Brodalumab for the Treatment of Moderate-to-Severe Psoriasis: An Expert Delphi Consensus Statement

Brodalumab is a recombinant, fully human immunoglobulin IgG2 monoclonal antibody specifically targeted against interleukin-17RA that has been approved for the treatment of moderate-to-severe psoriasis in Europe. We developed a Delphi consensus document focused on brodalumab for the treatment of moderate-to-severe psoriasis. Based on published literature and their clinical experience a steering committee drafted 17 statements covering 7 domains specific to the treatment of moderate-to-severe psoriasis with brodalumab. A panel of 32 Italian dermatologists indicated their level of agreement using a 5-point Likert scale (from 1 = "strongly disagree" to 5 = "strongly agree") using an online modified Delphi method. After the first round of voting (32 participants), positive consensus was reached for 15/17 (88.2%) of the proposed statements. Following a face-to-face virtual meeting, the steering committee decided that 5 statements would form "main principles" and 10 statements formed the final list. After a second round of voting, consensus was reached in 4/5 (80%) of the main principles and 8/10 (80%) for consensus statements. The final list of 5 main principles and 10 consensus statements identify key indications specific to the use of brodalumab in the treatment of moderate-to-severe psoriasis in Italy. These statements aid dermatologists in the management of patients with moderate-to-severe psoriasis.

Citing Articles

Italian Expert Opinion on Chronic Hand Eczema: from Guidelines to Clinical Practice.

Stingeni L, Fargnoli M, Guarneri F, Balato A, Corazza M, Belloni Fortina A Dermatol Ther (Heidelb). 2024; 15(1):75-93.

PMID: 39607665 PMC: 11785867. DOI: 10.1007/s13555-024-01312-y.

Real-World Data on Brodalumab Treatment in Patients with Moderate-to-Severe Plaque Psoriasis: An Observational Study from the Czech Republic BIOREP Registry.

Kojanova M, Turkova B, Gkalpakiotis S, Cetkovska P, Fialova J, Dolezal T Adv Ther. 2024; 41(10):3951-3971.

PMID: 39207667 PMC: 11399213. DOI: 10.1007/s12325-024-02952-4.

No Evidence of Gut Microbiota Alteration in Psoriasis Patients Switching to Brodalumab after Loss of TNFα Inhibition Effect.

Vizlin A, Bjorkman Y, Kumar Y, Gothe M, Gillstedt M, Osmancevic A Int J Mol Sci. 2024; 25(14).

PMID: 39062988 PMC: 11277239. DOI: 10.3390/ijms25147745.

Management of Clostridioides difficile infection: an Italian Delphi consensus.

Bassetti M, Cascio A, De Rosa F, Meschiari M, Parrella R, Petrosillo N J Antimicrob Chemother. 2024; 79(9):2103-2118.

PMID: 39008427 PMC: 11368432. DOI: 10.1093/jac/dkae179.

Risk of Skin Cancer in Patients with Psoriasis: Single-Center Retrospective Study Comparing Anti-TNFα and Phototherapy.

Trovato E, Dragotto M, Capalbo E, Cartocci A, Rubegni P, Calabrese L J Clin Med. 2024; 13(9).

PMID: 38730981 PMC: 11084754. DOI: 10.3390/jcm13092452.

References

Yamasaki K, Nakagawa H, Kubo Y, Ootaki K . Efficacy and safety of brodalumab in patients with generalized pustular psoriasis and psoriatic erythroderma: results from a 52-week, open-label study. Br J Dermatol. 2016; 176(3):741-751. DOI: 10.1111/bjd.14702. View

Meeuwis K, Potts Bleakman A, van de Kerkhof P, Dutronc Y, Henneges C, Kornberg L . Prevalence of genital psoriasis in patients with psoriasis. J Dermatolog Treat. 2018; 29(8):754-760. DOI: 10.1080/09546634.2018.1453125. View

Saunte D, Mrowietz U, Puig L, Zachariae C . Candida infections in patients with psoriasis and psoriatic arthritis treated with interleukin-17 inhibitors and their practical management. Br J Dermatol. 2016; 177(1):47-62. DOI: 10.1111/bjd.15015. View

Menter A, Bhutani T, Ehst B, Elewski B, Jacobson A . Narrative Review of the Emerging Therapeutic Role of Brodalumab in Difficult-to-Treat Psoriasis. Dermatol Ther (Heidelb). 2022; 12(6):1289-1302. PMC: 9209590. DOI: 10.1007/s13555-022-00746-6. View

Green L, Weinberg J, Menter A, Soung J, Lain E, Jacobson A . Clinical and Molecular Effects of Interleukin-17 Pathway Blockade in Psoriasis. J Drugs Dermatol. 2020; 19(2):138-143. DOI: 10.36849/JDD.2020.4645. View

