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Effectiveness and safety of bimekizumab for the treatment of plaque psoriasis: a real-life multicenter study-IL PSO (Italian landscape psoriasis).
Gargiulo, Luigi; Narcisi, Alessandra; Ibba, Luciano; Balato, Anna; Bianchi, Luca; Brianti, Pina; Buononato, Dario; Burlando, Martina; Caldarola, Giacomo; Campanati, Anna; Campione, Elena; Carrera, Carlo G; Carugno, Andrea; Cristaudo, Antonio; Cusano, Francesco; Dapavo, Paolo; Dattola, Annunziata; De Simone, Clara; Gaiani, Francesca M; Gisondi, Paolo; Giunta, Alessandro; Loconsole, Francesco; Maione, Vincenzo; Mortato, Edoardo; Marzano, Angelo V; Maurelli, Martina; Megna, Matteo; Mercuri, Santo R; Offidani, Annamaria; Orsini, Diego; Parodi, Aurora; Pellacani, Giovanni; Potestio, Luca; Quaglino, Pietro; Richetta, Antonio G; Romano, Francesca; Sena, Paolo; Venturini, Marina; Malagoli, Piergiorgio; Costanzo, Antonio.
Affiliation
  • Gargiulo L; Dermatology Unit, IRCCS Humanitas Research Hospital, Milan, Italy.
  • Narcisi A; Department of Biomedical Sciences, Humanitas University, Milan, Italy.
  • Ibba L; Dermatology Unit, IRCCS Humanitas Research Hospital, Milan, Italy.
  • Balato A; Dermatology Unit, IRCCS Humanitas Research Hospital, Milan, Italy.
  • Bianchi L; Department of Biomedical Sciences, Humanitas University, Milan, Italy.
  • Brianti P; Dermatology Unit, University of Campania L. Vanvitelli, Naples, Italy.
  • Buononato D; Dermatology, Department of Systems Medicine, University of Rome Tor Vergata, Rome, Italy.
  • Burlando M; Unit of Dermatology and Cosmetology, Vita-Salute San Raffaele University and Institute for Research and Care, Milan, Italy.
  • Caldarola G; Dermatology Unit, University of Campania L. Vanvitelli, Naples, Italy.
  • Campanati A; Section of Dermatology, Department of Health Sciences (DISSAL), IRCCS San Martino University Hospital, Genoa, Italy.
  • Campione E; Section of Dermatology, Department of Translational Medicine and Surgery, Catholic University of the Sacred Heart, Rome, Italy.
  • Carrera CG; Dermatology Unit, Agostino Gemelli University Hospital, Rome, Italy.
  • Carugno A; Department of Clinical and Molecular Sciences-Dermatological Clinic, Università Politecnica delle Marche, Ancona, Italy.
  • Cristaudo A; Dermatology, Department of Systems Medicine, University of Rome Tor Vergata, Rome, Italy.
  • Cusano F; Dermatology Unit, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan, Italy.
  • Dapavo P; Dermatology Unit, ASST Papa Giovanni XXIII Hospital, Bergamo, Italy.
  • Dattola A; PhD Program in Molecular and Translational Medicine (DIMET), University of Milan-Bicocca, Milan, Italy.
  • De Simone C; Clinical Dermatology Unit, San Gallicano Dermatological Institute IRCCS, Rome, Italy.
  • Gaiani FM; Department of Dermatology, Gaetano Rummo Hospital, Benevento, Italy.
  • Gisondi P; Department of Biomedical Science and Human Oncology, Second Dermatologic Clinic, University of Turin, Turin, Italy.
  • Giunta A; Dermatology Clinic, Department of Clinical Internal, Anesthesiological and Cardiovascular Sciences, Sapienza University, Rome, Italy.
  • Loconsole F; Section of Dermatology, Department of Translational Medicine and Surgery, Catholic University of the Sacred Heart, Rome, Italy.
  • Maione V; Dermatology Unit, Agostino Gemelli University Hospital, Rome, Italy.
  • Mortato E; Department of Dermatology, Dermatology Unit Azienda Ospedaliera San Donato Milanese, Milan, Italy.
  • Marzano AV; Department of Medicine, Section of Dermatology and Venereology, University of Verona, Verona, Italy.
  • Maurelli M; Dermatology, Department of Systems Medicine, University of Rome Tor Vergata, Rome, Italy.
  • Megna M; Department of Dermatology, University of Bari, Bari, Italy.
  • Mercuri SR; Department of Dermatology, ASST Spedali Civili Hospital, Brescia, Italy.
  • Offidani A; Department of Dermatology, University of Bari, Bari, Italy.
  • Orsini D; Dermatology Unit, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan, Italy.
  • Parodi A; Department of Pathophysiology and Transplantation, Università degli Studi di Milano, Milan, Italy.
  • Pellacani G; Department of Medicine, Section of Dermatology and Venereology, University of Verona, Verona, Italy.
  • Potestio L; Section of Dermatology, Department of Clinical Medicine and Surgery, University of Naples Federico II, Naples, Italy.
  • Quaglino P; Unit of Dermatology and Cosmetology, Vita-Salute San Raffaele University and Institute for Research and Care, Milan, Italy.
  • Richetta AG; Department of Clinical and Molecular Sciences-Dermatological Clinic, Università Politecnica delle Marche, Ancona, Italy.
  • Romano F; Clinical Dermatology Unit, San Gallicano Dermatological Institute IRCCS, Rome, Italy.
  • Sena P; Section of Dermatology, Department of Health Sciences (DISSAL), IRCCS San Martino University Hospital, Genoa, Italy.
  • Venturini M; Dermatology Clinic, Department of Clinical Internal, Anesthesiological and Cardiovascular Sciences, Sapienza University, Rome, Italy.
  • Malagoli P; Section of Dermatology, Department of Clinical Medicine and Surgery, University of Naples Federico II, Naples, Italy.
  • Costanzo A; Department of Biomedical Science and Human Oncology, Second Dermatologic Clinic, University of Turin, Turin, Italy.
Front Med (Lausanne) ; 10: 1243843, 2023.
Article in En | MEDLINE | ID: mdl-37614958
ABSTRACT

Introduction:

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.

Method:

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.

Results:

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.

Conclusion:

Our experience supports the effectiveness and tolerability of bimekizumab in a real-world setting with similar results compared with phase-III clinical trials.
Key words

Full text: 1 Collection: 01-internacional Database: MEDLINE Type of study: Clinical_trials / Observational_studies Aspects: Patient_preference Language: En Journal: Front Med (Lausanne) Year: 2023 Document type: Article Affiliation country:

Full text: 1 Collection: 01-internacional Database: MEDLINE Type of study: Clinical_trials / Observational_studies Aspects: Patient_preference Language: En Journal: Front Med (Lausanne) Year: 2023 Document type: Article Affiliation country: