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. 2024 Apr 1;14(2):e2024152.
doi: 10.5826/dpc.1402a152.

Long-Term Effectiveness of Brodalumab for the Treatment of Moderate-To-Severe Psoriasis: A Real-Life Multicenter Study of Up to 3 Years in a Real-Life Italian Cohort

Giacomo Caldarola  1   2 , Marco Galluzzo  3   4 , Nicoletta Bernardini  5 , Elisabetta Botti  4 , Eleonora De Luca  1   2 , Clara De Simone  1   2 , Marco Mariani  6 , Gaia Moretta  7 , Sabatino Pallotta  7 , Elena Campione  3   4 , Ketty Peris  1   2
Affiliations

Long-Term Effectiveness of Brodalumab for the Treatment of Moderate-To-Severe Psoriasis: A Real-Life Multicenter Study of Up to 3 Years in a Real-Life Italian Cohort

Giacomo Caldarola et al. Dermatol Pract Concept. .

Abstract

Introduction: Data about the long-term effectiveness of brodalumab could be valuable in assessing patient adherence to treatment and improving psoriasis management.

Objective: The aim of our study was to evaluate the drug survival of brodalumab and identify any predictive factors for discontinuation.

Methods: A multicenter retrospective study was conducted in patients with moderate-to-severe psoriasis who were treated for up to 3 years. We extracted data from patient files, related to the characteristics of the patients and the disease. Drug survival analysis was descriptively analyzed using Kaplan-Meier survival curves. Univariable and multivariable analyses were performed to assess baseline patient characteristics that predicted clinical response.

Results: The study included 90 patients. Among them, 28 (31.1%) suspended brodalumab through the observation period. At weeks 52, 104 and 156 the median PASI score were 0.0 [0.0 - 0.8], 0.0 [0.0 - 1.0] and 0.0 [0.0 - 0.0], respectively. The estimated cumulative survival rates at weeks 52 and 104 were 86.32% and 78.09%, respectively. In the multivariable survival analysis, predictor factors for overall discontinuation included body mass index (BMI) (OR 1.10, 95% CI 1.03 - 1.18), baseline PASI (OR 1.06, 95% CI 1.02 - 1.10), and psoriatic arthritis (OR 5.05, 95% CI 0.89 - 13.50).

Conclusions: Brodalumab has shown long-term effectiveness for up to 3 years. Considering baseline disease severity and patient characteristics could aid in optimizing the long-term management of psoriasis.

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Conflict of interest statement

Competing Interests: G Caldarola has received consulting fees, honoraria and support for attending meetings from Abbvie, Lilly, Janssen, UCB, Novartis and Leopharma; C De Simone has received support for consulting fees, honoraria and support for attending meetings from Abbvie, Lilly, Janssen, UCB, Novartis, Leopharma, Sanofi and Almiral; K Peris has received support for consulting fees and honoraria from Abbvie, Almirall, Biogen, Celgene, Janssen Galderma, Novartis, Lilly, Novartis, Pierre Fabre, Sandoz, Sanofi and Sun Pharma. M Galluzzo declare to have acted as speakers and/or consultants for AbbVie, Almirall, Eli-Lilly, Janssen-Cilag, LeoPharma, Novartis and Sanofi, outside the submitted work. E Campione served as a consultant for Almirall, BMS, Amgen, and UCB. G Moretta has received consulting fees, honoraria and support for attending meetings from Abbvie, Leopharma, Sanofi and Lilly. All other authors declare that they have no conflicts of interest relevant to this manuscript.

Figures

Figure 1
Figure 1
Kaplan–Meier curves of (A) overall drug survival; (B) discontinuation because of adverse events or other events; and (C) discontinuation because of a lack or loss of efficacy (confidence interval [CI] in light gray).
Figure 2
Figure 2
Patient #1. (A) At baseline. (B) At week 6. (C) At week 108.
Figure 3
Figure 3
Patient #2. (A) At baseline. (B) Recurrence of psoriasis on the scalp after neurosurgical intervention and 3 months after brodalumab discontinuation. (C) At week 160.
Figure 4
Figure 4
Patient #3. (A) At baseline. (B) At week 12.
Figure 5
Figure 5
Patient #4, at baseline and after 4 weeks and 3 years of treatment with brodalumab. The hyperchromic patches canbe attributed to post-inflammatory hyperpigmented outcomes.
See this image and copyright information in PMC

References

    1. Blair HA. Brodalumab: a review in moderate to severe plaque psoriasis. Drugs. 2018;78(4):495–504. - PubMed
    1. Russell CB, Rand H. Gene expression profiles normalized in psoriatic skin by treatment with brodalumab, a human anti-IL-17 receptor monoclonal antibody. J Immunol. 2014;192(8):3828–3836. - PubMed
    1. Papp KA, Reich K, Paul C, Blauvelt A, Baran W, Bolduc C, Toth D, Langley RG, Cather J, Gottlieb AB, Thaçi D, Krueger JG, Russell CB, Milmont CE, Li J, Klekotka PA, Kricorian G, Nirula A. A prospective phase III, randomized, double-blind, placebo-controlled study of brodalumab in patients with moderate-to-severe plaque psoriasis. Br J Dermatol. 2016 Aug;175(2):273–86. doi: 10.1111/bjd.14493. Epub 2016 Jun 23. - DOI - PubMed
    1. Lebwohl M, Strober B, Menter A, Gordon K, Weglowska J, Puig L, Papp K, Spelman L, Toth D, Kerdel F, Armstrong AW, Stingl G, Kimball AB, Bachelez H, Wu JJ, Crowley J, Langley RG, Blicharski T, Paul C, Lacour JP, Tyring S, Kircik L, Chimenti S, Callis Duffin K, Bagel J, Koo J, Aras G, Li J, Song W, Milmont CE, Shi Y, Erondu N, Klekotka P, Kotzin B, Nirula A. Phase 3 Studies Comparing Brodalumab with Ustekinumab in Psoriasis. N Engl J Med. 2015 Oct;373(14):1318–28. doi: 10.1056/NEJMoa1503824. - DOI - PubMed
    1. Puig L, Lebwohl M, Bachelez H, Sobell J, Jacobson AA. Long-term efficacy and safety of brodalumab in the treatment of psoriasis: 120-week results from the randomized, double-blind, placebo- and active comparator-controlled phase 3 AMAGINE-2 trial. J Am Acad Dermatol. 2020 Feb;82(2):352–359. doi: 10.1016/j.jaad.2019.05.095. Epub 2019 Jun 5. - DOI - PubMed

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