Effectiveness and safety of bimekizumab for the treatment of plaque psoriasis: a real-life multicenter study—IL PSO (Italian landscape psoriasis)
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 retrosp...
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Frontiers Media S.A.
2023-08-01
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| Series: | Frontiers in Medicine |
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| Online Access: | https://www.frontiersin.org/articles/10.3389/fmed.2023.1243843/full |
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| author | 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 |
| author_facet | 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 |
| author_sort | Luigi Gargiulo |
| collection | DOAJ |
| description | 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. |
| first_indexed | 2024-03-12T16:57:00Z |
| format | Article |
| id | doaj.art-a57a586330ad40f1847d355dbee4ceef |
| institution | Directory Open Access Journal |
| issn | 2296-858X |
| language | English |
| last_indexed | 2024-03-12T16:57:00Z |
| publishDate | 2023-08-01 |
| publisher | Frontiers Media S.A. |
| record_format | Article |
| series | Frontiers in Medicine |
| spelling | doaj.art-a57a586330ad40f1847d355dbee4ceef2023-08-08T05:42:57ZengFrontiers Media S.A.Frontiers in Medicine2296-858X2023-08-011010.3389/fmed.2023.12438431243843Effectiveness and safety of bimekizumab for the treatment of plaque psoriasis: a real-life multicenter study—IL PSO (Italian landscape psoriasis)Luigi Gargiulo0Luigi Gargiulo1Alessandra Narcisi2Luciano Ibba3Luciano Ibba4Anna Balato5Luca Bianchi6Pina Brianti7Dario Buononato8Martina Burlando9Giacomo Caldarola10Giacomo Caldarola11Anna Campanati12Elena Campione13Carlo G. Carrera14Andrea Carugno15Andrea Carugno16Antonio Cristaudo17Francesco Cusano18Paolo Dapavo19Annunziata Dattola20Clara De Simone21Clara De Simone22Francesca M. Gaiani23Paolo Gisondi24Alessandro Giunta25Francesco Loconsole26Vincenzo Maione27Edoardo Mortato28Angelo V. Marzano29Angelo V. Marzano30Martina Maurelli31Matteo Megna32Santo R. Mercuri33Annamaria Offidani34Diego Orsini35Aurora Parodi36Giovanni Pellacani37Luca Potestio38Pietro Quaglino39Antonio G. Richetta40Francesca Romano41Paolo Sena42Marina Venturini43Piergiorgio Malagoli44Antonio Costanzo45Antonio Costanzo46Dermatology Unit, IRCCS Humanitas Research Hospital, Milan, ItalyDepartment of Biomedical Sciences, Humanitas University, Milan, ItalyDermatology Unit, IRCCS Humanitas Research Hospital, Milan, ItalyDermatology Unit, IRCCS Humanitas Research Hospital, Milan, ItalyDepartment of Biomedical Sciences, Humanitas University, Milan, ItalyDermatology Unit, University of Campania L. Vanvitelli, Naples, ItalyDermatology, Department of Systems Medicine, University of Rome Tor Vergata, Rome, ItalyUnit of Dermatology and Cosmetology, Vita-Salute San Raffaele University and Institute for Research and Care, Milan, ItalyDermatology Unit, University of Campania L. Vanvitelli, Naples, ItalySection of Dermatology, Department of Health Sciences (DISSAL), IRCCS San Martino University Hospital, Genoa, ItalySection of Dermatology, Department of Translational Medicine and Surgery, Catholic University of the Sacred Heart, Rome, ItalyDermatology Unit, Agostino Gemelli University Hospital, Rome, ItalyDepartment of Clinical and Molecular Sciences—Dermatological Clinic, Università Politecnica delle Marche, Ancona, ItalyDermatology, Department of Systems Medicine, University of Rome Tor Vergata, Rome, Italy0Dermatology Unit, Fondazione IRCCS Ca’ Granda Ospedale Maggiore Policlinico, Milan, Italy1Dermatology Unit, ASST Papa Giovanni XXIII Hospital, Bergamo, Italy2PhD Program in Molecular and Translational Medicine (DIMET), University of Milan-Bicocca, Milan, Italy3Clinical Dermatology Unit, San Gallicano Dermatological Institute IRCCS, Rome, Italy4Department of Dermatology, Gaetano Rummo Hospital, Benevento, Italy5Department of Biomedical Science and Human Oncology, Second Dermatologic Clinic, University of Turin, Turin, Italy6Dermatology Clinic, Department of Clinical Internal, Anesthesiological and Cardiovascular Sciences, Sapienza University, Rome, ItalySection