Brown A, OConnor P, Roberts T, Wakefield R, Karim Z, Emery P . Recommendations for musculoskeletal ultrasonography by rheumatologists: setting global standards for best practice by expert consensus. Arthritis Rheum. 2005; 53(1):83-92. DOI: 10.1002/art.20926. View

Roman M, Chiu M . Spotlight on brodalumab in the treatment of moderate-to-severe plaque psoriasis: design, development, and potential place in therapy. Drug Des Devel Ther. 2017; 11:2065-2075. PMC: 5511025. DOI: 10.2147/DDDT.S113683. View

Galluzzo M, Caldarola G, De Simone C, Bernardini N, Moretta G, Pallotta S . Use of brodalumab for the treatment of chronic plaque psoriasis: a one-year real-life study in the Lazio region, Italy. Expert Opin Biol Ther. 2021; 21(9):1299-1310. DOI: 10.1080/14712598.2021.1941862. View

Kokolakis G, Vadstrup K, Hansen J, Carrascosa J . Increased Skin Clearance and Quality of Life Improvement with Brodalumab Compared with Ustekinumab in Psoriasis Patients with Aggravating Lifestyle Factors. Dermatol Ther (Heidelb). 2021; 11(6):2027-2042. PMC: 8611142. DOI: 10.1007/s13555-021-00618-5. View

10.

Callis Duffin K, Mason M, Gordon K, Harrison R, Crabtree M, Guana A . Characterization of Patients with Psoriasis in Challenging-to-Treat Body Areas in the Corrona Psoriasis Registry. Dermatology. 2020; 237(1):46-55. PMC: 7845438. DOI: 10.1159/000504841. View

11.

Papp K, Leonardi C, Menter A, Ortonne J, Krueger J, Kricorian G . Brodalumab, an anti-interleukin-17-receptor antibody for psoriasis. N Engl J Med. 2012; 366(13):1181-9. DOI: 10.1056/NEJMoa1109017. View

12.

Papp K, Menter A, Leonardi C, Soung J, Weiss S, Pillai R . Long-term efficacy and safety of brodalumab in psoriasis through 120 weeks and after withdrawal and retreatment: subgroup analysis of a randomized phase III trial (AMAGINE-1). Br J Dermatol. 2020; 183(6):1037-1048. PMC: 7754427. DOI: 10.1111/bjd.19132. View

13.

Gisondi P, Fargnoli M, Amerio P, Argenziano G, Bardazzi F, Bianchi L . Italian adaptation of EuroGuiDerm guideline on the systemic treatment of chronic plaque psoriasis. Ital J Dermatol Venerol. 2022; 157(Suppl. 1 to No. 1):1-78. DOI: 10.23736/S2784-8671.21.07132-2. View

14.

Blakely K, Gooderham M . Management of scalp psoriasis: current perspectives. Psoriasis (Auckl). 2018; 6:33-40. PMC: 5683126. DOI: 10.2147/PTT.S85330. View

15.

Pinter A, Bonnekoh B, Hadshiew I, Zimmer S . Brodalumab for the treatment of moderate-to-severe psoriasis: case series and literature review. Clin Cosmet Investig Dermatol. 2019; 12:509-517. PMC: 6628099. DOI: 10.2147/CCID.S211938. View

16.

Prignano F, Pescitelli L, Trovato E, Di Cesare A, Cuccia A, Mazzatenta C . Tuscany consensus for the treatment of moderate-severe psoriasis: update and focus on practical guidelines for place in therapy of anti-IL-17 and anti-IL-23 biologics. Ital J Dermatol Venerol. 2022; 157(6):469-479. DOI: 10.23736/S2784-8671.22.07355-8. View

17.

Fresegna D, Bullitta S, Musella A, Rizzo F, Vito F, Guadalupi L . Re-Examining the Role of TNF in MS Pathogenesis and Therapy. Cells. 2020; 9(10). PMC: 7602209. DOI: 10.3390/cells9102290. View

18.

Kisielnicka A, Szczerkowska-Dobosz A, Nowicki R . The influence of body weight of patients with chronic plaque psoriasis on biological treatment response. Postepy Dermatol Alergol. 2020; 37(2):168-173. PMC: 7262805. DOI: 10.5114/ada.2020.94835. View

19.

Burden A, Mrowietz U, Skalicky A, Rentz A, Esser D, Gloede T . Symptom Experience and Content Validity of the Psoriasis Symptom Scale (PSS) in Patients with Generalized Pustular Psoriasis (GPP). Dermatol Ther (Heidelb). 2022; 12(6):1367-1381. PMC: 9209619. DOI: 10.1007/s13555-022-00736-8. View

20.

Papp K, Reid C, Foley P, Sinclair R, Salinger D, Williams G . 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):2466-2469. DOI: 10.1038/jid.2012.163. View