Frontiers in Medicine (Aug 2023)
Effectiveness and safety of bimekizumab for the treatment of plaque psoriasis: a real-life multicenter study—IL PSO (Italian landscape psoriasis)
- Luigi Gargiulo,
- Luigi Gargiulo,
- Alessandra Narcisi,
- Luciano Ibba,
- Luciano Ibba,
- Anna Balato,
- Luca Bianchi,
- Pina Brianti,
- Dario Buononato,
- Martina Burlando,
- Giacomo Caldarola,
- Giacomo Caldarola,
- Anna Campanati,
- Elena Campione,
- Carlo G. Carrera,
- Andrea Carugno,
- Andrea Carugno,
- Antonio Cristaudo,
- Francesco Cusano,
- Paolo Dapavo,
- Annunziata Dattola,
- Clara De Simone,
- Clara De Simone,
- Francesca M. Gaiani,
- Paolo Gisondi,
- Alessandro Giunta,
- Francesco Loconsole,
- Vincenzo Maione,
- Edoardo Mortato,
- Angelo V. Marzano,
- Angelo V. Marzano,
- Martina Maurelli,
- Matteo Megna,
- Santo R. Mercuri,
- Annamaria Offidani,
- Diego Orsini,
- Aurora Parodi,
- Giovanni Pellacani,
- Luca Potestio,
- Pietro Quaglino,
- Antonio G. Richetta,
- Francesca Romano,
- Paolo Sena,
- Marina Venturini,
- Piergiorgio Malagoli,
- Antonio Costanzo,
- Antonio Costanzo
Affiliations
- Luigi Gargiulo
- Dermatology Unit, IRCCS Humanitas Research Hospital, Milan, Italy
- Luigi Gargiulo
- Department of Biomedical Sciences, Humanitas University, Milan, Italy
- Alessandra Narcisi
- Dermatology Unit, IRCCS Humanitas Research Hospital, Milan, Italy
- Luciano Ibba
- Dermatology Unit, IRCCS Humanitas Research Hospital, Milan, Italy
- Luciano Ibba
- Department of Biomedical Sciences, Humanitas University, Milan, Italy
- Anna Balato
- Dermatology Unit, University of Campania L. Vanvitelli, Naples, Italy
- Luca Bianchi
- Dermatology, Department of Systems Medicine, University of Rome Tor Vergata, Rome, Italy
- Pina Brianti
- Unit of Dermatology and Cosmetology, Vita-Salute San Raffaele University and Institute for Research and Care, Milan, Italy
- Dario Buononato
- Dermatology Unit, University of Campania L. Vanvitelli, Naples, Italy
- Martina Burlando
- Section of Dermatology, Department of Health Sciences (DISSAL), IRCCS San Martino University Hospital, Genoa, Italy
- Giacomo Caldarola
- Section of Dermatology, Department of Translational Medicine and Surgery, Catholic University of the Sacred Heart, Rome, Italy
- Giacomo Caldarola
- Dermatology Unit, Agostino Gemelli University Hospital, Rome, Italy
- Anna Campanati
- Department of Clinical and Molecular Sciences—Dermatological Clinic, Università Politecnica delle Marche, Ancona, Italy
- Elena Campione
- Dermatology, Department of Systems Medicine, University of Rome Tor Vergata, Rome, Italy
- Carlo G. Carrera
- 0Dermatology Unit, Fondazione IRCCS Ca’ Granda Ospedale Maggiore Policlinico, Milan, Italy
- Andrea Carugno
- 1Dermatology Unit, ASST Papa Giovanni XXIII Hospital, Bergamo, Italy
- Andrea Carugno
- 2PhD Program in Molecular and Translational Medicine (DIMET), University of Milan-Bicocca, Milan, Italy
- Antonio Cristaudo
- 3Clinical Dermatology Unit, San Gallicano Dermatological Institute IRCCS, Rome, Italy
- Francesco Cusano
- 4Department of Dermatology, Gaetano Rummo Hospital, Benevento, Italy
- Paolo Dapavo
- 5Department of Biomedical Science and Human Oncology, Second Dermatologic Clinic, University of Turin, Turin, Italy
- Annunziata Dattola
- 6Dermatology Clinic, Department of Clinical Internal, Anesthesiological and Cardiovascular Sciences, Sapienza University, Rome, Italy
- Clara De Simone
- Section of Dermatology, Department of Translational Medicine and Surgery, Catholic University of the Sacred Heart, Rome, Italy
