Effectiveness and safety of bimekizumab for the treatment of plaque psoriasis: a real-life multicenter study-IL PSO (Italian landscape psoriasis).

bimekizumab biologics psoriasis psoriasis treatment real-life

Journal

Frontiers in medicine
ISSN: 2296-858X
Titre abrégé: Front Med (Lausanne)
Pays: Switzerland
ID NLM: 101648047

Informations de publication

Date de publication:
2023
Historique:
received: 21 06 2023
accepted: 27 07 2023
medline: 24 8 2023
pubmed: 24 8 2023
entrez: 24 8 2023
Statut: epublish

Résumé

Bimekizumab is a monoclonal antibody that targets Interleukin-17 A and F, approved for the treatment of moderate-to-severe plaque psoriasis. While bimekizumab has been evaluated in several phase-III clinical trials, real-world evidence is still very limited. This multicenter retrospective study included patients affected by plaque psoriasis treated with bimekizumab from May 1, 2022 to April 30, 2023, at 19 Italian referral hospitals. Patients affected by moderate-to-severe plaque psoriasis eligible for systemic treatments were included. The effectiveness of bimekizumab was evaluated in terms of reduction in psoriasis area and severity index (PASI) compared with baseline at weeks 4 and 16. The main outcomes were the percentages of patients achieving an improvement of at least 75% (PASI75), 90% (PASI90) and 100% (PASI100) in PASI score. The study included 237 patients who received at least one injection of bimekizumab. One hundred and seventy-one patients and 114 reached four and 16 weeks of follow-up, respectively. Complete skin clearance was achieved by 43.3% and 75.4% of patients at weeks 4 and 16, respectively. At week 16, 86.8% of patients reported no impact on their quality of life. At week 16, there were no significant differences between bio-naïve and bio-experienced patients in terms of PASI75, PASI90 and PASI100. The most commonly reported adverse events (AEs) were oral candidiasis (10.1%). No severe AEs or AEs leading to discontinuation were observed throughout the study. Our experience supports the effectiveness and tolerability of bimekizumab in a real-world setting with similar results compared with phase-III clinical trials.

Identifiants

pubmed: 37614958
doi: 10.3389/fmed.2023.1243843
pmc: PMC10442506
doi:

Types de publication

Journal Article

Langues

eng

Pagination

1243843

Informations de copyright

Copyright © 2023 Gargiulo, Narcisi, Ibba, Balato, Bianchi, Brianti, Buononato, Burlando, Caldarola, Campanati, Campione, Carrera, Carugno, Cristaudo, Cusano, Dapavo, Dattola, De Simone, Gaiani, Gisondi, Giunta, Loconsole, Maione, Mortato, Marzano, Maurelli, Megna, Mercuri, Offidani, Orsini, Parodi, Pellacani, Potestio, Quaglino, Richetta, Romano, Sena, Venturini, Malagoli and Costanzo.

