via CrossMark

Cite this article

Blair, H.A. Brodalumab: A Review in Moderate to Severe Plaque Psoriasis. Drugs 78, 495–504 (2018). https://doi.org/10.1007/s40265-018-0888-4

Download citation

  • Published:

  • Issue Date:

  • DOI: https://doi.org/10.1007/s40265-018-0888-4

Search

Navigation