- Clara De Simone
- Dermatology Unit, Agostino Gemelli University Hospital, Rome, Italy
- Francesca M. Gaiani
- 7Department of Dermatology, Dermatology Unit Azienda Ospedaliera San Donato Milanese, Milan, Italy
- Paolo Gisondi
- 8Department of Medicine, Section of Dermatology and Venereology, University of Verona, Verona, Italy
- Alessandro Giunta
- Dermatology, Department of Systems Medicine, University of Rome Tor Vergata, Rome, Italy
- Francesco Loconsole
- 9Department of Dermatology, University of Bari, Bari, Italy
- Vincenzo Maione
- 0Department of Dermatology, ASST Spedali Civili Hospital, Brescia, Italy
- Edoardo Mortato
- 9Department of Dermatology, University of Bari, Bari, Italy
- Angelo V. Marzano
- 0Dermatology Unit, Fondazione IRCCS Ca’ Granda Ospedale Maggiore Policlinico, Milan, Italy
- Angelo V. Marzano
- 1Department of Pathophysiology and Transplantation, Università degli Studi di Milano, Milan, Italy
- Martina Maurelli
- 8Department of Medicine, Section of Dermatology and Venereology, University of Verona, Verona, Italy
- Matteo Megna
- 2Section of Dermatology, Department of Clinical Medicine and Surgery, University of Naples Federico II, Naples, Italy
- Santo R. Mercuri
- Unit of Dermatology and Cosmetology, Vita-Salute San Raffaele University and Institute for Research and Care, Milan, Italy
- Annamaria Offidani
- Department of Clinical and Molecular Sciences—Dermatological Clinic, Università Politecnica delle Marche, Ancona, Italy
- Diego Orsini
- 3Clinical Dermatology Unit, San Gallicano Dermatological Institute IRCCS, Rome, Italy
- Aurora Parodi
- Section of Dermatology, Department of Health Sciences (DISSAL), IRCCS San Martino University Hospital, Genoa, Italy
- Giovanni Pellacani
- 6Dermatology Clinic, Department of Clinical Internal, Anesthesiological and Cardiovascular Sciences, Sapienza University, Rome, Italy
- Luca Potestio
- 2Section of Dermatology, Department of Clinical Medicine and Surgery, University of Naples Federico II, Naples, Italy
- Pietro Quaglino
- 5Department of Biomedical Science and Human Oncology, Second Dermatologic Clinic, University of Turin, Turin, Italy
- Antonio G. Richetta
- 6Dermatology Clinic, Department of Clinical Internal, Anesthesiological and Cardiovascular Sciences, Sapienza University, Rome, Italy
- Francesca Romano
- 3Department of Precision Medicine, Dermatology Unit, Università degli Studi della Campania L. Vanvitelli, Naples, Italy
- Paolo Sena
- 1Dermatology Unit, ASST Papa Giovanni XXIII Hospital, Bergamo, Italy
- Marina Venturini
- 0Department of Dermatology, ASST Spedali Civili Hospital, Brescia, Italy
- Piergiorgio Malagoli
- 7Department of Dermatology, Dermatology Unit Azienda Ospedaliera San Donato Milanese, Milan, Italy
- Antonio Costanzo
- Dermatology Unit, IRCCS Humanitas Research Hospital, Milan, Italy
- Antonio Costanzo
- Department of Biomedical Sciences, Humanitas University, Milan, Italy
- DOI
- https://doi.org/10.3389/fmed.2023.1243843
- Journal volume & issue
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Vol. 10
Abstract
IntroductionBimekizumab 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.MethodThis 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.ResultsThe 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.ConclusionOur experience supports the effectiveness and tolerability of bimekizumab in a real-world setting with similar results compared with phase-III clinical trials.
Keywords