Déclaration de conflit d'intérêts

LG has been a consultant for Almirall. PM has been a speaker for AbbVie, Lilly, Novartis, Janssen-Cilag, Celgene, Leopharma, and Almirall. AB has received honoraria for participation in advisory boards, meetings, or as speaker for AbbVie, Celgene, Janssen-Cilag, Eli Lilly, Novartis Pharma, Pfizer, Sanofi-Genzyme, and UCB Pharma. LB has received honoraria as a speaker or consultant for AbbVie, Janssen, Almirall Eli-Lilly, Leopharma, Novartis, Sanofi, Pfizer, and UCB Pharma. GC reports consulting fees or honorarium and payment for lectures from Lilly and Novartis. CD reports consulting fees or honorarium from Abbvie, Amgen, Novartis, Celgene, Sanofi, UCB Pharma, Janssen, and Lilly and payment for lectures from Abbvie, Lilly, Novartis, UCB Pharma, and Celgene. PG has been a consultant and/or speaker for Abbvie, Almirall, Amgen, Janssen, Leo-Pharma, Eli-Lilly, Novartis, Pierre Febre, Sandoz, Sanofi, and UCB. MB has acted as a speaker and consultant for AbbVie, Janssen, Amgen, Novartis, Eli Lilly, and UCB Pharma. CC has served as a board participant or speaker for Abbvie, Lilly, Janssen, Novartis, Celgene, Almirall, and Leopharma. PD has been a speaker for Novartis, Abbvie, Sanofi, UCB, Janssen, Lilly, and LeoPharma. FG acted as a speaker or consultant for Novartis, Abbvie, Eli Lilly, Celgene, LeoPharma, and Almirall. AG received grants or is an investigator for Biogen and Lilly; and is a consultant/advisory board/speaker for AbbVie, Almirall, Celgene, Janssen, Leo Pharma, Eli Lilly, Merck Sharpe Dohme, Novartis, Pfizer, Sandoz, and UCB. FL served on advisory boards and/or received honoraria for lectures from Abbvie, Janssen-Cilag, Novartis, Lilly, Sanofi. AM reports consultancy/advisory boards disease-relevant honoraria from AbbVie, Boehringer-Ingelheim, Novartis, Pfizer, Sanofi, and UCB. MMe acted as a speaker or consultant for Abbvie, Eli Lilly, Janssen, Leo-Pharma, UCB, and Novartis. AO acted as a speaker and consultant for Abbvie, Eli Lilly, Novartis, Celgene, Sanofi, Galderma, Leo Pharma, and Pierre Fabre. MV served as a speaker or advisory board member for Abbvie, Almirall, Amgen, Eli-Lilly, Galderma, Leo Pharma, Novartis, Pierre Fabre, and UCB Pharma. ACo has served as an advisory board member, consultant and has received fees and speaker’s honoraria or has participated in clinical trials for Abbvie, Almirall, Biogen, LEO Pharma, Lilly, Janssen, Novartis, Pfizer, Sanofi Genzyme, and UCB-Pharma. AN has served on advisory boards, received honoraria for lectures and research grants from Almirall, Abbvie, Leo Pharma, Celgene, Eli Lilly, Janssen, Novartis, Sanofi-Genzyme, Amgen, and Boehringer Ingelheim. The remaining authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest.

Références

J Allergy Clin Immunol. 2017 Mar;139(3):923-932.e8
pubmed: 27502297
Ital J Dermatol Venerol. 2022 Feb;157(Suppl. 1 to No. 1):1-78
pubmed: 35262308
Dermatol Ther (Heidelb). 2022 May;12(5):1263-1270
pubmed: 35460018
JAMA. 2020 May 19;323(19):1945-1960
pubmed: 32427307
J Cosmet Dermatol. 2023 Mar;22(3):1146-1148
pubmed: 36448190
Dermatol Ther. 2022 Dec;35(12):e15952
pubmed: 36269298
JAMA Dermatol. 2022 Jul 1;158(7):735-744
pubmed: 35544084
Lancet. 2021 Feb 6;397(10273):487-498
pubmed: 33549193
N Engl J Med. 2021 Jul 8;385(2):130-141
pubmed: 33891379
Lancet. 2021 Feb 6;397(10273):475-486
pubmed: 33549192
N Engl J Med. 2021 Jul 8;385(2):142-152
pubmed: 33891380

Auteurs

Luigi Gargiulo (L)

Dermatology Unit, IRCCS Humanitas Research Hospital, Milan, Italy.
Department of Biomedical Sciences, Humanitas University, Milan, Italy.

Alessandra Narcisi (A)

Dermatology Unit, IRCCS Humanitas Research Hospital, Milan, Italy.

Luciano Ibba (L)

Dermatology Unit, IRCCS Humanitas Research Hospital, Milan, Italy.
Department of Biomedical Sciences, Humanitas University, Milan, Italy.

Anna Balato (A)

Dermatology Unit, University of Campania L. Vanvitelli, Naples, Italy.

Luca Bianchi (L)

Dermatology, Department of Systems Medicine, University of Rome Tor Vergata, Rome, Italy.

Pina Brianti (P)

Unit of Dermatology and Cosmetology, Vita-Salute San Raffaele University and Institute for Research and Care, Milan, Italy.

Dario Buononato (D)

Dermatology Unit, University of Campania L. Vanvitelli, Naples, Italy.

Martina Burlando (M)

Section of Dermatology, Department of Health Sciences (DISSAL), IRCCS San Martino University Hospital, Genoa, Italy.

Giacomo Caldarola (G)

Section of Dermatology, Department of Translational Medicine and Surgery, Catholic University of the Sacred Heart, Rome, Italy.
Dermatology Unit, Agostino Gemelli University Hospital, Rome, Italy.

Anna Campanati (A)

Department of Clinical and Molecular Sciences-Dermatological Clinic, Università Politecnica delle Marche, Ancona, Italy.