of Dermatology, Department of Translational Medicine and Surgery, Catholic University of the Sacred Heart, Rome, ItalyDermatology Unit, Agostino Gemelli University Hospital, Rome, Italy7Department of Dermatology, Dermatology Unit Azienda Ospedaliera San Donato Milanese, Milan, Italy8Department of Medicine, Section of Dermatology and Venereology, University of Verona, Verona, ItalyDermatology, Department of Systems Medicine, University of Rome Tor Vergata, Rome, Italy9Department of Dermatology, University of Bari, Bari, Italy0Department of Dermatology, ASST Spedali Civili Hospital, Brescia, Italy9Department of Dermatology, University of Bari, Bari, Italy0Dermatology Unit, Fondazione IRCCS Ca’ Granda Ospedale Maggiore Policlinico, Milan, Italy1Department of Pathophysiology and Transplantation, Università degli Studi di Milano, Milan, Italy8Department of Medicine, Section of Dermatology and Venereology, University of Verona, Verona, Italy2Section of Dermatology, Department of Clinical Medicine and Surgery, University of Naples Federico II, Naples, ItalyUnit of Dermatology and Cosmetology, Vita-Salute San Raffaele University and Institute for Research and Care, Milan, ItalyDepartment of Clinical and Molecular Sciences—Dermatological Clinic, Università Politecnica delle Marche, Ancona, Italy3Clinical Dermatology Unit, San Gallicano Dermatological Institute IRCCS, Rome, ItalySection of Dermatology, Department of Health Sciences (DISSAL), IRCCS San Martino University Hospital, Genoa, Italy6Dermatology Clinic, Department of Clinical Internal, Anesthesiological and Cardiovascular Sciences, Sapienza University, Rome, Italy2Section of Dermatology, Department of Clinical Medicine and Surgery, University of Naples Federico II, Naples, Italy5Department of Biomedical Science and Human Oncology, Second Dermatologic Clinic, University of Turin, Turin, Italy6Dermatology Clinic, Department of Clinical Internal, Anesthesiological and Cardiovascular Sciences, Sapienza University, Rome, Italy3Department of Precision Medicine, Dermatology Unit, Università degli Studi della Campania L. Vanvitelli, Naples, Italy1Dermatology Unit, ASST Papa Giovanni XXIII Hospital, Bergamo, Italy0Department of Dermatology, ASST Spedali Civili Hospital, Brescia, Italy7Department of Dermatology, Dermatology Unit Azienda Ospedaliera San Donato Milanese, Milan, ItalyDermatology Unit, IRCCS Humanitas Research Hospital, Milan, ItalyDepartment of Biomedical Sciences, Humanitas University, Milan, ItalyIntroductionBimekizumab 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.https://www.frontiersin.org/articles/10.3389/fmed.2023.1243843/fullbiologicsbimekizumabpsoriasispsoriasis treatmentreal-life |
| spellingShingle | 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 Effectiveness and safety of bimekizumab for the treatment of plaque psoriasis: a real-life multicenter study—IL PSO (Italian landscape psoriasis) Frontiers in Medicine biologics bimekizumab psoriasis psoriasis treatment real-life |
| title | Effectiveness and safety of bimekizumab for the treatment of plaque psoriasis: a real-life multicenter study—IL PSO (Italian landscape psoriasis) |
| title_full | Effectiveness and safety of bimekizumab for the treatment of plaque psoriasis: a real-life multicenter study—IL PSO (Italian landscape psoriasis) |
| title_fullStr | Effectiveness and safety of bimekizumab for the treatment of plaque psoriasis: a real-life multicenter study—IL PSO (Italian landscape psoriasis) |
| title_full_unstemmed | Effectiveness and safety of bimekizumab for the treatment of plaque psoriasis: a real-life multicenter study—IL PSO (Italian landscape psoriasis) |
| title_short | Effectiveness and safety of bimekizumab for the treatment of plaque psoriasis: a real-life multicenter study—IL PSO (Italian landscape psoriasis) |
| title_sort | effectiveness and safety of bimekizumab for the treatment of plaque psoriasis a real life multicenter study il pso italian landscape psoriasis |
| topic | biologics bimekizumab psoriasis psoriasis treatment real-life |
| url | https://www.frontiersin.org/articles/10.3389/fmed.2023.1243843/full |
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