Elena Campione (E)

Dermatology, Department of Systems Medicine, University of Rome Tor Vergata, Rome, Italy.

Carlo G Carrera (CG)

Dermatology Unit, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan, Italy.

Andrea Carugno (A)

Dermatology Unit, ASST Papa Giovanni XXIII Hospital, Bergamo, Italy.
PhD Program in Molecular and Translational Medicine (DIMET), University of Milan-Bicocca, Milan, Italy.

Antonio Cristaudo (A)

Clinical Dermatology Unit, San Gallicano Dermatological Institute IRCCS, Rome, Italy.

Francesco Cusano (F)

Department of Dermatology, Gaetano Rummo Hospital, Benevento, Italy.

Paolo Dapavo (P)

Department of Biomedical Science and Human Oncology, Second Dermatologic Clinic, University of Turin, Turin, Italy.

Annunziata Dattola (A)

Dermatology Clinic, Department of Clinical Internal, Anesthesiological and Cardiovascular Sciences, Sapienza University, Rome, Italy.

Clara De Simone (C)

Section of Dermatology, Department of Translational Medicine and Surgery, Catholic University of the Sacred Heart, Rome, Italy.
Dermatology Unit, Agostino Gemelli University Hospital, Rome, Italy.

Francesca M Gaiani (FM)

Department of Dermatology, Dermatology Unit Azienda Ospedaliera San Donato Milanese, Milan, Italy.

Paolo Gisondi (P)

Department of Medicine, Section of Dermatology and Venereology, University of Verona, Verona, Italy.

Alessandro Giunta (A)

Dermatology, Department of Systems Medicine, University of Rome Tor Vergata, Rome, Italy.

Francesco Loconsole (F)

Department of Dermatology, University of Bari, Bari, Italy.

Vincenzo Maione (V)

Department of Dermatology, ASST Spedali Civili Hospital, Brescia, Italy.

Edoardo Mortato (E)

Department of Dermatology, University of Bari, Bari, Italy.

Angelo V Marzano (AV)

Dermatology Unit, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan, Italy.
Department of Pathophysiology and Transplantation, Università degli Studi di Milano, Milan, Italy.

Martina Maurelli (M)

Department of Medicine, Section of Dermatology and Venereology, University of Verona, Verona, Italy.

Matteo Megna (M)

Section of Dermatology, Department of Clinical Medicine and Surgery, University of Naples Federico II, Naples, Italy.

Santo R Mercuri (SR)

Unit of Dermatology and Cosmetology, Vita-Salute San Raffaele University and Institute for Research and Care, Milan, Italy.

Annamaria Offidani (A)

Department of Clinical and Molecular Sciences-Dermatological Clinic, Università Politecnica delle Marche, Ancona, Italy.

Diego Orsini (D)

Clinical Dermatology Unit, San Gallicano Dermatological Institute IRCCS, Rome, Italy.

Aurora Parodi (A)

Section of Dermatology, Department of Health Sciences (DISSAL), IRCCS San Martino University Hospital, Genoa, Italy.

Giovanni Pellacani (G)

Dermatology Clinic, Department of Clinical Internal, Anesthesiological and Cardiovascular Sciences, Sapienza University, Rome, Italy.

Luca Potestio (L)

Section of Dermatology, Department of Clinical Medicine and Surgery, University of Naples Federico II, Naples, Italy.

Pietro Quaglino (P)

Department of Biomedical Science and Human Oncology, Second Dermatologic Clinic, University of Turin, Turin, Italy.

Antonio G Richetta (AG)

Dermatology Clinic, Department of Clinical Internal, Anesthesiological and Cardiovascular Sciences, Sapienza University, Rome, Italy.

Francesca Romano (F)

Department of Precision Medicine, Dermatology Unit, Università degli Studi della Campania L. Vanvitelli, Naples, Italy.

Paolo Sena (P)

Dermatology Unit, ASST Papa Giovanni XXIII Hospital, Bergamo, Italy.

Marina Venturini (M)

Department of Dermatology, ASST Spedali Civili Hospital, Brescia, Italy.

Piergiorgio Malagoli (P)

Department of Dermatology, Dermatology Unit Azienda Ospedaliera San Donato Milanese, Milan, Italy.

Antonio Costanzo (A)

Dermatology Unit, IRCCS Humanitas Research Hospital, Milan, Italy.
Department of Biomedical Sciences, Humanitas University, Milan, Italy.

Classifications MeSH